Alicia Ault

PHILADELPHIA — Giving N-acetylcysteine as an adjunctive agent may reduce the risk of acute renal injury following contrast imaging procedures in high-risk patients, Dr. Venkatesh Jayaraman reported at the annual meeting of the American Society of Nephrology.

Dr. Jayaraman, a nephrology fellow at Lankenau Hospital in Wynnewood, Pa., and associates reviewed the records of 380 patients who underwent coronary angiography in August 2001-January 2004, to evaluate a N-acetylcysteine protocol that was instituted in 2001.

Patients received 600 mg of oral N-acetylcysteine twice daily on the day before and the day of the procedure and were followed for 48 hours. By definition, low-risk patients had a serum creatinine level of 1.5 mg/dL or less; high-risk patients were those with more than 1.5 mg/dL.

Among the 318 low-risk patients, there were 8 cases (3%) of contrast-related acute renal failure (ARF). In the 62 high-risk patients, there were 12 cases of ARF (19%). In the low-risk group, 9% of patients received acetylcysteine, compared with 86% of those in the high-risk group.

The investigators concluded that acetylcysteine had a significant effect on the risk of ARF in high-risk, but not low-risk patients. Only about 10% of the high-risk patients who got the drug developed ARF.

PHILADELPHIA — Giving N-acetylcysteine as an adjunctive agent may reduce the risk of acute renal injury following contrast imaging procedures in high-risk patients, Dr. Venkatesh Jayaraman reported at the annual meeting of the American Society of Nephrology.

Dr. Jayaraman, a nephrology fellow at Lankenau Hospital in Wynnewood, Pa., and associates reviewed the records of 380 patients who underwent coronary angiography in August 2001-January 2004, to evaluate a N-acetylcysteine protocol that was instituted in 2001.

Patients received 600 mg of oral N-acetylcysteine twice daily on the day before and the day of the procedure and were followed for 48 hours. By definition, low-risk patients had a serum creatinine level of 1.5 mg/dL or less; high-risk patients were those with more than 1.5 mg/dL.

Among the 318 low-risk patients, there were 8 cases (3%) of contrast-related acute renal failure (ARF). In the 62 high-risk patients, there were 12 cases of ARF (19%). In the low-risk group, 9% of patients received acetylcysteine, compared with 86% of those in the high-risk group.

The investigators concluded that acetylcysteine had a significant effect on the risk of ARF in high-risk, but not low-risk patients. Only about 10% of the high-risk patients who got the drug developed ARF.

PHILADELPHIA — Giving N-acetylcysteine as an adjunctive agent may reduce the risk of acute renal injury following contrast imaging procedures in high-risk patients, Dr. Venkatesh Jayaraman reported at the annual meeting of the American Society of Nephrology.

Dr. Jayaraman, a nephrology fellow at Lankenau Hospital in Wynnewood, Pa., and associates reviewed the records of 380 patients who underwent coronary angiography in August 2001-January 2004, to evaluate a N-acetylcysteine protocol that was instituted in 2001.

Patients received 600 mg of oral N-acetylcysteine twice daily on the day before and the day of the procedure and were followed for 48 hours. By definition, low-risk patients had a serum creatinine level of 1.5 mg/dL or less; high-risk patients were those with more than 1.5 mg/dL.

Among the 318 low-risk patients, there were 8 cases (3%) of contrast-related acute renal failure (ARF). In the 62 high-risk patients, there were 12 cases of ARF (19%). In the low-risk group, 9% of patients received acetylcysteine, compared with 86% of those in the high-risk group.

The investigators concluded that acetylcysteine had a significant effect on the risk of ARF in high-risk, but not low-risk patients. Only about 10% of the high-risk patients who got the drug developed ARF.

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

“I absolutely think it's a trend,” said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. Also, residents should be on call in-house only once every 3 nights, the ACGME guidelines state.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room “for educational aspects, and not simply to do chore work,” he said.

“It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do,” said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

“Smaller programs with a busy service are a lot more likely to put in alternative ways to providing the care,” said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

But he said that there is no hard evidence that a big shift has occurred.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the authors, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a lot of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR. At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. “I think they've seen what continuity of care is, and they appreciate that.”

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than are the junior-level residents, who are on staff for only a month, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest. They also conduct preoperative patient evaluations and postoperative management in the intensive care unit, “troubleshooting from minute to minute,” Ms. Hance said.

PAs and nurse-practitioners are invaluable to a surgical team because they know the routines. DR. PRAGER

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

“I absolutely think it's a trend,” said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. Also, residents should be on call in-house only once every 3 nights, the ACGME guidelines state.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room “for educational aspects, and not simply to do chore work,” he said.

“It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do,” said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

“Smaller programs with a busy service are a lot more likely to put in alternative ways to providing the care,” said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

But he said that there is no hard evidence that a big shift has occurred.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the authors, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a lot of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR. At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. “I think they've seen what continuity of care is, and they appreciate that.”

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than are the junior-level residents, who are on staff for only a month, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest. They also conduct preoperative patient evaluations and postoperative management in the intensive care unit, “troubleshooting from minute to minute,” Ms. Hance said.

PAs and nurse-practitioners are invaluable to a surgical team because they know the routines. DR. PRAGER

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

“I absolutely think it's a trend,” said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. Also, residents should be on call in-house only once every 3 nights, the ACGME guidelines state.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room “for educational aspects, and not simply to do chore work,” he said.

“It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do,” said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

“Smaller programs with a busy service are a lot more likely to put in alternative ways to providing the care,” said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

But he said that there is no hard evidence that a big shift has occurred.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the authors, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a lot of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR. At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. “I think they've seen what continuity of care is, and they appreciate that.”

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than are the junior-level residents, who are on staff for only a month, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest. They also conduct preoperative patient evaluations and postoperative management in the intensive care unit, “troubleshooting from minute to minute,” Ms. Hance said.

PAs and nurse-practitioners are invaluable to a surgical team because they know the routines. DR. PRAGER

CHICAGO — A laparoscopic approach to appendectomy in the elderly appears to reduce mortality and complications, Dr. Andrew Harrell said at the annual meeting of the Society for Surgery of the Alimentary Tract.

Using data from the North Carolina Hospital Association Patient Data System, Dr. Harrell and his colleagues analyzed results for all patients who had an ICD-9 code for appendectomy in 1997–2003 who were either urgent or emergent. They then compared outcomes for patients aged 18–64 years and those aged 65 and over, and for those who had open and laparoscopic procedures.

During the time period analyzed, there were 28,929 appendectomies in the younger age group and 3,009 in the older group. Use of the laparoscopic approach in people over age 65 increased from 10.6% of appendectomies in 1997 to 21% in 2003, said Dr. Harrell of the division of gastrointestinal and minimally invasive surgery at the Carolinas Medical Center in Charlotte, N.C.

The elderly had a longer length of stay in the hospital (7.2 days vs. 3.5 days for the younger group), regardless of whether the procedure was open or laparoscopic. Complication rates and death rates were also higher in the elderly than in younger patients: 22.1% vs. 9% and 2.2% vs. 0.15%, respectively.

But, when older patients underwent laparoscopic appendectomy, all the outcomes improved, said Dr. Harrell. The length of stay decreased to 4.6 days, and 14.4% experienced complications, compared with 23.8% of those undergoing the open procedure. Mortality declined to 0.4% for the laparoscopic approach, compared with 2.7% for the open procedure. Laparoscopic charges, however, were higher than those for the younger group's less invasive surgery, at $16,670 compared with $11,160.

Dr. John Hunter, chairman of surgery at Oregon Health and Science University, Portland, said that although the data were intriguing, he found many flaws in the analysis. The patients who had laparoscopy appeared to be younger, healthier, and predominantly female, said Dr. Hunter, who discussed the paper at the meeting.

This imbalance seems to make direct comparisons between the groups difficult, Dr. Hunter said.

Dr. Harrell said that he and his colleagues did notice a difference, but a subset and a multivariate analysis (controlling for age, gender, and comorbidities) still showed significantly shorter hospitalizations for the laparoscopic group and a higher rate of routine discharge to the patient's home, when compared with the open surgery group.

CHICAGO — A laparoscopic approach to appendectomy in the elderly appears to reduce mortality and complications, Dr. Andrew Harrell said at the annual meeting of the Society for Surgery of the Alimentary Tract.

Using data from the North Carolina Hospital Association Patient Data System, Dr. Harrell and his colleagues analyzed results for all patients who had an ICD-9 code for appendectomy in 1997–2003 who were either urgent or emergent. They then compared outcomes for patients aged 18–64 years and those aged 65 and over, and for those who had open and laparoscopic procedures.

During the time period analyzed, there were 28,929 appendectomies in the younger age group and 3,009 in the older group. Use of the laparoscopic approach in people over age 65 increased from 10.6% of appendectomies in 1997 to 21% in 2003, said Dr. Harrell of the division of gastrointestinal and minimally invasive surgery at the Carolinas Medical Center in Charlotte, N.C.

The elderly had a longer length of stay in the hospital (7.2 days vs. 3.5 days for the younger group), regardless of whether the procedure was open or laparoscopic. Complication rates and death rates were also higher in the elderly than in younger patients: 22.1% vs. 9% and 2.2% vs. 0.15%, respectively.

But, when older patients underwent laparoscopic appendectomy, all the outcomes improved, said Dr. Harrell. The length of stay decreased to 4.6 days, and 14.4% experienced complications, compared with 23.8% of those undergoing the open procedure. Mortality declined to 0.4% for the laparoscopic approach, compared with 2.7% for the open procedure. Laparoscopic charges, however, were higher than those for the younger group's less invasive surgery, at $16,670 compared with $11,160.

Dr. John Hunter, chairman of surgery at Oregon Health and Science University, Portland, said that although the data were intriguing, he found many flaws in the analysis. The patients who had laparoscopy appeared to be younger, healthier, and predominantly female, said Dr. Hunter, who discussed the paper at the meeting.

This imbalance seems to make direct comparisons between the groups difficult, Dr. Hunter said.

Dr. Harrell said that he and his colleagues did notice a difference, but a subset and a multivariate analysis (controlling for age, gender, and comorbidities) still showed significantly shorter hospitalizations for the laparoscopic group and a higher rate of routine discharge to the patient's home, when compared with the open surgery group.

CHICAGO — A laparoscopic approach to appendectomy in the elderly appears to reduce mortality and complications, Dr. Andrew Harrell said at the annual meeting of the Society for Surgery of the Alimentary Tract.

Using data from the North Carolina Hospital Association Patient Data System, Dr. Harrell and his colleagues analyzed results for all patients who had an ICD-9 code for appendectomy in 1997–2003 who were either urgent or emergent. They then compared outcomes for patients aged 18–64 years and those aged 65 and over, and for those who had open and laparoscopic procedures.

During the time period analyzed, there were 28,929 appendectomies in the younger age group and 3,009 in the older group. Use of the laparoscopic approach in people over age 65 increased from 10.6% of appendectomies in 1997 to 21% in 2003, said Dr. Harrell of the division of gastrointestinal and minimally invasive surgery at the Carolinas Medical Center in Charlotte, N.C.

The elderly had a longer length of stay in the hospital (7.2 days vs. 3.5 days for the younger group), regardless of whether the procedure was open or laparoscopic. Complication rates and death rates were also higher in the elderly than in younger patients: 22.1% vs. 9% and 2.2% vs. 0.15%, respectively.

