The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.

Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme will market the drug as Zontivity.

It comes in a tablet formulation.

At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.

"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, reported in the FDA statement.

"In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommend approval of the novel antiplatelet drug for reducing atherothrombotic events in patients with a history of MI – the indication proposed by Merck. The recommended dose is one 2.5-mg tablet per day.

Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about how to use the drug. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.

The indication also includes the statement that treatment with vorapaxar has been shown to reduce the rate of the combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.

The company conducted two phase III studies in two different groups of patients. In the TRACER (The Thrombin Receptor Antagonist for Clinical Event Reduction in ACS) study, which compared vorapaxar with placebo, added to standard therapy, as acute therapy (2.5 mg per day after a 40-mg loading dose, or placebo) in almost 13,000 hospitalized patients randomized within 24 hours of presenting with ACS (with non-ST elevation), it reduced the risk of atherothrombotic events (N. Engl. J. Med. 2012;366:20-33).

The study, however, was terminated early after an increased risk of major bleeding, including ICH, was detected and the company stopped the treatment in patients with a history of stroke or new stroke in the other phase III trial, the TRA 2P–TIMI 50 (Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Events) study. The company dropped plans to pursue the acute ACS indication.

The approved indication is based on the results of the TRA 2P–TIMI 50 study, which randomized 26,449 patients to placebo or 2.5 mg of vorapaxar a day, added to standard therapy (including other antiplatelet agents) in 26,449 outpatients with a previous MI, previous ischemic stroke, or peripheral arterial disease (N. Engl. J. Med. 2012;366:1404-13). (Almost 80% of the patients in the study who met the criteria in the proposed indication were on dual antiplatelet therapy with aspirin and a thienopyridine.)

In the overall cohort, including those who had to stop treatment early, compared with placebo, the risk of the primary composite endpoint of cardiovascular death, MI, stroke, or urgent coronary revascularization was reduced by 12%, and the risk of a secondary efficacy endpoint (CV death, MI, stroke) was reduced by 13% over 3 years among those treated with vorapaxar – effects that were statistically significant, Merck said.

The risk of severe or moderate bleeding was increased by 51% among those on vorapaxar over placebo.

The ICH rate over 3 years was 1% among those on vorapaxar, compared with 0.6% among those on placebo, but the absolute risk was higher in those with a history of stroke, according to Merck.

There is "clearly an unmet need" in this group of patients with a history of MI, "and a lack of therapies that have been shown to really be beneficial long term in this population," said the panel chair, Dr. Philip Sager, chair of the scientific programs committee, Cardiac Safety Research Consortium, San Francisco. "While there certainly is some bleeding risk, the benefits on the primary endpoint and secondary endpoint clearly outweigh those risks, and the benefit-risk relationship is positive," he added.

The panelist who voted against approval, Dr. Mori Krantz, director of the Colorado Prevention Center, Denver Health Medical Center, agreed that the primary efficacy endpoint had been met but was concerned about the size of the benefit and the large number of people needed to treat to benefit one patient.

"Although the intracranial hemorrhages and the major bleeds were potentially manageable, I worry about the amplification of that signal," because triple antiplatelet therapy is "unprecedented," he added.

Other safety concerns cited by panelists included a lack of an antidote and the lack of an effect in people weighing less than 60 kg (132 lb), an unresolved issue.

[email protected]

The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.

Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme will market the drug as Zontivity.

It comes in a tablet formulation.

At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.

"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, reported in the FDA statement.

"In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommend approval of the novel antiplatelet drug for reducing atherothrombotic events in patients with a history of MI – the indication proposed by Merck. The recommended dose is one 2.5-mg tablet per day.

Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about how to use the drug. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.

The indication also includes the statement that treatment with vorapaxar has been shown to reduce the rate of the combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.

The company conducted two phase III studies in two different groups of patients. In the TRACER (The Thrombin Receptor Antagonist for Clinical Event Reduction in ACS) study, which compared vorapaxar with placebo, added to standard therapy, as acute therapy (2.5 mg per day after a 40-mg loading dose, or placebo) in almost 13,000 hospitalized patients randomized within 24 hours of presenting with ACS (with non-ST elevation), it reduced the risk of atherothrombotic events (N. Engl. J. Med. 2012;366:20-33).

The study, however, was terminated early after an increased risk of major bleeding, including ICH, was detected and the company stopped the treatment in patients with a history of stroke or new stroke in the other phase III trial, the TRA 2P–TIMI 50 (Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Events) study. The company dropped plans to pursue the acute ACS indication.

The approved indication is based on the results of the TRA 2P–TIMI 50 study, which randomized 26,449 patients to placebo or 2.5 mg of vorapaxar a day, added to standard therapy (including other antiplatelet agents) in 26,449 outpatients with a previous MI, previous ischemic stroke, or peripheral arterial disease (N. Engl. J. Med. 2012;366:1404-13). (Almost 80% of the patients in the study who met the criteria in the proposed indication were on dual antiplatelet therapy with aspirin and a thienopyridine.)

In the overall cohort, including those who had to stop treatment early, compared with placebo, the risk of the primary composite endpoint of cardiovascular death, MI, stroke, or urgent coronary revascularization was reduced by 12%, and the risk of a secondary efficacy endpoint (CV death, MI, stroke) was reduced by 13% over 3 years among those treated with vorapaxar – effects that were statistically significant, Merck said.

The risk of severe or moderate bleeding was increased by 51% among those on vorapaxar over placebo.

The ICH rate over 3 years was 1% among those on vorapaxar, compared with 0.6% among those on placebo, but the absolute risk was higher in those with a history of stroke, according to Merck.

There is "clearly an unmet need" in this group of patients with a history of MI, "and a lack of therapies that have been shown to really be beneficial long term in this population," said the panel chair, Dr. Philip Sager, chair of the scientific programs committee, Cardiac Safety Research Consortium, San Francisco. "While there certainly is some bleeding risk, the benefits on the primary endpoint and secondary endpoint clearly outweigh those risks, and the benefit-risk relationship is positive," he added.

The panelist who voted against approval, Dr. Mori Krantz, director of the Colorado Prevention Center, Denver Health Medical Center, agreed that the primary efficacy endpoint had been met but was concerned about the size of the benefit and the large number of people needed to treat to benefit one patient.

"Although the intracranial hemorrhages and the major bleeds were potentially manageable, I worry about the amplification of that signal," because triple antiplatelet therapy is "unprecedented," he added.

Other safety concerns cited by panelists included a lack of an antidote and the lack of an effect in people weighing less than 60 kg (132 lb), an unresolved issue.

[email protected]

The novel antiplatelet drug vorapaxar has been approved for reducing the risk of myocardial infarction, stroke, cardiovascular death, and need for coronary revascularization procedures in patients with a previous MI or peripheral arterial disease, the Food and Drug Administration announced on May 8.

Vorapaxar is an antagonist of protease-activated receptor-1 (PAR-1), which inhibits the action of thrombin on the platelet, and is the first drug in this class to be approved. Merck Sharp & Dohme will market the drug as Zontivity.

It comes in a tablet formulation.

At a meeting in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 to recommend approval of vorapaxar.

"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death," Dr. Ellis F. Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, reported in the FDA statement.

"In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year," he noted.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommend approval of the novel antiplatelet drug for reducing atherothrombotic events in patients with a history of MI – the indication proposed by Merck. The recommended dose is one 2.5-mg tablet per day.

Because of the increased risk of bleeding, including life-threatening and fatal bleeding, the drug’s prescribing information includes a boxed warning about this risk and a medication guide informing patients about how to use the drug. A history of stroke, or transient ischemic attack, and a history of intracranial bleeding are contraindications.

The indication also includes the statement that treatment with vorapaxar has been shown to reduce the rate of the combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.

The company conducted two phase III studies in two different groups of patients. In the TRACER (The Thrombin Receptor Antagonist for Clinical Event Reduction in ACS) study, which compared vorapaxar with placebo, added to standard therapy, as acute therapy (2.5 mg per day after a 40-mg loading dose, or placebo) in almost 13,000 hospitalized patients randomized within 24 hours of presenting with ACS (with non-ST elevation), it reduced the risk of atherothrombotic events (N. Engl. J. Med. 2012;366:20-33).

The study, however, was terminated early after an increased risk of major bleeding, including ICH, was detected and the company stopped the treatment in patients with a history of stroke or new stroke in the other phase III trial, the TRA 2P–TIMI 50 (Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Events) study. The company dropped plans to pursue the acute ACS indication.

