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The new NOACs are generally the best bet
New NOACs have largely replaced the need for vitamin K antagonists
The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation that Campbell and Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs) began. Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice. Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.
Pharmacologic design
The targeted drug design of NOACs provides many pharmacologic advantages. Compared with VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs. Additionally, NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low molecular weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities which may influence drug effect and clearance.
Lastly, it should be mentioned that the pharmacologic benefits of NOACs are not only beneficial from a patient perspective, but also from a health care systems standpoint as their use may provide an opportunity to deliver more cost-effective care. Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared with warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that, at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.
Patient selection
The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs versus VKAs or placebos for the management of nonvalvular atrial fibrillation (AF), venous thromboembolism (VTE), and as adjunctive therapy for patients with acute coronary syndrome.6 Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation where NOACs have significant reductions in stroke, intracranial hemorrhage, and all-cause mortality, compared with warfarin while displaying variable effects with regards to gastrointestinal bleeding.6,7
In patients with VTE, NOACs have been found to have similar efficacy, compared with VKAs, with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6 Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, it should be noted that NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon the class of anticoagulant to use.
Overcoming challenges
Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life-threatening bleeding complications. Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monocolonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently in phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9 Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable, compared with VKAs, and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.
Conclusions
Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the health care system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.
Madhukar S. Patel, MD, and Elliot L. Chaikof, MD, are from the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported having no conflicts of interest.
References
1. J Am Vet Med Assoc 1924;64:553-575
3. Hematology Am Soc Hematol Educ Program 2013;2013:464-470
4. Eur Heart J 2013;34:2094-2106
6. Nat Rev Cardiol 2014;11:693-703
8. N Engl J Med 2015;373:511-520
9. N Engl J Med 2014;371:2141-2142
What the doctor didn’t order: unintended consequences and pitfalls of NOACs
Recently, several new oral anticoagulants (NOACs) have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once or twice daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute VTE and AF.
Dabigatran and edoxaban
Similar to warfarin, dabigatran and edoxaban require the use of a LMWH or UFH “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent which can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke, compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3
Rivaroxaban and apixaban
Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique amongst the NOACs, have been tested for extended therapy of acute deep vein thrombosis after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding, compared with placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding, compared with warfarin.6
Consequences and pitfalls with NOACs
Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels or reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects. With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published the times when it might be useful to obtain levels. These times include:
• When a patient is bleeding.
• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL min.
• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.
• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.
• Patients with deteriorating renal function.
• During perioperative management.
• During reversal of anticoagulation.
• When there is suspicion of overdose.
• Assessment of compliance in patients suffering thrombotic events while on treatment.7
Currently, there exists no commercially available reversal agent for any of the NOACs, and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials are lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8
Currently there are no national guidelines or large scale studies to guide bridging NOACs for procedures.
The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double-edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.
The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important in order to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.
So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that despite all the benefits, they also each carry a risk of bleeding as they all target portions of the coagulation mechanism. We caution that, as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.
Thomas Wakefield, MD, is the Stanley Professor of Vascular Surgery; head, section of vascular surgery; and director, Samuel and Jean Frankel Cardiovascular Center. Andrea Obi, MD, is a vascular surgery fellow and Dawn Coleman MD, is the program director, section of vascular surgery, all at the University of Michigan, Ann Arbor. They reported having no conflicts of interest.
References
1. N Engl J Med. 2009;361:2342-2352
2. J Vasc Surg: Venous and Lymphatic Disorders. 2013;1:418-426
3. N Engl J Med 2013;369:1406-1415
4. N Engl J Med 2010;363:2499-2510
5. N Engl J Med 2013;368:699-708
6. Arteriosclerosis, thrombosis, and vascular biology 2015;35:1056-1065
7. J Thrombosis and Haemostasis 2013;11:756-760
New NOACs have largely replaced the need for vitamin K antagonists
The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation that Campbell and Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs) began. Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice. Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.
Pharmacologic design
The targeted drug design of NOACs provides many pharmacologic advantages. Compared with VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs. Additionally, NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low molecular weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities which may influence drug effect and clearance.
Lastly, it should be mentioned that the pharmacologic benefits of NOACs are not only beneficial from a patient perspective, but also from a health care systems standpoint as their use may provide an opportunity to deliver more cost-effective care. Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared with warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that, at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.
Patient selection
The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs versus VKAs or placebos for the management of nonvalvular atrial fibrillation (AF), venous thromboembolism (VTE), and as adjunctive therapy for patients with acute coronary syndrome.6 Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation where NOACs have significant reductions in stroke, intracranial hemorrhage, and all-cause mortality, compared with warfarin while displaying variable effects with regards to gastrointestinal bleeding.6,7
In patients with VTE, NOACs have been found to have similar efficacy, compared with VKAs, with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6 Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, it should be noted that NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon the class of anticoagulant to use.
Overcoming challenges
Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life-threatening bleeding complications. Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monocolonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently in phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9 Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable, compared with VKAs, and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.
Conclusions
Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the health care system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.
Madhukar S. Patel, MD, and Elliot L. Chaikof, MD, are from the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported having no conflicts of interest.
References
1. J Am Vet Med Assoc 1924;64:553-575
3. Hematology Am Soc Hematol Educ Program 2013;2013:464-470
4. Eur Heart J 2013;34:2094-2106
6. Nat Rev Cardiol 2014;11:693-703
8. N Engl J Med 2015;373:511-520
9. N Engl J Med 2014;371:2141-2142
What the doctor didn’t order: unintended consequences and pitfalls of NOACs
Recently, several new oral anticoagulants (NOACs) have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once or twice daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute VTE and AF.
Dabigatran and edoxaban
Similar to warfarin, dabigatran and edoxaban require the use of a LMWH or UFH “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent which can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke, compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3
Rivaroxaban and apixaban
Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique amongst the NOACs, have been tested for extended therapy of acute deep vein thrombosis after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding, compared with placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding, compared with warfarin.6
Consequences and pitfalls with NOACs
Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels or reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects. With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published the times when it might be useful to obtain levels. These times include:
• When a patient is bleeding.
• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL min.
• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.
• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.
• Patients with deteriorating renal function.
• During perioperative management.
• During reversal of anticoagulation.
• When there is suspicion of overdose.
• Assessment of compliance in patients suffering thrombotic events while on treatment.7
Currently, there exists no commercially available reversal agent for any of the NOACs, and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials are lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8
Currently there are no national guidelines or large scale studies to guide bridging NOACs for procedures.
The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double-edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.
The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important in order to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.
So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that despite all the benefits, they also each carry a risk of bleeding as they all target portions of the coagulation mechanism. We caution that, as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.
Thomas Wakefield, MD, is the Stanley Professor of Vascular Surgery; head, section of vascular surgery; and director, Samuel and Jean Frankel Cardiovascular Center. Andrea Obi, MD, is a vascular surgery fellow and Dawn Coleman MD, is the program director, section of vascular surgery, all at the University of Michigan, Ann Arbor. They reported having no conflicts of interest.
References
1. N Engl J Med. 2009;361:2342-2352
2. J Vasc Surg: Venous and Lymphatic Disorders. 2013;1:418-426
3. N Engl J Med 2013;369:1406-1415
4. N Engl J Med 2010;363:2499-2510
5. N Engl J Med 2013;368:699-708
6. Arteriosclerosis, thrombosis, and vascular biology 2015;35:1056-1065
7. J Thrombosis and Haemostasis 2013;11:756-760
New NOACs have largely replaced the need for vitamin K antagonists
The discovery of oral anticoagulants began in 1924, when Schofield linked the death of grazing cattle from internal hemorrhage to the consumption of spoiled sweet clover hay.1 It was not until 1941, however, while trying to understand this observation that Campbell and Link were able to identify the dicoumarol anticoagulant, which formed as a result of the spoiling process.2 Ultimately, after noting that vitamin K led to reversal of the dicoumarol effect, synthesis of the first class of oral anticoagulants, known as vitamin K antagonists (VKAs) began. Despite the numerous challenges associated with managing patients using this class of anticoagulants, VKAs have become the mainstay of oral anticoagulation therapy for the past 70 years. Over the past 5 years, however, new oral anticoagulants (NOACs) have emerged and are changing clinical practice. Mechanistically, these medications are targeted therapies and work as either direct thrombin inhibitors (dabigatran etexilate) or direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban). Given their favorable pharmacologic design, NOACs have the potential to replace VKAs as they not only have an encouraging safety profile, but also are therapeutically equivalent or even superior to VKAs when used in certain patient populations.
Pharmacologic design
The targeted drug design of NOACs provides many pharmacologic advantages. Compared with VKAs, NOACs have a notably more predictable pharmacologic profile and relatively wide therapeutic window, which allows for fixed dosing, a rapid onset and offset, and fewer drug interactions.3 These characteristics eliminate the need for the routine dose monitoring and serial dose adjustments frequently associated with VKAs. Additionally, NOACs less commonly require bridging therapy with parenteral unfractionated heparin or low molecular weight heparins (LMWH) while awaiting therapeutic drug levels, as these levels are reached sooner and more predictably than with VKAs.4 As with any medication, however, appropriate consideration should to be given to specific patient populations such as those who are older or have significant comorbidities which may influence drug effect and clearance.
Lastly, it should be mentioned that the pharmacologic benefits of NOACs are not only beneficial from a patient perspective, but also from a health care systems standpoint as their use may provide an opportunity to deliver more cost-effective care. Specifically, economic models using available clinical trial data for stroke prevention in nonvalvular atrial fibrillation have shown that NOACs (apixaban, dabigatran, and rivaroxaban) are cost-effective alternatives when compared with warfarin.5 Although the results from such economic analyses are limited by the modeling assumptions they rely upon, these findings suggest that, at least initially, cost should not be used as a prohibitive reason for adopting these new therapeutics.
Patient selection
The decision to institute oral anticoagulation therapy depends on each patient’s individualized bleeding risk to benefit of ischemia prevention ratio. A major determinant of this ratio is the clinical indication for which anticoagulation is begun. Numerous phase III clinical trials have been conducted comparing the use of NOACs versus VKAs or placebos for the management of nonvalvular atrial fibrillation (AF), venous thromboembolism (VTE), and as adjunctive therapy for patients with acute coronary syndrome.6 Meta-analyses of randomized trials have shown the most significant benefit to be in patients with nonvalvular atrial fibrillation where NOACs have significant reductions in stroke, intracranial hemorrhage, and all-cause mortality, compared with warfarin while displaying variable effects with regards to gastrointestinal bleeding.6,7
In patients with VTE, NOACs have been found to have similar efficacy, compared with VKAs, with regard to the prevention of VTE or VTE-related death, and have been noted to have a better safety profile.6 Lastly, when studied as an adjunctive agent to dual antiplatelet therapy in patients with acute coronary syndrome, it should be noted that NOACs have been associated with an increased bleeding risk without a significant decrease in thrombosis risk.6 Taken together, these data suggest that the primary indication for instituting NOAC therapy should be considered strongly when deciding upon the class of anticoagulant to use.
Overcoming challenges
Since the introduction of NOACs, there has been concern over the lack of specific antidotes to therapy, especially when administered in patients with impaired clearance, a high likelihood of need for an urgent or emergent procedure, or those presenting with life-threatening bleeding complications. Most recently, however, interim analysis from clinical trial data has shown complete reversal of the direct thrombin inhibitor dabigatran with the humanized monocolonal antibody idarucizumab within minutes of administration in greater than 88% of patients studied.8 Similarly, agents such as a PER977 are currently in phase II clinical trials as they have been shown to form noncovalent hydrogen bonds and charge-charge interactions with oral factor Xa inhibitors as well as oral thrombin inhibitors leading to their reversal.9 Given these promising findings, it likely will not be long until reversal agents for NOACs become clinically available. Until that time, it is encouraging that the bleeding profile of these drugs has been found to be favorable, compared with VKAs, and their short half-life allows for a relatively expeditious natural reversal of their anticoagulant effect as the drug is eliminated.
Conclusions
Unlike the serendipitous path leading to the discovery of the first class of oral anticoagulants (VKAs), NOACs have been specifically designed to provide targeted anticoagulation and to address the shortcomings of VKAs. To this end, NOACs are becoming increasingly important in the management of patients with specific clinical conditions such as nonvalvular atrial fibrillation and venous thromboembolism where they have been shown to provide a larger net clinical benefit relative to the available alternatives. Furthermore, with economic analyses providing evidence that NOACs are cost-effective for the health care system and clinical trial results suggesting progress in the development of antidotes for reversal, it is likely that with growing experience, these agents will replace VKAs as the mainstay for prophylactic and therapeutic oral anticoagulation in targeted patient populations.
Madhukar S. Patel, MD, and Elliot L. Chaikof, MD, are from the department of surgery, Beth Israel Deaconess Medical Center, Boston. They reported having no conflicts of interest.
References
1. J Am Vet Med Assoc 1924;64:553-575
3. Hematology Am Soc Hematol Educ Program 2013;2013:464-470
4. Eur Heart J 2013;34:2094-2106
6. Nat Rev Cardiol 2014;11:693-703
8. N Engl J Med 2015;373:511-520
9. N Engl J Med 2014;371:2141-2142
What the doctor didn’t order: unintended consequences and pitfalls of NOACs
Recently, several new oral anticoagulants (NOACs) have gained FDA approval to replace warfarin, capturing the attention of popular media. These include dabigatran, rivaroxaban, apixaban, and edoxaban. Dabigatran targets activated factor II (factor IIa), while rivaroxaban, apixaban, and edoxaban target activated factor X (factor Xa). Easy to take with a once or twice daily pill, with no cumbersome monitoring, they represent a seemingly ideal treatment for the chronically anticoagulated patient. All agents are currently FDA approved in the United States for treatment of acute VTE and AF.
Dabigatran and edoxaban
Similar to warfarin, dabigatran and edoxaban require the use of a LMWH or UFH “bridge” when therapy is beginning, while rivaroxaban and apixaban are instituted as monotherapy without such a bridge. Dabigatran etexilate (PradaxaR, Boehringer Ingelheim) has the longest half-life of all of the NOACs at 12-17 hours, and this half-life is prolonged with increasing age and decreasing renal function.1 It is the only new agent which can be at least partially reversed with dialysis.2 Edoxaban (SavaysaR, Daiichi Sankyo) carries a boxed warning stating that this agent is less effective in AF patients with a creatinine clearance greater than 95 mL/min, and that kidney function should be assessed prior to starting treatment: Such patients have a greater risk of stroke, compared with similar patients treated with warfarin. Edoxaban is the only agent specifically tested at a lower dose in patients at significantly increased risk of bleeding complications (low body weight and/or decreased creatinine clearance).3
Rivaroxaban and apixaban
Rivaroxaban (XareltoR, Bayer and Janssen), and apixaban (EliquisR, Bristol Myers-Squibb), unique amongst the NOACs, have been tested for extended therapy of acute deep vein thrombosis after treatment of 6-12 months. They were found to result in a significant decrease in recurrent VTE without an increase in major bleeding, compared with placebo.4,5 Rivaroxaban has once-daily dosing and apixaban has twice-daily dosing; both are immediate monotherapy, making them quite convenient for patients. Apixaban is the only agent among the NOACs to have a slight decrease in gastrointestinal bleeding, compared with warfarin.6
Consequences and pitfalls with NOACs
Problems with these new drugs, which may diminish our current level of enthusiasm for these agents to totally replace warfarin, include the inability to reliably follow their levels or reverse their anticoagulant effects, the lack of data available on bridging when other procedures need to be performed, their short half-lives, and the lack of data on their anti-inflammatory effects. With regard to monitoring of anticoagulation, the International Society of Thrombosis and Hemostasis (ISTH) has published the times when it might be useful to obtain levels. These times include:
• When a patient is bleeding.
• Before surgery or an invasive procedure when the patient has taken the drug in the previous 24 hours, or longer if creatinine clearance (CrCl) is less than 50 mL min.
• Identification of subtherapeutic or supratherapeutic levels in patients taking other drugs that are known to affect pharmacokinetics.
• Identification of subtherapeutic or supratherapeutic levels in patients at body weight extremes.
• Patients with deteriorating renal function.
• During perioperative management.
