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What is causing her abdominal pain?
CASE: A healthy, nulliparous, 20-year-old woman visits her ObGyn to report a 2-day history of right lower quadrant pain. Her last menstrual period was appropriately timed and normal. She is not sexually active. Upon examination, she exhibits minimal left and right lower quadrant tenderness. Examination with the vaginal speculum reveals no vaginal or cervical abnormalities, and bimanual examination reveals a uterus of normal size, with cervical motion tenderness but no adnexal fullness or mass. For this reason, transvaginal ultrasound (TVUS) is performed. It reveals an enlarged, edematous appendix adjacent to a normal-appearing right ovary (FIGURE 1).
No uterine or ovarian pathology is noted. Because the appendix is enlarged on TVUS, Doppler interrogation is added, which shows abundant vascularity of the appendix (FIGURE 2).
What do these findings suggest?
Acute appendicitis is the most likely diagnosis, as both the physical findings and ultrasound imaging point to it. The patient is referred to a general surgeon, who examines her, noting that she is afebrile, with tenderness in the right lower quadrant. She exhibits localized guarding at McBurneys point, with mild rebound. There is no sign of organomegaly. Bowel sounds are normal, with no distention. The patient undergoes laparoscopy, which confirms the diagnosis. The appendix is resected successfully, and rupture is averted (FIGURE 3).
The patient is discharged home on the first postoperative day. At a follow-up visit 2 weeks later, she is fully recovered and has returned to full and normal activity.
Clinicians who are familiar with the appearance of an inflamed appendix on TVUS may be able to expedite the management of women with appendicitis, avoiding the potential delay, expense, and radiation exposure associated with computed tomography imaging of the abdomen and pelvis.
Acknowledgment
The authors are grateful to Grace J. Horton, RDMS, and Christine L. Bubier, AS, RT(R), RDMS, who generated the images in this case.
Do you have a DIAGNOSTIC IN-SIGHT?
Submit a query for your image-based case! [email protected]
CASE: A healthy, nulliparous, 20-year-old woman visits her ObGyn to report a 2-day history of right lower quadrant pain. Her last menstrual period was appropriately timed and normal. She is not sexually active. Upon examination, she exhibits minimal left and right lower quadrant tenderness. Examination with the vaginal speculum reveals no vaginal or cervical abnormalities, and bimanual examination reveals a uterus of normal size, with cervical motion tenderness but no adnexal fullness or mass. For this reason, transvaginal ultrasound (TVUS) is performed. It reveals an enlarged, edematous appendix adjacent to a normal-appearing right ovary (FIGURE 1).
No uterine or ovarian pathology is noted. Because the appendix is enlarged on TVUS, Doppler interrogation is added, which shows abundant vascularity of the appendix (FIGURE 2).
What do these findings suggest?
Acute appendicitis is the most likely diagnosis, as both the physical findings and ultrasound imaging point to it. The patient is referred to a general surgeon, who examines her, noting that she is afebrile, with tenderness in the right lower quadrant. She exhibits localized guarding at McBurneys point, with mild rebound. There is no sign of organomegaly. Bowel sounds are normal, with no distention. The patient undergoes laparoscopy, which confirms the diagnosis. The appendix is resected successfully, and rupture is averted (FIGURE 3).
The patient is discharged home on the first postoperative day. At a follow-up visit 2 weeks later, she is fully recovered and has returned to full and normal activity.
Clinicians who are familiar with the appearance of an inflamed appendix on TVUS may be able to expedite the management of women with appendicitis, avoiding the potential delay, expense, and radiation exposure associated with computed tomography imaging of the abdomen and pelvis.
Acknowledgment
The authors are grateful to Grace J. Horton, RDMS, and Christine L. Bubier, AS, RT(R), RDMS, who generated the images in this case.
Do you have a DIAGNOSTIC IN-SIGHT?
Submit a query for your image-based case! [email protected]
CASE: A healthy, nulliparous, 20-year-old woman visits her ObGyn to report a 2-day history of right lower quadrant pain. Her last menstrual period was appropriately timed and normal. She is not sexually active. Upon examination, she exhibits minimal left and right lower quadrant tenderness. Examination with the vaginal speculum reveals no vaginal or cervical abnormalities, and bimanual examination reveals a uterus of normal size, with cervical motion tenderness but no adnexal fullness or mass. For this reason, transvaginal ultrasound (TVUS) is performed. It reveals an enlarged, edematous appendix adjacent to a normal-appearing right ovary (FIGURE 1).
No uterine or ovarian pathology is noted. Because the appendix is enlarged on TVUS, Doppler interrogation is added, which shows abundant vascularity of the appendix (FIGURE 2).
What do these findings suggest?
Acute appendicitis is the most likely diagnosis, as both the physical findings and ultrasound imaging point to it. The patient is referred to a general surgeon, who examines her, noting that she is afebrile, with tenderness in the right lower quadrant. She exhibits localized guarding at McBurneys point, with mild rebound. There is no sign of organomegaly. Bowel sounds are normal, with no distention. The patient undergoes laparoscopy, which confirms the diagnosis. The appendix is resected successfully, and rupture is averted (FIGURE 3).
The patient is discharged home on the first postoperative day. At a follow-up visit 2 weeks later, she is fully recovered and has returned to full and normal activity.
Clinicians who are familiar with the appearance of an inflamed appendix on TVUS may be able to expedite the management of women with appendicitis, avoiding the potential delay, expense, and radiation exposure associated with computed tomography imaging of the abdomen and pelvis.
Acknowledgment
The authors are grateful to Grace J. Horton, RDMS, and Christine L. Bubier, AS, RT(R), RDMS, who generated the images in this case.
Do you have a DIAGNOSTIC IN-SIGHT?
Submit a query for your image-based case! [email protected]
Acute Compartment Syndrome: To Save a Limb
Acute compartment syndrome (ACS) is a condition in which elevated pressures in the confined space of a closed fascial compartment lead to vascular compromise. Typically, ACS develops in the distal extremities after a traumatic event, such as a fracture, crush, or burn injury. A dangerous cycle ensues, involving increased compartmental pressure, decreased tissue perfusion, and continuing ischemia; fluids leak from the vasculature, perpetuating the process.1
Diagnosis of ACS requires a high level of clinical suspicion combined with a keen understanding of the risk factors for ACS and its pathophysiology, as well as astute awareness of the subtle clinical exam findings that usually accompany objective pressure measurements. Though most common in the extremities, ACS may also develop in the buttock, pelvis, or abdominal or spinal musculature.2-5
Prompt recognition and management of ACS are critical: This condition is considered a surgical emergency requiring immediate attention. Urgent decompression by fasciotomy is the definitive treatment6—an essential intervention to prevent critical tissue ischemia and necrosis. Failure to release the fascia in a timely manner can result in poor outcomes for patients, including but not limited to chronic pain, paralysis, sensory or motor deficits, loss of limb, deformity, and renal failure secondary to rhabdomyolysis.7,8
Clinical assessment and severity of injury are the two main factors that lead to prompt diagnosis and treatment of ACS. However, distracting injuries or an unconsciousness patient may interfere with the assessment, decreasing its accuracy.7 Heightened awareness of ACS is paramount so that clinicians can better recognize the condition before complications arise.
EPIDEMIOLOGY
ACS is typically associated with long bone injuries after significant trauma or crush injuries (eg, in a motor vehicle collision). Less often, severe burns, gun shot wounds, snake bites, poor anticoagulation, prolonged surgery (including procedures involving prolonged elevation of a limb),9 nephrotic syndrome, IV infiltrations, and other volume-expanding pathologies can present a similar risk.10-15 Essentially, ACS is a self-perpetuating process resulting from either increased compartmental content (eg, bleeding, edema) or reduced compartment size (eg, tight casting, burns).7,16
Ninety percent of cases of ACS in the extremities occur in men,15 and males younger than 35 have the greatest incidence of posttraumatic ACS.15,17,18 Although fractures account for nearly 70% of confirmed cases of ACS, soft-tissue injuries (particularly vascular injuries15) are also associated with ACS.18 Clinicians should be aware of a key misconception: that open fractures relieve intracompartmental pressure, reducing the risk for ACS. Rather, the damage and inflammation that occur in open fractures pose the same risk for ACS as do closed fractures.15
PATIENT PRESENTATION
A key consideration, in addition to the history and mechanism of injury or illness, is that patient’s description of the pain: The conscious patient will complain of pain that worsens progressively over time and that usually seems out of proportion to the physical exam findings or apparent injury.19 For this reason, serial assessments are recommended; worsening pain is indicative of rapid evolution of ACS, with the possibility of irreversible necrosis.20
Pain with passive stretch is an excellent indicator that the pathology is progressing.2 The “classic P” signs and symptoms of ACS are progressively later findings that represent markedly significant ischemia and injury already in progress: paresthesia, paresis/paralysis, poikilothermia (the inability of the patient to maintain a constant core temperature), pulselessness, and pallor.17
Diminishment of pain suggests a poor prognosis, as this indicates that the tissue is likely nonviable and necrotic by that point.1
Clinicians must be mindful that, in patients with central or peripheral nerve deficits or in those who have undergone nerve blocks or regional anesthesia, pain may be absent; in these instances, the risk for delayed diagnosis is increased.14,21 Furthermore, pain tolerance varies among patients, and distracting injuries may also cloud the clinical picture.
The diagnosis of ACS is not easily made. Thus, clinical suspicion should be elevated in any high-energy scenario: an extensive burn, overly restrictive casting, or volume-expanding disorder—especially in patients who present with pain that is out of proportion to the injury or is worsening progressively.1,7
PHYSICAL EXAMINATION
Physical examination and assessment should be repeated every two to four hours. The examining clinician should focus on pain characteristics, the skin, and the “classic P” signs mentioned above. Marked tenderness out of proportion to the injury, unmanageable pain, and pain on passive movement of the limb are the strongest indicators of developing ACS. These findings are nearly universal in the conscious patient, but they can be confused with primary pain of the injury itself. Additional findings of sensory or motor impairments may help raise the clinician’s suspicion for ACS but are nonspecific.1,7,23 Palpable tenseness is a common observation in ACS, but a clinician’s subjective measurement of skin firmness has little value as an objective strategy.22 Absence of distal pulses, decreased skin temperature, and pallor are very late signs that pressures are sufficiently high to cause complete arterial occlusion.20 Thus, clinicians should not wait for absent pulses or pallor to begin treatment. Suspicion for ACS should arise as soon as pain associated with trauma or surgery intensifies or becomes unmanageable.
DIAGNOSTIC TOOLS
ACS is diagnosed based on the previously mentioned clinical signs, along with objective evidence of decreased tissue perfusion in the affected limbs.24 Direct intracompartmental pressure measurements, obtained using a needle- or catheter-based technique, are the most common means of identifying ACS.7 However, near infrared spectroscopy and infrared imaging have also been found helpful.7, 25
Direct Intracompartmental Pressure Monitoring
Supported by clinical findings, direct measurement of the intracompartmental pressure (ICP) using a needle transducer is the most accurate method for detecting ACS and guiding treatment choices. Several measurement options are available, including a handheld needle manometer, which records single-pressure readings, or a wick or slit catheter, which can record continuous pressures.13 The choice between devices is based on facility/provider preference, as any commercial pressure device can be used with similar accuracies. When no such device is available, an 18-gauge needle with a set-up resembling an arterial line is another option.1
When using these instruments, it is essential for the provider to implement proper sterile technique and to record pressures from compartments within a 5-cm radius of the injury site.17 Furthermore, clinicians should be aware that the ICP can vary greatly and that tolerance to increased pressure varies with the patient’s diastolic blood pressure.
Normal capillary perfusion pressure (diastolic blood pressure minus compartment pressure) is approximately 30 mm Hg. Therefore, absolute ICP readings above 30 mm Hg can be diagnostic of ACS and indicative of fasciotomy. Likewise, a perfusion pressure below 30 mm Hg is also diagnostic. Based on consensus, either calculation can be used.16,17
Infrared Spectroscopy and Imaging
Barker and colleagues7 describe use of near infrared spectroscopy (NIRS) as a method to diagnose lower-extremity ACS. Noninvasive skin probes can detect the absorption spectra of mixed venous hemoglobin levels beneath the skin to determine oxygen saturation (StO2). StO2 measured by NIRS is location dependent, enabling the clinician to monitor oxygenation levels in any illuminated tissue. NIRS has great potential for use in confirming a diagnosis of ACS since decreased perfusion pressure from elevated ICP correlates well with decreased StO2. However, this technique has limitations that currently prevent its widespread use as a diagnostic tool.7
Use of noninvasive infrared imaging has also been investigated. Katz and colleagues25 describe the use of a long-wave infrared camera and thermographic imaging analysis software to detect differences in surface temperatures in patients’ limbs after blunt trauma. The researchers were able to correlate declines in temperature with decreased blood flow. They proposed that this modality be used to make the diagnosis of ACS before the development of muscle ischemia and necrosis. This software is still being investigated.25
Imaging Studies
CT or MRI can be helpful in identifying swelling, hematomas, or areas of necrosis, but their specificity is not sufficient to confirm elevated compartmental pressures24; additionally, MRI cannot distinguish between swelling resulting from soft-tissue injury and swelling in muscles affected by ACS.26, 27
Ultrasound also has potential as a diagnostic tool, as it helps clinicians visualize soft-tissue structures and assess the patency of large arteries and veins; the absence of venous outflow may suggest ACS. However, the efficacy of ultrasound in diagnosing ACS has proven inconsistent, and it is not recommended over direct ICP measurements. Instead, ultrasound can be relied on as an adjunctive modality.13
Blood Tests
Laboratory tests cannot contribute toward the diagnosis of ACS, but assessment of renal function and skeletal muscle breakdown is important to identify potential complications of ACS. Obtaining baseline levels in blood urea nitrogen and creatinine will help identify changes in kidney function, while potassium, urates, creatine phosphokinase (CPK), and myoglobin can be measured to assess for muscle breakdown. Findings of myoglobinuria with elevated CPK are strongly indicative of rhabdomyolysis, which can easily precipitate acute renal failure.8
Results from a complete blood count or prothrombin time/partial thromboplastin time may facilitate monitoring for blood loss or identification of contributing bleeding disorders. Because surgery remains the definitive treatment for ACS, a type and screen is essential in the workup, as blood products and transfusion are likely to be required during treatment.
MANAGEMENT
Fasciotomy remains the standard of care for patients presenting with the clinical signs and symptoms of increased compartment pressure consistent with ACS.16 Researchers engaged in animal studies and human case reports have shown that fasciotomy must be performed within six hours of injury to prevent adverse outcomes.8,16,28
As definitive treatment for ACS, a complete fasciotomy of all compartments in the vicinity of the injury should be performed. The most effective approach for fasciotomy consists of two long skin incisions (ie, double-incision radical dissection, to prevent concomitant increased pressure within the boundary of the skin), on opposite aspects of the affected limb, to ensure that all compartmental fascia can be decompressed.17,26,28
Delayed primary intention on postop day 5 is the preferred method for fasciotomy wound closure. Wounds should remain open to allow limb swelling to subside. In severe cases, when delayed primary intention cannot be performed in the window of time described, split-thickness skin grafts can be used. Postoperative wounds should be packed open with bulky dressings and changed daily. Negative-pressure wound dressings can be used for improved and accelerated wound closure.29
In the setting of ACS or limb ischemia, it is important to consider the possibility that tissue destruction will lead to significant myoglobinuria and potentially rhabdomyolysis.8 In patients presenting with crush injuries, or trauma patients who experience a significant rise in creatine kinase, the kidneys should be protected via extracellular resuscitation with isotonic fluids. The goal of resuscitation is to maintain urinary output of at least 200 mL/h to prevent renal failure.29
PATIENT EDUCATION
Patients who undergo fasciotomy within 12 hours of onset of signs and symptoms of ACS retain normal limb function in 68% of cases. However, this outcome falls to 8% if fasciotomy is delayed longer than 12 hours.30 Patients should understand that return to normal function usually takes two to three months and requires active participation by the patient. Furthermore, 20% of patients have some motor and sensory deficits at one year postfasciotomy.17
FOLLOW-UP
After fasciotomy, patients will require adequate pain control and an extensive rehabilitation program. Early physical therapy should progress slowly, with focus on range-of-motion and stretching exercises. Once patients have regained the ability to ambulate, resistance exercises and moderate exercise activities should be implemented to return them to their regular activities.31
CONCLUSION
ACS figures significantly in the long-term morbidity and mortality associated with trauma. Clinical research and laboratory science have indicated that ACS must be treated within six hours to prevent life-long deformity and disability. New diagnostic and therapeutic approaches must be investigated to improve outcomes. The most widely accepted surgical approach is the double-incision radical dissection of all fascia within the affected limb.
Appropriate management must include protection of the patient’s kidneys, given the risk for rhabdomyolysis, as well as extensive postoperative physical therapy. Given the invasive treatment required for ACS, progression toward full recovery is a long and difficult process. However, with prompt recognition and early intervention, full return to normal function is possible, with little to no deformity or dysfunction.
REFERECNES
1. Murdock M, Murdoch MM. Compartment syndrome: a review of the literature. Clin Podiatr Med Surg. 2012;29:301-310, viii.
2. Osteen KD, Haque SH. Bilateral gluteal compartment syndrome following right total knee revision: a case report. Ochsner J. 2012;12:141-144.
3. Paryavi E, Jobin CM, Ludwig SC, et al. Acute exertional lumbar paraspinal compartment syndrome. Spine. 2010;35:E1529-E1533.
4. Bosch U, Tscherne H. The pelvic compartment syndrome. Arch Ortho Trauma Surg. 1992;111:314-317.
5. Maeda A, Wakabayashi K, Suzuki H. Acute limb ischemia due to abdominal compartment syndrome. Catheter Cardiovasc Interv. 2013 Jun 19. [Epub ahead of print]
6. Masquelet AC. Acute compartment syndrome of the leg: pressure measurement and fasciotomy. Orthop Trumatol Surg Res. 2010;96:913-917.
7. Barker T, Midwinter M, Porter K. The diagnosis of acute lower limb compartment syndrome: applications of near infrared spectroscopy. Trauma. 2011;13:125-136.
8. Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med. 2009;361:62-72.
9. Karmaniolou I, Staikou C. Compartment syndrome as a complication of the lithotomy position. West Indian Med J. 2010;59:698-701.
10. Pietrangiolillo Z, Frassoldati R, Leonelli V, et al. Compartment syndrome after viper-bite in toddler: case report and review of literature. Acta Biomed. 2012;83:44-50.
11. Kakkar R, Ellis M, Fearon PV. Compartment syndrome of the thigh as a complication of anticoagulant therapy in a patient with a left ventricular assist device (Berlin Heart). Gen Thorac Cardiovasc Surg. 2010;58: 477-479.
12. Balogh ZJ, Leppäniemi A. Patient populations at risk for intra-abdominal hypertension and abdominal compartment syndrome. Am Surg. 2011;77 suppl 1:S12-S16.
13. Zimmerman DC, Kapoor T, Elfond M, Scott P. Spontaneous compartment syndrome of the upper arm in a patient receiving anticoagulation therapy. J Emerg Med. 2013;44:e53-e56.
14. Olson SA. Acute compartment syndrome in lower extremity musculoskeletal trauma. J Am Acad Orthop Surg. 2005;13(7):436-444.
15. Branco BC, Inaba K, Barmparas G, et al. Incidence and predictors for the need for fasciotomy after extremity trauma: a 10-year review in a mature level I trauma centre. Injury. 2011;42:1157-1163.
16. Wall CJ, Richardson, Lowe AJ, et al. Survey of management of acute, traumatic compartment syndrome of the leg in Australia. ANZ J Surg. 2007;77:733-737.
17. Wall CJ, Lynch J, Harris IA, et al; Liverpool (Sydney) and Royal Melbourne Hospitals. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma. ANZ J Surg. 2010;80:151-156.
18. McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome: who is at risk? J Bone Joint Surg. 2000;82:200-203.
19. Khan M, Hodkinson SL. Acute compartment syndrome—presenting as severe pain in an extremity out of proportion with the injury. J R Army Med Corps. 1997;143:165-166.
20. Percival TJ, White JM, Ricci MA. Compartment syndrome in the setting of vascular injury. Perspect Vasc Surg Endovasc Ther. 2011;23(2):119-124.
21. Badhe S, Baiju D, Elliot R, et al. The ‘silent’ compartment syndrome. Injury. 2009;40:220-222.
22. Shuler FD, Dietz MJ. Physicians’ ability to manually detect isolated elevations in leg intracompartmental pressure. J Bone Joint Surg Am. 2010;92:361-367.
23. Taylor RM, Sullivan MP, Mehta S. Acute compartment syndrome: obtaining diagnosis, providing treatment, and minimizing medicolegal risk. Curr Rev Musculoskelet Med. 2012;5(3):206-213.
24. McDonald S, Bearcroft P. Compartment syndromes. Semin Musculoskelet Radiol. 2010;14:236-244.
25. Katz LM, Nauriyal V, Nagaraj S, et al. Infrared imaging of trauma patients for detection of acute compartment syndrome of the leg. Crit Care Med. 2008;36:1756-1761.
26. Shadgan B, Menon M, Sanders D, et al. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010;53:329-334.
27. Rominger M, Lukosch C, Bachmann G, et al. Compartment syndrome: value of MR imaging. Radiology. 1995;197:296.
28. Kashuk JL, Moore EE, Pinski S, et al. Lower extremity compartment syndrome in the acute care surgery paradigm: safety lessons learned. Patient Saf Surg. 2009;3(1):11.
29. Rasul AT Jr. Acute compartment syndrome (2011). emedicine.medscape.com/article/307668-overview#showall. Accessed June 25, 2013.
30. Sheridan GW, Matsen FA 3rd. Fasciotomy in the treatment of the acute compartment syndrome. J Bone Joint Surg Am. 1976;58(1):112-115.
31. Schubert AG. Exertional compartment syndrome: review of the literature and proposed rehabilitation guidelines following surgical release. Intern J Sports Phys Ther. 2011;6:126-141.
Acute compartment syndrome (ACS) is a condition in which elevated pressures in the confined space of a closed fascial compartment lead to vascular compromise. Typically, ACS develops in the distal extremities after a traumatic event, such as a fracture, crush, or burn injury. A dangerous cycle ensues, involving increased compartmental pressure, decreased tissue perfusion, and continuing ischemia; fluids leak from the vasculature, perpetuating the process.1
Diagnosis of ACS requires a high level of clinical suspicion combined with a keen understanding of the risk factors for ACS and its pathophysiology, as well as astute awareness of the subtle clinical exam findings that usually accompany objective pressure measurements. Though most common in the extremities, ACS may also develop in the buttock, pelvis, or abdominal or spinal musculature.2-5
Prompt recognition and management of ACS are critical: This condition is considered a surgical emergency requiring immediate attention. Urgent decompression by fasciotomy is the definitive treatment6—an essential intervention to prevent critical tissue ischemia and necrosis. Failure to release the fascia in a timely manner can result in poor outcomes for patients, including but not limited to chronic pain, paralysis, sensory or motor deficits, loss of limb, deformity, and renal failure secondary to rhabdomyolysis.7,8
Clinical assessment and severity of injury are the two main factors that lead to prompt diagnosis and treatment of ACS. However, distracting injuries or an unconsciousness patient may interfere with the assessment, decreasing its accuracy.7 Heightened awareness of ACS is paramount so that clinicians can better recognize the condition before complications arise.
EPIDEMIOLOGY
ACS is typically associated with long bone injuries after significant trauma or crush injuries (eg, in a motor vehicle collision). Less often, severe burns, gun shot wounds, snake bites, poor anticoagulation, prolonged surgery (including procedures involving prolonged elevation of a limb),9 nephrotic syndrome, IV infiltrations, and other volume-expanding pathologies can present a similar risk.10-15 Essentially, ACS is a self-perpetuating process resulting from either increased compartmental content (eg, bleeding, edema) or reduced compartment size (eg, tight casting, burns).7,16
Ninety percent of cases of ACS in the extremities occur in men,15 and males younger than 35 have the greatest incidence of posttraumatic ACS.15,17,18 Although fractures account for nearly 70% of confirmed cases of ACS, soft-tissue injuries (particularly vascular injuries15) are also associated with ACS.18 Clinicians should be aware of a key misconception: that open fractures relieve intracompartmental pressure, reducing the risk for ACS. Rather, the damage and inflammation that occur in open fractures pose the same risk for ACS as do closed fractures.15
PATIENT PRESENTATION
A key consideration, in addition to the history and mechanism of injury or illness, is that patient’s description of the pain: The conscious patient will complain of pain that worsens progressively over time and that usually seems out of proportion to the physical exam findings or apparent injury.19 For this reason, serial assessments are recommended; worsening pain is indicative of rapid evolution of ACS, with the possibility of irreversible necrosis.20
Pain with passive stretch is an excellent indicator that the pathology is progressing.2 The “classic P” signs and symptoms of ACS are progressively later findings that represent markedly significant ischemia and injury already in progress: paresthesia, paresis/paralysis, poikilothermia (the inability of the patient to maintain a constant core temperature), pulselessness, and pallor.17
Diminishment of pain suggests a poor prognosis, as this indicates that the tissue is likely nonviable and necrotic by that point.1
Clinicians must be mindful that, in patients with central or peripheral nerve deficits or in those who have undergone nerve blocks or regional anesthesia, pain may be absent; in these instances, the risk for delayed diagnosis is increased.14,21 Furthermore, pain tolerance varies among patients, and distracting injuries may also cloud the clinical picture.