The approved indication is based on the results of the TRA 2P–TIMI 50 study, which randomized 26,449 patients to placebo or 2.5 mg of vorapaxar a day, added to standard therapy (including other antiplatelet agents) in 26,449 outpatients with a previous MI, previous ischemic stroke, or peripheral arterial disease (N. Engl. J. Med. 2012;366:1404-13). (Almost 80% of the patients in the study who met the criteria in the proposed indication were on dual antiplatelet therapy with aspirin and a thienopyridine.)

In the overall cohort, including those who had to stop treatment early, compared with placebo, the risk of the primary composite endpoint of cardiovascular death, MI, stroke, or urgent coronary revascularization was reduced by 12%, and the risk of a secondary efficacy endpoint (CV death, MI, stroke) was reduced by 13% over 3 years among those treated with vorapaxar – effects that were statistically significant, Merck said.

The risk of severe or moderate bleeding was increased by 51% among those on vorapaxar over placebo.

The ICH rate over 3 years was 1% among those on vorapaxar, compared with 0.6% among those on placebo, but the absolute risk was higher in those with a history of stroke, according to Merck.

There is "clearly an unmet need" in this group of patients with a history of MI, "and a lack of therapies that have been shown to really be beneficial long term in this population," said the panel chair, Dr. Philip Sager, chair of the scientific programs committee, Cardiac Safety Research Consortium, San Francisco. "While there certainly is some bleeding risk, the benefits on the primary endpoint and secondary endpoint clearly outweigh those risks, and the benefit-risk relationship is positive," he added.

The panelist who voted against approval, Dr. Mori Krantz, director of the Colorado Prevention Center, Denver Health Medical Center, agreed that the primary efficacy endpoint had been met but was concerned about the size of the benefit and the large number of people needed to treat to benefit one patient.

"Although the intracranial hemorrhages and the major bleeds were potentially manageable, I worry about the amplification of that signal," because triple antiplatelet therapy is "unprecedented," he added.

Other safety concerns cited by panelists included a lack of an antidote and the lack of an effect in people weighing less than 60 kg (132 lb), an unresolved issue.

[email protected]

Thrombolytic therapy decreased all-cause mortality in patients with hemodynamically stable pulmonary embolism associated with right ventricular dysfunction – those at "intermediate risk," according to a meta-analysis published online June 17 in JAMA.

The investigators described their study of 16 randomized, controlled clinical trials involving 2,115 patients as "the first analysis of thrombolysis in PE that has sufficient statistical power to detect associations with a meaningful mortality reduction." If their findings are confirmed in future randomized clinical trials, "there may be a shift in the treatment of selected patients with intermediate-risk PE using thrombolytics."

However, "the optimism regarding this clinical advantage must be tempered by [our] finding of significantly increased risk of major bleeding and intracranial hemorrhage associated with thrombolytic therapy, particularly for patients older than 65 years," said Dr. Saurav Chatterjee of the division of cardiology, St. Luke’s-Roosevelt Hospital Center of the Mount Sinai Health System, New York, and his associates (JAMA 2014;311:2414-21).

The study population included 1,499 patients who had hemodynamically stable PE associated with right ventricular dysfunction, the largest subset of patients seen in clinical practice and the group for whom the risks and benefits of thrombolysis are the most unclear.

After a mean follow-up of 82 days, overall mortality was 2.17% in patients who received thrombolysis, compared with 3.89% in those who received anticoagulation. In addition, the risk of recurrent PE was significantly lower with thrombolytic therapy (1.17%) than with anticoagulation (3.04%).

However, the rate of major bleeding was 9.24% for thrombolytic therapy, compared with 3.42% for anticoagulation. And the rate of intracranial hemorrhage was 1.46% for thrombolysis, compared with 0.19% for anticoagulation, the investigators said.

The bleeding risk was especially high in patients aged 65 years and older. Attenuation of this risk in younger patients suggests that they may be considered stronger candidates for thrombolytic therapy, Dr. Chatterjee and his associates said.

Dr. Chatterjee reported no financial conflicts; his associates reported ties to AstraZeneca, Boston Scientific, Cardiostem, Cordis, EKOS Corporation, Embolitech, GenWay, Johnson & Johnson, Soteria, and Vascular Magnetics.

Thrombolytic therapy decreased all-cause mortality in patients with hemodynamically stable pulmonary embolism associated with right ventricular dysfunction – those at "intermediate risk," according to a meta-analysis published online June 17 in JAMA.

The investigators described their study of 16 randomized, controlled clinical trials involving 2,115 patients as "the first analysis of thrombolysis in PE that has sufficient statistical power to detect associations with a meaningful mortality reduction." If their findings are confirmed in future randomized clinical trials, "there may be a shift in the treatment of selected patients with intermediate-risk PE using thrombolytics."

However, "the optimism regarding this clinical advantage must be tempered by [our] finding of significantly increased risk of major bleeding and intracranial hemorrhage associated with thrombolytic therapy, particularly for patients older than 65 years," said Dr. Saurav Chatterjee of the division of cardiology, St. Luke’s-Roosevelt Hospital Center of the Mount Sinai Health System, New York, and his associates (JAMA 2014;311:2414-21).

The study population included 1,499 patients who had hemodynamically stable PE associated with right ventricular dysfunction, the largest subset of patients seen in clinical practice and the group for whom the risks and benefits of thrombolysis are the most unclear.

After a mean follow-up of 82 days, overall mortality was 2.17% in patients who received thrombolysis, compared with 3.89% in those who received anticoagulation. In addition, the risk of recurrent PE was significantly lower with thrombolytic therapy (1.17%) than with anticoagulation (3.04%).

However, the rate of major bleeding was 9.24% for thrombolytic therapy, compared with 3.42% for anticoagulation. And the rate of intracranial hemorrhage was 1.46% for thrombolysis, compared with 0.19% for anticoagulation, the investigators said.

The bleeding risk was especially high in patients aged 65 years and older. Attenuation of this risk in younger patients suggests that they may be considered stronger candidates for thrombolytic therapy, Dr. Chatterjee and his associates said.

Dr. Chatterjee reported no financial conflicts; his associates reported ties to AstraZeneca, Boston Scientific, Cardiostem, Cordis, EKOS Corporation, Embolitech, GenWay, Johnson & Johnson, Soteria, and Vascular Magnetics.

Thrombolytic therapy decreased all-cause mortality in patients with hemodynamically stable pulmonary embolism associated with right ventricular dysfunction – those at "intermediate risk," according to a meta-analysis published online June 17 in JAMA.

The investigators described their study of 16 randomized, controlled clinical trials involving 2,115 patients as "the first analysis of thrombolysis in PE that has sufficient statistical power to detect associations with a meaningful mortality reduction." If their findings are confirmed in future randomized clinical trials, "there may be a shift in the treatment of selected patients with intermediate-risk PE using thrombolytics."

However, "the optimism regarding this clinical advantage must be tempered by [our] finding of significantly increased risk of major bleeding and intracranial hemorrhage associated with thrombolytic therapy, particularly for patients older than 65 years," said Dr. Saurav Chatterjee of the division of cardiology, St. Luke’s-Roosevelt Hospital Center of the Mount Sinai Health System, New York, and his associates (JAMA 2014;311:2414-21).

The study population included 1,499 patients who had hemodynamically stable PE associated with right ventricular dysfunction, the largest subset of patients seen in clinical practice and the group for whom the risks and benefits of thrombolysis are the most unclear.

After a mean follow-up of 82 days, overall mortality was 2.17% in patients who received thrombolysis, compared with 3.89% in those who received anticoagulation. In addition, the risk of recurrent PE was significantly lower with thrombolytic therapy (1.17%) than with anticoagulation (3.04%).

However, the rate of major bleeding was 9.24% for thrombolytic therapy, compared with 3.42% for anticoagulation. And the rate of intracranial hemorrhage was 1.46% for thrombolysis, compared with 0.19% for anticoagulation, the investigators said.

The bleeding risk was especially high in patients aged 65 years and older. Attenuation of this risk in younger patients suggests that they may be considered stronger candidates for thrombolytic therapy, Dr. Chatterjee and his associates said.