• During reversal of anticoagulation.
• When there is suspicion of overdose.
• Assessment of compliance in patients suffering thrombotic events while on treatment.7
Currently, there exists no commercially available reversal agent for any of the NOACs, and existing reversal agents for traditional anticoagulants are of limited, if any, use. Drugs under development include agents for the factor Xa inhibitors and for the thrombin inhibitor. Until the time that specific reversal agents exist, supportive care is the mainstay of therapy. In cases of trauma or severe or life-threatening bleeding, administration of concentrated clotting factors (prothrombin complex concentrate) or dialysis (dabigatran only) may be utilized. However, data from large clinical trials are lacking. A recent study of 90 patients receiving an antibody directed against dabigatran has revealed that the anticoagulant effects of dabigatran were reversed safely within minutes of administration; however drug levels were not consistently suppressed at 24 hours in 20% of the cohort.8
Currently there are no national guidelines or large scale studies to guide bridging NOACs for procedures.
The relatively short half-life for these agents makes it likely that traditional bridging as is practiced for warfarin is not necessary.9 However, this represents a double-edged sword; withholding anticoagulation for two doses (such as if a patient becomes ill or a clinician is overly cautious around the time of a procedure) may leave the patient unprotected.
The final question with the new agents is their anti-inflammatory effects. We know that heparin and LMWH have significant pleiotropic effects that are not necessarily related to their anticoagulant effects. These effects are important in order to decrease the inflammatory nature of the thrombus and its effect on the vein wall. We do not know if the new oral agents have similar effects, as this has never fully been tested. In view of the fact that two of the agents are being used as monotherapy agents without any heparin/LMWH bridge, the anti-inflammatory properties of these new agents should be defined to make sure that such a bridge is not necessary.
So, in summary, although these agents have much to offer, there are many questions that remain to be addressed and answered before they totally replace traditional approaches to anticoagulation, in the realm of VTE. It must not be overlooked that despite all the benefits, they also each carry a risk of bleeding as they all target portions of the coagulation mechanism. We caution that, as with any “gift horse,” physicians should perhaps examine the data more closely and proceed with caution.
Thomas Wakefield, MD, is the Stanley Professor of Vascular Surgery; head, section of vascular surgery; and director, Samuel and Jean Frankel Cardiovascular Center. Andrea Obi, MD, is a vascular surgery fellow and Dawn Coleman MD, is the program director, section of vascular surgery, all at the University of Michigan, Ann Arbor. They reported having no conflicts of interest.
References
1. N Engl J Med. 2009;361:2342-2352
2. J Vasc Surg: Venous and Lymphatic Disorders. 2013;1:418-426
3. N Engl J Med 2013;369:1406-1415
4. N Engl J Med 2010;363:2499-2510
5. N Engl J Med 2013;368:699-708
6. Arteriosclerosis, thrombosis, and vascular biology 2015;35:1056-1065
7. J Thrombosis and Haemostasis 2013;11:756-760
Commentary: INR instability in the NOAC era
Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.3
Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.3 Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.
Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.
Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.11 Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.12 Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.4
Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.13
In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.
For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.
PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.
Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.17 Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.18 NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.
Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.
Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.
References
2. Nat Rev Cardiol. 2014;11:693-703.
5. J Thromb Haemost. 2010;8:2182-91.
6. Thromb Haemost. 2009;101:552-6.
7. Am J Cardiovasc Drugs. 2015;15:205-11.
8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
10. J Med Econ. 2015;18:333-40.
11. Thromb Haemost. 2016;116:480-5.
12. Ann Intern Med. 2009;150:73-83.
13. JAMA Cardiol. 2016;1:172-80.
14. N Engl J Med. 2013;369:2093-104.
15. JAMA Intern Med. 2015;175:18-24.
16. J Am Coll Cardiol. 2014;63:891-900.
Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.3
Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.3 Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.
Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.
Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.11 Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.12 Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.4
Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.13
In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.
For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.
PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.
Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.17 Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.18 NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.
Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.
Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.
References
2. Nat Rev Cardiol. 2014;11:693-703.
5. J Thromb Haemost. 2010;8:2182-91.
6. Thromb Haemost. 2009;101:552-6.
7. Am J Cardiovasc Drugs. 2015;15:205-11.
8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
10. J Med Econ. 2015;18:333-40.
11. Thromb Haemost. 2016;116:480-5.
12. Ann Intern Med. 2009;150:73-83.
13. JAMA Cardiol. 2016;1:172-80.
14. N Engl J Med. 2013;369:2093-104.
15. JAMA Intern Med. 2015;175:18-24.
16. J Am Coll Cardiol. 2014;63:891-900.
Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.3
Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.3 Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.
Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.
Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.11 Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.12 Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.4
Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.13
In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.
For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.
PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.
Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.17 Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.18 NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.
Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.
Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.
References
2. Nat Rev Cardiol. 2014;11:693-703.
5. J Thromb Haemost. 2010;8:2182-91.
6. Thromb Haemost. 2009;101:552-6.
7. Am J Cardiovasc Drugs. 2015;15:205-11.
8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
10. J Med Econ. 2015;18:333-40.
11. Thromb Haemost. 2016;116:480-5.
12. Ann Intern Med. 2009;150:73-83.
13. JAMA Cardiol. 2016;1:172-80.
14. N Engl J Med. 2013;369:2093-104.
15. JAMA Intern Med. 2015;175:18-24.
16. J Am Coll Cardiol. 2014;63:891-900.
Size does matter
I grew up in a small town. I went to a small college. And I live and practiced in a small town in a sparsely populated state. Clearly, I’m partial to smallness. I have practiced in a two-man partnership, a solo practice, a small group, and finally in a large multicenter organization. The 10 years I practiced by myself were the most productive. It was also the most rewarding period of my life both professionally and financially.
The small group environment was a close second as a far as job satisfaction. What little I lost in autonomy was almost balanced by professional stimulation and camaraderie or working shoulder to shoulder with peers. However, all that was lost as our small group was engulfed by a larger entity. Our overhead inflated to a point that it was almost unsustainable. Meetings gobbled up productive office time. Even making little changes that might have allowed us to adapt to the changing clinical landscape seemed to take forever. That is, if they ever happened at all.
From my personal experience, health care delivery doesn’t benefit from the economics of scale that is claimed by other industries. Bigger is not better for health care delivery.
When the promoters of the Affordable Care Act promised that it would encourage cost saving and quality enhancing mergers of health delivery organizations, many other physicians and I had serious doubts about this claim. It turns that our concerns were well founded. The consolidations that were predicted and so eagerly anticipated by the architects of the ACA have occurred, but have not resulted in the promised cost savings or quality improvement.
The results have been so disappointing that Dr. Bob Kocher, special assistant to President Obama for health care and economic policy from 2009 to 2010, has felt the need to issue a mea culpa in the form of an op-ed piece in the Wall Street Journal (“How I Was Wrong About ObamaCare,” July 31, 2016). Although Dr. Kocher still believes organizing medicine into networks “that can share information, coordinate care for patients, and manage risk is critical for delivering higher-quality care, generating cost savings and improving the experience for patients,” he acknowledges, “having every provider in health care ‘owned’ by a single organization is more likely to be a barrier to better care.”
He cites recent evidence that “savings and quality improvement are generated much more often by independent primary care doctors than large hospital-centric health systems.” Small independent practices know their patients better. Unencumbered by the weight of multiple organizational layers, they can more nimbly adjust to change. And there will always be change.
Dr. Kocher also admits that he and his co-crafters of the ACA were mistaken in their belief that “it would take three to five years for physicians to use electronic health records effectively.” Unfortunately, he places the failure on what he views as delay tactics by organized medicine. Sadly, he shares this blind spot with too many other former and current government health care officials, most of whom who have never suffered under the burden of a user-unfriendly, free time–wasting, electronic medical record system.
While it is nice of Dr. Kocher to acknowledge his revelation about size, it comes too late. The bridges have already been burned. Most of the smaller independent practices he now realizes could have provided a solution to the accelerating cost of medical care are gone. In some cases, one of forces driving small practices to merge was the cost and complexity of converting to electronic medical records.
The mea culpa that we really need to hear now is the one admitting that the roll out of the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009 and meaningful use requirements were poorly conceived and implemented. Electronic health record systems that are capable of seamlessly communicating with one another, and are inexpensive, intuitive, and user friendly might have allowed more small independent practices to survive.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
I grew up in a small town. I went to a small college. And I live and practiced in a small town in a sparsely populated state. Clearly, I’m partial to smallness. I have practiced in a two-man partnership, a solo practice, a small group, and finally in a large multicenter organization. The 10 years I practiced by myself were the most productive. It was also the most rewarding period of my life both professionally and financially.
The small group environment was a close second as a far as job satisfaction. What little I lost in autonomy was almost balanced by professional stimulation and camaraderie or working shoulder to shoulder with peers. However, all that was lost as our small group was engulfed by a larger entity. Our overhead inflated to a point that it was almost unsustainable. Meetings gobbled up productive office time. Even making little changes that might have allowed us to adapt to the changing clinical landscape seemed to take forever. That is, if they ever happened at all.
From my personal experience, health care delivery doesn’t benefit from the economics of scale that is claimed by other industries. Bigger is not better for health care delivery.
When the promoters of the Affordable Care Act promised that it would encourage cost saving and quality enhancing mergers of health delivery organizations, many other physicians and I had serious doubts about this claim. It turns that our concerns were well founded. The consolidations that were predicted and so eagerly anticipated by the architects of the ACA have occurred, but have not resulted in the promised cost savings or quality improvement.
The results have been so disappointing that Dr. Bob Kocher, special assistant to President Obama for health care and economic policy from 2009 to 2010, has felt the need to issue a mea culpa in the form of an op-ed piece in the Wall Street Journal (“How I Was Wrong About ObamaCare,” July 31, 2016). Although Dr. Kocher still believes organizing medicine into networks “that can share information, coordinate care for patients, and manage risk is critical for delivering higher-quality care, generating cost savings and improving the experience for patients,” he acknowledges, “having every provider in health care ‘owned’ by a single organization is more likely to be a barrier to better care.”
He cites recent evidence that “savings and quality improvement are generated much more often by independent primary care doctors than large hospital-centric health systems.” Small independent practices know their patients better. Unencumbered by the weight of multiple organizational layers, they can more nimbly adjust to change. And there will always be change.
Dr. Kocher also admits that he and his co-crafters of the ACA were mistaken in their belief that “it would take three to five years for physicians to use electronic health records effectively.” Unfortunately, he places the failure on what he views as delay tactics by organized medicine. Sadly, he shares this blind spot with too many other former and current government health care officials, most of whom who have never suffered under the burden of a user-unfriendly, free time–wasting, electronic medical record system.
While it is nice of Dr. Kocher to acknowledge his revelation about size, it comes too late. The bridges have already been burned. Most of the smaller independent practices he now realizes could have provided a solution to the accelerating cost of medical care are gone. In some cases, one of forces driving small practices to merge was the cost and complexity of converting to electronic medical records.
The mea culpa that we really need to hear now is the one admitting that the roll out of the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009 and meaningful use requirements were poorly conceived and implemented. Electronic health record systems that are capable of seamlessly communicating with one another, and are inexpensive, intuitive, and user friendly might have allowed more small independent practices to survive.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
I grew up in a small town. I went to a small college. And I live and practiced in a small town in a sparsely populated state. Clearly, I’m partial to smallness. I have practiced in a two-man partnership, a solo practice, a small group, and finally in a large multicenter organization. The 10 years I practiced by myself were the most productive. It was also the most rewarding period of my life both professionally and financially.
The small group environment was a close second as a far as job satisfaction. What little I lost in autonomy was almost balanced by professional stimulation and camaraderie or working shoulder to shoulder with peers. However, all that was lost as our small group was engulfed by a larger entity. Our overhead inflated to a point that it was almost unsustainable. Meetings gobbled up productive office time. Even making little changes that might have allowed us to adapt to the changing clinical landscape seemed to take forever. That is, if they ever happened at all.
From my personal experience, health care delivery doesn’t benefit from the economics of scale that is claimed by other industries. Bigger is not better for health care delivery.
When the promoters of the Affordable Care Act promised that it would encourage cost saving and quality enhancing mergers of health delivery organizations, many other physicians and I had serious doubts about this claim. It turns that our concerns were well founded. The consolidations that were predicted and so eagerly anticipated by the architects of the ACA have occurred, but have not resulted in the promised cost savings or quality improvement.
The results have been so disappointing that Dr. Bob Kocher, special assistant to President Obama for health care and economic policy from 2009 to 2010, has felt the need to issue a mea culpa in the form of an op-ed piece in the Wall Street Journal (“How I Was Wrong About ObamaCare,” July 31, 2016). Although Dr. Kocher still believes organizing medicine into networks “that can share information, coordinate care for patients, and manage risk is critical for delivering higher-quality care, generating cost savings and improving the experience for patients,” he acknowledges, “having every provider in health care ‘owned’ by a single organization is more likely to be a barrier to better care.”
He cites recent evidence that “savings and quality improvement are generated much more often by independent primary care doctors than large hospital-centric health systems.” Small independent practices know their patients better. Unencumbered by the weight of multiple organizational layers, they can more nimbly adjust to change. And there will always be change.
Dr. Kocher also admits that he and his co-crafters of the ACA were mistaken in their belief that “it would take three to five years for physicians to use electronic health records effectively.” Unfortunately, he places the failure on what he views as delay tactics by organized medicine. Sadly, he shares this blind spot with too many other former and current government health care officials, most of whom who have never suffered under the burden of a user-unfriendly, free time–wasting, electronic medical record system.
While it is nice of Dr. Kocher to acknowledge his revelation about size, it comes too late. The bridges have already been burned. Most of the smaller independent practices he now realizes could have provided a solution to the accelerating cost of medical care are gone. In some cases, one of forces driving small practices to merge was the cost and complexity of converting to electronic medical records.
The mea culpa that we really need to hear now is the one admitting that the roll out of the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009 and meaningful use requirements were poorly conceived and implemented. Electronic health record systems that are capable of seamlessly communicating with one another, and are inexpensive, intuitive, and user friendly might have allowed more small independent practices to survive.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
Help at a cost
Have you read the study with the weighty title of “Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice?” (Pediatrics. 2016, July 29. doi: 10.1542/peds.2015-4367). You should! Of course, it’s easy for me to admonish you because my active practice days are behind me, and I have the time to read things with intimidating titles. But if you have had the time it takes to read the handwriting on the wall, you know that fee for service (FFS) is on the endangered list and is being replaced by a variety of other payment models, many of which are based on some form of capitation. Even just a cursory reading of this study from the Center of Healthcare Innovation and Policy Research at George Washington University should help you appreciate the complexities implicit in the transition from FFS to capitation and give you a sense of how it might affect the way you practice.
To amass the data they needed to run their computer models, the investigators had to make some assumptions. Here are just a few: The average pediatrician salary was pegged at $180,000, and she/he would be seeing 25 patients per day for 220 clinical days in the year. The practice she/he is working in has a staff to physician ratio of 3.2. Do you even know what your practice’s staff to physician ratio is? Is it ever discussed? How do their assumptions square with your reality?
The researchers also assumed that when practices transition to a capitated system many of them also adopt a primary care medical home (PCMH) model that often includes changes in staffing ratios almost always resulting in a higher staff to physician ratio. When the researchers fed their model even modest increases in staff to physician ratio from 3.2 to 4.0 or 4.4, the result was an increase in the break-even payment rate of between 12% and 23%. However, this study doesn’t answer whether related changes in panel size and patient outcome would make these increases sustainable.
It also doesn’t include the complexities that are inherent in the trend toward part-time employment. How good is your practice at optimizing physician to staff ratios when several physicians have chosen to work part-time? Are the physicians’ schedules arranged to minimize resource-wasting overlap in staffing? How efficient are you at utilizing support staff? For example, do you do your own measurements as part of your exam and give immunizations? How does this compare with your peers? Is your efficiency paying for some of their overhead?
If you are already using a PCMH model, how efficient have you been in using the additional support staff that it requires? Measuring the improvement in quality the change has created is difficult, but it should be fairly easy to determine the cost of the added staffing.
