ACS Surgery News

It’s no April Fool’s joke: Brace for a 2% Medicare pay cut starting April 1 now that Congress and the president have failed to reach a deficit-reduction agreement to avoid $85 billion in federal spending cuts known as the sequester.

The deadline for an agreement was March 1, but the pay cut won’t kick in for another month, according to the Centers for Medicare and Medicaid Services.

The Medicare cut will impact physicians, hospitals, other health care providers, health plans, and prescription drug plans but will not directly impact beneficiaries.

Although the 2% cut is lower than the reductions in other federal agencies, physicians said it will still have a significant impact. Dr. Jeremy Lazarus, president of the American Medical Association, said that the cut comes at an especially bad time because physician payment rates have risen only about 4% over the last decade or so while the cost of caring for patients has climbed by more than 20%.

"A 2% cut erases half of what’s been gained over the past 12 years and continues to widen that gap between what Medicare pays and what it actually costs to care for patients," Dr. Lazarus said. "This is on top of the yearly concerns about even larger cuts that we’ve been going through over the last decade."

The cuts, and the back-and-forth in Washington over sequestration, add to physicians’ general concerns about the instability of Medicare payments, Dr. Lazarus said. That could lead some physicians to stop accepting Medicare patients.

"It’s a very difficult time to plan your practice and plan hiring new employees because you don’t understand what you’re going to be getting paid and what you can afford," said Dr. David L. Bronson, president of the American College of Physicians.

Other federal health agencies also will be affected by the cuts. The sequester calls for across-the-board cuts of about 5% annually from nondefense discretionary programs, but since the cuts will spread over 7 months instead of 12, the real percentage reductions will be closer to 9% for nondefense programs, according to a spokesperson from the Health Resources and Services Administration, which handles physician training and loan repayment programs.

At the National Institutes of Health, for example, officials estimate that they will have to cut about $1.6 billion from their biomedical research portfolio. That means the agency will be unable to award hundreds of new grants that otherwise would have been funded. It also will slow the pace of research in areas like cancer, development of a universal influenza vaccine covering all flu strains, and Alzheimer’s research, according to NIH Director Francis Collins.

"We will slow down research as a result of this," Dr. Collins said on a press call on Feb. 25.

[email protected]

It’s no April Fool’s joke: Brace for a 2% Medicare pay cut starting April 1 now that Congress and the president have failed to reach a deficit-reduction agreement to avoid $85 billion in federal spending cuts known as the sequester.

The deadline for an agreement was March 1, but the pay cut won’t kick in for another month, according to the Centers for Medicare and Medicaid Services.

The Medicare cut will impact physicians, hospitals, other health care providers, health plans, and prescription drug plans but will not directly impact beneficiaries.

Although the 2% cut is lower than the reductions in other federal agencies, physicians said it will still have a significant impact. Dr. Jeremy Lazarus, president of the American Medical Association, said that the cut comes at an especially bad time because physician payment rates have risen only about 4% over the last decade or so while the cost of caring for patients has climbed by more than 20%.

"A 2% cut erases half of what’s been gained over the past 12 years and continues to widen that gap between what Medicare pays and what it actually costs to care for patients," Dr. Lazarus said. "This is on top of the yearly concerns about even larger cuts that we’ve been going through over the last decade."

The cuts, and the back-and-forth in Washington over sequestration, add to physicians’ general concerns about the instability of Medicare payments, Dr. Lazarus said. That could lead some physicians to stop accepting Medicare patients.

"It’s a very difficult time to plan your practice and plan hiring new employees because you don’t understand what you’re going to be getting paid and what you can afford," said Dr. David L. Bronson, president of the American College of Physicians.

Other federal health agencies also will be affected by the cuts. The sequester calls for across-the-board cuts of about 5% annually from nondefense discretionary programs, but since the cuts will spread over 7 months instead of 12, the real percentage reductions will be closer to 9% for nondefense programs, according to a spokesperson from the Health Resources and Services Administration, which handles physician training and loan repayment programs.

At the National Institutes of Health, for example, officials estimate that they will have to cut about $1.6 billion from their biomedical research portfolio. That means the agency will be unable to award hundreds of new grants that otherwise would have been funded. It also will slow the pace of research in areas like cancer, development of a universal influenza vaccine covering all flu strains, and Alzheimer’s research, according to NIH Director Francis Collins.

"We will slow down research as a result of this," Dr. Collins said on a press call on Feb. 25.

[email protected]

It’s no April Fool’s joke: Brace for a 2% Medicare pay cut starting April 1 now that Congress and the president have failed to reach a deficit-reduction agreement to avoid $85 billion in federal spending cuts known as the sequester.

The deadline for an agreement was March 1, but the pay cut won’t kick in for another month, according to the Centers for Medicare and Medicaid Services.

The Medicare cut will impact physicians, hospitals, other health care providers, health plans, and prescription drug plans but will not directly impact beneficiaries.

Although the 2% cut is lower than the reductions in other federal agencies, physicians said it will still have a significant impact. Dr. Jeremy Lazarus, president of the American Medical Association, said that the cut comes at an especially bad time because physician payment rates have risen only about 4% over the last decade or so while the cost of caring for patients has climbed by more than 20%.

"A 2% cut erases half of what’s been gained over the past 12 years and continues to widen that gap between what Medicare pays and what it actually costs to care for patients," Dr. Lazarus said. "This is on top of the yearly concerns about even larger cuts that we’ve been going through over the last decade."

The cuts, and the back-and-forth in Washington over sequestration, add to physicians’ general concerns about the instability of Medicare payments, Dr. Lazarus said. That could lead some physicians to stop accepting Medicare patients.

"It’s a very difficult time to plan your practice and plan hiring new employees because you don’t understand what you’re going to be getting paid and what you can afford," said Dr. David L. Bronson, president of the American College of Physicians.

Other federal health agencies also will be affected by the cuts. The sequester calls for across-the-board cuts of about 5% annually from nondefense discretionary programs, but since the cuts will spread over 7 months instead of 12, the real percentage reductions will be closer to 9% for nondefense programs, according to a spokesperson from the Health Resources and Services Administration, which handles physician training and loan repayment programs.

At the National Institutes of Health, for example, officials estimate that they will have to cut about $1.6 billion from their biomedical research portfolio. That means the agency will be unable to award hundreds of new grants that otherwise would have been funded. It also will slow the pace of research in areas like cancer, development of a universal influenza vaccine covering all flu strains, and Alzheimer’s research, according to NIH Director Francis Collins.

"We will slow down research as a result of this," Dr. Collins said on a press call on Feb. 25.

[email protected]

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

Bariatric surgery can significantly reduce the need for insulin and can even induce complete remission of type 2 diabetes mellitus, but some forms of the procedure pose too much risk and should be shunned, said a diabetes specialist at the annual advanced postgraduate course held by the American Diabetes Association.

Depending on the type of procedure, weight loss in the first year following bariatric surgery can range from about 30 kg to more than 50 kg, and the surgery can reduce the risk of mortality for formerly obese patients by about 25%, said Dr. John Bantle, professor of medicine and director of the division of endocrinology and diabetes at the University of Minnesota in Minneapolis.

Bariatric surgery should be considered in type 2 diabetic patients with a body mass index greater than 35 kg/m², and may also benefit patients with a BMI of 30-35, although there is not enough evidence to support the latter assertion, Dr. Bantle said.

"I would choose laparoscopic gastric bypass as the procedure to recommend. I think laparoscopic gastric banding doesn’t have enough efficacy, and duodenal switch has too many complications," he said.