Dr. Chatterjee reported no financial conflicts; his associates reported ties to AstraZeneca, Boston Scientific, Cardiostem, Cordis, EKOS Corporation, Embolitech, GenWay, Johnson & Johnson, Soteria, and Vascular Magnetics.

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Because of the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

Resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia (122 minutes vs. 100 minutes; P less than .001) times.

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjustment for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps because of prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, Duke University, Durham, N.C.,who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15-30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be titled "Academic centers increase emergency surgery complications." Other attendees questioned whether the poor outcomes reflect resident training and supervision.

Dr. George Velmahos, Massachusetts General Hospital, Boston, questioned whether hospitals have a medical/legal responsibility to inform patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis said that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis reported no conflicts.

[email protected]

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Because of the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

Resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia (122 minutes vs. 100 minutes; P less than .001) times.

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjustment for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps because of prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, Duke University, Durham, N.C.,who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15-30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be titled "Academic centers increase emergency surgery complications." Other attendees questioned whether the poor outcomes reflect resident training and supervision.

Dr. George Velmahos, Massachusetts General Hospital, Boston, questioned whether hospitals have a medical/legal responsibility to inform patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis said that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis reported no conflicts.

[email protected]

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Because of the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

Resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia (122 minutes vs. 100 minutes; P less than .001) times.

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjustment for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps because of prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, Duke University, Durham, N.C.,who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15-30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be titled "Academic centers increase emergency surgery complications." Other attendees questioned whether the poor outcomes reflect resident training and supervision.

Dr. George Velmahos, Massachusetts General Hospital, Boston, questioned whether hospitals have a medical/legal responsibility to inform patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis said that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis reported no conflicts.

[email protected]

America! America! God shed His grace on thee

And crown Thy good with brotherhood

From sea to shining sea!

I fondly remember singing "America the Beautiful" with my classmates when I was a little girl. America has grown by leaps and bounds since my childhood – the pulse of the nation as well as its makeup. One of my fondest memories as a child was traveling to New York. We had a layover in Washington and the airport was filled with people of various skin tones speaking all sorts of languages I had never been exposed to before. It was very exciting! It was my first truly multicultural experience.

Funny, I ultimately relocated to the D.C. area, and my neighbors are literally from all over the world: India, Thailand, Jamaica, Africa, China – and it doesn’t stop there. Naturally, the patient population I serve also reflects this great diversity. As the country becomes more diverse each and every day, we, as practitioners, must be able to communicate effectively with our entire patient base, not just the ones who speak English fluently.

This is quite a challenge. Yes, most hospitals have a language line or an on-call interpreter to help out, but I believe we also need to take some responsibility for improving our ability to communicate as well. While I am not advocating trying to master a new language, or two or three, we can all learn a few basic terms of the foreign languages we encounter most.

Consider that language lines do malfunction. Family members are sometimes not present. And interpreters may not always be available at the drop of a hat. Technology, though, is ever burgeoning. It’s easy to download a smartphone app, such as Medical Spanish: Healthcare Phrasebook with Audio. Google Translate can be helpful for scores of languages, though I would use this site with caution when it comes to patient care.

There is a slew of reputable patient information written in different languages available on the Internet as well.

The Agency for Healthcare Research and Quality offers a guide tool: Improving Patient Safety Systems for Patients with Limited English Proficiency: A Guide for Hospitals. The guide notes that approximately 57 million people speak a language other than English at home and 25 million are defined as limited-English-proficient (LEP). LEP patients were noted to have longer lengths of stay in the hospital and were at greater risk for line infections, surgical infections, falls, and pressure ulcers. They are more likely to be readmitted, as well.

Although it is always best to have a qualified interpreter to help us care for LEP patients, there may be times when one is simply unavailable in an acceptable period of time. Friends and family members can help fill some of the gaps in those instances, but it never hurts for the clinician to know a few vital words as well, such as pain or shortness of breath.

America’s culture is ever evolving, and we must evolve with it. Being able to provide high-quality care to all of our patients is our goal. Standards are important, but sometimes thinking out of the box can be effective as well.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

America! America! God shed His grace on thee

And crown Thy good with brotherhood

From sea to shining sea!

I fondly remember singing "America the Beautiful" with my classmates when I was a little girl. America has grown by leaps and bounds since my childhood – the pulse of the nation as well as its makeup. One of my fondest memories as a child was traveling to New York. We had a layover in Washington and the airport was filled with people of various skin tones speaking all sorts of languages I had never been exposed to before. It was very exciting! It was my first truly multicultural experience.

Funny, I ultimately relocated to the D.C. area, and my neighbors are literally from all over the world: India, Thailand, Jamaica, Africa, China – and it doesn’t stop there. Naturally, the patient population I serve also reflects this great diversity. As the country becomes more diverse each and every day, we, as practitioners, must be able to communicate effectively with our entire patient base, not just the ones who speak English fluently.

This is quite a challenge. Yes, most hospitals have a language line or an on-call interpreter to help out, but I believe we also need to take some responsibility for improving our ability to communicate as well. While I am not advocating trying to master a new language, or two or three, we can all learn a few basic terms of the foreign languages we encounter most.

Consider that language lines do malfunction. Family members are sometimes not present. And interpreters may not always be available at the drop of a hat. Technology, though, is ever burgeoning. It’s easy to download a smartphone app, such as Medical Spanish: Healthcare Phrasebook with Audio. Google Translate can be helpful for scores of languages, though I would use this site with caution when it comes to patient care.

There is a slew of reputable patient information written in different languages available on the Internet as well.

The Agency for Healthcare Research and Quality offers a guide tool: Improving Patient Safety Systems for Patients with Limited English Proficiency: A Guide for Hospitals. The guide notes that approximately 57 million people speak a language other than English at home and 25 million are defined as limited-English-proficient (LEP). LEP patients were noted to have longer lengths of stay in the hospital and were at greater risk for line infections, surgical infections, falls, and pressure ulcers. They are more likely to be readmitted, as well.

Although it is always best to have a qualified interpreter to help us care for LEP patients, there may be times when one is simply unavailable in an acceptable period of time. Friends and family members can help fill some of the gaps in those instances, but it never hurts for the clinician to know a few vital words as well, such as pain or shortness of breath.

America’s culture is ever evolving, and we must evolve with it. Being able to provide high-quality care to all of our patients is our goal. Standards are important, but sometimes thinking out of the box can be effective as well.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

America! America! God shed His grace on thee

And crown Thy good with brotherhood

From sea to shining sea!

I fondly remember singing "America the Beautiful" with my classmates when I was a little girl. America has grown by leaps and bounds since my childhood – the pulse of the nation as well as its makeup. One of my fondest memories as a child was traveling to New York. We had a layover in Washington and the airport was filled with people of various skin tones speaking all sorts of languages I had never been exposed to before. It was very exciting! It was my first truly multicultural experience.

Funny, I ultimately relocated to the D.C. area, and my neighbors are literally from all over the world: India, Thailand, Jamaica, Africa, China – and it doesn’t stop there. Naturally, the patient population I serve also reflects this great diversity. As the country becomes more diverse each and every day, we, as practitioners, must be able to communicate effectively with our entire patient base, not just the ones who speak English fluently.

This is quite a challenge. Yes, most hospitals have a language line or an on-call interpreter to help out, but I believe we also need to take some responsibility for improving our ability to communicate as well. While I am not advocating trying to master a new language, or two or three, we can all learn a few basic terms of the foreign languages we encounter most.

Consider that language lines do malfunction. Family members are sometimes not present. And interpreters may not always be available at the drop of a hat. Technology, though, is ever burgeoning. It’s easy to download a smartphone app, such as Medical Spanish: Healthcare Phrasebook with Audio. Google Translate can be helpful for scores of languages, though I would use this site with caution when it comes to patient care.

There is a slew of reputable patient information written in different languages available on the Internet as well.

The Agency for Healthcare Research and Quality offers a guide tool: Improving Patient Safety Systems for Patients with Limited English Proficiency: A Guide for Hospitals. The guide notes that approximately 57 million people speak a language other than English at home and 25 million are defined as limited-English-proficient (LEP). LEP patients were noted to have longer lengths of stay in the hospital and were at greater risk for line infections, surgical infections, falls, and pressure ulcers. They are more likely to be readmitted, as well.

Although it is always best to have a qualified interpreter to help us care for LEP patients, there may be times when one is simply unavailable in an acceptable period of time. Friends and family members can help fill some of the gaps in those instances, but it never hurts for the clinician to know a few vital words as well, such as pain or shortness of breath.