The diagnosis of ACS is not easily made. Thus, clinical suspicion should be elevated in any high-energy scenario: an extensive burn, overly restrictive casting, or volume-expanding disorder—especially in patients who present with pain that is out of proportion to the injury or is worsening progressively.1,7
PHYSICAL EXAMINATION
Physical examination and assessment should be repeated every two to four hours. The examining clinician should focus on pain characteristics, the skin, and the “classic P” signs mentioned above. Marked tenderness out of proportion to the injury, unmanageable pain, and pain on passive movement of the limb are the strongest indicators of developing ACS. These findings are nearly universal in the conscious patient, but they can be confused with primary pain of the injury itself. Additional findings of sensory or motor impairments may help raise the clinician’s suspicion for ACS but are nonspecific.1,7,23 Palpable tenseness is a common observation in ACS, but a clinician’s subjective measurement of skin firmness has little value as an objective strategy.22 Absence of distal pulses, decreased skin temperature, and pallor are very late signs that pressures are sufficiently high to cause complete arterial occlusion.20 Thus, clinicians should not wait for absent pulses or pallor to begin treatment. Suspicion for ACS should arise as soon as pain associated with trauma or surgery intensifies or becomes unmanageable.
DIAGNOSTIC TOOLS
ACS is diagnosed based on the previously mentioned clinical signs, along with objective evidence of decreased tissue perfusion in the affected limbs.24 Direct intracompartmental pressure measurements, obtained using a needle- or catheter-based technique, are the most common means of identifying ACS.7 However, near infrared spectroscopy and infrared imaging have also been found helpful.7, 25
Direct Intracompartmental Pressure Monitoring
Supported by clinical findings, direct measurement of the intracompartmental pressure (ICP) using a needle transducer is the most accurate method for detecting ACS and guiding treatment choices. Several measurement options are available, including a handheld needle manometer, which records single-pressure readings, or a wick or slit catheter, which can record continuous pressures.13 The choice between devices is based on facility/provider preference, as any commercial pressure device can be used with similar accuracies. When no such device is available, an 18-gauge needle with a set-up resembling an arterial line is another option.1
When using these instruments, it is essential for the provider to implement proper sterile technique and to record pressures from compartments within a 5-cm radius of the injury site.17 Furthermore, clinicians should be aware that the ICP can vary greatly and that tolerance to increased pressure varies with the patient’s diastolic blood pressure.
Normal capillary perfusion pressure (diastolic blood pressure minus compartment pressure) is approximately 30 mm Hg. Therefore, absolute ICP readings above 30 mm Hg can be diagnostic of ACS and indicative of fasciotomy. Likewise, a perfusion pressure below 30 mm Hg is also diagnostic. Based on consensus, either calculation can be used.16,17
Infrared Spectroscopy and Imaging
Barker and colleagues7 describe use of near infrared spectroscopy (NIRS) as a method to diagnose lower-extremity ACS. Noninvasive skin probes can detect the absorption spectra of mixed venous hemoglobin levels beneath the skin to determine oxygen saturation (StO2). StO2 measured by NIRS is location dependent, enabling the clinician to monitor oxygenation levels in any illuminated tissue. NIRS has great potential for use in confirming a diagnosis of ACS since decreased perfusion pressure from elevated ICP correlates well with decreased StO2. However, this technique has limitations that currently prevent its widespread use as a diagnostic tool.7
Use of noninvasive infrared imaging has also been investigated. Katz and colleagues25 describe the use of a long-wave infrared camera and thermographic imaging analysis software to detect differences in surface temperatures in patients’ limbs after blunt trauma. The researchers were able to correlate declines in temperature with decreased blood flow. They proposed that this modality be used to make the diagnosis of ACS before the development of muscle ischemia and necrosis. This software is still being investigated.25
Imaging Studies
CT or MRI can be helpful in identifying swelling, hematomas, or areas of necrosis, but their specificity is not sufficient to confirm elevated compartmental pressures24; additionally, MRI cannot distinguish between swelling resulting from soft-tissue injury and swelling in muscles affected by ACS.26, 27
Ultrasound also has potential as a diagnostic tool, as it helps clinicians visualize soft-tissue structures and assess the patency of large arteries and veins; the absence of venous outflow may suggest ACS. However, the efficacy of ultrasound in diagnosing ACS has proven inconsistent, and it is not recommended over direct ICP measurements. Instead, ultrasound can be relied on as an adjunctive modality.13
Blood Tests
Laboratory tests cannot contribute toward the diagnosis of ACS, but assessment of renal function and skeletal muscle breakdown is important to identify potential complications of ACS. Obtaining baseline levels in blood urea nitrogen and creatinine will help identify changes in kidney function, while potassium, urates, creatine phosphokinase (CPK), and myoglobin can be measured to assess for muscle breakdown. Findings of myoglobinuria with elevated CPK are strongly indicative of rhabdomyolysis, which can easily precipitate acute renal failure.8
Results from a complete blood count or prothrombin time/partial thromboplastin time may facilitate monitoring for blood loss or identification of contributing bleeding disorders. Because surgery remains the definitive treatment for ACS, a type and screen is essential in the workup, as blood products and transfusion are likely to be required during treatment.
MANAGEMENT
Fasciotomy remains the standard of care for patients presenting with the clinical signs and symptoms of increased compartment pressure consistent with ACS.16 Researchers engaged in animal studies and human case reports have shown that fasciotomy must be performed within six hours of injury to prevent adverse outcomes.8,16,28
As definitive treatment for ACS, a complete fasciotomy of all compartments in the vicinity of the injury should be performed. The most effective approach for fasciotomy consists of two long skin incisions (ie, double-incision radical dissection, to prevent concomitant increased pressure within the boundary of the skin), on opposite aspects of the affected limb, to ensure that all compartmental fascia can be decompressed.17,26,28
Delayed primary intention on postop day 5 is the preferred method for fasciotomy wound closure. Wounds should remain open to allow limb swelling to subside. In severe cases, when delayed primary intention cannot be performed in the window of time described, split-thickness skin grafts can be used. Postoperative wounds should be packed open with bulky dressings and changed daily. Negative-pressure wound dressings can be used for improved and accelerated wound closure.29
In the setting of ACS or limb ischemia, it is important to consider the possibility that tissue destruction will lead to significant myoglobinuria and potentially rhabdomyolysis.8 In patients presenting with crush injuries, or trauma patients who experience a significant rise in creatine kinase, the kidneys should be protected via extracellular resuscitation with isotonic fluids. The goal of resuscitation is to maintain urinary output of at least 200 mL/h to prevent renal failure.29
PATIENT EDUCATION
Patients who undergo fasciotomy within 12 hours of onset of signs and symptoms of ACS retain normal limb function in 68% of cases. However, this outcome falls to 8% if fasciotomy is delayed longer than 12 hours.30 Patients should understand that return to normal function usually takes two to three months and requires active participation by the patient. Furthermore, 20% of patients have some motor and sensory deficits at one year postfasciotomy.17
FOLLOW-UP
After fasciotomy, patients will require adequate pain control and an extensive rehabilitation program. Early physical therapy should progress slowly, with focus on range-of-motion and stretching exercises. Once patients have regained the ability to ambulate, resistance exercises and moderate exercise activities should be implemented to return them to their regular activities.31
CONCLUSION
ACS figures significantly in the long-term morbidity and mortality associated with trauma. Clinical research and laboratory science have indicated that ACS must be treated within six hours to prevent life-long deformity and disability. New diagnostic and therapeutic approaches must be investigated to improve outcomes. The most widely accepted surgical approach is the double-incision radical dissection of all fascia within the affected limb.
Appropriate management must include protection of the patient’s kidneys, given the risk for rhabdomyolysis, as well as extensive postoperative physical therapy. Given the invasive treatment required for ACS, progression toward full recovery is a long and difficult process. However, with prompt recognition and early intervention, full return to normal function is possible, with little to no deformity or dysfunction.
REFERECNES
1. Murdock M, Murdoch MM. Compartment syndrome: a review of the literature. Clin Podiatr Med Surg. 2012;29:301-310, viii.
2. Osteen KD, Haque SH. Bilateral gluteal compartment syndrome following right total knee revision: a case report. Ochsner J. 2012;12:141-144.
3. Paryavi E, Jobin CM, Ludwig SC, et al. Acute exertional lumbar paraspinal compartment syndrome. Spine. 2010;35:E1529-E1533.
4. Bosch U, Tscherne H. The pelvic compartment syndrome. Arch Ortho Trauma Surg. 1992;111:314-317.
5. Maeda A, Wakabayashi K, Suzuki H. Acute limb ischemia due to abdominal compartment syndrome. Catheter Cardiovasc Interv. 2013 Jun 19. [Epub ahead of print]
6. Masquelet AC. Acute compartment syndrome of the leg: pressure measurement and fasciotomy. Orthop Trumatol Surg Res. 2010;96:913-917.
7. Barker T, Midwinter M, Porter K. The diagnosis of acute lower limb compartment syndrome: applications of near infrared spectroscopy. Trauma. 2011;13:125-136.
8. Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med. 2009;361:62-72.
9. Karmaniolou I, Staikou C. Compartment syndrome as a complication of the lithotomy position. West Indian Med J. 2010;59:698-701.
10. Pietrangiolillo Z, Frassoldati R, Leonelli V, et al. Compartment syndrome after viper-bite in toddler: case report and review of literature. Acta Biomed. 2012;83:44-50.
11. Kakkar R, Ellis M, Fearon PV. Compartment syndrome of the thigh as a complication of anticoagulant therapy in a patient with a left ventricular assist device (Berlin Heart). Gen Thorac Cardiovasc Surg. 2010;58: 477-479.
12. Balogh ZJ, Leppäniemi A. Patient populations at risk for intra-abdominal hypertension and abdominal compartment syndrome. Am Surg. 2011;77 suppl 1:S12-S16.
13. Zimmerman DC, Kapoor T, Elfond M, Scott P. Spontaneous compartment syndrome of the upper arm in a patient receiving anticoagulation therapy. J Emerg Med. 2013;44:e53-e56.
14. Olson SA. Acute compartment syndrome in lower extremity musculoskeletal trauma. J Am Acad Orthop Surg. 2005;13(7):436-444.
15. Branco BC, Inaba K, Barmparas G, et al. Incidence and predictors for the need for fasciotomy after extremity trauma: a 10-year review in a mature level I trauma centre. Injury. 2011;42:1157-1163.
16. Wall CJ, Richardson, Lowe AJ, et al. Survey of management of acute, traumatic compartment syndrome of the leg in Australia. ANZ J Surg. 2007;77:733-737.
17. Wall CJ, Lynch J, Harris IA, et al; Liverpool (Sydney) and Royal Melbourne Hospitals. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma. ANZ J Surg. 2010;80:151-156.
18. McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome: who is at risk? J Bone Joint Surg. 2000;82:200-203.
19. Khan M, Hodkinson SL. Acute compartment syndrome—presenting as severe pain in an extremity out of proportion with the injury. J R Army Med Corps. 1997;143:165-166.
20. Percival TJ, White JM, Ricci MA. Compartment syndrome in the setting of vascular injury. Perspect Vasc Surg Endovasc Ther. 2011;23(2):119-124.
21. Badhe S, Baiju D, Elliot R, et al. The ‘silent’ compartment syndrome. Injury. 2009;40:220-222.
22. Shuler FD, Dietz MJ. Physicians’ ability to manually detect isolated elevations in leg intracompartmental pressure. J Bone Joint Surg Am. 2010;92:361-367.
23. Taylor RM, Sullivan MP, Mehta S. Acute compartment syndrome: obtaining diagnosis, providing treatment, and minimizing medicolegal risk. Curr Rev Musculoskelet Med. 2012;5(3):206-213.
24. McDonald S, Bearcroft P. Compartment syndromes. Semin Musculoskelet Radiol. 2010;14:236-244.
25. Katz LM, Nauriyal V, Nagaraj S, et al. Infrared imaging of trauma patients for detection of acute compartment syndrome of the leg. Crit Care Med. 2008;36:1756-1761.
26. Shadgan B, Menon M, Sanders D, et al. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010;53:329-334.
27. Rominger M, Lukosch C, Bachmann G, et al. Compartment syndrome: value of MR imaging. Radiology. 1995;197:296.
28. Kashuk JL, Moore EE, Pinski S, et al. Lower extremity compartment syndrome in the acute care surgery paradigm: safety lessons learned. Patient Saf Surg. 2009;3(1):11.
29. Rasul AT Jr. Acute compartment syndrome (2011). emedicine.medscape.com/article/307668-overview#showall. Accessed June 25, 2013.
30. Sheridan GW, Matsen FA 3rd. Fasciotomy in the treatment of the acute compartment syndrome. J Bone Joint Surg Am. 1976;58(1):112-115.
31. Schubert AG. Exertional compartment syndrome: review of the literature and proposed rehabilitation guidelines following surgical release. Intern J Sports Phys Ther. 2011;6:126-141.
Acute compartment syndrome (ACS) is a condition in which elevated pressures in the confined space of a closed fascial compartment lead to vascular compromise. Typically, ACS develops in the distal extremities after a traumatic event, such as a fracture, crush, or burn injury. A dangerous cycle ensues, involving increased compartmental pressure, decreased tissue perfusion, and continuing ischemia; fluids leak from the vasculature, perpetuating the process.1
Diagnosis of ACS requires a high level of clinical suspicion combined with a keen understanding of the risk factors for ACS and its pathophysiology, as well as astute awareness of the subtle clinical exam findings that usually accompany objective pressure measurements. Though most common in the extremities, ACS may also develop in the buttock, pelvis, or abdominal or spinal musculature.2-5
Prompt recognition and management of ACS are critical: This condition is considered a surgical emergency requiring immediate attention. Urgent decompression by fasciotomy is the definitive treatment6—an essential intervention to prevent critical tissue ischemia and necrosis. Failure to release the fascia in a timely manner can result in poor outcomes for patients, including but not limited to chronic pain, paralysis, sensory or motor deficits, loss of limb, deformity, and renal failure secondary to rhabdomyolysis.7,8
Clinical assessment and severity of injury are the two main factors that lead to prompt diagnosis and treatment of ACS. However, distracting injuries or an unconsciousness patient may interfere with the assessment, decreasing its accuracy.7 Heightened awareness of ACS is paramount so that clinicians can better recognize the condition before complications arise.
EPIDEMIOLOGY
ACS is typically associated with long bone injuries after significant trauma or crush injuries (eg, in a motor vehicle collision). Less often, severe burns, gun shot wounds, snake bites, poor anticoagulation, prolonged surgery (including procedures involving prolonged elevation of a limb),9 nephrotic syndrome, IV infiltrations, and other volume-expanding pathologies can present a similar risk.10-15 Essentially, ACS is a self-perpetuating process resulting from either increased compartmental content (eg, bleeding, edema) or reduced compartment size (eg, tight casting, burns).7,16
Ninety percent of cases of ACS in the extremities occur in men,15 and males younger than 35 have the greatest incidence of posttraumatic ACS.15,17,18 Although fractures account for nearly 70% of confirmed cases of ACS, soft-tissue injuries (particularly vascular injuries15) are also associated with ACS.18 Clinicians should be aware of a key misconception: that open fractures relieve intracompartmental pressure, reducing the risk for ACS. Rather, the damage and inflammation that occur in open fractures pose the same risk for ACS as do closed fractures.15
PATIENT PRESENTATION
A key consideration, in addition to the history and mechanism of injury or illness, is that patient’s description of the pain: The conscious patient will complain of pain that worsens progressively over time and that usually seems out of proportion to the physical exam findings or apparent injury.19 For this reason, serial assessments are recommended; worsening pain is indicative of rapid evolution of ACS, with the possibility of irreversible necrosis.20
Pain with passive stretch is an excellent indicator that the pathology is progressing.2 The “classic P” signs and symptoms of ACS are progressively later findings that represent markedly significant ischemia and injury already in progress: paresthesia, paresis/paralysis, poikilothermia (the inability of the patient to maintain a constant core temperature), pulselessness, and pallor.17
Diminishment of pain suggests a poor prognosis, as this indicates that the tissue is likely nonviable and necrotic by that point.1
Clinicians must be mindful that, in patients with central or peripheral nerve deficits or in those who have undergone nerve blocks or regional anesthesia, pain may be absent; in these instances, the risk for delayed diagnosis is increased.14,21 Furthermore, pain tolerance varies among patients, and distracting injuries may also cloud the clinical picture.
The diagnosis of ACS is not easily made. Thus, clinical suspicion should be elevated in any high-energy scenario: an extensive burn, overly restrictive casting, or volume-expanding disorder—especially in patients who present with pain that is out of proportion to the injury or is worsening progressively.1,7
PHYSICAL EXAMINATION
Physical examination and assessment should be repeated every two to four hours. The examining clinician should focus on pain characteristics, the skin, and the “classic P” signs mentioned above. Marked tenderness out of proportion to the injury, unmanageable pain, and pain on passive movement of the limb are the strongest indicators of developing ACS. These findings are nearly universal in the conscious patient, but they can be confused with primary pain of the injury itself. Additional findings of sensory or motor impairments may help raise the clinician’s suspicion for ACS but are nonspecific.1,7,23 Palpable tenseness is a common observation in ACS, but a clinician’s subjective measurement of skin firmness has little value as an objective strategy.22 Absence of distal pulses, decreased skin temperature, and pallor are very late signs that pressures are sufficiently high to cause complete arterial occlusion.20 Thus, clinicians should not wait for absent pulses or pallor to begin treatment. Suspicion for ACS should arise as soon as pain associated with trauma or surgery intensifies or becomes unmanageable.
DIAGNOSTIC TOOLS
ACS is diagnosed based on the previously mentioned clinical signs, along with objective evidence of decreased tissue perfusion in the affected limbs.24 Direct intracompartmental pressure measurements, obtained using a needle- or catheter-based technique, are the most common means of identifying ACS.7 However, near infrared spectroscopy and infrared imaging have also been found helpful.7, 25
Direct Intracompartmental Pressure Monitoring
Supported by clinical findings, direct measurement of the intracompartmental pressure (ICP) using a needle transducer is the most accurate method for detecting ACS and guiding treatment choices. Several measurement options are available, including a handheld needle manometer, which records single-pressure readings, or a wick or slit catheter, which can record continuous pressures.13 The choice between devices is based on facility/provider preference, as any commercial pressure device can be used with similar accuracies. When no such device is available, an 18-gauge needle with a set-up resembling an arterial line is another option.1
When using these instruments, it is essential for the provider to implement proper sterile technique and to record pressures from compartments within a 5-cm radius of the injury site.17 Furthermore, clinicians should be aware that the ICP can vary greatly and that tolerance to increased pressure varies with the patient’s diastolic blood pressure.
Normal capillary perfusion pressure (diastolic blood pressure minus compartment pressure) is approximately 30 mm Hg. Therefore, absolute ICP readings above 30 mm Hg can be diagnostic of ACS and indicative of fasciotomy. Likewise, a perfusion pressure below 30 mm Hg is also diagnostic. Based on consensus, either calculation can be used.16,17
Infrared Spectroscopy and Imaging
Barker and colleagues7 describe use of near infrared spectroscopy (NIRS) as a method to diagnose lower-extremity ACS. Noninvasive skin probes can detect the absorption spectra of mixed venous hemoglobin levels beneath the skin to determine oxygen saturation (StO2). StO2 measured by NIRS is location dependent, enabling the clinician to monitor oxygenation levels in any illuminated tissue. NIRS has great potential for use in confirming a diagnosis of ACS since decreased perfusion pressure from elevated ICP correlates well with decreased StO2. However, this technique has limitations that currently prevent its widespread use as a diagnostic tool.7
Use of noninvasive infrared imaging has also been investigated. Katz and colleagues25 describe the use of a long-wave infrared camera and thermographic imaging analysis software to detect differences in surface temperatures in patients’ limbs after blunt trauma. The researchers were able to correlate declines in temperature with decreased blood flow. They proposed that this modality be used to make the diagnosis of ACS before the development of muscle ischemia and necrosis. This software is still being investigated.25
Imaging Studies
CT or MRI can be helpful in identifying swelling, hematomas, or areas of necrosis, but their specificity is not sufficient to confirm elevated compartmental pressures24; additionally, MRI cannot distinguish between swelling resulting from soft-tissue injury and swelling in muscles affected by ACS.26, 27
Ultrasound also has potential as a diagnostic tool, as it helps clinicians visualize soft-tissue structures and assess the patency of large arteries and veins; the absence of venous outflow may suggest ACS. However, the efficacy of ultrasound in diagnosing ACS has proven inconsistent, and it is not recommended over direct ICP measurements. Instead, ultrasound can be relied on as an adjunctive modality.13
Blood Tests
Laboratory tests cannot contribute toward the diagnosis of ACS, but assessment of renal function and skeletal muscle breakdown is important to identify potential complications of ACS. Obtaining baseline levels in blood urea nitrogen and creatinine will help identify changes in kidney function, while potassium, urates, creatine phosphokinase (CPK), and myoglobin can be measured to assess for muscle breakdown. Findings of myoglobinuria with elevated CPK are strongly indicative of rhabdomyolysis, which can easily precipitate acute renal failure.8
Results from a complete blood count or prothrombin time/partial thromboplastin time may facilitate monitoring for blood loss or identification of contributing bleeding disorders. Because surgery remains the definitive treatment for ACS, a type and screen is essential in the workup, as blood products and transfusion are likely to be required during treatment.
MANAGEMENT
Fasciotomy remains the standard of care for patients presenting with the clinical signs and symptoms of increased compartment pressure consistent with ACS.16 Researchers engaged in animal studies and human case reports have shown that fasciotomy must be performed within six hours of injury to prevent adverse outcomes.8,16,28
As definitive treatment for ACS, a complete fasciotomy of all compartments in the vicinity of the injury should be performed. The most effective approach for fasciotomy consists of two long skin incisions (ie, double-incision radical dissection, to prevent concomitant increased pressure within the boundary of the skin), on opposite aspects of the affected limb, to ensure that all compartmental fascia can be decompressed.17,26,28
Delayed primary intention on postop day 5 is the preferred method for fasciotomy wound closure. Wounds should remain open to allow limb swelling to subside. In severe cases, when delayed primary intention cannot be performed in the window of time described, split-thickness skin grafts can be used. Postoperative wounds should be packed open with bulky dressings and changed daily. Negative-pressure wound dressings can be used for improved and accelerated wound closure.29
In the setting of ACS or limb ischemia, it is important to consider the possibility that tissue destruction will lead to significant myoglobinuria and potentially rhabdomyolysis.8 In patients presenting with crush injuries, or trauma patients who experience a significant rise in creatine kinase, the kidneys should be protected via extracellular resuscitation with isotonic fluids. The goal of resuscitation is to maintain urinary output of at least 200 mL/h to prevent renal failure.29
PATIENT EDUCATION
Patients who undergo fasciotomy within 12 hours of onset of signs and symptoms of ACS retain normal limb function in 68% of cases. However, this outcome falls to 8% if fasciotomy is delayed longer than 12 hours.30 Patients should understand that return to normal function usually takes two to three months and requires active participation by the patient. Furthermore, 20% of patients have some motor and sensory deficits at one year postfasciotomy.17
FOLLOW-UP
After fasciotomy, patients will require adequate pain control and an extensive rehabilitation program. Early physical therapy should progress slowly, with focus on range-of-motion and stretching exercises. Once patients have regained the ability to ambulate, resistance exercises and moderate exercise activities should be implemented to return them to their regular activities.31
CONCLUSION
ACS figures significantly in the long-term morbidity and mortality associated with trauma. Clinical research and laboratory science have indicated that ACS must be treated within six hours to prevent life-long deformity and disability. New diagnostic and therapeutic approaches must be investigated to improve outcomes. The most widely accepted surgical approach is the double-incision radical dissection of all fascia within the affected limb.