But, when older patients underwent laparoscopic appendectomy, all the outcomes improved, said Dr. Harrell. The length of stay decreased to 4.6 days, and 14.4% experienced complications, compared with 23.8% of those undergoing the open procedure. Mortality declined to 0.4% for the laparoscopic approach, compared with 2.7% for the open procedure. Laparoscopic charges, however, were higher than those for the younger group's less invasive surgery, at $16,670 compared with $11,160.

Dr. John Hunter, chairman of surgery at Oregon Health and Science University, Portland, said that although the data were intriguing, he found many flaws in the analysis. The patients who had laparoscopy appeared to be younger, healthier, and predominantly female, said Dr. Hunter, who discussed the paper at the meeting.

This imbalance seems to make direct comparisons between the groups difficult, Dr. Hunter said.

Dr. Harrell said that he and his colleagues did notice a difference, but a subset and a multivariate analysis (controlling for age, gender, and comorbidities) still showed significantly shorter hospitalizations for the laparoscopic group and a higher rate of routine discharge to the patient's home, when compared with the open surgery group.

PHILADELPHIA — Patients with heart failure who are taking nesiritide and who develop acute renal failure may be at an increased risk of death, Dr. Jose Iglesias said at the annual meeting of the American Society of Nephrology.

He presented new data showing that the use of nesiritide in patients with heart failure was not an independent predictor of mortality, but that it may be associated with an increased risk of mortality among patients who develop acute renal failure (ARF) after administration of neseritide.

Nesiritide (Natrecor) fell under scrutiny following the publication in early 2005 of two studies showing that it had no real benefit in heart failure and might increase the risk of death, Dr. Iglesias of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine said in presenting two studies on the topic. He conducted the research with associates at his institution, the Community Medical Center of Toms River (N.J.), and the University of Illinois at Chicago.

Both studies looked at patients with heart failure at the Toms River hospital, which admits close to 2,000 patients for that diagnosis each year.

In one study, the researchers analyzed 60-day mortality and ARF risk in 219 consecutive patients who came to the hospital for heart failure, including 71 who were given nesiritide. Overall, there was no significant difference in ARF between patients who received the drug (29%) and those who did not get an infusion (20%). Nor was there a big difference in mortality: 23% for those receiving nesiritide and 16% for those who did not get the drug.

In the nondrug group, lower glomerular filtration rate and older age were independent predictors of ARF. For the nesiritide group, hypertension and elevated blood urea nitrogen/serum creatinine were independent predictors. Mortality predictors in the nesiritide group included brain natriuretic peptide, intensive care admission, blood urea nitrogen/serum creatinine, and digoxin use.

However, 12 patients (23%) died after developing ARF, and 9 of those were taking nesiritide, suggesting an association. The researchers looked for some sort of link and found that among patients who died after developing ARF, the drug was an independent predictor of mortality when they used Cox analysis.

Dr. Iglesias and his colleagues concluded that patients who received nesiritide and who then developed ARF may be at increased risk of death.

In a larger, not-yet-completed investigation, he and his colleagues studied 1,412 heart failure patients, of whom 335 received nesiritide. Of the 1,412 patients, 186 (13%) developed ARF. Among those, 82 (44%) had received nesiritide, which was associated with a significant increase in the risk of ARF (odds ratio of 5.93). Patients who developed ARF also had significantly higher mortality: 18%, compared with 5% for those without ARF (odds ratio of 4).

The independent predictors for ARF were chronic renal failure, inotropic support, and nesiritide. Using a univariate analysis, the researchers found that the independent predictors for mortality included older age, digoxin use, nesiritide, inotropic support, chronic renal failure, and a history of hypertension.

Both Dr. Iglesias and a coauthor, Dr. Lance Berger, receive honoraria from Fremont, Calif.-based Scios Inc., which makes Natrecor.

PHILADELPHIA — Patients with heart failure who are taking nesiritide and who develop acute renal failure may be at an increased risk of death, Dr. Jose Iglesias said at the annual meeting of the American Society of Nephrology.

He presented new data showing that the use of nesiritide in patients with heart failure was not an independent predictor of mortality, but that it may be associated with an increased risk of mortality among patients who develop acute renal failure (ARF) after administration of neseritide.

Nesiritide (Natrecor) fell under scrutiny following the publication in early 2005 of two studies showing that it had no real benefit in heart failure and might increase the risk of death, Dr. Iglesias of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine said in presenting two studies on the topic. He conducted the research with associates at his institution, the Community Medical Center of Toms River (N.J.), and the University of Illinois at Chicago.

Both studies looked at patients with heart failure at the Toms River hospital, which admits close to 2,000 patients for that diagnosis each year.

In one study, the researchers analyzed 60-day mortality and ARF risk in 219 consecutive patients who came to the hospital for heart failure, including 71 who were given nesiritide. Overall, there was no significant difference in ARF between patients who received the drug (29%) and those who did not get an infusion (20%). Nor was there a big difference in mortality: 23% for those receiving nesiritide and 16% for those who did not get the drug.

In the nondrug group, lower glomerular filtration rate and older age were independent predictors of ARF. For the nesiritide group, hypertension and elevated blood urea nitrogen/serum creatinine were independent predictors. Mortality predictors in the nesiritide group included brain natriuretic peptide, intensive care admission, blood urea nitrogen/serum creatinine, and digoxin use.

However, 12 patients (23%) died after developing ARF, and 9 of those were taking nesiritide, suggesting an association. The researchers looked for some sort of link and found that among patients who died after developing ARF, the drug was an independent predictor of mortality when they used Cox analysis.

Dr. Iglesias and his colleagues concluded that patients who received nesiritide and who then developed ARF may be at increased risk of death.

In a larger, not-yet-completed investigation, he and his colleagues studied 1,412 heart failure patients, of whom 335 received nesiritide. Of the 1,412 patients, 186 (13%) developed ARF. Among those, 82 (44%) had received nesiritide, which was associated with a significant increase in the risk of ARF (odds ratio of 5.93). Patients who developed ARF also had significantly higher mortality: 18%, compared with 5% for those without ARF (odds ratio of 4).

The independent predictors for ARF were chronic renal failure, inotropic support, and nesiritide. Using a univariate analysis, the researchers found that the independent predictors for mortality included older age, digoxin use, nesiritide, inotropic support, chronic renal failure, and a history of hypertension.

Both Dr. Iglesias and a coauthor, Dr. Lance Berger, receive honoraria from Fremont, Calif.-based Scios Inc., which makes Natrecor.

PHILADELPHIA — Patients with heart failure who are taking nesiritide and who develop acute renal failure may be at an increased risk of death, Dr. Jose Iglesias said at the annual meeting of the American Society of Nephrology.

He presented new data showing that the use of nesiritide in patients with heart failure was not an independent predictor of mortality, but that it may be associated with an increased risk of mortality among patients who develop acute renal failure (ARF) after administration of neseritide.

Nesiritide (Natrecor) fell under scrutiny following the publication in early 2005 of two studies showing that it had no real benefit in heart failure and might increase the risk of death, Dr. Iglesias of the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine said in presenting two studies on the topic. He conducted the research with associates at his institution, the Community Medical Center of Toms River (N.J.), and the University of Illinois at Chicago.

Both studies looked at patients with heart failure at the Toms River hospital, which admits close to 2,000 patients for that diagnosis each year.

In one study, the researchers analyzed 60-day mortality and ARF risk in 219 consecutive patients who came to the hospital for heart failure, including 71 who were given nesiritide. Overall, there was no significant difference in ARF between patients who received the drug (29%) and those who did not get an infusion (20%). Nor was there a big difference in mortality: 23% for those receiving nesiritide and 16% for those who did not get the drug.

In the nondrug group, lower glomerular filtration rate and older age were independent predictors of ARF. For the nesiritide group, hypertension and elevated blood urea nitrogen/serum creatinine were independent predictors. Mortality predictors in the nesiritide group included brain natriuretic peptide, intensive care admission, blood urea nitrogen/serum creatinine, and digoxin use.

However, 12 patients (23%) died after developing ARF, and 9 of those were taking nesiritide, suggesting an association. The researchers looked for some sort of link and found that among patients who died after developing ARF, the drug was an independent predictor of mortality when they used Cox analysis.

Dr. Iglesias and his colleagues concluded that patients who received nesiritide and who then developed ARF may be at increased risk of death.

In a larger, not-yet-completed investigation, he and his colleagues studied 1,412 heart failure patients, of whom 335 received nesiritide. Of the 1,412 patients, 186 (13%) developed ARF. Among those, 82 (44%) had received nesiritide, which was associated with a significant increase in the risk of ARF (odds ratio of 5.93). Patients who developed ARF also had significantly higher mortality: 18%, compared with 5% for those without ARF (odds ratio of 4).

The independent predictors for ARF were chronic renal failure, inotropic support, and nesiritide. Using a univariate analysis, the researchers found that the independent predictors for mortality included older age, digoxin use, nesiritide, inotropic support, chronic renal failure, and a history of hypertension.

Both Dr. Iglesias and a coauthor, Dr. Lance Berger, receive honoraria from Fremont, Calif.-based Scios Inc., which makes Natrecor.

Peripheral arterial disease affects 15–20 million Americans, but it is not being properly diagnosed or treated, according to the authors of new guidelines for the management of PAD.

“Severe peripheral arterial disease is essentially an overlooked medical emergency in the United States,” said Dr. Alan T. Hirsch, chairman of the guidelines writing committee, in a briefing with reporters.

Cochair Dr. Ziv J. Haskal said a lack of focus on PAD—both by patients and physicians—has led to an average 4-month delay in diagnosing critical limb ischemia. Up to 80% of amputations may be due to that condition, and 60% may be preventable by earlier interventions, said Dr. Haskal, director of the vascular and interventional radiology division at New York-Presbyterian Hospital/Columbia University Medical Center in New York.

Though the panel cochairs emphasized that PAD is underdiagnosed and undertreated, they hesitated to point fingers.

“This isn't about looking back with blame. This is about looking forward,” Dr. Hirsch said.

The committee called on physicians to routinely ask patients if they have PAD symptoms, and to adopt physical exam techniques to ferret out blockages in the legs, feet, aorta, kidneys, and intestines.

Guidelines on PAD have been published before, but none have had such broad backing, noted Dr. Hirsch, who is director of Abbott Northwestern Hospital's Vascular Center in Minneapolis.

The American Heart Association/ American College of Cardiology Guidelines for the Management of Patients With Peripheral Arterial Disease is a product of the American Association for Vascular Surgery/Society for Vascular Surgery, the Society for Cardiovascular Angiography and Interventions, the Society of Interventional Radiology, the Society for Vascular Medicine and Biology, and the ACC/AHA Task Force on Practice Guidelines. They were endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; the National Heart, Lung, and Blood Institute; the Society for Vascular Nursing; the TransAtlantic Inter-Society Consensus; and the Vascular Disease Foundation.

The 17-member committee, which included representatives of most of these organizations, pored over 1,300 peer-reviewed studies to provide what Dr. Hirsch called “very powerful, evidence-based tools.”

The guidelines cover the diagnosis and management of atherosclerotic, aneurysmal, and thromboembolic PAD, but are limited to the abdominal aorta and its branches, the kidneys, the intestines, the legs, and the feet. Separate guidelines will be issued by the ACC in the spring on extracranial and vertebral arteries.