The investigators acknowledge that they have not included the cost of immunization in their models, and I don’t think that they expect to us take their numbers too seriously. But the first line in the authors’ conclusion is the reason that you should take the time to read this study. “Practices are more likely to succeed in capitated models if pediatricians understand how these models alter practice finances.”
You may have gone into pediatrics because of the noble causes that the specialty espouses. But it’s time to swallow hard and acknowledge that this is one of those situations in which it is all about the money. You need to keep informed.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
Have you read the study with the weighty title of “Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice?” (Pediatrics. 2016, July 29. doi: 10.1542/peds.2015-4367). You should! Of course, it’s easy for me to admonish you because my active practice days are behind me, and I have the time to read things with intimidating titles. But if you have had the time it takes to read the handwriting on the wall, you know that fee for service (FFS) is on the endangered list and is being replaced by a variety of other payment models, many of which are based on some form of capitation. Even just a cursory reading of this study from the Center of Healthcare Innovation and Policy Research at George Washington University should help you appreciate the complexities implicit in the transition from FFS to capitation and give you a sense of how it might affect the way you practice.
To amass the data they needed to run their computer models, the investigators had to make some assumptions. Here are just a few: The average pediatrician salary was pegged at $180,000, and she/he would be seeing 25 patients per day for 220 clinical days in the year. The practice she/he is working in has a staff to physician ratio of 3.2. Do you even know what your practice’s staff to physician ratio is? Is it ever discussed? How do their assumptions square with your reality?
The researchers also assumed that when practices transition to a capitated system many of them also adopt a primary care medical home (PCMH) model that often includes changes in staffing ratios almost always resulting in a higher staff to physician ratio. When the researchers fed their model even modest increases in staff to physician ratio from 3.2 to 4.0 or 4.4, the result was an increase in the break-even payment rate of between 12% and 23%. However, this study doesn’t answer whether related changes in panel size and patient outcome would make these increases sustainable.
It also doesn’t include the complexities that are inherent in the trend toward part-time employment. How good is your practice at optimizing physician to staff ratios when several physicians have chosen to work part-time? Are the physicians’ schedules arranged to minimize resource-wasting overlap in staffing? How efficient are you at utilizing support staff? For example, do you do your own measurements as part of your exam and give immunizations? How does this compare with your peers? Is your efficiency paying for some of their overhead?
If you are already using a PCMH model, how efficient have you been in using the additional support staff that it requires? Measuring the improvement in quality the change has created is difficult, but it should be fairly easy to determine the cost of the added staffing.
The investigators acknowledge that they have not included the cost of immunization in their models, and I don’t think that they expect to us take their numbers too seriously. But the first line in the authors’ conclusion is the reason that you should take the time to read this study. “Practices are more likely to succeed in capitated models if pediatricians understand how these models alter practice finances.”
You may have gone into pediatrics because of the noble causes that the specialty espouses. But it’s time to swallow hard and acknowledge that this is one of those situations in which it is all about the money. You need to keep informed.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
Have you read the study with the weighty title of “Fully Capitated Payment Breakeven Rate for a Mid-Size Pediatric Practice?” (Pediatrics. 2016, July 29. doi: 10.1542/peds.2015-4367). You should! Of course, it’s easy for me to admonish you because my active practice days are behind me, and I have the time to read things with intimidating titles. But if you have had the time it takes to read the handwriting on the wall, you know that fee for service (FFS) is on the endangered list and is being replaced by a variety of other payment models, many of which are based on some form of capitation. Even just a cursory reading of this study from the Center of Healthcare Innovation and Policy Research at George Washington University should help you appreciate the complexities implicit in the transition from FFS to capitation and give you a sense of how it might affect the way you practice.
To amass the data they needed to run their computer models, the investigators had to make some assumptions. Here are just a few: The average pediatrician salary was pegged at $180,000, and she/he would be seeing 25 patients per day for 220 clinical days in the year. The practice she/he is working in has a staff to physician ratio of 3.2. Do you even know what your practice’s staff to physician ratio is? Is it ever discussed? How do their assumptions square with your reality?
The researchers also assumed that when practices transition to a capitated system many of them also adopt a primary care medical home (PCMH) model that often includes changes in staffing ratios almost always resulting in a higher staff to physician ratio. When the researchers fed their model even modest increases in staff to physician ratio from 3.2 to 4.0 or 4.4, the result was an increase in the break-even payment rate of between 12% and 23%. However, this study doesn’t answer whether related changes in panel size and patient outcome would make these increases sustainable.
It also doesn’t include the complexities that are inherent in the trend toward part-time employment. How good is your practice at optimizing physician to staff ratios when several physicians have chosen to work part-time? Are the physicians’ schedules arranged to minimize resource-wasting overlap in staffing? How efficient are you at utilizing support staff? For example, do you do your own measurements as part of your exam and give immunizations? How does this compare with your peers? Is your efficiency paying for some of their overhead?
If you are already using a PCMH model, how efficient have you been in using the additional support staff that it requires? Measuring the improvement in quality the change has created is difficult, but it should be fairly easy to determine the cost of the added staffing.
The investigators acknowledge that they have not included the cost of immunization in their models, and I don’t think that they expect to us take their numbers too seriously. But the first line in the authors’ conclusion is the reason that you should take the time to read this study. “Practices are more likely to succeed in capitated models if pediatricians understand how these models alter practice finances.”
You may have gone into pediatrics because of the noble causes that the specialty espouses. But it’s time to swallow hard and acknowledge that this is one of those situations in which it is all about the money. You need to keep informed.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
Commentary: Should board exams include a technical skill assessment? A European perspective
The incidence of vascular diseases is steadily increasing because of an aging population. Vascular surgery is the only specialty that can offer all modalities of vascular therapy (endovascular, open, and conservative). It is therefore necessary to ensure implementation of all these modalities in a modern vascular surgical curricula. The creation of a vascular specialist curriculum is undoubtedly the best way to overcome further fragmentation of vascular provision and to prevent the increasingly financially-driven incentives that can mislead treatment. For obvious reasons this would be a major benefit for our patients and for our specialty.
Another reason for updating the vascular surgical curricula is the significant reduction of open aortic and peripheral vascular surgical training cases, such as abdominal aortic aneurysms and superficial femoral artery occlusions.1 Since the vast majority of these patients are now treated by endovascular means, the remaining vascular disease morphologies can technically be very demanding when requiring open vascular surgery procedures.
Nevertheless, the public and our patients quite understandably expect to be treated by well trained and competent vascular surgeons/specialists. As in all other professions, a proper assessment of all vascular competencies is therefore considered to be mandatory at the end of the training period for a vascular specialist. To this end, several proposals have been made to improve both the structure and different assessment tools including the Vascular Surgical Milestones Project,2 the Vascular Surgery In-Training Examinations (VSITE),3 the use of procedure-based assessments (PBA),4 or objective structured assessments of technical skills (OSATS).5 In addition, simulation workshops (using computer- or life-like synthetic models) play an increasing role in teaching vascular residents the ever-increasing number of different open and endovascular surgical techniques.6,7
Traditionally, the final board examination at the end of the vascular surgical training period consists of an oral assessment or a computer-based test. The obvious crucial question is whether a practical examination should be a added as a mandatory part of a vascular exit exam. This article gives an overview of the board examination of the European Board of Vascular Surgery (EBVS) at the UEMS (Union of European Medical Specialists), which adopted a technical skills assessment in 2006.
The European Vascular Surgical Examination
The UEMS was founded in 1958 as an official body of the European Union (EU). The UEMS has the remits to accredit medical meetings,8 to promote free professional movement of all doctors within Europe, and to ensure high quality of training and associated specialist standards via UEMS examinations.9,10 Currently, the UEMS represents the national medical societies of 37 member states. To date there are 42 UEMS Specialist Sections (separate and independent disciplines), UEMS Divisions (key areas within the independent disciplines, such as Interventional Radiology) and some so-called “Multidisciplinary Joint Committees” (such as Phlebology).
Since 2005, vascular surgery has been represented as an independent medical discipline within the UEMS.Politically, this was a tremendously important step that has helped many European countries to establish vascular surgery on a national level as a separate specialty. The most recent examples are Switzerland (since 2014) and Austria (since 2015).
European vascular surgical examinations have been offered since 1996. The Fellowship of the European Board in Vascular Surgery (FEBVS) is voluntary in most European countries, but in some countries, such as Switzerland and the Netherlands, the European exam has now replaced the national specialist exam.12 Other countries also are in the process of accepting this European standard as a national standard, including Romania, Austria, and Sweden.
The European exam consists of a written section and a combined oral and practical exam. Candidates must be in possession of a national specialist title for surgery or vascular surgery (in countries with a monospecialty). Applications from non-EU countries also are accepted.
Applications must be made in writing, giving details of open-operative and endovascular experience. A distinction is made between assisted operations, independently performed surgery with assistance, and actual independently performed surgical procedures without specialist tutorial assistance. All candidates admitted to the examination have to pass a one-day oral and practical examination, which includes questioning on theoretical background knowledge and its practical application. This takes place mostly in the context of specific clinical case studies as well as via practical examinations on pulsatile perfused lifelike models.
The following procedures are assessed: an infrarenal aortic anastomosis, a carotid endarterectomy, and a distal bypass anastomosis.6,13,14 In the endovascular part of the examination, the applicant’s ability to introduce a guide-wire into the renal artery is assessed.15 Unlike the case in many national tests, FEBVS candidates are also presented with a specialist English-language publication (usually from the European Journal of Vascular and Endovascular Surgery). This article is then discussed with two examiners, with respect to its quality as well as its methodological content and significance. Many examination candidates fear this hurdle the most, but in fact very few participants fail this part of the test.
The European exam is designed to be unbiased and fair, with two examiners at each test station who carry out their assessments independent of each other. During the course of the examination, each candidate is interviewed by approximately 10 assessors. The assessment is validated by way of an evaluation form. The assessing auditors’ communications skills are themselves judged by observers. In the event of communication difficulties, observers are subsequently consulted.
Despite the challenging test procedures, the number of participants in the European Specialist Exam for Vascular Surgery has steadily increased in recent years. For this reason, since 2012, two examination sessions per year have been offered, one during the Annual Meeting of the European Society for Vascular Surgery (ESVS) and one at the European Vascular Course (EVC) in Maastricht. The failure rate each year fluctuates around 20%.
Benefits of being a Fellow of the European Board of Vascular Surgery (FEBVS)
There are a number of very good reasons to sit a European examination and acquire the title of Fellow of the European Board of Vascular Surgery (FEBVS). Some of them are:
Evidence of competency in job applications. Many managers know that the European exam is theoretically and practically challenging, and comprehensive. Confidence in candidates (specialists and senior physicians) who have passed the European test is therefore higher. That in turn increases the chances of getting the desired position especially when applying abroad!
Verification of open surgical and endovascular skills. Filling in the logbook16 helps to maintain a transparent open/endovascular portfolio. It is an extremely sophisticated tool to capture expertise and experience.
Commitment to the need for a European standard. The UEMS has set itself the goal of setting a European standard for medical specialists at the highest level. The European specialist exam projects this. All FEBVS support this goal via their application.
Commitment to academic knowledge-based vascular surgery. The European Vascular Surgery specialist exam covers theoretical background, knowledge of the main studies, basic academic skills, and the ability to comprehensively apply this knowledge to case studies from the entire vascular field. By obtaining this exam, all FEBVS confirm their commitment to an evidence-based approach to vascular surgery.
Commitment to competency-based vascular surgery. The European Vascular Surgery specialist exam covers a practical assessment on open vascular surgical and endovascular key competencies. By passing this part of the exam, all FEBVS give evidence that they are technically competent vascular surgeons.
Desire to belong to the best of the profession. The European specialist exam is certainly more demanding than many national board certifications. However, it offers an opportunity to belong to the European vascular surgical elite.
In conclusion, the European experience on board examinations including skills assessment shows pretty clearly that this sort of comprehensive examination is feasible. Moreover, the increasing number of applications indicates the growing attractiveness of the European certification and qualification as FEBVS. The long-term goal will be to make this examination mandatory for all EU countries – still a long way to go. By the way, since the status of FEBVS is also achievable by non-EU countries, Brexit will not prevent vascular surgeons from the United Kingdom to qualify as FEBVS in the future!
Dr. Eckstein is the Past President of the Board and Section of Vascular Surgery at the Union of European Medical Specialists (UEMS) and Past President of the German Vascular Society (DGG), and an associate editor for Vascular Specialist.
References
1. J Vasc Surg. 2014;60:945-49
2. J Vasc Surg. 2009;49:1140-6
3. Vascular surgery qualifying examination and Vsite
4. Health Technol Assess. 2011;15:i-xxi, 1-162
6. J Vasc Surg. 2013;57:1422-8
8. International Angiology. 2007;26:361-6
9. Eur J Vasc Endovasc Surg. 2009;37:109-15
10. J Vasc Surg. 2008;48:69S-75S; discussion 75S
12. Eur J Vasc Endovasc Surg. 2013;46:719-25
13. J Vasc Surg. 2013;57:1148-54
14. Brit J Surg. 2006;93:1132-8
 |
Dr. Malachi Sheahan III |
Dr. Eckstein’s excellent review highlights the challenges the European Union faces in trying to standardize its certification in vascular surgery. Among European nations, the training pathways in vascular surgery are extremely varied, yet the European Economic Union calls for a medical specialist who is certified in one country to be able to practice that specialty in any EEU nation. While participation in the Fellowship of the European Board in Vascular Surgery is still mostly optional, it does provide a path toward a standard of quality that includes competence in open and endovascular procedures. In the United States, we face a similar dilemma with the advent of the integrated vascular residencies. Curricula, case volumes, and rotations still vary wildly between programs and in comparison with traditional fellowships. One solution is the Fundamentals of Vascular and Endovascular Surgery (FVEVS) project. Currently in its pilot stage, the FVEVS is designed to ensure the attainment of basic technical competencies by the mid-trainee level so the later years are focused on advanced open and endovascular training.
Dr. Malachi Sheahan III is the Associate Medical Editor for Vascular Specialist.
|
Dr. Malachi Sheahan III |
Dr. Eckstein’s excellent review highlights the challenges the European Union faces in trying to standardize its certification in vascular surgery. Among European nations, the training pathways in vascular surgery are extremely varied, yet the European Economic Union calls for a medical specialist who is certified in one country to be able to practice that specialty in any EEU nation. While participation in the Fellowship of the European Board in Vascular Surgery is still mostly optional, it does provide a path toward a standard of quality that includes competence in open and endovascular procedures. In the United States, we face a similar dilemma with the advent of the integrated vascular residencies. Curricula, case volumes, and rotations still vary wildly between programs and in comparison with traditional fellowships. One solution is the Fundamentals of Vascular and Endovascular Surgery (FVEVS) project. Currently in its pilot stage, the FVEVS is designed to ensure the attainment of basic technical competencies by the mid-trainee level so the later years are focused on advanced open and endovascular training.
Dr. Malachi Sheahan III is the Associate Medical Editor for Vascular Specialist.
|
Dr. Malachi Sheahan III |
Dr. Eckstein’s excellent review highlights the challenges the European Union faces in trying to standardize its certification in vascular surgery. Among European nations, the training pathways in vascular surgery are extremely varied, yet the European Economic Union calls for a medical specialist who is certified in one country to be able to practice that specialty in any EEU nation. While participation in the Fellowship of the European Board in Vascular Surgery is still mostly optional, it does provide a path toward a standard of quality that includes competence in open and endovascular procedures. In the United States, we face a similar dilemma with the advent of the integrated vascular residencies. Curricula, case volumes, and rotations still vary wildly between programs and in comparison with traditional fellowships. One solution is the Fundamentals of Vascular and Endovascular Surgery (FVEVS) project. Currently in its pilot stage, the FVEVS is designed to ensure the attainment of basic technical competencies by the mid-trainee level so the later years are focused on advanced open and endovascular training.
Dr. Malachi Sheahan III is the Associate Medical Editor for Vascular Specialist.
The incidence of vascular diseases is steadily increasing because of an aging population. Vascular surgery is the only specialty that can offer all modalities of vascular therapy (endovascular, open, and conservative). It is therefore necessary to ensure implementation of all these modalities in a modern vascular surgical curricula. The creation of a vascular specialist curriculum is undoubtedly the best way to overcome further fragmentation of vascular provision and to prevent the increasingly financially-driven incentives that can mislead treatment. For obvious reasons this would be a major benefit for our patients and for our specialty.
