Perioperative Medicine

DALLAS – New-onset postoperative atrial fibrillation following cardiac surgery occurs in two distinct phases, with different risk factors for each.

That’s the key finding in an analysis of the recent experience at the University of Alabama, Birmingham, where new-onset postoperative AF occurred in 27% of 1,583 consecutive patients who underwent coronary artery bypass graft and/or valve surgery.

The first peak in the onset of postoperative AF occurred in the first 3 hours after surgery. This was followed by a sharp decline in incidence over the next 24 hours. The second peak happened at postoperative day 2, followed by a more gradual tail off, Dr. Spencer J. Melby reported at the American Heart Association scientific sessions.

Ninety-six percent of all cases of postoperative AF in this retrospective chart review began within the first 7 days after surgery. Of the 423 patients who developed this common and vexing condition, 16% did so within the first 24 hours, 48% had their onset at 24-72 hours, and 36% did so after 72 hours, according to Dr. Melby, a cardiothoracic surgeon at the university.

In a multivariate analysis, the most potent risk factor for onset of postoperative AF during the first phase was mitral valve repair or replacement, which was associated with a 2.5-fold increased risk. The other significant risk factors for early-onset AF were older age – with 70-year-olds having a 1.6-fold greater risk than 50-year-olds – and longer ischemic time, with patients whose cross-clamp time was 70 minutes having a 1.3-fold greater risk compared with those who had a cross-clamp time of 35 minutes.

Advanced age was also a risk factor for late-phase onset of AF, but it was a stronger risk factor there than for early onset AF, with 70-year-olds being at threefold greater risk than 50-year-olds – nearly twice as great a risk as for early-onset postoperative AF. The other significant risk factors for late-phase postoperative AF in a multivariate analysis were white race, with a 1.9-fold increased risk, and heavier body weight, with patients weighing 100 kg being at 1.6-fold greater risk than those tipping the scales at 70 kg.

"We believe that these different risk factors at each time phase are indicative of change over time in the mechanisms that drive postoperative atrial fibrillation," the surgeon said.

The first peak may be the result of tissue trauma, which is typically greater with more complex operations having longer cross-clamp times. And mitral valve procedures often entail contact with the left atrium.

"We’ve found that in patients with onset in the second peak there’s a polymorphonuclear leukocyte riot going on in the pericardial space after surgery. Inflammation is high, oxidative stress is high. Troponin levels are extremely high in the pericardial fluid, so there are problems in the heart muscle itself. The body is trying to heal and may be overdoing it as reflected by the inflammation in that space," Dr. Melby explained.

Dr. Brendan M. Everett, session cochair, noted that postoperative day 2 is when a host of process-of-care issues potentially relevant to postoperative AF come into play.

"Postop day 2 is when pain control begins to slip a bit. Patients are mobilized, chest tubes are pulled. A lot of factors are going on that are very important overall to getting a patient up and out of the hospital but are serious stimuli – adrenergic and otherwise – that may force a patient to go into atrial fibrillation," observed Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.

Audience members praised Dr. Melby’s study as having "tremendous implications" for clinical practice, especially with regard to patient management guidelines. Dr. Melby noted that postoperative AF is a costly matter: It increases hospital length of stay by 1-2 days at a cost of roughly $10,000 per episode. Nationally, postoperative AF costs $4 billion per year.

Dr. Melby reported having no financial conflicts regarding his study.

[email protected]

DALLAS – New-onset postoperative atrial fibrillation following cardiac surgery occurs in two distinct phases, with different risk factors for each.

That’s the key finding in an analysis of the recent experience at the University of Alabama, Birmingham, where new-onset postoperative AF occurred in 27% of 1,583 consecutive patients who underwent coronary artery bypass graft and/or valve surgery.

The first peak in the onset of postoperative AF occurred in the first 3 hours after surgery. This was followed by a sharp decline in incidence over the next 24 hours. The second peak happened at postoperative day 2, followed by a more gradual tail off, Dr. Spencer J. Melby reported at the American Heart Association scientific sessions.

Ninety-six percent of all cases of postoperative AF in this retrospective chart review began within the first 7 days after surgery. Of the 423 patients who developed this common and vexing condition, 16% did so within the first 24 hours, 48% had their onset at 24-72 hours, and 36% did so after 72 hours, according to Dr. Melby, a cardiothoracic surgeon at the university.

In a multivariate analysis, the most potent risk factor for onset of postoperative AF during the first phase was mitral valve repair or replacement, which was associated with a 2.5-fold increased risk. The other significant risk factors for early-onset AF were older age – with 70-year-olds having a 1.6-fold greater risk than 50-year-olds – and longer ischemic time, with patients whose cross-clamp time was 70 minutes having a 1.3-fold greater risk compared with those who had a cross-clamp time of 35 minutes.

Advanced age was also a risk factor for late-phase onset of AF, but it was a stronger risk factor there than for early onset AF, with 70-year-olds being at threefold greater risk than 50-year-olds – nearly twice as great a risk as for early-onset postoperative AF. The other significant risk factors for late-phase postoperative AF in a multivariate analysis were white race, with a 1.9-fold increased risk, and heavier body weight, with patients weighing 100 kg being at 1.6-fold greater risk than those tipping the scales at 70 kg.

"We believe that these different risk factors at each time phase are indicative of change over time in the mechanisms that drive postoperative atrial fibrillation," the surgeon said.

The first peak may be the result of tissue trauma, which is typically greater with more complex operations having longer cross-clamp times. And mitral valve procedures often entail contact with the left atrium.

"We’ve found that in patients with onset in the second peak there’s a polymorphonuclear leukocyte riot going on in the pericardial space after surgery. Inflammation is high, oxidative stress is high. Troponin levels are extremely high in the pericardial fluid, so there are problems in the heart muscle itself. The body is trying to heal and may be overdoing it as reflected by the inflammation in that space," Dr. Melby explained.

Dr. Brendan M. Everett, session cochair, noted that postoperative day 2 is when a host of process-of-care issues potentially relevant to postoperative AF come into play.

"Postop day 2 is when pain control begins to slip a bit. Patients are mobilized, chest tubes are pulled. A lot of factors are going on that are very important overall to getting a patient up and out of the hospital but are serious stimuli – adrenergic and otherwise – that may force a patient to go into atrial fibrillation," observed Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.

Audience members praised Dr. Melby’s study as having "tremendous implications" for clinical practice, especially with regard to patient management guidelines. Dr. Melby noted that postoperative AF is a costly matter: It increases hospital length of stay by 1-2 days at a cost of roughly $10,000 per episode. Nationally, postoperative AF costs $4 billion per year.

Dr. Melby reported having no financial conflicts regarding his study.

[email protected]

DALLAS – New-onset postoperative atrial fibrillation following cardiac surgery occurs in two distinct phases, with different risk factors for each.

That’s the key finding in an analysis of the recent experience at the University of Alabama, Birmingham, where new-onset postoperative AF occurred in 27% of 1,583 consecutive patients who underwent coronary artery bypass graft and/or valve surgery.

The first peak in the onset of postoperative AF occurred in the first 3 hours after surgery. This was followed by a sharp decline in incidence over the next 24 hours. The second peak happened at postoperative day 2, followed by a more gradual tail off, Dr. Spencer J. Melby reported at the American Heart Association scientific sessions.

Ninety-six percent of all cases of postoperative AF in this retrospective chart review began within the first 7 days after surgery. Of the 423 patients who developed this common and vexing condition, 16% did so within the first 24 hours, 48% had their onset at 24-72 hours, and 36% did so after 72 hours, according to Dr. Melby, a cardiothoracic surgeon at the university.

In a multivariate analysis, the most potent risk factor for onset of postoperative AF during the first phase was mitral valve repair or replacement, which was associated with a 2.5-fold increased risk. The other significant risk factors for early-onset AF were older age – with 70-year-olds having a 1.6-fold greater risk than 50-year-olds – and longer ischemic time, with patients whose cross-clamp time was 70 minutes having a 1.3-fold greater risk compared with those who had a cross-clamp time of 35 minutes.

Advanced age was also a risk factor for late-phase onset of AF, but it was a stronger risk factor there than for early onset AF, with 70-year-olds being at threefold greater risk than 50-year-olds – nearly twice as great a risk as for early-onset postoperative AF. The other significant risk factors for late-phase postoperative AF in a multivariate analysis were white race, with a 1.9-fold increased risk, and heavier body weight, with patients weighing 100 kg being at 1.6-fold greater risk than those tipping the scales at 70 kg.

"We believe that these different risk factors at each time phase are indicative of change over time in the mechanisms that drive postoperative atrial fibrillation," the surgeon said.

The first peak may be the result of tissue trauma, which is typically greater with more complex operations having longer cross-clamp times. And mitral valve procedures often entail contact with the left atrium.

"We’ve found that in patients with onset in the second peak there’s a polymorphonuclear leukocyte riot going on in the pericardial space after surgery. Inflammation is high, oxidative stress is high. Troponin levels are extremely high in the pericardial fluid, so there are problems in the heart muscle itself. The body is trying to heal and may be overdoing it as reflected by the inflammation in that space," Dr. Melby explained.

Dr. Brendan M. Everett, session cochair, noted that postoperative day 2 is when a host of process-of-care issues potentially relevant to postoperative AF come into play.

"Postop day 2 is when pain control begins to slip a bit. Patients are mobilized, chest tubes are pulled. A lot of factors are going on that are very important overall to getting a patient up and out of the hospital but are serious stimuli – adrenergic and otherwise – that may force a patient to go into atrial fibrillation," observed Dr. Everett, director of the general cardiology inpatient service at Brigham and Women’s Hospital, Boston.

Audience members praised Dr. Melby’s study as having "tremendous implications" for clinical practice, especially with regard to patient management guidelines. Dr. Melby noted that postoperative AF is a costly matter: It increases hospital length of stay by 1-2 days at a cost of roughly $10,000 per episode. Nationally, postoperative AF costs $4 billion per year.

Dr. Melby reported having no financial conflicts regarding his study.

[email protected]

ORLANDO – Effective management of acute pain in children is important not only for improving comfort, but also for improving outcomes, according to Dr. Joseph D. Tobias.

"The important thing to realize is that there are many benefits (of pain management). Although we walk a fine line between adverse effects and benefits, many times with adequate analgesia we put patients in a better place, Dr. Tobias, chief of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio, said at the annual meeting of the American Academy of Pediatrics.

That’s because with inadequate analgesia there are a host of humoral factors, including increased endogenous catecholamines, that have adverse physiologic effects on oxygen consumption, CO₂ production, and on the immune system, he explained.

Multiple studies have demonstrated that aggressive pain management has beneficial immune effects, he added, noting that patients with adequate pain management are less likely to experience infections and that neonates and infants without adequate pain management may experience chronic pain and pain syndromes later in life because of the neuroplasticity of the infant brain.

He recommends the classic "stepwise ladder" approach to pain management in pediatric patients with acute pain following surgery, trauma, or acute illness, for example. Step 1 involves administration of nonopioids and adjuvants.

"But even as we move to step 2 and add opioids, it’s very important to keep the nonopioids and adjuvants going. I don’t think anybody should ever be in the hospital on [patient-controlled analgesia] getting opioids and not getting nonsteroidal [drugs], acetaminophen, and other adjuvants, because what you’re going to do is decrease your opioid requirements, and as you do that, you then decrease opioid-related side effects," he said.

Keep in mind that the maximum dose of oral or rectal acetaminophen has been decreased from 4 to 3 grams, he said, noting that reports of significant toxicity with acetaminophen have been increasing, so it is important to limit the dose.

The same holds true for the new intravenous preparation of acetaminophen, given reports of 10-fold overdose (10 mg/mL concentration).

"We need to be cognizant of that," he said.

A number of salicylates and NSAIDs are also available for use in children. Ibuprofen is among the most commonly used, and also is now available in an intravenous formulation.

Ketorolac is another good treatment option, but intravenous acetaminophen is preferable in children under age 1 year, because of concerns regarding decreased renal perfusion, he said.

Other emerging options that are making their way from the adult to the pediatric pain-management arena are ketamine, gabapentin and pregabalin, dexamethasone, and dexmedetomidine, all of which appear to have some potential benefits for improving pain management and reducing the need for opioids.