The guidelines offer background on each condition, including causes, risk factors, prevalence, and how to recognize it. Diagnosis and treatment recommendations are given, along with a corresponding rating of the level of evidence that supports the test or therapy.

Primary care physicians need to take on more responsibility for identifying PAD, the guidelines committee said.

“The key to this is it requires awareness among primary care physicians,” said Dr. Norman R. Hertzer, a cochair and chairman emeritus of the department of vascular surgery at the Cleveland Clinic.

For lower-extremity PAD, diagnosis can be confirmed with an ankle brachial index, which should be done for individuals at high risk for blockages in the legs or suspected of having such blockages.

Dr. Hirsch said that this recommendation would require a change in clinical practice, but that it “is important even for those with negligible to no symptoms because it represents a powerful opportunity” to prevent stroke, gangrene, amputation, or death. The guidelines have a table identifying patients who should have an ankle brachial index performed.

Dr. Haskal noted that PAD in the kidneys can lead to loss of function or difficult-to-control hypertension, which can affect heart function. Primary care physicians should consult the guidelines' algorithms on identifying who is at risk and who should be screened, he said. Screening is done largely with proven noninvasive imaging techniques such as duplex ultrasound.

Dr. Hertzer said screening is also crucial to identifying abdominal aortic aneurysms before they rupture. The mortality rate from a ruptured aneurysm—50%—has remained unchanged for decades, he said. But the risk of death after an elective repair is only 5%.

“A routine physical exam should not just involve listening to the chest and taking a chest x-ray. It should also include an abdominal exam in the office, and we've emphasized that in the guidelines,” Dr. Hertzer said.

The guidelines give recommendations on exam techniques and on treatment options, including a comparison of open abdominal repair vs. endograft repair. The endograft appeals to patients and poses a lower operative risk in sicker patients, but it has a higher rate of late complications and requires lifelong surveillance with CT scans to determine the stability of the graft and an absence of leaks, he said.

The ACC/AHA committee is planning several ways to make sure health care providers—especially those on the front lines—know about the new guidelines. An introductory Webcast was broadcast in December, and continuing medical education slides are being created for training programs, Dr. Hirsch said.

The ACC will also prepare wall charts and pocket guides. Eventually, the ACC will start to measure whether the guidelines are improving public health, but that is farther down the road, Dr. Hirsch said.

The guidelines appear in summary form on the ACC Web site at www.acc.org/clinical/guidelines/pad/summary.pdfwww.heart.org

Peripheral arterial disease affects 15–20 million Americans, but it is not being properly diagnosed or treated, according to the authors of new guidelines for the management of PAD.

“Severe peripheral arterial disease is essentially an overlooked medical emergency in the United States,” said Dr. Alan T. Hirsch, chairman of the guidelines writing committee, in a briefing with reporters.

Cochair Dr. Ziv J. Haskal said a lack of focus on PAD—both by patients and physicians—has led to an average 4-month delay in diagnosing critical limb ischemia. Up to 80% of amputations may be due to that condition, and 60% may be preventable by earlier interventions, said Dr. Haskal, director of the vascular and interventional radiology division at New York-Presbyterian Hospital/Columbia University Medical Center in New York.

Though the panel cochairs emphasized that PAD is underdiagnosed and undertreated, they hesitated to point fingers.

“This isn't about looking back with blame. This is about looking forward,” Dr. Hirsch said.

The committee called on physicians to routinely ask patients if they have PAD symptoms, and to adopt physical exam techniques to ferret out blockages in the legs, feet, aorta, kidneys, and intestines.

Guidelines on PAD have been published before, but none have had such broad backing, noted Dr. Hirsch, who is director of Abbott Northwestern Hospital's Vascular Center in Minneapolis.

The American Heart Association/ American College of Cardiology Guidelines for the Management of Patients With Peripheral Arterial Disease is a product of the American Association for Vascular Surgery/Society for Vascular Surgery, the Society for Cardiovascular Angiography and Interventions, the Society of Interventional Radiology, the Society for Vascular Medicine and Biology, and the ACC/AHA Task Force on Practice Guidelines. They were endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; the National Heart, Lung, and Blood Institute; the Society for Vascular Nursing; the TransAtlantic Inter-Society Consensus; and the Vascular Disease Foundation.

The 17-member committee, which included representatives of most of these organizations, pored over 1,300 peer-reviewed studies to provide what Dr. Hirsch called “very powerful, evidence-based tools.”

The guidelines cover the diagnosis and management of atherosclerotic, aneurysmal, and thromboembolic PAD, but are limited to the abdominal aorta and its branches, the kidneys, the intestines, the legs, and the feet. Separate guidelines will be issued by the ACC in the spring on extracranial and vertebral arteries.

The guidelines offer background on each condition, including causes, risk factors, prevalence, and how to recognize it. Diagnosis and treatment recommendations are given, along with a corresponding rating of the level of evidence that supports the test or therapy.

Primary care physicians need to take on more responsibility for identifying PAD, the guidelines committee said.

“The key to this is it requires awareness among primary care physicians,” said Dr. Norman R. Hertzer, a cochair and chairman emeritus of the department of vascular surgery at the Cleveland Clinic.

For lower-extremity PAD, diagnosis can be confirmed with an ankle brachial index, which should be done for individuals at high risk for blockages in the legs or suspected of having such blockages.

Dr. Hirsch said that this recommendation would require a change in clinical practice, but that it “is important even for those with negligible to no symptoms because it represents a powerful opportunity” to prevent stroke, gangrene, amputation, or death. The guidelines have a table identifying patients who should have an ankle brachial index performed.

Dr. Haskal noted that PAD in the kidneys can lead to loss of function or difficult-to-control hypertension, which can affect heart function. Primary care physicians should consult the guidelines' algorithms on identifying who is at risk and who should be screened, he said. Screening is done largely with proven noninvasive imaging techniques such as duplex ultrasound.

Dr. Hertzer said screening is also crucial to identifying abdominal aortic aneurysms before they rupture. The mortality rate from a ruptured aneurysm—50%—has remained unchanged for decades, he said. But the risk of death after an elective repair is only 5%.

“A routine physical exam should not just involve listening to the chest and taking a chest x-ray. It should also include an abdominal exam in the office, and we've emphasized that in the guidelines,” Dr. Hertzer said.

The guidelines give recommendations on exam techniques and on treatment options, including a comparison of open abdominal repair vs. endograft repair. The endograft appeals to patients and poses a lower operative risk in sicker patients, but it has a higher rate of late complications and requires lifelong surveillance with CT scans to determine the stability of the graft and an absence of leaks, he said.

The ACC/AHA committee is planning several ways to make sure health care providers—especially those on the front lines—know about the new guidelines. An introductory Webcast was broadcast in December, and continuing medical education slides are being created for training programs, Dr. Hirsch said.

The ACC will also prepare wall charts and pocket guides. Eventually, the ACC will start to measure whether the guidelines are improving public health, but that is farther down the road, Dr. Hirsch said.

The guidelines appear in summary form on the ACC Web site at www.acc.org/clinical/guidelines/pad/summary.pdfwww.heart.org

Peripheral arterial disease affects 15–20 million Americans, but it is not being properly diagnosed or treated, according to the authors of new guidelines for the management of PAD.

“Severe peripheral arterial disease is essentially an overlooked medical emergency in the United States,” said Dr. Alan T. Hirsch, chairman of the guidelines writing committee, in a briefing with reporters.

Cochair Dr. Ziv J. Haskal said a lack of focus on PAD—both by patients and physicians—has led to an average 4-month delay in diagnosing critical limb ischemia. Up to 80% of amputations may be due to that condition, and 60% may be preventable by earlier interventions, said Dr. Haskal, director of the vascular and interventional radiology division at New York-Presbyterian Hospital/Columbia University Medical Center in New York.

Though the panel cochairs emphasized that PAD is underdiagnosed and undertreated, they hesitated to point fingers.

“This isn't about looking back with blame. This is about looking forward,” Dr. Hirsch said.

The committee called on physicians to routinely ask patients if they have PAD symptoms, and to adopt physical exam techniques to ferret out blockages in the legs, feet, aorta, kidneys, and intestines.

Guidelines on PAD have been published before, but none have had such broad backing, noted Dr. Hirsch, who is director of Abbott Northwestern Hospital's Vascular Center in Minneapolis.

The American Heart Association/ American College of Cardiology Guidelines for the Management of Patients With Peripheral Arterial Disease is a product of the American Association for Vascular Surgery/Society for Vascular Surgery, the Society for Cardiovascular Angiography and Interventions, the Society of Interventional Radiology, the Society for Vascular Medicine and Biology, and the ACC/AHA Task Force on Practice Guidelines. They were endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; the National Heart, Lung, and Blood Institute; the Society for Vascular Nursing; the TransAtlantic Inter-Society Consensus; and the Vascular Disease Foundation.

The 17-member committee, which included representatives of most of these organizations, pored over 1,300 peer-reviewed studies to provide what Dr. Hirsch called “very powerful, evidence-based tools.”

The guidelines cover the diagnosis and management of atherosclerotic, aneurysmal, and thromboembolic PAD, but are limited to the abdominal aorta and its branches, the kidneys, the intestines, the legs, and the feet. Separate guidelines will be issued by the ACC in the spring on extracranial and vertebral arteries.

The guidelines offer background on each condition, including causes, risk factors, prevalence, and how to recognize it. Diagnosis and treatment recommendations are given, along with a corresponding rating of the level of evidence that supports the test or therapy.

Primary care physicians need to take on more responsibility for identifying PAD, the guidelines committee said.

“The key to this is it requires awareness among primary care physicians,” said Dr. Norman R. Hertzer, a cochair and chairman emeritus of the department of vascular surgery at the Cleveland Clinic.

For lower-extremity PAD, diagnosis can be confirmed with an ankle brachial index, which should be done for individuals at high risk for blockages in the legs or suspected of having such blockages.

Dr. Hirsch said that this recommendation would require a change in clinical practice, but that it “is important even for those with negligible to no symptoms because it represents a powerful opportunity” to prevent stroke, gangrene, amputation, or death. The guidelines have a table identifying patients who should have an ankle brachial index performed.

Dr. Haskal noted that PAD in the kidneys can lead to loss of function or difficult-to-control hypertension, which can affect heart function. Primary care physicians should consult the guidelines' algorithms on identifying who is at risk and who should be screened, he said. Screening is done largely with proven noninvasive imaging techniques such as duplex ultrasound.

Dr. Hertzer said screening is also crucial to identifying abdominal aortic aneurysms before they rupture. The mortality rate from a ruptured aneurysm—50%—has remained unchanged for decades, he said. But the risk of death after an elective repair is only 5%.

“A routine physical exam should not just involve listening to the chest and taking a chest x-ray. It should also include an abdominal exam in the office, and we've emphasized that in the guidelines,” Dr. Hertzer said.

The guidelines give recommendations on exam techniques and on treatment options, including a comparison of open abdominal repair vs. endograft repair. The endograft appeals to patients and poses a lower operative risk in sicker patients, but it has a higher rate of late complications and requires lifelong surveillance with CT scans to determine the stability of the graft and an absence of leaks, he said.