Appropriate management must include protection of the patient’s kidneys, given the risk for rhabdomyolysis, as well as extensive postoperative physical therapy. Given the invasive treatment required for ACS, progression toward full recovery is a long and difficult process. However, with prompt recognition and early intervention, full return to normal function is possible, with little to no deformity or dysfunction.
REFERECNES
1. Murdock M, Murdoch MM. Compartment syndrome: a review of the literature. Clin Podiatr Med Surg. 2012;29:301-310, viii.
2. Osteen KD, Haque SH. Bilateral gluteal compartment syndrome following right total knee revision: a case report. Ochsner J. 2012;12:141-144.
3. Paryavi E, Jobin CM, Ludwig SC, et al. Acute exertional lumbar paraspinal compartment syndrome. Spine. 2010;35:E1529-E1533.
4. Bosch U, Tscherne H. The pelvic compartment syndrome. Arch Ortho Trauma Surg. 1992;111:314-317.
5. Maeda A, Wakabayashi K, Suzuki H. Acute limb ischemia due to abdominal compartment syndrome. Catheter Cardiovasc Interv. 2013 Jun 19. [Epub ahead of print]
6. Masquelet AC. Acute compartment syndrome of the leg: pressure measurement and fasciotomy. Orthop Trumatol Surg Res. 2010;96:913-917.
7. Barker T, Midwinter M, Porter K. The diagnosis of acute lower limb compartment syndrome: applications of near infrared spectroscopy. Trauma. 2011;13:125-136.
8. Bosch X, Poch E, Grau JM. Rhabdomyolysis and acute kidney injury. N Engl J Med. 2009;361:62-72.
9. Karmaniolou I, Staikou C. Compartment syndrome as a complication of the lithotomy position. West Indian Med J. 2010;59:698-701.
10. Pietrangiolillo Z, Frassoldati R, Leonelli V, et al. Compartment syndrome after viper-bite in toddler: case report and review of literature. Acta Biomed. 2012;83:44-50.
11. Kakkar R, Ellis M, Fearon PV. Compartment syndrome of the thigh as a complication of anticoagulant therapy in a patient with a left ventricular assist device (Berlin Heart). Gen Thorac Cardiovasc Surg. 2010;58: 477-479.
12. Balogh ZJ, Leppäniemi A. Patient populations at risk for intra-abdominal hypertension and abdominal compartment syndrome. Am Surg. 2011;77 suppl 1:S12-S16.
13. Zimmerman DC, Kapoor T, Elfond M, Scott P. Spontaneous compartment syndrome of the upper arm in a patient receiving anticoagulation therapy. J Emerg Med. 2013;44:e53-e56.
14. Olson SA. Acute compartment syndrome in lower extremity musculoskeletal trauma. J Am Acad Orthop Surg. 2005;13(7):436-444.
15. Branco BC, Inaba K, Barmparas G, et al. Incidence and predictors for the need for fasciotomy after extremity trauma: a 10-year review in a mature level I trauma centre. Injury. 2011;42:1157-1163.
16. Wall CJ, Richardson, Lowe AJ, et al. Survey of management of acute, traumatic compartment syndrome of the leg in Australia. ANZ J Surg. 2007;77:733-737.
17. Wall CJ, Lynch J, Harris IA, et al; Liverpool (Sydney) and Royal Melbourne Hospitals. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma. ANZ J Surg. 2010;80:151-156.
18. McQueen MM, Gaston P, Court-Brown CM. Acute compartment syndrome: who is at risk? J Bone Joint Surg. 2000;82:200-203.
19. Khan M, Hodkinson SL. Acute compartment syndrome—presenting as severe pain in an extremity out of proportion with the injury. J R Army Med Corps. 1997;143:165-166.
20. Percival TJ, White JM, Ricci MA. Compartment syndrome in the setting of vascular injury. Perspect Vasc Surg Endovasc Ther. 2011;23(2):119-124.
21. Badhe S, Baiju D, Elliot R, et al. The ‘silent’ compartment syndrome. Injury. 2009;40:220-222.
22. Shuler FD, Dietz MJ. Physicians’ ability to manually detect isolated elevations in leg intracompartmental pressure. J Bone Joint Surg Am. 2010;92:361-367.
23. Taylor RM, Sullivan MP, Mehta S. Acute compartment syndrome: obtaining diagnosis, providing treatment, and minimizing medicolegal risk. Curr Rev Musculoskelet Med. 2012;5(3):206-213.
24. McDonald S, Bearcroft P. Compartment syndromes. Semin Musculoskelet Radiol. 2010;14:236-244.
25. Katz LM, Nauriyal V, Nagaraj S, et al. Infrared imaging of trauma patients for detection of acute compartment syndrome of the leg. Crit Care Med. 2008;36:1756-1761.
26. Shadgan B, Menon M, Sanders D, et al. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010;53:329-334.
27. Rominger M, Lukosch C, Bachmann G, et al. Compartment syndrome: value of MR imaging. Radiology. 1995;197:296.
28. Kashuk JL, Moore EE, Pinski S, et al. Lower extremity compartment syndrome in the acute care surgery paradigm: safety lessons learned. Patient Saf Surg. 2009;3(1):11.
29. Rasul AT Jr. Acute compartment syndrome (2011). emedicine.medscape.com/article/307668-overview#showall. Accessed June 25, 2013.
30. Sheridan GW, Matsen FA 3rd. Fasciotomy in the treatment of the acute compartment syndrome. J Bone Joint Surg Am. 1976;58(1):112-115.
31. Schubert AG. Exertional compartment syndrome: review of the literature and proposed rehabilitation guidelines following surgical release. Intern J Sports Phys Ther. 2011;6:126-141.
How to Choose a Contraceptive for Your Postpartum Patient
Q: What’s a vital aspect of the care we provide to postpartum patients?
A: Optimal timing of evaluation for contraception.
Good timing minimizes the likelihood that postpartum contraception will be initiated too early or too late to be effective.
The choice of a contraceptive method for a postpartum woman also requires a careful balancing act. On one side: the risks of contraception to the mother and her newborn. On the other: the risk for unintended pregnancy. Among the concerns that need to be addressed in contraceptive decision-making are:
• Whether the woman has resumed sexual intercourse
• Infant feeding practices
• Risk for venous thromboembolism (VTE)
• Logistics of various long-acting reversible contraceptives and tubal sterilization.
In this article, we outline the components of effective contraceptive counseling and decision-making. We also summarize recent recommendations from the CDC on the use of various contraceptive methods during the postpartum period.
FIRST: START AT THREE WEEKS
The traditional six-week postpartum visit was timed to take place after complete involution of the uterus following vaginal delivery. However, involution occurs too late to prevent unintended pregnancy because ovulation can—and often does—occur as early as the fourth postpartum week among nonbreastfeeding women.
In the past, when it was more common to fit a contraceptive diaphragm after pregnancy, six weeks may have been the best timing for the visit. Today, given the high safety and efficacy of modern contraceptive methods (even when initiated before complete involution), as well as the importance of safe birth spacing, the routine postpartum visit is more appropriately scheduled at three weeks for women who have had an uneventful delivery.
In some cases, of course, it may be appropriate to schedule a visit even earlier, depending on the medical needs of the mother (which may include staple removal after cesarean delivery, follow-up blood pressure assessment for patients who have gestational hypertension, etc). That said, the first postpartum visit should be routinely scheduled for no later than three weeks for healthy women who have had an uncomplicated delivery.1
The data support this approach. In one study, 57% of women reported the resumption of intercourse by the sixth postpartum week.2 A routine three-week postpartum visit instead of a visit at six weeks would reduce unmet contraceptive needs among this group of women.
HOW INFANT FEEDING PRACTICES COME INTO PLAY
Both the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics recommend six months of exclusive breastfeeding because of recognized health benefits for both the mother and her infant. Exclusive breastfeeding is also a requirement if a woman desires to use breastfeeding as a contraceptive method.
Healthy People 2010 is a set of US health objectives that includes goals for breastfeeding rates. Although the percentage of infants who were ever breastfed has reached the 75% target of Healthy People 2010, according to data from the National Health and Nutrition Examination Survey (NHANES), the percentage of infants who were breastfed at six months of age has changed only minimally.3 For Mexican-American infants, that rate is 40%, compared with 35% for non-Hispanic whites and 20% for non-Hispanic black infants.3 Rates of exclusive breastfeeding are even lower, highlighting the importance of early breastfeeding support and contraceptive guidance during the postpartum period—support and guidance that can be offered at a three-week postpartum visit.
EXTENT OF BREASTFEEDING TO BE ASSESSED
Full or nearly full breastfeeding should be encouraged, along with frequent feeding of the infant. In addition, the contraceptive effect of lactation during the first six months of breastfeeding should be emphasized (see sidebar on the lactational amenorrhea method [LAM] of contraception).
Keep in mind, however, that a substantial number of nursing mothers who are not breastfeeding exclusively will ovulate before the six-week postpartum visit. Data suggest that approximately 50% of all nonbreastfeeding women will ovulate before the six-week visit, with some ovulating as early as postpartum day 25.4
For this reason, you need to determine the extent of breastfeeding at the three-week visit to determine whether LAM is a contraceptive option for your patient. Full or nearly full breastfeeding means that the vast majority of feeding is breastfeeding and that breastfeeding is not replaced by any other kind of feeding. Frequent feeding means that the infant is breastfed when hungry, be it day or night, which implies at least one nighttime feeding. If evaluation at the three-week visit indicates that breastfeeding is no longer full or nearly full and frequent, another form of contraception should be initiated.5
For most women, the benefits of initiating a progestin-only or nonhormonal method of contraception at this time outweigh the risks, regardless of breastfeeding status, according to the CDC’s medical eligibility criteria for contraceptive use.6
HOW THE RISK FOR VTE AFFECTS THE CHOICE OF CONTRACEPTIVE
The hematologic changes of normal pregnancy shift coagulability and fibrinolytic systems toward a state of hypercoagulability. This physiologic process reduces the risk for puerperal hemorrhage; however, it also predisposes women to VTE during pregnancy and into the postpartum period. Studies assessing the risk for VTE in postpartum women indicate that it increases by a factor of 22 to 84 during the first six weeks, compared with the risk in nonpregnant, nonpostpartum women of reproductive age.7 This heightened risk is most pronounced immediately after delivery, declining rapidly over the first 21 days after delivery and returning to a near-baseline level by 42 days postpartum.
By the time of the recommended three-week postpartum visit, the period of highest VTE risk has passed. For women who are no longer breastfeeding, the benefits of all hormonal contraceptive methods, including those that contain estrogen, outweigh their risks, according to a newly released update to recommendations from the CDC (see Table 1).6 Although combined oral contraceptives are known to increase the risk for VTE by a factor of 3 to 7, data suggest that healthy women who do not have additional risk factors for VTE (eg, thrombophilia, obesity, smoking, or age 35 or older) can use them safely.6
The updated recommendations discourage use of estrogen-containing contraceptives before 21 days postpartum because they present an unacceptable level of risk (regardless of breastfeeding status). But they allow the use of combined hormonal contraceptives in otherwise healthy, breastfeeding women after 30 days postpartum. For women who have additional risk factors for VTE, the risks of combined hormonal contraceptives outweigh the benefits until six weeks postpartum, regardless of breastfeeding status.6
In contrast, progestin-only and nonhormonal contraceptive methods can be safely initiated by both breastfeeding and nonbreastfeeding women before 21 days postpartum, which means that women can begin using them before discharge from the hospital.
WHEN TO CONSIDER LARC OR STERILIZATION
Long-acting reversible contraceptives (LARC) are an important postpartum contraceptive option because they offer highly effective protection against pregnancy that can begin as soon as the placenta is delivered. LARC methods include contraceptive implants and intrauterine devices (IUDs).
According to the CDC’s medical eligibility criteria for contraceptive use, implants can be placed immediately after delivery of the placenta without restriction.8
The copper IUD can be placed within 10 minutes after delivery of the placenta without restriction. If this window is missed, the benefits of inserting the IUD still outweigh the risks. Because four weeks postpartum is another time when the copper IUD can be inserted without restriction, the three-week visit is a reasonable time to screen and schedule a patient for insertion.
The benefits of insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) are also believed to outweigh the risks before four weeks postpartum. Like the copper IUD, the LNG-IUS can be inserted without restriction at four weeks postpartum or later.
There is no need for a pelvic exam at the three-week postpartum visit among women who undergo immediate postplacental insertion of the copper IUD or LNG-IUS. In fact, women can delay the exam until involution is complete.
Sterilization is best after complete involution
Interval tubal sterilization by laparoscopic, bilateral tubal fulguration or hysteroscopic microinsert placement is one of the most effective ways to prevent pregnancy. Both methods are best performed after the completion of involution and the return of normal coagulation; scheduling can take place at the three-week postpartum visit.
Given the benefit of depot medroxyprogesterone acetate (DMPA) in endometrial suppression before hysteroscopic sterilization, it is reasonable to consider administering DMPA at the three-week postpartum visit in anticipation of surgery after involution is complete.
THE BOTTOM LINE
Since most contraceptive methods can be safely initiated at or shortly after a three-weeks’ postpartum visit, there is no longer any reason to time the routine postpartum visit to coincide with the completion of involution. For healthy women who have had an uneventful delivery, the routine postpartum visit should occur at three weeks.
REFERENCES
1. Speroff L, Mishell DR. The postpartum visit: it’s time for a change in order to optimally initiate contraception. Contraception. 2008;78(2): 90–98.
2. Connolly A, Thorp J, Pahel L. Effects of pregnancy and childbirth on postpartum sexual function: a longitudinal prospective study. Int Urogynecol J Pelvic Floor Dysfunct. 2005; 16(4):263–267.
3. McDowell MA, Wang C-Y, Kennedy-Stephenson J. Breastfeeding in the United States: Findings from the National Health and Nutrition Examination Surveys 1999–2006. NCHS Data Briefs. 2008;5:1–8.
4. Jackson E, Glasier A. Return of ovulation and menses in postpartum, nonlactating women: a systematic review. Obstet Gynecol. 2011;117(3):657–662.
5. Kennedy K, Rivera R, McNeilly A. Consensus statement on the use of breastfeeding as a family planning method. Contraception. 1988; 39(5):477–496.
6. Centers for Disease Control and Prevention. Update to CDC’s US Medical Eligibility Criteria for Contraceptive Use, 2010: Revised recommendations for the use of contraceptive methods during the postpartum period. MMWR. 2011;60(26):878–883.
7. Jackson E, Curtis K, Gaffield M. Risk of venous thromboembolism during the postpartum period: a systematic review. Obstet Gynecol. 2011;117(3):691–703.
8. Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR. 2010;59(No. RR-4):1–86.
9. Kletzky OA, Marrs RP, Howard WF, McCormick W, Mishell DR Jr. Prolactin synthesis and release during pregnancy and puerperium. Am J Obstet Gynecol. 1980;136(4):545–550.
10. Labbok MH, Hight-Laukaran V, Peterson AE, Fletcher V, von Hertzen H, Van Look PF. Multicenter study of the Lactional Amenorrhea Method (LAM): I. Efficacy, duration, and implications for clinical application. Contraception. 1997;55(6):327–336.
11. Valdes V, Labbok MH, Pugin E, Perez A. The efficacy of the Lactational Amenorrhea Method (LAM) among working women. Contraception. 2000;62(5):217–219.
Q: What’s a vital aspect of the care we provide to postpartum patients?
A: Optimal timing of evaluation for contraception.
Good timing minimizes the likelihood that postpartum contraception will be initiated too early or too late to be effective.
The choice of a contraceptive method for a postpartum woman also requires a careful balancing act. On one side: the risks of contraception to the mother and her newborn. On the other: the risk for unintended pregnancy. Among the concerns that need to be addressed in contraceptive decision-making are:
• Whether the woman has resumed sexual intercourse
• Infant feeding practices
• Risk for venous thromboembolism (VTE)
• Logistics of various long-acting reversible contraceptives and tubal sterilization.
In this article, we outline the components of effective contraceptive counseling and decision-making. We also summarize recent recommendations from the CDC on the use of various contraceptive methods during the postpartum period.
FIRST: START AT THREE WEEKS
The traditional six-week postpartum visit was timed to take place after complete involution of the uterus following vaginal delivery. However, involution occurs too late to prevent unintended pregnancy because ovulation can—and often does—occur as early as the fourth postpartum week among nonbreastfeeding women.
In the past, when it was more common to fit a contraceptive diaphragm after pregnancy, six weeks may have been the best timing for the visit. Today, given the high safety and efficacy of modern contraceptive methods (even when initiated before complete involution), as well as the importance of safe birth spacing, the routine postpartum visit is more appropriately scheduled at three weeks for women who have had an uneventful delivery.
In some cases, of course, it may be appropriate to schedule a visit even earlier, depending on the medical needs of the mother (which may include staple removal after cesarean delivery, follow-up blood pressure assessment for patients who have gestational hypertension, etc). That said, the first postpartum visit should be routinely scheduled for no later than three weeks for healthy women who have had an uncomplicated delivery.1
The data support this approach. In one study, 57% of women reported the resumption of intercourse by the sixth postpartum week.2 A routine three-week postpartum visit instead of a visit at six weeks would reduce unmet contraceptive needs among this group of women.
HOW INFANT FEEDING PRACTICES COME INTO PLAY
Both the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics recommend six months of exclusive breastfeeding because of recognized health benefits for both the mother and her infant. Exclusive breastfeeding is also a requirement if a woman desires to use breastfeeding as a contraceptive method.
Healthy People 2010 is a set of US health objectives that includes goals for breastfeeding rates. Although the percentage of infants who were ever breastfed has reached the 75% target of Healthy People 2010, according to data from the National Health and Nutrition Examination Survey (NHANES), the percentage of infants who were breastfed at six months of age has changed only minimally.3 For Mexican-American infants, that rate is 40%, compared with 35% for non-Hispanic whites and 20% for non-Hispanic black infants.3 Rates of exclusive breastfeeding are even lower, highlighting the importance of early breastfeeding support and contraceptive guidance during the postpartum period—support and guidance that can be offered at a three-week postpartum visit.
EXTENT OF BREASTFEEDING TO BE ASSESSED
Full or nearly full breastfeeding should be encouraged, along with frequent feeding of the infant. In addition, the contraceptive effect of lactation during the first six months of breastfeeding should be emphasized (see sidebar on the lactational amenorrhea method [LAM] of contraception).
Keep in mind, however, that a substantial number of nursing mothers who are not breastfeeding exclusively will ovulate before the six-week postpartum visit. Data suggest that approximately 50% of all nonbreastfeeding women will ovulate before the six-week visit, with some ovulating as early as postpartum day 25.4
For this reason, you need to determine the extent of breastfeeding at the three-week visit to determine whether LAM is a contraceptive option for your patient. Full or nearly full breastfeeding means that the vast majority of feeding is breastfeeding and that breastfeeding is not replaced by any other kind of feeding. Frequent feeding means that the infant is breastfed when hungry, be it day or night, which implies at least one nighttime feeding. If evaluation at the three-week visit indicates that breastfeeding is no longer full or nearly full and frequent, another form of contraception should be initiated.5
For most women, the benefits of initiating a progestin-only or nonhormonal method of contraception at this time outweigh the risks, regardless of breastfeeding status, according to the CDC’s medical eligibility criteria for contraceptive use.6
HOW THE RISK FOR VTE AFFECTS THE CHOICE OF CONTRACEPTIVE
The hematologic changes of normal pregnancy shift coagulability and fibrinolytic systems toward a state of hypercoagulability. This physiologic process reduces the risk for puerperal hemorrhage; however, it also predisposes women to VTE during pregnancy and into the postpartum period. Studies assessing the risk for VTE in postpartum women indicate that it increases by a factor of 22 to 84 during the first six weeks, compared with the risk in nonpregnant, nonpostpartum women of reproductive age.7 This heightened risk is most pronounced immediately after delivery, declining rapidly over the first 21 days after delivery and returning to a near-baseline level by 42 days postpartum.
By the time of the recommended three-week postpartum visit, the period of highest VTE risk has passed. For women who are no longer breastfeeding, the benefits of all hormonal contraceptive methods, including those that contain estrogen, outweigh their risks, according to a newly released update to recommendations from the CDC (see Table 1).6 Although combined oral contraceptives are known to increase the risk for VTE by a factor of 3 to 7, data suggest that healthy women who do not have additional risk factors for VTE (eg, thrombophilia, obesity, smoking, or age 35 or older) can use them safely.6
The updated recommendations discourage use of estrogen-containing contraceptives before 21 days postpartum because they present an unacceptable level of risk (regardless of breastfeeding status). But they allow the use of combined hormonal contraceptives in otherwise healthy, breastfeeding women after 30 days postpartum. For women who have additional risk factors for VTE, the risks of combined hormonal contraceptives outweigh the benefits until six weeks postpartum, regardless of breastfeeding status.6
In contrast, progestin-only and nonhormonal contraceptive methods can be safely initiated by both breastfeeding and nonbreastfeeding women before 21 days postpartum, which means that women can begin using them before discharge from the hospital.
WHEN TO CONSIDER LARC OR STERILIZATION
Long-acting reversible contraceptives (LARC) are an important postpartum contraceptive option because they offer highly effective protection against pregnancy that can begin as soon as the placenta is delivered. LARC methods include contraceptive implants and intrauterine devices (IUDs).
According to the CDC’s medical eligibility criteria for contraceptive use, implants can be placed immediately after delivery of the placenta without restriction.8
The copper IUD can be placed within 10 minutes after delivery of the placenta without restriction. If this window is missed, the benefits of inserting the IUD still outweigh the risks. Because four weeks postpartum is another time when the copper IUD can be inserted without restriction, the three-week visit is a reasonable time to screen and schedule a patient for insertion.
The benefits of insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) are also believed to outweigh the risks before four weeks postpartum. Like the copper IUD, the LNG-IUS can be inserted without restriction at four weeks postpartum or later.
There is no need for a pelvic exam at the three-week postpartum visit among women who undergo immediate postplacental insertion of the copper IUD or LNG-IUS. In fact, women can delay the exam until involution is complete.
Sterilization is best after complete involution
Interval tubal sterilization by laparoscopic, bilateral tubal fulguration or hysteroscopic microinsert placement is one of the most effective ways to prevent pregnancy. Both methods are best performed after the completion of involution and the return of normal coagulation; scheduling can take place at the three-week postpartum visit.
Given the benefit of depot medroxyprogesterone acetate (DMPA) in endometrial suppression before hysteroscopic sterilization, it is reasonable to consider administering DMPA at the three-week postpartum visit in anticipation of surgery after involution is complete.
THE BOTTOM LINE
Since most contraceptive methods can be safely initiated at or shortly after a three-weeks’ postpartum visit, there is no longer any reason to time the routine postpartum visit to coincide with the completion of involution. For healthy women who have had an uneventful delivery, the routine postpartum visit should occur at three weeks.
REFERENCES
1. Speroff L, Mishell DR. The postpartum visit: it’s time for a change in order to optimally initiate contraception. Contraception. 2008;78(2): 90–98.
2. Connolly A, Thorp J, Pahel L. Effects of pregnancy and childbirth on postpartum sexual function: a longitudinal prospective study. Int Urogynecol J Pelvic Floor Dysfunct. 2005; 16(4):263–267.
3. McDowell MA, Wang C-Y, Kennedy-Stephenson J. Breastfeeding in the United States: Findings from the National Health and Nutrition Examination Surveys 1999–2006. NCHS Data Briefs. 2008;5:1–8.
4. Jackson E, Glasier A. Return of ovulation and menses in postpartum, nonlactating women: a systematic review. Obstet Gynecol. 2011;117(3):657–662.
5. Kennedy K, Rivera R, McNeilly A. Consensus statement on the use of breastfeeding as a family planning method. Contraception. 1988; 39(5):477–496.
6. Centers for Disease Control and Prevention. Update to CDC’s US Medical Eligibility Criteria for Contraceptive Use, 2010: Revised recommendations for the use of contraceptive methods during the postpartum period. MMWR. 2011;60(26):878–883.
7. Jackson E, Curtis K, Gaffield M. Risk of venous thromboembolism during the postpartum period: a systematic review. Obstet Gynecol. 2011;117(3):691–703.
8. Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR. 2010;59(No. RR-4):1–86.
9. Kletzky OA, Marrs RP, Howard WF, McCormick W, Mishell DR Jr. Prolactin synthesis and release during pregnancy and puerperium. Am J Obstet Gynecol. 1980;136(4):545–550.
10. Labbok MH, Hight-Laukaran V, Peterson AE, Fletcher V, von Hertzen H, Van Look PF. Multicenter study of the Lactional Amenorrhea Method (LAM): I. Efficacy, duration, and implications for clinical application. Contraception. 1997;55(6):327–336.
11. Valdes V, Labbok MH, Pugin E, Perez A. The efficacy of the Lactational Amenorrhea Method (LAM) among working women. Contraception. 2000;62(5):217–219.
Q: What’s a vital aspect of the care we provide to postpartum patients?
A: Optimal timing of evaluation for contraception.
Good timing minimizes the likelihood that postpartum contraception will be initiated too early or too late to be effective.
The choice of a contraceptive method for a postpartum woman also requires a careful balancing act. On one side: the risks of contraception to the mother and her newborn. On the other: the risk for unintended pregnancy. Among the concerns that need to be addressed in contraceptive decision-making are:
• Whether the woman has resumed sexual intercourse
• Infant feeding practices
• Risk for venous thromboembolism (VTE)
• Logistics of various long-acting reversible contraceptives and tubal sterilization.
In this article, we outline the components of effective contraceptive counseling and decision-making. We also summarize recent recommendations from the CDC on the use of various contraceptive methods during the postpartum period.
FIRST: START AT THREE WEEKS
The traditional six-week postpartum visit was timed to take place after complete involution of the uterus following vaginal delivery. However, involution occurs too late to prevent unintended pregnancy because ovulation can—and often does—occur as early as the fourth postpartum week among nonbreastfeeding women.
In the past, when it was more common to fit a contraceptive diaphragm after pregnancy, six weeks may have been the best timing for the visit. Today, given the high safety and efficacy of modern contraceptive methods (even when initiated before complete involution), as well as the importance of safe birth spacing, the routine postpartum visit is more appropriately scheduled at three weeks for women who have had an uneventful delivery.
In some cases, of course, it may be appropriate to schedule a visit even earlier, depending on the medical needs of the mother (which may include staple removal after cesarean delivery, follow-up blood pressure assessment for patients who have gestational hypertension, etc). That said, the first postpartum visit should be routinely scheduled for no later than three weeks for healthy women who have had an uncomplicated delivery.1
The data support this approach. In one study, 57% of women reported the resumption of intercourse by the sixth postpartum week.2 A routine three-week postpartum visit instead of a visit at six weeks would reduce unmet contraceptive needs among this group of women.
HOW INFANT FEEDING PRACTICES COME INTO PLAY
Both the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics recommend six months of exclusive breastfeeding because of recognized health benefits for both the mother and her infant. Exclusive breastfeeding is also a requirement if a woman desires to use breastfeeding as a contraceptive method.
Healthy People 2010 is a set of US health objectives that includes goals for breastfeeding rates. Although the percentage of infants who were ever breastfed has reached the 75% target of Healthy People 2010, according to data from the National Health and Nutrition Examination Survey (NHANES), the percentage of infants who were breastfed at six months of age has changed only minimally.3 For Mexican-American infants, that rate is 40%, compared with 35% for non-Hispanic whites and 20% for non-Hispanic black infants.3 Rates of exclusive breastfeeding are even lower, highlighting the importance of early breastfeeding support and contraceptive guidance during the postpartum period—support and guidance that can be offered at a three-week postpartum visit.
EXTENT OF BREASTFEEDING TO BE ASSESSED
Full or nearly full breastfeeding should be encouraged, along with frequent feeding of the infant. In addition, the contraceptive effect of lactation during the first six months of breastfeeding should be emphasized (see sidebar on the lactational amenorrhea method [LAM] of contraception).
Keep in mind, however, that a substantial number of nursing mothers who are not breastfeeding exclusively will ovulate before the six-week postpartum visit. Data suggest that approximately 50% of all nonbreastfeeding women will ovulate before the six-week visit, with some ovulating as early as postpartum day 25.4
For this reason, you need to determine the extent of breastfeeding at the three-week visit to determine whether LAM is a contraceptive option for your patient. Full or nearly full breastfeeding means that the vast majority of feeding is breastfeeding and that breastfeeding is not replaced by any other kind of feeding. Frequent feeding means that the infant is breastfed when hungry, be it day or night, which implies at least one nighttime feeding. If evaluation at the three-week visit indicates that breastfeeding is no longer full or nearly full and frequent, another form of contraception should be initiated.5
For most women, the benefits of initiating a progestin-only or nonhormonal method of contraception at this time outweigh the risks, regardless of breastfeeding status, according to the CDC’s medical eligibility criteria for contraceptive use.6
HOW THE RISK FOR VTE AFFECTS THE CHOICE OF CONTRACEPTIVE
The hematologic changes of normal pregnancy shift coagulability and fibrinolytic systems toward a state of hypercoagulability. This physiologic process reduces the risk for puerperal hemorrhage; however, it also predisposes women to VTE during pregnancy and into the postpartum period. Studies assessing the risk for VTE in postpartum women indicate that it increases by a factor of 22 to 84 during the first six weeks, compared with the risk in nonpregnant, nonpostpartum women of reproductive age.7 This heightened risk is most pronounced immediately after delivery, declining rapidly over the first 21 days after delivery and returning to a near-baseline level by 42 days postpartum.
By the time of the recommended three-week postpartum visit, the period of highest VTE risk has passed. For women who are no longer breastfeeding, the benefits of all hormonal contraceptive methods, including those that contain estrogen, outweigh their risks, according to a newly released update to recommendations from the CDC (see Table 1).6 Although combined oral contraceptives are known to increase the risk for VTE by a factor of 3 to 7, data suggest that healthy women who do not have additional risk factors for VTE (eg, thrombophilia, obesity, smoking, or age 35 or older) can use them safely.6
The updated recommendations discourage use of estrogen-containing contraceptives before 21 days postpartum because they present an unacceptable level of risk (regardless of breastfeeding status). But they allow the use of combined hormonal contraceptives in otherwise healthy, breastfeeding women after 30 days postpartum. For women who have additional risk factors for VTE, the risks of combined hormonal contraceptives outweigh the benefits until six weeks postpartum, regardless of breastfeeding status.6
In contrast, progestin-only and nonhormonal contraceptive methods can be safely initiated by both breastfeeding and nonbreastfeeding women before 21 days postpartum, which means that women can begin using them before discharge from the hospital.
WHEN TO CONSIDER LARC OR STERILIZATION
Long-acting reversible contraceptives (LARC) are an important postpartum contraceptive option because they offer highly effective protection against pregnancy that can begin as soon as the placenta is delivered. LARC methods include contraceptive implants and intrauterine devices (IUDs).
According to the CDC’s medical eligibility criteria for contraceptive use, implants can be placed immediately after delivery of the placenta without restriction.8
The copper IUD can be placed within 10 minutes after delivery of the placenta without restriction. If this window is missed, the benefits of inserting the IUD still outweigh the risks. Because four weeks postpartum is another time when the copper IUD can be inserted without restriction, the three-week visit is a reasonable time to screen and schedule a patient for insertion.
The benefits of insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) are also believed to outweigh the risks before four weeks postpartum. Like the copper IUD, the LNG-IUS can be inserted without restriction at four weeks postpartum or later.
There is no need for a pelvic exam at the three-week postpartum visit among women who undergo immediate postplacental insertion of the copper IUD or LNG-IUS. In fact, women can delay the exam until involution is complete.
Sterilization is best after complete involution
Interval tubal sterilization by laparoscopic, bilateral tubal fulguration or hysteroscopic microinsert placement is one of the most effective ways to prevent pregnancy. Both methods are best performed after the completion of involution and the return of normal coagulation; scheduling can take place at the three-week postpartum visit.
Given the benefit of depot medroxyprogesterone acetate (DMPA) in endometrial suppression before hysteroscopic sterilization, it is reasonable to consider administering DMPA at the three-week postpartum visit in anticipation of surgery after involution is complete.
THE BOTTOM LINE
Since most contraceptive methods can be safely initiated at or shortly after a three-weeks’ postpartum visit, there is no longer any reason to time the routine postpartum visit to coincide with the completion of involution. For healthy women who have had an uneventful delivery, the routine postpartum visit should occur at three weeks.
REFERENCES
1. Speroff L, Mishell DR. The postpartum visit: it’s time for a change in order to optimally initiate contraception. Contraception. 2008;78(2): 90–98.
2. Connolly A, Thorp J, Pahel L. Effects of pregnancy and childbirth on postpartum sexual function: a longitudinal prospective study. Int Urogynecol J Pelvic Floor Dysfunct. 2005; 16(4):263–267.
3. McDowell MA, Wang C-Y, Kennedy-Stephenson J. Breastfeeding in the United States: Findings from the National Health and Nutrition Examination Surveys 1999–2006. NCHS Data Briefs. 2008;5:1–8.
4. Jackson E, Glasier A. Return of ovulation and menses in postpartum, nonlactating women: a systematic review. Obstet Gynecol. 2011;117(3):657–662.
5. Kennedy K, Rivera R, McNeilly A. Consensus statement on the use of breastfeeding as a family planning method. Contraception. 1988; 39(5):477–496.
6. Centers for Disease Control and Prevention. Update to CDC’s US Medical Eligibility Criteria for Contraceptive Use, 2010: Revised recommendations for the use of contraceptive methods during the postpartum period. MMWR. 2011;60(26):878–883.
7. Jackson E, Curtis K, Gaffield M. Risk of venous thromboembolism during the postpartum period: a systematic review. Obstet Gynecol. 2011;117(3):691–703.
8. Centers for Disease Control and Prevention. US Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR. 2010;59(No. RR-4):1–86.
9. Kletzky OA, Marrs RP, Howard WF, McCormick W, Mishell DR Jr. Prolactin synthesis and release during pregnancy and puerperium. Am J Obstet Gynecol. 1980;136(4):545–550.
10. Labbok MH, Hight-Laukaran V, Peterson AE, Fletcher V, von Hertzen H, Van Look PF. Multicenter study of the Lactional Amenorrhea Method (LAM): I. Efficacy, duration, and implications for clinical application. Contraception. 1997;55(6):327–336.
11. Valdes V, Labbok MH, Pugin E, Perez A. The efficacy of the Lactational Amenorrhea Method (LAM) among working women. Contraception. 2000;62(5):217–219.
Battle of the Contraceptives
Because half of US pregnancies continue to be unintended, rates of induced abortion in our patients remain high. In addition, unintended pregnancies lead to negative health and social consequences for women and infants. A report from the Contraceptive Choice Project, spearheaded by Dr. Jeffrey Peipert from the Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, Missouri, and published in New England Journal of Medicine, underscores the high efficacy of long-acting reversible contraceptives, a term referring to intrauterine devices (IUDs) and the contraceptive implant, in preventing unintended pregnancy in a US population.
Details of the study
Eligibility criteria for the Project included age 14 to 45, residence in the St. Louis, Missouri, area, and the need for contraception. The woman’s contraceptive of choice was made available at no charge, with most women choosing a long-acting method. The published study includes outcomes for
7,486 women who used oral contraceptives (OCs), the patch, the ring, an IUD, an implant, or depot medroxyprogesterone acetate (DMPA) injections.
Among women using OCs, the patch, or the ring, the pregnancy rate was 4.55 per 100 participant-years. This rate was nearly 22-fold higher than that observed in women using IUDs or the implant (hazard ratio, 21.8): that rate was 0.27 per 100 participant-years. A similar low rate of pregnancy was noted among women who chose DMPA and returned every three months for follow-up injections.
Among women younger than 21 who used OCs, the patch, or the ring, the rate of unintended pregnancy was twice as high as in older women using these same methods. By contrast, regardless of age, pregnancy rates were uniformly low among women using long-acting methods.
Study limitations
The authors point out that their study design was not randomized—participants were at high risk for unintended pregnancy and willing to begin using a new contraceptive method, which could have resulted in higher adherence rates and lower failure rates.
Access is ongoing
barrier to use
These important data from the Contraceptive Choice Project clarify that long-acting reversible contraceptives represent powerful tools to help women minimize unintended pregnancy and induced abortion, and that women will choose these methods if they are accessible.
The findings in this report also make it clear that rates of unintended pregnancy are particularly high among adolescents using shorter-acting hor monal contraceptives (OCs, patch, or ring) and that longer-acting contraceptives are particularly useful in our younger patients. Other recent reports have provided clear evidence that immediately providing long-acting contraceptives after childbirth or induced abortion reduces unintended pregnancy in these settings.1,2
In the US, inadequate access to long-acting reversible contraceptives continues to constrain use. Accordingly, insurance pol icies that fully cover longer-acting contraceptives could go a long way toward reducing the rate of unintended pregnancies and induced abortions in our patients.
If long-acting reversible contraceptives become more widely available in the US, I look forward to a time when the great majority of our patients’ pregnancies are planned and when far fewer women will face the troubling prospect of an induced abortion.
References
1. Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do immediate postpartum contraceptive implants make a difference? Am J Obstet Gynecol. 2012;206(6):481.e1–e7.
2. Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med. 2011;364(23):2208–2217.
Because half of US pregnancies continue to be unintended, rates of induced abortion in our patients remain high. In addition, unintended pregnancies lead to negative health and social consequences for women and infants. A report from the Contraceptive Choice Project, spearheaded by Dr. Jeffrey Peipert from the Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, Missouri, and published in New England Journal of Medicine, underscores the high efficacy of long-acting reversible contraceptives, a term referring to intrauterine devices (IUDs) and the contraceptive implant, in preventing unintended pregnancy in a US population.
Details of the study
Eligibility criteria for the Project included age 14 to 45, residence in the St. Louis, Missouri, area, and the need for contraception. The woman’s contraceptive of choice was made available at no charge, with most women choosing a long-acting method. The published study includes outcomes for
7,486 women who used oral contraceptives (OCs), the patch, the ring, an IUD, an implant, or depot medroxyprogesterone acetate (DMPA) injections.
Among women using OCs, the patch, or the ring, the pregnancy rate was 4.55 per 100 participant-years. This rate was nearly 22-fold higher than that observed in women using IUDs or the implant (hazard ratio, 21.8): that rate was 0.27 per 100 participant-years. A similar low rate of pregnancy was noted among women who chose DMPA and returned every three months for follow-up injections.
Among women younger than 21 who used OCs, the patch, or the ring, the rate of unintended pregnancy was twice as high as in older women using these same methods. By contrast, regardless of age, pregnancy rates were uniformly low among women using long-acting methods.
Study limitations
The authors point out that their study design was not randomized—participants were at high risk for unintended pregnancy and willing to begin using a new contraceptive method, which could have resulted in higher adherence rates and lower failure rates.
Access is ongoing
barrier to use
These important data from the Contraceptive Choice Project clarify that long-acting reversible contraceptives represent powerful tools to help women minimize unintended pregnancy and induced abortion, and that women will choose these methods if they are accessible.
The findings in this report also make it clear that rates of unintended pregnancy are particularly high among adolescents using shorter-acting hor monal contraceptives (OCs, patch, or ring) and that longer-acting contraceptives are particularly useful in our younger patients. Other recent reports have provided clear evidence that immediately providing long-acting contraceptives after childbirth or induced abortion reduces unintended pregnancy in these settings.1,2
In the US, inadequate access to long-acting reversible contraceptives continues to constrain use. Accordingly, insurance pol icies that fully cover longer-acting contraceptives could go a long way toward reducing the rate of unintended pregnancies and induced abortions in our patients.
If long-acting reversible contraceptives become more widely available in the US, I look forward to a time when the great majority of our patients’ pregnancies are planned and when far fewer women will face the troubling prospect of an induced abortion.
References
1. Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do immediate postpartum contraceptive implants make a difference? Am J Obstet Gynecol. 2012;206(6):481.e1–e7.
2. Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med. 2011;364(23):2208–2217.
Because half of US pregnancies continue to be unintended, rates of induced abortion in our patients remain high. In addition, unintended pregnancies lead to negative health and social consequences for women and infants. A report from the Contraceptive Choice Project, spearheaded by Dr. Jeffrey Peipert from the Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, Missouri, and published in New England Journal of Medicine, underscores the high efficacy of long-acting reversible contraceptives, a term referring to intrauterine devices (IUDs) and the contraceptive implant, in preventing unintended pregnancy in a US population.
Details of the study
Eligibility criteria for the Project included age 14 to 45, residence in the St. Louis, Missouri, area, and the need for contraception. The woman’s contraceptive of choice was made available at no charge, with most women choosing a long-acting method. The published study includes outcomes for
7,486 women who used oral contraceptives (OCs), the patch, the ring, an IUD, an implant, or depot medroxyprogesterone acetate (DMPA) injections.
Among women using OCs, the patch, or the ring, the pregnancy rate was 4.55 per 100 participant-years. This rate was nearly 22-fold higher than that observed in women using IUDs or the implant (hazard ratio, 21.8): that rate was 0.27 per 100 participant-years. A similar low rate of pregnancy was noted among women who chose DMPA and returned every three months for follow-up injections.
Among women younger than 21 who used OCs, the patch, or the ring, the rate of unintended pregnancy was twice as high as in older women using these same methods. By contrast, regardless of age, pregnancy rates were uniformly low among women using long-acting methods.
Study limitations
The authors point out that their study design was not randomized—participants were at high risk for unintended pregnancy and willing to begin using a new contraceptive method, which could have resulted in higher adherence rates and lower failure rates.
Access is ongoing
barrier to use
These important data from the Contraceptive Choice Project clarify that long-acting reversible contraceptives represent powerful tools to help women minimize unintended pregnancy and induced abortion, and that women will choose these methods if they are accessible.
The findings in this report also make it clear that rates of unintended pregnancy are particularly high among adolescents using shorter-acting hor monal contraceptives (OCs, patch, or ring) and that longer-acting contraceptives are particularly useful in our younger patients. Other recent reports have provided clear evidence that immediately providing long-acting contraceptives after childbirth or induced abortion reduces unintended pregnancy in these settings.1,2
In the US, inadequate access to long-acting reversible contraceptives continues to constrain use. Accordingly, insurance pol icies that fully cover longer-acting contraceptives could go a long way toward reducing the rate of unintended pregnancies and induced abortions in our patients.
If long-acting reversible contraceptives become more widely available in the US, I look forward to a time when the great majority of our patients’ pregnancies are planned and when far fewer women will face the troubling prospect of an induced abortion.
References
1. Tocce KM, Sheeder JL, Teal SB. Rapid repeat pregnancy in adolescents: do immediate postpartum contraceptive implants make a difference? Am J Obstet Gynecol. 2012;206(6):481.e1–e7.
2. Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med. 2011;364(23):2208–2217.
Rats! A Toxic Ingestion in an Unattended Toddler
UPDATE ON CONTRACEPTION
Women spend about 5 years of their reproductive lives trying to get pregnant and the other three decades trying to avoid it.1 Nearly half of all pregnancies are unintended, and 40% of these end in abortion.2 In the past 15 years, new contraceptive options have been developed to address this staggering statistic (FIGURE 1). Despite these innovations, the unintended pregnancy rate has increased continually since 1994 (FIGURE 2).23
What are we doing wrong? In this article, we will review how recent innovations are disseminated through the medical community in the context of three specific contraceptive technologies:
-
hysteroscopic sterilization (Essure)
-
ulipristal acetate emergency contraception (Ella)
-
the 13.5-mg levonorgestrel-releasing intrauterine system (Skyla).
In the process, we assess the available data on the intended and potential impacts of these technologies and describe how ObGyns can best translate these data when considering how to incorporate these new technologies into practice.
| FIGURE 2: Changes in the unintended pregnancy rate, 1981–2006 |
How contraceptive technologies spread in the medical community
Innovations spread through communication channels between individuals of a social network, who are then given time to adopt them. As opinion leaders of a social network become early adopters of a technology, dissemination of the innovation through the social network accelerates.4 This phenomenon is best described by the “diffusion of innovations theory” popularized in 1962 by sociologist Everett Rogers for agricultural applications; he also applied the model to public health.5 The variables he determined to be involved in the acceptance of an innovation are:
-
its relative advantage compared with existing technologies
-
compatibility with current practice
-
low complexity
-
high “trialability” (a potential adopter can easily attempt to use the innovation in his or her practice)
-
high “observability” (the results are easily observed and described to colleagues).
In contrast to new technology itself, medical evidence does not spread rapidly. Data generally spread far more slowly than new technology, typically taking longer than 10 years to influence medical practice.6,7 Opinion leaders can impair the dissemination of data by relying on anecdotal evidence to justify their recommendations.8 Negative findings that challenge these intuitive beliefs can take even longer to disseminate, allowing certain innovations to diffuse through the medical community faster than reports of any associated problems.9
Related article Let’s increase our use of IUDs and improve contraceptive effectiveness in this country Robert L. Barbieri, MD (Editorial, August 2012)
How hysteroscopic sterilization gained widespread adoption
Gariepy AM, Creinin MD, Schwarz EB, Smith KJ. Reliability of laparoscopic compared with hysteroscopic sterilization at 1 year: a decision analysis. Obstet Gynecol. 2011;118(2):273–279.
Since its introduction into the market in 2002, more than 650,000 Essure hysteroscopic sterilization procedures have been performed worldwide.10 This procedure has diffused quickly through the medical community because of the characteristics we mentioned earlier, which ease acceptance in any network:
-
Relative advantage compared with existing technologies. Compared with existing laparoscopic sterilization methods, hysteroscopic sterilization was seen as a less invasive office procedure that could be performed more cost-effectively under local anesthesia, with very high efficacy, if successful.
-
Compatibility with current practice. Because many clinicians were providing in-office hysteroscopy, adding sterilization was a simple step.
-
Low complexity. Hysteroscopic sterilization builds on operative hysteroscopic skills with which gynecologists are familiar.
-
High trialability. The manufacturer’s representatives were willing to bring the instruments to any office for clinicians to try in their practice. The company worked with hysteroscopic equipment companies to create significant discounts for providers who would perform the procedure regularly.
-
High observability. Successful deployment of the devices, and the appearance of the confirmation test, were visualized and described easily as clinicians spoke to other clinicians, helping with dissemination.
Despite these features, however, new data suggest that hysteroscopic sterilization is less effective than laparoscopic sterilization. A successful Essure procedure requires:
-
visualization of both tubal ostia on hysteroscopy
-
successful deployment of the microinserts at the appropriate position
-
hysterosalpingography at least 3 months later (with use of an alternate form of contraception in the interim)
-
demonstrated tubal occlusion by the Essure devices (not by tubal spasm) on hysterosalpingogram.
Although 5-year data collected by the makers of Essure (and posted on their Web site) show a very high rate of efficacy and a failure rate of 0.17%, these data come from women who completed all of the required steps for successful sterilization and study follow-up.
How hysteroscopic sterilization compares with the laparoscopic approach
Gariepy and colleagues created an evidence-based clinical decision analysis to estimate the probability of successful sterilization after a hysteroscopic procedure in the operating room (OR) or office versus laparoscopic sterilization. A decision analysis, which includes the range of data available to assess different outcomes, is the best methodology to provide population-level information about likelihoods, including rare events (eg, pregnancy after sterilization), in the absence of a randomized trial.
A decision analysis assigns women to outcomes based on their intended method of sterilization, mimicking real-life situations created by the multiple steps required for successful completion of the procedure and confirmation of sterilization. When the probabilities of failing these steps are taken into account, 94% and 95% of women choosing hysteroscopic sterilization in the office and OR, respectively, would be successfully sterilized within 1 year, compared with a success rate of 99% in those who opt for laparoscopic sterilization. The estimates of hysteroscopic success include 6% of women who would attempt hysteroscopy but ultimately be sterilized via laparoscopy, and 5% of women who would decline further sterilization attempts after hysteroscopic sterilization fails.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE Hysteroscopic sterilization has its advantages, including a very high efficacy rate among women who meet all the criteria for successful occlusion. Among these criteria is confirmation, by hysterosalpingography, of occlusion 3 months after deployment of the microinserts.10 However, the efficacy of hysteroscopic sterilization is inferior at a population level; therefore, it should not be used indiscriminately. Rather, hysteroscopic sterilization may be a better option for women for whom laparoscopy itself carries a high risk, such as women with complicated diabetes or severe cardiopulmonary disease. While we await similar studies or further trials that evaluate population-based estimates of pregnancy rates, women considering sterilization should be counseled accordingly. |
How limits on access can prevent widespread use of effective contraception
American College of Obstetricians and Gynecologists. Access to emergency contraception. Committee Opinion No. 542. Obstet Gynecol. 2012;120(5):1250–1253.