Watch for interactions and adverse effects

Be sure to assess for potential drug interactions in children on several medications and to protect against the adverse gastrointestinal tract effects of nonsteroidal drugs, Dr. Tobias advised.

"If you’re using nonsteroidals, especially postoperatively in patients, it’s always a good idea to combine them with a proton pump inhibitor, or an H2 antagonist," he said, noting that that these can generally be discontinued once the patient is tolerating a regular diet.

Effects on renal function are also an important concern, particularly in those with preexisting renal dysfunction, concomitant use of other nephrotoxic agents, hypovolemia, hypoperfusion, and prolonged administration.

Bleeding is another concern, particularly in those receiving ketorolac, which shouldn’t be used in children undergoing tonsillectomy or in other cases involving increased bleeding risk, he said.

As for opioids, morphine and hydromorphone are the most commonly used in children, accounting for about 99% of usage.

Morphine is more often associated with pruritus in older children and adolescents, so hydromorphone may be a better option to start with in these patients.

"As far as dosing guidelines, I think it’s very important to adjust the dose based on the patient’s status and follow pain scores. I think everybody in the hospital needs to have their pain score checked. It doesn’t matter which (pain scale) you use," Dr. Tobias said.

Also, a steady-state serum concentration should be maintained with avoidance of peaks and troughs, and patients on opioids should be monitored for adverse effects, he said, noting that patient-controlled analgesia (PCA) devices are useful – after a loading dose – to maintain those concentrations. PCA devices can be used by children as young as 5 or 6 years of age; nurse-controlled analgesia is best for those who are younger or have cognitive impairment.

A lower basal infusion rate (4-5 mcg/kg per hour) allows for better sleep while reducing side effects, he said.

Among the concerning side effects of opioids are constipation and respiratory depression.

"Remember, you develop tolerance least quickly to their effects on the GI tract ... when you’re sending kids home from the hospital on opioids, make sure you focus on their bowel habits, or they’re going to be back, they’re going to be constipated, they’re not going to be ambulating, they may not be as well hydrated, so we really need to focus on the GI tract," he said.

Respiratory depression is recognized as an increasing concern.

"When these kids are getting PCA on the floor, make sure you have ready access to resuscitation equipment should you need it," he said.

"Especially as the population gets bigger, we may have more undiagnosed OSA [obstructive sleep apnea], so all of our patients get their respiratory rates checked, they’re on pulse oximetry. In really high-risk patients, we’re using end tidal transcutaneous CO₂ monitoring," he said, adding: "Remember, hypoxemia is a late finding of opioid-related respiratory depression. You’re going to see a slight elevation in carbon dioxide first."

Adverse effects are most common in those at the extremes of age, in those with underlying systemic diseases, and in those receiving other agents that are central nervous system depressants.

Of course, the best way to limit side effects is to use adjunctive agents, Dr. Tobias said.

"Maximize the use of nonsteroidals and acetaminophen, and you’re going to use a lot less opioid," he said.

Another important approach to reducing opioid use is the perioperative use of regional anesthesia.

"If you’re working in the hospital taking care of kids after major surgical procedures, I think if you partner with the anesthesia team there’s a lot you can do perioperatively to almost eliminate the need for intravenous opioids," he said.

For a femur fracture patient, for example, a catheter can be placed near the femoral nerve to provide analgesia, or the lateral femoral cutaneous nerve can be blocked. Ultrasound has "really opened the door for regional anesthesia."

Home infusion devices are also available.

"So if you’re having your anterior cruciate ligament repaired, where I work, you’re going to go home with a femoral nerve catheter and a home infusion device that will work for 3 days and really limit your need for parenteral and oral opioids," he said.

Outside of the operating room, regional anesthesia can be used to treat pain that is unresponsive to opioids or if the opioids are causing side effects. Cases involving sickle cell vaso-occlusive crisis, multiple trauma, or burns are scenarios in which regional anesthesia can be particularly useful, he said.

Dr. Tobias reported having no disclosures.

ORLANDO – Effective management of acute pain in children is important not only for improving comfort, but also for improving outcomes, according to Dr. Joseph D. Tobias.

"The important thing to realize is that there are many benefits (of pain management). Although we walk a fine line between adverse effects and benefits, many times with adequate analgesia we put patients in a better place, Dr. Tobias, chief of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio, said at the annual meeting of the American Academy of Pediatrics.

That’s because with inadequate analgesia there are a host of humoral factors, including increased endogenous catecholamines, that have adverse physiologic effects on oxygen consumption, CO₂ production, and on the immune system, he explained.

Multiple studies have demonstrated that aggressive pain management has beneficial immune effects, he added, noting that patients with adequate pain management are less likely to experience infections and that neonates and infants without adequate pain management may experience chronic pain and pain syndromes later in life because of the neuroplasticity of the infant brain.

He recommends the classic "stepwise ladder" approach to pain management in pediatric patients with acute pain following surgery, trauma, or acute illness, for example. Step 1 involves administration of nonopioids and adjuvants.

"But even as we move to step 2 and add opioids, it’s very important to keep the nonopioids and adjuvants going. I don’t think anybody should ever be in the hospital on [patient-controlled analgesia] getting opioids and not getting nonsteroidal [drugs], acetaminophen, and other adjuvants, because what you’re going to do is decrease your opioid requirements, and as you do that, you then decrease opioid-related side effects," he said.

Keep in mind that the maximum dose of oral or rectal acetaminophen has been decreased from 4 to 3 grams, he said, noting that reports of significant toxicity with acetaminophen have been increasing, so it is important to limit the dose.

The same holds true for the new intravenous preparation of acetaminophen, given reports of 10-fold overdose (10 mg/mL concentration).

"We need to be cognizant of that," he said.

A number of salicylates and NSAIDs are also available for use in children. Ibuprofen is among the most commonly used, and also is now available in an intravenous formulation.

Ketorolac is another good treatment option, but intravenous acetaminophen is preferable in children under age 1 year, because of concerns regarding decreased renal perfusion, he said.

Other emerging options that are making their way from the adult to the pediatric pain-management arena are ketamine, gabapentin and pregabalin, dexamethasone, and dexmedetomidine, all of which appear to have some potential benefits for improving pain management and reducing the need for opioids.

Watch for interactions and adverse effects

Be sure to assess for potential drug interactions in children on several medications and to protect against the adverse gastrointestinal tract effects of nonsteroidal drugs, Dr. Tobias advised.

"If you’re using nonsteroidals, especially postoperatively in patients, it’s always a good idea to combine them with a proton pump inhibitor, or an H2 antagonist," he said, noting that that these can generally be discontinued once the patient is tolerating a regular diet.

Effects on renal function are also an important concern, particularly in those with preexisting renal dysfunction, concomitant use of other nephrotoxic agents, hypovolemia, hypoperfusion, and prolonged administration.

Bleeding is another concern, particularly in those receiving ketorolac, which shouldn’t be used in children undergoing tonsillectomy or in other cases involving increased bleeding risk, he said.

As for opioids, morphine and hydromorphone are the most commonly used in children, accounting for about 99% of usage.

Morphine is more often associated with pruritus in older children and adolescents, so hydromorphone may be a better option to start with in these patients.

"As far as dosing guidelines, I think it’s very important to adjust the dose based on the patient’s status and follow pain scores. I think everybody in the hospital needs to have their pain score checked. It doesn’t matter which (pain scale) you use," Dr. Tobias said.

Also, a steady-state serum concentration should be maintained with avoidance of peaks and troughs, and patients on opioids should be monitored for adverse effects, he said, noting that patient-controlled analgesia (PCA) devices are useful – after a loading dose – to maintain those concentrations. PCA devices can be used by children as young as 5 or 6 years of age; nurse-controlled analgesia is best for those who are younger or have cognitive impairment.

A lower basal infusion rate (4-5 mcg/kg per hour) allows for better sleep while reducing side effects, he said.

Among the concerning side effects of opioids are constipation and respiratory depression.

"Remember, you develop tolerance least quickly to their effects on the GI tract ... when you’re sending kids home from the hospital on opioids, make sure you focus on their bowel habits, or they’re going to be back, they’re going to be constipated, they’re not going to be ambulating, they may not be as well hydrated, so we really need to focus on the GI tract," he said.

Respiratory depression is recognized as an increasing concern.

"When these kids are getting PCA on the floor, make sure you have ready access to resuscitation equipment should you need it," he said.

"Especially as the population gets bigger, we may have more undiagnosed OSA [obstructive sleep apnea], so all of our patients get their respiratory rates checked, they’re on pulse oximetry. In really high-risk patients, we’re using end tidal transcutaneous CO₂ monitoring," he said, adding: "Remember, hypoxemia is a late finding of opioid-related respiratory depression. You’re going to see a slight elevation in carbon dioxide first."

Adverse effects are most common in those at the extremes of age, in those with underlying systemic diseases, and in those receiving other agents that are central nervous system depressants.

Of course, the best way to limit side effects is to use adjunctive agents, Dr. Tobias said.

"Maximize the use of nonsteroidals and acetaminophen, and you’re going to use a lot less opioid," he said.

Another important approach to reducing opioid use is the perioperative use of regional anesthesia.

"If you’re working in the hospital taking care of kids after major surgical procedures, I think if you partner with the anesthesia team there’s a lot you can do perioperatively to almost eliminate the need for intravenous opioids," he said.

For a femur fracture patient, for example, a catheter can be placed near the femoral nerve to provide analgesia, or the lateral femoral cutaneous nerve can be blocked. Ultrasound has "really opened the door for regional anesthesia."

Home infusion devices are also available.

"So if you’re having your anterior cruciate ligament repaired, where I work, you’re going to go home with a femoral nerve catheter and a home infusion device that will work for 3 days and really limit your need for parenteral and oral opioids," he said.

Outside of the operating room, regional anesthesia can be used to treat pain that is unresponsive to opioids or if the opioids are causing side effects. Cases involving sickle cell vaso-occlusive crisis, multiple trauma, or burns are scenarios in which regional anesthesia can be particularly useful, he said.

Dr. Tobias reported having no disclosures.

ORLANDO – Effective management of acute pain in children is important not only for improving comfort, but also for improving outcomes, according to Dr. Joseph D. Tobias.

"The important thing to realize is that there are many benefits (of pain management). Although we walk a fine line between adverse effects and benefits, many times with adequate analgesia we put patients in a better place, Dr. Tobias, chief of anesthesiology and pain medicine at Nationwide Children’s Hospital in Columbus, Ohio, said at the annual meeting of the American Academy of Pediatrics.

That’s because with inadequate analgesia there are a host of humoral factors, including increased endogenous catecholamines, that have adverse physiologic effects on oxygen consumption, CO₂ production, and on the immune system, he explained.

Multiple studies have demonstrated that aggressive pain management has beneficial immune effects, he added, noting that patients with adequate pain management are less likely to experience infections and that neonates and infants without adequate pain management may experience chronic pain and pain syndromes later in life because of the neuroplasticity of the infant brain.

He recommends the classic "stepwise ladder" approach to pain management in pediatric patients with acute pain following surgery, trauma, or acute illness, for example. Step 1 involves administration of nonopioids and adjuvants.

"But even as we move to step 2 and add opioids, it’s very important to keep the nonopioids and adjuvants going. I don’t think anybody should ever be in the hospital on [patient-controlled analgesia] getting opioids and not getting nonsteroidal [drugs], acetaminophen, and other adjuvants, because what you’re going to do is decrease your opioid requirements, and as you do that, you then decrease opioid-related side effects," he said.

Keep in mind that the maximum dose of oral or rectal acetaminophen has been decreased from 4 to 3 grams, he said, noting that reports of significant toxicity with acetaminophen have been increasing, so it is important to limit the dose.

The same holds true for the new intravenous preparation of acetaminophen, given reports of 10-fold overdose (10 mg/mL concentration).

"We need to be cognizant of that," he said.

A number of salicylates and NSAIDs are also available for use in children. Ibuprofen is among the most commonly used, and also is now available in an intravenous formulation.