The ACC/AHA committee is planning several ways to make sure health care providers—especially those on the front lines—know about the new guidelines. An introductory Webcast was broadcast in December, and continuing medical education slides are being created for training programs, Dr. Hirsch said.

The ACC will also prepare wall charts and pocket guides. Eventually, the ACC will start to measure whether the guidelines are improving public health, but that is farther down the road, Dr. Hirsch said.

The guidelines appear in summary form on the ACC Web site at www.acc.org/clinical/guidelines/pad/summary.pdfwww.heart.org

WASHINGTON — Patients who received carotid stents had an incidence of stroke similar to those who underwent carotid endarterectomy, according to initial follow-up data from two large studies and an ongoing registry, reported Dr. Jay Yadav at a symposium sponsored by the Cardiovascular Research Foundation.

He presented results from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, the U.S. Carotid Feasibility Study (USFS), and the SAPPHIRE registry. Enrollment in SAPPHIRE was terminated not long after it began, as an interim analysis showed that stenting had a marked benefit over surgery. The 3-year follow-up data were not as striking as were earlier findings but still indicated that stenting had durable benefits: Stented patients were less likely to require repeat procedures compared with those treated by endarterectomy, and stenting reduced the future stroke risk to a baseline rate of 1%, Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation's department of cardiovascular medicine, said at a press briefing.

He said the results of the two studies and the SAPPHIRE registry should be heartening to the federal Medicare program. “You're not going to need a repeat proce-dure, so it's cost effective,” he commented.”

SAPPHIRE data showed that the 1% incremental annual risk of stroke in the stent arms was similar to that seen with endarterectomy, according to Dr. Yadav, who was an investigator in the study.

In SAPPHIRE, 334 patients—all at high risk for stroke—were randomized to endarterectomy or a stent (Cordis Corp.'s Precise Nitinol self-expanding stent, deployed with the Angioguard XP Emboli Capture Guidewire System). Each patient was seen by a panel consisting of a surgeon, an interventionalist, and a neurologist; if they could not agree on randomization, patients were put in the SAPPHIRE registry. In that group, 406 were deemed an unacceptable risk for endarterectomy, and were given a stent, and 7 were considered an unacceptable risk for stenting and assigned to surgery. The registry then, consists of ultra- high-risk patients, said Dr. Yadav.

For the randomized patients, the absolute change in the stroke rate between 30 days and 3 years was close to 4% for both groups. At 3 years, the incidence of stroke was still comparable at about 7% for each treatment group. At that time point, stroke follow-up data were available for 112 (67%) of the 167 endarterectomy patients and 139 (83%) of 167 stent patients.

There was a more significant difference in the incidence of target lesion revascularization. At 3 years, the rate was 7% for endarterectomy (with follow-up for 67%, or 112 patients), compared with 3% for the stent (with data on 139, or 83% of the group).

“We're seeing now in many, many, studies, once your carotid is fixed by metal stent or surgery, your risk of stroke will drop to 1% per year,” said Dr. Yadav, adding that overall there was “clearly a lower repeat procedure rate for stenting.” For nonrandomized patients in the SAPPHIRE registry, the absolute change in stroke between 30 days and 3 years for stented patients was 5%, and for the USFS, it was 3%.

The USFS was conducted before SAPPHIRE; it was a prospective, nonrandomized study to evaluate the Precise stent, with or without the Angioguard guidewire. In the study, 261 patients who had been deemed too high risk for endarterectomy were divided into symptomatic (greater than 60% stenosis by ultrasound or angiography) or asymptomatic (greater than 80% stenosis). The target lesion revascularization rate at 3 years was 2.5% for the 406 SAPPHIRE registry patients, and 2.7% for the high-risk USFS patients.

Dr. Roxana Mehran, medical director of the data coordinating and analysis center at the Cardiovascular Research Foundation in New York, cautioned that there are not similar 3-year data on endarterectomy, so not much is known about the recurrence rates with the procedure. But both Dr. Mehran and Dr. Yadav agreed that stenting was likely to cause less damage to the carotid tissue than surgery. “Endarterectomy is a fairly brutal procedure, but it does work,” said Dr. Yadav. But, he said, the restenosis rates appear to be lower with stenting than with the surgical procedure.

WASHINGTON — Patients who received carotid stents had an incidence of stroke similar to those who underwent carotid endarterectomy, according to initial follow-up data from two large studies and an ongoing registry, reported Dr. Jay Yadav at a symposium sponsored by the Cardiovascular Research Foundation.

He presented results from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, the U.S. Carotid Feasibility Study (USFS), and the SAPPHIRE registry. Enrollment in SAPPHIRE was terminated not long after it began, as an interim analysis showed that stenting had a marked benefit over surgery. The 3-year follow-up data were not as striking as were earlier findings but still indicated that stenting had durable benefits: Stented patients were less likely to require repeat procedures compared with those treated by endarterectomy, and stenting reduced the future stroke risk to a baseline rate of 1%, Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation's department of cardiovascular medicine, said at a press briefing.

He said the results of the two studies and the SAPPHIRE registry should be heartening to the federal Medicare program. “You're not going to need a repeat proce-dure, so it's cost effective,” he commented.”

SAPPHIRE data showed that the 1% incremental annual risk of stroke in the stent arms was similar to that seen with endarterectomy, according to Dr. Yadav, who was an investigator in the study.

In SAPPHIRE, 334 patients—all at high risk for stroke—were randomized to endarterectomy or a stent (Cordis Corp.'s Precise Nitinol self-expanding stent, deployed with the Angioguard XP Emboli Capture Guidewire System). Each patient was seen by a panel consisting of a surgeon, an interventionalist, and a neurologist; if they could not agree on randomization, patients were put in the SAPPHIRE registry. In that group, 406 were deemed an unacceptable risk for endarterectomy, and were given a stent, and 7 were considered an unacceptable risk for stenting and assigned to surgery. The registry then, consists of ultra- high-risk patients, said Dr. Yadav.

For the randomized patients, the absolute change in the stroke rate between 30 days and 3 years was close to 4% for both groups. At 3 years, the incidence of stroke was still comparable at about 7% for each treatment group. At that time point, stroke follow-up data were available for 112 (67%) of the 167 endarterectomy patients and 139 (83%) of 167 stent patients.

There was a more significant difference in the incidence of target lesion revascularization. At 3 years, the rate was 7% for endarterectomy (with follow-up for 67%, or 112 patients), compared with 3% for the stent (with data on 139, or 83% of the group).

“We're seeing now in many, many, studies, once your carotid is fixed by metal stent or surgery, your risk of stroke will drop to 1% per year,” said Dr. Yadav, adding that overall there was “clearly a lower repeat procedure rate for stenting.” For nonrandomized patients in the SAPPHIRE registry, the absolute change in stroke between 30 days and 3 years for stented patients was 5%, and for the USFS, it was 3%.

The USFS was conducted before SAPPHIRE; it was a prospective, nonrandomized study to evaluate the Precise stent, with or without the Angioguard guidewire. In the study, 261 patients who had been deemed too high risk for endarterectomy were divided into symptomatic (greater than 60% stenosis by ultrasound or angiography) or asymptomatic (greater than 80% stenosis). The target lesion revascularization rate at 3 years was 2.5% for the 406 SAPPHIRE registry patients, and 2.7% for the high-risk USFS patients.

Dr. Roxana Mehran, medical director of the data coordinating and analysis center at the Cardiovascular Research Foundation in New York, cautioned that there are not similar 3-year data on endarterectomy, so not much is known about the recurrence rates with the procedure. But both Dr. Mehran and Dr. Yadav agreed that stenting was likely to cause less damage to the carotid tissue than surgery. “Endarterectomy is a fairly brutal procedure, but it does work,” said Dr. Yadav. But, he said, the restenosis rates appear to be lower with stenting than with the surgical procedure.

WASHINGTON — Patients who received carotid stents had an incidence of stroke similar to those who underwent carotid endarterectomy, according to initial follow-up data from two large studies and an ongoing registry, reported Dr. Jay Yadav at a symposium sponsored by the Cardiovascular Research Foundation.

He presented results from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, the U.S. Carotid Feasibility Study (USFS), and the SAPPHIRE registry. Enrollment in SAPPHIRE was terminated not long after it began, as an interim analysis showed that stenting had a marked benefit over surgery. The 3-year follow-up data were not as striking as were earlier findings but still indicated that stenting had durable benefits: Stented patients were less likely to require repeat procedures compared with those treated by endarterectomy, and stenting reduced the future stroke risk to a baseline rate of 1%, Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation's department of cardiovascular medicine, said at a press briefing.

He said the results of the two studies and the SAPPHIRE registry should be heartening to the federal Medicare program. “You're not going to need a repeat proce-dure, so it's cost effective,” he commented.”

SAPPHIRE data showed that the 1% incremental annual risk of stroke in the stent arms was similar to that seen with endarterectomy, according to Dr. Yadav, who was an investigator in the study.

In SAPPHIRE, 334 patients—all at high risk for stroke—were randomized to endarterectomy or a stent (Cordis Corp.'s Precise Nitinol self-expanding stent, deployed with the Angioguard XP Emboli Capture Guidewire System). Each patient was seen by a panel consisting of a surgeon, an interventionalist, and a neurologist; if they could not agree on randomization, patients were put in the SAPPHIRE registry. In that group, 406 were deemed an unacceptable risk for endarterectomy, and were given a stent, and 7 were considered an unacceptable risk for stenting and assigned to surgery. The registry then, consists of ultra- high-risk patients, said Dr. Yadav.

For the randomized patients, the absolute change in the stroke rate between 30 days and 3 years was close to 4% for both groups. At 3 years, the incidence of stroke was still comparable at about 7% for each treatment group. At that time point, stroke follow-up data were available for 112 (67%) of the 167 endarterectomy patients and 139 (83%) of 167 stent patients.

There was a more significant difference in the incidence of target lesion revascularization. At 3 years, the rate was 7% for endarterectomy (with follow-up for 67%, or 112 patients), compared with 3% for the stent (with data on 139, or 83% of the group).

“We're seeing now in many, many, studies, once your carotid is fixed by metal stent or surgery, your risk of stroke will drop to 1% per year,” said Dr. Yadav, adding that overall there was “clearly a lower repeat procedure rate for stenting.” For nonrandomized patients in the SAPPHIRE registry, the absolute change in stroke between 30 days and 3 years for stented patients was 5%, and for the USFS, it was 3%.

The USFS was conducted before SAPPHIRE; it was a prospective, nonrandomized study to evaluate the Precise stent, with or without the Angioguard guidewire. In the study, 261 patients who had been deemed too high risk for endarterectomy were divided into symptomatic (greater than 60% stenosis by ultrasound or angiography) or asymptomatic (greater than 80% stenosis). The target lesion revascularization rate at 3 years was 2.5% for the 406 SAPPHIRE registry patients, and 2.7% for the high-risk USFS patients.

Dr. Roxana Mehran, medical director of the data coordinating and analysis center at the Cardiovascular Research Foundation in New York, cautioned that there are not similar 3-year data on endarterectomy, so not much is known about the recurrence rates with the procedure. But both Dr. Mehran and Dr. Yadav agreed that stenting was likely to cause less damage to the carotid tissue than surgery. “Endarterectomy is a fairly brutal procedure, but it does work,” said Dr. Yadav. But, he said, the restenosis rates appear to be lower with stenting than with the surgical procedure.