Looking back at Look AHEAD

The most recent follow-up data from the Action for Health in Diabetes (Look AHEAD) study compared cardiovascular event rates among patients randomized to either an intensive lifestyle intervention or a diabetes support and education program. Analysis showed that the lifestyle intervention was associated with significantly more weight loss (–4.7% vs. –1.1% at 4 years, P less than .001), and with a more favorable change in fitness levels, hemoglobin A_1c, systolic blood pressure, high-density lipoprotein cholesterol levels, and triglyceride levels (P less than .001 for all comparisons) (Arch. Intern. Med. 2010;170:1566-75).

However, in September 2012, the National Institutes of Health, acting on the advice of the trial’s data and safety monitoring team, halted the lifestyle intervention because the primary endpoint of reduction in cardiovascular events had not been reached and would be unlikely to do so in the 2 years remaining in the study.

Although the trial failed to meet the cardiovascular endpoint, there was no evidence of harm, and patients who were randomized to the intervention had reduced need for diabetes medications, less sleep apnea, and increases in both physical mobility and quality of life.

"In data that are still under analysis and not yet published, I think we are going to see that there was some benefit on microvascular complications," Dr. Bantle said.

Choose procedures wisely

If lifestyle interventions are not sufficient, bariatric surgery may be helpful, Dr. Bantle said. Procedures commonly used in the United States include laparoscopic gastric banding, Roux-en-Y gastric bypass, and increasingly, sleeve gastrectomy and biliopancreatic diversion with duodenal switch.

The latter procedure is similar to a jejunoileal bypass, an early type of bariatric surgery that is no longer performed due to the high complication rate. Biliopancreatic diversion with duodenal switch involves division of the stomach and creation of a small gastric pouch that is drained with a loop of intestine attached downward to the ileum toward its head, so that biliary and pancreatic drainage occurs through the small intestine before the digestive juices meet up with food for digestion and absorption toward the end of the intestinal tract.

"I think this procedure is a really bad idea; it’s too much like a jejunoileal bypass with anastomosis, and I advise all my patients who are considering bariatric surgery to decline the option to pursue this procedure," he said.

Evidence favors surgery

Reviewing the evidence, Dr. Bantle pointed to a 2005 meta-analysis of 147 studies of bariatric surgery for obesity, which showed a mean 30.2-kg weight loss at 12 months and 34.8-kg loss after 36 months in patients who had a gastric banding procedure, compared with 43.5 kg and 41.5 kg, respectively, for gastric bypass, and 51.9 kg and 53.1 kg for those who had surgery with a duodenal switch procedure (Ann. Intern. Med. 2005;142:547-59).

The study also showed, however, that the rate of adverse events, including reflux, vomiting, dysphagia, and dumping syndrome, was markedly higher for patients who underwent a duodenal switch, at 37.7%, compared with 7.0% for gastric banding and 16.9% for gastric bypass.

A 2007 Swedish study also saw a reduction in mortality at a mean of 10.9 years of follow-up among 2,010 obese patients who underwent bariatric surgery compared with 2,037 patients who received standard medical management. The hazard ratio for death in the surgical patients was 0.76 (P = .04). The most common causes of death were myocardial infarction, which occurred in 13 surgical patients and 25 controls, and cancer, which occurred in 29 surgical patients and 47 controls (N. Engl. J. Med. 2007;357:741-52).

Similarly, a retrospective cohort study comparing 7,925 obese people who underwent gastric bypass surgery with the same number of obese controls matched by age, gender, and BMI showed that after a mean follow-up of 7.1 years, adjusted mortality for surgical patients was 37.6 per 10,000 person-years, compared with 57.1 per 10,000 for controls, a relative difference of 40%. Additionally, diabetes-specific mortality declined by 92% in the gastric bypass patients (N. Engl. J. Med. 2007;357:753-61).

Following surgery, it is important to ensure that patients have a protein intake of 60-120 g daily, and if they have undergone gastric bypass or duodenal switch procedures their diet should be supplemented with a multivitamin containing folate, thiamine, iron, vitamin B₁₂, calcium, and vitamin D, Dr. Bantle said.

"I would suggest that the earlier the surgery is done, the better. Remission of diabetes is predicted by short duration of diabetes, need for few diabetes medications, and high postprandial C-peptide, so if a patient is considering [bariatric surgery], I typically get a postprandial C-peptide and use that to counsel them about whether or not they’re likely to have remission of diabetes after the procedure," he concluded.

Dr. Bantle reported having no financial disclosures.

When analyzed as a dynamic factor over time, use of the ventilator bundle was not associated with the prevention of ventilator-associated pneumonia in a study of over 600 patients.

The finding raises doubts about the widespread use of the bundle among intensive care units and calls into question efforts to make ventilator-associated pneumonias a "never event," said lead author Dr. Martin A Croce and his associates.

"While quality improvement initiatives are extremely important in the care of critically ill and injured patients, any potential penalty for institutions that actively participate in such initiatives is unwarranted," they wrote.

Their study, appearing in the February issue of the Journal of Trauma and Acute Care Surgery, involved 630 patients at six level 1 trauma centers over a 16-month period (J. Trauma Acute Care Surg. 2013;74:354-62).

All trauma patients who were admitted to an intensive care unit and received mechanical ventilation for at least 48 hours were eligible for study inclusion (90% with blunt trauma). They were followed daily in the ICU until the development of ventilator-associated pneumonia (VAP), ICU discharge, or death.

Dr. Croce, chief of the trauma division at the University of Tennessee Health Science Center, Memphis, and colleagues assessed compliance among these patients with the Institute for Healthcare Improvement (IHI) ventilator bundle, which is a set of core measures to be assessed daily and designed to improve the outcomes of mechanical ventilation.

The four core measures assessed in this study were presence of stress ulcer prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a daily sedation vacation with assessment of weaning.

"Oral chlorhexidine was not part of the bundle since it was added by the IHI after the study protocol was already approved," the authors wrote.

Overall, 36% of patients developed VAP (96% diagnosed with bronchoalveolar lavage), and the overall mortality was 15%.

Sixteen patients were censored from the final analysis since they developed VAP late – that is, after 16 days in the study – and the authors assumed that the efficacy of the ventilator bundle would be greatest early in an ICU stay. In the end, a total of 210 patients were available for analysis.

The investigators then looked at the impact of the ventilator bundle on VAP in two ways: by individual patient and by patient-days.

To assess individual patient compliance, the authors summed each patient’s bundle compliance score and then divided by the number of patients.

"Although this method is commonly used to calculate compliance, this method may not accurately measure bundle or component compliance because patients with either short or long stays are weighted equally," Dr. Croce and his associates said.

"Thus, equal weight is given to less severely injured patients with perfect or near-perfect compliance as is given to more severely injured patients with contraindications to some bundle components," they added.

Indeed, in this analysis, overall patient compliance with the bundle was significantly linked to a decrease in VAP.

"To avoid this bias toward short stays, compliance was also calculated by patient-days," they noted. In this method, they counted each day’s compliance as a unique event.

"Bundle compliance is a dynamic, time-dependent process during which an individual patient’s status may change from noncompliant to compliant ... depending on the patient’s condition," Dr. Croce and his associates wrote. For example, DVT prophylaxis may be held in advance of surgery and restarted again later.

In this analysis, ventilator bundle compliance was associated with neither the development nor the prevention of VAP, with a hazard ratio for bundle compliance of 1.26 (95% confidence interval, 0.845-1.877.