America’s culture is ever evolving, and we must evolve with it. Being able to provide high-quality care to all of our patients is our goal. Standards are important, but sometimes thinking out of the box can be effective as well.

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Cryolipolysis has emerged as a popular noninvasive treatment option for reducing localized areas of fat. The technology was developed on the premise that cold temperatures can selectively damage subcutaneous fat while leaving the overlying skin unharmed, as demonstrated by popsicle panniculitis. In this process, when subcutaneous fat is cooled below body temperature but above freezing, the fat undergoes cell death followed by a local inflammatory response, a localized panniculitis, that gradually results in a reduction of fat in that area.

Dr. Dieter Manstein and Dr. R. Rox Anderson pioneered the concept of cryolipolysis in 2008. The technology was approved by the Food and Drug Administration in 2010 in the form of the Zeltiq device. The device has different-sized hand pieces with a vacuum connection that, after it is applied to the skin, cools the subcutaneous fat without damaging the top layers of skin. Each area is treated for 1 hour, and 20%-30% of the fat cells are expected to be reduced with a single treatment. Typical responses after treatment include numbness, but some patients may also experience bruising and discomfort, all of which typically last no longer than 2-3 weeks.

If discomfort occurs in my patients, I find they report it more often in the lower abdomen than the love handles. Paradoxical adipose hyperplasia was recently reported for the first time in a male patient in his 40s (in the lower abdomen) (JAMA Dermatol. 2014;150:317-9).

In my experience, there is no difference in efficacy or adverse events seen in patients of different ethnicities. One study found no difference in efficacy or adverse events of cryolipolysis in Chinese patients (Lasers Surg. Med. 2012;44:125-30), but no other study of cryolipolysis in ethnic patients has been published.

I was involved in the clinical trials for this device prior to FDA approval where one love handle was treated on a patient and the other side was used as a control. Based on this experience and my experience using the device in practice, it is not a replacement for abdominoplasty or liposuction, but it is a useful technology in the right candidate. The patients who seem to do the best are those who are 10-15 pounds from their goal weight, are not obese (body mass index less than 30 kg/m²), and have a discrete bulge (typically love handles or abdomen) that they can’t get rid of with good diet and exercise alone. Massage for a few minutes after treatment seems to increase efficacy (Lasers Surg. Med. 2014;46:20-6).

Some patients may require more than one treatment to achieve their desired results, but I recommend waiting at least 2-3 months before opting for additional treatment. Choosing the right candidates and providing patients with realistic expectations seem to be the most helpful in this process.

Dr. Wesley practices dermatology in Beverly Hills, Calif.

Cryolipolysis has emerged as a popular noninvasive treatment option for reducing localized areas of fat. The technology was developed on the premise that cold temperatures can selectively damage subcutaneous fat while leaving the overlying skin unharmed, as demonstrated by popsicle panniculitis. In this process, when subcutaneous fat is cooled below body temperature but above freezing, the fat undergoes cell death followed by a local inflammatory response, a localized panniculitis, that gradually results in a reduction of fat in that area.

Dr. Dieter Manstein and Dr. R. Rox Anderson pioneered the concept of cryolipolysis in 2008. The technology was approved by the Food and Drug Administration in 2010 in the form of the Zeltiq device. The device has different-sized hand pieces with a vacuum connection that, after it is applied to the skin, cools the subcutaneous fat without damaging the top layers of skin. Each area is treated for 1 hour, and 20%-30% of the fat cells are expected to be reduced with a single treatment. Typical responses after treatment include numbness, but some patients may also experience bruising and discomfort, all of which typically last no longer than 2-3 weeks.

If discomfort occurs in my patients, I find they report it more often in the lower abdomen than the love handles. Paradoxical adipose hyperplasia was recently reported for the first time in a male patient in his 40s (in the lower abdomen) (JAMA Dermatol. 2014;150:317-9).

In my experience, there is no difference in efficacy or adverse events seen in patients of different ethnicities. One study found no difference in efficacy or adverse events of cryolipolysis in Chinese patients (Lasers Surg. Med. 2012;44:125-30), but no other study of cryolipolysis in ethnic patients has been published.

I was involved in the clinical trials for this device prior to FDA approval where one love handle was treated on a patient and the other side was used as a control. Based on this experience and my experience using the device in practice, it is not a replacement for abdominoplasty or liposuction, but it is a useful technology in the right candidate. The patients who seem to do the best are those who are 10-15 pounds from their goal weight, are not obese (body mass index less than 30 kg/m²), and have a discrete bulge (typically love handles or abdomen) that they can’t get rid of with good diet and exercise alone. Massage for a few minutes after treatment seems to increase efficacy (Lasers Surg. Med. 2014;46:20-6).

Some patients may require more than one treatment to achieve their desired results, but I recommend waiting at least 2-3 months before opting for additional treatment. Choosing the right candidates and providing patients with realistic expectations seem to be the most helpful in this process.

Dr. Wesley practices dermatology in Beverly Hills, Calif.

Cryolipolysis has emerged as a popular noninvasive treatment option for reducing localized areas of fat. The technology was developed on the premise that cold temperatures can selectively damage subcutaneous fat while leaving the overlying skin unharmed, as demonstrated by popsicle panniculitis. In this process, when subcutaneous fat is cooled below body temperature but above freezing, the fat undergoes cell death followed by a local inflammatory response, a localized panniculitis, that gradually results in a reduction of fat in that area.

Dr. Dieter Manstein and Dr. R. Rox Anderson pioneered the concept of cryolipolysis in 2008. The technology was approved by the Food and Drug Administration in 2010 in the form of the Zeltiq device. The device has different-sized hand pieces with a vacuum connection that, after it is applied to the skin, cools the subcutaneous fat without damaging the top layers of skin. Each area is treated for 1 hour, and 20%-30% of the fat cells are expected to be reduced with a single treatment. Typical responses after treatment include numbness, but some patients may also experience bruising and discomfort, all of which typically last no longer than 2-3 weeks.

If discomfort occurs in my patients, I find they report it more often in the lower abdomen than the love handles. Paradoxical adipose hyperplasia was recently reported for the first time in a male patient in his 40s (in the lower abdomen) (JAMA Dermatol. 2014;150:317-9).

In my experience, there is no difference in efficacy or adverse events seen in patients of different ethnicities. One study found no difference in efficacy or adverse events of cryolipolysis in Chinese patients (Lasers Surg. Med. 2012;44:125-30), but no other study of cryolipolysis in ethnic patients has been published.

I was involved in the clinical trials for this device prior to FDA approval where one love handle was treated on a patient and the other side was used as a control. Based on this experience and my experience using the device in practice, it is not a replacement for abdominoplasty or liposuction, but it is a useful technology in the right candidate. The patients who seem to do the best are those who are 10-15 pounds from their goal weight, are not obese (body mass index less than 30 kg/m²), and have a discrete bulge (typically love handles or abdomen) that they can’t get rid of with good diet and exercise alone. Massage for a few minutes after treatment seems to increase efficacy (Lasers Surg. Med. 2014;46:20-6).

Some patients may require more than one treatment to achieve their desired results, but I recommend waiting at least 2-3 months before opting for additional treatment. Choosing the right candidates and providing patients with realistic expectations seem to be the most helpful in this process.

Dr. Wesley practices dermatology in Beverly Hills, Calif.

The US Food and Drug Administration (FDA) recently approved paroxetine mesylate 7.5 mg (Brisdelle) for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). Paroxetine, formerly known as low-dose mesylate salt of paroxetine (LDMP), is a nonhormonal agent, which makes it an alternative hot flash therapy for menopausal women who cannot or do not want to use hormones. Paroxetine mesylate (Pexeva, Brisdelle) and paroxetine hydrochloride (Paxil, and generics) are two salts of the same active compound (paroxetine). They may have somewhat different metabolism.

The efficacy and safety of paroxetine mesylate, a selective serotonin-reuptake inhibitor (SSRI), were evaluated individually in three Phase 2 or 3 multicenter, double-blind, randomized, placebo-controlled trials, published by James Simon, MD, from George Washington University School of Medicine, and colleagues,¹ and Joffe and colleagues.² Most treatment-emergent adverse events (TEAEs) in the individual studies were mild or moderate in severity, with minimal acute discontinuation symptoms reported on treatment cessation.