WASHINGTON – Learning to differentiate between drug-seeking behavior and unmet pain needs can help emergency physicians cope better with chronic pain patients, who are frequent emergency department visitors, said Dr. James Ducharme at the annual meeting of the American College of Emergency Physicians.

It can be hard to determine when a patient is requesting medications for true pain as opposed to seeking them for diversion, he said.

However, if anything, patients are not given enough pain medication by emergency physicians–and, often, if they ask for a pharmaceutical by name, they are identified, usually incorrectly, as addicts, said Dr. Ducharme, who is professor of emergency medicine at Dalhousie University in Halifax, N.S., Canada, and clinical director of the emergency medicine department at Saint John Regional Hospital, N.B.

According to Dr. Ducharme, about 70% of people presenting to the emergency department have a pain complaint, but only about one-half of 1% are addicted.

When pain goes untreated, however, chronic pain patients, such as those with sickle cell disease, have behavioral traits that, taken alone, resemble those of addicts, he said. They see the ED as the place of last resort when they have not been helped elsewhere. Physicians often give these patients a short-acting opioid and then discharge them.

This is a mistake, though, because many chronic pain patients are already taking long-acting opioids. By giving them the shorter-acting formulations, the physicians may be creating tolerance.

Opioids also do not provide any long-term benefit to fibromyalgia patients or to those with neuralgic pain; myofascial pain syndrome; or chronic, stable, nonmalignant pain such as back pain. It is incumbent on the physician to explain this to patients, Dr. Ducharme said.

Migraineurs and others with recurrent conditions tend to know what works for them and will ask for the medication by name, but ED physicians may mistake that behavior for drug seeking, he said.

“It's not their fault if they know what they're talking about,” Dr. Ducharme pointed out, adding that migraineurs also tend to visit an emergency department only once or twice a year.

However, migraine headaches, dental pain, back pain, and recurrent abdominal pain are common scenarios cited by drug takers to procure opioids, he said. Not surprisingly, many physicians doubt these patients' veracity.

But there are ways of treating pain without rewarding addicts, he noted.

If abuse is suspected, the suspicions should be voiced to the patient. If the issue is not resolved, give the patient an oral analgesic such as morphine, but only enough to last until a physician can be seen the following day. There are other options: a dental block with bupivacaine for dental pain, for instance. The patient should not get a prescription, Dr. Ducharme said.

Physicians should not be confrontational with patients, but should suggest that they have a problem and then try to do whatever possible to treat the abuse. “If all we do is try to get them out of the ED and not address the abuse, we are ethically failing,” Dr. Ducharme said.

Unfortunately, there are no evidence-based rules for identifying drug abusers, he said, adding that being objective is also difficult. The physician's own perceptions–of who is an abuser and of what pain should look like–can shape his or her judgment about who is truly in pain and who is seeking drugs for diversion, he said.

Dr. Ducharme gave some rules of thumb. Patients who aggressively complain about needing more drugs and who hoard during periods of reduced symptoms, request specific drugs, or openly acquire similar drugs from other medical sources may not be recreational drug takers or addicts, he said.

Patients who sell prescription drugs, steal them from others, and get them from nonmedical sources are much more likely to be drug takers, he said.

Another difficulty is treating addicts in pain, as they will need large doses of a medication. Physicians should accept that reality and consider alternatives to opioids, such as epidural or regional anesthesia, ketamine infusion, and NSAIDs, Dr. Ducharme said.

Most so-called drug takers, however, are patients whose pain is poorly controlled. ED physicians can help end the cycle by having good references for patients when they go back out into the community. And, he reiterated, drug abusers should get an objective assessment and good medical treatment, despite their history.

Dr. Ducharme disclosed that he has received a speaker honorarium in the past from Purdue Pharma, the manufacturer of painkillers such as MS Contin and OxyContin.

WASHINGTON – Learning to differentiate between drug-seeking behavior and unmet pain needs can help emergency physicians cope better with chronic pain patients, who are frequent emergency department visitors, said Dr. James Ducharme at the annual meeting of the American College of Emergency Physicians.

It can be hard to determine when a patient is requesting medications for true pain as opposed to seeking them for diversion, he said.

However, if anything, patients are not given enough pain medication by emergency physicians–and, often, if they ask for a pharmaceutical by name, they are identified, usually incorrectly, as addicts, said Dr. Ducharme, who is professor of emergency medicine at Dalhousie University in Halifax, N.S., Canada, and clinical director of the emergency medicine department at Saint John Regional Hospital, N.B.

According to Dr. Ducharme, about 70% of people presenting to the emergency department have a pain complaint, but only about one-half of 1% are addicted.

When pain goes untreated, however, chronic pain patients, such as those with sickle cell disease, have behavioral traits that, taken alone, resemble those of addicts, he said. They see the ED as the place of last resort when they have not been helped elsewhere. Physicians often give these patients a short-acting opioid and then discharge them.

This is a mistake, though, because many chronic pain patients are already taking long-acting opioids. By giving them the shorter-acting formulations, the physicians may be creating tolerance.

Opioids also do not provide any long-term benefit to fibromyalgia patients or to those with neuralgic pain; myofascial pain syndrome; or chronic, stable, nonmalignant pain such as back pain. It is incumbent on the physician to explain this to patients, Dr. Ducharme said.

Migraineurs and others with recurrent conditions tend to know what works for them and will ask for the medication by name, but ED physicians may mistake that behavior for drug seeking, he said.

“It's not their fault if they know what they're talking about,” Dr. Ducharme pointed out, adding that migraineurs also tend to visit an emergency department only once or twice a year.

However, migraine headaches, dental pain, back pain, and recurrent abdominal pain are common scenarios cited by drug takers to procure opioids, he said. Not surprisingly, many physicians doubt these patients' veracity.

But there are ways of treating pain without rewarding addicts, he noted.

If abuse is suspected, the suspicions should be voiced to the patient. If the issue is not resolved, give the patient an oral analgesic such as morphine, but only enough to last until a physician can be seen the following day. There are other options: a dental block with bupivacaine for dental pain, for instance. The patient should not get a prescription, Dr. Ducharme said.

Physicians should not be confrontational with patients, but should suggest that they have a problem and then try to do whatever possible to treat the abuse. “If all we do is try to get them out of the ED and not address the abuse, we are ethically failing,” Dr. Ducharme said.

Unfortunately, there are no evidence-based rules for identifying drug abusers, he said, adding that being objective is also difficult. The physician's own perceptions–of who is an abuser and of what pain should look like–can shape his or her judgment about who is truly in pain and who is seeking drugs for diversion, he said.

Dr. Ducharme gave some rules of thumb. Patients who aggressively complain about needing more drugs and who hoard during periods of reduced symptoms, request specific drugs, or openly acquire similar drugs from other medical sources may not be recreational drug takers or addicts, he said.

Patients who sell prescription drugs, steal them from others, and get them from nonmedical sources are much more likely to be drug takers, he said.

Another difficulty is treating addicts in pain, as they will need large doses of a medication. Physicians should accept that reality and consider alternatives to opioids, such as epidural or regional anesthesia, ketamine infusion, and NSAIDs, Dr. Ducharme said.

Most so-called drug takers, however, are patients whose pain is poorly controlled. ED physicians can help end the cycle by having good references for patients when they go back out into the community. And, he reiterated, drug abusers should get an objective assessment and good medical treatment, despite their history.

Dr. Ducharme disclosed that he has received a speaker honorarium in the past from Purdue Pharma, the manufacturer of painkillers such as MS Contin and OxyContin.

WASHINGTON – Learning to differentiate between drug-seeking behavior and unmet pain needs can help emergency physicians cope better with chronic pain patients, who are frequent emergency department visitors, said Dr. James Ducharme at the annual meeting of the American College of Emergency Physicians.

It can be hard to determine when a patient is requesting medications for true pain as opposed to seeking them for diversion, he said.

However, if anything, patients are not given enough pain medication by emergency physicians–and, often, if they ask for a pharmaceutical by name, they are identified, usually incorrectly, as addicts, said Dr. Ducharme, who is professor of emergency medicine at Dalhousie University in Halifax, N.S., Canada, and clinical director of the emergency medicine department at Saint John Regional Hospital, N.B.

According to Dr. Ducharme, about 70% of people presenting to the emergency department have a pain complaint, but only about one-half of 1% are addicted.

When pain goes untreated, however, chronic pain patients, such as those with sickle cell disease, have behavioral traits that, taken alone, resemble those of addicts, he said. They see the ED as the place of last resort when they have not been helped elsewhere. Physicians often give these patients a short-acting opioid and then discharge them.

This is a mistake, though, because many chronic pain patients are already taking long-acting opioids. By giving them the shorter-acting formulations, the physicians may be creating tolerance.

Opioids also do not provide any long-term benefit to fibromyalgia patients or to those with neuralgic pain; myofascial pain syndrome; or chronic, stable, nonmalignant pain such as back pain. It is incumbent on the physician to explain this to patients, Dr. Ducharme said.

Migraineurs and others with recurrent conditions tend to know what works for them and will ask for the medication by name, but ED physicians may mistake that behavior for drug seeking, he said.

“It's not their fault if they know what they're talking about,” Dr. Ducharme pointed out, adding that migraineurs also tend to visit an emergency department only once or twice a year.

However, migraine headaches, dental pain, back pain, and recurrent abdominal pain are common scenarios cited by drug takers to procure opioids, he said. Not surprisingly, many physicians doubt these patients' veracity.

But there are ways of treating pain without rewarding addicts, he noted.

If abuse is suspected, the suspicions should be voiced to the patient. If the issue is not resolved, give the patient an oral analgesic such as morphine, but only enough to last until a physician can be seen the following day. There are other options: a dental block with bupivacaine for dental pain, for instance. The patient should not get a prescription, Dr. Ducharme said.

Physicians should not be confrontational with patients, but should suggest that they have a problem and then try to do whatever possible to treat the abuse. “If all we do is try to get them out of the ED and not address the abuse, we are ethically failing,” Dr. Ducharme said.

Unfortunately, there are no evidence-based rules for identifying drug abusers, he said, adding that being objective is also difficult. The physician's own perceptions–of who is an abuser and of what pain should look like–can shape his or her judgment about who is truly in pain and who is seeking drugs for diversion, he said.

Dr. Ducharme gave some rules of thumb. Patients who aggressively complain about needing more drugs and who hoard during periods of reduced symptoms, request specific drugs, or openly acquire similar drugs from other medical sources may not be recreational drug takers or addicts, he said.

Patients who sell prescription drugs, steal them from others, and get them from nonmedical sources are much more likely to be drug takers, he said.

Another difficulty is treating addicts in pain, as they will need large doses of a medication. Physicians should accept that reality and consider alternatives to opioids, such as epidural or regional anesthesia, ketamine infusion, and NSAIDs, Dr. Ducharme said.

Most so-called drug takers, however, are patients whose pain is poorly controlled. ED physicians can help end the cycle by having good references for patients when they go back out into the community. And, he reiterated, drug abusers should get an objective assessment and good medical treatment, despite their history.

Dr. Ducharme disclosed that he has received a speaker honorarium in the past from Purdue Pharma, the manufacturer of painkillers such as MS Contin and OxyContin.