In fact, in this analysis, the only variable associated with VAP was male sex (hazard ratio, 1.75; 95% CI, 1.233-2.483).

"It is important that [the Centers for Medicare and Medicaid Services] and third-party payers realize that in trauma patients, VAP is closely associated with uncontrollable risk factors such as sex and injury severity and its prevention is not associated with the four components of the IHI ventilator bundle," they said.

Dr. Croce and his coinvestigators stated that the study was funded by the National Trauma Institute and the U.S. Army. They disclosed no relevant conflicts of interest.

When analyzed as a dynamic factor over time, use of the ventilator bundle was not associated with the prevention of ventilator-associated pneumonia in a study of over 600 patients.

The finding raises doubts about the widespread use of the bundle among intensive care units and calls into question efforts to make ventilator-associated pneumonias a "never event," said lead author Dr. Martin A Croce and his associates.

"While quality improvement initiatives are extremely important in the care of critically ill and injured patients, any potential penalty for institutions that actively participate in such initiatives is unwarranted," they wrote.

Their study, appearing in the February issue of the Journal of Trauma and Acute Care Surgery, involved 630 patients at six level 1 trauma centers over a 16-month period (J. Trauma Acute Care Surg. 2013;74:354-62).

All trauma patients who were admitted to an intensive care unit and received mechanical ventilation for at least 48 hours were eligible for study inclusion (90% with blunt trauma). They were followed daily in the ICU until the development of ventilator-associated pneumonia (VAP), ICU discharge, or death.

Dr. Croce, chief of the trauma division at the University of Tennessee Health Science Center, Memphis, and colleagues assessed compliance among these patients with the Institute for Healthcare Improvement (IHI) ventilator bundle, which is a set of core measures to be assessed daily and designed to improve the outcomes of mechanical ventilation.

The four core measures assessed in this study were presence of stress ulcer prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a daily sedation vacation with assessment of weaning.

"Oral chlorhexidine was not part of the bundle since it was added by the IHI after the study protocol was already approved," the authors wrote.

Overall, 36% of patients developed VAP (96% diagnosed with bronchoalveolar lavage), and the overall mortality was 15%.

Sixteen patients were censored from the final analysis since they developed VAP late – that is, after 16 days in the study – and the authors assumed that the efficacy of the ventilator bundle would be greatest early in an ICU stay. In the end, a total of 210 patients were available for analysis.

The investigators then looked at the impact of the ventilator bundle on VAP in two ways: by individual patient and by patient-days.

To assess individual patient compliance, the authors summed each patient’s bundle compliance score and then divided by the number of patients.

"Although this method is commonly used to calculate compliance, this method may not accurately measure bundle or component compliance because patients with either short or long stays are weighted equally," Dr. Croce and his associates said.

"Thus, equal weight is given to less severely injured patients with perfect or near-perfect compliance as is given to more severely injured patients with contraindications to some bundle components," they added.

Indeed, in this analysis, overall patient compliance with the bundle was significantly linked to a decrease in VAP.

"To avoid this bias toward short stays, compliance was also calculated by patient-days," they noted. In this method, they counted each day’s compliance as a unique event.

"Bundle compliance is a dynamic, time-dependent process during which an individual patient’s status may change from noncompliant to compliant ... depending on the patient’s condition," Dr. Croce and his associates wrote. For example, DVT prophylaxis may be held in advance of surgery and restarted again later.

In this analysis, ventilator bundle compliance was associated with neither the development nor the prevention of VAP, with a hazard ratio for bundle compliance of 1.26 (95% confidence interval, 0.845-1.877.

In fact, in this analysis, the only variable associated with VAP was male sex (hazard ratio, 1.75; 95% CI, 1.233-2.483).

"It is important that [the Centers for Medicare and Medicaid Services] and third-party payers realize that in trauma patients, VAP is closely associated with uncontrollable risk factors such as sex and injury severity and its prevention is not associated with the four components of the IHI ventilator bundle," they said.

Dr. Croce and his coinvestigators stated that the study was funded by the National Trauma Institute and the U.S. Army. They disclosed no relevant conflicts of interest.

When analyzed as a dynamic factor over time, use of the ventilator bundle was not associated with the prevention of ventilator-associated pneumonia in a study of over 600 patients.

The finding raises doubts about the widespread use of the bundle among intensive care units and calls into question efforts to make ventilator-associated pneumonias a "never event," said lead author Dr. Martin A Croce and his associates.

"While quality improvement initiatives are extremely important in the care of critically ill and injured patients, any potential penalty for institutions that actively participate in such initiatives is unwarranted," they wrote.

Their study, appearing in the February issue of the Journal of Trauma and Acute Care Surgery, involved 630 patients at six level 1 trauma centers over a 16-month period (J. Trauma Acute Care Surg. 2013;74:354-62).

All trauma patients who were admitted to an intensive care unit and received mechanical ventilation for at least 48 hours were eligible for study inclusion (90% with blunt trauma). They were followed daily in the ICU until the development of ventilator-associated pneumonia (VAP), ICU discharge, or death.

Dr. Croce, chief of the trauma division at the University of Tennessee Health Science Center, Memphis, and colleagues assessed compliance among these patients with the Institute for Healthcare Improvement (IHI) ventilator bundle, which is a set of core measures to be assessed daily and designed to improve the outcomes of mechanical ventilation.

The four core measures assessed in this study were presence of stress ulcer prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a daily sedation vacation with assessment of weaning.

"Oral chlorhexidine was not part of the bundle since it was added by the IHI after the study protocol was already approved," the authors wrote.

Overall, 36% of patients developed VAP (96% diagnosed with bronchoalveolar lavage), and the overall mortality was 15%.

Sixteen patients were censored from the final analysis since they developed VAP late – that is, after 16 days in the study – and the authors assumed that the efficacy of the ventilator bundle would be greatest early in an ICU stay. In the end, a total of 210 patients were available for analysis.

The investigators then looked at the impact of the ventilator bundle on VAP in two ways: by individual patient and by patient-days.

To assess individual patient compliance, the authors summed each patient’s bundle compliance score and then divided by the number of patients.

"Although this method is commonly used to calculate compliance, this method may not accurately measure bundle or component compliance because patients with either short or long stays are weighted equally," Dr. Croce and his associates said.

"Thus, equal weight is given to less severely injured patients with perfect or near-perfect compliance as is given to more severely injured patients with contraindications to some bundle components," they added.

Indeed, in this analysis, overall patient compliance with the bundle was significantly linked to a decrease in VAP.

"To avoid this bias toward short stays, compliance was also calculated by patient-days," they noted. In this method, they counted each day’s compliance as a unique event.

"Bundle compliance is a dynamic, time-dependent process during which an individual patient’s status may change from noncompliant to compliant ... depending on the patient’s condition," Dr. Croce and his associates wrote. For example, DVT prophylaxis may be held in advance of surgery and restarted again later.

In this analysis, ventilator bundle compliance was associated with neither the development nor the prevention of VAP, with a hazard ratio for bundle compliance of 1.26 (95% confidence interval, 0.845-1.877.

In fact, in this analysis, the only variable associated with VAP was male sex (hazard ratio, 1.75; 95% CI, 1.233-2.483).

"It is important that [the Centers for Medicare and Medicaid Services] and third-party payers realize that in trauma patients, VAP is closely associated with uncontrollable risk factors such as sex and injury severity and its prevention is not associated with the four components of the IHI ventilator bundle," they said.

Dr. Croce and his coinvestigators stated that the study was funded by the National Trauma Institute and the U.S. Army. They disclosed no relevant conflicts of interest.