In a study³ presented April 29, at the 2014 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG) in Chicago, Illinois, Simon and colleagues further reported on the overall tolerability and safety profile of paroxetine mesylate 7.5 mg using pooled data from the three randomized trials. In their post-hoc analyses, they specifically examined the emergence of adverse events linked to the use of SSRIs when prescribed for psychiatric disorders at therapeutically higher doses than 7.5 mg. The adverse events focused on included weight gain, decreased libido, and sleep disturbance, as well as suicidality, abnormal bleeding, and bone fracture.

Study details. A total of 1,276 postmenopausal women (approximately 70% white) aged 40 years or older (median age, 54 years) with moderate to severe VMS (7−8 hot flashes/day; 50−60 hot flashes/wk) received either paroxetine mesylate or placebo at bedtime for 8 (Phase 2), 12 (Phase 3), or 24 (Phase 3) weeks. The study was sponsored by Noven Therapeutics, LLC.

Treatment-emergent adverse events and discontinuation
About half (50.4%) of the 635 women in the paroxetine group and 47.0% of the 641 women in the placebo group reported at least one TEAE. Most commonly reported TEAEs in the paroxetine group (reported in ≥2% of patients and with a twofold or higher frequency than in the placebo group) were nausea, fatigue, and dizziness.

TEAEs that were determined to be related to the study drug were reported in 19.5% in the paroxetine group and in 17.6% in the placebo group. These most frequent TEAEs were fatigue, nausea, dizziness, and diarrhea.

Severe AEs were reported in 3.9% and 3.6% of women in the paroxetine and placebo groups, respectively, although the investigator determined that less than 1% were related to paroxetine treatment.

TEAEs that led to discontinuation occurred in 4.7% of paroxetine-treated women and in 3.7% of placebo-treated women, although the incidence of study drug interruptions from TEAEs was similar (0.9%) between treatments. The most frequent adverse reactions leading to discontinuation in the paroxetine arm were abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).

Of the most common AEs, nausea occurred mainly within the first 4 weeks of treatment; fatigue occurred primarily within the first week of treatment and decreased in frequency with continued therapy. Incidences and types of AEs that began after 12 weeks were similar to those that began during the first 12 weeks of treatment.

AEs related to SSRIs not found to be problematic
No differences were found between groups with regard to TEAEs related to weight, libido, or sleep. No clinically meaningful changes in laboratory values, vital signs, or ECGs were observed with either group. No clinically important findings on abnormal bleeding, bone fracture, or suicidality were evident in the paroxetine arm.

In the Phase 3 studies:

• One suicide attempt was reported in the paroxetine group in the 24-week study, but was determined by investigators to be unrelated to treatment

• Incidence rates of gastrointestinal and other bleeding events were similar between groups

• Five bone fractures were reported: One in the paroxetine group and four among three participants in the placebo group.

One death occurred in the 12-week Phase 3 study due to acute respiratory failure with evidence of hypertension-mediated pulmonary edema and hypertensive cardiovascular disease. The investigator did not consider the death to be related to the study drug.

Study conclusion
The authors concluded that paroxetine 7.5 mg had favorable tolerability in menopausal women with moderate to severe VMS.

“Paroxetine 7.5 mg offers a nonhormonal treatment option for women who seek treatment for moderate to severe hot flashes associated with menopause,” said Dr. Simon.³ 

Tell us what you think! Send your Letter to the Editor: [email protected]

The US Food and Drug Administration (FDA) recently approved paroxetine mesylate 7.5 mg (Brisdelle) for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). Paroxetine, formerly known as low-dose mesylate salt of paroxetine (LDMP), is a nonhormonal agent, which makes it an alternative hot flash therapy for menopausal women who cannot or do not want to use hormones. Paroxetine mesylate (Pexeva, Brisdelle) and paroxetine hydrochloride (Paxil, and generics) are two salts of the same active compound (paroxetine). They may have somewhat different metabolism.

The efficacy and safety of paroxetine mesylate, a selective serotonin-reuptake inhibitor (SSRI), were evaluated individually in three Phase 2 or 3 multicenter, double-blind, randomized, placebo-controlled trials, published by James Simon, MD, from George Washington University School of Medicine, and colleagues,¹ and Joffe and colleagues.² Most treatment-emergent adverse events (TEAEs) in the individual studies were mild or moderate in severity, with minimal acute discontinuation symptoms reported on treatment cessation.

In a study³ presented April 29, at the 2014 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG) in Chicago, Illinois, Simon and colleagues further reported on the overall tolerability and safety profile of paroxetine mesylate 7.5 mg using pooled data from the three randomized trials. In their post-hoc analyses, they specifically examined the emergence of adverse events linked to the use of SSRIs when prescribed for psychiatric disorders at therapeutically higher doses than 7.5 mg. The adverse events focused on included weight gain, decreased libido, and sleep disturbance, as well as suicidality, abnormal bleeding, and bone fracture.

Study details. A total of 1,276 postmenopausal women (approximately 70% white) aged 40 years or older (median age, 54 years) with moderate to severe VMS (7−8 hot flashes/day; 50−60 hot flashes/wk) received either paroxetine mesylate or placebo at bedtime for 8 (Phase 2), 12 (Phase 3), or 24 (Phase 3) weeks. The study was sponsored by Noven Therapeutics, LLC.

Treatment-emergent adverse events and discontinuation
About half (50.4%) of the 635 women in the paroxetine group and 47.0% of the 641 women in the placebo group reported at least one TEAE. Most commonly reported TEAEs in the paroxetine group (reported in ≥2% of patients and with a twofold or higher frequency than in the placebo group) were nausea, fatigue, and dizziness.

TEAEs that were determined to be related to the study drug were reported in 19.5% in the paroxetine group and in 17.6% in the placebo group. These most frequent TEAEs were fatigue, nausea, dizziness, and diarrhea.

Severe AEs were reported in 3.9% and 3.6% of women in the paroxetine and placebo groups, respectively, although the investigator determined that less than 1% were related to paroxetine treatment.

TEAEs that led to discontinuation occurred in 4.7% of paroxetine-treated women and in 3.7% of placebo-treated women, although the incidence of study drug interruptions from TEAEs was similar (0.9%) between treatments. The most frequent adverse reactions leading to discontinuation in the paroxetine arm were abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).

Of the most common AEs, nausea occurred mainly within the first 4 weeks of treatment; fatigue occurred primarily within the first week of treatment and decreased in frequency with continued therapy. Incidences and types of AEs that began after 12 weeks were similar to those that began during the first 12 weeks of treatment.

AEs related to SSRIs not found to be problematic
No differences were found between groups with regard to TEAEs related to weight, libido, or sleep. No clinically meaningful changes in laboratory values, vital signs, or ECGs were observed with either group. No clinically important findings on abnormal bleeding, bone fracture, or suicidality were evident in the paroxetine arm.

In the Phase 3 studies:

• One suicide attempt was reported in the paroxetine group in the 24-week study, but was determined by investigators to be unrelated to treatment

• Incidence rates of gastrointestinal and other bleeding events were similar between groups

• Five bone fractures were reported: One in the paroxetine group and four among three participants in the placebo group.

One death occurred in the 12-week Phase 3 study due to acute respiratory failure with evidence of hypertension-mediated pulmonary edema and hypertensive cardiovascular disease. The investigator did not consider the death to be related to the study drug.

Study conclusion
The authors concluded that paroxetine 7.5 mg had favorable tolerability in menopausal women with moderate to severe VMS.

“Paroxetine 7.5 mg offers a nonhormonal treatment option for women who seek treatment for moderate to severe hot flashes associated with menopause,” said Dr. Simon.³ 

Tell us what you think! Send your Letter to the Editor: [email protected]

The US Food and Drug Administration (FDA) recently approved paroxetine mesylate 7.5 mg (Brisdelle) for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). Paroxetine, formerly known as low-dose mesylate salt of paroxetine (LDMP), is a nonhormonal agent, which makes it an alternative hot flash therapy for menopausal women who cannot or do not want to use hormones. Paroxetine mesylate (Pexeva, Brisdelle) and paroxetine hydrochloride (Paxil, and generics) are two salts of the same active compound (paroxetine). They may have somewhat different metabolism.