Another reason for updating the vascular surgical curricula is the significant reduction of open aortic and peripheral vascular surgical training cases, such as abdominal aortic aneurysms and superficial femoral artery occlusions.1 Since the vast majority of these patients are now treated by endovascular means, the remaining vascular disease morphologies can technically be very demanding when requiring open vascular surgery procedures.
Nevertheless, the public and our patients quite understandably expect to be treated by well trained and competent vascular surgeons/specialists. As in all other professions, a proper assessment of all vascular competencies is therefore considered to be mandatory at the end of the training period for a vascular specialist. To this end, several proposals have been made to improve both the structure and different assessment tools including the Vascular Surgical Milestones Project,2 the Vascular Surgery In-Training Examinations (VSITE),3 the use of procedure-based assessments (PBA),4 or objective structured assessments of technical skills (OSATS).5 In addition, simulation workshops (using computer- or life-like synthetic models) play an increasing role in teaching vascular residents the ever-increasing number of different open and endovascular surgical techniques.6,7
Traditionally, the final board examination at the end of the vascular surgical training period consists of an oral assessment or a computer-based test. The obvious crucial question is whether a practical examination should be a added as a mandatory part of a vascular exit exam. This article gives an overview of the board examination of the European Board of Vascular Surgery (EBVS) at the UEMS (Union of European Medical Specialists), which adopted a technical skills assessment in 2006.
The European Vascular Surgical Examination
The UEMS was founded in 1958 as an official body of the European Union (EU). The UEMS has the remits to accredit medical meetings,8 to promote free professional movement of all doctors within Europe, and to ensure high quality of training and associated specialist standards via UEMS examinations.9,10 Currently, the UEMS represents the national medical societies of 37 member states. To date there are 42 UEMS Specialist Sections (separate and independent disciplines), UEMS Divisions (key areas within the independent disciplines, such as Interventional Radiology) and some so-called “Multidisciplinary Joint Committees” (such as Phlebology).
Since 2005, vascular surgery has been represented as an independent medical discipline within the UEMS.Politically, this was a tremendously important step that has helped many European countries to establish vascular surgery on a national level as a separate specialty. The most recent examples are Switzerland (since 2014) and Austria (since 2015).
European vascular surgical examinations have been offered since 1996. The Fellowship of the European Board in Vascular Surgery (FEBVS) is voluntary in most European countries, but in some countries, such as Switzerland and the Netherlands, the European exam has now replaced the national specialist exam.12 Other countries also are in the process of accepting this European standard as a national standard, including Romania, Austria, and Sweden.
The European exam consists of a written section and a combined oral and practical exam. Candidates must be in possession of a national specialist title for surgery or vascular surgery (in countries with a monospecialty). Applications from non-EU countries also are accepted.
Applications must be made in writing, giving details of open-operative and endovascular experience. A distinction is made between assisted operations, independently performed surgery with assistance, and actual independently performed surgical procedures without specialist tutorial assistance. All candidates admitted to the examination have to pass a one-day oral and practical examination, which includes questioning on theoretical background knowledge and its practical application. This takes place mostly in the context of specific clinical case studies as well as via practical examinations on pulsatile perfused lifelike models.
The following procedures are assessed: an infrarenal aortic anastomosis, a carotid endarterectomy, and a distal bypass anastomosis.6,13,14 In the endovascular part of the examination, the applicant’s ability to introduce a guide-wire into the renal artery is assessed.15 Unlike the case in many national tests, FEBVS candidates are also presented with a specialist English-language publication (usually from the European Journal of Vascular and Endovascular Surgery). This article is then discussed with two examiners, with respect to its quality as well as its methodological content and significance. Many examination candidates fear this hurdle the most, but in fact very few participants fail this part of the test.
The European exam is designed to be unbiased and fair, with two examiners at each test station who carry out their assessments independent of each other. During the course of the examination, each candidate is interviewed by approximately 10 assessors. The assessment is validated by way of an evaluation form. The assessing auditors’ communications skills are themselves judged by observers. In the event of communication difficulties, observers are subsequently consulted.
Despite the challenging test procedures, the number of participants in the European Specialist Exam for Vascular Surgery has steadily increased in recent years. For this reason, since 2012, two examination sessions per year have been offered, one during the Annual Meeting of the European Society for Vascular Surgery (ESVS) and one at the European Vascular Course (EVC) in Maastricht. The failure rate each year fluctuates around 20%.
Benefits of being a Fellow of the European Board of Vascular Surgery (FEBVS)
There are a number of very good reasons to sit a European examination and acquire the title of Fellow of the European Board of Vascular Surgery (FEBVS). Some of them are:
Evidence of competency in job applications. Many managers know that the European exam is theoretically and practically challenging, and comprehensive. Confidence in candidates (specialists and senior physicians) who have passed the European test is therefore higher. That in turn increases the chances of getting the desired position especially when applying abroad!
Verification of open surgical and endovascular skills. Filling in the logbook16 helps to maintain a transparent open/endovascular portfolio. It is an extremely sophisticated tool to capture expertise and experience.
Commitment to the need for a European standard. The UEMS has set itself the goal of setting a European standard for medical specialists at the highest level. The European specialist exam projects this. All FEBVS support this goal via their application.
Commitment to academic knowledge-based vascular surgery. The European Vascular Surgery specialist exam covers theoretical background, knowledge of the main studies, basic academic skills, and the ability to comprehensively apply this knowledge to case studies from the entire vascular field. By obtaining this exam, all FEBVS confirm their commitment to an evidence-based approach to vascular surgery.
Commitment to competency-based vascular surgery. The European Vascular Surgery specialist exam covers a practical assessment on open vascular surgical and endovascular key competencies. By passing this part of the exam, all FEBVS give evidence that they are technically competent vascular surgeons.
Desire to belong to the best of the profession. The European specialist exam is certainly more demanding than many national board certifications. However, it offers an opportunity to belong to the European vascular surgical elite.
In conclusion, the European experience on board examinations including skills assessment shows pretty clearly that this sort of comprehensive examination is feasible. Moreover, the increasing number of applications indicates the growing attractiveness of the European certification and qualification as FEBVS. The long-term goal will be to make this examination mandatory for all EU countries – still a long way to go. By the way, since the status of FEBVS is also achievable by non-EU countries, Brexit will not prevent vascular surgeons from the United Kingdom to qualify as FEBVS in the future!
Dr. Eckstein is the Past President of the Board and Section of Vascular Surgery at the Union of European Medical Specialists (UEMS) and Past President of the German Vascular Society (DGG), and an associate editor for Vascular Specialist.
References
1. J Vasc Surg. 2014;60:945-49
2. J Vasc Surg. 2009;49:1140-6
3. Vascular surgery qualifying examination and Vsite
4. Health Technol Assess. 2011;15:i-xxi, 1-162
6. J Vasc Surg. 2013;57:1422-8
8. International Angiology. 2007;26:361-6
9. Eur J Vasc Endovasc Surg. 2009;37:109-15
10. J Vasc Surg. 2008;48:69S-75S; discussion 75S
12. Eur J Vasc Endovasc Surg. 2013;46:719-25
13. J Vasc Surg. 2013;57:1148-54
14. Brit J Surg. 2006;93:1132-8
The incidence of vascular diseases is steadily increasing because of an aging population. Vascular surgery is the only specialty that can offer all modalities of vascular therapy (endovascular, open, and conservative). It is therefore necessary to ensure implementation of all these modalities in a modern vascular surgical curricula. The creation of a vascular specialist curriculum is undoubtedly the best way to overcome further fragmentation of vascular provision and to prevent the increasingly financially-driven incentives that can mislead treatment. For obvious reasons this would be a major benefit for our patients and for our specialty.
Another reason for updating the vascular surgical curricula is the significant reduction of open aortic and peripheral vascular surgical training cases, such as abdominal aortic aneurysms and superficial femoral artery occlusions.1 Since the vast majority of these patients are now treated by endovascular means, the remaining vascular disease morphologies can technically be very demanding when requiring open vascular surgery procedures.
Nevertheless, the public and our patients quite understandably expect to be treated by well trained and competent vascular surgeons/specialists. As in all other professions, a proper assessment of all vascular competencies is therefore considered to be mandatory at the end of the training period for a vascular specialist. To this end, several proposals have been made to improve both the structure and different assessment tools including the Vascular Surgical Milestones Project,2 the Vascular Surgery In-Training Examinations (VSITE),3 the use of procedure-based assessments (PBA),4 or objective structured assessments of technical skills (OSATS).5 In addition, simulation workshops (using computer- or life-like synthetic models) play an increasing role in teaching vascular residents the ever-increasing number of different open and endovascular surgical techniques.6,7
Traditionally, the final board examination at the end of the vascular surgical training period consists of an oral assessment or a computer-based test. The obvious crucial question is whether a practical examination should be a added as a mandatory part of a vascular exit exam. This article gives an overview of the board examination of the European Board of Vascular Surgery (EBVS) at the UEMS (Union of European Medical Specialists), which adopted a technical skills assessment in 2006.
The European Vascular Surgical Examination
The UEMS was founded in 1958 as an official body of the European Union (EU). The UEMS has the remits to accredit medical meetings,8 to promote free professional movement of all doctors within Europe, and to ensure high quality of training and associated specialist standards via UEMS examinations.9,10 Currently, the UEMS represents the national medical societies of 37 member states. To date there are 42 UEMS Specialist Sections (separate and independent disciplines), UEMS Divisions (key areas within the independent disciplines, such as Interventional Radiology) and some so-called “Multidisciplinary Joint Committees” (such as Phlebology).
Since 2005, vascular surgery has been represented as an independent medical discipline within the UEMS.Politically, this was a tremendously important step that has helped many European countries to establish vascular surgery on a national level as a separate specialty. The most recent examples are Switzerland (since 2014) and Austria (since 2015).
European vascular surgical examinations have been offered since 1996. The Fellowship of the European Board in Vascular Surgery (FEBVS) is voluntary in most European countries, but in some countries, such as Switzerland and the Netherlands, the European exam has now replaced the national specialist exam.12 Other countries also are in the process of accepting this European standard as a national standard, including Romania, Austria, and Sweden.
The European exam consists of a written section and a combined oral and practical exam. Candidates must be in possession of a national specialist title for surgery or vascular surgery (in countries with a monospecialty). Applications from non-EU countries also are accepted.
Applications must be made in writing, giving details of open-operative and endovascular experience. A distinction is made between assisted operations, independently performed surgery with assistance, and actual independently performed surgical procedures without specialist tutorial assistance. All candidates admitted to the examination have to pass a one-day oral and practical examination, which includes questioning on theoretical background knowledge and its practical application. This takes place mostly in the context of specific clinical case studies as well as via practical examinations on pulsatile perfused lifelike models.
The following procedures are assessed: an infrarenal aortic anastomosis, a carotid endarterectomy, and a distal bypass anastomosis.6,13,14 In the endovascular part of the examination, the applicant’s ability to introduce a guide-wire into the renal artery is assessed.15 Unlike the case in many national tests, FEBVS candidates are also presented with a specialist English-language publication (usually from the European Journal of Vascular and Endovascular Surgery). This article is then discussed with two examiners, with respect to its quality as well as its methodological content and significance. Many examination candidates fear this hurdle the most, but in fact very few participants fail this part of the test.
The European exam is designed to be unbiased and fair, with two examiners at each test station who carry out their assessments independent of each other. During the course of the examination, each candidate is interviewed by approximately 10 assessors. The assessment is validated by way of an evaluation form. The assessing auditors’ communications skills are themselves judged by observers. In the event of communication difficulties, observers are subsequently consulted.
Despite the challenging test procedures, the number of participants in the European Specialist Exam for Vascular Surgery has steadily increased in recent years. For this reason, since 2012, two examination sessions per year have been offered, one during the Annual Meeting of the European Society for Vascular Surgery (ESVS) and one at the European Vascular Course (EVC) in Maastricht. The failure rate each year fluctuates around 20%.
Benefits of being a Fellow of the European Board of Vascular Surgery (FEBVS)
There are a number of very good reasons to sit a European examination and acquire the title of Fellow of the European Board of Vascular Surgery (FEBVS). Some of them are:
Evidence of competency in job applications. Many managers know that the European exam is theoretically and practically challenging, and comprehensive. Confidence in candidates (specialists and senior physicians) who have passed the European test is therefore higher. That in turn increases the chances of getting the desired position especially when applying abroad!
Verification of open surgical and endovascular skills. Filling in the logbook16 helps to maintain a transparent open/endovascular portfolio. It is an extremely sophisticated tool to capture expertise and experience.
Commitment to the need for a European standard. The UEMS has set itself the goal of setting a European standard for medical specialists at the highest level. The European specialist exam projects this. All FEBVS support this goal via their application.
Commitment to academic knowledge-based vascular surgery. The European Vascular Surgery specialist exam covers theoretical background, knowledge of the main studies, basic academic skills, and the ability to comprehensively apply this knowledge to case studies from the entire vascular field. By obtaining this exam, all FEBVS confirm their commitment to an evidence-based approach to vascular surgery.
Commitment to competency-based vascular surgery. The European Vascular Surgery specialist exam covers a practical assessment on open vascular surgical and endovascular key competencies. By passing this part of the exam, all FEBVS give evidence that they are technically competent vascular surgeons.
Desire to belong to the best of the profession. The European specialist exam is certainly more demanding than many national board certifications. However, it offers an opportunity to belong to the European vascular surgical elite.
In conclusion, the European experience on board examinations including skills assessment shows pretty clearly that this sort of comprehensive examination is feasible. Moreover, the increasing number of applications indicates the growing attractiveness of the European certification and qualification as FEBVS. The long-term goal will be to make this examination mandatory for all EU countries – still a long way to go. By the way, since the status of FEBVS is also achievable by non-EU countries, Brexit will not prevent vascular surgeons from the United Kingdom to qualify as FEBVS in the future!
Dr. Eckstein is the Past President of the Board and Section of Vascular Surgery at the Union of European Medical Specialists (UEMS) and Past President of the German Vascular Society (DGG), and an associate editor for Vascular Specialist.
References
1. J Vasc Surg. 2014;60:945-49
2. J Vasc Surg. 2009;49:1140-6
3. Vascular surgery qualifying examination and Vsite
4. Health Technol Assess. 2011;15:i-xxi, 1-162
6. J Vasc Surg. 2013;57:1422-8
8. International Angiology. 2007;26:361-6
9. Eur J Vasc Endovasc Surg. 2009;37:109-15
10. J Vasc Surg. 2008;48:69S-75S; discussion 75S
12. Eur J Vasc Endovasc Surg. 2013;46:719-25
13. J Vasc Surg. 2013;57:1148-54
14. Brit J Surg. 2006;93:1132-8
A Boxed Warning for Inadequate Psoriasis Treatment
The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”1 However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?
Psoriasis is associated with an increased risk for cardiovascular disease.2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and TH17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.6 Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.6 Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.9
Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.10 Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.11
Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.12 Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.9 Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).13 Patients also may experience physical discomfort from pain and itching.14 Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.15 The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.15 Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.16 Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.17
Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.16 The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: warning and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. US Food and Drug Administration website. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm075096.pdf. Published October 6, 2011. Accessed August 10, 2016.
- Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a population-based cohort study. Ann Rheum Dis. 2015;74:326-332.
- Rose S, Sheth NH, Baker JF, et al. A comparison of vascular inflammation in psoriasis, rheumatoid arthritis, and healthy subjects by FDG-PET/CT: a pilot study. Am J Cardiovasc Dis. 2013;3:273-278.
- Shlyankevich J, Mehta NN, Krueger JG, et al. Accumulating evidence for the association and shared pathogenic mechanisms between psoriasis and cardiovascular-related comorbidities. Am J Med. 2014;127:1148-1153.
- Lee MK, Kim HS, Cho EB, et al. A study of awareness and screening behavior of cardiovascular risk factors in patients with psoriasis and dermatologists. Ann Dermatol. 2015;27:59-65.