As required under the Affordable Care Act (ACA), the Centers for Medicare & Medicaid Services (CMS) established the Physician Compare website in January 2011. This site currently features information on Medicare physicians and other eligible professionals (EPs) who participate in the Physician Quality Reporting System (PQRS).

In the 2013 Medicare Physician fee schedule (MPFS) final rule, CMS lays out a framework for expanding the website by collecting information on physician quality, efficiency, patient experience of care, and how such information will be made available on Physician Compare. This column details how CMS’ plan may impact surgeons. For additional information on the Physician Compare website, visit the Medicare website at http://www.medicare.gov/find-a-doctor/provider-search.aspx?AspxAutoDetectCookieSupport=1.

CMS lists basic provider information as well as information on whether a provider has successfully participated in the PQRS program and/or Electronic Prescribing (eRx) Incentive Program. CMS collects basic provider information through the Medicare Provider Enrollment, Chain, and Ownership System (PECOS), making it imperative that the information a provider has on file in the PECOS system is up to date and accurate.

Using Physician Compare, EPs may obtain definitive information about physicians and other health care professionals by selecting a location and specialty. The results provide information on specialty, practice locations, group practice and hospital affiliations, Medicare assignment status, education, languages spoken, gender, and so on.

The ACA also mandates that CMS use the most recent incentive program information to indicate whether a professional has satisfactorily participated in the PQRS program and/or is a successful electronic prescriber under the eRx Incentive Program.

CMS is planning to include updated administrative information on an EP’s page as well as information regarding physician performance. CMS plans to enhance the administrative data by adding information on whether a physician or other health care professional is accepting new Medicare patients, board certification information, improved foreign language, and hospital affiliation data. CMS also intends to include the names of EPs who are successfully participating in the PQRS, the PQRS Maintenance of Certification bonus program, and the eRx Incentive Program. When feasible, CMS will post the names of EPs who are successfully participating in the Electronic Health Record (EHR) Incentive Program. As noted in the 2013 MPFS final rule, CMS will display an indicator on the profile Web page of an EP to acknowledge satisfactory participation in the incentive programs.

Under the ACA, CMS is required to implement a plan no later than January 1, 2013, and make publicly available on the Physician Compare website information on physician performance that provides comparable quality and patient experience measures. The 2013 fee schedule finalized CMS’ plan to use data from the existing PQRS program as a first step toward making physician measure performance information public on Physician Compare. CMS has finalized the decision to make public on Physician Compare, beginning later in 2013 or early 2014, the performance rates on the quality measures that group practices submit under the 2012 PQRS group practice reporting option Web-interface and the Medicare Shared Savings Program, as well as patient experience of care data.

Moreover, CMS will only post quality measure information on groups of 100 or more EPs and must meet a sample size of 20 patients who prove to be statistically valid and reliable. To ensure that the data are statistically valid, CMS will not report on a measure if a measure meeting the minimum threshold is invalid or unreliable for any reason. Additionally, CMS plans to post on the Physician Compare website in 2014 several composite measures that reflect group performance across related measures. CMS also intends to work with specialty societies in the future to include specialty society data that are already collected for other purposes and go through appropriate testing. Lastly, CMS plans to post information on individual-level data beginning in 2015 but will address the details of doing so in future rulemaking.

Although CMS will start posting physician performance and patient experience of care data in 2014, they will begin by only posting information on groups of 100 or more EPs. Before posting the patient experience of care data, CMS will provide group practices and accountable care organizations with a 30-day period to preview their quality data and how it will appear on the Physician Compare website. Eventually, CMS will include individual-level data on Physician Compare, and specific details on how this information will be presented will be decided in future rulemaking. EPs are encouraged to regularly check their profiles to ensure the accuracy of the information being provided.

Should there be any errors, providers are encouraged to log into their PECOS account, which is available at https://pecos.cms.hhs.gov/pecos/login.do. For more information on PECOS accounts, visit http://www.medicare.gov/find-a-doctor/staticpages/provider-resources/overview.aspx. By providing consumers with quality-of-care information, CMS’ goal is to help consumers make informed decisions about their health care and also encourage clinicians to improve the quality of care that they provide to their patients. 

Ms. Golak is the Quality Associate in the ACS Division of Advocacy and Health Policy in Washington DC.

As required under the Affordable Care Act (ACA), the Centers for Medicare & Medicaid Services (CMS) established the Physician Compare website in January 2011. This site currently features information on Medicare physicians and other eligible professionals (EPs) who participate in the Physician Quality Reporting System (PQRS).

In the 2013 Medicare Physician fee schedule (MPFS) final rule, CMS lays out a framework for expanding the website by collecting information on physician quality, efficiency, patient experience of care, and how such information will be made available on Physician Compare. This column details how CMS’ plan may impact surgeons. For additional information on the Physician Compare website, visit the Medicare website at http://www.medicare.gov/find-a-doctor/provider-search.aspx?AspxAutoDetectCookieSupport=1.

CMS lists basic provider information as well as information on whether a provider has successfully participated in the PQRS program and/or Electronic Prescribing (eRx) Incentive Program. CMS collects basic provider information through the Medicare Provider Enrollment, Chain, and Ownership System (PECOS), making it imperative that the information a provider has on file in the PECOS system is up to date and accurate.

Using Physician Compare, EPs may obtain definitive information about physicians and other health care professionals by selecting a location and specialty. The results provide information on specialty, practice locations, group practice and hospital affiliations, Medicare assignment status, education, languages spoken, gender, and so on.

The ACA also mandates that CMS use the most recent incentive program information to indicate whether a professional has satisfactorily participated in the PQRS program and/or is a successful electronic prescriber under the eRx Incentive Program.

CMS is planning to include updated administrative information on an EP’s page as well as information regarding physician performance. CMS plans to enhance the administrative data by adding information on whether a physician or other health care professional is accepting new Medicare patients, board certification information, improved foreign language, and hospital affiliation data. CMS also intends to include the names of EPs who are successfully participating in the PQRS, the PQRS Maintenance of Certification bonus program, and the eRx Incentive Program. When feasible, CMS will post the names of EPs who are successfully participating in the Electronic Health Record (EHR) Incentive Program. As noted in the 2013 MPFS final rule, CMS will display an indicator on the profile Web page of an EP to acknowledge satisfactory participation in the incentive programs.

Under the ACA, CMS is required to implement a plan no later than January 1, 2013, and make publicly available on the Physician Compare website information on physician performance that provides comparable quality and patient experience measures. The 2013 fee schedule finalized CMS’ plan to use data from the existing PQRS program as a first step toward making physician measure performance information public on Physician Compare. CMS has finalized the decision to make public on Physician Compare, beginning later in 2013 or early 2014, the performance rates on the quality measures that group practices submit under the 2012 PQRS group practice reporting option Web-interface and the Medicare Shared Savings Program, as well as patient experience of care data.

Moreover, CMS will only post quality measure information on groups of 100 or more EPs and must meet a sample size of 20 patients who prove to be statistically valid and reliable. To ensure that the data are statistically valid, CMS will not report on a measure if a measure meeting the minimum threshold is invalid or unreliable for any reason. Additionally, CMS plans to post on the Physician Compare website in 2014 several composite measures that reflect group performance across related measures. CMS also intends to work with specialty societies in the future to include specialty society data that are already collected for other purposes and go through appropriate testing. Lastly, CMS plans to post information on individual-level data beginning in 2015 but will address the details of doing so in future rulemaking.