Ketorolac is another good treatment option, but intravenous acetaminophen is preferable in children under age 1 year, because of concerns regarding decreased renal perfusion, he said.

Other emerging options that are making their way from the adult to the pediatric pain-management arena are ketamine, gabapentin and pregabalin, dexamethasone, and dexmedetomidine, all of which appear to have some potential benefits for improving pain management and reducing the need for opioids.

Watch for interactions and adverse effects

Be sure to assess for potential drug interactions in children on several medications and to protect against the adverse gastrointestinal tract effects of nonsteroidal drugs, Dr. Tobias advised.

"If you’re using nonsteroidals, especially postoperatively in patients, it’s always a good idea to combine them with a proton pump inhibitor, or an H2 antagonist," he said, noting that that these can generally be discontinued once the patient is tolerating a regular diet.

Effects on renal function are also an important concern, particularly in those with preexisting renal dysfunction, concomitant use of other nephrotoxic agents, hypovolemia, hypoperfusion, and prolonged administration.

Bleeding is another concern, particularly in those receiving ketorolac, which shouldn’t be used in children undergoing tonsillectomy or in other cases involving increased bleeding risk, he said.

As for opioids, morphine and hydromorphone are the most commonly used in children, accounting for about 99% of usage.

Morphine is more often associated with pruritus in older children and adolescents, so hydromorphone may be a better option to start with in these patients.

"As far as dosing guidelines, I think it’s very important to adjust the dose based on the patient’s status and follow pain scores. I think everybody in the hospital needs to have their pain score checked. It doesn’t matter which (pain scale) you use," Dr. Tobias said.

Also, a steady-state serum concentration should be maintained with avoidance of peaks and troughs, and patients on opioids should be monitored for adverse effects, he said, noting that patient-controlled analgesia (PCA) devices are useful – after a loading dose – to maintain those concentrations. PCA devices can be used by children as young as 5 or 6 years of age; nurse-controlled analgesia is best for those who are younger or have cognitive impairment.

A lower basal infusion rate (4-5 mcg/kg per hour) allows for better sleep while reducing side effects, he said.

Among the concerning side effects of opioids are constipation and respiratory depression.

"Remember, you develop tolerance least quickly to their effects on the GI tract ... when you’re sending kids home from the hospital on opioids, make sure you focus on their bowel habits, or they’re going to be back, they’re going to be constipated, they’re not going to be ambulating, they may not be as well hydrated, so we really need to focus on the GI tract," he said.

Respiratory depression is recognized as an increasing concern.

"When these kids are getting PCA on the floor, make sure you have ready access to resuscitation equipment should you need it," he said.

"Especially as the population gets bigger, we may have more undiagnosed OSA [obstructive sleep apnea], so all of our patients get their respiratory rates checked, they’re on pulse oximetry. In really high-risk patients, we’re using end tidal transcutaneous CO₂ monitoring," he said, adding: "Remember, hypoxemia is a late finding of opioid-related respiratory depression. You’re going to see a slight elevation in carbon dioxide first."

Adverse effects are most common in those at the extremes of age, in those with underlying systemic diseases, and in those receiving other agents that are central nervous system depressants.

Of course, the best way to limit side effects is to use adjunctive agents, Dr. Tobias said.

"Maximize the use of nonsteroidals and acetaminophen, and you’re going to use a lot less opioid," he said.

Another important approach to reducing opioid use is the perioperative use of regional anesthesia.

"If you’re working in the hospital taking care of kids after major surgical procedures, I think if you partner with the anesthesia team there’s a lot you can do perioperatively to almost eliminate the need for intravenous opioids," he said.

For a femur fracture patient, for example, a catheter can be placed near the femoral nerve to provide analgesia, or the lateral femoral cutaneous nerve can be blocked. Ultrasound has "really opened the door for regional anesthesia."

Home infusion devices are also available.

"So if you’re having your anterior cruciate ligament repaired, where I work, you’re going to go home with a femoral nerve catheter and a home infusion device that will work for 3 days and really limit your need for parenteral and oral opioids," he said.

Outside of the operating room, regional anesthesia can be used to treat pain that is unresponsive to opioids or if the opioids are causing side effects. Cases involving sickle cell vaso-occlusive crisis, multiple trauma, or burns are scenarios in which regional anesthesia can be particularly useful, he said.

Dr. Tobias reported having no disclosures.

POINT: SCIP is both efficacious and effective.

The Surgical Care Improvement Project (SCIP) was a national campaign that set out to reduce surgical mortality and morbidity by 25% by 2010 through recommendations in targeted areas: wound infections, perioperative MIs, and venous thromboembolism. The recommendations have become pay-for-performance measures. There are seven in the area of infectious disease to reduce surgical site infections. There is one measure for reducing perioperative MI: Continue beta-blockers (for patients who are on them) in the perioperative period. For venous thromboembolism prevention, give prophylaxis within 24 hours before to 24 hours after surgery.

It’s key to understand the difference between efficacy and effectiveness. I think we would all agree that the SCIP measures have efficacy. Efficacy trials determine whether an intervention produces the expected result under ideal circumstances. Effectiveness trials measure the degree of beneficial effect under "real world" clinical conditions. The problem with effectiveness trials is that those real-world conditions may change the effect, or they might just change the ability to measure the effect.

I believe that the SCIP measures have proven efficacy because they all are based upon randomized controlled trials that were identified by systematic reviews amenable to meta-analysis. All of these measures are Level 1 recommendations, based on the highest forms of evidence. The studies that Dr. Barash uses to criticize SCIP measures are cohort studies. They do not randomize. There may be unknown confounding variables.

There have been effectiveness trials that show that the SCIP measures do work. One showed a 27% decrease in surgical site infections, another showed a 62% decrease in surgical site infections, and a third showed a 39% decrease in surgical site infections.

Perhaps the strongest endorsement of efficacy of the SCIP measures comes from Dr. Kaveh G. Shojania, who has written several reviews of the efficacy of medical interventions. This guy is like Mikey from the old Life cereal commercials ... he hates everything. He said there were 11 patient safety practices rated most highly in terms of strength of the evidence, and 3 are SCIP measures: appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk, use of perioperative beta-blockers in appropriate patients, and appropriate use of antibiotic prophylaxis in surgical patients (AHRQ Publication No. 01-E058).

Several trials published by pretty good researchers in reputable journals show a lack of effectiveness of SCIP measures. Even those researchers admit to the efficacy of SCIP measures. The lead investigator of the best effectiveness trial, a retrospective cohort study, wrote, "There are several explanations as to why we did not observe an association between timely antibiotic administration and surgical site infection (SSI). The first is that timely antibiotic administration does not diminish SSI risk. This is an unlikely interpretation. There are numerous randomized controlled trials and observational studies that demonstrate the efficacy of prophylactic antibiotics in reducing SSI for various surgical procedures" (Ann. Surg. 2011;254:494-9).

A separate retrospective cohort study showed a decrease in surgical site infection only if two or more SCIP recommendations were followed (JAMA 2010;303:2479-85). Shocking – if you give the wrong antibiotic at the right time, it might not work.

Another retrospective cohort study found no association with adjusted complications and SCIP compliance. Hospitals in the lowest compliance group had patients in lower-income ZIP codes and lower unadjusted complication rates. So, poor people go home and don’t come back, perhaps because of payment considerations. The study didn’t have enough patients; it also used measures that don’t apply to SCIP (Arch. Surg. 2010;145:999-1004).

SCIP did not design these measures for pay-for-performance programs. The intent was to decrease perioperative complications by 25% by 2010. When you start changing the baseline with pay-for-performance, it doesn’t work. In a study by Hawkins et al., the authors tested the hypothesis that documented compliance with antibiotic prophylaxis guidelines on a pediatric surgery service does not reflect adherence to guidelines as intended. In a 7-week observational study of elective pediatric surgical cases, adherence was evaluated for appropriate administration, type, timing, weight-based dosing, and redosing of antibiotics. Prophylactic antibiotics were administered appropriately in 141 of 143 cases (99%). Of 100 cases in which antibiotic prophylaxis was indicated, compliance was documented in 100% of cases in the electronic medical record; but only 48% of cases adhered to all five guidelines. Lack of adherence was due primarily to dosing or timing errors.

The SCIP measures, however, are based on best evidence. They are tightly linked with the desired outcomes. They are measurable and effectible, as demonstrated in multiple randomized controlled trials. Studies of effectiveness have had variable results due to methodological flaws.

Dr. Lagasse is a professor of anesthesiology and director of quality management at the Yale School of Medicine, New Haven, Conn. He is on the steering committee for the Surgical Care Improvement Project. He reported having no financial disclosures.

COUNTERPOINT: Studies have not shown effectiveness.

When it was created, SCIP did not reflect reality. SCIP started at the U.S. Department of Veterans Affairs, which conducted a 10-year study. They found a 25% relative risk reduction, but that was only a 0.8% absolute risk reduction for the incidence of complications, a drop from about 3.1% to about 2.3% (Arch. Surg. 2002;137:20-27).

It would be great to have randomized controlled trials on the effectiveness of SCIP, but it’s not happening. We’re going to have to go by high-fidelity observational trials, which according to a number of researchers in the field have the same impact as randomized controlled trials.

One study of 35,543 patients in 44 hospitals found a whopping 27% reduction in surgical site infections, but that was only a 0.6% absolute reduction, from about 2.5% to about 1.9% (Am. J. Surg. 2005;190:9-15). There was no significant difference between groups.

Another study showed improved compliance with SCIP measures, but no change in surgical site infection rate (Dis. Colon Rectum 2010;53:24-30). This is the theme in study after study after study.

A 2008 study enrolled 9,195 patients undergoing colorectal, orthopedic, or vascular surgery and looked at SCIP compliance vs. surgical site infection. The SCIP rate correlated with the hospital case mix. If you look at the SCIP rate in terms of antibiotic timing, SCIP is not significant. The study basically showed that variables other than timely antibiotic administration are affecting surgical site infection rates (J. Am. Coll. Surg. 2008;206:814-19).

Hospital performance on process measures may not be a good marker of surgical site infection or the outcome we’re looking at, according to another study, which reported that unmeasured effects may have a larger impact than the measured effects (Health Serv. Res. 2008;43:1464-84).

There is a randomized controlled trial that randomized patients to strict control with the SCIP measures or routine treatment at the hospital. The SCIP-treated patients had nearly twice the incidence of surgical site infections as the patients receiving standard treatment. The authors concluded that combining each of the SCIP factors into one big category doesn’t necessarily work (Arch. Surg. 2011;146:263-9).

Should we be evaluating outcome measures with performance measures (e.g., percent timely antibiotic administration) to determine whether they work or not? One editorial evaluated eight articles with data on 31,448 patients, looking just at antibiotic administration within 1 hour of surgery, a SCIP measure. It found a higher infection rate if antibiotics were administered within 30 minutes of incision (JAMA 2010;303:2527-2528).

There was no significant difference in another study between standard of care and SCIP for venous thromboembolism (Am. J. Surg. 2012;204:591-97). The authors wrote that there is no convincing evidence that improvements in compliance are associated with better outcomes. We see this time and time again.

When people find that SCIP is not working, they turn to other measures to reduce surgical site infection. The Comprehensive Unit-based Safety Program (CUSP) is targeted at a specific problem that a specific hospital is having in managing infections. It’s not coming from Washington; it’s based at the hospital. One study showed that following CUSP, there was a significant reduction in surgical site infections despite the fact that previous to that there was 95% compliance with SCIP standards (J. Am. Coll. Surg. 2012;215:193-200). SCIP was working, but it wasn’t affecting outcome.

Dr. Lagasse and I interpret one key study very differently. He abstracts a sentence from a Limitations section of the study and makes a sweeping generalization out of context. But the study showed no relationship between facility adherence to SCIP and the surgical site infection rate. The authors concluded, "Policies regarding continued SCIP measurement and reporting should be reassessed" (Ann. Surg. 2011;254:494-99).

The largest SCIP study to date from a single entity involved 32,459 patients in the Veterans Affairs medical system. Overall, antibiotics were administered within 28 minutes of surgical incision. Once they adjusted for confounders, they found no significant relationship between surgical site infection and the SCIP measures (JAMA 2013;148:649-57). No one has proven that giving antibiotics within 60 minutes of surgical incision gives you a lower infection rate.