The efficacy and safety of paroxetine mesylate, a selective serotonin-reuptake inhibitor (SSRI), were evaluated individually in three Phase 2 or 3 multicenter, double-blind, randomized, placebo-controlled trials, published by James Simon, MD, from George Washington University School of Medicine, and colleagues,¹ and Joffe and colleagues.² Most treatment-emergent adverse events (TEAEs) in the individual studies were mild or moderate in severity, with minimal acute discontinuation symptoms reported on treatment cessation.

In a study³ presented April 29, at the 2014 Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG) in Chicago, Illinois, Simon and colleagues further reported on the overall tolerability and safety profile of paroxetine mesylate 7.5 mg using pooled data from the three randomized trials. In their post-hoc analyses, they specifically examined the emergence of adverse events linked to the use of SSRIs when prescribed for psychiatric disorders at therapeutically higher doses than 7.5 mg. The adverse events focused on included weight gain, decreased libido, and sleep disturbance, as well as suicidality, abnormal bleeding, and bone fracture.

Study details. A total of 1,276 postmenopausal women (approximately 70% white) aged 40 years or older (median age, 54 years) with moderate to severe VMS (7−8 hot flashes/day; 50−60 hot flashes/wk) received either paroxetine mesylate or placebo at bedtime for 8 (Phase 2), 12 (Phase 3), or 24 (Phase 3) weeks. The study was sponsored by Noven Therapeutics, LLC.

Treatment-emergent adverse events and discontinuation
About half (50.4%) of the 635 women in the paroxetine group and 47.0% of the 641 women in the placebo group reported at least one TEAE. Most commonly reported TEAEs in the paroxetine group (reported in ≥2% of patients and with a twofold or higher frequency than in the placebo group) were nausea, fatigue, and dizziness.

TEAEs that were determined to be related to the study drug were reported in 19.5% in the paroxetine group and in 17.6% in the placebo group. These most frequent TEAEs were fatigue, nausea, dizziness, and diarrhea.

Severe AEs were reported in 3.9% and 3.6% of women in the paroxetine and placebo groups, respectively, although the investigator determined that less than 1% were related to paroxetine treatment.

TEAEs that led to discontinuation occurred in 4.7% of paroxetine-treated women and in 3.7% of placebo-treated women, although the incidence of study drug interruptions from TEAEs was similar (0.9%) between treatments. The most frequent adverse reactions leading to discontinuation in the paroxetine arm were abdominal pain (0.3%), attention disturbances (0.3%), headache (0.3%), and suicidal ideation (0.3%).

Of the most common AEs, nausea occurred mainly within the first 4 weeks of treatment; fatigue occurred primarily within the first week of treatment and decreased in frequency with continued therapy. Incidences and types of AEs that began after 12 weeks were similar to those that began during the first 12 weeks of treatment.

AEs related to SSRIs not found to be problematic
No differences were found between groups with regard to TEAEs related to weight, libido, or sleep. No clinically meaningful changes in laboratory values, vital signs, or ECGs were observed with either group. No clinically important findings on abnormal bleeding, bone fracture, or suicidality were evident in the paroxetine arm.

In the Phase 3 studies:

• One suicide attempt was reported in the paroxetine group in the 24-week study, but was determined by investigators to be unrelated to treatment

• Incidence rates of gastrointestinal and other bleeding events were similar between groups

• Five bone fractures were reported: One in the paroxetine group and four among three participants in the placebo group.

One death occurred in the 12-week Phase 3 study due to acute respiratory failure with evidence of hypertension-mediated pulmonary edema and hypertensive cardiovascular disease. The investigator did not consider the death to be related to the study drug.

Study conclusion
The authors concluded that paroxetine 7.5 mg had favorable tolerability in menopausal women with moderate to severe VMS.

“Paroxetine 7.5 mg offers a nonhormonal treatment option for women who seek treatment for moderate to severe hot flashes associated with menopause,” said Dr. Simon.³ 

Tell us what you think! Send your Letter to the Editor: [email protected]

CHICAGO – After a decade on therapy with imatinib, a majority of patients with chronic myeloid leukemia will experience an adverse drug reaction, but most reactions are mild and manageable, according to results from a study presented at the annual meeting of the American Society of Clinical Oncology.

Of 1,375 patients with CML who received imatinib (Gleevec) monotherapy at some point, 1,018 (74%) had nonhematologic toxicities sometime during therapy, but only 199 (14%) had grade 3 or 4 toxicities, and there were no deaths attributed to imatinib, reported Dr. Rüdiger Hehlmann of the University of Heidelberg, Germany, and his colleagues.

Adverse drug reactions were manageable even when imatinib was combined with interferon-alfa (IFN-alfa), the investigators from the German CML Study Group reported in a poster at the meeting.

"After 10 years, imatinib continues to be an excellent choice for most patients with CML," they wrote.

In the 13 years that have elapsed since imatinib was approved in the United States as the first-in-class tyrosine kinase inhibitor, second-generation TKIs and other targeted agents have emerged, drawing attention to the safety of the older regimen.

The investigators evaluated long-term follow-up data and analyzed adverse drug reaction data for 1,501 patients treated with imatinib monotherapy in doses of 400 or 800 mg/day, as well as imatinib 400 mg in combination with IFN-alfa.

At the most recent evaluation, in November 2013, 164 patients had died, 1,003 were still on imatinib, 275 had been switched to a second-generation TKI, and 106 underwent bone marrow transplant (some patients received more than one therapy, accounting for the difference in total numbers).

The median follow-up time was 6.5 years, with some patients on study for as long as 11.5 years.

The probability of 10-year survival was 84%, and of 10-year progression-free survival was 81%.

An analysis of survival by molecular response rates showed an overall survival rate of 89% for those who achieved a major molecular response (MR, defined as a BCR-ABL RNA level of 0.1% or less), and 74% for those who achieved MR 4.5 (a 4.5 log₁₀reduction or greater in BCR-ABL transcripts).

The 8-year probabilities for all grades of adverse events among the patients who received imatinib monotherapy were 41% for edema or fluid overload, 38% for gastrointestinal toxicities, 25% for myalgia/arthralgia, 20% for rash, 17% for musculoskeletal events, 17% for fatigue, 11% for neurological toxicities, and 10% for flulike symptoms.

Five patients had grade 2 or 3 peripheral arterial occlusive disease, but it was not clear whether these events were associated with imatinib.

For most patients the first adverse drug reaction occurred within 3 years of starting on imatinib, with the frequency of reactions decreasing thereafter.

Dr. Hehlmann disclosed receiving research support from Novartis, marketer of imatinib.

CHICAGO – After a decade on therapy with imatinib, a majority of patients with chronic myeloid leukemia will experience an adverse drug reaction, but most reactions are mild and manageable, according to results from a study presented at the annual meeting of the American Society of Clinical Oncology.

Of 1,375 patients with CML who received imatinib (Gleevec) monotherapy at some point, 1,018 (74%) had nonhematologic toxicities sometime during therapy, but only 199 (14%) had grade 3 or 4 toxicities, and there were no deaths attributed to imatinib, reported Dr. Rüdiger Hehlmann of the University of Heidelberg, Germany, and his colleagues.

Adverse drug reactions were manageable even when imatinib was combined with interferon-alfa (IFN-alfa), the investigators from the German CML Study Group reported in a poster at the meeting.

"After 10 years, imatinib continues to be an excellent choice for most patients with CML," they wrote.

In the 13 years that have elapsed since imatinib was approved in the United States as the first-in-class tyrosine kinase inhibitor, second-generation TKIs and other targeted agents have emerged, drawing attention to the safety of the older regimen.

The investigators evaluated long-term follow-up data and analyzed adverse drug reaction data for 1,501 patients treated with imatinib monotherapy in doses of 400 or 800 mg/day, as well as imatinib 400 mg in combination with IFN-alfa.

At the most recent evaluation, in November 2013, 164 patients had died, 1,003 were still on imatinib, 275 had been switched to a second-generation TKI, and 106 underwent bone marrow transplant (some patients received more than one therapy, accounting for the difference in total numbers).

The median follow-up time was 6.5 years, with some patients on study for as long as 11.5 years.

The probability of 10-year survival was 84%, and of 10-year progression-free survival was 81%.

An analysis of survival by molecular response rates showed an overall survival rate of 89% for those who achieved a major molecular response (MR, defined as a BCR-ABL RNA level of 0.1% or less), and 74% for those who achieved MR 4.5 (a 4.5 log₁₀reduction or greater in BCR-ABL transcripts).