Although CMS will start posting physician performance and patient experience of care data in 2014, they will begin by only posting information on groups of 100 or more EPs. Before posting the patient experience of care data, CMS will provide group practices and accountable care organizations with a 30-day period to preview their quality data and how it will appear on the Physician Compare website. Eventually, CMS will include individual-level data on Physician Compare, and specific details on how this information will be presented will be decided in future rulemaking. EPs are encouraged to regularly check their profiles to ensure the accuracy of the information being provided.

Should there be any errors, providers are encouraged to log into their PECOS account, which is available at https://pecos.cms.hhs.gov/pecos/login.do. For more information on PECOS accounts, visit http://www.medicare.gov/find-a-doctor/staticpages/provider-resources/overview.aspx. By providing consumers with quality-of-care information, CMS’ goal is to help consumers make informed decisions about their health care and also encourage clinicians to improve the quality of care that they provide to their patients. 

Ms. Golak is the Quality Associate in the ACS Division of Advocacy and Health Policy in Washington DC.

As required under the Affordable Care Act (ACA), the Centers for Medicare & Medicaid Services (CMS) established the Physician Compare website in January 2011. This site currently features information on Medicare physicians and other eligible professionals (EPs) who participate in the Physician Quality Reporting System (PQRS).

In the 2013 Medicare Physician fee schedule (MPFS) final rule, CMS lays out a framework for expanding the website by collecting information on physician quality, efficiency, patient experience of care, and how such information will be made available on Physician Compare. This column details how CMS’ plan may impact surgeons. For additional information on the Physician Compare website, visit the Medicare website at http://www.medicare.gov/find-a-doctor/provider-search.aspx?AspxAutoDetectCookieSupport=1.

CMS lists basic provider information as well as information on whether a provider has successfully participated in the PQRS program and/or Electronic Prescribing (eRx) Incentive Program. CMS collects basic provider information through the Medicare Provider Enrollment, Chain, and Ownership System (PECOS), making it imperative that the information a provider has on file in the PECOS system is up to date and accurate.

Using Physician Compare, EPs may obtain definitive information about physicians and other health care professionals by selecting a location and specialty. The results provide information on specialty, practice locations, group practice and hospital affiliations, Medicare assignment status, education, languages spoken, gender, and so on.

The ACA also mandates that CMS use the most recent incentive program information to indicate whether a professional has satisfactorily participated in the PQRS program and/or is a successful electronic prescriber under the eRx Incentive Program.

CMS is planning to include updated administrative information on an EP’s page as well as information regarding physician performance. CMS plans to enhance the administrative data by adding information on whether a physician or other health care professional is accepting new Medicare patients, board certification information, improved foreign language, and hospital affiliation data. CMS also intends to include the names of EPs who are successfully participating in the PQRS, the PQRS Maintenance of Certification bonus program, and the eRx Incentive Program. When feasible, CMS will post the names of EPs who are successfully participating in the Electronic Health Record (EHR) Incentive Program. As noted in the 2013 MPFS final rule, CMS will display an indicator on the profile Web page of an EP to acknowledge satisfactory participation in the incentive programs.

Under the ACA, CMS is required to implement a plan no later than January 1, 2013, and make publicly available on the Physician Compare website information on physician performance that provides comparable quality and patient experience measures. The 2013 fee schedule finalized CMS’ plan to use data from the existing PQRS program as a first step toward making physician measure performance information public on Physician Compare. CMS has finalized the decision to make public on Physician Compare, beginning later in 2013 or early 2014, the performance rates on the quality measures that group practices submit under the 2012 PQRS group practice reporting option Web-interface and the Medicare Shared Savings Program, as well as patient experience of care data.

Moreover, CMS will only post quality measure information on groups of 100 or more EPs and must meet a sample size of 20 patients who prove to be statistically valid and reliable. To ensure that the data are statistically valid, CMS will not report on a measure if a measure meeting the minimum threshold is invalid or unreliable for any reason. Additionally, CMS plans to post on the Physician Compare website in 2014 several composite measures that reflect group performance across related measures. CMS also intends to work with specialty societies in the future to include specialty society data that are already collected for other purposes and go through appropriate testing. Lastly, CMS plans to post information on individual-level data beginning in 2015 but will address the details of doing so in future rulemaking.

Although CMS will start posting physician performance and patient experience of care data in 2014, they will begin by only posting information on groups of 100 or more EPs. Before posting the patient experience of care data, CMS will provide group practices and accountable care organizations with a 30-day period to preview their quality data and how it will appear on the Physician Compare website. Eventually, CMS will include individual-level data on Physician Compare, and specific details on how this information will be presented will be decided in future rulemaking. EPs are encouraged to regularly check their profiles to ensure the accuracy of the information being provided.

Should there be any errors, providers are encouraged to log into their PECOS account, which is available at https://pecos.cms.hhs.gov/pecos/login.do. For more information on PECOS accounts, visit http://www.medicare.gov/find-a-doctor/staticpages/provider-resources/overview.aspx. By providing consumers with quality-of-care information, CMS’ goal is to help consumers make informed decisions about their health care and also encourage clinicians to improve the quality of care that they provide to their patients. 

Ms. Golak is the Quality Associate in the ACS Division of Advocacy and Health Policy in Washington DC.

Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in the Feb. 27 issue of JAMA.

"Currently, there is no consensus regarding appropriate surveillance intervals for patients with (AAAs) [abdominal aortic aneurysms]. By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.

Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.

Dr. Thompson and his colleagues reviewed randomized trials, observational studies, and papers presented at vascular surgical conferences that included data sets with 100 or more patients who underwent repeated ultrasound measurements of the diameter of AAAs over time. This yielded 18 data sets that included 15,471 subjects with AAA diameters between 3.0 and 5.4 cm, because 5.5 cm is usually the threshold at which surgical repair of the lesion is recommended.

The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women.

Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm.

Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.

These data can be used to guide the decision of how often to perform ultrasound surveillance of AAAs in men. Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.

"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7," the investigators wrote (JAMA 2013;309:806-13).

However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.

The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. The higher risk of AAA rupture in women is well known, although the reasons for this discrepancy are not yet certain. Researchers have proposed that differences in anatomy, structure, sex hormones, and smoking habits all may play a role.

"The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," Dr. Thompson and his associates wrote.

A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have a higher operative mortality than men and a poorer outcome at postoperative hospital discharge, the investigators noted.

This study was supported by the U.K. National Institute for Health Research’s Health Technology Assessment Programme. The authors reported that they had no relevant financial conflicts, although individual members had participated in aneurysm clinical trials.

Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in the Feb. 27 issue of JAMA.

"Currently, there is no consensus regarding appropriate surveillance intervals for patients with (AAAs) [abdominal aortic aneurysms]. By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.

Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.

Dr. Thompson and his colleagues reviewed randomized trials, observational studies, and papers presented at vascular surgical conferences that included data sets with 100 or more patients who underwent repeated ultrasound measurements of the diameter of AAAs over time. This yielded 18 data sets that included 15,471 subjects with AAA diameters between 3.0 and 5.4 cm, because 5.5 cm is usually the threshold at which surgical repair of the lesion is recommended.

The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women.

Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm.

Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.

These data can be used to guide the decision of how often to perform ultrasound surveillance of AAAs in men. Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.

"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7," the investigators wrote (JAMA 2013;309:806-13).

However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.

The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. The higher risk of AAA rupture in women is well known, although the reasons for this discrepancy are not yet certain. Researchers have proposed that differences in anatomy, structure, sex hormones, and smoking habits all may play a role.

"The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," Dr. Thompson and his associates wrote.