SCIP measures divert resources and divert clinical care. They obscure the nuances of care. They may harm the hospital and the provider, and they raise unnecessary legal risk if an antibiotic is not given within 60 minutes of incision.

Dr. Barash is a professor of anesthesiology at Yale University, New Haven, Conn. He reported having no financial disclosures.

These are excerpts from a debate at the annual meeting of the American Society of Anesthesiologists.

POINT: SCIP is both efficacious and effective.

The Surgical Care Improvement Project (SCIP) was a national campaign that set out to reduce surgical mortality and morbidity by 25% by 2010 through recommendations in targeted areas: wound infections, perioperative MIs, and venous thromboembolism. The recommendations have become pay-for-performance measures. There are seven in the area of infectious disease to reduce surgical site infections. There is one measure for reducing perioperative MI: Continue beta-blockers (for patients who are on them) in the perioperative period. For venous thromboembolism prevention, give prophylaxis within 24 hours before to 24 hours after surgery.

It’s key to understand the difference between efficacy and effectiveness. I think we would all agree that the SCIP measures have efficacy. Efficacy trials determine whether an intervention produces the expected result under ideal circumstances. Effectiveness trials measure the degree of beneficial effect under "real world" clinical conditions. The problem with effectiveness trials is that those real-world conditions may change the effect, or they might just change the ability to measure the effect.

I believe that the SCIP measures have proven efficacy because they all are based upon randomized controlled trials that were identified by systematic reviews amenable to meta-analysis. All of these measures are Level 1 recommendations, based on the highest forms of evidence. The studies that Dr. Barash uses to criticize SCIP measures are cohort studies. They do not randomize. There may be unknown confounding variables.

There have been effectiveness trials that show that the SCIP measures do work. One showed a 27% decrease in surgical site infections, another showed a 62% decrease in surgical site infections, and a third showed a 39% decrease in surgical site infections.

Perhaps the strongest endorsement of efficacy of the SCIP measures comes from Dr. Kaveh G. Shojania, who has written several reviews of the efficacy of medical interventions. This guy is like Mikey from the old Life cereal commercials ... he hates everything. He said there were 11 patient safety practices rated most highly in terms of strength of the evidence, and 3 are SCIP measures: appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk, use of perioperative beta-blockers in appropriate patients, and appropriate use of antibiotic prophylaxis in surgical patients (AHRQ Publication No. 01-E058).

Several trials published by pretty good researchers in reputable journals show a lack of effectiveness of SCIP measures. Even those researchers admit to the efficacy of SCIP measures. The lead investigator of the best effectiveness trial, a retrospective cohort study, wrote, "There are several explanations as to why we did not observe an association between timely antibiotic administration and surgical site infection (SSI). The first is that timely antibiotic administration does not diminish SSI risk. This is an unlikely interpretation. There are numerous randomized controlled trials and observational studies that demonstrate the efficacy of prophylactic antibiotics in reducing SSI for various surgical procedures" (Ann. Surg. 2011;254:494-9).

A separate retrospective cohort study showed a decrease in surgical site infection only if two or more SCIP recommendations were followed (JAMA 2010;303:2479-85). Shocking – if you give the wrong antibiotic at the right time, it might not work.

Another retrospective cohort study found no association with adjusted complications and SCIP compliance. Hospitals in the lowest compliance group had patients in lower-income ZIP codes and lower unadjusted complication rates. So, poor people go home and don’t come back, perhaps because of payment considerations. The study didn’t have enough patients; it also used measures that don’t apply to SCIP (Arch. Surg. 2010;145:999-1004).

SCIP did not design these measures for pay-for-performance programs. The intent was to decrease perioperative complications by 25% by 2010. When you start changing the baseline with pay-for-performance, it doesn’t work. In a study by Hawkins et al., the authors tested the hypothesis that documented compliance with antibiotic prophylaxis guidelines on a pediatric surgery service does not reflect adherence to guidelines as intended. In a 7-week observational study of elective pediatric surgical cases, adherence was evaluated for appropriate administration, type, timing, weight-based dosing, and redosing of antibiotics. Prophylactic antibiotics were administered appropriately in 141 of 143 cases (99%). Of 100 cases in which antibiotic prophylaxis was indicated, compliance was documented in 100% of cases in the electronic medical record; but only 48% of cases adhered to all five guidelines. Lack of adherence was due primarily to dosing or timing errors.

The SCIP measures, however, are based on best evidence. They are tightly linked with the desired outcomes. They are measurable and effectible, as demonstrated in multiple randomized controlled trials. Studies of effectiveness have had variable results due to methodological flaws.

Dr. Lagasse is a professor of anesthesiology and director of quality management at the Yale School of Medicine, New Haven, Conn. He is on the steering committee for the Surgical Care Improvement Project. He reported having no financial disclosures.

COUNTERPOINT: Studies have not shown effectiveness.

When it was created, SCIP did not reflect reality. SCIP started at the U.S. Department of Veterans Affairs, which conducted a 10-year study. They found a 25% relative risk reduction, but that was only a 0.8% absolute risk reduction for the incidence of complications, a drop from about 3.1% to about 2.3% (Arch. Surg. 2002;137:20-27).

It would be great to have randomized controlled trials on the effectiveness of SCIP, but it’s not happening. We’re going to have to go by high-fidelity observational trials, which according to a number of researchers in the field have the same impact as randomized controlled trials.

One study of 35,543 patients in 44 hospitals found a whopping 27% reduction in surgical site infections, but that was only a 0.6% absolute reduction, from about 2.5% to about 1.9% (Am. J. Surg. 2005;190:9-15). There was no significant difference between groups.

Another study showed improved compliance with SCIP measures, but no change in surgical site infection rate (Dis. Colon Rectum 2010;53:24-30). This is the theme in study after study after study.

A 2008 study enrolled 9,195 patients undergoing colorectal, orthopedic, or vascular surgery and looked at SCIP compliance vs. surgical site infection. The SCIP rate correlated with the hospital case mix. If you look at the SCIP rate in terms of antibiotic timing, SCIP is not significant. The study basically showed that variables other than timely antibiotic administration are affecting surgical site infection rates (J. Am. Coll. Surg. 2008;206:814-19).

Hospital performance on process measures may not be a good marker of surgical site infection or the outcome we’re looking at, according to another study, which reported that unmeasured effects may have a larger impact than the measured effects (Health Serv. Res. 2008;43:1464-84).

There is a randomized controlled trial that randomized patients to strict control with the SCIP measures or routine treatment at the hospital. The SCIP-treated patients had nearly twice the incidence of surgical site infections as the patients receiving standard treatment. The authors concluded that combining each of the SCIP factors into one big category doesn’t necessarily work (Arch. Surg. 2011;146:263-9).

Should we be evaluating outcome measures with performance measures (e.g., percent timely antibiotic administration) to determine whether they work or not? One editorial evaluated eight articles with data on 31,448 patients, looking just at antibiotic administration within 1 hour of surgery, a SCIP measure. It found a higher infection rate if antibiotics were administered within 30 minutes of incision (JAMA 2010;303:2527-2528).

There was no significant difference in another study between standard of care and SCIP for venous thromboembolism (Am. J. Surg. 2012;204:591-97). The authors wrote that there is no convincing evidence that improvements in compliance are associated with better outcomes. We see this time and time again.

When people find that SCIP is not working, they turn to other measures to reduce surgical site infection. The Comprehensive Unit-based Safety Program (CUSP) is targeted at a specific problem that a specific hospital is having in managing infections. It’s not coming from Washington; it’s based at the hospital. One study showed that following CUSP, there was a significant reduction in surgical site infections despite the fact that previous to that there was 95% compliance with SCIP standards (J. Am. Coll. Surg. 2012;215:193-200). SCIP was working, but it wasn’t affecting outcome.

Dr. Lagasse and I interpret one key study very differently. He abstracts a sentence from a Limitations section of the study and makes a sweeping generalization out of context. But the study showed no relationship between facility adherence to SCIP and the surgical site infection rate. The authors concluded, "Policies regarding continued SCIP measurement and reporting should be reassessed" (Ann. Surg. 2011;254:494-99).

The largest SCIP study to date from a single entity involved 32,459 patients in the Veterans Affairs medical system. Overall, antibiotics were administered within 28 minutes of surgical incision. Once they adjusted for confounders, they found no significant relationship between surgical site infection and the SCIP measures (JAMA 2013;148:649-57). No one has proven that giving antibiotics within 60 minutes of surgical incision gives you a lower infection rate.

SCIP measures divert resources and divert clinical care. They obscure the nuances of care. They may harm the hospital and the provider, and they raise unnecessary legal risk if an antibiotic is not given within 60 minutes of incision.

Dr. Barash is a professor of anesthesiology at Yale University, New Haven, Conn. He reported having no financial disclosures.

These are excerpts from a debate at the annual meeting of the American Society of Anesthesiologists.

POINT: SCIP is both efficacious and effective.

The Surgical Care Improvement Project (SCIP) was a national campaign that set out to reduce surgical mortality and morbidity by 25% by 2010 through recommendations in targeted areas: wound infections, perioperative MIs, and venous thromboembolism. The recommendations have become pay-for-performance measures. There are seven in the area of infectious disease to reduce surgical site infections. There is one measure for reducing perioperative MI: Continue beta-blockers (for patients who are on them) in the perioperative period. For venous thromboembolism prevention, give prophylaxis within 24 hours before to 24 hours after surgery.

It’s key to understand the difference between efficacy and effectiveness. I think we would all agree that the SCIP measures have efficacy. Efficacy trials determine whether an intervention produces the expected result under ideal circumstances. Effectiveness trials measure the degree of beneficial effect under "real world" clinical conditions. The problem with effectiveness trials is that those real-world conditions may change the effect, or they might just change the ability to measure the effect.

I believe that the SCIP measures have proven efficacy because they all are based upon randomized controlled trials that were identified by systematic reviews amenable to meta-analysis. All of these measures are Level 1 recommendations, based on the highest forms of evidence. The studies that Dr. Barash uses to criticize SCIP measures are cohort studies. They do not randomize. There may be unknown confounding variables.

There have been effectiveness trials that show that the SCIP measures do work. One showed a 27% decrease in surgical site infections, another showed a 62% decrease in surgical site infections, and a third showed a 39% decrease in surgical site infections.

Perhaps the strongest endorsement of efficacy of the SCIP measures comes from Dr. Kaveh G. Shojania, who has written several reviews of the efficacy of medical interventions. This guy is like Mikey from the old Life cereal commercials ... he hates everything. He said there were 11 patient safety practices rated most highly in terms of strength of the evidence, and 3 are SCIP measures: appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk, use of perioperative beta-blockers in appropriate patients, and appropriate use of antibiotic prophylaxis in surgical patients (AHRQ Publication No. 01-E058).

Several trials published by pretty good researchers in reputable journals show a lack of effectiveness of SCIP measures. Even those researchers admit to the efficacy of SCIP measures. The lead investigator of the best effectiveness trial, a retrospective cohort study, wrote, "There are several explanations as to why we did not observe an association between timely antibiotic administration and surgical site infection (SSI). The first is that timely antibiotic administration does not diminish SSI risk. This is an unlikely interpretation. There are numerous randomized controlled trials and observational studies that demonstrate the efficacy of prophylactic antibiotics in reducing SSI for various surgical procedures" (Ann. Surg. 2011;254:494-9).

A separate retrospective cohort study showed a decrease in surgical site infection only if two or more SCIP recommendations were followed (JAMA 2010;303:2479-85). Shocking – if you give the wrong antibiotic at the right time, it might not work.

Another retrospective cohort study found no association with adjusted complications and SCIP compliance. Hospitals in the lowest compliance group had patients in lower-income ZIP codes and lower unadjusted complication rates. So, poor people go home and don’t come back, perhaps because of payment considerations. The study didn’t have enough patients; it also used measures that don’t apply to SCIP (Arch. Surg. 2010;145:999-1004).