Recent demands for disclosure of data on hospital infection rates have spurred efforts not only to measure and publicize the numbers but also to demonstrate progress in controlling infections. The pressure is on to improve performance, because many insurers, employers, state and federal regulatory agencies, and consumer groups view infection control as a proxy for quality and patient safety.

During the past year, 39 states introduced legislation and 6 states passed laws requiring hospitals to disclose nosocomial infections to the state, and—in many instances—also to the public (N. Engl. J. Med. 2005;353:225–7).

But most surveillance and measurement efforts have been made behind closed doors. For example, the Centers for Disease Control and Prevention lets hospitals compare infection rates with other hospitals through the National Healthcare Safety Network, but this information is not available to the public.

The Joint Commission on Accreditation of Healthcare Organizations says it does not maintain statistics on hospital infections, although it recently published a study tracking how well hospitals did in giving antibiotics to pneumonia patients, among other quality of care measures (N. Engl. J. Med. 2005;353:255–64).

And the Centers for Medicare and Medicaid Services (CMS) sponsored a pilot project in which hospitals that focused on improving infection control were able to decrease the overall infection rate by 27%.

Robert A. Weinstein, M.D., recently said that those efforts are “a reality” and could lead to improved performance (N. Engl. J. Med. 2005;353:225–7). But to allow for meaningful comparisons among facilities and to spur better quality care, the measures should include such assessments as timely administration of perioperative antibiotic prophylaxis, vascular catheter insertion practices, and hand hygiene, said Dr. Weinstein, chairman of infectious diseases at the John H. Stroger Hospital of Cook County (Ill.). Infection control report cards should also track rates of infection in the ICU that are associated with central vascular catheters; reoperation or rehospitalizations for surgical site infections; rates of nosocomial influenza; and infections caused by multidrug-resistant organisms, he added.

Focus Brings Improvement

Many of those suggested measures were used to track performance in a group of hospitals that participated in the National Surgical Infection Prevention Collaborative. The collaborative was sponsored by CMS and managed by Qualis Health, a Medicare Quality Improvement organization that monitors quality for Washington state, Idaho, and Alaska. Of the 56 hospitals that joined the 12-month project, 44 reported enough data to draw conclusions (Am. J. Surg. 2005;190:9–15).

At each hospital, a team identified a limited set of surgical procedures or surgeons and tracked them for at least 30 days post procedure to determine the proportion of patients getting prophylactic drugs within an hour before the incision, the proportion getting appropriate agents, and the proportion who had prophylaxis discontinued within 24 hours. After identifying the procedures or surgeons to be monitored and gauging a baseline rate for each process to be measured, interdisciplinary teams worked on instituting ways to improve processes.

Over the year, 35,543 patients were tracked. The infection rate was 2.28% in the first 3 months (215 infections among 9,435 cases during that time period); it fell to 1.65% by the last 3 reporting months, constituting a 28% reduction.

Lead author E. Patchen Dellinger, M.D., chief of the division of general surgery at the University of Washington's Eastside Specialty Center, said in an interview that the collaborative focused partly on getting hospitals to more closely identify and monitor infections such as having a nurse check on a patient a set number of times post procedure, or conducting telephone follow-up to ask about problems with wound healing.

The hospitals did not receive any financial assistance for participation; for most, it cost the equivalent of a full-time nurse for the year, Dr. Dellinger estimated.

Achieving initial progress is the easy part, he observed. “The hardest thing is spreading the gains beyond the pilot population and then holding the gains and not backsiding.”

Spreading and Holding the Gains

Evergreen Hospital is one facility that has managed to keep improving, said Stuart Schrader, R.N., director of surgical services for the 244-bed community facility in Kirkland, Wash. The hospital did not have a grasp on baseline infection rates, although they appeared to be low (about 0.25% in 1999), Mr. Schrader said in an interview.

But the rate climbed each year, hitting 0.7% in 2001. After joining the project and learning some new surveillance techniques, the hospital found that its rate was closer to 1.1%.

Since then, the hospital has adopted quality improvement measures, such as using a convective warming blanket on patients preoperatively and requiring the anesthesiologist to shake hands with each patient—the “warm hands” test—to make sure he or she is normothermic during surgery. Patients are kept warm with the same blankets post procedure in order to ensure proper blood flow to the wound area and thus prevent infection. The hospital has also increased the temperature in its eight operating rooms, and purchased jackets and vests with pockets for cold packs to keep the staff and surgeons comfortable, Mr. Schrader said.

To ensure that patients always receive antibiotics an hour before the procedure, the anesthesiologist is required to call the holding room nurse, who administers the antibiotic.

Razors have been mostly replaced with clippers for shaving hair around surgical sites, which reduces nicks that could invite infection, Mr. Schrader said.

Evergreen has cut its infection rate to 0.85%.

Mr. Schrader expects infection control to continue to be an area of focus. “The hard part was putting the energy into making the changes,” he said. “Once the changes were made, it became a normal way of life.”

Recent demands for disclosure of data on hospital infection rates have spurred efforts not only to measure and publicize the numbers but also to demonstrate progress in controlling infections. The pressure is on to improve performance, because many insurers, employers, state and federal regulatory agencies, and consumer groups view infection control as a proxy for quality and patient safety.

During the past year, 39 states introduced legislation and 6 states passed laws requiring hospitals to disclose nosocomial infections to the state, and—in many instances—also to the public (N. Engl. J. Med. 2005;353:225–7).

But most surveillance and measurement efforts have been made behind closed doors. For example, the Centers for Disease Control and Prevention lets hospitals compare infection rates with other hospitals through the National Healthcare Safety Network, but this information is not available to the public.

The Joint Commission on Accreditation of Healthcare Organizations says it does not maintain statistics on hospital infections, although it recently published a study tracking how well hospitals did in giving antibiotics to pneumonia patients, among other quality of care measures (N. Engl. J. Med. 2005;353:255–64).

And the Centers for Medicare and Medicaid Services (CMS) sponsored a pilot project in which hospitals that focused on improving infection control were able to decrease the overall infection rate by 27%.

Robert A. Weinstein, M.D., recently said that those efforts are “a reality” and could lead to improved performance (N. Engl. J. Med. 2005;353:225–7). But to allow for meaningful comparisons among facilities and to spur better quality care, the measures should include such assessments as timely administration of perioperative antibiotic prophylaxis, vascular catheter insertion practices, and hand hygiene, said Dr. Weinstein, chairman of infectious diseases at the John H. Stroger Hospital of Cook County (Ill.). Infection control report cards should also track rates of infection in the ICU that are associated with central vascular catheters; reoperation or rehospitalizations for surgical site infections; rates of nosocomial influenza; and infections caused by multidrug-resistant organisms, he added.

Focus Brings Improvement

Many of those suggested measures were used to track performance in a group of hospitals that participated in the National Surgical Infection Prevention Collaborative. The collaborative was sponsored by CMS and managed by Qualis Health, a Medicare Quality Improvement organization that monitors quality for Washington state, Idaho, and Alaska. Of the 56 hospitals that joined the 12-month project, 44 reported enough data to draw conclusions (Am. J. Surg. 2005;190:9–15).

At each hospital, a team identified a limited set of surgical procedures or surgeons and tracked them for at least 30 days post procedure to determine the proportion of patients getting prophylactic drugs within an hour before the incision, the proportion getting appropriate agents, and the proportion who had prophylaxis discontinued within 24 hours. After identifying the procedures or surgeons to be monitored and gauging a baseline rate for each process to be measured, interdisciplinary teams worked on instituting ways to improve processes.

Over the year, 35,543 patients were tracked. The infection rate was 2.28% in the first 3 months (215 infections among 9,435 cases during that time period); it fell to 1.65% by the last 3 reporting months, constituting a 28% reduction.

Lead author E. Patchen Dellinger, M.D., chief of the division of general surgery at the University of Washington's Eastside Specialty Center, said in an interview that the collaborative focused partly on getting hospitals to more closely identify and monitor infections such as having a nurse check on a patient a set number of times post procedure, or conducting telephone follow-up to ask about problems with wound healing.

The hospitals did not receive any financial assistance for participation; for most, it cost the equivalent of a full-time nurse for the year, Dr. Dellinger estimated.

Achieving initial progress is the easy part, he observed. “The hardest thing is spreading the gains beyond the pilot population and then holding the gains and not backsiding.”

Spreading and Holding the Gains

Evergreen Hospital is one facility that has managed to keep improving, said Stuart Schrader, R.N., director of surgical services for the 244-bed community facility in Kirkland, Wash. The hospital did not have a grasp on baseline infection rates, although they appeared to be low (about 0.25% in 1999), Mr. Schrader said in an interview.

But the rate climbed each year, hitting 0.7% in 2001. After joining the project and learning some new surveillance techniques, the hospital found that its rate was closer to 1.1%.

Since then, the hospital has adopted quality improvement measures, such as using a convective warming blanket on patients preoperatively and requiring the anesthesiologist to shake hands with each patient—the “warm hands” test—to make sure he or she is normothermic during surgery. Patients are kept warm with the same blankets post procedure in order to ensure proper blood flow to the wound area and thus prevent infection. The hospital has also increased the temperature in its eight operating rooms, and purchased jackets and vests with pockets for cold packs to keep the staff and surgeons comfortable, Mr. Schrader said.

To ensure that patients always receive antibiotics an hour before the procedure, the anesthesiologist is required to call the holding room nurse, who administers the antibiotic.

Razors have been mostly replaced with clippers for shaving hair around surgical sites, which reduces nicks that could invite infection, Mr. Schrader said.

Evergreen has cut its infection rate to 0.85%.

Mr. Schrader expects infection control to continue to be an area of focus. “The hard part was putting the energy into making the changes,” he said. “Once the changes were made, it became a normal way of life.”

Recent demands for disclosure of data on hospital infection rates have spurred efforts not only to measure and publicize the numbers but also to demonstrate progress in controlling infections. The pressure is on to improve performance, because many insurers, employers, state and federal regulatory agencies, and consumer groups view infection control as a proxy for quality and patient safety.

During the past year, 39 states introduced legislation and 6 states passed laws requiring hospitals to disclose nosocomial infections to the state, and—in many instances—also to the public (N. Engl. J. Med. 2005;353:225–7).

But most surveillance and measurement efforts have been made behind closed doors. For example, the Centers for Disease Control and Prevention lets hospitals compare infection rates with other hospitals through the National Healthcare Safety Network, but this information is not available to the public.

The Joint Commission on Accreditation of Healthcare Organizations says it does not maintain statistics on hospital infections, although it recently published a study tracking how well hospitals did in giving antibiotics to pneumonia patients, among other quality of care measures (N. Engl. J. Med. 2005;353:255–64).

And the Centers for Medicare and Medicaid Services (CMS) sponsored a pilot project in which hospitals that focused on improving infection control were able to decrease the overall infection rate by 27%.

Robert A. Weinstein, M.D., recently said that those efforts are “a reality” and could lead to improved performance (N. Engl. J. Med. 2005;353:225–7). But to allow for meaningful comparisons among facilities and to spur better quality care, the measures should include such assessments as timely administration of perioperative antibiotic prophylaxis, vascular catheter insertion practices, and hand hygiene, said Dr. Weinstein, chairman of infectious diseases at the John H. Stroger Hospital of Cook County (Ill.). Infection control report cards should also track rates of infection in the ICU that are associated with central vascular catheters; reoperation or rehospitalizations for surgical site infections; rates of nosocomial influenza; and infections caused by multidrug-resistant organisms, he added.