- Voiculescu VM, Lupu M, Papagheorghe L, et al. Psoriasis and metabolic syndrome—scientific evidence and therapeutic implications. J Med Life. 2014;7:468-471.
- Wu JJ, Poon KY, Bebchuk JD. Association between the type and length of tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis. J Drugs Dermatol. 2013;12:899-903.
- Famenini S, Sako EY, Wu JJ. Effect of treating psoriasis on cardiovascular comorbidities: focus on TNF inhibitors. Am J Clin Dermatol. 2014;15:45-50.
- Gottlieb AB, Kalb RE, Langley RG, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies. J Drugs Dermatol. 2014;13:1441-1448.
- Chimenti MS, Graceffa D, Perricone R. Anti-TNFα discontinuation in rheumatoid and psoriatic arthritis: is it possible after disease remission [published online Apr 21, 2011]? Autoimmun Rev. 2011;10:636-640.
- Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis. 2014;73:1000-1006.
- Pietrzak A, Bartosinska J, Blaszczyk R, et al. Increased serum level of N-terminal Pro-B-type natriuretic peptide as a possible biomarker of cardiovascular risk in psoriatic patients. J Eur Acad Dermatol Venereol. 2015;29:1010-1014.
- Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3, pt 1):401-407.
- Pettey AA, Balkrishnan R, Rapp SR, et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49:271-275.
- Garshick MK, Kimball AB. Psoriasis and the life cycle of persistent life effects. Dermatol Clin. 2015;33:25-39.
- Feldman SR, Malakouti M, Koo JY. Social impact of the burden of psoriasis: effects on patients and practice. Dermatol Online J. August 17, 2014;20. pii:13030/qt48r4w8h2.
- Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651-658.
The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”1 However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?
Psoriasis is associated with an increased risk for cardiovascular disease.2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and TH17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.6 Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.6 Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.9
Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.10 Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.11
Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.12 Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.9 Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).13 Patients also may experience physical discomfort from pain and itching.14 Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.15 The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.15 Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.16 Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.17
Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.16 The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.
The US Food and Drug Administration uses the term boxed warning to highlight potentially dangerous situations associated with prescription drugs. A boxed warning is used when “[T]here is an adverse reaction so serious in proportion to the potential benefit from the drug (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it be considered in assessing the risks and benefits of using the drug.”1 However, drugs are not the only potential cause of severe adverse outcomes in patients with psoriasis. Untreated psoriasis also is a well-established cause of serious morbidity and mortality. What are the risks of inadequate psoriasis treatment?
Psoriasis is associated with an increased risk for cardiovascular disease.2-4 Patients with psoriasis also have a higher prevalence of classic cardiovascular risk factors including smoking, diabetes mellitus, hypertension, obesity, and hyperlipidemia.5,6 Psoriasis is a T-cell mediated disease process driven by IL-23 and TH17 helper cell–derived proinflammatory cytokines, sharing certain genetic aspects with metabolic syndrome.6 Cytokine actions on insulin signaling, lipid metabolism, and adipogenesis may underlie the increased prevalence of metabolic syndrome and cardiovascular risk factors in patients with psoriasis. In addition to treating the cutaneous manifestations of psoriasis, reducing inflammation in these patients reduces C-reactive protein and lipid peroxidation and increases high-density lipoprotein levels.6 Tumor necrosis factor α blockers decrease the risk for cardiovascular disease in patients with psoriasis.7,8 Lower than expected rates of cardiovascular disease also have been reported in a large cohort of psoriasis patients (ie, PSOLAR [Psoriasis Longitudinal Assessment and Registry] registry) being treated with either ustekinumab or tumor necrosis factor α blockers.9
Psoriatic arthritis is a chronic inflammatory disease in which active inflammation results in progressive joint destruction.10 Tumor necrosis factor α inhibitors suppress disease progression, preserve function, and delay destruction of the joints. Ustekinumab also helps control psoriatic arthritis and inhibits radiographic progression of joint disease.11
Importantly, untreated moderate to severe psoriasis is associated with several comorbidities that may lead to early death such as heart attacks and strokes.12 Furthermore, patients not taking biologic medications may have higher death rates than patients taking biologic medications.9 Psoriasis also is associated with tremendous suffering and negative psychosocial effects. The mental and physical impact of the disease is comparable to other major medical conditions (eg, cancer, arthritis, hypertension, heart disease, diabetes, depression).13 Patients also may experience physical discomfort from pain and itching.14 Children with psoriasis may experience bullying, which is associated with an increased number of depressive episodes, thereby increasing their risk for developing psychiatric conditions such as depression and anxiety as adults.15 The stigma associated with psoriasis may affect patients’ ability to build relationships. Patients with psoriasis experience higher divorce rates than patients with other chronic medical conditions, and direct involvement of genital regions may negatively impact patients’ sex lives. Patients have noted that the stigma of psoriasis also is associated with the inability to obtain employment.15 Almost one-third of patients with psoriasis who are either not working or are retired base their work status on their skin condition.16 Furthermore, psoriasis may contribute to economic burden for patients due to indirect costs associated with work absenteeism.17
Adequate treatment of psoriasis improves patients’ physical and psychological health as well as their ability to function in the workplace. However, despite the benefits of treatment, 30% of patients with severe psoriasis and 53% of patients with moderate psoriasis receive no treatment or only topical medications instead of systemic therapies.16 The potential adverse events of inadequate psoriasis treatment far outweigh any potential benefits of withholding treatment. Perhaps a boxed warning should be issued for inadequate treatment of psoriasis patients.
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: warning and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. US Food and Drug Administration website. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm075096.pdf. Published October 6, 2011. Accessed August 10, 2016.
- Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a population-based cohort study. Ann Rheum Dis. 2015;74:326-332.
- Rose S, Sheth NH, Baker JF, et al. A comparison of vascular inflammation in psoriasis, rheumatoid arthritis, and healthy subjects by FDG-PET/CT: a pilot study. Am J Cardiovasc Dis. 2013;3:273-278.
- Shlyankevich J, Mehta NN, Krueger JG, et al. Accumulating evidence for the association and shared pathogenic mechanisms between psoriasis and cardiovascular-related comorbidities. Am J Med. 2014;127:1148-1153.
- Lee MK, Kim HS, Cho EB, et al. A study of awareness and screening behavior of cardiovascular risk factors in patients with psoriasis and dermatologists. Ann Dermatol. 2015;27:59-65.
- Voiculescu VM, Lupu M, Papagheorghe L, et al. Psoriasis and metabolic syndrome—scientific evidence and therapeutic implications. J Med Life. 2014;7:468-471.
- Wu JJ, Poon KY, Bebchuk JD. Association between the type and length of tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis. J Drugs Dermatol. 2013;12:899-903.
- Famenini S, Sako EY, Wu JJ. Effect of treating psoriasis on cardiovascular comorbidities: focus on TNF inhibitors. Am J Clin Dermatol. 2014;15:45-50.
- Gottlieb AB, Kalb RE, Langley RG, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies. J Drugs Dermatol. 2014;13:1441-1448.
- Chimenti MS, Graceffa D, Perricone R. Anti-TNFα discontinuation in rheumatoid and psoriatic arthritis: is it possible after disease remission [published online Apr 21, 2011]? Autoimmun Rev. 2011;10:636-640.
- Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis. 2014;73:1000-1006.
- Pietrzak A, Bartosinska J, Blaszczyk R, et al. Increased serum level of N-terminal Pro-B-type natriuretic peptide as a possible biomarker of cardiovascular risk in psoriatic patients. J Eur Acad Dermatol Venereol. 2015;29:1010-1014.
- Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3, pt 1):401-407.
- Pettey AA, Balkrishnan R, Rapp SR, et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49:271-275.
- Garshick MK, Kimball AB. Psoriasis and the life cycle of persistent life effects. Dermatol Clin. 2015;33:25-39.
- Feldman SR, Malakouti M, Koo JY. Social impact of the burden of psoriasis: effects on patients and practice. Dermatol Online J. August 17, 2014;20. pii:13030/qt48r4w8h2.
- Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651-658.
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: warning and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format. US Food and Drug Administration website. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm075096.pdf. Published October 6, 2011. Accessed August 10, 2016.
- Ogdie A, Yu Y, Haynes K, et al. Risk of major cardiovascular events in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a population-based cohort study. Ann Rheum Dis. 2015;74:326-332.
- Rose S, Sheth NH, Baker JF, et al. A comparison of vascular inflammation in psoriasis, rheumatoid arthritis, and healthy subjects by FDG-PET/CT: a pilot study. Am J Cardiovasc Dis. 2013;3:273-278.
- Shlyankevich J, Mehta NN, Krueger JG, et al. Accumulating evidence for the association and shared pathogenic mechanisms between psoriasis and cardiovascular-related comorbidities. Am J Med. 2014;127:1148-1153.
- Lee MK, Kim HS, Cho EB, et al. A study of awareness and screening behavior of cardiovascular risk factors in patients with psoriasis and dermatologists. Ann Dermatol. 2015;27:59-65.
- Voiculescu VM, Lupu M, Papagheorghe L, et al. Psoriasis and metabolic syndrome—scientific evidence and therapeutic implications. J Med Life. 2014;7:468-471.
- Wu JJ, Poon KY, Bebchuk JD. Association between the type and length of tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis. J Drugs Dermatol. 2013;12:899-903.
- Famenini S, Sako EY, Wu JJ. Effect of treating psoriasis on cardiovascular comorbidities: focus on TNF inhibitors. Am J Clin Dermatol. 2014;15:45-50.
- Gottlieb AB, Kalb RE, Langley RG, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies. J Drugs Dermatol. 2014;13:1441-1448.
- Chimenti MS, Graceffa D, Perricone R. Anti-TNFα discontinuation in rheumatoid and psoriatic arthritis: is it possible after disease remission [published online Apr 21, 2011]? Autoimmun Rev. 2011;10:636-640.
- Kavanaugh A, Ritchlin C, Rahman P, et al. Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials. Ann Rheum Dis. 2014;73:1000-1006.
- Pietrzak A, Bartosinska J, Blaszczyk R, et al. Increased serum level of N-terminal Pro-B-type natriuretic peptide as a possible biomarker of cardiovascular risk in psoriatic patients. J Eur Acad Dermatol Venereol. 2015;29:1010-1014.
- Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3, pt 1):401-407.
- Pettey AA, Balkrishnan R, Rapp SR, et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49:271-275.
- Garshick MK, Kimball AB. Psoriasis and the life cycle of persistent life effects. Dermatol Clin. 2015;33:25-39.
- Feldman SR, Malakouti M, Koo JY. Social impact of the burden of psoriasis: effects on patients and practice. Dermatol Online J. August 17, 2014;20. pii:13030/qt48r4w8h2.
- Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651-658.
Back to Basics: The Role of the Team Physician
Editor’s Note: AJO Deputy Editor-in-Chief Robin West, MD, is the Head Team Physician for the Washington Redskins and the Washington Nationals. She has previously served as a team physician for 2 Super Bowl-winning Pittsburgh Steelers teams. I am pleased to “hand off” this issue to her.
—Bryan T. Hanypsiak, MD
The summer is over, football season has begun, and team physicians are busy trying to manage and treat the plethora of injuries that come with the game. Football is one of the most popular sports played by young athletes. Youth participation (ages 6-14 years) in tackle football was 2.169 million in 2015, according to a study conducted by the Physical Activity Council and presented by USA Football. There were 1.084 million boys (and 1500 girls) playing high school football in the 2014-2015 season, nearly twice the number of the next most popular sport, track and field, according to the National Federation of State High School Associations.Due to the sheer volume of athletes and high-impact nature of the game, football leads all other sports in the number of sustained injuries.
Team physicians have the leadership role in the organization, management, and provision of care of the athletes on the team. The roles and responsibilities of the team physician are ever-evolving. The team physician has to meet certain medical qualifications and education requirements, and understand the ethical and medicolegal issues.
The American Academy of Orthopaedic Surgeons and several other medical associations have put together a Team Physician Consensus Statement (available at http://bit.ly/2b8rOzS). All team physicians, coaches, and athletic trainers should read and understand this statement, as it delineates the qualifications, duties, and responsibilities of the team physician.
Our Football Issue focuses on the most common injuries that the team physician will encounter during the season. Our goal is to create a comprehensive guide for the team physician on the acute management of these injuries. As team physicians, we have to make quick return-to-play decisions that are often difficult, as we are dealing with extremely competitive athletes and coaches in the heat of the moment. Since we can’t control the high levels of adrenalin, loud stadium, or rapid speed of the game, we need to be prepared to perform a comprehensive evaluation and diagnosis under these circumstances. This return-to-play decision should be based solely on the severity of the injury and safety of the player. As a team physician, you are responsible for making the “final call” on when the player is safe to return to the game.
This issue includes a section on the most common medical issues (ophthalmology, dental, and dermatology), concussion, exertional heat stroke, knee injuries, and foot and ankle injuries. We also have a special list of the most common items to include in the athletic trainer’s medical bag when covering a high school or collegiate football game (see page 376). Our prominent contributing authors all have extensive experience covering high school, collegiate, and professional teams.
I hope that our Football Issue helps you to keep your athletes safe and injury-free, which is necessary to have a successful season. Remember, as the team physician, your primary focus is the well being of the players. The success of the team only comes when the players are healthy. A cohesive, well-organized medical team, led by the head athletic trainer and team physician, is a key component to the care of the athletes. It truly takes a village to provide top-notch medical care to a football team.
Am J Orthop. 2016;45(6):338. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
Editor’s Note: AJO Deputy Editor-in-Chief Robin West, MD, is the Head Team Physician for the Washington Redskins and the Washington Nationals. She has previously served as a team physician for 2 Super Bowl-winning Pittsburgh Steelers teams. I am pleased to “hand off” this issue to her.
—Bryan T. Hanypsiak, MD
The summer is over, football season has begun, and team physicians are busy trying to manage and treat the plethora of injuries that come with the game. Football is one of the most popular sports played by young athletes. Youth participation (ages 6-14 years) in tackle football was 2.169 million in 2015, according to a study conducted by the Physical Activity Council and presented by USA Football. There were 1.084 million boys (and 1500 girls) playing high school football in the 2014-2015 season, nearly twice the number of the next most popular sport, track and field, according to the National Federation of State High School Associations.Due to the sheer volume of athletes and high-impact nature of the game, football leads all other sports in the number of sustained injuries.
Team physicians have the leadership role in the organization, management, and provision of care of the athletes on the team. The roles and responsibilities of the team physician are ever-evolving. The team physician has to meet certain medical qualifications and education requirements, and understand the ethical and medicolegal issues.
The American Academy of Orthopaedic Surgeons and several other medical associations have put together a Team Physician Consensus Statement (available at http://bit.ly/2b8rOzS). All team physicians, coaches, and athletic trainers should read and understand this statement, as it delineates the qualifications, duties, and responsibilities of the team physician.
Our Football Issue focuses on the most common injuries that the team physician will encounter during the season. Our goal is to create a comprehensive guide for the team physician on the acute management of these injuries. As team physicians, we have to make quick return-to-play decisions that are often difficult, as we are dealing with extremely competitive athletes and coaches in the heat of the moment. Since we can’t control the high levels of adrenalin, loud stadium, or rapid speed of the game, we need to be prepared to perform a comprehensive evaluation and diagnosis under these circumstances. This return-to-play decision should be based solely on the severity of the injury and safety of the player. As a team physician, you are responsible for making the “final call” on when the player is safe to return to the game.
This issue includes a section on the most common medical issues (ophthalmology, dental, and dermatology), concussion, exertional heat stroke, knee injuries, and foot and ankle injuries. We also have a special list of the most common items to include in the athletic trainer’s medical bag when covering a high school or collegiate football game (see page 376). Our prominent contributing authors all have extensive experience covering high school, collegiate, and professional teams.
I hope that our Football Issue helps you to keep your athletes safe and injury-free, which is necessary to have a successful season. Remember, as the team physician, your primary focus is the well being of the players. The success of the team only comes when the players are healthy. A cohesive, well-organized medical team, led by the head athletic trainer and team physician, is a key component to the care of the athletes. It truly takes a village to provide top-notch medical care to a football team.