SCIP did not design these measures for pay-for-performance programs. The intent was to decrease perioperative complications by 25% by 2010. When you start changing the baseline with pay-for-performance, it doesn’t work. In a study by Hawkins et al., the authors tested the hypothesis that documented compliance with antibiotic prophylaxis guidelines on a pediatric surgery service does not reflect adherence to guidelines as intended. In a 7-week observational study of elective pediatric surgical cases, adherence was evaluated for appropriate administration, type, timing, weight-based dosing, and redosing of antibiotics. Prophylactic antibiotics were administered appropriately in 141 of 143 cases (99%). Of 100 cases in which antibiotic prophylaxis was indicated, compliance was documented in 100% of cases in the electronic medical record; but only 48% of cases adhered to all five guidelines. Lack of adherence was due primarily to dosing or timing errors.

The SCIP measures, however, are based on best evidence. They are tightly linked with the desired outcomes. They are measurable and effectible, as demonstrated in multiple randomized controlled trials. Studies of effectiveness have had variable results due to methodological flaws.

Dr. Lagasse is a professor of anesthesiology and director of quality management at the Yale School of Medicine, New Haven, Conn. He is on the steering committee for the Surgical Care Improvement Project. He reported having no financial disclosures.

COUNTERPOINT: Studies have not shown effectiveness.

When it was created, SCIP did not reflect reality. SCIP started at the U.S. Department of Veterans Affairs, which conducted a 10-year study. They found a 25% relative risk reduction, but that was only a 0.8% absolute risk reduction for the incidence of complications, a drop from about 3.1% to about 2.3% (Arch. Surg. 2002;137:20-27).

It would be great to have randomized controlled trials on the effectiveness of SCIP, but it’s not happening. We’re going to have to go by high-fidelity observational trials, which according to a number of researchers in the field have the same impact as randomized controlled trials.

One study of 35,543 patients in 44 hospitals found a whopping 27% reduction in surgical site infections, but that was only a 0.6% absolute reduction, from about 2.5% to about 1.9% (Am. J. Surg. 2005;190:9-15). There was no significant difference between groups.

Another study showed improved compliance with SCIP measures, but no change in surgical site infection rate (Dis. Colon Rectum 2010;53:24-30). This is the theme in study after study after study.

A 2008 study enrolled 9,195 patients undergoing colorectal, orthopedic, or vascular surgery and looked at SCIP compliance vs. surgical site infection. The SCIP rate correlated with the hospital case mix. If you look at the SCIP rate in terms of antibiotic timing, SCIP is not significant. The study basically showed that variables other than timely antibiotic administration are affecting surgical site infection rates (J. Am. Coll. Surg. 2008;206:814-19).

Hospital performance on process measures may not be a good marker of surgical site infection or the outcome we’re looking at, according to another study, which reported that unmeasured effects may have a larger impact than the measured effects (Health Serv. Res. 2008;43:1464-84).

There is a randomized controlled trial that randomized patients to strict control with the SCIP measures or routine treatment at the hospital. The SCIP-treated patients had nearly twice the incidence of surgical site infections as the patients receiving standard treatment. The authors concluded that combining each of the SCIP factors into one big category doesn’t necessarily work (Arch. Surg. 2011;146:263-9).

Should we be evaluating outcome measures with performance measures (e.g., percent timely antibiotic administration) to determine whether they work or not? One editorial evaluated eight articles with data on 31,448 patients, looking just at antibiotic administration within 1 hour of surgery, a SCIP measure. It found a higher infection rate if antibiotics were administered within 30 minutes of incision (JAMA 2010;303:2527-2528).

There was no significant difference in another study between standard of care and SCIP for venous thromboembolism (Am. J. Surg. 2012;204:591-97). The authors wrote that there is no convincing evidence that improvements in compliance are associated with better outcomes. We see this time and time again.

When people find that SCIP is not working, they turn to other measures to reduce surgical site infection. The Comprehensive Unit-based Safety Program (CUSP) is targeted at a specific problem that a specific hospital is having in managing infections. It’s not coming from Washington; it’s based at the hospital. One study showed that following CUSP, there was a significant reduction in surgical site infections despite the fact that previous to that there was 95% compliance with SCIP standards (J. Am. Coll. Surg. 2012;215:193-200). SCIP was working, but it wasn’t affecting outcome.

Dr. Lagasse and I interpret one key study very differently. He abstracts a sentence from a Limitations section of the study and makes a sweeping generalization out of context. But the study showed no relationship between facility adherence to SCIP and the surgical site infection rate. The authors concluded, "Policies regarding continued SCIP measurement and reporting should be reassessed" (Ann. Surg. 2011;254:494-99).

The largest SCIP study to date from a single entity involved 32,459 patients in the Veterans Affairs medical system. Overall, antibiotics were administered within 28 minutes of surgical incision. Once they adjusted for confounders, they found no significant relationship between surgical site infection and the SCIP measures (JAMA 2013;148:649-57). No one has proven that giving antibiotics within 60 minutes of surgical incision gives you a lower infection rate.

SCIP measures divert resources and divert clinical care. They obscure the nuances of care. They may harm the hospital and the provider, and they raise unnecessary legal risk if an antibiotic is not given within 60 minutes of incision.

Dr. Barash is a professor of anesthesiology at Yale University, New Haven, Conn. He reported having no financial disclosures.

These are excerpts from a debate at the annual meeting of the American Society of Anesthesiologists.

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

DENVER – The clinical success of ceftaroline fosamil exceeded 80% in patients with acute bacterial skin and skin structure infections, including those with underlying comorbidities and those with infections caused by methicillin-resistant Staphylococcus aureus, a multicenter, industry-funded trial demonstrated.

"At one time, MRSA infections used to be a tertiary care phenomenon," Dr. Ananthakrishnan Ramani said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

"Nowadays, MRSA has become a problem in the community as well. We have seen that it’s no longer bacteremia and sepsis, but also bacterial skin and skin structure infections. Ceftaroline fosamil is the only [Food and Drug Administration]–approved cephalosporin which has activity against MRSA. That’s why this medicine is fascinating to me as an internal medicine physician and as an infectious diseases doc, because we know cephalosporins very well," he said.

Developed by Oakland, Calif.–based Cerexa Inc., ceftaroline fosamil was approved in 2010 for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia. The purpose of the current trial, known as CAPTURE, was to retrospectively evaluate information on the routine clinical use of intravenous ceftaroline fosamil in the United States.

At the meeting, Dr. Ramani and his associates presented data limited to 1,030 patients with ABSSSI who were treated with the agent at one of 38 centers from September 2011 through February 2013. They focused their analysis on patient demographics, disease characteristics, antibiotics, pathogens, and outcomes.

Of the 1,030 patients with ABSSSI, mean age was 58 years, mean body mass index was 34 kg/m², and 54% were male. Nearly two-thirds (73%) were overweight or obese and 46% had diabetes mellitus. The three most common types of infection were deep/extensive cellulitis (59%), major abscesses (19%), and infected ulcers (15%); the most common infections sites were the leg/thigh (47%) and foot (24%) and infected surgical wounds (13%).

Prior to administration of ceftaroline fosamil, 77% of the patients had received antibiotics, and concurrent antibiotics, mostly clindamycin, were used in 37% of cases, said Dr. Ramani, who practices in Catskill, N.Y.

The overall clinical success rate was 85%. It was slightly lower for patients with diabetes (83%) and slightly higher for obese patients (88%). When analyzed by infection type, ceftaroline fosamil therapy achieved clinical success in 86% of major abscesses, 85% of deep/excessive cellulitis cases, 79% of infected surgical wounds, and 79% of infected ulcers, he said.

The researchers also found that clinical success was achieved in 80% of patients with diabetes and MRSA and in 83% of obese patients with MRSA. In addition, clinical success in MRSA infections with ceftaroline fosamil monotherapy was 83%, while success with concurrent therapy was 76%.

Cerexa funded the trial. Dr. Ramani has received research funding from the company.

[email protected]

DENVER – The clinical success of ceftaroline fosamil exceeded 80% in patients with acute bacterial skin and skin structure infections, including those with underlying comorbidities and those with infections caused by methicillin-resistant Staphylococcus aureus, a multicenter, industry-funded trial demonstrated.

"At one time, MRSA infections used to be a tertiary care phenomenon," Dr. Ananthakrishnan Ramani said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

"Nowadays, MRSA has become a problem in the community as well. We have seen that it’s no longer bacteremia and sepsis, but also bacterial skin and skin structure infections. Ceftaroline fosamil is the only [Food and Drug Administration]–approved cephalosporin which has activity against MRSA. That’s why this medicine is fascinating to me as an internal medicine physician and as an infectious diseases doc, because we know cephalosporins very well," he said.

Developed by Oakland, Calif.–based Cerexa Inc., ceftaroline fosamil was approved in 2010 for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia. The purpose of the current trial, known as CAPTURE, was to retrospectively evaluate information on the routine clinical use of intravenous ceftaroline fosamil in the United States.

At the meeting, Dr. Ramani and his associates presented data limited to 1,030 patients with ABSSSI who were treated with the agent at one of 38 centers from September 2011 through February 2013. They focused their analysis on patient demographics, disease characteristics, antibiotics, pathogens, and outcomes.

Of the 1,030 patients with ABSSSI, mean age was 58 years, mean body mass index was 34 kg/m², and 54% were male. Nearly two-thirds (73%) were overweight or obese and 46% had diabetes mellitus. The three most common types of infection were deep/extensive cellulitis (59%), major abscesses (19%), and infected ulcers (15%); the most common infections sites were the leg/thigh (47%) and foot (24%) and infected surgical wounds (13%).

Prior to administration of ceftaroline fosamil, 77% of the patients had received antibiotics, and concurrent antibiotics, mostly clindamycin, were used in 37% of cases, said Dr. Ramani, who practices in Catskill, N.Y.

The overall clinical success rate was 85%. It was slightly lower for patients with diabetes (83%) and slightly higher for obese patients (88%). When analyzed by infection type, ceftaroline fosamil therapy achieved clinical success in 86% of major abscesses, 85% of deep/excessive cellulitis cases, 79% of infected surgical wounds, and 79% of infected ulcers, he said.

The researchers also found that clinical success was achieved in 80% of patients with diabetes and MRSA and in 83% of obese patients with MRSA. In addition, clinical success in MRSA infections with ceftaroline fosamil monotherapy was 83%, while success with concurrent therapy was 76%.

Cerexa funded the trial. Dr. Ramani has received research funding from the company.

[email protected]

DENVER – The clinical success of ceftaroline fosamil exceeded 80% in patients with acute bacterial skin and skin structure infections, including those with underlying comorbidities and those with infections caused by methicillin-resistant Staphylococcus aureus, a multicenter, industry-funded trial demonstrated.

"At one time, MRSA infections used to be a tertiary care phenomenon," Dr. Ananthakrishnan Ramani said in an interview during a poster session at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

"Nowadays, MRSA has become a problem in the community as well. We have seen that it’s no longer bacteremia and sepsis, but also bacterial skin and skin structure infections. Ceftaroline fosamil is the only [Food and Drug Administration]–approved cephalosporin which has activity against MRSA. That’s why this medicine is fascinating to me as an internal medicine physician and as an infectious diseases doc, because we know cephalosporins very well," he said.

Developed by Oakland, Calif.–based Cerexa Inc., ceftaroline fosamil was approved in 2010 for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia. The purpose of the current trial, known as CAPTURE, was to retrospectively evaluate information on the routine clinical use of intravenous ceftaroline fosamil in the United States.

At the meeting, Dr. Ramani and his associates presented data limited to 1,030 patients with ABSSSI who were treated with the agent at one of 38 centers from September 2011 through February 2013. They focused their analysis on patient demographics, disease characteristics, antibiotics, pathogens, and outcomes.

Of the 1,030 patients with ABSSSI, mean age was 58 years, mean body mass index was 34 kg/m², and 54% were male. Nearly two-thirds (73%) were overweight or obese and 46% had diabetes mellitus. The three most common types of infection were deep/extensive cellulitis (59%), major abscesses (19%), and infected ulcers (15%); the most common infections sites were the leg/thigh (47%) and foot (24%) and infected surgical wounds (13%).