Focus Brings Improvement

Many of those suggested measures were used to track performance in a group of hospitals that participated in the National Surgical Infection Prevention Collaborative. The collaborative was sponsored by CMS and managed by Qualis Health, a Medicare Quality Improvement organization that monitors quality for Washington state, Idaho, and Alaska. Of the 56 hospitals that joined the 12-month project, 44 reported enough data to draw conclusions (Am. J. Surg. 2005;190:9–15).

At each hospital, a team identified a limited set of surgical procedures or surgeons and tracked them for at least 30 days post procedure to determine the proportion of patients getting prophylactic drugs within an hour before the incision, the proportion getting appropriate agents, and the proportion who had prophylaxis discontinued within 24 hours. After identifying the procedures or surgeons to be monitored and gauging a baseline rate for each process to be measured, interdisciplinary teams worked on instituting ways to improve processes.

Over the year, 35,543 patients were tracked. The infection rate was 2.28% in the first 3 months (215 infections among 9,435 cases during that time period); it fell to 1.65% by the last 3 reporting months, constituting a 28% reduction.

Lead author E. Patchen Dellinger, M.D., chief of the division of general surgery at the University of Washington's Eastside Specialty Center, said in an interview that the collaborative focused partly on getting hospitals to more closely identify and monitor infections such as having a nurse check on a patient a set number of times post procedure, or conducting telephone follow-up to ask about problems with wound healing.

The hospitals did not receive any financial assistance for participation; for most, it cost the equivalent of a full-time nurse for the year, Dr. Dellinger estimated.

Achieving initial progress is the easy part, he observed. “The hardest thing is spreading the gains beyond the pilot population and then holding the gains and not backsiding.”

Spreading and Holding the Gains

Evergreen Hospital is one facility that has managed to keep improving, said Stuart Schrader, R.N., director of surgical services for the 244-bed community facility in Kirkland, Wash. The hospital did not have a grasp on baseline infection rates, although they appeared to be low (about 0.25% in 1999), Mr. Schrader said in an interview.

But the rate climbed each year, hitting 0.7% in 2001. After joining the project and learning some new surveillance techniques, the hospital found that its rate was closer to 1.1%.

Since then, the hospital has adopted quality improvement measures, such as using a convective warming blanket on patients preoperatively and requiring the anesthesiologist to shake hands with each patient—the “warm hands” test—to make sure he or she is normothermic during surgery. Patients are kept warm with the same blankets post procedure in order to ensure proper blood flow to the wound area and thus prevent infection. The hospital has also increased the temperature in its eight operating rooms, and purchased jackets and vests with pockets for cold packs to keep the staff and surgeons comfortable, Mr. Schrader said.

To ensure that patients always receive antibiotics an hour before the procedure, the anesthesiologist is required to call the holding room nurse, who administers the antibiotic.

Razors have been mostly replaced with clippers for shaving hair around surgical sites, which reduces nicks that could invite infection, Mr. Schrader said.

Evergreen has cut its infection rate to 0.85%.

Mr. Schrader expects infection control to continue to be an area of focus. “The hard part was putting the energy into making the changes,” he said. “Once the changes were made, it became a normal way of life.”

WASHINGTON — Participation in a training program on carotid stenting can offset interventionalist inexperience, judging from the early findings of a large postmarketing study of the procedure as performed in community settings, said Jay Yadav, M.D., at a symposium sponsored by the Cardiovascular Research Foundation.

The training program for physicians contributed to the procedure's success, said Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation, who presented results on the first 1,603 patients in the Carotid RX Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study.

The study, sponsored by Guidant Corp., aims to look at 2,500 patients in total. It was designed to determine whether stenting with Acculink/Accunet can be performed safely, to identify and catalog rare or unanticipated events with the devices, and to evaluate the training program.

The company agreed on the program's design in collaboration with the Food and Drug Administration and the Center for Medicare and Medicaid Services. CMS hoped to get more data on the procedure, especially in asymptomatic patients. The Acculink/Accunet system was approved in August 2004 for high-risk, symptomatic patients, but CMS agreed to reimburse hospitals participating in CAPTURE for procedures conducted on symptomatic and asymptomatic candidates, said Jim Neupert, vice president of marketing for Guidant Endovascular Solutions.

To enter the program, physicians must already have performed a certain number of procedures, he said. Training usually consists of 2 days of lectures and hands-on training using an anatomic model and simulator. Patients who participate in CAPTURE must be evaluated before enrollment, within 24 hours of the procedure, and 30 days postprocedure by an independent neurologist. They also have a 30-day follow-up visit with the interventionalist.

Most patients (74%) were seen by physicians with “medium” stenting experience—that is, they had conducted 10 or fewer carotid procedures as the primary operator. Ten percent of patients were seen by physicians who had conducted five procedures as the primary operator, using Acculink/Accunet, and 16% of patients were seen by physicians with “low” experience, which was defined as having conducted 25 carotid angiograms, 10 peripheral procedures with self-expanding stents, and 10 procedures with the 0.014-inch guidewire in the Acculink system.

Most patients (63%) were treated by interventional cardiologists, 20% by vascular surgeons or neurosurgeons, and 17% by an interventional radiologist or interventional neuroradiologist.

Mean patient age was 73 years; 81% were over age 65, and 24% were over age 80. Hypertension and hypercholesterolemia were seen in 80%–90% of patients. Of the asymptomatic patients, 90% had greater than 80% stenosis; 74% of symptomatic patients had that level.

The adverse event rate was similar to that in the pivotal approval study for these devices, the Acculink/Accunet for Revascularization of Carotids in High-Risk Patients (ARCHER) trial, said Dr. Yadav, who is on the study's executive committee and does not receive personal funding from Guidant.

Within 30 days of the procedure, the death rate in CAPTURE was 1.6% (with 1.1% deemed stroke-related), compared with 2.1% in the ARCHER trial. The stroke rate was 4% (vs. 6%), and the incidence of MI was 1% (vs. 2%).

At 5%, the stroke rate was similar in patients whose physicians had greater experience, compared with those whose physicians had medium (4%) or low (5%) experience. Dr. Yadav said age seemed to be an important variable, noting that patients over 80 years old had worse outcomes, but would still do better with stenting than with medical management.

The patients' ages and whether they were symptomatic interacted to affect mortality and morbidity. Within 30 days of the procedure, the death rate for symptomatic patients under age 80 was 2%, vs. 10% for the over-80 group. Of the symptomatic patients, 8 of the 48 octogenarians (17%) had a stroke, vs. 12 of the 108 patients younger than 80 (11%). The difference was not as striking in asymptomatic patients. Eleven (1%) under age 80 died within 30 days, vs. 7 (2%) of those over 80. There were 18 (6%) strokes in the over-80 group, vs. 27 (2%) in the under-80 group.

WASHINGTON — Participation in a training program on carotid stenting can offset interventionalist inexperience, judging from the early findings of a large postmarketing study of the procedure as performed in community settings, said Jay Yadav, M.D., at a symposium sponsored by the Cardiovascular Research Foundation.

The training program for physicians contributed to the procedure's success, said Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation, who presented results on the first 1,603 patients in the Carotid RX Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study.

The study, sponsored by Guidant Corp., aims to look at 2,500 patients in total. It was designed to determine whether stenting with Acculink/Accunet can be performed safely, to identify and catalog rare or unanticipated events with the devices, and to evaluate the training program.

The company agreed on the program's design in collaboration with the Food and Drug Administration and the Center for Medicare and Medicaid Services. CMS hoped to get more data on the procedure, especially in asymptomatic patients. The Acculink/Accunet system was approved in August 2004 for high-risk, symptomatic patients, but CMS agreed to reimburse hospitals participating in CAPTURE for procedures conducted on symptomatic and asymptomatic candidates, said Jim Neupert, vice president of marketing for Guidant Endovascular Solutions.

To enter the program, physicians must already have performed a certain number of procedures, he said. Training usually consists of 2 days of lectures and hands-on training using an anatomic model and simulator. Patients who participate in CAPTURE must be evaluated before enrollment, within 24 hours of the procedure, and 30 days postprocedure by an independent neurologist. They also have a 30-day follow-up visit with the interventionalist.

Most patients (74%) were seen by physicians with “medium” stenting experience—that is, they had conducted 10 or fewer carotid procedures as the primary operator. Ten percent of patients were seen by physicians who had conducted five procedures as the primary operator, using Acculink/Accunet, and 16% of patients were seen by physicians with “low” experience, which was defined as having conducted 25 carotid angiograms, 10 peripheral procedures with self-expanding stents, and 10 procedures with the 0.014-inch guidewire in the Acculink system.

Most patients (63%) were treated by interventional cardiologists, 20% by vascular surgeons or neurosurgeons, and 17% by an interventional radiologist or interventional neuroradiologist.

Mean patient age was 73 years; 81% were over age 65, and 24% were over age 80. Hypertension and hypercholesterolemia were seen in 80%–90% of patients. Of the asymptomatic patients, 90% had greater than 80% stenosis; 74% of symptomatic patients had that level.

The adverse event rate was similar to that in the pivotal approval study for these devices, the Acculink/Accunet for Revascularization of Carotids in High-Risk Patients (ARCHER) trial, said Dr. Yadav, who is on the study's executive committee and does not receive personal funding from Guidant.

Within 30 days of the procedure, the death rate in CAPTURE was 1.6% (with 1.1% deemed stroke-related), compared with 2.1% in the ARCHER trial. The stroke rate was 4% (vs. 6%), and the incidence of MI was 1% (vs. 2%).

At 5%, the stroke rate was similar in patients whose physicians had greater experience, compared with those whose physicians had medium (4%) or low (5%) experience. Dr. Yadav said age seemed to be an important variable, noting that patients over 80 years old had worse outcomes, but would still do better with stenting than with medical management.

The patients' ages and whether they were symptomatic interacted to affect mortality and morbidity. Within 30 days of the procedure, the death rate for symptomatic patients under age 80 was 2%, vs. 10% for the over-80 group. Of the symptomatic patients, 8 of the 48 octogenarians (17%) had a stroke, vs. 12 of the 108 patients younger than 80 (11%). The difference was not as striking in asymptomatic patients. Eleven (1%) under age 80 died within 30 days, vs. 7 (2%) of those over 80. There were 18 (6%) strokes in the over-80 group, vs. 27 (2%) in the under-80 group.

WASHINGTON — Participation in a training program on carotid stenting can offset interventionalist inexperience, judging from the early findings of a large postmarketing study of the procedure as performed in community settings, said Jay Yadav, M.D., at a symposium sponsored by the Cardiovascular Research Foundation.

The training program for physicians contributed to the procedure's success, said Dr. Yadav, head of vascular intervention at the Cleveland Clinic Foundation, who presented results on the first 1,603 patients in the Carotid RX Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study.

The study, sponsored by Guidant Corp., aims to look at 2,500 patients in total. It was designed to determine whether stenting with Acculink/Accunet can be performed safely, to identify and catalog rare or unanticipated events with the devices, and to evaluate the training program.

