Alicia Ault

WASHINGTON — Most patients presenting with flank pain turn out to have kidney stones, but there is a very small but real potential that the cause may be a ruptured abdominal aortic aneurysm, according to Flavia Nobay, M.D., who spoke at the annual meeting of the American College of Emergency Physicians.

In general, 10% of men and 3% of women will experience a kidney stone, and 70% of kidney stones occur in people aged 20–50 years. The main risk factor is a previous stone; a family history of kidney stones is also predictive, making it 2.5 times more likely the patient will have a stone.

If patients present with unilateral cost-vertebral angle pain, abrupt onset of pain, and hematuria, there is a 90% probability of having a stone, said Dr. Nobay, of the division of emergency medicine at the University of California, San Francisco.

Yet it is still important to be certain of the diagnosis, she said. For instance, 10%–30% of stones are negative for hematuria, and patients often present writhing in pain, which also occurs with aortic dissection.

For the 10% of patients who do not have stones, there is a variety of potential diagnoses. A 1993 study in the European Journal of Vascular Surgery found that 9.5% of patients older than 65 years who were referred for renal colic imaging were diagnosed with aortic dissection, but that study has never been replicated, Dr. Nobay said.

However, one-quarter to one-half of abdominal aortic aneurysm (AAA) cases are misdiagnosed, and the most common misdiagnosis is a renal stone, she said. The risk factors for AAA include a first-degree relative with dissection, smoking, hypertension, peripheral vascular disease, and undifferentiated flank pain.

The best way to differentiate between AAA and a kidney stone is to take a careful history and use CT scans, although CT imaging can't be done with unstable patients.

Vascular catastrophe is rare, however, affecting only 0.18% of patients with acute flank pain, Dr. Nobay said. Among the other potential diagnoses are herpes zoster, appendicitis, pyelonephritis, diverticulitis, and bowel obstruction. She said she usually gets several laboratory measures: a urinalysis for hematuria, leukocytes, and nitrites and a BUN with creatinine, which gives, at minimum, a baseline of kidney function.

CT imaging studies should be conducted in patients with no prior history of stones and in patients who have an unclear diagnosis, an underlying renal disorder, or are febrile. A CT scan is highly accurate except in patients taking indinavir, which makes kidney stones radiolucent. Current protocols call for 3–5-mm cuts without intravenous contrast.

Though a scan can't give any data on kidney function, it can help diagnose hydronephrosis, hydroureter, and perinephric stranding—all of which are secondary signs of stones, she said.

If no kidney stone is found on a CT scan, the stone could be between the cuts or it may recently have been passed.

Ultrasound is good for spotting proximal stones that are larger than 5 mm, intracalyceal stones, and distal stones at the ureterovesical junction. And unlike CT scans, there's no radiation exposure, and it is less expensive.

But the method might miss some stones, because it provides inadequate imaging of the renal collecting system and the ureter, and it is very much operator dependent, she said. It is a promising technology, but is not superior to CT, Dr. Nobay said.

The intravenous pyelogram provides high sensitivity and specificity for stones, but the procedure is not as cost-effective as CT, she said.

Kidney stone patients should be given pain medication, starting with intravenous ketorolac and other nonsteroidal anti-inflammatory drugs, which are often as effective as opiates, Dr. Nobay said.

Many clinicians have made the mistake of overhydrating patients; but if patients are already adequately hydrated, more fluid will cause a bigger fluid backup, leading to more pain, Dr. Nobay said. Only moderate hydration is necessary.

Stones of less than 2 mm pass in 8 days on average; 2–4 mm stones take about 12 days, and those larger than 4 mm pass in an average of 22 days. Patients with stones larger than 7 mm, or those who have failed on pain medications after 2–4 weeks, need an urgent urological consultation.

In the past, surgeons looked only at stones larger than 5 mm for intervention, but the size recently has been increased to 7 mm, Dr. Nobay said.

WASHINGTON — Most patients presenting with flank pain turn out to have kidney stones, but there is a very small but real potential that the cause may be a ruptured abdominal aortic aneurysm, according to Flavia Nobay, M.D., who spoke at the annual meeting of the American College of Emergency Physicians.

In general, 10% of men and 3% of women will experience a kidney stone, and 70% of kidney stones occur in people aged 20–50 years. The main risk factor is a previous stone; a family history of kidney stones is also predictive, making it 2.5 times more likely the patient will have a stone.

If patients present with unilateral cost-vertebral angle pain, abrupt onset of pain, and hematuria, there is a 90% probability of having a stone, said Dr. Nobay, of the division of emergency medicine at the University of California, San Francisco.

Yet it is still important to be certain of the diagnosis, she said. For instance, 10%–30% of stones are negative for hematuria, and patients often present writhing in pain, which also occurs with aortic dissection.

For the 10% of patients who do not have stones, there is a variety of potential diagnoses. A 1993 study in the European Journal of Vascular Surgery found that 9.5% of patients older than 65 years who were referred for renal colic imaging were diagnosed with aortic dissection, but that study has never been replicated, Dr. Nobay said.

However, one-quarter to one-half of abdominal aortic aneurysm (AAA) cases are misdiagnosed, and the most common misdiagnosis is a renal stone, she said. The risk factors for AAA include a first-degree relative with dissection, smoking, hypertension, peripheral vascular disease, and undifferentiated flank pain.

The best way to differentiate between AAA and a kidney stone is to take a careful history and use CT scans, although CT imaging can't be done with unstable patients.