Ulipristal acetate as emergency contraception (EC) was introduced to the market in 2010. As was noted in this Update in 2011, ulipristal acetate is more effective than progestin-only emergency contraception and maintains this efficacy for a longer period of time.11 Despite these clear advantages, ulipristal acetate is unlikely to realize its full potential.
Data related to EC as a public health benefit have been largely disappointing. Increased access and availability have not yet reduced the unintended pregnancy rate in the United States. Although use of EC increased from 4.2% in 2002 to 11% in 2008,12 even women with a knowledge of EC do not always use it when needed.13,14
Use of ulipristal acetate, in particular, remains limited because it lacks one important requirement for rapid diffusion—access. Although it is clinically superior to the progestin-only method of EC, is compatible with current practice, and has both high trialability and high observability, access to the drug remains too complex for easy dissemination due to its prescription-only status. Because women can now obtain progestin-only EC over the counter, the use of ulipristal acetate is likely to remain low unless the access barrier to this effective oral EC regimen is reduced.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE When counseling women of reproductive age about contraception, offer them an advance prescription for ulipristal acetate and advise them of its greater efficacy, compared with progestin-only emergency contraception. |
Skyla versus other IUDs: What the data reveal
Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012;97(3):616–622.e1–e3.
The 13.5-mg levonorgestrel-releasing intrauterine system (Skyla) boasts a smaller frame and a narrower inserter than the two intrauterine devices (IUDs) already on the market (ParaGard and Mirena), a lower amount of levonorgestrel than the other levonorgestrel-releasing IUD (Mirena), and 3 years of continuous contraception. Both of the IUDs that predated Skyla are backed by data supporting their efficacy and safety in nulliparous women,15-18 but a number of clinicians and opinion leaders have stated that Skyla’s smaller frame and inserter make it an ideal IUD for the narrower cervical canal and smaller endometrial cavity of nulliparous women,19 including Gemzell-Danielsson and colleagues.
Skyla meets the prerequisites for rapid diffusion; it is highly compatible with current practice and easy to place and use. Of all these characteristics, the relative advantage granted by its size is most likely to promote its diffusion through the medical community.
Ease of placement versus Mirena
Clinical information about Skyla is currently available from two sources. The first is the product package insert, which includes selected data from the product’s Phase 3 study. This study included 1,432 participants, of whom 556 (38.8%) were nulliparous and 540 (37.7%) were treated in the United States.20
The second source is a published, peer-reviewed Phase 2 trial comparing Mirena with two smaller, lower-dose levonorgestrel-releasing devices, with the lowest-dose product corresponding to the marketed Skyla product.21 In the Phase 2 trial, all 738 women given Mirena or the smaller devices experienced successful placement, with 98.5% of placements achieved on the first attempt. Investigators rated placement for the smaller devices “easy” in 455 of 484 (94.0%) women, compared with 219 of 254 (86.2%) women given Mirena (P <.001). Most of the women given the smaller devices rated their pain with insertion as “mild pain” or “no pain,” compared with those given Mirena (72.3% vs 57.9%; P <.001). Adverse events were similar between users of the different products, except that significantly more women were classified as having an ovarian cyst among Mirena users than among users of the smaller, low-dose devices (22% vs 6%; P <.0001).
Little difference in "clinically relevant" effects
The claim that Skyla has an advantage over Mirena or ParaGard falls short on closer inspection. Although a clinician may prefer easy insertion and a patient with no pain, only very difficult or severely painful placements have clinical relevance.
Investigators rated only 4 of 254 (1.6%) Mirena insertions as “very difficult,” compared with 4 of 484 (0.8%) for the smaller devices (P=.46). Further, women found Mirena insertion to cause severe pain in only 17 of 254 (6.7%) insertions, compared with 21 of 484 (4.3%) placements of the smaller devices (P=.22). The smaller device and inserter, therefore, may have no clinical advantage.
Adverse events were similar
The data on adverse events are similarly misleading. Investigators in the Phase 2 study found that the lower-dose levonorgestrel-releasing IUDs had an 8.6% rate of ovarian cysts and the Mirena had a 22% rate (P <.0001). However, the Phase 2 study included a pelvic ultrasound examination at every visit, and ovarian cysts were included as an adverse event if the size was 3 cm or greater, regardless of symptoms.
Complaints of abdominal or low abdominal pain were as common among Mirena users as among users of the smaller devices, so this finding likely represents asymptomatic, clinically irrelevant cysts.
Most ovarian cysts found in users of the levonorgestrel-releasing intrauterine system are asymptomatic.22
Fewer Skyla users developed amenorrhea
Bleeding patterns differed between the products. Users of the smaller, low-dose device reported slightly more spotting and bleeding over the course of a month. In the Phase 2 trial, at the end of 3 years, only 12.7% of Skyla users achieved amenorrhea, compared with 23.6% of Mirena users. The amenorrhea rate for Mirena was very similar to the 20% rate reported in earlier studies,23,24 but the rate for Skyla was even lower (6%) in the larger Phase 3 study.
What about efficacy?
If there are no real advantages to be gained from the size of the device and inserter in terms of pain, and no real improvement in adverse effects or bleeding patterns, what about efficacy?
No direct comparisons are available, but if the devices are evaluated in terms of their first-year Pearl index rating from Phase 3 studies for approval in the United States, then among a cohort of 100,000 users, about 190 Mirena users would become pregnant in the first year, compared with 410 Skyla users.
All IUDs are considered highly effective contraceptives, but small relative differences can have a large impact on a population level if the methods are not used correctly or patients are not counseled appropriately. Although it is more effective than user-dependent contraceptives such as the pill, Skyla is the least effective of the highly effective methods available. If the device has any real benefits in comparison with the other IUDs, they must be better demonstrated with additional data.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
ObGyns have done much to increase the use of long-acting reversible contraceptives such as the IUD (Mirena, ParaGard), the etonogestrel implant (Implanon, Nexplanon), and the injectable contraceptive depot medroxyprogesterone acetate (Depo-Provera). We applaud this success and urge ObGyns to continue prescribing these options.
In addition, if we want to have a positive impact on the unintended pregnancy rate, we need to increase awareness of, access to, and use of the most effective contraceptive options in our community of providers and among our patients. We also need to eliminate barriers to use of the most effective methods—eg, discussing ulipristal acetate with our patients and providing advance prescriptions. We also need to be cautious about adopting some innovations, as the data for Skyla and Essure illustrate. They may be terrific options for very specific populations of women, but indiscriminate use may, paradoxically, increase the rate of unintended pregnancy.
Women spend about 5 years of their reproductive lives trying to get pregnant and the other three decades trying to avoid it.1 Nearly half of all pregnancies are unintended, and 40% of these end in abortion.2 In the past 15 years, new contraceptive options have been developed to address this staggering statistic (FIGURE 1). Despite these innovations, the unintended pregnancy rate has increased continually since 1994 (FIGURE 2).23
What are we doing wrong? In this article, we will review how recent innovations are disseminated through the medical community in the context of three specific contraceptive technologies:
-
hysteroscopic sterilization (Essure)
-
ulipristal acetate emergency contraception (Ella)
-
the 13.5-mg levonorgestrel-releasing intrauterine system (Skyla).
In the process, we assess the available data on the intended and potential impacts of these technologies and describe how ObGyns can best translate these data when considering how to incorporate these new technologies into practice.
| FIGURE 2: Changes in the unintended pregnancy rate, 1981–2006 |
How contraceptive technologies spread in the medical community
Innovations spread through communication channels between individuals of a social network, who are then given time to adopt them. As opinion leaders of a social network become early adopters of a technology, dissemination of the innovation through the social network accelerates.4 This phenomenon is best described by the “diffusion of innovations theory” popularized in 1962 by sociologist Everett Rogers for agricultural applications; he also applied the model to public health.5 The variables he determined to be involved in the acceptance of an innovation are:
-
its relative advantage compared with existing technologies
-
compatibility with current practice
-
low complexity
-
high “trialability” (a potential adopter can easily attempt to use the innovation in his or her practice)
-
high “observability” (the results are easily observed and described to colleagues).
In contrast to new technology itself, medical evidence does not spread rapidly. Data generally spread far more slowly than new technology, typically taking longer than 10 years to influence medical practice.6,7 Opinion leaders can impair the dissemination of data by relying on anecdotal evidence to justify their recommendations.8 Negative findings that challenge these intuitive beliefs can take even longer to disseminate, allowing certain innovations to diffuse through the medical community faster than reports of any associated problems.9
Related article Let’s increase our use of IUDs and improve contraceptive effectiveness in this country Robert L. Barbieri, MD (Editorial, August 2012)
How hysteroscopic sterilization gained widespread adoption
Gariepy AM, Creinin MD, Schwarz EB, Smith KJ. Reliability of laparoscopic compared with hysteroscopic sterilization at 1 year: a decision analysis. Obstet Gynecol. 2011;118(2):273–279.
Since its introduction into the market in 2002, more than 650,000 Essure hysteroscopic sterilization procedures have been performed worldwide.10 This procedure has diffused quickly through the medical community because of the characteristics we mentioned earlier, which ease acceptance in any network:
-
Relative advantage compared with existing technologies. Compared with existing laparoscopic sterilization methods, hysteroscopic sterilization was seen as a less invasive office procedure that could be performed more cost-effectively under local anesthesia, with very high efficacy, if successful.
-
Compatibility with current practice. Because many clinicians were providing in-office hysteroscopy, adding sterilization was a simple step.
-
Low complexity. Hysteroscopic sterilization builds on operative hysteroscopic skills with which gynecologists are familiar.
-
High trialability. The manufacturer’s representatives were willing to bring the instruments to any office for clinicians to try in their practice. The company worked with hysteroscopic equipment companies to create significant discounts for providers who would perform the procedure regularly.
-
High observability. Successful deployment of the devices, and the appearance of the confirmation test, were visualized and described easily as clinicians spoke to other clinicians, helping with dissemination.
Despite these features, however, new data suggest that hysteroscopic sterilization is less effective than laparoscopic sterilization. A successful Essure procedure requires:
-
visualization of both tubal ostia on hysteroscopy
-
successful deployment of the microinserts at the appropriate position
-
hysterosalpingography at least 3 months later (with use of an alternate form of contraception in the interim)
-
demonstrated tubal occlusion by the Essure devices (not by tubal spasm) on hysterosalpingogram.
Although 5-year data collected by the makers of Essure (and posted on their Web site) show a very high rate of efficacy and a failure rate of 0.17%, these data come from women who completed all of the required steps for successful sterilization and study follow-up.
How hysteroscopic sterilization compares with the laparoscopic approach
Gariepy and colleagues created an evidence-based clinical decision analysis to estimate the probability of successful sterilization after a hysteroscopic procedure in the operating room (OR) or office versus laparoscopic sterilization. A decision analysis, which includes the range of data available to assess different outcomes, is the best methodology to provide population-level information about likelihoods, including rare events (eg, pregnancy after sterilization), in the absence of a randomized trial.
A decision analysis assigns women to outcomes based on their intended method of sterilization, mimicking real-life situations created by the multiple steps required for successful completion of the procedure and confirmation of sterilization. When the probabilities of failing these steps are taken into account, 94% and 95% of women choosing hysteroscopic sterilization in the office and OR, respectively, would be successfully sterilized within 1 year, compared with a success rate of 99% in those who opt for laparoscopic sterilization. The estimates of hysteroscopic success include 6% of women who would attempt hysteroscopy but ultimately be sterilized via laparoscopy, and 5% of women who would decline further sterilization attempts after hysteroscopic sterilization fails.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE Hysteroscopic sterilization has its advantages, including a very high efficacy rate among women who meet all the criteria for successful occlusion. Among these criteria is confirmation, by hysterosalpingography, of occlusion 3 months after deployment of the microinserts.10 However, the efficacy of hysteroscopic sterilization is inferior at a population level; therefore, it should not be used indiscriminately. Rather, hysteroscopic sterilization may be a better option for women for whom laparoscopy itself carries a high risk, such as women with complicated diabetes or severe cardiopulmonary disease. While we await similar studies or further trials that evaluate population-based estimates of pregnancy rates, women considering sterilization should be counseled accordingly. |
How limits on access can prevent widespread use of effective contraception
American College of Obstetricians and Gynecologists. Access to emergency contraception. Committee Opinion No. 542. Obstet Gynecol. 2012;120(5):1250–1253.
Ulipristal acetate as emergency contraception (EC) was introduced to the market in 2010. As was noted in this Update in 2011, ulipristal acetate is more effective than progestin-only emergency contraception and maintains this efficacy for a longer period of time.11 Despite these clear advantages, ulipristal acetate is unlikely to realize its full potential.
Data related to EC as a public health benefit have been largely disappointing. Increased access and availability have not yet reduced the unintended pregnancy rate in the United States. Although use of EC increased from 4.2% in 2002 to 11% in 2008,12 even women with a knowledge of EC do not always use it when needed.13,14
Use of ulipristal acetate, in particular, remains limited because it lacks one important requirement for rapid diffusion—access. Although it is clinically superior to the progestin-only method of EC, is compatible with current practice, and has both high trialability and high observability, access to the drug remains too complex for easy dissemination due to its prescription-only status. Because women can now obtain progestin-only EC over the counter, the use of ulipristal acetate is likely to remain low unless the access barrier to this effective oral EC regimen is reduced.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE When counseling women of reproductive age about contraception, offer them an advance prescription for ulipristal acetate and advise them of its greater efficacy, compared with progestin-only emergency contraception. |
Skyla versus other IUDs: What the data reveal
Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012;97(3):616–622.e1–e3.
The 13.5-mg levonorgestrel-releasing intrauterine system (Skyla) boasts a smaller frame and a narrower inserter than the two intrauterine devices (IUDs) already on the market (ParaGard and Mirena), a lower amount of levonorgestrel than the other levonorgestrel-releasing IUD (Mirena), and 3 years of continuous contraception. Both of the IUDs that predated Skyla are backed by data supporting their efficacy and safety in nulliparous women,15-18 but a number of clinicians and opinion leaders have stated that Skyla’s smaller frame and inserter make it an ideal IUD for the narrower cervical canal and smaller endometrial cavity of nulliparous women,19 including Gemzell-Danielsson and colleagues.
Skyla meets the prerequisites for rapid diffusion; it is highly compatible with current practice and easy to place and use. Of all these characteristics, the relative advantage granted by its size is most likely to promote its diffusion through the medical community.
Ease of placement versus Mirena
Clinical information about Skyla is currently available from two sources. The first is the product package insert, which includes selected data from the product’s Phase 3 study. This study included 1,432 participants, of whom 556 (38.8%) were nulliparous and 540 (37.7%) were treated in the United States.20
The second source is a published, peer-reviewed Phase 2 trial comparing Mirena with two smaller, lower-dose levonorgestrel-releasing devices, with the lowest-dose product corresponding to the marketed Skyla product.21 In the Phase 2 trial, all 738 women given Mirena or the smaller devices experienced successful placement, with 98.5% of placements achieved on the first attempt. Investigators rated placement for the smaller devices “easy” in 455 of 484 (94.0%) women, compared with 219 of 254 (86.2%) women given Mirena (P <.001). Most of the women given the smaller devices rated their pain with insertion as “mild pain” or “no pain,” compared with those given Mirena (72.3% vs 57.9%; P <.001). Adverse events were similar between users of the different products, except that significantly more women were classified as having an ovarian cyst among Mirena users than among users of the smaller, low-dose devices (22% vs 6%; P <.0001).
Little difference in "clinically relevant" effects
The claim that Skyla has an advantage over Mirena or ParaGard falls short on closer inspection. Although a clinician may prefer easy insertion and a patient with no pain, only very difficult or severely painful placements have clinical relevance.
Investigators rated only 4 of 254 (1.6%) Mirena insertions as “very difficult,” compared with 4 of 484 (0.8%) for the smaller devices (P=.46). Further, women found Mirena insertion to cause severe pain in only 17 of 254 (6.7%) insertions, compared with 21 of 484 (4.3%) placements of the smaller devices (P=.22). The smaller device and inserter, therefore, may have no clinical advantage.
Adverse events were similar
The data on adverse events are similarly misleading. Investigators in the Phase 2 study found that the lower-dose levonorgestrel-releasing IUDs had an 8.6% rate of ovarian cysts and the Mirena had a 22% rate (P <.0001). However, the Phase 2 study included a pelvic ultrasound examination at every visit, and ovarian cysts were included as an adverse event if the size was 3 cm or greater, regardless of symptoms.
Complaints of abdominal or low abdominal pain were as common among Mirena users as among users of the smaller devices, so this finding likely represents asymptomatic, clinically irrelevant cysts.
Most ovarian cysts found in users of the levonorgestrel-releasing intrauterine system are asymptomatic.22
Fewer Skyla users developed amenorrhea
Bleeding patterns differed between the products. Users of the smaller, low-dose device reported slightly more spotting and bleeding over the course of a month. In the Phase 2 trial, at the end of 3 years, only 12.7% of Skyla users achieved amenorrhea, compared with 23.6% of Mirena users. The amenorrhea rate for Mirena was very similar to the 20% rate reported in earlier studies,23,24 but the rate for Skyla was even lower (6%) in the larger Phase 3 study.
What about efficacy?
If there are no real advantages to be gained from the size of the device and inserter in terms of pain, and no real improvement in adverse effects or bleeding patterns, what about efficacy?
No direct comparisons are available, but if the devices are evaluated in terms of their first-year Pearl index rating from Phase 3 studies for approval in the United States, then among a cohort of 100,000 users, about 190 Mirena users would become pregnant in the first year, compared with 410 Skyla users.
All IUDs are considered highly effective contraceptives, but small relative differences can have a large impact on a population level if the methods are not used correctly or patients are not counseled appropriately. Although it is more effective than user-dependent contraceptives such as the pill, Skyla is the least effective of the highly effective methods available. If the device has any real benefits in comparison with the other IUDs, they must be better demonstrated with additional data.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
ObGyns have done much to increase the use of long-acting reversible contraceptives such as the IUD (Mirena, ParaGard), the etonogestrel implant (Implanon, Nexplanon), and the injectable contraceptive depot medroxyprogesterone acetate (Depo-Provera). We applaud this success and urge ObGyns to continue prescribing these options.
In addition, if we want to have a positive impact on the unintended pregnancy rate, we need to increase awareness of, access to, and use of the most effective contraceptive options in our community of providers and among our patients. We also need to eliminate barriers to use of the most effective methods—eg, discussing ulipristal acetate with our patients and providing advance prescriptions. We also need to be cautious about adopting some innovations, as the data for Skyla and Essure illustrate. They may be terrific options for very specific populations of women, but indiscriminate use may, paradoxically, increase the rate of unintended pregnancy.
Women spend about 5 years of their reproductive lives trying to get pregnant and the other three decades trying to avoid it.1 Nearly half of all pregnancies are unintended, and 40% of these end in abortion.2 In the past 15 years, new contraceptive options have been developed to address this staggering statistic (FIGURE 1). Despite these innovations, the unintended pregnancy rate has increased continually since 1994 (FIGURE 2).23
What are we doing wrong? In this article, we will review how recent innovations are disseminated through the medical community in the context of three specific contraceptive technologies:
-
hysteroscopic sterilization (Essure)
-
ulipristal acetate emergency contraception (Ella)
-
the 13.5-mg levonorgestrel-releasing intrauterine system (Skyla).
In the process, we assess the available data on the intended and potential impacts of these technologies and describe how ObGyns can best translate these data when considering how to incorporate these new technologies into practice.
| FIGURE 2: Changes in the unintended pregnancy rate, 1981–2006 |
How contraceptive technologies spread in the medical community
Innovations spread through communication channels between individuals of a social network, who are then given time to adopt them. As opinion leaders of a social network become early adopters of a technology, dissemination of the innovation through the social network accelerates.4 This phenomenon is best described by the “diffusion of innovations theory” popularized in 1962 by sociologist Everett Rogers for agricultural applications; he also applied the model to public health.5 The variables he determined to be involved in the acceptance of an innovation are:
-
its relative advantage compared with existing technologies
-
compatibility with current practice
-
low complexity
-
high “trialability” (a potential adopter can easily attempt to use the innovation in his or her practice)
-
high “observability” (the results are easily observed and described to colleagues).
In contrast to new technology itself, medical evidence does not spread rapidly. Data generally spread far more slowly than new technology, typically taking longer than 10 years to influence medical practice.6,7 Opinion leaders can impair the dissemination of data by relying on anecdotal evidence to justify their recommendations.8 Negative findings that challenge these intuitive beliefs can take even longer to disseminate, allowing certain innovations to diffuse through the medical community faster than reports of any associated problems.9
Related article Let’s increase our use of IUDs and improve contraceptive effectiveness in this country Robert L. Barbieri, MD (Editorial, August 2012)
How hysteroscopic sterilization gained widespread adoption
Gariepy AM, Creinin MD, Schwarz EB, Smith KJ. Reliability of laparoscopic compared with hysteroscopic sterilization at 1 year: a decision analysis. Obstet Gynecol. 2011;118(2):273–279.
Since its introduction into the market in 2002, more than 650,000 Essure hysteroscopic sterilization procedures have been performed worldwide.10 This procedure has diffused quickly through the medical community because of the characteristics we mentioned earlier, which ease acceptance in any network:
-
Relative advantage compared with existing technologies. Compared with existing laparoscopic sterilization methods, hysteroscopic sterilization was seen as a less invasive office procedure that could be performed more cost-effectively under local anesthesia, with very high efficacy, if successful.
-
Compatibility with current practice. Because many clinicians were providing in-office hysteroscopy, adding sterilization was a simple step.
-
Low complexity. Hysteroscopic sterilization builds on operative hysteroscopic skills with which gynecologists are familiar.
-
High trialability. The manufacturer’s representatives were willing to bring the instruments to any office for clinicians to try in their practice. The company worked with hysteroscopic equipment companies to create significant discounts for providers who would perform the procedure regularly.
-
High observability. Successful deployment of the devices, and the appearance of the confirmation test, were visualized and described easily as clinicians spoke to other clinicians, helping with dissemination.
Despite these features, however, new data suggest that hysteroscopic sterilization is less effective than laparoscopic sterilization. A successful Essure procedure requires:
-
visualization of both tubal ostia on hysteroscopy
-
successful deployment of the microinserts at the appropriate position
-
hysterosalpingography at least 3 months later (with use of an alternate form of contraception in the interim)
-
demonstrated tubal occlusion by the Essure devices (not by tubal spasm) on hysterosalpingogram.
Although 5-year data collected by the makers of Essure (and posted on their Web site) show a very high rate of efficacy and a failure rate of 0.17%, these data come from women who completed all of the required steps for successful sterilization and study follow-up.
How hysteroscopic sterilization compares with the laparoscopic approach
Gariepy and colleagues created an evidence-based clinical decision analysis to estimate the probability of successful sterilization after a hysteroscopic procedure in the operating room (OR) or office versus laparoscopic sterilization. A decision analysis, which includes the range of data available to assess different outcomes, is the best methodology to provide population-level information about likelihoods, including rare events (eg, pregnancy after sterilization), in the absence of a randomized trial.
A decision analysis assigns women to outcomes based on their intended method of sterilization, mimicking real-life situations created by the multiple steps required for successful completion of the procedure and confirmation of sterilization. When the probabilities of failing these steps are taken into account, 94% and 95% of women choosing hysteroscopic sterilization in the office and OR, respectively, would be successfully sterilized within 1 year, compared with a success rate of 99% in those who opt for laparoscopic sterilization. The estimates of hysteroscopic success include 6% of women who would attempt hysteroscopy but ultimately be sterilized via laparoscopy, and 5% of women who would decline further sterilization attempts after hysteroscopic sterilization fails.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE Hysteroscopic sterilization has its advantages, including a very high efficacy rate among women who meet all the criteria for successful occlusion. Among these criteria is confirmation, by hysterosalpingography, of occlusion 3 months after deployment of the microinserts.10 However, the efficacy of hysteroscopic sterilization is inferior at a population level; therefore, it should not be used indiscriminately. Rather, hysteroscopic sterilization may be a better option for women for whom laparoscopy itself carries a high risk, such as women with complicated diabetes or severe cardiopulmonary disease. While we await similar studies or further trials that evaluate population-based estimates of pregnancy rates, women considering sterilization should be counseled accordingly. |
How limits on access can prevent widespread use of effective contraception
American College of Obstetricians and Gynecologists. Access to emergency contraception. Committee Opinion No. 542. Obstet Gynecol. 2012;120(5):1250–1253.