Prior to administration of ceftaroline fosamil, 77% of the patients had received antibiotics, and concurrent antibiotics, mostly clindamycin, were used in 37% of cases, said Dr. Ramani, who practices in Catskill, N.Y.

The overall clinical success rate was 85%. It was slightly lower for patients with diabetes (83%) and slightly higher for obese patients (88%). When analyzed by infection type, ceftaroline fosamil therapy achieved clinical success in 86% of major abscesses, 85% of deep/excessive cellulitis cases, 79% of infected surgical wounds, and 79% of infected ulcers, he said.

The researchers also found that clinical success was achieved in 80% of patients with diabetes and MRSA and in 83% of obese patients with MRSA. In addition, clinical success in MRSA infections with ceftaroline fosamil monotherapy was 83%, while success with concurrent therapy was 76%.

Cerexa funded the trial. Dr. Ramani has received research funding from the company.

[email protected]

SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.

Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.

Sherry Boschert/IMNG Medical Media

The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.

The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.

Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.

Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.

The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.

Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.

Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.

Results did not differ by subgroups.

Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.

Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.

The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.

The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).

Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.

Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.

Sherry Boschert/IMNG Medical Media

The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.

The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.

Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.

Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.

The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.

Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.

Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.

Results did not differ by subgroups.

Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.

Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.

The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.

The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).

Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Adverse event rates 1 year after implantation of a second-generation zotarolimus-eluting coronary stent were similar for 3,120 patients regardless of whether they took 3 months or 12 months of dual-antiplatelet therapy in a prospective trial that randomized 3,120 patients in real-world settings.

Six percent in the 3-month group and 5.8% in the 12-month group developed one or more adverse events that were included in a composite primary endpoint: death from any cause; myocardial infarction; stroke; or major bleeding, Dr. Fausto Feres and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting. The results were significant in a noninferiority analysis.

Sherry Boschert/IMNG Medical Media

The results should comfort clinicians who think they have to stop dual-antiplatelet therapy (DAPT) earlier than recommended in some patients who are at higher risk for bleeding complications, such as the elderly and patients with a history of hemorrhagic events, said Dr. Feres, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, an institution known for pioneering stent procedures.

The study tapped 33 clinical sites to enroll Brazilian patients who were undergoing percutaneous coronary intervention (PCI) with the second-generation Endeavor zotarolimus-eluting stent. All patients had stable or unstable angina or a recent MI, at least one coronary lesion suitable for PCI with the Endeavor stent, and a native vessel diameter of at least 2.5 mm with stenosis greater than 50%. The cohort consisted mainly of patients with stable coronary artery disease and a low risk of acute coronary syndrome.

Equal numbers were randomized to 3 or 12 months of DAPT with aspirin and 75 mg/day of clopidogrel to reduce the risk of thrombotic events. Current guidelines call for 12 months of DAPT after stent implantation. One-year follow-up data were available for 98% in each group.

Known as the OPTIMIZE trial (Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice), the study found that more than 99% of patients in each group completed 3 months of DAPT. One year after stent implantation, 6% who had been randomized to the 3-month group were still on DAPT, as were 97% of those randomized to the 12-month group.

The individual components of the combined endpoint did not differ significantly at 1-year follow-up. All-cause mortality was seen in 1.9% and 1.7% of the 3- and 12-month therapy groups; MI rates were 0.8% and 0.6%, respectively; stroke rates were 0.3% and 0.1%; and major bleeding occurred in 0.2% and 0.4%. Landmark analyses also found no significant differences between groups for these endpoints at 3 months.

Rates of definite or probable stent thrombosis at 1 year were 0.3% in the 3-month therapy group and 0.1% in the 12-month group, which was not a significant difference. There was a trend toward higher risk of bleeding at 1 year in patients on 12 months of DAPT, seen in 1% compared with 0.4% of those on 3 months of therapy, Dr. Feres reported at the meeting, cosponsored by the American College of Cardiology.

Secondary outcomes at 1 year showed that rates of other adverse clinical events also did not differ significantly between the two groups. Eight percent in the 3-month group and 7% in the 12-month group developed one or more major adverse coronary events: death, MI, emergent coronary artery bypass grafting, or target lesion revascularization. Three percent in each group died, 3% in each developed an MI, 4% in each had either cardiac death or an MI, and 0.3% in each developed a stroke. Major bleeding occurred in 0.6% of the 3-month group and 0.9% of the 12-month group. Target lesion revascularization rates were 3.5% in the 3-month group and 3.2% in the 12-month group.

Results did not differ by subgroups.

Rates for the primary outcome were lower than expected in both arms of the trial. Investigators expected a 9% rate, not the roughly 6% rate seen in both arms. The rate of major adverse coronary events at 1 year, however, was 8.4% in the 3-month group and 7.5% in the 12-month group.

Two previous studies in Italy and Korea of shortened-duration DAPT for patients receiving drug-eluting stents compared 6 months of therapy with 12 months of therapy. One other previous trial compared 3 months with 12 months of DAPT but compared two different stents, he said. All suggested that 12 months of DAPT may not always be needed, he said in an interview.

The current study excluded patients with primary or rescue PCI for ST-segment elevation MI, lesions located in a saphenous vein graft, patients with a previous PCI with a drug-eluting stent, and other less common exclusion criteria.

The findings from OPTIMIZE were published online concurrently with Dr. Feres’ presentation (JAMA 2013 Oct. 31 [doi: 10.1001/jama.2013.282183]).

Dr. Feres reported having financial relationships with BioSensors, Eli Lilly, and Medtronic, which markets the Endeavor stent and funded the study.

[email protected]

On Twitter @sherryboschert

Critical illness survivors who experienced a long period of delirium during an intensive care unit stay can have long-term global cognition and executive function scores similar to those seen in traumatic brain injury and Alzheimer’s patients, according to a multicenter prospective cohort study.

The finding of an association between longer duration of delirium and worse long-term global cognition and executive function was independent of sedative or analgesic medication use, age, preexisting cognitive impairment, the burden of coexisting conditions, and ongoing organ failure during ICU care, Dr. P.P. Pandharipande of Vanderbilt University, Nashville, Tenn., and his colleagues reported. The findings were published Oct. 2 in The New England Journal of Medicine.

Courtesy Vanderbilt University

Of 821 patients with respiratory failure, cardiogenic shock, or septic shock who were treated in a medical or surgical ICU, 6% had cognitive impairment at baseline and 74% experienced delirium during their hospital stay. Median global cognition scores at 3 and 12 months as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were 79 and 80, respectively.

"These scores were approximately 1.5 [standard deviations] below the age-adjusted population mean of 100 plus or minus 15 and were similar to scores for patients with mild cognitive impairment. At 3-months, 40% of the patients had global cognition scores that were worse than those typically seen in patients with moderate traumatic brain injury, and 26% had scores 2 SD below the population means, which were similar to scores for patients with mild Alzheimer’s disease," the investigators reported.

The deficits occurred regardless of patient age and persisted to 12 months, with 34% and 24% of patients demonstrating scores similar to those for patients with moderate traumatic brain injury and for patients with mild Alzheimer’s disease, respectively, they said (N. Engl. J. Med. 2013;369:1306-16).

Duration of delirium was significantly associated with worse global cognition and significantly worse executive function at both 3- and 12-month follow-up. For example, patients with a 5-day mean duration of delirium had mean RBANS scores that were 6.3 points lower at 3 months and 5.6 points lower at 12 months than those with no delirium. They had Trails B executive-function scores that were 5.1 points lower at 3 months and 6.0 points lower at 12 months.

"A longer duration of delirium was also a risk factor for worse function in several individual RBANS domains," Dr. Pandharipande and his associates noted.

Although the investigators hypothesized that higher doses of sedative and analgesic use also would be independently associated with more severe cognitive impairment at 12 months, this did not prove to be the case. The use of higher benzodiazepine doses during hospitalization, however, was associated with worse executive function scores at 3 months.

The patients, who had a median age of 61 years and high severity of illness, were enrolled in the Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors (BRAIN-ICU) study between March, 2007 and May, 2010. Delirium was assessed by the Confusion Assessment Method for the ICU, and level of consciousness was assessed using the Richmond Agitation-Sedation Scale.

It remains unclear whether any preventive or treatment strategies can reduce the risk of long-term cognitive impairment after critical illness, they said, noting that this is of concern, as "long-term cognitive impairment after critical illness may be a growing public health problem, given the large number of acutely ill patients being treated in intensive care units globally."

Though limited by an inability to test patients’ cognition before their emergent illness (although the investigators took several precautions to address this limitation), and by the fact that some patients were unable to complete all cognitive tests, the findings nevertheless demonstrate that cognitive impairment after critical illness is very common – even more so among those with longer duration of delirium – and can persist for at least 1 year, they said.

It is "possible that patients who are vulnerable to delirium owing to severe critical illness are also vulnerable to long-term cognitive impairment and that delirium does not play a causal role in the development of persistent cognitive impairment," investigators noted.

This study was supported by grants from the National Institutes of Health and the Veteran’s Affairs Clinical Science Research and Development Service, as well as by a Mentored Research Training Grant from the Foundation for Anesthesia Education and Research and the VA Tennessee Valley Geriatric Research Education and Clinical Center. Multiple study authors reported disclosures; details are available with the full text of the article at NEJM.org.

Critical illness survivors who experienced a long period of delirium during an intensive care unit stay can have long-term global cognition and executive function scores similar to those seen in traumatic brain injury and Alzheimer’s patients, according to a multicenter prospective cohort study.

The finding of an association between longer duration of delirium and worse long-term global cognition and executive function was independent of sedative or analgesic medication use, age, preexisting cognitive impairment, the burden of coexisting conditions, and ongoing organ failure during ICU care, Dr. P.P. Pandharipande of Vanderbilt University, Nashville, Tenn., and his colleagues reported. The findings were published Oct. 2 in The New England Journal of Medicine.

Courtesy Vanderbilt University

Of 821 patients with respiratory failure, cardiogenic shock, or septic shock who were treated in a medical or surgical ICU, 6% had cognitive impairment at baseline and 74% experienced delirium during their hospital stay. Median global cognition scores at 3 and 12 months as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were 79 and 80, respectively.

"These scores were approximately 1.5 [standard deviations] below the age-adjusted population mean of 100 plus or minus 15 and were similar to scores for patients with mild cognitive impairment. At 3-months, 40% of the patients had global cognition scores that were worse than those typically seen in patients with moderate traumatic brain injury, and 26% had scores 2 SD below the population means, which were similar to scores for patients with mild Alzheimer’s disease," the investigators reported.

The deficits occurred regardless of patient age and persisted to 12 months, with 34% and 24% of patients demonstrating scores similar to those for patients with moderate traumatic brain injury and for patients with mild Alzheimer’s disease, respectively, they said (N. Engl. J. Med. 2013;369:1306-16).

Duration of delirium was significantly associated with worse global cognition and significantly worse executive function at both 3- and 12-month follow-up. For example, patients with a 5-day mean duration of delirium had mean RBANS scores that were 6.3 points lower at 3 months and 5.6 points lower at 12 months than those with no delirium. They had Trails B executive-function scores that were 5.1 points lower at 3 months and 6.0 points lower at 12 months.

"A longer duration of delirium was also a risk factor for worse function in several individual RBANS domains," Dr. Pandharipande and his associates noted.

Although the investigators hypothesized that higher doses of sedative and analgesic use also would be independently associated with more severe cognitive impairment at 12 months, this did not prove to be the case. The use of higher benzodiazepine doses during hospitalization, however, was associated with worse executive function scores at 3 months.

The patients, who had a median age of 61 years and high severity of illness, were enrolled in the Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors (BRAIN-ICU) study between March, 2007 and May, 2010. Delirium was assessed by the Confusion Assessment Method for the ICU, and level of consciousness was assessed using the Richmond Agitation-Sedation Scale.

It remains unclear whether any preventive or treatment strategies can reduce the risk of long-term cognitive impairment after critical illness, they said, noting that this is of concern, as "long-term cognitive impairment after critical illness may be a growing public health problem, given the large number of acutely ill patients being treated in intensive care units globally."