Am J Orthop. 2016;45(6):338. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
Editor’s Note: AJO Deputy Editor-in-Chief Robin West, MD, is the Head Team Physician for the Washington Redskins and the Washington Nationals. She has previously served as a team physician for 2 Super Bowl-winning Pittsburgh Steelers teams. I am pleased to “hand off” this issue to her.
—Bryan T. Hanypsiak, MD
The summer is over, football season has begun, and team physicians are busy trying to manage and treat the plethora of injuries that come with the game. Football is one of the most popular sports played by young athletes. Youth participation (ages 6-14 years) in tackle football was 2.169 million in 2015, according to a study conducted by the Physical Activity Council and presented by USA Football. There were 1.084 million boys (and 1500 girls) playing high school football in the 2014-2015 season, nearly twice the number of the next most popular sport, track and field, according to the National Federation of State High School Associations.Due to the sheer volume of athletes and high-impact nature of the game, football leads all other sports in the number of sustained injuries.
Team physicians have the leadership role in the organization, management, and provision of care of the athletes on the team. The roles and responsibilities of the team physician are ever-evolving. The team physician has to meet certain medical qualifications and education requirements, and understand the ethical and medicolegal issues.
The American Academy of Orthopaedic Surgeons and several other medical associations have put together a Team Physician Consensus Statement (available at http://bit.ly/2b8rOzS). All team physicians, coaches, and athletic trainers should read and understand this statement, as it delineates the qualifications, duties, and responsibilities of the team physician.
Our Football Issue focuses on the most common injuries that the team physician will encounter during the season. Our goal is to create a comprehensive guide for the team physician on the acute management of these injuries. As team physicians, we have to make quick return-to-play decisions that are often difficult, as we are dealing with extremely competitive athletes and coaches in the heat of the moment. Since we can’t control the high levels of adrenalin, loud stadium, or rapid speed of the game, we need to be prepared to perform a comprehensive evaluation and diagnosis under these circumstances. This return-to-play decision should be based solely on the severity of the injury and safety of the player. As a team physician, you are responsible for making the “final call” on when the player is safe to return to the game.
This issue includes a section on the most common medical issues (ophthalmology, dental, and dermatology), concussion, exertional heat stroke, knee injuries, and foot and ankle injuries. We also have a special list of the most common items to include in the athletic trainer’s medical bag when covering a high school or collegiate football game (see page 376). Our prominent contributing authors all have extensive experience covering high school, collegiate, and professional teams.
I hope that our Football Issue helps you to keep your athletes safe and injury-free, which is necessary to have a successful season. Remember, as the team physician, your primary focus is the well being of the players. The success of the team only comes when the players are healthy. A cohesive, well-organized medical team, led by the head athletic trainer and team physician, is a key component to the care of the athletes. It truly takes a village to provide top-notch medical care to a football team.
Am J Orthop. 2016;45(6):338. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
Taking hysteroscopy to the office
Along with global endometrial ablation, diagnostic and minor operative hysteroscopy are excellent procedures to bring into your office environment. These operations are generally of short duration and provide little risk to the patient. Moreover, reimbursement exceeds that for the hospital setting. A constant revenue stream can be created after an initial moderate expenditure.
The key to a successful office procedure is patient comfort; this begins with minimizing pain and trauma. In our practice, we note decreased pain when performing vaginoscopy and hysteroscopy without the use of a speculum or tenaculum. This is well substantiated in literature by Professor Stefano Bettocchi, who immediately preceded me as president of the International Society for Gynecologic Endoscopy (ISGE).
In this issue of Master Class in Gynecologic Surgery, I have asked my partner, Aarathi Cholkeri-Singh, MD, to discuss vaginoscopy. Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois at Chicago, lecturer at Rosalind Franklin University of Medicine and Science, and associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.
She also serves as codirector of the AAGL/Society of Reproductive Surgeons fellowship in minimally invasive gynecologic surgery and director of gynecologic surgical education at Advocate Lutheran, and is chair for a postgraduate course on hysteroscopy at the upcoming AAGL 45th Annual Global Congress. Among her publications is a recent review in the Journal of Minimally Invasive Gynecology on hysteroscopy for infertile women (doi:10.1016/j.jmig.2014.12.163).
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, and past president of the AAGL and the International Society for Gynecologic Endoscopy. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. He reported having no financial disclosures relevant to this column. Email him at [email protected].
Along with global endometrial ablation, diagnostic and minor operative hysteroscopy are excellent procedures to bring into your office environment. These operations are generally of short duration and provide little risk to the patient. Moreover, reimbursement exceeds that for the hospital setting. A constant revenue stream can be created after an initial moderate expenditure.
The key to a successful office procedure is patient comfort; this begins with minimizing pain and trauma. In our practice, we note decreased pain when performing vaginoscopy and hysteroscopy without the use of a speculum or tenaculum. This is well substantiated in literature by Professor Stefano Bettocchi, who immediately preceded me as president of the International Society for Gynecologic Endoscopy (ISGE).
In this issue of Master Class in Gynecologic Surgery, I have asked my partner, Aarathi Cholkeri-Singh, MD, to discuss vaginoscopy. Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois at Chicago, lecturer at Rosalind Franklin University of Medicine and Science, and associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.
She also serves as codirector of the AAGL/Society of Reproductive Surgeons fellowship in minimally invasive gynecologic surgery and director of gynecologic surgical education at Advocate Lutheran, and is chair for a postgraduate course on hysteroscopy at the upcoming AAGL 45th Annual Global Congress. Among her publications is a recent review in the Journal of Minimally Invasive Gynecology on hysteroscopy for infertile women (doi:10.1016/j.jmig.2014.12.163).
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, and past president of the AAGL and the International Society for Gynecologic Endoscopy. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. He reported having no financial disclosures relevant to this column. Email him at [email protected].
Along with global endometrial ablation, diagnostic and minor operative hysteroscopy are excellent procedures to bring into your office environment. These operations are generally of short duration and provide little risk to the patient. Moreover, reimbursement exceeds that for the hospital setting. A constant revenue stream can be created after an initial moderate expenditure.
The key to a successful office procedure is patient comfort; this begins with minimizing pain and trauma. In our practice, we note decreased pain when performing vaginoscopy and hysteroscopy without the use of a speculum or tenaculum. This is well substantiated in literature by Professor Stefano Bettocchi, who immediately preceded me as president of the International Society for Gynecologic Endoscopy (ISGE).
In this issue of Master Class in Gynecologic Surgery, I have asked my partner, Aarathi Cholkeri-Singh, MD, to discuss vaginoscopy. Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois at Chicago, lecturer at Rosalind Franklin University of Medicine and Science, and associate director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.
She also serves as codirector of the AAGL/Society of Reproductive Surgeons fellowship in minimally invasive gynecologic surgery and director of gynecologic surgical education at Advocate Lutheran, and is chair for a postgraduate course on hysteroscopy at the upcoming AAGL 45th Annual Global Congress. Among her publications is a recent review in the Journal of Minimally Invasive Gynecology on hysteroscopy for infertile women (doi:10.1016/j.jmig.2014.12.163).
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, and past president of the AAGL and the International Society for Gynecologic Endoscopy. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill.; director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. He reported having no financial disclosures relevant to this column. Email him at [email protected].
The benefits of integrating in-office hysteroscopy
The benefits of integrating hysteroscopy into office practice are compelling. Most importantly, patients appreciate the comfort and convenience of having hysteroscopic procedures done in a familiar setting. Patients can generally be in and out of the office in less than 30 minutes for a diagnostic procedure, and in less than 1-2 hours for an operative procedure.
Not only is an in-office approach patient centered and clinically valuable, but it is more efficient and economically favorable for the gynecologic surgeon. Physicians earn higher reimbursement for diagnostic hysteroscopies, as well as many therapeutic and operative hysteroscopies, when these procedures are done in the office rather than when they’re performed in a hospital or an outpatient center.
Transitioning to in-office hysteroscopy need not be daunting: The setup is relatively simple and does not require an operating suite, just a dedicated exam room. And the need for premedication and local anesthesia can be low, particularly when a vaginoscopic approach to hysteroscopy is employed. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after only a few vaginoscopic procedures.
A vaginoscopic approach avoids the use of a vaginal speculum or cervical tenaculum, significantly decreasing discomfort or pain. Not using these instruments is the only difference between this and traditional hysteroscopy. It is a less invasive approach that is much more tolerable for patients. And for the surgeon, it can be easier and quicker and provides equally good visualization without any impairment in cervical passage.
Described in the literature as far back as the 1950s, vaginoscopy has its roots in the pediatric/adolescent population, where it was used for the removal of foreign bodies and evaluation of the vagina and external cervical os.
More recently, Stefano Bettocchi, MD, and Luigi Selvaggi, MD, in Italy were the first to describe a vaginoscopic approach to hysteroscopy for evaluating the endocervical canal and uterine cavity.
In a series of papers from 1997 to 2004, Dr. Bettocchi and Dr. Selvaggi documented their efforts to improve patient tolerance during diagnostic hysteroscopies. When they used both the speculum and tenaculum in 163 patients, with local anesthesia, 8% reported severe pain, 11% reported moderate pain, and 69% reported mild pain. Only 12% reported no discomfort. With speculum use only, and no anesthesia, in 308 patients, none reported severe pain, 2% reported moderate pain, 32% reported mild pain, and 66% reported no discomfort. When neither instrument was used (again, no anesthesia), patient discomfort was nearly eliminated: In 680 procedures, patients had a 96% no-discomfort rate (J Am Assoc Gynecol Laparosc. 1997 Feb;4[2]:255-8; Curr Opin Obstet Gynecol. 2003 Aug;15[4]:303-8; Obstet Gynecol Clin North Am. 2004 Sep;31[3]:641-54, xi).
Since then, research has affirmed the differences in patient tolerance and has shown that there is no significant difference between traditional and vaginoscopic hysteroscopy in the rate of procedure failure (0%-10%).
In my practice, in addition to vaginal or cervical examination and evaluation of the uterine cavity, I utilize a vaginoscopic approach to perform minor therapeutic and operative procedures such as biopsies, polypectomies, tubal occlusion using the Essure system, and removal of lost intrauterine devices. I can assess infertility, trauma, abnormal uterine bleeding, and mesh erosion, and provide pre- and postsurgical evaluations. In all of these cases, I use minimal premedication and only rarely need any local anesthetic and/or sedation.
Instrumentation and technique
There are a variety of hysteroscopes available on the market, from single-channel flexible diagnostic hysteroscopes that are 3 mm to 4 mm in diameter, to “see-and-treat” operative hysteroscopes that are rigid and have various diameters and camera lens angles.
A hysteroscope with a 5.5-mm outer diameter works well for a vaginoscopic approach that avoids cervical dilation. Accessory instrumentation includes semirigid 5 Fr 35-cm–long biopsy forceps, scissors, and alligator forceps.
In timing the procedure, our main goal is a thin uterine lining. This can be achieved by scheduling the procedure during the early proliferative phase of the menstrual cycle or by using a gonadotropin-releasing hormone agonist or a transdermal or transvaginal contraceptive medication.
By far the most important element of pain control and analgesia is the time spent with each patient to thoroughly discuss the experience of hysteroscopy and to set expectations about what she will hear, see, and feel. An unexpected experience can worsen anxiety, which in turn can worsen pain. If everything is as familiar and relaxed as possible, there will be little need for analgesia.
I tell patients in preprocedure counseling that the distention of the uterine walls usually causes some cramping, and that NSAIDs can minimize this cramping. In rare cases, when a patient is very worried about her pain tolerance, I will prescribe diazepam. However, many of my patients opt to do nothing other than take ibuprofen. On a case-by-case basis, you can determine with your patient what type and level of analgesia and preprocedure medication will be best.
Paracervical blocks are an option for some surgical patients, but I advise my patients to move forward without the block and assure them that it can be administered later if needed. Thus far, I’ve never proceeded with a paracervical block. There are other methods and sites for introducing local anesthesia, including intracervical, by injection or topical, or topical intracavitary techniques. Nevertheless, it is unclear from randomized controlled trials whether local anesthesia is effective. Trials of paracervical blocks similarly have had inconsistent outcomes.
I do commonly premedicate patients – mainly nulliparous patients and postmenopausal patients – with misoprostol, which softens the cervix and facilitates an easier entry of the hysteroscope into the cervix.
Published studies on misoprostol administration before hysteroscopy have had mixed results. A Cochrane review from 2015 concluded there is moderate-quality evidence in support of preoperative ripening with the agent, while another meta-analysis also published in 2015 concluded that data are poor and do not support its use. Recently, however, there appear to be more supportive studies demonstrating or suggesting that misoprostol is effective in reducing discomfort.
Patient discomfort is also minimized when there is little manipulation of the hysteroscope. Scopes that are angled (12, 25, or 30 degrees) allow optimal visualization with minimal movement; the scope can be brought to the midline of the uterine cavity and the light cord rotated to the 3:00 and 9:00 o’clock positions to enable visualization of the cornu. A 0-degree scope, on the other hand, must be manipulated quite a bit for the same degree of visualization, potentially increasing patient discomfort.
Prior to hysteroscopy, the cervix and vagina are cleaned with a small-diameter swab dipped in povidone-iodine or chlorhexidine gluconate in the case of allergies. One or two 1,000-cc bags of saline inserted into pressure bags are attached to Y-type tubing. (A diagnostic procedure rarely will require two bags.) I spread the labia initially while guiding the scope into the posterior fornix of the vagina. If the leakage of fluid causes inadequate distension of the vaginal walls, I will gently pinch the labia together with gauze.
I then gently pull back the scope and manipulate it posteriorly to visualize the external cervical os anteriorly. The hysteroscope may then be introduced through the cervical os, endocervical canal, and uterine cavity, with care taken so that the instrument does not rub against the cervix or the uterine tissue and cause trauma, pain, and bleeding. The uterus will progressively align with the cervix and vagina, thereby eliminating the need for a tenaculum to straighten the uterine axis.
Fluid monitoring is important, especially during operative hysteroscopy. In my practice, a nurse watches inflow and outflow amounts while I explain what I am doing and visualizing. Some patients like to be able to view the surgery, so I am always ready to tilt the screen accordingly.
The economics
How do you know if office hysteroscopy is right for you? Your own surgical skill and the skills of your staff, who must be trained to handle and sterilize equipment and to consistently assist you, are major factors, as is ensurance of a return on your investment.
One manufacturer contacted for this Master Class lists the price of a complete office tower (light source, camera, and monitor) at approximately $9,700 and the price of a rigid hysteroscope, sheath, and hand instruments at about $6,300. A complete setup for office hysteroscopy, including a standard operative (rigid) hysteroscope, should therefore cost between $15,000 and $17,000. Companies also offer leasing options for about $300-400/month.
Flexible hysteroscopes cost about $6,000 more, which prompts many gynecologic surgeons to focus their investment on a rigid scope that can be used for both diagnostic and therapeutic procedures. Disposables cost $10 or less, and $40-50 or less, for each diagnostic and operative hysteroscopy, respectively.
A look at the Medicare Relative Value Units (RVUs) – a key component of the Medicare reimbursement system and a standard for many payers in determining compensation – shows higher reimbursement for quite a few hysteroscopic codes when these procedures are performed in the office.
Total RVUs have three components:
1. Physician work, including time and the technical skill and intensity of effort it takes to perform a service or procedure.
2. Practice expenses, such as rent, equipment and supplies, and nonphysician salaries.
3. Malpractice insurance premiums.
Each component is multiplied by a factor that accounts for geographic cost variations, and each total RVU is multiplied by a dollar amount known as the conversion factor.
Practice expense (PE) RVUs for services provided in a “facility” (e.g., hospital or outpatient clinic) are often lower than office-based PE RVUs for the same services. Hysteroscopy is no exception. The PE RVU value for diagnostic hysteroscopy performed in the office, for instance, is approximately 5 units, compared with 1.64 units for diagnostic hysteroscopy performed in a facility.
Information on hysteroscopic procedures, and their associated RVUs, on geographic practice cost indices and on pricing, can be accessed using Medicare’s Physician Fee Schedule lookup tool (www.cms.gov/apps/physician-fee-schedule/overview.aspx).