Ulipristal acetate as emergency contraception (EC) was introduced to the market in 2010. As was noted in this Update in 2011, ulipristal acetate is more effective than progestin-only emergency contraception and maintains this efficacy for a longer period of time.11 Despite these clear advantages, ulipristal acetate is unlikely to realize its full potential.
Data related to EC as a public health benefit have been largely disappointing. Increased access and availability have not yet reduced the unintended pregnancy rate in the United States. Although use of EC increased from 4.2% in 2002 to 11% in 2008,12 even women with a knowledge of EC do not always use it when needed.13,14
Use of ulipristal acetate, in particular, remains limited because it lacks one important requirement for rapid diffusion—access. Although it is clinically superior to the progestin-only method of EC, is compatible with current practice, and has both high trialability and high observability, access to the drug remains too complex for easy dissemination due to its prescription-only status. Because women can now obtain progestin-only EC over the counter, the use of ulipristal acetate is likely to remain low unless the access barrier to this effective oral EC regimen is reduced.
|
WHAT THIS EVIDENCE MEANS FOR PRACTICE When counseling women of reproductive age about contraception, offer them an advance prescription for ulipristal acetate and advise them of its greater efficacy, compared with progestin-only emergency contraception. |
Skyla versus other IUDs: What the data reveal
Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012;97(3):616–622.e1–e3.
The 13.5-mg levonorgestrel-releasing intrauterine system (Skyla) boasts a smaller frame and a narrower inserter than the two intrauterine devices (IUDs) already on the market (ParaGard and Mirena), a lower amount of levonorgestrel than the other levonorgestrel-releasing IUD (Mirena), and 3 years of continuous contraception. Both of the IUDs that predated Skyla are backed by data supporting their efficacy and safety in nulliparous women,15-18 but a number of clinicians and opinion leaders have stated that Skyla’s smaller frame and inserter make it an ideal IUD for the narrower cervical canal and smaller endometrial cavity of nulliparous women,19 including Gemzell-Danielsson and colleagues.
Skyla meets the prerequisites for rapid diffusion; it is highly compatible with current practice and easy to place and use. Of all these characteristics, the relative advantage granted by its size is most likely to promote its diffusion through the medical community.
Ease of placement versus Mirena
Clinical information about Skyla is currently available from two sources. The first is the product package insert, which includes selected data from the product’s Phase 3 study. This study included 1,432 participants, of whom 556 (38.8%) were nulliparous and 540 (37.7%) were treated in the United States.20
The second source is a published, peer-reviewed Phase 2 trial comparing Mirena with two smaller, lower-dose levonorgestrel-releasing devices, with the lowest-dose product corresponding to the marketed Skyla product.21 In the Phase 2 trial, all 738 women given Mirena or the smaller devices experienced successful placement, with 98.5% of placements achieved on the first attempt. Investigators rated placement for the smaller devices “easy” in 455 of 484 (94.0%) women, compared with 219 of 254 (86.2%) women given Mirena (P <.001). Most of the women given the smaller devices rated their pain with insertion as “mild pain” or “no pain,” compared with those given Mirena (72.3% vs 57.9%; P <.001). Adverse events were similar between users of the different products, except that significantly more women were classified as having an ovarian cyst among Mirena users than among users of the smaller, low-dose devices (22% vs 6%; P <.0001).
Little difference in "clinically relevant" effects
The claim that Skyla has an advantage over Mirena or ParaGard falls short on closer inspection. Although a clinician may prefer easy insertion and a patient with no pain, only very difficult or severely painful placements have clinical relevance.
Investigators rated only 4 of 254 (1.6%) Mirena insertions as “very difficult,” compared with 4 of 484 (0.8%) for the smaller devices (P=.46). Further, women found Mirena insertion to cause severe pain in only 17 of 254 (6.7%) insertions, compared with 21 of 484 (4.3%) placements of the smaller devices (P=.22). The smaller device and inserter, therefore, may have no clinical advantage.
Adverse events were similar
The data on adverse events are similarly misleading. Investigators in the Phase 2 study found that the lower-dose levonorgestrel-releasing IUDs had an 8.6% rate of ovarian cysts and the Mirena had a 22% rate (P <.0001). However, the Phase 2 study included a pelvic ultrasound examination at every visit, and ovarian cysts were included as an adverse event if the size was 3 cm or greater, regardless of symptoms.
Complaints of abdominal or low abdominal pain were as common among Mirena users as among users of the smaller devices, so this finding likely represents asymptomatic, clinically irrelevant cysts.
Most ovarian cysts found in users of the levonorgestrel-releasing intrauterine system are asymptomatic.22
Fewer Skyla users developed amenorrhea
Bleeding patterns differed between the products. Users of the smaller, low-dose device reported slightly more spotting and bleeding over the course of a month. In the Phase 2 trial, at the end of 3 years, only 12.7% of Skyla users achieved amenorrhea, compared with 23.6% of Mirena users. The amenorrhea rate for Mirena was very similar to the 20% rate reported in earlier studies,23,24 but the rate for Skyla was even lower (6%) in the larger Phase 3 study.
What about efficacy?
If there are no real advantages to be gained from the size of the device and inserter in terms of pain, and no real improvement in adverse effects or bleeding patterns, what about efficacy?
No direct comparisons are available, but if the devices are evaluated in terms of their first-year Pearl index rating from Phase 3 studies for approval in the United States, then among a cohort of 100,000 users, about 190 Mirena users would become pregnant in the first year, compared with 410 Skyla users.
All IUDs are considered highly effective contraceptives, but small relative differences can have a large impact on a population level if the methods are not used correctly or patients are not counseled appropriately. Although it is more effective than user-dependent contraceptives such as the pill, Skyla is the least effective of the highly effective methods available. If the device has any real benefits in comparison with the other IUDs, they must be better demonstrated with additional data.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
ObGyns have done much to increase the use of long-acting reversible contraceptives such as the IUD (Mirena, ParaGard), the etonogestrel implant (Implanon, Nexplanon), and the injectable contraceptive depot medroxyprogesterone acetate (Depo-Provera). We applaud this success and urge ObGyns to continue prescribing these options.
In addition, if we want to have a positive impact on the unintended pregnancy rate, we need to increase awareness of, access to, and use of the most effective contraceptive options in our community of providers and among our patients. We also need to eliminate barriers to use of the most effective methods—eg, discussing ulipristal acetate with our patients and providing advance prescriptions. We also need to be cautious about adopting some innovations, as the data for Skyla and Essure illustrate. They may be terrific options for very specific populations of women, but indiscriminate use may, paradoxically, increase the rate of unintended pregnancy.
The chicken or the egg: Obesity or psoriasis?
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MILWAUKEE – Excess adiposity occurred prior to psoriasis in 93% of 29 overweight and obese psoriatic children, in a chart review examining the relationship between psoriasis and obesity.
Further, 78% of patients were obese before developing psoriasis, Dr. Lauren Becker reported at the annual meeting of the Society for Pediatric Dermatology.
Although the authors anticipated that most of the children would show increased adiposity before psoriasis based on clinical observations, "none of us predicted that it would be 27 of 29," she said in an interview. "It really was incredible, and even the ones who were normal weight became overweight or obese within a year of their psoriasis."
The review was sparked by a recent international study, led by senior author Dr. Amy Paller of Northwestern University in Chicago, in which 38% of psoriatic children had excess central adiposity (high waist-to-height ratio) compared with 21% of controls. The odds of obesity were also several times higher than those reported for adults with psoriasis, jumping 4.29-fold overall in psoriatic children versus controls, 4.92-fold in those with severe versus mild psoriasis, and 7.6-fold in the United States. (JAMA Dermatol. 2013;149:166-76).
Although other studies in children support an association between obesity and psoriasis, the international study was the first to measure central adiposity, a more sensitive indicator of cardiovascular risk in children than BMI, Dr. Kelly Cordoro remarked in a separate lecture on the comorbidities of pediatric psoriasis at the meeting.
"Adiposity, hypertension, hyperlipidemia, and diabetes are increased in prevalence among pediatric psoriasis patients, but the obesity association is the strongest," she said. "It’s global, and the effect is most pronounced in the United States, where in particular, central obesity is highest and has the accompanying higher cardiovascular risk."
Previous research has shown that obesity is strongly correlated with psoriasis in adults. A recent meta-analysis showed that psoriatic adults were more likely to be obese than those without psoriasis (pooled odds ratio, 1.66), and that the odds were even higher in patients with severe versus mild psoriasis (OR, 2.23, vs. OR, 1.46) (Nutr. Diabetes 2012 ;2:e54).
Both clinicians observed that psoriasis and obesity are chronic inflammatory states, marked by overexpression of circulating proinflammatory cytokines derived from Th1 and Th17 lymphocyte subsets, as well as tumor necrosis factor–alpha and adipokines. In addition, a fat cell is a microenvironment of inflammation, with adipose tissue releasing proinflammatory cytokines such as interleukin-6 and TNF-alpha.
The two diseases drive one another, but the exact relationship remains unclear, said Dr. Becker, a pediatrician and dermatology fellow at Northwestern at the time of the study. In addition, the impact on quality of life and social interactions of being both obese or overweight and having psoriasis may predispose patients to mental and physical health problems.
"Children with excess adiposity or with the highly visible lesions of psoriasis are more often teased or bullied, which may contribute to the tendency to become socially isolated, decrease physical activity, and increase eating," she said. "It really is a vicious circle."
Although the data are clear that psoriasis and obesity are associated, the current chart review suggesting that obesity precedes psoriasis is too small to definitively answer the question, Dr. Cordoro, a pediatric dermatologist at the University of California, San Francisco, said in an interview.
Dr. Becker said obesity clearly came before psoriasis in their study cohort, but agreed that further study is needed to confirm the results. She also stressed the need for biomarker analyses to identify overweight/obese children who are at risk for psoriasis, and studies to address whether weight loss can reverse the severity of pediatric psoriasis.
For example, data from a study of overweight psoriatic adults showed that eating a low-calorie diet improved psoriasis severity and quality of life after 4 months (JAMA Dermatol. 2013;149:795-801).
However, in the absence of adequate data, clinicians should consider metabolic testing to determine whether their overweight pediatric patients are on the path to the metabolic syndrome, Dr. Becker and Dr. Cordoro suggested. Metabolic testing was not performed on any of the 29 children in the chart review, although 48% had a family history of hyperlipidemia and 45% had a family history of obesity.
The average age of the children was 12.6 years; the average age of onset of obesity was 4 years (range, 2-12 years), and the average age of onset of psoriasis was 9 years (range, 2-14 years).
Two obese patients were able to reduce their BMIs from obese to overweight status 1 year after being diagnosed with psoriasis; however, both have remained in the 85th-95th BMI percentile for more than 2 years, Dr. Becker said. Both of the children who had a normal BMI prior to their psoriasis had a BMI in the overweight or obese range within 1 year after diagnosis, Dr. Becker noted.
Dr. Cordoro also made an impassioned plea for clinicians to address the significant psychosocial comorbidity present in psoriatic children.
"You can think about obesity, psoriasis, and depression as being reciprocal exacerbating factors, such that each triggers the other and represents an insult to self-esteem and the overall well-being of these patients," she said. "They end up having high stress levels and really dismal quality of life. These issues are as important in the management of the child as the medical considerations."
Dr. Becker, her coauthors, and Dr. Cordoro reported having no relevant financial disclosures.
To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.
Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.
MILWAUKEE – Excess adiposity occurred prior to psoriasis in 93% of 29 overweight and obese psoriatic children, in a chart review examining the relationship between psoriasis and obesity.
Further, 78% of patients were obese before developing psoriasis, Dr. Lauren Becker reported at the annual meeting of the Society for Pediatric Dermatology.
Although the authors anticipated that most of the children would show increased adiposity before psoriasis based on clinical observations, "none of us predicted that it would be 27 of 29," she said in an interview. "It really was incredible, and even the ones who were normal weight became overweight or obese within a year of their psoriasis."
The review was sparked by a recent international study, led by senior author Dr. Amy Paller of Northwestern University in Chicago, in which 38% of psoriatic children had excess central adiposity (high waist-to-height ratio) compared with 21% of controls. The odds of obesity were also several times higher than those reported for adults with psoriasis, jumping 4.29-fold overall in psoriatic children versus controls, 4.92-fold in those with severe versus mild psoriasis, and 7.6-fold in the United States. (JAMA Dermatol. 2013;149:166-76).
Although other studies in children support an association between obesity and psoriasis, the international study was the first to measure central adiposity, a more sensitive indicator of cardiovascular risk in children than BMI, Dr. Kelly Cordoro remarked in a separate lecture on the comorbidities of pediatric psoriasis at the meeting.
"Adiposity, hypertension, hyperlipidemia, and diabetes are increased in prevalence among pediatric psoriasis patients, but the obesity association is the strongest," she said. "It’s global, and the effect is most pronounced in the United States, where in particular, central obesity is highest and has the accompanying higher cardiovascular risk."
Previous research has shown that obesity is strongly correlated with psoriasis in adults. A recent meta-analysis showed that psoriatic adults were more likely to be obese than those without psoriasis (pooled odds ratio, 1.66), and that the odds were even higher in patients with severe versus mild psoriasis (OR, 2.23, vs. OR, 1.46) (Nutr. Diabetes 2012 ;2:e54).
Both clinicians observed that psoriasis and obesity are chronic inflammatory states, marked by overexpression of circulating proinflammatory cytokines derived from Th1 and Th17 lymphocyte subsets, as well as tumor necrosis factor–alpha and adipokines. In addition, a fat cell is a microenvironment of inflammation, with adipose tissue releasing proinflammatory cytokines such as interleukin-6 and TNF-alpha.
The two diseases drive one another, but the exact relationship remains unclear, said Dr. Becker, a pediatrician and dermatology fellow at Northwestern at the time of the study. In addition, the impact on quality of life and social interactions of being both obese or overweight and having psoriasis may predispose patients to mental and physical health problems.
"Children with excess adiposity or with the highly visible lesions of psoriasis are more often teased or bullied, which may contribute to the tendency to become socially isolated, decrease physical activity, and increase eating," she said. "It really is a vicious circle."
Although the data are clear that psoriasis and obesity are associated, the current chart review suggesting that obesity precedes psoriasis is too small to definitively answer the question, Dr. Cordoro, a pediatric dermatologist at the University of California, San Francisco, said in an interview.
Dr. Becker said obesity clearly came before psoriasis in their study cohort, but agreed that further study is needed to confirm the results. She also stressed the need for biomarker analyses to identify overweight/obese children who are at risk for psoriasis, and studies to address whether weight loss can reverse the severity of pediatric psoriasis.
For example, data from a study of overweight psoriatic adults showed that eating a low-calorie diet improved psoriasis severity and quality of life after 4 months (JAMA Dermatol. 2013;149:795-801).
However, in the absence of adequate data, clinicians should consider metabolic testing to determine whether their overweight pediatric patients are on the path to the metabolic syndrome, Dr. Becker and Dr. Cordoro suggested. Metabolic testing was not performed on any of the 29 children in the chart review, although 48% had a family history of hyperlipidemia and 45% had a family history of obesity.
The average age of the children was 12.6 years; the average age of onset of obesity was 4 years (range, 2-12 years), and the average age of onset of psoriasis was 9 years (range, 2-14 years).
Two obese patients were able to reduce their BMIs from obese to overweight status 1 year after being diagnosed with psoriasis; however, both have remained in the 85th-95th BMI percentile for more than 2 years, Dr. Becker said. Both of the children who had a normal BMI prior to their psoriasis had a BMI in the overweight or obese range within 1 year after diagnosis, Dr. Becker noted.
Dr. Cordoro also made an impassioned plea for clinicians to address the significant psychosocial comorbidity present in psoriatic children.
"You can think about obesity, psoriasis, and depression as being reciprocal exacerbating factors, such that each triggers the other and represents an insult to self-esteem and the overall well-being of these patients," she said. "They end up having high stress levels and really dismal quality of life. These issues are as important in the management of the child as the medical considerations."
Dr. Becker, her coauthors, and Dr. Cordoro reported having no relevant financial disclosures.
To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.
Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.
MILWAUKEE – Excess adiposity occurred prior to psoriasis in 93% of 29 overweight and obese psoriatic children, in a chart review examining the relationship between psoriasis and obesity.
Further, 78% of patients were obese before developing psoriasis, Dr. Lauren Becker reported at the annual meeting of the Society for Pediatric Dermatology.
Although the authors anticipated that most of the children would show increased adiposity before psoriasis based on clinical observations, "none of us predicted that it would be 27 of 29," she said in an interview. "It really was incredible, and even the ones who were normal weight became overweight or obese within a year of their psoriasis."
The review was sparked by a recent international study, led by senior author Dr. Amy Paller of Northwestern University in Chicago, in which 38% of psoriatic children had excess central adiposity (high waist-to-height ratio) compared with 21% of controls. The odds of obesity were also several times higher than those reported for adults with psoriasis, jumping 4.29-fold overall in psoriatic children versus controls, 4.92-fold in those with severe versus mild psoriasis, and 7.6-fold in the United States. (JAMA Dermatol. 2013;149:166-76).
Although other studies in children support an association between obesity and psoriasis, the international study was the first to measure central adiposity, a more sensitive indicator of cardiovascular risk in children than BMI, Dr. Kelly Cordoro remarked in a separate lecture on the comorbidities of pediatric psoriasis at the meeting.
"Adiposity, hypertension, hyperlipidemia, and diabetes are increased in prevalence among pediatric psoriasis patients, but the obesity association is the strongest," she said. "It’s global, and the effect is most pronounced in the United States, where in particular, central obesity is highest and has the accompanying higher cardiovascular risk."
Previous research has shown that obesity is strongly correlated with psoriasis in adults. A recent meta-analysis showed that psoriatic adults were more likely to be obese than those without psoriasis (pooled odds ratio, 1.66), and that the odds were even higher in patients with severe versus mild psoriasis (OR, 2.23, vs. OR, 1.46) (Nutr. Diabetes 2012 ;2:e54).
Both clinicians observed that psoriasis and obesity are chronic inflammatory states, marked by overexpression of circulating proinflammatory cytokines derived from Th1 and Th17 lymphocyte subsets, as well as tumor necrosis factor–alpha and adipokines. In addition, a fat cell is a microenvironment of inflammation, with adipose tissue releasing proinflammatory cytokines such as interleukin-6 and TNF-alpha.
The two diseases drive one another, but the exact relationship remains unclear, said Dr. Becker, a pediatrician and dermatology fellow at Northwestern at the time of the study. In addition, the impact on quality of life and social interactions of being both obese or overweight and having psoriasis may predispose patients to mental and physical health problems.
"Children with excess adiposity or with the highly visible lesions of psoriasis are more often teased or bullied, which may contribute to the tendency to become socially isolated, decrease physical activity, and increase eating," she said. "It really is a vicious circle."
Although the data are clear that psoriasis and obesity are associated, the current chart review suggesting that obesity precedes psoriasis is too small to definitively answer the question, Dr. Cordoro, a pediatric dermatologist at the University of California, San Francisco, said in an interview.
Dr. Becker said obesity clearly came before psoriasis in their study cohort, but agreed that further study is needed to confirm the results. She also stressed the need for biomarker analyses to identify overweight/obese children who are at risk for psoriasis, and studies to address whether weight loss can reverse the severity of pediatric psoriasis.
For example, data from a study of overweight psoriatic adults showed that eating a low-calorie diet improved psoriasis severity and quality of life after 4 months (JAMA Dermatol. 2013;149:795-801).
However, in the absence of adequate data, clinicians should consider metabolic testing to determine whether their overweight pediatric patients are on the path to the metabolic syndrome, Dr. Becker and Dr. Cordoro suggested. Metabolic testing was not performed on any of the 29 children in the chart review, although 48% had a family history of hyperlipidemia and 45% had a family history of obesity.
The average age of the children was 12.6 years; the average age of onset of obesity was 4 years (range, 2-12 years), and the average age of onset of psoriasis was 9 years (range, 2-14 years).
Two obese patients were able to reduce their BMIs from obese to overweight status 1 year after being diagnosed with psoriasis; however, both have remained in the 85th-95th BMI percentile for more than 2 years, Dr. Becker said. Both of the children who had a normal BMI prior to their psoriasis had a BMI in the overweight or obese range within 1 year after diagnosis, Dr. Becker noted.
Dr. Cordoro also made an impassioned plea for clinicians to address the significant psychosocial comorbidity present in psoriatic children.
"You can think about obesity, psoriasis, and depression as being reciprocal exacerbating factors, such that each triggers the other and represents an insult to self-esteem and the overall well-being of these patients," she said. "They end up having high stress levels and really dismal quality of life. These issues are as important in the management of the child as the medical considerations."
Dr. Becker, her coauthors, and Dr. Cordoro reported having no relevant financial disclosures.
To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.
AT THE SPD ANNUAL MEETING
Painful Nail with Longitudinal Erythronychia
A 46-year-old Caucasian woman was referred to our dermatology clinic with a one year history of progressively increasing pain radiating from the proximal nail fold of her right middle finger. She denied any history of trauma and noted that the pain was worse when her finger was exposed to cold.
On examination, we noted that there was a red line that extended the length of the nail, beginning at the area of pain and ending distally, where the nail split (FIGURE).
FIGURE
Red line extends from area of pain to area of nail splitting
What is your diagnosis?
How would you treat this patient?
Diagnosis: Subungual glomus tumor
Glomus tumor is a rare vascular neoplasm derived from the cells of the glomus body, a specialized arteriovenous shunt involved in temperature regulation. Glomus bodies are most abundant in the extremities, and 75% of glomus tumors are found in the hand.1 The most common location is the subungual region, where glomus bodies are highly concentrated.
These lesions are typically benign, although a malignant variant has been reported in 1% of cases.1,2 Glomus tumors are most common in adults 30 to 50 years of age, with subungual tumors occurring more often in women.3 The majority of glomus tumors are solitary and less than 1 cm in size.2,4 Multiple tumors may be familial and tend to occur in children.2,4
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital practitioners made the correct diagnosis.Patients with subungual glomus tumors present with intense pain that they may describe as shooting or pulsating in nature.
The pain may be spontaneous or triggered by mild trauma or changes in temperature—especially warm to cold. The classic triad of symptoms includes pinpoint tenderness, paroxysmal pain, and cold hypersensitivity. 3,4 The glomus tumor may appear as a focal bluish to erythematous discoloration visible through the nail plate, and in some cases the tumor may form a palpable nodule. Nail deformities such as ridging and distal fissuring occur in approximately one-third of patients.4
Longitudinal erythronychia, as seen in our patient, results when the glomus tumor exerts pressure on the distal nail matrix. This force leads to a thinning of the nail plate and the formation of a groove on the ventral surface of the nail. Swelling of the underlying nail bed with engorgement of vessels produces the red streak that is seen through the thinned nail.5 And, because the affected portion of the nail is fragile, it tends to split distally.
Longitudinal erythronychia with nail dystrophy involving multiple nails is also seen in inflammatory diseases, such as lichen planus and Darier disease, due to multifocal loss of nail matrix function.5
Differential Dx includes subungual warts, Bowen’s disease
Clinical mimics of glomus tumors include neuromas, melanomas, Bowen’s disease, arthritis, gout, paronychia, causalgia, subungual exostosis, osteochondroma, and subungual warts. (The TABLE1,6-8 describes some of the more common mimics.)
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital-based practitioners correctly made the diagnosis.3
Suspect a glomus tumor? Perform these tests
Three clinical tests can aid in evaluating for glomus tumors.
- Love’s test involves applying pressure to the affected fingertip using the head of a pin or the end of a paperclip. The point of maximal tenderness locates the tumor.
- In Hildreth’s test, the physician applies a tourniquet to the digit and repeats the Love’s test. The test is considered suggestive of glomus tumor if the patient no longer experiences tenderness with pressure.
- The cold sensitivity test requires that the physician expose the finger to cold by, say, placing the finger in an ice bath. This exposure will elicit increased pain in a patient who has a glomus tumor.
The sensitivity and specificity of these tests, according to one study involving 18 patients, is as follows: Love’s test (100%, 78%); Hildreth’s test (77.4%, 100%); and the cold sensitivity test (100%, 100%).9 Clinical suspicion must be confirmed by histopathologic examination and the patient must be alerted to the risks of biopsy, which include permanent nail deformity.