Though limited by an inability to test patients’ cognition before their emergent illness (although the investigators took several precautions to address this limitation), and by the fact that some patients were unable to complete all cognitive tests, the findings nevertheless demonstrate that cognitive impairment after critical illness is very common – even more so among those with longer duration of delirium – and can persist for at least 1 year, they said.

It is "possible that patients who are vulnerable to delirium owing to severe critical illness are also vulnerable to long-term cognitive impairment and that delirium does not play a causal role in the development of persistent cognitive impairment," investigators noted.

This study was supported by grants from the National Institutes of Health and the Veteran’s Affairs Clinical Science Research and Development Service, as well as by a Mentored Research Training Grant from the Foundation for Anesthesia Education and Research and the VA Tennessee Valley Geriatric Research Education and Clinical Center. Multiple study authors reported disclosures; details are available with the full text of the article at NEJM.org.

Critical illness survivors who experienced a long period of delirium during an intensive care unit stay can have long-term global cognition and executive function scores similar to those seen in traumatic brain injury and Alzheimer’s patients, according to a multicenter prospective cohort study.

The finding of an association between longer duration of delirium and worse long-term global cognition and executive function was independent of sedative or analgesic medication use, age, preexisting cognitive impairment, the burden of coexisting conditions, and ongoing organ failure during ICU care, Dr. P.P. Pandharipande of Vanderbilt University, Nashville, Tenn., and his colleagues reported. The findings were published Oct. 2 in The New England Journal of Medicine.

Courtesy Vanderbilt University

Of 821 patients with respiratory failure, cardiogenic shock, or septic shock who were treated in a medical or surgical ICU, 6% had cognitive impairment at baseline and 74% experienced delirium during their hospital stay. Median global cognition scores at 3 and 12 months as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were 79 and 80, respectively.

"These scores were approximately 1.5 [standard deviations] below the age-adjusted population mean of 100 plus or minus 15 and were similar to scores for patients with mild cognitive impairment. At 3-months, 40% of the patients had global cognition scores that were worse than those typically seen in patients with moderate traumatic brain injury, and 26% had scores 2 SD below the population means, which were similar to scores for patients with mild Alzheimer’s disease," the investigators reported.

The deficits occurred regardless of patient age and persisted to 12 months, with 34% and 24% of patients demonstrating scores similar to those for patients with moderate traumatic brain injury and for patients with mild Alzheimer’s disease, respectively, they said (N. Engl. J. Med. 2013;369:1306-16).

Duration of delirium was significantly associated with worse global cognition and significantly worse executive function at both 3- and 12-month follow-up. For example, patients with a 5-day mean duration of delirium had mean RBANS scores that were 6.3 points lower at 3 months and 5.6 points lower at 12 months than those with no delirium. They had Trails B executive-function scores that were 5.1 points lower at 3 months and 6.0 points lower at 12 months.

"A longer duration of delirium was also a risk factor for worse function in several individual RBANS domains," Dr. Pandharipande and his associates noted.

Although the investigators hypothesized that higher doses of sedative and analgesic use also would be independently associated with more severe cognitive impairment at 12 months, this did not prove to be the case. The use of higher benzodiazepine doses during hospitalization, however, was associated with worse executive function scores at 3 months.

The patients, who had a median age of 61 years and high severity of illness, were enrolled in the Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors (BRAIN-ICU) study between March, 2007 and May, 2010. Delirium was assessed by the Confusion Assessment Method for the ICU, and level of consciousness was assessed using the Richmond Agitation-Sedation Scale.

It remains unclear whether any preventive or treatment strategies can reduce the risk of long-term cognitive impairment after critical illness, they said, noting that this is of concern, as "long-term cognitive impairment after critical illness may be a growing public health problem, given the large number of acutely ill patients being treated in intensive care units globally."

Though limited by an inability to test patients’ cognition before their emergent illness (although the investigators took several precautions to address this limitation), and by the fact that some patients were unable to complete all cognitive tests, the findings nevertheless demonstrate that cognitive impairment after critical illness is very common – even more so among those with longer duration of delirium – and can persist for at least 1 year, they said.

It is "possible that patients who are vulnerable to delirium owing to severe critical illness are also vulnerable to long-term cognitive impairment and that delirium does not play a causal role in the development of persistent cognitive impairment," investigators noted.

This study was supported by grants from the National Institutes of Health and the Veteran’s Affairs Clinical Science Research and Development Service, as well as by a Mentored Research Training Grant from the Foundation for Anesthesia Education and Research and the VA Tennessee Valley Geriatric Research Education and Clinical Center. Multiple study authors reported disclosures; details are available with the full text of the article at NEJM.org.

Hospitals that conduct a high volume of surgical procedures and have a low 30-day mortality rate have lower readmission rates, according to a new study. Even so, about one in seven patients discharged after major surgery is readmitted in the first 30 days, the authors found.

The researchers also showed that strictly following surgical process measures – such as infection control techniques – was only weakly associated with reduced readmissions.

The results are not terribly surprising, according to the authors, Dr. Thomas C. Tsai and his colleagues from Harvard University, Brigham and Women’s Hospital, and the Veterans Affairs Boston Healthcare System. The researchers could not specifically determine why the higher-volume, lower-mortality hospitals had lower readmission rates, but they speculated that these facilities have systems in place to protect surgical patients from bad outcomes that might bring them back to the hospital. Their study was published Sept. 18 in the New England Journal of Medicine (2013;369:1134-42).

The Medicare program now penalizes hospitals for excess readmissions after discharge for heart failure, heart attack, and pneumonia. For fiscal year 2013, which ends on Oct. 1, hospitals will be penalized 1% of their total Medicare billings if readmissions are too high. In fiscal 2014, chronic obstructive pulmonary disease and coronary artery bypass grafting will be added to the list of monitored conditions. The penalty rises to 2% in fiscal year 2014 and 3% in fiscal 2015. In coming years, the Centers for Medicare and Medicaid Services is expected to add more surgical procedures to the readmission penalty list.

The researchers analyzed national Medicare data, which comprised 479,471 discharges from 3,004 hospitals. These hospitals accounted for 90% of the discharges for the six major procedures studied: coronary artery bypass grafting, pulmonary lobectomy, endovascular repair of abdominal aortic aneurysm, open repair of AAA, colectomy, and hip replacement. The authors also analyzed Hospital Quality Alliance (HQA) surgical care scores. The HQA score is calculated based on how well hospitals perform on process measures established by the Surgical Care Improvement Project.

The three measures of surgical quality included the HQA score, procedure volume, and 30-day mortality. The primary outcome measure was a hospital-level composite of the six procedure-specific, risk-adjusted readmission rates at 30 days. The authors compared the characteristics of patients who were readmitted within 30 days with those who were not, and compared the characteristics of hospitals that had composite readmission rates above the median with those that had rates below the median.

The median composite risk-adjusted 30-day readmission rate was 13%. Patients who were readmitted tended to be older (78 years vs. 77 years) and had more comorbidities. The hospitals with readmission rates below the median were more likely to be nonprofit, nonteaching, and located in the West. They also had a higher number of full-time nurses per 1,000 patient-days and a lower proportion of Medicaid patients.

There was no significant difference between urban and rural hospitals.

The authors used multivariate models to gauge the impact of quality measures on readmission rates. After accounting for hospital characteristics, they found that hospitals with the highest volume of procedures had a readmission rate just under the median, compared with those with the lowest procedure volumes, which had a readmission rate of close to 17%.

Hospitals in the lowest quartile for mortality rates had a 13% readmission rate, compared with 14% for those in the highest mortality quartile.

Overall, there was no significant difference in readmissions between the hospitals that performed the best on the HQA score and those that were the poorest performers. That might be because there was only a very small variation in performance on the HQA score – with a median of 99% for high performers and 92% for low performers, said the authors.

Policymakers should be reassured by their consistent findings that readmissions are linked to certain quality measures – volume and mortality, the investigators said. But a direct link is still not definitive, said Dr. Tsai and his colleagues. Previous studies have indicated that volume did help reduce readmissions, while others have shown no relationship.

But those studies were conducted before the widespread use of minimally invasive procedures and process measures aimed at reducing postsurgical complications, the authors said.

The authors reported no relevant conflicts of interest.

[email protected]

On Twitter @aliciaault

Hospitals that conduct a high volume of surgical procedures and have a low 30-day mortality rate have lower readmission rates, according to a new study. Even so, about one in seven patients discharged after major surgery is readmitted in the first 30 days, the authors found.

The researchers also showed that strictly following surgical process measures – such as infection control techniques – was only weakly associated with reduced readmissions.

The results are not terribly surprising, according to the authors, Dr. Thomas C. Tsai and his colleagues from Harvard University, Brigham and Women’s Hospital, and the Veterans Affairs Boston Healthcare System. The researchers could not specifically determine why the higher-volume, lower-mortality hospitals had lower readmission rates, but they speculated that these facilities have systems in place to protect surgical patients from bad outcomes that might bring them back to the hospital. Their study was published Sept. 18 in the New England Journal of Medicine (2013;369:1134-42).

The Medicare program now penalizes hospitals for excess readmissions after discharge for heart failure, heart attack, and pneumonia. For fiscal year 2013, which ends on Oct. 1, hospitals will be penalized 1% of their total Medicare billings if readmissions are too high. In fiscal 2014, chronic obstructive pulmonary disease and coronary artery bypass grafting will be added to the list of monitored conditions. The penalty rises to 2% in fiscal year 2014 and 3% in fiscal 2015. In coming years, the Centers for Medicare and Medicaid Services is expected to add more surgical procedures to the readmission penalty list.

The researchers analyzed national Medicare data, which comprised 479,471 discharges from 3,004 hospitals. These hospitals accounted for 90% of the discharges for the six major procedures studied: coronary artery bypass grafting, pulmonary lobectomy, endovascular repair of abdominal aortic aneurysm, open repair of AAA, colectomy, and hip replacement. The authors also analyzed Hospital Quality Alliance (HQA) surgical care scores. The HQA score is calculated based on how well hospitals perform on process measures established by the Surgical Care Improvement Project.

The three measures of surgical quality included the HQA score, procedure volume, and 30-day mortality. The primary outcome measure was a hospital-level composite of the six procedure-specific, risk-adjusted readmission rates at 30 days. The authors compared the characteristics of patients who were readmitted within 30 days with those who were not, and compared the characteristics of hospitals that had composite readmission rates above the median with those that had rates below the median.

The median composite risk-adjusted 30-day readmission rate was 13%. Patients who were readmitted tended to be older (78 years vs. 77 years) and had more comorbidities. The hospitals with readmission rates below the median were more likely to be nonprofit, nonteaching, and located in the West. They also had a higher number of full-time nurses per 1,000 patient-days and a lower proportion of Medicaid patients.

There was no significant difference between urban and rural hospitals.

The authors used multivariate models to gauge the impact of quality measures on readmission rates. After accounting for hospital characteristics, they found that hospitals with the highest volume of procedures had a readmission rate just under the median, compared with those with the lowest procedure volumes, which had a readmission rate of close to 17%.

Hospitals in the lowest quartile for mortality rates had a 13% readmission rate, compared with 14% for those in the highest mortality quartile.

Overall, there was no significant difference in readmissions between the hospitals that performed the best on the HQA score and those that were the poorest performers. That might be because there was only a very small variation in performance on the HQA score – with a median of 99% for high performers and 92% for low performers, said the authors.

Policymakers should be reassured by their consistent findings that readmissions are linked to certain quality measures – volume and mortality, the investigators said. But a direct link is still not definitive, said Dr. Tsai and his colleagues. Previous studies have indicated that volume did help reduce readmissions, while others have shown no relationship.

But those studies were conducted before the widespread use of minimally invasive procedures and process measures aimed at reducing postsurgical complications, the authors said.

The authors reported no relevant conflicts of interest.

[email protected]

On Twitter @aliciaault

Hospitals that conduct a high volume of surgical procedures and have a low 30-day mortality rate have lower readmission rates, according to a new study. Even so, about one in seven patients discharged after major surgery is readmitted in the first 30 days, the authors found.