The company agreed on the program's design in collaboration with the Food and Drug Administration and the Center for Medicare and Medicaid Services. CMS hoped to get more data on the procedure, especially in asymptomatic patients. The Acculink/Accunet system was approved in August 2004 for high-risk, symptomatic patients, but CMS agreed to reimburse hospitals participating in CAPTURE for procedures conducted on symptomatic and asymptomatic candidates, said Jim Neupert, vice president of marketing for Guidant Endovascular Solutions.

To enter the program, physicians must already have performed a certain number of procedures, he said. Training usually consists of 2 days of lectures and hands-on training using an anatomic model and simulator. Patients who participate in CAPTURE must be evaluated before enrollment, within 24 hours of the procedure, and 30 days postprocedure by an independent neurologist. They also have a 30-day follow-up visit with the interventionalist.

Most patients (74%) were seen by physicians with “medium” stenting experience—that is, they had conducted 10 or fewer carotid procedures as the primary operator. Ten percent of patients were seen by physicians who had conducted five procedures as the primary operator, using Acculink/Accunet, and 16% of patients were seen by physicians with “low” experience, which was defined as having conducted 25 carotid angiograms, 10 peripheral procedures with self-expanding stents, and 10 procedures with the 0.014-inch guidewire in the Acculink system.

Most patients (63%) were treated by interventional cardiologists, 20% by vascular surgeons or neurosurgeons, and 17% by an interventional radiologist or interventional neuroradiologist.

Mean patient age was 73 years; 81% were over age 65, and 24% were over age 80. Hypertension and hypercholesterolemia were seen in 80%–90% of patients. Of the asymptomatic patients, 90% had greater than 80% stenosis; 74% of symptomatic patients had that level.

The adverse event rate was similar to that in the pivotal approval study for these devices, the Acculink/Accunet for Revascularization of Carotids in High-Risk Patients (ARCHER) trial, said Dr. Yadav, who is on the study's executive committee and does not receive personal funding from Guidant.

Within 30 days of the procedure, the death rate in CAPTURE was 1.6% (with 1.1% deemed stroke-related), compared with 2.1% in the ARCHER trial. The stroke rate was 4% (vs. 6%), and the incidence of MI was 1% (vs. 2%).

At 5%, the stroke rate was similar in patients whose physicians had greater experience, compared with those whose physicians had medium (4%) or low (5%) experience. Dr. Yadav said age seemed to be an important variable, noting that patients over 80 years old had worse outcomes, but would still do better with stenting than with medical management.

The patients' ages and whether they were symptomatic interacted to affect mortality and morbidity. Within 30 days of the procedure, the death rate for symptomatic patients under age 80 was 2%, vs. 10% for the over-80 group. Of the symptomatic patients, 8 of the 48 octogenarians (17%) had a stroke, vs. 12 of the 108 patients younger than 80 (11%). The difference was not as striking in asymptomatic patients. Eleven (1%) under age 80 died within 30 days, vs. 7 (2%) of those over 80. There were 18 (6%) strokes in the over-80 group, vs. 27 (2%) in the under-80 group.

WASHINGTON — Data from a U.S. registry of drug-eluting stent use suggest that there is little difference between the two commercially available models, Charles Simonton, M.D., said at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Simonton reported on interim results of the Strategic Transcatheter Evaluation of New Therapies (STENT) registry, which aimed to track patterns of use and the comparative safety and efficacy of the Cypher, a sirolimus-eluting stent made by Cordis Corp., and the Taxus, a paclitaxel-eluting stent made by Boston Scientific.

The registry was supported by unrestricted grants from Boston Scientific, Cordis Corp., Possis Medical, and The Medicines Company. The two drugs have different mechanisms of action, but the STENT data “would suggest the actual clinical outcome for the patients is identical,” said Dr. Simonton, director of adult cardiology research at Carolinas Heart Institute (Charlotte, N.C.) and a principal investigator in the study.

The data for the registry were entered into a secure Web site by each of eight participating coronary interventional centers. The goal was to prospectively enroll between 8,000 and 10,000 consecutive cases per year. The data had to be entered within 60 days of each predetermined time period: in-hospital, 3- and 9-month data; and key events, such as stent thrombosis and target vessel revascularization (TVR), were adjudicated by physicians.

From May 2003 through September 2004, 8,013 patients who had primary coronary interventions were eligible for the registry, and 6,659 (83%) of those consented to inclusion. At 9 months, there was complete follow-up on 6,336. Not all the patients received drug-eluting stents; of those who did, there were complete data on 2,282 patients who received the Cypher and 1,476 who received the Taxus.

Among those who received stents, the major adverse cardiac events (MACE) rate was 7.9% for Cypher and 6.8% for Taxus. The death rate was 2.7% for Cypher and 2.1% for Taxus. Myocardial infarction rates were also similar, at 2.2% for Cypher and 1.8% for Taxus. Just under 4% of Cypher patients had a second procedure in the target vessel, compared with 2.8% of Taxus patients.

The TVR rates were very close, with 95 (4.2%) Cypher patients and 50 (3.4%) Taxus patients requiring revascularization. There was a low rate of subacute stent thrombosis: 0.7% for Cypher and 0.5% for Taxus.

There was no statistically significant difference between the two for time to TVR or MACE, said Dr. Simonton.

The Taxus group might have been at a slight disadvantage because it was a little older and had more incidents of acute coronary syndrome and a marginally lower preprocedure Thrombolysis in Myocardial Infarction Study Group (TIMI) grade flow, he said. But the majority of the baseline characteristics were similar between the two groups, and a risk-adjusted multivariable analysis for MACE and TVR showed no significant differences.

The results so far argue for both stents to stay in the catheterization lab, said Dr. Simonton. The choice on which one to use may in part be decided by price and deliverability, he said.

“If the clinical outcomes look the same, it comes down to deliverability—how easy [it is] to use the stent,” he said. But, he added, there are no objective ways to measure that deliverability.

WASHINGTON — Data from a U.S. registry of drug-eluting stent use suggest that there is little difference between the two commercially available models, Charles Simonton, M.D., said at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Simonton reported on interim results of the Strategic Transcatheter Evaluation of New Therapies (STENT) registry, which aimed to track patterns of use and the comparative safety and efficacy of the Cypher, a sirolimus-eluting stent made by Cordis Corp., and the Taxus, a paclitaxel-eluting stent made by Boston Scientific.

The registry was supported by unrestricted grants from Boston Scientific, Cordis Corp., Possis Medical, and The Medicines Company. The two drugs have different mechanisms of action, but the STENT data “would suggest the actual clinical outcome for the patients is identical,” said Dr. Simonton, director of adult cardiology research at Carolinas Heart Institute (Charlotte, N.C.) and a principal investigator in the study.

The data for the registry were entered into a secure Web site by each of eight participating coronary interventional centers. The goal was to prospectively enroll between 8,000 and 10,000 consecutive cases per year. The data had to be entered within 60 days of each predetermined time period: in-hospital, 3- and 9-month data; and key events, such as stent thrombosis and target vessel revascularization (TVR), were adjudicated by physicians.

From May 2003 through September 2004, 8,013 patients who had primary coronary interventions were eligible for the registry, and 6,659 (83%) of those consented to inclusion. At 9 months, there was complete follow-up on 6,336. Not all the patients received drug-eluting stents; of those who did, there were complete data on 2,282 patients who received the Cypher and 1,476 who received the Taxus.

Among those who received stents, the major adverse cardiac events (MACE) rate was 7.9% for Cypher and 6.8% for Taxus. The death rate was 2.7% for Cypher and 2.1% for Taxus. Myocardial infarction rates were also similar, at 2.2% for Cypher and 1.8% for Taxus. Just under 4% of Cypher patients had a second procedure in the target vessel, compared with 2.8% of Taxus patients.

The TVR rates were very close, with 95 (4.2%) Cypher patients and 50 (3.4%) Taxus patients requiring revascularization. There was a low rate of subacute stent thrombosis: 0.7% for Cypher and 0.5% for Taxus.

There was no statistically significant difference between the two for time to TVR or MACE, said Dr. Simonton.

The Taxus group might have been at a slight disadvantage because it was a little older and had more incidents of acute coronary syndrome and a marginally lower preprocedure Thrombolysis in Myocardial Infarction Study Group (TIMI) grade flow, he said. But the majority of the baseline characteristics were similar between the two groups, and a risk-adjusted multivariable analysis for MACE and TVR showed no significant differences.

The results so far argue for both stents to stay in the catheterization lab, said Dr. Simonton. The choice on which one to use may in part be decided by price and deliverability, he said.

“If the clinical outcomes look the same, it comes down to deliverability—how easy [it is] to use the stent,” he said. But, he added, there are no objective ways to measure that deliverability.

WASHINGTON — Data from a U.S. registry of drug-eluting stent use suggest that there is little difference between the two commercially available models, Charles Simonton, M.D., said at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Simonton reported on interim results of the Strategic Transcatheter Evaluation of New Therapies (STENT) registry, which aimed to track patterns of use and the comparative safety and efficacy of the Cypher, a sirolimus-eluting stent made by Cordis Corp., and the Taxus, a paclitaxel-eluting stent made by Boston Scientific.

The registry was supported by unrestricted grants from Boston Scientific, Cordis Corp., Possis Medical, and The Medicines Company. The two drugs have different mechanisms of action, but the STENT data “would suggest the actual clinical outcome for the patients is identical,” said Dr. Simonton, director of adult cardiology research at Carolinas Heart Institute (Charlotte, N.C.) and a principal investigator in the study.

The data for the registry were entered into a secure Web site by each of eight participating coronary interventional centers. The goal was to prospectively enroll between 8,000 and 10,000 consecutive cases per year. The data had to be entered within 60 days of each predetermined time period: in-hospital, 3- and 9-month data; and key events, such as stent thrombosis and target vessel revascularization (TVR), were adjudicated by physicians.

From May 2003 through September 2004, 8,013 patients who had primary coronary interventions were eligible for the registry, and 6,659 (83%) of those consented to inclusion. At 9 months, there was complete follow-up on 6,336. Not all the patients received drug-eluting stents; of those who did, there were complete data on 2,282 patients who received the Cypher and 1,476 who received the Taxus.

Among those who received stents, the major adverse cardiac events (MACE) rate was 7.9% for Cypher and 6.8% for Taxus. The death rate was 2.7% for Cypher and 2.1% for Taxus. Myocardial infarction rates were also similar, at 2.2% for Cypher and 1.8% for Taxus. Just under 4% of Cypher patients had a second procedure in the target vessel, compared with 2.8% of Taxus patients.

The TVR rates were very close, with 95 (4.2%) Cypher patients and 50 (3.4%) Taxus patients requiring revascularization. There was a low rate of subacute stent thrombosis: 0.7% for Cypher and 0.5% for Taxus.

There was no statistically significant difference between the two for time to TVR or MACE, said Dr. Simonton.

The Taxus group might have been at a slight disadvantage because it was a little older and had more incidents of acute coronary syndrome and a marginally lower preprocedure Thrombolysis in Myocardial Infarction Study Group (TIMI) grade flow, he said. But the majority of the baseline characteristics were similar between the two groups, and a risk-adjusted multivariable analysis for MACE and TVR showed no significant differences.

The results so far argue for both stents to stay in the catheterization lab, said Dr. Simonton. The choice on which one to use may in part be decided by price and deliverability, he said.

“If the clinical outcomes look the same, it comes down to deliverability—how easy [it is] to use the stent,” he said. But, he added, there are no objective ways to measure that deliverability.