In addition, imaging studies may aid in the diagnosis as well as determine the preoperative size and location of the tumor. Radiography may show bone erosion in certain cases, and it is useful in differentiating a glomus tumor from subungual exostosis.10 Magnetic resonance imaging and ultrasound imaging have also been used to identify glomus tumors and to aid in determining the method of excision.10,11
Surgical excision is the preferred approach
While there are reports of successful treatment with laser and sclerotherapy, surgical excision remains the accepted intervention to relieve pain and minimize recurrence.12,13 The optimal surgical approach, which depends on the location of the tumor,13,14 will minimize the risk of postsurgical nail deformity while allowing for complete tumor removal.
Patients report relief of symptoms following excision, although it may take several weeks for the pain to resolve completely.1 The rate of recurrence following excision is estimated at 10% to 20%.1 This may be due to incomplete excision or the development of a new lesion. Therefore, patients should be re-evaluated and considered for possible re-exploration if symptoms return or persist for more than 3 months after the excision.13
A biopsy for our patient
While the intent of our biopsy was diagnostic, it also proved to be therapeutic as our patient experienced complete resolution of her pain immediately after the procedure. Six months later, she remained asymptomatic and reported no nail deformity. We counseled her on the possibility that her symptoms might return and encouraged her to come back in for further care as needed.
Correspondence
Thomas M. Beachkofsky, MD, Wilford Hall Medical Center, Department of Dermatology, 2200 Bergquist Drive, Suite 1, Lackland AFB, TX 78236-9908; [email protected]
1. Baran R, Richert B. Common nail tumors. Dermatol Clin. 206;24:297-311.
2. Gombos Z, Zhang PJ. Glomus tumor. Arch Pathol Lab Med. 2008;132:1448-1452.
3. Heys SD, Brittenden J, Atkinson P, et al. Glomus tumour: an analysis of 43 patients and review of the literature. Br J Surg. 1992;79:345-347.
4. McDermott EM, Weiss AP. Glomus tumors. J Hand Surg Am. 2006;31:1397-1400.
5. De Berker DA, Perrin C, Baran R. Localized longitudinal erythronychia: diagnostic significance and physical explanation. Arch Dermatol. 2004;140:1253-1257.
6. Grundmeier N, Hamm H, Weissbrich B, et al. High-risk human papillomavirus infection in Bowen’s disease of the nail unit: report of three cases and review of the literature. Dermatology. 2011;223:293-300.
7. Bach DQ, McQueen AA, Lio PA. A refractory wart? Subungual exostosis. Ann Emerg Med. 2011;58:e3-e4.
8. Garman ME, Orengo IF, Netscher D, et al. On glomus tumors, warts, and razors. Dermatol Surg. 2003;29:192-194.
9. Bhaskaranand K, Navadgi BC. Glomus tumour of the hand. J Hand Surg Br. 2002;27:229-231.
10. Takemura N, Fujii N, Tanaka T. Subungual glomus tumor diagnosis based on imaging. J Dermatol. 2006;33:389-393.
11. Matsunaga A, Ochiai T, Abe I, et al. Subungual glomus tumour: evaluation of ultrasound imaging in preoperative assessment. Eur J Dermatol. 2007;17:67-69.
12. Vergilis-Kalner IJ, Friedman PM, Goldberg LH. Long-pulse 595-nm pulsed dye laser for the treatment of a glomus tumor. Dermatol Surg. 2010;36:1463-1465.
13. Netscher DT, Aburto J, Koepplinger M. Subungual glomus tumor. J Hand Surg Am. 2012;37:821-823.
14. Takata H, Ikuta Y, Ishida O, et al. Treatment of subungual glomus tumour. Hand Surg. 2001;6:25-27.
A 46-year-old Caucasian woman was referred to our dermatology clinic with a one year history of progressively increasing pain radiating from the proximal nail fold of her right middle finger. She denied any history of trauma and noted that the pain was worse when her finger was exposed to cold.
On examination, we noted that there was a red line that extended the length of the nail, beginning at the area of pain and ending distally, where the nail split (FIGURE).
FIGURE
Red line extends from area of pain to area of nail splitting
What is your diagnosis?
How would you treat this patient?
Diagnosis: Subungual glomus tumor
Glomus tumor is a rare vascular neoplasm derived from the cells of the glomus body, a specialized arteriovenous shunt involved in temperature regulation. Glomus bodies are most abundant in the extremities, and 75% of glomus tumors are found in the hand.1 The most common location is the subungual region, where glomus bodies are highly concentrated.
These lesions are typically benign, although a malignant variant has been reported in 1% of cases.1,2 Glomus tumors are most common in adults 30 to 50 years of age, with subungual tumors occurring more often in women.3 The majority of glomus tumors are solitary and less than 1 cm in size.2,4 Multiple tumors may be familial and tend to occur in children.2,4
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital practitioners made the correct diagnosis.Patients with subungual glomus tumors present with intense pain that they may describe as shooting or pulsating in nature.
The pain may be spontaneous or triggered by mild trauma or changes in temperature—especially warm to cold. The classic triad of symptoms includes pinpoint tenderness, paroxysmal pain, and cold hypersensitivity. 3,4 The glomus tumor may appear as a focal bluish to erythematous discoloration visible through the nail plate, and in some cases the tumor may form a palpable nodule. Nail deformities such as ridging and distal fissuring occur in approximately one-third of patients.4
Longitudinal erythronychia, as seen in our patient, results when the glomus tumor exerts pressure on the distal nail matrix. This force leads to a thinning of the nail plate and the formation of a groove on the ventral surface of the nail. Swelling of the underlying nail bed with engorgement of vessels produces the red streak that is seen through the thinned nail.5 And, because the affected portion of the nail is fragile, it tends to split distally.
Longitudinal erythronychia with nail dystrophy involving multiple nails is also seen in inflammatory diseases, such as lichen planus and Darier disease, due to multifocal loss of nail matrix function.5
Differential Dx includes subungual warts, Bowen’s disease
Clinical mimics of glomus tumors include neuromas, melanomas, Bowen’s disease, arthritis, gout, paronychia, causalgia, subungual exostosis, osteochondroma, and subungual warts. (The TABLE1,6-8 describes some of the more common mimics.)
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital-based practitioners correctly made the diagnosis.3
Suspect a glomus tumor? Perform these tests
Three clinical tests can aid in evaluating for glomus tumors.
- Love’s test involves applying pressure to the affected fingertip using the head of a pin or the end of a paperclip. The point of maximal tenderness locates the tumor.
- In Hildreth’s test, the physician applies a tourniquet to the digit and repeats the Love’s test. The test is considered suggestive of glomus tumor if the patient no longer experiences tenderness with pressure.
- The cold sensitivity test requires that the physician expose the finger to cold by, say, placing the finger in an ice bath. This exposure will elicit increased pain in a patient who has a glomus tumor.
The sensitivity and specificity of these tests, according to one study involving 18 patients, is as follows: Love’s test (100%, 78%); Hildreth’s test (77.4%, 100%); and the cold sensitivity test (100%, 100%).9 Clinical suspicion must be confirmed by histopathologic examination and the patient must be alerted to the risks of biopsy, which include permanent nail deformity.
In addition, imaging studies may aid in the diagnosis as well as determine the preoperative size and location of the tumor. Radiography may show bone erosion in certain cases, and it is useful in differentiating a glomus tumor from subungual exostosis.10 Magnetic resonance imaging and ultrasound imaging have also been used to identify glomus tumors and to aid in determining the method of excision.10,11
Surgical excision is the preferred approach
While there are reports of successful treatment with laser and sclerotherapy, surgical excision remains the accepted intervention to relieve pain and minimize recurrence.12,13 The optimal surgical approach, which depends on the location of the tumor,13,14 will minimize the risk of postsurgical nail deformity while allowing for complete tumor removal.
Patients report relief of symptoms following excision, although it may take several weeks for the pain to resolve completely.1 The rate of recurrence following excision is estimated at 10% to 20%.1 This may be due to incomplete excision or the development of a new lesion. Therefore, patients should be re-evaluated and considered for possible re-exploration if symptoms return or persist for more than 3 months after the excision.13
A biopsy for our patient
While the intent of our biopsy was diagnostic, it also proved to be therapeutic as our patient experienced complete resolution of her pain immediately after the procedure. Six months later, she remained asymptomatic and reported no nail deformity. We counseled her on the possibility that her symptoms might return and encouraged her to come back in for further care as needed.
Correspondence
Thomas M. Beachkofsky, MD, Wilford Hall Medical Center, Department of Dermatology, 2200 Bergquist Drive, Suite 1, Lackland AFB, TX 78236-9908; [email protected]
A 46-year-old Caucasian woman was referred to our dermatology clinic with a one year history of progressively increasing pain radiating from the proximal nail fold of her right middle finger. She denied any history of trauma and noted that the pain was worse when her finger was exposed to cold.
On examination, we noted that there was a red line that extended the length of the nail, beginning at the area of pain and ending distally, where the nail split (FIGURE).
FIGURE
Red line extends from area of pain to area of nail splitting
What is your diagnosis?
How would you treat this patient?
Diagnosis: Subungual glomus tumor
Glomus tumor is a rare vascular neoplasm derived from the cells of the glomus body, a specialized arteriovenous shunt involved in temperature regulation. Glomus bodies are most abundant in the extremities, and 75% of glomus tumors are found in the hand.1 The most common location is the subungual region, where glomus bodies are highly concentrated.
These lesions are typically benign, although a malignant variant has been reported in 1% of cases.1,2 Glomus tumors are most common in adults 30 to 50 years of age, with subungual tumors occurring more often in women.3 The majority of glomus tumors are solitary and less than 1 cm in size.2,4 Multiple tumors may be familial and tend to occur in children.2,4
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital practitioners made the correct diagnosis.Patients with subungual glomus tumors present with intense pain that they may describe as shooting or pulsating in nature.
The pain may be spontaneous or triggered by mild trauma or changes in temperature—especially warm to cold. The classic triad of symptoms includes pinpoint tenderness, paroxysmal pain, and cold hypersensitivity. 3,4 The glomus tumor may appear as a focal bluish to erythematous discoloration visible through the nail plate, and in some cases the tumor may form a palpable nodule. Nail deformities such as ridging and distal fissuring occur in approximately one-third of patients.4
Longitudinal erythronychia, as seen in our patient, results when the glomus tumor exerts pressure on the distal nail matrix. This force leads to a thinning of the nail plate and the formation of a groove on the ventral surface of the nail. Swelling of the underlying nail bed with engorgement of vessels produces the red streak that is seen through the thinned nail.5 And, because the affected portion of the nail is fragile, it tends to split distally.
Longitudinal erythronychia with nail dystrophy involving multiple nails is also seen in inflammatory diseases, such as lichen planus and Darier disease, due to multifocal loss of nail matrix function.5
Differential Dx includes subungual warts, Bowen’s disease
Clinical mimics of glomus tumors include neuromas, melanomas, Bowen’s disease, arthritis, gout, paronychia, causalgia, subungual exostosis, osteochondroma, and subungual warts. (The TABLE1,6-8 describes some of the more common mimics.)
In an analysis of 43 patients with glomus tumors, only 19% of referring practitioners and 49% of hospital-based practitioners correctly made the diagnosis.3
Suspect a glomus tumor? Perform these tests
Three clinical tests can aid in evaluating for glomus tumors.
- Love’s test involves applying pressure to the affected fingertip using the head of a pin or the end of a paperclip. The point of maximal tenderness locates the tumor.
- In Hildreth’s test, the physician applies a tourniquet to the digit and repeats the Love’s test. The test is considered suggestive of glomus tumor if the patient no longer experiences tenderness with pressure.
- The cold sensitivity test requires that the physician expose the finger to cold by, say, placing the finger in an ice bath. This exposure will elicit increased pain in a patient who has a glomus tumor.
The sensitivity and specificity of these tests, according to one study involving 18 patients, is as follows: Love’s test (100%, 78%); Hildreth’s test (77.4%, 100%); and the cold sensitivity test (100%, 100%).9 Clinical suspicion must be confirmed by histopathologic examination and the patient must be alerted to the risks of biopsy, which include permanent nail deformity.
In addition, imaging studies may aid in the diagnosis as well as determine the preoperative size and location of the tumor. Radiography may show bone erosion in certain cases, and it is useful in differentiating a glomus tumor from subungual exostosis.10 Magnetic resonance imaging and ultrasound imaging have also been used to identify glomus tumors and to aid in determining the method of excision.10,11
Surgical excision is the preferred approach
While there are reports of successful treatment with laser and sclerotherapy, surgical excision remains the accepted intervention to relieve pain and minimize recurrence.12,13 The optimal surgical approach, which depends on the location of the tumor,13,14 will minimize the risk of postsurgical nail deformity while allowing for complete tumor removal.
Patients report relief of symptoms following excision, although it may take several weeks for the pain to resolve completely.1 The rate of recurrence following excision is estimated at 10% to 20%.1 This may be due to incomplete excision or the development of a new lesion. Therefore, patients should be re-evaluated and considered for possible re-exploration if symptoms return or persist for more than 3 months after the excision.13
A biopsy for our patient
While the intent of our biopsy was diagnostic, it also proved to be therapeutic as our patient experienced complete resolution of her pain immediately after the procedure. Six months later, she remained asymptomatic and reported no nail deformity. We counseled her on the possibility that her symptoms might return and encouraged her to come back in for further care as needed.
Correspondence
Thomas M. Beachkofsky, MD, Wilford Hall Medical Center, Department of Dermatology, 2200 Bergquist Drive, Suite 1, Lackland AFB, TX 78236-9908; [email protected]
1. Baran R, Richert B. Common nail tumors. Dermatol Clin. 206;24:297-311.
2. Gombos Z, Zhang PJ. Glomus tumor. Arch Pathol Lab Med. 2008;132:1448-1452.
3. Heys SD, Brittenden J, Atkinson P, et al. Glomus tumour: an analysis of 43 patients and review of the literature. Br J Surg. 1992;79:345-347.
4. McDermott EM, Weiss AP. Glomus tumors. J Hand Surg Am. 2006;31:1397-1400.
5. De Berker DA, Perrin C, Baran R. Localized longitudinal erythronychia: diagnostic significance and physical explanation. Arch Dermatol. 2004;140:1253-1257.
6. Grundmeier N, Hamm H, Weissbrich B, et al. High-risk human papillomavirus infection in Bowen’s disease of the nail unit: report of three cases and review of the literature. Dermatology. 2011;223:293-300.
7. Bach DQ, McQueen AA, Lio PA. A refractory wart? Subungual exostosis. Ann Emerg Med. 2011;58:e3-e4.
8. Garman ME, Orengo IF, Netscher D, et al. On glomus tumors, warts, and razors. Dermatol Surg. 2003;29:192-194.
9. Bhaskaranand K, Navadgi BC. Glomus tumour of the hand. J Hand Surg Br. 2002;27:229-231.
10. Takemura N, Fujii N, Tanaka T. Subungual glomus tumor diagnosis based on imaging. J Dermatol. 2006;33:389-393.
11. Matsunaga A, Ochiai T, Abe I, et al. Subungual glomus tumour: evaluation of ultrasound imaging in preoperative assessment. Eur J Dermatol. 2007;17:67-69.
12. Vergilis-Kalner IJ, Friedman PM, Goldberg LH. Long-pulse 595-nm pulsed dye laser for the treatment of a glomus tumor. Dermatol Surg. 2010;36:1463-1465.
13. Netscher DT, Aburto J, Koepplinger M. Subungual glomus tumor. J Hand Surg Am. 2012;37:821-823.
14. Takata H, Ikuta Y, Ishida O, et al. Treatment of subungual glomus tumour. Hand Surg. 2001;6:25-27.
1. Baran R, Richert B. Common nail tumors. Dermatol Clin. 206;24:297-311.
2. Gombos Z, Zhang PJ. Glomus tumor. Arch Pathol Lab Med. 2008;132:1448-1452.
3. Heys SD, Brittenden J, Atkinson P, et al. Glomus tumour: an analysis of 43 patients and review of the literature. Br J Surg. 1992;79:345-347.
4. McDermott EM, Weiss AP. Glomus tumors. J Hand Surg Am. 2006;31:1397-1400.
5. De Berker DA, Perrin C, Baran R. Localized longitudinal erythronychia: diagnostic significance and physical explanation. Arch Dermatol. 2004;140:1253-1257.
6. Grundmeier N, Hamm H, Weissbrich B, et al. High-risk human papillomavirus infection in Bowen’s disease of the nail unit: report of three cases and review of the literature. Dermatology. 2011;223:293-300.
7. Bach DQ, McQueen AA, Lio PA. A refractory wart? Subungual exostosis. Ann Emerg Med. 2011;58:e3-e4.
8. Garman ME, Orengo IF, Netscher D, et al. On glomus tumors, warts, and razors. Dermatol Surg. 2003;29:192-194.
9. Bhaskaranand K, Navadgi BC. Glomus tumour of the hand. J Hand Surg Br. 2002;27:229-231.
10. Takemura N, Fujii N, Tanaka T. Subungual glomus tumor diagnosis based on imaging. J Dermatol. 2006;33:389-393.
11. Matsunaga A, Ochiai T, Abe I, et al. Subungual glomus tumour: evaluation of ultrasound imaging in preoperative assessment. Eur J Dermatol. 2007;17:67-69.
12. Vergilis-Kalner IJ, Friedman PM, Goldberg LH. Long-pulse 595-nm pulsed dye laser for the treatment of a glomus tumor. Dermatol Surg. 2010;36:1463-1465.
13. Netscher DT, Aburto J, Koepplinger M. Subungual glomus tumor. J Hand Surg Am. 2012;37:821-823.
14. Takata H, Ikuta Y, Ishida O, et al. Treatment of subungual glomus tumour. Hand Surg. 2001;6:25-27.
Do Asymptomatic Adults Need Screening EKGs?
PROBABLY NOT. Although certain electrocardiogram (EKG) findings in asymptomatic adults are associated with increased mortality (strength of recommendation [SOR]: A, high-quality cohort studies), no randomized trials demonstrate that any intervention based on abnormal screening EKGs improves outcomes in this group of patients. Comparison to a baseline EKG has a minimal effect on emergency department (ED) management.(SOR: B, 2 prospective studies and one retrospective study).
Evidence summary
The US Pooling Project divided EKG abnormalities into major and minor findings.1 A number of large cohort studies have shown that both major and minor findings are associated with an elevated odds ratio for mortality (TABLE).1-5 However, these studies, completed before the development of modern medical management of acute coronary syndrome and stable coronary artery disease, may no longer estimate mortality accurately. Moreover, no studies have examined the effect of screening EKGs on coronary heart disease (CHD) outcomes.
Neither major nor minor EKG abnormalities linked to higher mortality
A 2012 cohort study—which included Q-waves as major criteria and examined fewer minor abnormalities than previous studies—followed 2192 patients 70 to 79 years of age for 8 years.6 The study enrolled a higher percentage of women and blacks than earlier investigations had.
Major EKG abnormalities predicted an increase in CHD events (hazard ratio [HR]=1.51; 95% confidence interval [CI], 1.20-1.90) as did minor abnormalities (HR=1.35; 95% CI, 1.02-1.81). In contrast to earlier studies, which tended to enroll younger patients, neither type of abnormality was associated with a significantly increased risk of all-cause mortality.6
Including EKG abnormalities in a regression model of traditional risk factors improved stratification (overall net reclassification improvement [NRI]=7.4%; 95% CI, 3.1%-19.0%).6 No low-risk patients were reclassified as high risk and no high-risk patients were reclassified as low risk. Overall, 156 intermediate risk patients were correctly reclassified and an equal number were incorrectly reclassified. Adding EKG abnormalities to the Framingham Risk Score (which hasn’t been validated in adults >75 years) didn’t significantly improve stratification (NRI=5.7%; 95% CI, −0.4% to 11.8%).6
Comparing ED with baseline EKGs has little effect on management
A 1980 retrospective study looked at 236 patients with acute chest pain and no known CHD who were seen in the ED. Comparing routine baseline EKGs obtained before ED presentation for 6 of 41 patients with equivocal EKGs in the ED—including T-wave inversions, nonspecific T-wave and ST-segment abnormalities, and bundle branch blocks—prevented 2 admissions (no EKG change from baseline) and caused 4 unnecessary admissions (EKG changed from baseline with no subsequent evidence of acute coronary syndromes).7
A 1985 prospective study of 84 ED patients, in which treating physicians were given baseline EKGs after committing to an initial disposition plan, showed that the baseline EKG altered the decision to admit or discharge in only one case.8
A 1990 prospective multicenter study of 5673 patients older than 30 years—41% of whom had known CHD—reported that when the current EKG was consistent with ischemia or infarction, a baseline EKG showing the changes to be old (10% of study population) increased the likelihood that the patient would be discharged from the ED to home (26% vs 12%; risk difference=14%; 95% CI, 7%-23%). Unlike previous studies, however, the exact role of the baseline EKG in the admission decision was isolated not by study design but rather by multivariate logistic regression modeling.9
Recommendations
The 2010 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for assessment of cardiovascular risk in asymptomatic adults states that a resting EKG is probably indicated in patients with diabetes and hypertension and that its usefulness in patients without these conditions isn’t well established.2
The US Preventive Services Task Force recommends against screening EKGs in adults at low risk for CHD events (grade D recommendation).10
1. Sosenko J, Gardner L. Relationship of blood pressure, serum cholesterol, smoking habit, relative weight and ECG abnormalities to incidence of major coronary events: final report of the pooling project. J Chronic Dis. 1978;31:201-306.
2. Greenland P, Alpert J, Beller G, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010;56:e50-e103.
3. Sox HC Jr, Garber AM, Littenberg B. The resting electrocardiogram as a screening test. A clinical analysis. Ann Intern Med. 1989;111:489-502.
4. DeBaquer D, De Backer G, Kornitzer M, et al. Prognostic value of ECG findings for total, cardiovascular disease, and coronary heart disease death in men and women. Heart. 1998;80: 570-577.
5. Whinnicup P, Goya W, Marcarlane P, et al. Resting electrocardiogram and risk of coronary heart disease in middle-aged British men. J Cardiovasc Risk. 1995;2:533-543.
6. Auer R, Bauer DC, Marques-Vidal P, et al. Association of major and minor ECG abnormalities with coronary heart disease events. JAMA. 2012;307:1497-1505.
7. Rubenstein LZ, Greenfield S. The baseline ECG in the evaluation of acute cardiac complaints. JAMA. 1980;244:2536-2539.
8. Hoffman JR, Igarashi E. Influence of electrocardiographic findings on admission decisions in patients with acute chest pain. Am J Med. 1985;79:699-707.
9. Lee TH, Cook EF, Weisberg MC, et al. Impact of the availability of a prior electrocardiogram on the triage of the patient with acute chest pain. J Gen Intern Med. 1990;5:381-388.
10. Chou R, Arora B, Dana T, et al. Screening asymptomatic adults with resting or exercise electrocardiography: a review of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2011;155:375-385.
PROBABLY NOT. Although certain electrocardiogram (EKG) findings in asymptomatic adults are associated with increased mortality (strength of recommendation [SOR]: A, high-quality cohort studies), no randomized trials demonstrate that any intervention based on abnormal screening EKGs improves outcomes in this group of patients. Comparison to a baseline EKG has a minimal effect on emergency department (ED) management.(SOR: B, 2 prospective studies and one retrospective study).
Evidence summary
The US Pooling Project divided EKG abnormalities into major and minor findings.1 A number of large cohort studies have shown that both major and minor findings are associated with an elevated odds ratio for mortality (TABLE).1-5 However, these studies, completed before the development of modern medical management of acute coronary syndrome and stable coronary artery disease, may no longer estimate mortality accurately. Moreover, no studies have examined the effect of screening EKGs on coronary heart disease (CHD) outcomes.
Neither major nor minor EKG abnormalities linked to higher mortality
A 2012 cohort study—which included Q-waves as major criteria and examined fewer minor abnormalities than previous studies—followed 2192 patients 70 to 79 years of age for 8 years.6 The study enrolled a higher percentage of women and blacks than earlier investigations had.