A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have a higher operative mortality than men and a poorer outcome at postoperative hospital discharge, the investigators noted.

This study was supported by the U.K. National Institute for Health Research’s Health Technology Assessment Programme. The authors reported that they had no relevant financial conflicts, although individual members had participated in aneurysm clinical trials.

Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in the Feb. 27 issue of JAMA.

"Currently, there is no consensus regarding appropriate surveillance intervals for patients with (AAAs) [abdominal aortic aneurysms]. By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.

Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.

Dr. Thompson and his colleagues reviewed randomized trials, observational studies, and papers presented at vascular surgical conferences that included data sets with 100 or more patients who underwent repeated ultrasound measurements of the diameter of AAAs over time. This yielded 18 data sets that included 15,471 subjects with AAA diameters between 3.0 and 5.4 cm, because 5.5 cm is usually the threshold at which surgical repair of the lesion is recommended.

The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women.

Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm.

Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.

These data can be used to guide the decision of how often to perform ultrasound surveillance of AAAs in men. Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.

"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7," the investigators wrote (JAMA 2013;309:806-13).

However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.

The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. The higher risk of AAA rupture in women is well known, although the reasons for this discrepancy are not yet certain. Researchers have proposed that differences in anatomy, structure, sex hormones, and smoking habits all may play a role.

"The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," Dr. Thompson and his associates wrote.

A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have a higher operative mortality than men and a poorer outcome at postoperative hospital discharge, the investigators noted.

This study was supported by the U.K. National Institute for Health Research’s Health Technology Assessment Programme. The authors reported that they had no relevant financial conflicts, although individual members had participated in aneurysm clinical trials.

Centers of Excellence for bariatric surgery – the only locations where the procedures are covered by Medicare – do not yield fewer complications or better outcomes for patients.

The Centers for Medicare and Medicaid Services established the Centers of Excellence in 2006 with an eye on increasing safety and decreasing negative outcomes.

Dr. Justin B. Dimick of the University of Michigan, Ann Arbor, and his colleagues, reviewed bariatric surgeries performed before and after that policy went into effect and found that there were no statistically significant improvement in complications, serious complications, or reoperations. Their findings were published Feb. 26 in JAMA.

The overall safety of bariatric surgery has increased over the years, Dr. Dimick noted, as surgeons have increasingly chosen less-invasive, lower-risk procedures such as laparoscopic gastric banding, rather than higher-risk, open procedures. Surgeons’ experience has increased and technology has improved as well; both trends have made the operations easier and less dangerous.

"Our study found large improvements in bariatric surgery outcomes over time even after adjusting for changes in procedure use," he wrote.

Taking into account patient factors such as age and comorbidities, procedure type, and year of operation, 5.5% of patients at a COE hospital had any complication, compared with 6% for those at a nondesignated facility. For serious complications, the rate was 2.2% at COEs vs. 2.5% at non-COEs. The reoperation rate was 0.83% for patients in COE hospitals, compared with 0.96% at nondesignated facilities (JAMA 2013;309:792-9).

The results were drawn from comparisons of discharge data from 2004-2009 in 12 states, chosen for geographic diversity. The discharges were for Medicare and non-Medicare patients, and the researchers examined outcomes for the 2 years before the CMS policy change and about 3 years after. Overall, there were 6,723 Medicare patients who had bariatric surgery before 2006, and 15,684 who had it afterward. For non-Medicare patients, the data covered 95,558 procedures before the change, and 155,117 afterward.

Facilities can gain the Centers of Excellence designation if they meet three primary criteria: provide accommodations for obese patients, and other structural elements; perform a minimum volume of 125 cases per year; and, submit data to either the American College of Surgeons or the American Society of Metabolic and Bariatric Surgery registry. Facilities are certified by the ACS or the ASMBS. Since 2006, the CMS has designated almost 600 facilities as a Bariatric Center of Excellence.

The structural resources required by the CMS do not differ much from what the Joint Commission requires, Dr. Dimick wrote, and volume standards don’t necessarily correlate with quality. He added that the registry data are not used in any kind of continuous quality improvement process, and thus probably do not have much of an impact.

The ACS and the ASMBS have been developing new outcomes measures and standards for that registry, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Public comment closed on Jan. 15. The organizations said they expected to incorporate any comments into a final draft.

The CMS policy restricting coverage to Centers of Excellence should be revisited, Dr. Dimick advised. The policy does not appear to improve outcomes and may even have the unintended consequence of "sacrificing long-term effectiveness for improved short-term safety."

The study was supported by grants from the National Institute on Aging and the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.

[email protected]

On Twitter @aliciaault

Centers of Excellence for bariatric surgery – the only locations where the procedures are covered by Medicare – do not yield fewer complications or better outcomes for patients.

The Centers for Medicare and Medicaid Services established the Centers of Excellence in 2006 with an eye on increasing safety and decreasing negative outcomes.

Dr. Justin B. Dimick of the University of Michigan, Ann Arbor, and his colleagues, reviewed bariatric surgeries performed before and after that policy went into effect and found that there were no statistically significant improvement in complications, serious complications, or reoperations. Their findings were published Feb. 26 in JAMA.

The overall safety of bariatric surgery has increased over the years, Dr. Dimick noted, as surgeons have increasingly chosen less-invasive, lower-risk procedures such as laparoscopic gastric banding, rather than higher-risk, open procedures. Surgeons’ experience has increased and technology has improved as well; both trends have made the operations easier and less dangerous.

"Our study found large improvements in bariatric surgery outcomes over time even after adjusting for changes in procedure use," he wrote.

Taking into account patient factors such as age and comorbidities, procedure type, and year of operation, 5.5% of patients at a COE hospital had any complication, compared with 6% for those at a nondesignated facility. For serious complications, the rate was 2.2% at COEs vs. 2.5% at non-COEs. The reoperation rate was 0.83% for patients in COE hospitals, compared with 0.96% at nondesignated facilities (JAMA 2013;309:792-9).

The results were drawn from comparisons of discharge data from 2004-2009 in 12 states, chosen for geographic diversity. The discharges were for Medicare and non-Medicare patients, and the researchers examined outcomes for the 2 years before the CMS policy change and about 3 years after. Overall, there were 6,723 Medicare patients who had bariatric surgery before 2006, and 15,684 who had it afterward. For non-Medicare patients, the data covered 95,558 procedures before the change, and 155,117 afterward.

Facilities can gain the Centers of Excellence designation if they meet three primary criteria: provide accommodations for obese patients, and other structural elements; perform a minimum volume of 125 cases per year; and, submit data to either the American College of Surgeons or the American Society of Metabolic and Bariatric Surgery registry. Facilities are certified by the ACS or the ASMBS. Since 2006, the CMS has designated almost 600 facilities as a Bariatric Center of Excellence.

The structural resources required by the CMS do not differ much from what the Joint Commission requires, Dr. Dimick wrote, and volume standards don’t necessarily correlate with quality. He added that the registry data are not used in any kind of continuous quality improvement process, and thus probably do not have much of an impact.

The ACS and the ASMBS have been developing new outcomes measures and standards for that registry, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Public comment closed on Jan. 15. The organizations said they expected to incorporate any comments into a final draft.

The CMS policy restricting coverage to Centers of Excellence should be revisited, Dr. Dimick advised. The policy does not appear to improve outcomes and may even have the unintended consequence of "sacrificing long-term effectiveness for improved short-term safety."

The study was supported by grants from the National Institute on Aging and the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.

[email protected]

On Twitter @aliciaault

Centers of Excellence for bariatric surgery – the only locations where the procedures are covered by Medicare – do not yield fewer complications or better outcomes for patients.