The 8-year probabilities for all grades of adverse events among the patients who received imatinib monotherapy were 41% for edema or fluid overload, 38% for gastrointestinal toxicities, 25% for myalgia/arthralgia, 20% for rash, 17% for musculoskeletal events, 17% for fatigue, 11% for neurological toxicities, and 10% for flulike symptoms.

Five patients had grade 2 or 3 peripheral arterial occlusive disease, but it was not clear whether these events were associated with imatinib.

For most patients the first adverse drug reaction occurred within 3 years of starting on imatinib, with the frequency of reactions decreasing thereafter.

Dr. Hehlmann disclosed receiving research support from Novartis, marketer of imatinib.

CHICAGO – After a decade on therapy with imatinib, a majority of patients with chronic myeloid leukemia will experience an adverse drug reaction, but most reactions are mild and manageable, according to results from a study presented at the annual meeting of the American Society of Clinical Oncology.

Of 1,375 patients with CML who received imatinib (Gleevec) monotherapy at some point, 1,018 (74%) had nonhematologic toxicities sometime during therapy, but only 199 (14%) had grade 3 or 4 toxicities, and there were no deaths attributed to imatinib, reported Dr. Rüdiger Hehlmann of the University of Heidelberg, Germany, and his colleagues.

Adverse drug reactions were manageable even when imatinib was combined with interferon-alfa (IFN-alfa), the investigators from the German CML Study Group reported in a poster at the meeting.

"After 10 years, imatinib continues to be an excellent choice for most patients with CML," they wrote.

In the 13 years that have elapsed since imatinib was approved in the United States as the first-in-class tyrosine kinase inhibitor, second-generation TKIs and other targeted agents have emerged, drawing attention to the safety of the older regimen.

The investigators evaluated long-term follow-up data and analyzed adverse drug reaction data for 1,501 patients treated with imatinib monotherapy in doses of 400 or 800 mg/day, as well as imatinib 400 mg in combination with IFN-alfa.

At the most recent evaluation, in November 2013, 164 patients had died, 1,003 were still on imatinib, 275 had been switched to a second-generation TKI, and 106 underwent bone marrow transplant (some patients received more than one therapy, accounting for the difference in total numbers).

The median follow-up time was 6.5 years, with some patients on study for as long as 11.5 years.

The probability of 10-year survival was 84%, and of 10-year progression-free survival was 81%.

An analysis of survival by molecular response rates showed an overall survival rate of 89% for those who achieved a major molecular response (MR, defined as a BCR-ABL RNA level of 0.1% or less), and 74% for those who achieved MR 4.5 (a 4.5 log₁₀reduction or greater in BCR-ABL transcripts).

The 8-year probabilities for all grades of adverse events among the patients who received imatinib monotherapy were 41% for edema or fluid overload, 38% for gastrointestinal toxicities, 25% for myalgia/arthralgia, 20% for rash, 17% for musculoskeletal events, 17% for fatigue, 11% for neurological toxicities, and 10% for flulike symptoms.

Five patients had grade 2 or 3 peripheral arterial occlusive disease, but it was not clear whether these events were associated with imatinib.

For most patients the first adverse drug reaction occurred within 3 years of starting on imatinib, with the frequency of reactions decreasing thereafter.

Dr. Hehlmann disclosed receiving research support from Novartis, marketer of imatinib.

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

CHICAGO – The prevalence of erosive esophagitis and Barrett’s esophagus is comparable in individuals regardless of whether they have gastroesophageal reflux symptoms, according to a population-based study.

"These results directly challenge the established GERD-based Barrett’s esophagus screening paradigm and provide strong rationale for using central obesity in Caucasian males with or without symptomatic GERD as criteria for Barrett’s esophagus screening," Dr. Nicholas R. Crews said at the annual Digestive Disease Week.

"In this study, waist-hip ratio was our surrogate marker for central obesity. It’s easily obtainable and usable in clinical practice," noted Dr. Crews of the Mayo Clinic in Rochester, Minn.

Barrett’s esophagus is the precursor lesion and principal risk factor for esophageal adenocarcinoma, a malignancy whose incidence in the United States and other developed nations is increasing at an alarming rate. Improved methods of screening for esophageal adenocarcinoma are sorely needed, he added.

Dr. Crews presented a study in which a representative sample of Olmsted County, Minn., residents over age 50 with no history of endoscopy were randomized to screening for Barrett’s esophagus by one of three methods: sedated endoscopy in the GI suite, unsedated transnasal endoscopy in the clinic, or unsedated transnasal endoscopy in a Mayo mobile research van.

Participants’ mean age was 70 years, 46% were men, 206 of the 209 were white, and only one-third of subjects had GERD symptoms.

The prevalence of esophagitis grades A-C proved to be 32% in the symptomatic GERD group and similar at 29% in those without GERD symptoms. Similarly, Barrett’s esophagus was identified in 8.7% of the symptomatic GERD group and 7.9% of subjects without GERD symptoms. Dysplasia was present in 1.4% of each group. The mean length of the esophageal segment with Barrett’s esophagus was 2.4 cm in patients with GERD symptoms and not significantly different in those who were asymptomatic.

Three risk factors proved significant as predictors of esophageal injury as defined by esophagitis or Barrett’s esophagus: male sex, central obesity as defined by a waist-hip ratio greater than 0.9, and consumption of more than two alcoholic drinks per day. Age, smoking status, and body mass index were not predictive.

The mean waist-to-hip ratio was 0.89 in screened subjects with no esophagitis or Barrett’s esophagus, 0.91 in those with positive endoscopic findings and symptomatic gastroesophageal reflux, and 0.95 in those with positive findings who were asymptomatic.

Audience members expressed skepticism about the notion of routinely screening for Barrett’s esophagus in individuals with central obesity in an era of an unprecedented obesity epidemic.

For example, Dr. Joel E. Richter, who described himself as "an anti-Barrett’s person," commented that he believes gastroenterologists are already overdiagnosing and overtreating the condition, needlessly alarming many patients.

In women, particularly, it’s increasingly clear that Barrett’s esophagus only rarely develops into esophageal adenocarcinoma, he said.

"Others have said that women with Barrett’s esophagus are as likely to get esophageal cancer as men are to get breast cancer," commented Dr. Richter, professor of internal medicine and director of the center for swallowing disorders at the University of South Florida, Tampa.

Another audience member told Dr. Crews, "I totally agree with you that we miss most people with Barrett’s by our current screening process. The problem is, it’s unclear whether it’s important or not to find them. To extrapolate from your study and say that anyone with central obesity ought to be screened for [Barrett’s esophagus] is a little strong, I think."

"It’s very controversial," Dr. Crews agreed. "It’s something we continue to struggle with."

He reported having no relevant financial conflicts.

[email protected]

If you are still on the fence on meaningful use – our government’s motivational strategy for popularizing electronic health records – the point of no return is rapidly approaching: If you want to qualify for at least a portion of the incentive money, plus avoid a 1% penalty (eventually rising to 5%) on your Medicare Part B reimbursements, this year is your final opportunity to join the party. And, unfortunately, it is not simply a matter of adopting an electronic record system.

Each year, you must attest to demonstrating "meaningful use" (MU) of that system. To do that, you must continually monitor your progress toward meeting the necessary percentage benchmarks, making course corrections as you go. If the numbers are not there when your practice is ready to attest, it will have all been for naught, and a major waste of time and resources.

That being the case, private practitioners who have not yet taken the plunge – and those who have, but are undecided on progressing to stage 2 – must ask themselves whether the significant temporal and monetary investment is worth the trouble.

Many, apparently, have decided that it is not. While a substantial percentage of eligible practitioners signed up for stage 1, approximately 20% of them stopped participating in 2013. And according to the Centers for Medicare & Medicaid Services’ own data, only 4 hospitals and 50 individual practitioners in the entire country had attested to stage 2 through March of 2014.

The American Medical Association has little faith in the program, at least in its current form. In an open letter to the CMS in May 2014, they predicted significantly higher dropout rates unless major modifications are made. Specifically, they singled out the requirement that providers meet all requirements at each stage. Rather than "all or nothing," they proposed a 75% achievement level to receive incentive payments, and a 50% minimum to avoid financial penalties. The AMA also recommended eliminating all benchmarks beyond physicians’ control, such as the stage 2 goal of 5% patient participation on the practice’s electronic health record (EHR) portal.