This tool is useful for calculating returns on investment. According to national payment amounts listed in August, a diagnostic hysteroscopy performed in the office will earn an average of $315.08 vs. $192.27 for each case performed in the hospital. If you perform 12 such procedures a year, that’s about $3,781 in the office, compared with $2,307 in the hospital.
This difference alone might not be worth an investment of $15,000 or more, but if you anticipate performing additional procedures with higher margins and higher reimbursement, such as 12 thermal endometrial ablations a year in combination with diagnostic hysteroscopy (which, according to the Medicare national fee schedule averages would earn $15,962 in the office vs. $4,971 in the hospital), or 12 Essure tubal occlusions ($22,595 vs. $5,263), the investment will look more favorable.
And if your patients are largely privately insured, your return on investment will occur much more quickly. In metropolitan Chicago, Blue Cross Blue Shield is reimbursing in-office diagnostic hysteroscopy at approximately $568, hysteroscopic ablations at $3,844, and Essure tubal occlusions at $3,885.
In addition to reimbursement levels, it’s important to consider the efficiencies of in-office hysteroscopy. You can perform an annual exam while the assistant sets up the room and greets each patient, for instance, or see another established patient while the assistant discharges your patient and turns the room over. Our patients, in turn, benefit from increased accessibility, with less time spent away from work or family, as well as more familiarity and comfort and reduced out-of-pocket expenses.
Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois in Chicago and is director of gynecologic surgical education and associate director of minimally invasive gynecology at Advocate Lutheran General Hospital. She is in private practice with Dr. Charles Miller and Dr. Kristen Sasaki at the Advanced Gynecologic Surgical Institute in Chicago. She is a consultant for DySIS Medical, Hologic, and Bayer HealthCare.
The benefits of integrating hysteroscopy into office practice are compelling. Most importantly, patients appreciate the comfort and convenience of having hysteroscopic procedures done in a familiar setting. Patients can generally be in and out of the office in less than 30 minutes for a diagnostic procedure, and in less than 1-2 hours for an operative procedure.
Not only is an in-office approach patient centered and clinically valuable, but it is more efficient and economically favorable for the gynecologic surgeon. Physicians earn higher reimbursement for diagnostic hysteroscopies, as well as many therapeutic and operative hysteroscopies, when these procedures are done in the office rather than when they’re performed in a hospital or an outpatient center.
Transitioning to in-office hysteroscopy need not be daunting: The setup is relatively simple and does not require an operating suite, just a dedicated exam room. And the need for premedication and local anesthesia can be low, particularly when a vaginoscopic approach to hysteroscopy is employed. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after only a few vaginoscopic procedures.
A vaginoscopic approach avoids the use of a vaginal speculum or cervical tenaculum, significantly decreasing discomfort or pain. Not using these instruments is the only difference between this and traditional hysteroscopy. It is a less invasive approach that is much more tolerable for patients. And for the surgeon, it can be easier and quicker and provides equally good visualization without any impairment in cervical passage.
Described in the literature as far back as the 1950s, vaginoscopy has its roots in the pediatric/adolescent population, where it was used for the removal of foreign bodies and evaluation of the vagina and external cervical os.
More recently, Stefano Bettocchi, MD, and Luigi Selvaggi, MD, in Italy were the first to describe a vaginoscopic approach to hysteroscopy for evaluating the endocervical canal and uterine cavity.
In a series of papers from 1997 to 2004, Dr. Bettocchi and Dr. Selvaggi documented their efforts to improve patient tolerance during diagnostic hysteroscopies. When they used both the speculum and tenaculum in 163 patients, with local anesthesia, 8% reported severe pain, 11% reported moderate pain, and 69% reported mild pain. Only 12% reported no discomfort. With speculum use only, and no anesthesia, in 308 patients, none reported severe pain, 2% reported moderate pain, 32% reported mild pain, and 66% reported no discomfort. When neither instrument was used (again, no anesthesia), patient discomfort was nearly eliminated: In 680 procedures, patients had a 96% no-discomfort rate (J Am Assoc Gynecol Laparosc. 1997 Feb;4[2]:255-8; Curr Opin Obstet Gynecol. 2003 Aug;15[4]:303-8; Obstet Gynecol Clin North Am. 2004 Sep;31[3]:641-54, xi).
Since then, research has affirmed the differences in patient tolerance and has shown that there is no significant difference between traditional and vaginoscopic hysteroscopy in the rate of procedure failure (0%-10%).
In my practice, in addition to vaginal or cervical examination and evaluation of the uterine cavity, I utilize a vaginoscopic approach to perform minor therapeutic and operative procedures such as biopsies, polypectomies, tubal occlusion using the Essure system, and removal of lost intrauterine devices. I can assess infertility, trauma, abnormal uterine bleeding, and mesh erosion, and provide pre- and postsurgical evaluations. In all of these cases, I use minimal premedication and only rarely need any local anesthetic and/or sedation.
Instrumentation and technique
There are a variety of hysteroscopes available on the market, from single-channel flexible diagnostic hysteroscopes that are 3 mm to 4 mm in diameter, to “see-and-treat” operative hysteroscopes that are rigid and have various diameters and camera lens angles.
A hysteroscope with a 5.5-mm outer diameter works well for a vaginoscopic approach that avoids cervical dilation. Accessory instrumentation includes semirigid 5 Fr 35-cm–long biopsy forceps, scissors, and alligator forceps.
In timing the procedure, our main goal is a thin uterine lining. This can be achieved by scheduling the procedure during the early proliferative phase of the menstrual cycle or by using a gonadotropin-releasing hormone agonist or a transdermal or transvaginal contraceptive medication.
By far the most important element of pain control and analgesia is the time spent with each patient to thoroughly discuss the experience of hysteroscopy and to set expectations about what she will hear, see, and feel. An unexpected experience can worsen anxiety, which in turn can worsen pain. If everything is as familiar and relaxed as possible, there will be little need for analgesia.
I tell patients in preprocedure counseling that the distention of the uterine walls usually causes some cramping, and that NSAIDs can minimize this cramping. In rare cases, when a patient is very worried about her pain tolerance, I will prescribe diazepam. However, many of my patients opt to do nothing other than take ibuprofen. On a case-by-case basis, you can determine with your patient what type and level of analgesia and preprocedure medication will be best.
Paracervical blocks are an option for some surgical patients, but I advise my patients to move forward without the block and assure them that it can be administered later if needed. Thus far, I’ve never proceeded with a paracervical block. There are other methods and sites for introducing local anesthesia, including intracervical, by injection or topical, or topical intracavitary techniques. Nevertheless, it is unclear from randomized controlled trials whether local anesthesia is effective. Trials of paracervical blocks similarly have had inconsistent outcomes.
I do commonly premedicate patients – mainly nulliparous patients and postmenopausal patients – with misoprostol, which softens the cervix and facilitates an easier entry of the hysteroscope into the cervix.
Published studies on misoprostol administration before hysteroscopy have had mixed results. A Cochrane review from 2015 concluded there is moderate-quality evidence in support of preoperative ripening with the agent, while another meta-analysis also published in 2015 concluded that data are poor and do not support its use. Recently, however, there appear to be more supportive studies demonstrating or suggesting that misoprostol is effective in reducing discomfort.
Patient discomfort is also minimized when there is little manipulation of the hysteroscope. Scopes that are angled (12, 25, or 30 degrees) allow optimal visualization with minimal movement; the scope can be brought to the midline of the uterine cavity and the light cord rotated to the 3:00 and 9:00 o’clock positions to enable visualization of the cornu. A 0-degree scope, on the other hand, must be manipulated quite a bit for the same degree of visualization, potentially increasing patient discomfort.
Prior to hysteroscopy, the cervix and vagina are cleaned with a small-diameter swab dipped in povidone-iodine or chlorhexidine gluconate in the case of allergies. One or two 1,000-cc bags of saline inserted into pressure bags are attached to Y-type tubing. (A diagnostic procedure rarely will require two bags.) I spread the labia initially while guiding the scope into the posterior fornix of the vagina. If the leakage of fluid causes inadequate distension of the vaginal walls, I will gently pinch the labia together with gauze.
I then gently pull back the scope and manipulate it posteriorly to visualize the external cervical os anteriorly. The hysteroscope may then be introduced through the cervical os, endocervical canal, and uterine cavity, with care taken so that the instrument does not rub against the cervix or the uterine tissue and cause trauma, pain, and bleeding. The uterus will progressively align with the cervix and vagina, thereby eliminating the need for a tenaculum to straighten the uterine axis.
Fluid monitoring is important, especially during operative hysteroscopy. In my practice, a nurse watches inflow and outflow amounts while I explain what I am doing and visualizing. Some patients like to be able to view the surgery, so I am always ready to tilt the screen accordingly.
The economics
How do you know if office hysteroscopy is right for you? Your own surgical skill and the skills of your staff, who must be trained to handle and sterilize equipment and to consistently assist you, are major factors, as is ensurance of a return on your investment.
One manufacturer contacted for this Master Class lists the price of a complete office tower (light source, camera, and monitor) at approximately $9,700 and the price of a rigid hysteroscope, sheath, and hand instruments at about $6,300. A complete setup for office hysteroscopy, including a standard operative (rigid) hysteroscope, should therefore cost between $15,000 and $17,000. Companies also offer leasing options for about $300-400/month.
Flexible hysteroscopes cost about $6,000 more, which prompts many gynecologic surgeons to focus their investment on a rigid scope that can be used for both diagnostic and therapeutic procedures. Disposables cost $10 or less, and $40-50 or less, for each diagnostic and operative hysteroscopy, respectively.
A look at the Medicare Relative Value Units (RVUs) – a key component of the Medicare reimbursement system and a standard for many payers in determining compensation – shows higher reimbursement for quite a few hysteroscopic codes when these procedures are performed in the office.
Total RVUs have three components:
1. Physician work, including time and the technical skill and intensity of effort it takes to perform a service or procedure.
2. Practice expenses, such as rent, equipment and supplies, and nonphysician salaries.
3. Malpractice insurance premiums.
Each component is multiplied by a factor that accounts for geographic cost variations, and each total RVU is multiplied by a dollar amount known as the conversion factor.
Practice expense (PE) RVUs for services provided in a “facility” (e.g., hospital or outpatient clinic) are often lower than office-based PE RVUs for the same services. Hysteroscopy is no exception. The PE RVU value for diagnostic hysteroscopy performed in the office, for instance, is approximately 5 units, compared with 1.64 units for diagnostic hysteroscopy performed in a facility.
Information on hysteroscopic procedures, and their associated RVUs, on geographic practice cost indices and on pricing, can be accessed using Medicare’s Physician Fee Schedule lookup tool (www.cms.gov/apps/physician-fee-schedule/overview.aspx).
This tool is useful for calculating returns on investment. According to national payment amounts listed in August, a diagnostic hysteroscopy performed in the office will earn an average of $315.08 vs. $192.27 for each case performed in the hospital. If you perform 12 such procedures a year, that’s about $3,781 in the office, compared with $2,307 in the hospital.
This difference alone might not be worth an investment of $15,000 or more, but if you anticipate performing additional procedures with higher margins and higher reimbursement, such as 12 thermal endometrial ablations a year in combination with diagnostic hysteroscopy (which, according to the Medicare national fee schedule averages would earn $15,962 in the office vs. $4,971 in the hospital), or 12 Essure tubal occlusions ($22,595 vs. $5,263), the investment will look more favorable.
And if your patients are largely privately insured, your return on investment will occur much more quickly. In metropolitan Chicago, Blue Cross Blue Shield is reimbursing in-office diagnostic hysteroscopy at approximately $568, hysteroscopic ablations at $3,844, and Essure tubal occlusions at $3,885.
In addition to reimbursement levels, it’s important to consider the efficiencies of in-office hysteroscopy. You can perform an annual exam while the assistant sets up the room and greets each patient, for instance, or see another established patient while the assistant discharges your patient and turns the room over. Our patients, in turn, benefit from increased accessibility, with less time spent away from work or family, as well as more familiarity and comfort and reduced out-of-pocket expenses.
Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois in Chicago and is director of gynecologic surgical education and associate director of minimally invasive gynecology at Advocate Lutheran General Hospital. She is in private practice with Dr. Charles Miller and Dr. Kristen Sasaki at the Advanced Gynecologic Surgical Institute in Chicago. She is a consultant for DySIS Medical, Hologic, and Bayer HealthCare.
The benefits of integrating hysteroscopy into office practice are compelling. Most importantly, patients appreciate the comfort and convenience of having hysteroscopic procedures done in a familiar setting. Patients can generally be in and out of the office in less than 30 minutes for a diagnostic procedure, and in less than 1-2 hours for an operative procedure.
Not only is an in-office approach patient centered and clinically valuable, but it is more efficient and economically favorable for the gynecologic surgeon. Physicians earn higher reimbursement for diagnostic hysteroscopies, as well as many therapeutic and operative hysteroscopies, when these procedures are done in the office rather than when they’re performed in a hospital or an outpatient center.
Transitioning to in-office hysteroscopy need not be daunting: The setup is relatively simple and does not require an operating suite, just a dedicated exam room. And the need for premedication and local anesthesia can be low, particularly when a vaginoscopic approach to hysteroscopy is employed. For most gynecologic surgeons, the necessary skills and comfort levels fall into place after only a few vaginoscopic procedures.
A vaginoscopic approach avoids the use of a vaginal speculum or cervical tenaculum, significantly decreasing discomfort or pain. Not using these instruments is the only difference between this and traditional hysteroscopy. It is a less invasive approach that is much more tolerable for patients. And for the surgeon, it can be easier and quicker and provides equally good visualization without any impairment in cervical passage.
Described in the literature as far back as the 1950s, vaginoscopy has its roots in the pediatric/adolescent population, where it was used for the removal of foreign bodies and evaluation of the vagina and external cervical os.
More recently, Stefano Bettocchi, MD, and Luigi Selvaggi, MD, in Italy were the first to describe a vaginoscopic approach to hysteroscopy for evaluating the endocervical canal and uterine cavity.
In a series of papers from 1997 to 2004, Dr. Bettocchi and Dr. Selvaggi documented their efforts to improve patient tolerance during diagnostic hysteroscopies. When they used both the speculum and tenaculum in 163 patients, with local anesthesia, 8% reported severe pain, 11% reported moderate pain, and 69% reported mild pain. Only 12% reported no discomfort. With speculum use only, and no anesthesia, in 308 patients, none reported severe pain, 2% reported moderate pain, 32% reported mild pain, and 66% reported no discomfort. When neither instrument was used (again, no anesthesia), patient discomfort was nearly eliminated: In 680 procedures, patients had a 96% no-discomfort rate (J Am Assoc Gynecol Laparosc. 1997 Feb;4[2]:255-8; Curr Opin Obstet Gynecol. 2003 Aug;15[4]:303-8; Obstet Gynecol Clin North Am. 2004 Sep;31[3]:641-54, xi).
Since then, research has affirmed the differences in patient tolerance and has shown that there is no significant difference between traditional and vaginoscopic hysteroscopy in the rate of procedure failure (0%-10%).
In my practice, in addition to vaginal or cervical examination and evaluation of the uterine cavity, I utilize a vaginoscopic approach to perform minor therapeutic and operative procedures such as biopsies, polypectomies, tubal occlusion using the Essure system, and removal of lost intrauterine devices. I can assess infertility, trauma, abnormal uterine bleeding, and mesh erosion, and provide pre- and postsurgical evaluations. In all of these cases, I use minimal premedication and only rarely need any local anesthetic and/or sedation.
Instrumentation and technique
There are a variety of hysteroscopes available on the market, from single-channel flexible diagnostic hysteroscopes that are 3 mm to 4 mm in diameter, to “see-and-treat” operative hysteroscopes that are rigid and have various diameters and camera lens angles.
A hysteroscope with a 5.5-mm outer diameter works well for a vaginoscopic approach that avoids cervical dilation. Accessory instrumentation includes semirigid 5 Fr 35-cm–long biopsy forceps, scissors, and alligator forceps.
In timing the procedure, our main goal is a thin uterine lining. This can be achieved by scheduling the procedure during the early proliferative phase of the menstrual cycle or by using a gonadotropin-releasing hormone agonist or a transdermal or transvaginal contraceptive medication.