The Centers for Medicare and Medicaid Services established the Centers of Excellence in 2006 with an eye on increasing safety and decreasing negative outcomes.

Dr. Justin B. Dimick of the University of Michigan, Ann Arbor, and his colleagues, reviewed bariatric surgeries performed before and after that policy went into effect and found that there were no statistically significant improvement in complications, serious complications, or reoperations. Their findings were published Feb. 26 in JAMA.

The overall safety of bariatric surgery has increased over the years, Dr. Dimick noted, as surgeons have increasingly chosen less-invasive, lower-risk procedures such as laparoscopic gastric banding, rather than higher-risk, open procedures. Surgeons’ experience has increased and technology has improved as well; both trends have made the operations easier and less dangerous.

"Our study found large improvements in bariatric surgery outcomes over time even after adjusting for changes in procedure use," he wrote.

Taking into account patient factors such as age and comorbidities, procedure type, and year of operation, 5.5% of patients at a COE hospital had any complication, compared with 6% for those at a nondesignated facility. For serious complications, the rate was 2.2% at COEs vs. 2.5% at non-COEs. The reoperation rate was 0.83% for patients in COE hospitals, compared with 0.96% at nondesignated facilities (JAMA 2013;309:792-9).

The results were drawn from comparisons of discharge data from 2004-2009 in 12 states, chosen for geographic diversity. The discharges were for Medicare and non-Medicare patients, and the researchers examined outcomes for the 2 years before the CMS policy change and about 3 years after. Overall, there were 6,723 Medicare patients who had bariatric surgery before 2006, and 15,684 who had it afterward. For non-Medicare patients, the data covered 95,558 procedures before the change, and 155,117 afterward.

Facilities can gain the Centers of Excellence designation if they meet three primary criteria: provide accommodations for obese patients, and other structural elements; perform a minimum volume of 125 cases per year; and, submit data to either the American College of Surgeons or the American Society of Metabolic and Bariatric Surgery registry. Facilities are certified by the ACS or the ASMBS. Since 2006, the CMS has designated almost 600 facilities as a Bariatric Center of Excellence.

The structural resources required by the CMS do not differ much from what the Joint Commission requires, Dr. Dimick wrote, and volume standards don’t necessarily correlate with quality. He added that the registry data are not used in any kind of continuous quality improvement process, and thus probably do not have much of an impact.

The ACS and the ASMBS have been developing new outcomes measures and standards for that registry, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Public comment closed on Jan. 15. The organizations said they expected to incorporate any comments into a final draft.

The CMS policy restricting coverage to Centers of Excellence should be revisited, Dr. Dimick advised. The policy does not appear to improve outcomes and may even have the unintended consequence of "sacrificing long-term effectiveness for improved short-term safety."

The study was supported by grants from the National Institute on Aging and the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.

[email protected]

On Twitter @aliciaault

HONOLULU – Just 1% of patients experienced a non-ST-elevation myocardial infarction following carotid-artery stenting or endarterectomy in a retrospective, nationally representative analysis of more than 1 million patients.

When it did occur, however, NSTEMI significantly increased periprocedural neurologic and cardiac complications, inpatient mortality, disability, and resource utilization – adding on average a full 10 days to hospital length of stay and nearly $85,000 in hospital charges, Dr. Amir Khan said during a plenary session at the International Stroke Conference. Dr. Khan is scheduled to present the study results at the annual meeting of the American Academy of Neurology in San Diego on March 20.

Patrice Wendling/IMNG Medical Media

He observed that postoperative evaluation for MI varied in the data set, as it does nationally, but that post hoc analyses from the POISE (Perioperative Ischemic Evaluation) trial revealed that 65% of patients with an MI after noncardiac surgery did not have ischemic symptoms (Ann. Intern. Med. 2011;154:523-8).

"So, we know that hospitals that don’t have active surveillance regimens for non-STEMI will miss a fair amount of this," said Dr. Khan, an endovascular surgical neuroradiology fellow at the University of Minnesota in Minneapolis.

The majority of perioperative MI is NSTEMI. While few studies have parsed out MI types, the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial showed that 80% of carotid endarterectomy (CEA) patients with periprocedural MI and all carotid angioplasty or stenting (CAS) patients with periprocedural MI were NSTEMI (N. Engl. J. Med. 2004;351:1493-1501).

In an effort to assess the frequency of periprocedural NSTEMI following CEA or CAS in practice and its relationship with outcomes, the researchers used data from the Nationwide Inpatient Sample for all adult patients who underwent CEA or CAS from 2002 to 2009. From this, hospital-weighted national estimates were generated using Healthcare Utilization Project algorithms.

Overall, 11,341 patients (1%) experienced an NSTEMI and 1,072,347 did not; 92% of all patients underwent endarterectomy.

Age, gender, and racial distribution were roughly similar between groups, although patients with NSTEMI had significantly higher baseline rates of atrial fibrillation (24% vs. 8%), heart failure (24% vs. 6.5%) and chronic renal insufficiency (16% vs. 5%), Dr. Khan noted.

In terms of health care usage, rates were slightly higher among NSTEMI patients for inpatient diagnostic cerebral angiography (19% vs. 13.5%), gastrostomy (3% vs. 0.4%), and postprocedure mechanical ventilation (0.5% vs. 0.3%; all P less than .0001).

Blood transfusions were conspicuously higher in those with NSTEMI at 20% vs. 3% in those without, he said. The average length of stay also jumped with NSTEMI from 2.8 days to 12.2 days, pushing hospital charges from an average of $29,160 to $113,317 (all P less than .0001).

Neurologic complications were seen in 6% of patients with NSTEMI vs. 1.4% without, while cardiac complications occurred in 31% vs. 1.5%. In addition, 31% of NSTEMI patients were moderately or severely disabled at discharge vs. just 6% without NSTEMI (all P less than .0001), Dr. Khan reported at the conference, sponsored by the American Heart Association.

In-hospital mortality was 6% in the NSTEMI group and 0.5% in the group without. The composite endpoint of cardiac or neurologic complication and/or death was reached by 38% vs. 3% (both P less than .0001).

When these numbers were plugged into a multivariate analysis that adjusted for age, gender, and comorbidities, the odds ratios for patients with NSTEMI were 3.6 for neurologic complications, 23.2 for cardiac complications, 8.6 for in-hospital mortality, 14.6 for the composite end point, and 5.5 for moderate to severe disability (all P less than .0001), he said.

During a discussion following the presentation, an audience member expressed concern about the complication rates, rising to say, "Often we make decisions about stroke treatment based only on what’s good for the brain. Well there’s no point in making the brain better if the person can have a heart attack and die of some other complications, and I really think this [study] emphasizes that."

Dr. Khan replied, "I totally agree and I think that is one of the take-home messages here ... "

Dr. Khan and his coauthors reported no disclosures.

[email protected]

HONOLULU – Just 1% of patients experienced a non-ST-elevation myocardial infarction following carotid-artery stenting or endarterectomy in a retrospective, nationally representative analysis of more than 1 million patients.

When it did occur, however, NSTEMI significantly increased periprocedural neurologic and cardiac complications, inpatient mortality, disability, and resource utilization – adding on average a full 10 days to hospital length of stay and nearly $85,000 in hospital charges, Dr. Amir Khan said during a plenary session at the International Stroke Conference. Dr. Khan is scheduled to present the study results at the annual meeting of the American Academy of Neurology in San Diego on March 20.