Another problem that falls outside the control of physicians is maintenance of EHR software. Nearly one EHR-equipped office in five, according to the CMS, is running software that does not meet stage 2 standards. The unfortunate owners of systems that cannot be upgraded before the stage 2 deadline will – through no fault of their own – be faced with a Morton’s fork of replacing their EHR on short notice or abandoning their quest for stage 2 attestation.

While the CMS has not yet indicated whether it has any inclination to address these issues or ease any of the requirements, one official did announce that the agency will be more flexible with its hardship exemptions on a case-by-case basis. Currently, such exemptions are available to new providers, those recovering from natural disasters, and others, such as pathologists, who do not interact face-to-face with patients.

So the question remains: Is the investment of time and resources needed to capture all of the data necessary for successful MU attestation worth making? Is it justified by the promise of MU incentive dollars and the benefits to your practice and your patients? And what exactly are those purported benefits, anyway?

Proponents maintain that integrated EHR will lead to improved documentation, which in turn should lead to improvements in patient care. Errors would be more easily identified because entries from generalists, specialists, labs, and others would be available to all at any time. All involved providers, theoretically, would be on the same page with every individual patient. The downside, of course, is that the real world seldom reflects the ideal situation envisioned by bureaucrats.

Ultimately, the choice is yours: Each private practitioner must decide whether starting (or continuing) meaningful use is worth the financial and time burden in his or her particular situation. If you are still undecided, time is almost up: You must begin your 90-day stage 1 reporting period in July 2014 in order to attest by the final deadline of October 1. The last calendar quarter to begin stage 2 reporting starts on October 1 as well. Detailed instructions for meeting stage 1 and stage 2 deadlines are available from many sources, including the American Academy of Dermatology website.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

If you are still on the fence on meaningful use – our government’s motivational strategy for popularizing electronic health records – the point of no return is rapidly approaching: If you want to qualify for at least a portion of the incentive money, plus avoid a 1% penalty (eventually rising to 5%) on your Medicare Part B reimbursements, this year is your final opportunity to join the party. And, unfortunately, it is not simply a matter of adopting an electronic record system.

Each year, you must attest to demonstrating "meaningful use" (MU) of that system. To do that, you must continually monitor your progress toward meeting the necessary percentage benchmarks, making course corrections as you go. If the numbers are not there when your practice is ready to attest, it will have all been for naught, and a major waste of time and resources.

That being the case, private practitioners who have not yet taken the plunge – and those who have, but are undecided on progressing to stage 2 – must ask themselves whether the significant temporal and monetary investment is worth the trouble.

Many, apparently, have decided that it is not. While a substantial percentage of eligible practitioners signed up for stage 1, approximately 20% of them stopped participating in 2013. And according to the Centers for Medicare & Medicaid Services’ own data, only 4 hospitals and 50 individual practitioners in the entire country had attested to stage 2 through March of 2014.

The American Medical Association has little faith in the program, at least in its current form. In an open letter to the CMS in May 2014, they predicted significantly higher dropout rates unless major modifications are made. Specifically, they singled out the requirement that providers meet all requirements at each stage. Rather than "all or nothing," they proposed a 75% achievement level to receive incentive payments, and a 50% minimum to avoid financial penalties. The AMA also recommended eliminating all benchmarks beyond physicians’ control, such as the stage 2 goal of 5% patient participation on the practice’s electronic health record (EHR) portal.

Another problem that falls outside the control of physicians is maintenance of EHR software. Nearly one EHR-equipped office in five, according to the CMS, is running software that does not meet stage 2 standards. The unfortunate owners of systems that cannot be upgraded before the stage 2 deadline will – through no fault of their own – be faced with a Morton’s fork of replacing their EHR on short notice or abandoning their quest for stage 2 attestation.

While the CMS has not yet indicated whether it has any inclination to address these issues or ease any of the requirements, one official did announce that the agency will be more flexible with its hardship exemptions on a case-by-case basis. Currently, such exemptions are available to new providers, those recovering from natural disasters, and others, such as pathologists, who do not interact face-to-face with patients.

So the question remains: Is the investment of time and resources needed to capture all of the data necessary for successful MU attestation worth making? Is it justified by the promise of MU incentive dollars and the benefits to your practice and your patients? And what exactly are those purported benefits, anyway?

Proponents maintain that integrated EHR will lead to improved documentation, which in turn should lead to improvements in patient care. Errors would be more easily identified because entries from generalists, specialists, labs, and others would be available to all at any time. All involved providers, theoretically, would be on the same page with every individual patient. The downside, of course, is that the real world seldom reflects the ideal situation envisioned by bureaucrats.

Ultimately, the choice is yours: Each private practitioner must decide whether starting (or continuing) meaningful use is worth the financial and time burden in his or her particular situation. If you are still undecided, time is almost up: You must begin your 90-day stage 1 reporting period in July 2014 in order to attest by the final deadline of October 1. The last calendar quarter to begin stage 2 reporting starts on October 1 as well. Detailed instructions for meeting stage 1 and stage 2 deadlines are available from many sources, including the American Academy of Dermatology website.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

If you are still on the fence on meaningful use – our government’s motivational strategy for popularizing electronic health records – the point of no return is rapidly approaching: If you want to qualify for at least a portion of the incentive money, plus avoid a 1% penalty (eventually rising to 5%) on your Medicare Part B reimbursements, this year is your final opportunity to join the party. And, unfortunately, it is not simply a matter of adopting an electronic record system.

Each year, you must attest to demonstrating "meaningful use" (MU) of that system. To do that, you must continually monitor your progress toward meeting the necessary percentage benchmarks, making course corrections as you go. If the numbers are not there when your practice is ready to attest, it will have all been for naught, and a major waste of time and resources.

That being the case, private practitioners who have not yet taken the plunge – and those who have, but are undecided on progressing to stage 2 – must ask themselves whether the significant temporal and monetary investment is worth the trouble.

Many, apparently, have decided that it is not. While a substantial percentage of eligible practitioners signed up for stage 1, approximately 20% of them stopped participating in 2013. And according to the Centers for Medicare & Medicaid Services’ own data, only 4 hospitals and 50 individual practitioners in the entire country had attested to stage 2 through March of 2014.

The American Medical Association has little faith in the program, at least in its current form. In an open letter to the CMS in May 2014, they predicted significantly higher dropout rates unless major modifications are made. Specifically, they singled out the requirement that providers meet all requirements at each stage. Rather than "all or nothing," they proposed a 75% achievement level to receive incentive payments, and a 50% minimum to avoid financial penalties. The AMA also recommended eliminating all benchmarks beyond physicians’ control, such as the stage 2 goal of 5% patient participation on the practice’s electronic health record (EHR) portal.

Another problem that falls outside the control of physicians is maintenance of EHR software. Nearly one EHR-equipped office in five, according to the CMS, is running software that does not meet stage 2 standards. The unfortunate owners of systems that cannot be upgraded before the stage 2 deadline will – through no fault of their own – be faced with a Morton’s fork of replacing their EHR on short notice or abandoning their quest for stage 2 attestation.

While the CMS has not yet indicated whether it has any inclination to address these issues or ease any of the requirements, one official did announce that the agency will be more flexible with its hardship exemptions on a case-by-case basis. Currently, such exemptions are available to new providers, those recovering from natural disasters, and others, such as pathologists, who do not interact face-to-face with patients.

So the question remains: Is the investment of time and resources needed to capture all of the data necessary for successful MU attestation worth making? Is it justified by the promise of MU incentive dollars and the benefits to your practice and your patients? And what exactly are those purported benefits, anyway?

Proponents maintain that integrated EHR will lead to improved documentation, which in turn should lead to improvements in patient care. Errors would be more easily identified because entries from generalists, specialists, labs, and others would be available to all at any time. All involved providers, theoretically, would be on the same page with every individual patient. The downside, of course, is that the real world seldom reflects the ideal situation envisioned by bureaucrats.

Ultimately, the choice is yours: Each private practitioner must decide whether starting (or continuing) meaningful use is worth the financial and time burden in his or her particular situation. If you are still undecided, time is almost up: You must begin your 90-day stage 1 reporting period in July 2014 in order to attest by the final deadline of October 1. The last calendar quarter to begin stage 2 reporting starts on October 1 as well. Detailed instructions for meeting stage 1 and stage 2 deadlines are available from many sources, including the American Academy of Dermatology website.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.