Major EKG abnormalities predicted an increase in CHD events (hazard ratio [HR]=1.51; 95% confidence interval [CI], 1.20-1.90) as did minor abnormalities (HR=1.35; 95% CI, 1.02-1.81). In contrast to earlier studies, which tended to enroll younger patients, neither type of abnormality was associated with a significantly increased risk of all-cause mortality.6
Including EKG abnormalities in a regression model of traditional risk factors improved stratification (overall net reclassification improvement [NRI]=7.4%; 95% CI, 3.1%-19.0%).6 No low-risk patients were reclassified as high risk and no high-risk patients were reclassified as low risk. Overall, 156 intermediate risk patients were correctly reclassified and an equal number were incorrectly reclassified. Adding EKG abnormalities to the Framingham Risk Score (which hasn’t been validated in adults >75 years) didn’t significantly improve stratification (NRI=5.7%; 95% CI, −0.4% to 11.8%).6
Comparing ED with baseline EKGs has little effect on management
A 1980 retrospective study looked at 236 patients with acute chest pain and no known CHD who were seen in the ED. Comparing routine baseline EKGs obtained before ED presentation for 6 of 41 patients with equivocal EKGs in the ED—including T-wave inversions, nonspecific T-wave and ST-segment abnormalities, and bundle branch blocks—prevented 2 admissions (no EKG change from baseline) and caused 4 unnecessary admissions (EKG changed from baseline with no subsequent evidence of acute coronary syndromes).7
A 1985 prospective study of 84 ED patients, in which treating physicians were given baseline EKGs after committing to an initial disposition plan, showed that the baseline EKG altered the decision to admit or discharge in only one case.8
A 1990 prospective multicenter study of 5673 patients older than 30 years—41% of whom had known CHD—reported that when the current EKG was consistent with ischemia or infarction, a baseline EKG showing the changes to be old (10% of study population) increased the likelihood that the patient would be discharged from the ED to home (26% vs 12%; risk difference=14%; 95% CI, 7%-23%). Unlike previous studies, however, the exact role of the baseline EKG in the admission decision was isolated not by study design but rather by multivariate logistic regression modeling.9
Recommendations
The 2010 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for assessment of cardiovascular risk in asymptomatic adults states that a resting EKG is probably indicated in patients with diabetes and hypertension and that its usefulness in patients without these conditions isn’t well established.2
The US Preventive Services Task Force recommends against screening EKGs in adults at low risk for CHD events (grade D recommendation).10
PROBABLY NOT. Although certain electrocardiogram (EKG) findings in asymptomatic adults are associated with increased mortality (strength of recommendation [SOR]: A, high-quality cohort studies), no randomized trials demonstrate that any intervention based on abnormal screening EKGs improves outcomes in this group of patients. Comparison to a baseline EKG has a minimal effect on emergency department (ED) management.(SOR: B, 2 prospective studies and one retrospective study).
Evidence summary
The US Pooling Project divided EKG abnormalities into major and minor findings.1 A number of large cohort studies have shown that both major and minor findings are associated with an elevated odds ratio for mortality (TABLE).1-5 However, these studies, completed before the development of modern medical management of acute coronary syndrome and stable coronary artery disease, may no longer estimate mortality accurately. Moreover, no studies have examined the effect of screening EKGs on coronary heart disease (CHD) outcomes.
Neither major nor minor EKG abnormalities linked to higher mortality
A 2012 cohort study—which included Q-waves as major criteria and examined fewer minor abnormalities than previous studies—followed 2192 patients 70 to 79 years of age for 8 years.6 The study enrolled a higher percentage of women and blacks than earlier investigations had.
Major EKG abnormalities predicted an increase in CHD events (hazard ratio [HR]=1.51; 95% confidence interval [CI], 1.20-1.90) as did minor abnormalities (HR=1.35; 95% CI, 1.02-1.81). In contrast to earlier studies, which tended to enroll younger patients, neither type of abnormality was associated with a significantly increased risk of all-cause mortality.6
Including EKG abnormalities in a regression model of traditional risk factors improved stratification (overall net reclassification improvement [NRI]=7.4%; 95% CI, 3.1%-19.0%).6 No low-risk patients were reclassified as high risk and no high-risk patients were reclassified as low risk. Overall, 156 intermediate risk patients were correctly reclassified and an equal number were incorrectly reclassified. Adding EKG abnormalities to the Framingham Risk Score (which hasn’t been validated in adults >75 years) didn’t significantly improve stratification (NRI=5.7%; 95% CI, −0.4% to 11.8%).6
Comparing ED with baseline EKGs has little effect on management
A 1980 retrospective study looked at 236 patients with acute chest pain and no known CHD who were seen in the ED. Comparing routine baseline EKGs obtained before ED presentation for 6 of 41 patients with equivocal EKGs in the ED—including T-wave inversions, nonspecific T-wave and ST-segment abnormalities, and bundle branch blocks—prevented 2 admissions (no EKG change from baseline) and caused 4 unnecessary admissions (EKG changed from baseline with no subsequent evidence of acute coronary syndromes).7
A 1985 prospective study of 84 ED patients, in which treating physicians were given baseline EKGs after committing to an initial disposition plan, showed that the baseline EKG altered the decision to admit or discharge in only one case.8
A 1990 prospective multicenter study of 5673 patients older than 30 years—41% of whom had known CHD—reported that when the current EKG was consistent with ischemia or infarction, a baseline EKG showing the changes to be old (10% of study population) increased the likelihood that the patient would be discharged from the ED to home (26% vs 12%; risk difference=14%; 95% CI, 7%-23%). Unlike previous studies, however, the exact role of the baseline EKG in the admission decision was isolated not by study design but rather by multivariate logistic regression modeling.9
Recommendations
The 2010 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for assessment of cardiovascular risk in asymptomatic adults states that a resting EKG is probably indicated in patients with diabetes and hypertension and that its usefulness in patients without these conditions isn’t well established.2
The US Preventive Services Task Force recommends against screening EKGs in adults at low risk for CHD events (grade D recommendation).10
1. Sosenko J, Gardner L. Relationship of blood pressure, serum cholesterol, smoking habit, relative weight and ECG abnormalities to incidence of major coronary events: final report of the pooling project. J Chronic Dis. 1978;31:201-306.
2. Greenland P, Alpert J, Beller G, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010;56:e50-e103.
3. Sox HC Jr, Garber AM, Littenberg B. The resting electrocardiogram as a screening test. A clinical analysis. Ann Intern Med. 1989;111:489-502.
4. DeBaquer D, De Backer G, Kornitzer M, et al. Prognostic value of ECG findings for total, cardiovascular disease, and coronary heart disease death in men and women. Heart. 1998;80: 570-577.
5. Whinnicup P, Goya W, Marcarlane P, et al. Resting electrocardiogram and risk of coronary heart disease in middle-aged British men. J Cardiovasc Risk. 1995;2:533-543.
6. Auer R, Bauer DC, Marques-Vidal P, et al. Association of major and minor ECG abnormalities with coronary heart disease events. JAMA. 2012;307:1497-1505.
7. Rubenstein LZ, Greenfield S. The baseline ECG in the evaluation of acute cardiac complaints. JAMA. 1980;244:2536-2539.
8. Hoffman JR, Igarashi E. Influence of electrocardiographic findings on admission decisions in patients with acute chest pain. Am J Med. 1985;79:699-707.
9. Lee TH, Cook EF, Weisberg MC, et al. Impact of the availability of a prior electrocardiogram on the triage of the patient with acute chest pain. J Gen Intern Med. 1990;5:381-388.
10. Chou R, Arora B, Dana T, et al. Screening asymptomatic adults with resting or exercise electrocardiography: a review of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2011;155:375-385.
1. Sosenko J, Gardner L. Relationship of blood pressure, serum cholesterol, smoking habit, relative weight and ECG abnormalities to incidence of major coronary events: final report of the pooling project. J Chronic Dis. 1978;31:201-306.
2. Greenland P, Alpert J, Beller G, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2010;56:e50-e103.
3. Sox HC Jr, Garber AM, Littenberg B. The resting electrocardiogram as a screening test. A clinical analysis. Ann Intern Med. 1989;111:489-502.
4. DeBaquer D, De Backer G, Kornitzer M, et al. Prognostic value of ECG findings for total, cardiovascular disease, and coronary heart disease death in men and women. Heart. 1998;80: 570-577.
5. Whinnicup P, Goya W, Marcarlane P, et al. Resting electrocardiogram and risk of coronary heart disease in middle-aged British men. J Cardiovasc Risk. 1995;2:533-543.
6. Auer R, Bauer DC, Marques-Vidal P, et al. Association of major and minor ECG abnormalities with coronary heart disease events. JAMA. 2012;307:1497-1505.
7. Rubenstein LZ, Greenfield S. The baseline ECG in the evaluation of acute cardiac complaints. JAMA. 1980;244:2536-2539.
8. Hoffman JR, Igarashi E. Influence of electrocardiographic findings on admission decisions in patients with acute chest pain. Am J Med. 1985;79:699-707.
9. Lee TH, Cook EF, Weisberg MC, et al. Impact of the availability of a prior electrocardiogram on the triage of the patient with acute chest pain. J Gen Intern Med. 1990;5:381-388.
10. Chou R, Arora B, Dana T, et al. Screening asymptomatic adults with resting or exercise electrocardiography: a review of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2011;155:375-385.
What is the Best Initial Treatment for Venous Stasis Ulcers?
THE MAINSTAY OF INITIAL TREATMENT of venous stasis ulcers is compression therapy (strength of recommendation [SOR]: A, systematic review of randomized controlled trials [RCTs]). Multicomponent compression therapy is slightly superior to single-component therapy (SOR: B, systematic review of RCTs with inconsistent results). The various types of dressings available for managing venous stasis ulcers aresimilarly efficacious (SOR: A, systematic review of RCTs).
Systemic therapies such as aspirin (SOR: B, single RCT) and pentoxifylline (SOR: A, systematic review of RCTs) improve healing rates whereas antibiotics don’t (SOR: A, systematic review of RCTs). Cadexomer iodine, a topical antiseptic, improves ulcer healing but may not be feasible in most clinical settings because of the frequent dressing changes required (SOR: B, single RCT).
Evidence summary
A systematic review found 7 RCTs with a total of 686 subjects that compared compression with no compression for venous leg ulcers.1 Although the outcome data were too heterogeneous for a meta-analysis, the 4 studies in which statistical analysis was possible showed that compression healed venous leg ulcers faster than no compression (relative risk [RR] range=1.2 to 4 in favor of compression), as detailed in the TABLE. Notably, only 2 of the studies achieved statistical significance (P<.05).
Two other studies in this review, with 20 and 245 patients, compared 4-component with single-component compression. In the smaller study, multicomponent compression produced more completely healed ulcers at 12 weeks, but the difference wasn’t statistically significant.
In the larger study, nonhealing at 24 weeks was much less common among patients treated with multicomponent compression than single-component therapy (RR=0.74; 95% confidence interval [CI], 0.59-0.92; number needed to treat [NNT]=5.7; P=.009), and median time to healing was shorter(78 vs 168 days; statistical significance not reported).
The reviewers concluded that compression increases ulcer healing rates compared with no compression and that multicomponent systems are more effective than single component systems.1
Similar results, different costs among dressing types
A systematic review and meta-analysis of 42 RCTs that included 3001 patients compared multiple dressing types, including hydrocolloid, foam, alginate, and low-adherent dressings, used beneath compression.2 The study found no significant differences in healing rates among the dressings, although costs varied widely.
Systemic therapy: Aspirin and pentoxifylline help
Systemic or topical treatments are an alternative for patients with contraindications or intolerance to compression. An RCT of 20 patients that compared aspirin 300 mg/day with placebo found higher ulcer healing rates in the aspirin group after 4 months (38% vs 0%; NNT=2.6; P<.007). Improvement, defined as reduction in ulcer size, occurred in 52%of patients treated with aspirin but only 26%treated with placebo(NNT=3.8;P<.007).3
A systematic review of 11 trials (N=841) found that pentoxifylline accelerated healing rates vs placebo (NNT=4; 95% CI, 3-6); the authors recommended its use in conjunction with compression therapy when possible.4
Another systematic review of 5 RCTs (N=232) found that systemic antibiotics didn’t improve outcomes significantly more than placebo.5
Topical cadexomer iodine: Effective, but is it feasible?
One of the 5 reviewed RCTs (60 patients) found that topical cadexomer iodine produced more frequent healing than standard care at 6 weeks (NNT=3;95%CI,2-19).5 However, the cadexomer regimen involved daily dressing changes, which might limit feasibility in many clinical settings.
Systemic aspirin and pentoxifylline improve healing rates, but systemic antibiotics don’t. Other interventions to consider for venous ulcers include hyperbaric oxygen and venous surgery.
Recommendations
The Association for the Advancement of Wound Care recommends compression therapy and limb elevation to reduce edema. They also recommend cleaning the ulcer with a safe cleanser, debriding nonvital tissue, maintaining a moist wound environment, and managing pain and odor.6
The Wound, Ostomy, and Continence Nurses Society and the American Society of Plastic Surgeons make similar recommendations: ulcer debridement, edema management, infection control, and pain management.7,8
1. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2009;(1):CD000265.
2. Palfreyman SJ, Nelson EA, Lochiel R, et al. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006;(3):CD001103.
3. Layton AM, Ibbotson SH, Davies JA, et al. Randomized trial of oral aspirin for chronic venous leg ulcers. Lancet. 1994;344:164-165.
4. JullAB,ArrollB, ParagV, et al. Pentoxifylline fortreating venous leg ulcers. Cochrane Database Syst Rev. 2007;(3):CD001733.
5. O’Meara S, Al-Kurdi D, Ovington LG, et al. Antibiotics and antiseptics for venous leg ulcers. CochraneDatabase Syst Rev. 2010;(1):CD003557.
6. Association fortheAdvancement of WoundCare (AAWC) venous ulcer guideline. 2010. Available at: http://aawconline.org/wpcontent/uploads/2012/03/AAWC-Venous-UlcerGuideline-Update+Algorithm-v28.pdf. Accessed November 16, 2012.
7. Wound, Ostomy, and Continence Nurses Society. Guideline for management of wounds in patients with lower-extremity venous disease. 2011. Available at: http://guideline.gov/content.aspx?id=38249. Accessed November 16, 2012.
8. American Society of Plastic Surgeons. Evidence-based clinicalpracticeguideline:Chronicwoundsofthelowerextremity. 2007. Available at: http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidencepractice/Evidence-based-Clinical-Practice-GuidelineChronic-Wounds-of-the-Lower-Extremity.pdf. Accessed November 16, 2012.
THE MAINSTAY OF INITIAL TREATMENT of venous stasis ulcers is compression therapy (strength of recommendation [SOR]: A, systematic review of randomized controlled trials [RCTs]). Multicomponent compression therapy is slightly superior to single-component therapy (SOR: B, systematic review of RCTs with inconsistent results). The various types of dressings available for managing venous stasis ulcers aresimilarly efficacious (SOR: A, systematic review of RCTs).
Systemic therapies such as aspirin (SOR: B, single RCT) and pentoxifylline (SOR: A, systematic review of RCTs) improve healing rates whereas antibiotics don’t (SOR: A, systematic review of RCTs). Cadexomer iodine, a topical antiseptic, improves ulcer healing but may not be feasible in most clinical settings because of the frequent dressing changes required (SOR: B, single RCT).
Evidence summary
A systematic review found 7 RCTs with a total of 686 subjects that compared compression with no compression for venous leg ulcers.1 Although the outcome data were too heterogeneous for a meta-analysis, the 4 studies in which statistical analysis was possible showed that compression healed venous leg ulcers faster than no compression (relative risk [RR] range=1.2 to 4 in favor of compression), as detailed in the TABLE. Notably, only 2 of the studies achieved statistical significance (P<.05).
Two other studies in this review, with 20 and 245 patients, compared 4-component with single-component compression. In the smaller study, multicomponent compression produced more completely healed ulcers at 12 weeks, but the difference wasn’t statistically significant.
In the larger study, nonhealing at 24 weeks was much less common among patients treated with multicomponent compression than single-component therapy (RR=0.74; 95% confidence interval [CI], 0.59-0.92; number needed to treat [NNT]=5.7; P=.009), and median time to healing was shorter(78 vs 168 days; statistical significance not reported).
The reviewers concluded that compression increases ulcer healing rates compared with no compression and that multicomponent systems are more effective than single component systems.1
Similar results, different costs among dressing types
A systematic review and meta-analysis of 42 RCTs that included 3001 patients compared multiple dressing types, including hydrocolloid, foam, alginate, and low-adherent dressings, used beneath compression.2 The study found no significant differences in healing rates among the dressings, although costs varied widely.
Systemic therapy: Aspirin and pentoxifylline help
Systemic or topical treatments are an alternative for patients with contraindications or intolerance to compression. An RCT of 20 patients that compared aspirin 300 mg/day with placebo found higher ulcer healing rates in the aspirin group after 4 months (38% vs 0%; NNT=2.6; P<.007). Improvement, defined as reduction in ulcer size, occurred in 52%of patients treated with aspirin but only 26%treated with placebo(NNT=3.8;P<.007).3
A systematic review of 11 trials (N=841) found that pentoxifylline accelerated healing rates vs placebo (NNT=4; 95% CI, 3-6); the authors recommended its use in conjunction with compression therapy when possible.4
Another systematic review of 5 RCTs (N=232) found that systemic antibiotics didn’t improve outcomes significantly more than placebo.5
Topical cadexomer iodine: Effective, but is it feasible?
One of the 5 reviewed RCTs (60 patients) found that topical cadexomer iodine produced more frequent healing than standard care at 6 weeks (NNT=3;95%CI,2-19).5 However, the cadexomer regimen involved daily dressing changes, which might limit feasibility in many clinical settings.
Systemic aspirin and pentoxifylline improve healing rates, but systemic antibiotics don’t. Other interventions to consider for venous ulcers include hyperbaric oxygen and venous surgery.
Recommendations
The Association for the Advancement of Wound Care recommends compression therapy and limb elevation to reduce edema. They also recommend cleaning the ulcer with a safe cleanser, debriding nonvital tissue, maintaining a moist wound environment, and managing pain and odor.6
The Wound, Ostomy, and Continence Nurses Society and the American Society of Plastic Surgeons make similar recommendations: ulcer debridement, edema management, infection control, and pain management.7,8
THE MAINSTAY OF INITIAL TREATMENT of venous stasis ulcers is compression therapy (strength of recommendation [SOR]: A, systematic review of randomized controlled trials [RCTs]). Multicomponent compression therapy is slightly superior to single-component therapy (SOR: B, systematic review of RCTs with inconsistent results). The various types of dressings available for managing venous stasis ulcers aresimilarly efficacious (SOR: A, systematic review of RCTs).
Systemic therapies such as aspirin (SOR: B, single RCT) and pentoxifylline (SOR: A, systematic review of RCTs) improve healing rates whereas antibiotics don’t (SOR: A, systematic review of RCTs). Cadexomer iodine, a topical antiseptic, improves ulcer healing but may not be feasible in most clinical settings because of the frequent dressing changes required (SOR: B, single RCT).
Evidence summary
A systematic review found 7 RCTs with a total of 686 subjects that compared compression with no compression for venous leg ulcers.1 Although the outcome data were too heterogeneous for a meta-analysis, the 4 studies in which statistical analysis was possible showed that compression healed venous leg ulcers faster than no compression (relative risk [RR] range=1.2 to 4 in favor of compression), as detailed in the TABLE. Notably, only 2 of the studies achieved statistical significance (P<.05).
Two other studies in this review, with 20 and 245 patients, compared 4-component with single-component compression. In the smaller study, multicomponent compression produced more completely healed ulcers at 12 weeks, but the difference wasn’t statistically significant.
In the larger study, nonhealing at 24 weeks was much less common among patients treated with multicomponent compression than single-component therapy (RR=0.74; 95% confidence interval [CI], 0.59-0.92; number needed to treat [NNT]=5.7; P=.009), and median time to healing was shorter(78 vs 168 days; statistical significance not reported).
The reviewers concluded that compression increases ulcer healing rates compared with no compression and that multicomponent systems are more effective than single component systems.1
Similar results, different costs among dressing types
A systematic review and meta-analysis of 42 RCTs that included 3001 patients compared multiple dressing types, including hydrocolloid, foam, alginate, and low-adherent dressings, used beneath compression.2 The study found no significant differences in healing rates among the dressings, although costs varied widely.
Systemic therapy: Aspirin and pentoxifylline help
Systemic or topical treatments are an alternative for patients with contraindications or intolerance to compression. An RCT of 20 patients that compared aspirin 300 mg/day with placebo found higher ulcer healing rates in the aspirin group after 4 months (38% vs 0%; NNT=2.6; P<.007). Improvement, defined as reduction in ulcer size, occurred in 52%of patients treated with aspirin but only 26%treated with placebo(NNT=3.8;P<.007).3
A systematic review of 11 trials (N=841) found that pentoxifylline accelerated healing rates vs placebo (NNT=4; 95% CI, 3-6); the authors recommended its use in conjunction with compression therapy when possible.4
Another systematic review of 5 RCTs (N=232) found that systemic antibiotics didn’t improve outcomes significantly more than placebo.5
Topical cadexomer iodine: Effective, but is it feasible?
One of the 5 reviewed RCTs (60 patients) found that topical cadexomer iodine produced more frequent healing than standard care at 6 weeks (NNT=3;95%CI,2-19).5 However, the cadexomer regimen involved daily dressing changes, which might limit feasibility in many clinical settings.
Systemic aspirin and pentoxifylline improve healing rates, but systemic antibiotics don’t. Other interventions to consider for venous ulcers include hyperbaric oxygen and venous surgery.
Recommendations
The Association for the Advancement of Wound Care recommends compression therapy and limb elevation to reduce edema. They also recommend cleaning the ulcer with a safe cleanser, debriding nonvital tissue, maintaining a moist wound environment, and managing pain and odor.6
The Wound, Ostomy, and Continence Nurses Society and the American Society of Plastic Surgeons make similar recommendations: ulcer debridement, edema management, infection control, and pain management.7,8
1. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2009;(1):CD000265.
2. Palfreyman SJ, Nelson EA, Lochiel R, et al. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006;(3):CD001103.
3. Layton AM, Ibbotson SH, Davies JA, et al. Randomized trial of oral aspirin for chronic venous leg ulcers. Lancet. 1994;344:164-165.
4. JullAB,ArrollB, ParagV, et al. Pentoxifylline fortreating venous leg ulcers. Cochrane Database Syst Rev. 2007;(3):CD001733.
5. O’Meara S, Al-Kurdi D, Ovington LG, et al. Antibiotics and antiseptics for venous leg ulcers. CochraneDatabase Syst Rev. 2010;(1):CD003557.
6. Association fortheAdvancement of WoundCare (AAWC) venous ulcer guideline. 2010. Available at: http://aawconline.org/wpcontent/uploads/2012/03/AAWC-Venous-UlcerGuideline-Update+Algorithm-v28.pdf. Accessed November 16, 2012.
7. Wound, Ostomy, and Continence Nurses Society. Guideline for management of wounds in patients with lower-extremity venous disease. 2011. Available at: http://guideline.gov/content.aspx?id=38249. Accessed November 16, 2012.
8. American Society of Plastic Surgeons. Evidence-based clinicalpracticeguideline:Chronicwoundsofthelowerextremity. 2007. Available at: http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidencepractice/Evidence-based-Clinical-Practice-GuidelineChronic-Wounds-of-the-Lower-Extremity.pdf. Accessed November 16, 2012.
1. O’Meara S, Cullum NA, Nelson EA. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2009;(1):CD000265.
2. Palfreyman SJ, Nelson EA, Lochiel R, et al. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006;(3):CD001103.
3. Layton AM, Ibbotson SH, Davies JA, et al. Randomized trial of oral aspirin for chronic venous leg ulcers. Lancet. 1994;344:164-165.
4. JullAB,ArrollB, ParagV, et al. Pentoxifylline fortreating venous leg ulcers. Cochrane Database Syst Rev. 2007;(3):CD001733.
5. O’Meara S, Al-Kurdi D, Ovington LG, et al. Antibiotics and antiseptics for venous leg ulcers. CochraneDatabase Syst Rev. 2010;(1):CD003557.
6. Association fortheAdvancement of WoundCare (AAWC) venous ulcer guideline. 2010. Available at: http://aawconline.org/wpcontent/uploads/2012/03/AAWC-Venous-UlcerGuideline-Update+Algorithm-v28.pdf. Accessed November 16, 2012.
7. Wound, Ostomy, and Continence Nurses Society. Guideline for management of wounds in patients with lower-extremity venous disease. 2011. Available at: http://guideline.gov/content.aspx?id=38249. Accessed November 16, 2012.
8. American Society of Plastic Surgeons. Evidence-based clinicalpracticeguideline:Chronicwoundsofthelowerextremity. 2007. Available at: http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidencepractice/Evidence-based-Clinical-Practice-GuidelineChronic-Wounds-of-the-Lower-Extremity.pdf. Accessed November 16, 2012.