Patrice Wendling/IMNG Medical Media

He observed that postoperative evaluation for MI varied in the data set, as it does nationally, but that post hoc analyses from the POISE (Perioperative Ischemic Evaluation) trial revealed that 65% of patients with an MI after noncardiac surgery did not have ischemic symptoms (Ann. Intern. Med. 2011;154:523-8).

"So, we know that hospitals that don’t have active surveillance regimens for non-STEMI will miss a fair amount of this," said Dr. Khan, an endovascular surgical neuroradiology fellow at the University of Minnesota in Minneapolis.

The majority of perioperative MI is NSTEMI. While few studies have parsed out MI types, the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial showed that 80% of carotid endarterectomy (CEA) patients with periprocedural MI and all carotid angioplasty or stenting (CAS) patients with periprocedural MI were NSTEMI (N. Engl. J. Med. 2004;351:1493-1501).

In an effort to assess the frequency of periprocedural NSTEMI following CEA or CAS in practice and its relationship with outcomes, the researchers used data from the Nationwide Inpatient Sample for all adult patients who underwent CEA or CAS from 2002 to 2009. From this, hospital-weighted national estimates were generated using Healthcare Utilization Project algorithms.

Overall, 11,341 patients (1%) experienced an NSTEMI and 1,072,347 did not; 92% of all patients underwent endarterectomy.

Age, gender, and racial distribution were roughly similar between groups, although patients with NSTEMI had significantly higher baseline rates of atrial fibrillation (24% vs. 8%), heart failure (24% vs. 6.5%) and chronic renal insufficiency (16% vs. 5%), Dr. Khan noted.

In terms of health care usage, rates were slightly higher among NSTEMI patients for inpatient diagnostic cerebral angiography (19% vs. 13.5%), gastrostomy (3% vs. 0.4%), and postprocedure mechanical ventilation (0.5% vs. 0.3%; all P less than .0001).

Blood transfusions were conspicuously higher in those with NSTEMI at 20% vs. 3% in those without, he said. The average length of stay also jumped with NSTEMI from 2.8 days to 12.2 days, pushing hospital charges from an average of $29,160 to $113,317 (all P less than .0001).

Neurologic complications were seen in 6% of patients with NSTEMI vs. 1.4% without, while cardiac complications occurred in 31% vs. 1.5%. In addition, 31% of NSTEMI patients were moderately or severely disabled at discharge vs. just 6% without NSTEMI (all P less than .0001), Dr. Khan reported at the conference, sponsored by the American Heart Association.

In-hospital mortality was 6% in the NSTEMI group and 0.5% in the group without. The composite endpoint of cardiac or neurologic complication and/or death was reached by 38% vs. 3% (both P less than .0001).

When these numbers were plugged into a multivariate analysis that adjusted for age, gender, and comorbidities, the odds ratios for patients with NSTEMI were 3.6 for neurologic complications, 23.2 for cardiac complications, 8.6 for in-hospital mortality, 14.6 for the composite end point, and 5.5 for moderate to severe disability (all P less than .0001), he said.

During a discussion following the presentation, an audience member expressed concern about the complication rates, rising to say, "Often we make decisions about stroke treatment based only on what’s good for the brain. Well there’s no point in making the brain better if the person can have a heart attack and die of some other complications, and I really think this [study] emphasizes that."

Dr. Khan replied, "I totally agree and I think that is one of the take-home messages here ... "

Dr. Khan and his coauthors reported no disclosures.

[email protected]

HONOLULU – Just 1% of patients experienced a non-ST-elevation myocardial infarction following carotid-artery stenting or endarterectomy in a retrospective, nationally representative analysis of more than 1 million patients.

When it did occur, however, NSTEMI significantly increased periprocedural neurologic and cardiac complications, inpatient mortality, disability, and resource utilization – adding on average a full 10 days to hospital length of stay and nearly $85,000 in hospital charges, Dr. Amir Khan said during a plenary session at the International Stroke Conference. Dr. Khan is scheduled to present the study results at the annual meeting of the American Academy of Neurology in San Diego on March 20.

Patrice Wendling/IMNG Medical Media

He observed that postoperative evaluation for MI varied in the data set, as it does nationally, but that post hoc analyses from the POISE (Perioperative Ischemic Evaluation) trial revealed that 65% of patients with an MI after noncardiac surgery did not have ischemic symptoms (Ann. Intern. Med. 2011;154:523-8).

"So, we know that hospitals that don’t have active surveillance regimens for non-STEMI will miss a fair amount of this," said Dr. Khan, an endovascular surgical neuroradiology fellow at the University of Minnesota in Minneapolis.

The majority of perioperative MI is NSTEMI. While few studies have parsed out MI types, the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial showed that 80% of carotid endarterectomy (CEA) patients with periprocedural MI and all carotid angioplasty or stenting (CAS) patients with periprocedural MI were NSTEMI (N. Engl. J. Med. 2004;351:1493-1501).

In an effort to assess the frequency of periprocedural NSTEMI following CEA or CAS in practice and its relationship with outcomes, the researchers used data from the Nationwide Inpatient Sample for all adult patients who underwent CEA or CAS from 2002 to 2009. From this, hospital-weighted national estimates were generated using Healthcare Utilization Project algorithms.

Overall, 11,341 patients (1%) experienced an NSTEMI and 1,072,347 did not; 92% of all patients underwent endarterectomy.

Age, gender, and racial distribution were roughly similar between groups, although patients with NSTEMI had significantly higher baseline rates of atrial fibrillation (24% vs. 8%), heart failure (24% vs. 6.5%) and chronic renal insufficiency (16% vs. 5%), Dr. Khan noted.

In terms of health care usage, rates were slightly higher among NSTEMI patients for inpatient diagnostic cerebral angiography (19% vs. 13.5%), gastrostomy (3% vs. 0.4%), and postprocedure mechanical ventilation (0.5% vs. 0.3%; all P less than .0001).

Blood transfusions were conspicuously higher in those with NSTEMI at 20% vs. 3% in those without, he said. The average length of stay also jumped with NSTEMI from 2.8 days to 12.2 days, pushing hospital charges from an average of $29,160 to $113,317 (all P less than .0001).

Neurologic complications were seen in 6% of patients with NSTEMI vs. 1.4% without, while cardiac complications occurred in 31% vs. 1.5%. In addition, 31% of NSTEMI patients were moderately or severely disabled at discharge vs. just 6% without NSTEMI (all P less than .0001), Dr. Khan reported at the conference, sponsored by the American Heart Association.

In-hospital mortality was 6% in the NSTEMI group and 0.5% in the group without. The composite endpoint of cardiac or neurologic complication and/or death was reached by 38% vs. 3% (both P less than .0001).

When these numbers were plugged into a multivariate analysis that adjusted for age, gender, and comorbidities, the odds ratios for patients with NSTEMI were 3.6 for neurologic complications, 23.2 for cardiac complications, 8.6 for in-hospital mortality, 14.6 for the composite end point, and 5.5 for moderate to severe disability (all P less than .0001), he said.

During a discussion following the presentation, an audience member expressed concern about the complication rates, rising to say, "Often we make decisions about stroke treatment based only on what’s good for the brain. Well there’s no point in making the brain better if the person can have a heart attack and die of some other complications, and I really think this [study] emphasizes that."

Dr. Khan replied, "I totally agree and I think that is one of the take-home messages here ... "

Dr. Khan and his coauthors reported no disclosures.

[email protected]

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

[email protected]

On Twitter @naseemsmiller

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

[email protected]

On Twitter @naseemsmiller

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

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