By far the most important element of pain control and analgesia is the time spent with each patient to thoroughly discuss the experience of hysteroscopy and to set expectations about what she will hear, see, and feel. An unexpected experience can worsen anxiety, which in turn can worsen pain. If everything is as familiar and relaxed as possible, there will be little need for analgesia.
I tell patients in preprocedure counseling that the distention of the uterine walls usually causes some cramping, and that NSAIDs can minimize this cramping. In rare cases, when a patient is very worried about her pain tolerance, I will prescribe diazepam. However, many of my patients opt to do nothing other than take ibuprofen. On a case-by-case basis, you can determine with your patient what type and level of analgesia and preprocedure medication will be best.
Paracervical blocks are an option for some surgical patients, but I advise my patients to move forward without the block and assure them that it can be administered later if needed. Thus far, I’ve never proceeded with a paracervical block. There are other methods and sites for introducing local anesthesia, including intracervical, by injection or topical, or topical intracavitary techniques. Nevertheless, it is unclear from randomized controlled trials whether local anesthesia is effective. Trials of paracervical blocks similarly have had inconsistent outcomes.
I do commonly premedicate patients – mainly nulliparous patients and postmenopausal patients – with misoprostol, which softens the cervix and facilitates an easier entry of the hysteroscope into the cervix.
Published studies on misoprostol administration before hysteroscopy have had mixed results. A Cochrane review from 2015 concluded there is moderate-quality evidence in support of preoperative ripening with the agent, while another meta-analysis also published in 2015 concluded that data are poor and do not support its use. Recently, however, there appear to be more supportive studies demonstrating or suggesting that misoprostol is effective in reducing discomfort.
Patient discomfort is also minimized when there is little manipulation of the hysteroscope. Scopes that are angled (12, 25, or 30 degrees) allow optimal visualization with minimal movement; the scope can be brought to the midline of the uterine cavity and the light cord rotated to the 3:00 and 9:00 o’clock positions to enable visualization of the cornu. A 0-degree scope, on the other hand, must be manipulated quite a bit for the same degree of visualization, potentially increasing patient discomfort.
Prior to hysteroscopy, the cervix and vagina are cleaned with a small-diameter swab dipped in povidone-iodine or chlorhexidine gluconate in the case of allergies. One or two 1,000-cc bags of saline inserted into pressure bags are attached to Y-type tubing. (A diagnostic procedure rarely will require two bags.) I spread the labia initially while guiding the scope into the posterior fornix of the vagina. If the leakage of fluid causes inadequate distension of the vaginal walls, I will gently pinch the labia together with gauze.
I then gently pull back the scope and manipulate it posteriorly to visualize the external cervical os anteriorly. The hysteroscope may then be introduced through the cervical os, endocervical canal, and uterine cavity, with care taken so that the instrument does not rub against the cervix or the uterine tissue and cause trauma, pain, and bleeding. The uterus will progressively align with the cervix and vagina, thereby eliminating the need for a tenaculum to straighten the uterine axis.
Fluid monitoring is important, especially during operative hysteroscopy. In my practice, a nurse watches inflow and outflow amounts while I explain what I am doing and visualizing. Some patients like to be able to view the surgery, so I am always ready to tilt the screen accordingly.
The economics
How do you know if office hysteroscopy is right for you? Your own surgical skill and the skills of your staff, who must be trained to handle and sterilize equipment and to consistently assist you, are major factors, as is ensurance of a return on your investment.
One manufacturer contacted for this Master Class lists the price of a complete office tower (light source, camera, and monitor) at approximately $9,700 and the price of a rigid hysteroscope, sheath, and hand instruments at about $6,300. A complete setup for office hysteroscopy, including a standard operative (rigid) hysteroscope, should therefore cost between $15,000 and $17,000. Companies also offer leasing options for about $300-400/month.
Flexible hysteroscopes cost about $6,000 more, which prompts many gynecologic surgeons to focus their investment on a rigid scope that can be used for both diagnostic and therapeutic procedures. Disposables cost $10 or less, and $40-50 or less, for each diagnostic and operative hysteroscopy, respectively.
A look at the Medicare Relative Value Units (RVUs) – a key component of the Medicare reimbursement system and a standard for many payers in determining compensation – shows higher reimbursement for quite a few hysteroscopic codes when these procedures are performed in the office.
Total RVUs have three components:
1. Physician work, including time and the technical skill and intensity of effort it takes to perform a service or procedure.
2. Practice expenses, such as rent, equipment and supplies, and nonphysician salaries.
3. Malpractice insurance premiums.
Each component is multiplied by a factor that accounts for geographic cost variations, and each total RVU is multiplied by a dollar amount known as the conversion factor.
Practice expense (PE) RVUs for services provided in a “facility” (e.g., hospital or outpatient clinic) are often lower than office-based PE RVUs for the same services. Hysteroscopy is no exception. The PE RVU value for diagnostic hysteroscopy performed in the office, for instance, is approximately 5 units, compared with 1.64 units for diagnostic hysteroscopy performed in a facility.
Information on hysteroscopic procedures, and their associated RVUs, on geographic practice cost indices and on pricing, can be accessed using Medicare’s Physician Fee Schedule lookup tool (www.cms.gov/apps/physician-fee-schedule/overview.aspx).
This tool is useful for calculating returns on investment. According to national payment amounts listed in August, a diagnostic hysteroscopy performed in the office will earn an average of $315.08 vs. $192.27 for each case performed in the hospital. If you perform 12 such procedures a year, that’s about $3,781 in the office, compared with $2,307 in the hospital.
This difference alone might not be worth an investment of $15,000 or more, but if you anticipate performing additional procedures with higher margins and higher reimbursement, such as 12 thermal endometrial ablations a year in combination with diagnostic hysteroscopy (which, according to the Medicare national fee schedule averages would earn $15,962 in the office vs. $4,971 in the hospital), or 12 Essure tubal occlusions ($22,595 vs. $5,263), the investment will look more favorable.
And if your patients are largely privately insured, your return on investment will occur much more quickly. In metropolitan Chicago, Blue Cross Blue Shield is reimbursing in-office diagnostic hysteroscopy at approximately $568, hysteroscopic ablations at $3,844, and Essure tubal occlusions at $3,885.
In addition to reimbursement levels, it’s important to consider the efficiencies of in-office hysteroscopy. You can perform an annual exam while the assistant sets up the room and greets each patient, for instance, or see another established patient while the assistant discharges your patient and turns the room over. Our patients, in turn, benefit from increased accessibility, with less time spent away from work or family, as well as more familiarity and comfort and reduced out-of-pocket expenses.
Dr. Cholkeri-Singh is clinical assistant professor at the University of Illinois in Chicago and is director of gynecologic surgical education and associate director of minimally invasive gynecology at Advocate Lutheran General Hospital. She is in private practice with Dr. Charles Miller and Dr. Kristen Sasaki at the Advanced Gynecologic Surgical Institute in Chicago. She is a consultant for DySIS Medical, Hologic, and Bayer HealthCare.
PAs Should Focus on Patient Care, Not Unnecessary Testing
PAs are highly educated, trusted health care providers who lead patient-centered medical teams. Trained as experts in general medicine, we often pursue multiple specialties over the course of our careers—typically in three or four. PAs can decide to work in surgery, emergency care, orthopedics, oncology, pediatrics, dermatology, and many other areas. Moving among and between specialties is a hallmark of our profession. Unfortunately, a new proposal would alter how PAs are tested in order to maintain their certification—and, in 20 states, potentially jeopardize their license to practice.
The National Commission on Certification of PAs (NCCPA) has proposed significant changes to how PAs are recertified by requiring multiple exams, including a proctored, closed-book exam in a specialty area and two or three take-home exams during every 10-year recertification cycle. The proposal would in effect force PAs to choose a specialty and as a result undermine their ability to fill care gaps in hospitals, health systems, and communities.
The new requirements are cumbersome and unnecessary. PAs already undergo rigorous medical training and have initial licensing requirements that are similar to those of our physician, nurse practitioner, and pharmacist colleagues—none of whom are required to retest. PAs must graduate from an accredited program and take a test in general medicine in order to be licensed and certified in the first place. Throughout their careers, they have to complete extensive continuing medical education (CME). They also practice in clinical settings that continually inform and enhance their experience and base of knowledge.
Additional testing would take valuable time away from patients and could even discourage PAs from staying in a profession that is in high demand. More to the point, NCCPA has pursued its proposal even though studies have shown that recertification testing is not related to improvements in patient outcomes or safety.
AAPA recently received a message from longtime PA Peter Schuman, who is as passionate about patient care as he is leery of NCCPA’s recertification plan. “[NCCPA has] no significant, scientifically valid evidence to support their claims. I can honestly say that their testing requirements have not helped me care for patients better or become more knowledgeable in my field of practice/expertise one bit,” he wrote. “The PANRE is a waste of time and effort and is a source of great stress, taking time away from my patients, practice, and family. Enough is enough, NCCPA!”
The AAPA board has reached out to NCCPA and still hopes that it will engage in substantive discussions. Given the seriousness of our concerns, however, the AAPA Board voted recently to take steps toward the creation of an alternative certifying body for PAs. This vote came after careful deliberation and in response to the concerns of the thousands of professionals that AAPA represents. The decision was not made lightly and it reflects the priority of PAs to put patient care ahead of unnecessary testing.
AAPA is not alone in its opposition to recertification testing. A growing number of medical associations, including the American Medical Association (AMA), reject it as unnecessary and overly burdensome. AMA has rightly identified these exams as high-stakes tests because, it said, “failure to pass can result in a physician’s loss of privileges or employment.” Every PA would face similar consequences and, in 20 states, put their license at risk. At least 19 state medical associations have adopted similar resolutions in opposition to unnecessary retesting.
To be clear, AAPA does not oppose initial testing for certification and licensing and embraces the value of an exam in the licensing process. AAPA also strongly supports extensive CME and the benefits it provides.
We have not yet decided whether to establish a new certification organization. But we do know that there is no reason PAs should be singled out for additional testing when the extra requirement does not help patients and when other medical professionals are not required to do the same. Let PAs focus on patient care, not unwarranted test-taking.
PAs are highly educated, trusted health care providers who lead patient-centered medical teams. Trained as experts in general medicine, we often pursue multiple specialties over the course of our careers—typically in three or four. PAs can decide to work in surgery, emergency care, orthopedics, oncology, pediatrics, dermatology, and many other areas. Moving among and between specialties is a hallmark of our profession. Unfortunately, a new proposal would alter how PAs are tested in order to maintain their certification—and, in 20 states, potentially jeopardize their license to practice.
The National Commission on Certification of PAs (NCCPA) has proposed significant changes to how PAs are recertified by requiring multiple exams, including a proctored, closed-book exam in a specialty area and two or three take-home exams during every 10-year recertification cycle. The proposal would in effect force PAs to choose a specialty and as a result undermine their ability to fill care gaps in hospitals, health systems, and communities.
The new requirements are cumbersome and unnecessary. PAs already undergo rigorous medical training and have initial licensing requirements that are similar to those of our physician, nurse practitioner, and pharmacist colleagues—none of whom are required to retest. PAs must graduate from an accredited program and take a test in general medicine in order to be licensed and certified in the first place. Throughout their careers, they have to complete extensive continuing medical education (CME). They also practice in clinical settings that continually inform and enhance their experience and base of knowledge.
Additional testing would take valuable time away from patients and could even discourage PAs from staying in a profession that is in high demand. More to the point, NCCPA has pursued its proposal even though studies have shown that recertification testing is not related to improvements in patient outcomes or safety.
AAPA recently received a message from longtime PA Peter Schuman, who is as passionate about patient care as he is leery of NCCPA’s recertification plan. “[NCCPA has] no significant, scientifically valid evidence to support their claims. I can honestly say that their testing requirements have not helped me care for patients better or become more knowledgeable in my field of practice/expertise one bit,” he wrote. “The PANRE is a waste of time and effort and is a source of great stress, taking time away from my patients, practice, and family. Enough is enough, NCCPA!”
The AAPA board has reached out to NCCPA and still hopes that it will engage in substantive discussions. Given the seriousness of our concerns, however, the AAPA Board voted recently to take steps toward the creation of an alternative certifying body for PAs. This vote came after careful deliberation and in response to the concerns of the thousands of professionals that AAPA represents. The decision was not made lightly and it reflects the priority of PAs to put patient care ahead of unnecessary testing.
AAPA is not alone in its opposition to recertification testing. A growing number of medical associations, including the American Medical Association (AMA), reject it as unnecessary and overly burdensome. AMA has rightly identified these exams as high-stakes tests because, it said, “failure to pass can result in a physician’s loss of privileges or employment.” Every PA would face similar consequences and, in 20 states, put their license at risk. At least 19 state medical associations have adopted similar resolutions in opposition to unnecessary retesting.
To be clear, AAPA does not oppose initial testing for certification and licensing and embraces the value of an exam in the licensing process. AAPA also strongly supports extensive CME and the benefits it provides.
We have not yet decided whether to establish a new certification organization. But we do know that there is no reason PAs should be singled out for additional testing when the extra requirement does not help patients and when other medical professionals are not required to do the same. Let PAs focus on patient care, not unwarranted test-taking.
PAs are highly educated, trusted health care providers who lead patient-centered medical teams. Trained as experts in general medicine, we often pursue multiple specialties over the course of our careers—typically in three or four. PAs can decide to work in surgery, emergency care, orthopedics, oncology, pediatrics, dermatology, and many other areas. Moving among and between specialties is a hallmark of our profession. Unfortunately, a new proposal would alter how PAs are tested in order to maintain their certification—and, in 20 states, potentially jeopardize their license to practice.
The National Commission on Certification of PAs (NCCPA) has proposed significant changes to how PAs are recertified by requiring multiple exams, including a proctored, closed-book exam in a specialty area and two or three take-home exams during every 10-year recertification cycle. The proposal would in effect force PAs to choose a specialty and as a result undermine their ability to fill care gaps in hospitals, health systems, and communities.
The new requirements are cumbersome and unnecessary. PAs already undergo rigorous medical training and have initial licensing requirements that are similar to those of our physician, nurse practitioner, and pharmacist colleagues—none of whom are required to retest. PAs must graduate from an accredited program and take a test in general medicine in order to be licensed and certified in the first place. Throughout their careers, they have to complete extensive continuing medical education (CME). They also practice in clinical settings that continually inform and enhance their experience and base of knowledge.
Additional testing would take valuable time away from patients and could even discourage PAs from staying in a profession that is in high demand. More to the point, NCCPA has pursued its proposal even though studies have shown that recertification testing is not related to improvements in patient outcomes or safety.
AAPA recently received a message from longtime PA Peter Schuman, who is as passionate about patient care as he is leery of NCCPA’s recertification plan. “[NCCPA has] no significant, scientifically valid evidence to support their claims. I can honestly say that their testing requirements have not helped me care for patients better or become more knowledgeable in my field of practice/expertise one bit,” he wrote. “The PANRE is a waste of time and effort and is a source of great stress, taking time away from my patients, practice, and family. Enough is enough, NCCPA!”
The AAPA board has reached out to NCCPA and still hopes that it will engage in substantive discussions. Given the seriousness of our concerns, however, the AAPA Board voted recently to take steps toward the creation of an alternative certifying body for PAs. This vote came after careful deliberation and in response to the concerns of the thousands of professionals that AAPA represents. The decision was not made lightly and it reflects the priority of PAs to put patient care ahead of unnecessary testing.
AAPA is not alone in its opposition to recertification testing. A growing number of medical associations, including the American Medical Association (AMA), reject it as unnecessary and overly burdensome. AMA has rightly identified these exams as high-stakes tests because, it said, “failure to pass can result in a physician’s loss of privileges or employment.” Every PA would face similar consequences and, in 20 states, put their license at risk. At least 19 state medical associations have adopted similar resolutions in opposition to unnecessary retesting.
To be clear, AAPA does not oppose initial testing for certification and licensing and embraces the value of an exam in the licensing process. AAPA also strongly supports extensive CME and the benefits it provides.
We have not yet decided whether to establish a new certification organization. But we do know that there is no reason PAs should be singled out for additional testing when the extra requirement does not help patients and when other medical professionals are not required to do the same. Let PAs focus on patient care, not unwarranted test-taking.