The researchers also showed that strictly following surgical process measures – such as infection control techniques – was only weakly associated with reduced readmissions.

The results are not terribly surprising, according to the authors, Dr. Thomas C. Tsai and his colleagues from Harvard University, Brigham and Women’s Hospital, and the Veterans Affairs Boston Healthcare System. The researchers could not specifically determine why the higher-volume, lower-mortality hospitals had lower readmission rates, but they speculated that these facilities have systems in place to protect surgical patients from bad outcomes that might bring them back to the hospital. Their study was published Sept. 18 in the New England Journal of Medicine (2013;369:1134-42).

The Medicare program now penalizes hospitals for excess readmissions after discharge for heart failure, heart attack, and pneumonia. For fiscal year 2013, which ends on Oct. 1, hospitals will be penalized 1% of their total Medicare billings if readmissions are too high. In fiscal 2014, chronic obstructive pulmonary disease and coronary artery bypass grafting will be added to the list of monitored conditions. The penalty rises to 2% in fiscal year 2014 and 3% in fiscal 2015. In coming years, the Centers for Medicare and Medicaid Services is expected to add more surgical procedures to the readmission penalty list.

The researchers analyzed national Medicare data, which comprised 479,471 discharges from 3,004 hospitals. These hospitals accounted for 90% of the discharges for the six major procedures studied: coronary artery bypass grafting, pulmonary lobectomy, endovascular repair of abdominal aortic aneurysm, open repair of AAA, colectomy, and hip replacement. The authors also analyzed Hospital Quality Alliance (HQA) surgical care scores. The HQA score is calculated based on how well hospitals perform on process measures established by the Surgical Care Improvement Project.

The three measures of surgical quality included the HQA score, procedure volume, and 30-day mortality. The primary outcome measure was a hospital-level composite of the six procedure-specific, risk-adjusted readmission rates at 30 days. The authors compared the characteristics of patients who were readmitted within 30 days with those who were not, and compared the characteristics of hospitals that had composite readmission rates above the median with those that had rates below the median.

The median composite risk-adjusted 30-day readmission rate was 13%. Patients who were readmitted tended to be older (78 years vs. 77 years) and had more comorbidities. The hospitals with readmission rates below the median were more likely to be nonprofit, nonteaching, and located in the West. They also had a higher number of full-time nurses per 1,000 patient-days and a lower proportion of Medicaid patients.

There was no significant difference between urban and rural hospitals.

The authors used multivariate models to gauge the impact of quality measures on readmission rates. After accounting for hospital characteristics, they found that hospitals with the highest volume of procedures had a readmission rate just under the median, compared with those with the lowest procedure volumes, which had a readmission rate of close to 17%.

Hospitals in the lowest quartile for mortality rates had a 13% readmission rate, compared with 14% for those in the highest mortality quartile.

Overall, there was no significant difference in readmissions between the hospitals that performed the best on the HQA score and those that were the poorest performers. That might be because there was only a very small variation in performance on the HQA score – with a median of 99% for high performers and 92% for low performers, said the authors.

Policymakers should be reassured by their consistent findings that readmissions are linked to certain quality measures – volume and mortality, the investigators said. But a direct link is still not definitive, said Dr. Tsai and his colleagues. Previous studies have indicated that volume did help reduce readmissions, while others have shown no relationship.

But those studies were conducted before the widespread use of minimally invasive procedures and process measures aimed at reducing postsurgical complications, the authors said.

The authors reported no relevant conflicts of interest.

[email protected]

On Twitter @aliciaault

Washington University School of Medicine in St. Louis has led the charge for pediatric hospitalist sedation, offering a panel of experts who shared their insights on nitrous oxide sedation in a wide-ranging, hands-on session at Pediatric Hospital Medicine 2013. Some highlights of that session were:

Patrice Wendling/IMNG Medical Media

• Administer 50%-70% nitrous oxide (N₂O) based on the need for minimal, moderate, or deep sedation. Consider N₂O alone for procedures such as joint injections or voiding cystourethrograms.

• Augment N₂O with 0.15-0.3 mg/kg of oxycodone (maximum dose of 10 mg) to achieve deeper sedation and greater analgesia for more painful procedures such as abscess incision and drainage, burn debridement, and postoperative dressing change. To maximize the analgesic effect of the opioid, wait for its effect to peak at 60 minutes before administering N₂O.

• The peak effect of N₂O is usually seen within 2-3 minutes, so plan to perform the most painful portion of the procedure at least 2 minutes after the start of 70% N₂O. Titrate to 50% after about 5 minutes of 70% N₂O, with a total duration of N₂O not to exceed 15 minutes.

• Be alert for signs of emesis during sedation such as pallor, sweating, and elevation in heart rate, and position the patients appropriately so they do not aspirate, if there is emesis.

• The hospitalists’ only duty is to perform the sedation, but monitoring should be performed by qualified personnel according to American Academy of Pediatrics, American Society of Anesthesiologists, and local institutional guidelines. At St. Louis Children’s Hospital, a trained sedation nurse is present during and after sedation. Rescue equipment including continuous positive airway pressure (CPAP) bag, and suction and airway supplies should be readily available, if needed.

John Twombly/St. Louis Children's Hospital

• Administer 100% oxygen for 2-3 minutes after turning off the N₂O to prevent diffusion hypoxia and improve scavenging of exhaled N₂O and, thus, reduce the environmental N₂O exposure to sedation providers, nursing staff, and family members.

• Ensure that scavenging systems and proper airflow parameters are in place for rooms that use N₂O to reduce N₂O exposure. Use passive air monitoring badges to measure exposure and avoid exposing pregnant health care workers and family members by using good delivery techniques.

• Contraindications to N₂O sedation include, but are not limited to patients with any trapped air in a body cavity, such as those with bowel obstruction, recent tympanoplasty, or recent intraocular surgery; patients with elevated intracranial pressure; and those with a deficiency in vitamin B₁₂ or the enzyme 5, 10 methylenetetrahydrofolate reductase. Caution should be used in sickle cell patients, although gastroesophageal reflux disease is not a contraindication.

It has been noted that there have been reports of infertility, blood dyscrasias, and neurologic deficits with chronic exposure to nitrous oxide exposure. However, N₂O has been used safely in dental offices and OR suites for several decades.

The Washington University team included Dr. Mythili Srinivasan, Dr. Jon Chiles, Dr. Mike Turmelle, and Dr. Yasmeen Daud.

Washington University School of Medicine in St. Louis has led the charge for pediatric hospitalist sedation, offering a panel of experts who shared their insights on nitrous oxide sedation in a wide-ranging, hands-on session at Pediatric Hospital Medicine 2013. Some highlights of that session were:

Patrice Wendling/IMNG Medical Media

• Administer 50%-70% nitrous oxide (N₂O) based on the need for minimal, moderate, or deep sedation. Consider N₂O alone for procedures such as joint injections or voiding cystourethrograms.

• Augment N₂O with 0.15-0.3 mg/kg of oxycodone (maximum dose of 10 mg) to achieve deeper sedation and greater analgesia for more painful procedures such as abscess incision and drainage, burn debridement, and postoperative dressing change. To maximize the analgesic effect of the opioid, wait for its effect to peak at 60 minutes before administering N₂O.

• The peak effect of N₂O is usually seen within 2-3 minutes, so plan to perform the most painful portion of the procedure at least 2 minutes after the start of 70% N₂O. Titrate to 50% after about 5 minutes of 70% N₂O, with a total duration of N₂O not to exceed 15 minutes.

• Be alert for signs of emesis during sedation such as pallor, sweating, and elevation in heart rate, and position the patients appropriately so they do not aspirate, if there is emesis.

• The hospitalists’ only duty is to perform the sedation, but monitoring should be performed by qualified personnel according to American Academy of Pediatrics, American Society of Anesthesiologists, and local institutional guidelines. At St. Louis Children’s Hospital, a trained sedation nurse is present during and after sedation. Rescue equipment including continuous positive airway pressure (CPAP) bag, and suction and airway supplies should be readily available, if needed.

John Twombly/St. Louis Children's Hospital

• Administer 100% oxygen for 2-3 minutes after turning off the N₂O to prevent diffusion hypoxia and improve scavenging of exhaled N₂O and, thus, reduce the environmental N₂O exposure to sedation providers, nursing staff, and family members.

• Ensure that scavenging systems and proper airflow parameters are in place for rooms that use N₂O to reduce N₂O exposure. Use passive air monitoring badges to measure exposure and avoid exposing pregnant health care workers and family members by using good delivery techniques.

• Contraindications to N₂O sedation include, but are not limited to patients with any trapped air in a body cavity, such as those with bowel obstruction, recent tympanoplasty, or recent intraocular surgery; patients with elevated intracranial pressure; and those with a deficiency in vitamin B₁₂ or the enzyme 5, 10 methylenetetrahydrofolate reductase. Caution should be used in sickle cell patients, although gastroesophageal reflux disease is not a contraindication.

It has been noted that there have been reports of infertility, blood dyscrasias, and neurologic deficits with chronic exposure to nitrous oxide exposure. However, N₂O has been used safely in dental offices and OR suites for several decades.

The Washington University team included Dr. Mythili Srinivasan, Dr. Jon Chiles, Dr. Mike Turmelle, and Dr. Yasmeen Daud.

Washington University School of Medicine in St. Louis has led the charge for pediatric hospitalist sedation, offering a panel of experts who shared their insights on nitrous oxide sedation in a wide-ranging, hands-on session at Pediatric Hospital Medicine 2013. Some highlights of that session were:

Patrice Wendling/IMNG Medical Media

• Administer 50%-70% nitrous oxide (N₂O) based on the need for minimal, moderate, or deep sedation. Consider N₂O alone for procedures such as joint injections or voiding cystourethrograms.

• Augment N₂O with 0.15-0.3 mg/kg of oxycodone (maximum dose of 10 mg) to achieve deeper sedation and greater analgesia for more painful procedures such as abscess incision and drainage, burn debridement, and postoperative dressing change. To maximize the analgesic effect of the opioid, wait for its effect to peak at 60 minutes before administering N₂O.

• The peak effect of N₂O is usually seen within 2-3 minutes, so plan to perform the most painful portion of the procedure at least 2 minutes after the start of 70% N₂O. Titrate to 50% after about 5 minutes of 70% N₂O, with a total duration of N₂O not to exceed 15 minutes.

• Be alert for signs of emesis during sedation such as pallor, sweating, and elevation in heart rate, and position the patients appropriately so they do not aspirate, if there is emesis.

• The hospitalists’ only duty is to perform the sedation, but monitoring should be performed by qualified personnel according to American Academy of Pediatrics, American Society of Anesthesiologists, and local institutional guidelines. At St. Louis Children’s Hospital, a trained sedation nurse is present during and after sedation. Rescue equipment including continuous positive airway pressure (CPAP) bag, and suction and airway supplies should be readily available, if needed.

John Twombly/St. Louis Children's Hospital

• Administer 100% oxygen for 2-3 minutes after turning off the N₂O to prevent diffusion hypoxia and improve scavenging of exhaled N₂O and, thus, reduce the environmental N₂O exposure to sedation providers, nursing staff, and family members.

• Ensure that scavenging systems and proper airflow parameters are in place for rooms that use N₂O to reduce N₂O exposure. Use passive air monitoring badges to measure exposure and avoid exposing pregnant health care workers and family members by using good delivery techniques.

• Contraindications to N₂O sedation include, but are not limited to patients with any trapped air in a body cavity, such as those with bowel obstruction, recent tympanoplasty, or recent intraocular surgery; patients with elevated intracranial pressure; and those with a deficiency in vitamin B₁₂ or the enzyme 5, 10 methylenetetrahydrofolate reductase. Caution should be used in sickle cell patients, although gastroesophageal reflux disease is not a contraindication.

It has been noted that there have been reports of infertility, blood dyscrasias, and neurologic deficits with chronic exposure to nitrous oxide exposure. However, N₂O has been used safely in dental offices and OR suites for several decades.

The Washington University team included Dr. Mythili Srinivasan, Dr. Jon Chiles, Dr. Mike Turmelle, and Dr. Yasmeen Daud.

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

[email protected]

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

[email protected]

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

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