Vascular catastrophe is rare, however, affecting only 0.18% of patients with acute flank pain, Dr. Nobay said. Among the other potential diagnoses are herpes zoster, appendicitis, pyelonephritis, diverticulitis, and bowel obstruction. She said she usually gets several laboratory measures: a urinalysis for hematuria, leukocytes, and nitrites and a BUN with creatinine, which gives, at minimum, a baseline of kidney function.

CT imaging studies should be conducted in patients with no prior history of stones and in patients who have an unclear diagnosis, an underlying renal disorder, or are febrile. A CT scan is highly accurate except in patients taking indinavir, which makes kidney stones radiolucent. Current protocols call for 3–5-mm cuts without intravenous contrast.

Though a scan can't give any data on kidney function, it can help diagnose hydronephrosis, hydroureter, and perinephric stranding—all of which are secondary signs of stones, she said.

If no kidney stone is found on a CT scan, the stone could be between the cuts or it may recently have been passed.

Ultrasound is good for spotting proximal stones that are larger than 5 mm, intracalyceal stones, and distal stones at the ureterovesical junction. And unlike CT scans, there's no radiation exposure, and it is less expensive.

But the method might miss some stones, because it provides inadequate imaging of the renal collecting system and the ureter, and it is very much operator dependent, she said. It is a promising technology, but is not superior to CT, Dr. Nobay said.

The intravenous pyelogram provides high sensitivity and specificity for stones, but the procedure is not as cost-effective as CT, she said.

Kidney stone patients should be given pain medication, starting with intravenous ketorolac and other nonsteroidal anti-inflammatory drugs, which are often as effective as opiates, Dr. Nobay said.

Many clinicians have made the mistake of overhydrating patients; but if patients are already adequately hydrated, more fluid will cause a bigger fluid backup, leading to more pain, Dr. Nobay said. Only moderate hydration is necessary.

Stones of less than 2 mm pass in 8 days on average; 2–4 mm stones take about 12 days, and those larger than 4 mm pass in an average of 22 days. Patients with stones larger than 7 mm, or those who have failed on pain medications after 2–4 weeks, need an urgent urological consultation.

In the past, surgeons looked only at stones larger than 5 mm for intervention, but the size recently has been increased to 7 mm, Dr. Nobay said.

WASHINGTON — Most patients presenting with flank pain turn out to have kidney stones, but there is a very small but real potential that the cause may be a ruptured abdominal aortic aneurysm, according to Flavia Nobay, M.D., who spoke at the annual meeting of the American College of Emergency Physicians.

In general, 10% of men and 3% of women will experience a kidney stone, and 70% of kidney stones occur in people aged 20–50 years. The main risk factor is a previous stone; a family history of kidney stones is also predictive, making it 2.5 times more likely the patient will have a stone.

If patients present with unilateral cost-vertebral angle pain, abrupt onset of pain, and hematuria, there is a 90% probability of having a stone, said Dr. Nobay, of the division of emergency medicine at the University of California, San Francisco.

Yet it is still important to be certain of the diagnosis, she said. For instance, 10%–30% of stones are negative for hematuria, and patients often present writhing in pain, which also occurs with aortic dissection.

For the 10% of patients who do not have stones, there is a variety of potential diagnoses. A 1993 study in the European Journal of Vascular Surgery found that 9.5% of patients older than 65 years who were referred for renal colic imaging were diagnosed with aortic dissection, but that study has never been replicated, Dr. Nobay said.

However, one-quarter to one-half of abdominal aortic aneurysm (AAA) cases are misdiagnosed, and the most common misdiagnosis is a renal stone, she said. The risk factors for AAA include a first-degree relative with dissection, smoking, hypertension, peripheral vascular disease, and undifferentiated flank pain.

The best way to differentiate between AAA and a kidney stone is to take a careful history and use CT scans, although CT imaging can't be done with unstable patients.

Vascular catastrophe is rare, however, affecting only 0.18% of patients with acute flank pain, Dr. Nobay said. Among the other potential diagnoses are herpes zoster, appendicitis, pyelonephritis, diverticulitis, and bowel obstruction. She said she usually gets several laboratory measures: a urinalysis for hematuria, leukocytes, and nitrites and a BUN with creatinine, which gives, at minimum, a baseline of kidney function.

CT imaging studies should be conducted in patients with no prior history of stones and in patients who have an unclear diagnosis, an underlying renal disorder, or are febrile. A CT scan is highly accurate except in patients taking indinavir, which makes kidney stones radiolucent. Current protocols call for 3–5-mm cuts without intravenous contrast.

Though a scan can't give any data on kidney function, it can help diagnose hydronephrosis, hydroureter, and perinephric stranding—all of which are secondary signs of stones, she said.

If no kidney stone is found on a CT scan, the stone could be between the cuts or it may recently have been passed.

Ultrasound is good for spotting proximal stones that are larger than 5 mm, intracalyceal stones, and distal stones at the ureterovesical junction. And unlike CT scans, there's no radiation exposure, and it is less expensive.

But the method might miss some stones, because it provides inadequate imaging of the renal collecting system and the ureter, and it is very much operator dependent, she said. It is a promising technology, but is not superior to CT, Dr. Nobay said.

The intravenous pyelogram provides high sensitivity and specificity for stones, but the procedure is not as cost-effective as CT, she said.

Kidney stone patients should be given pain medication, starting with intravenous ketorolac and other nonsteroidal anti-inflammatory drugs, which are often as effective as opiates, Dr. Nobay said.

Many clinicians have made the mistake of overhydrating patients; but if patients are already adequately hydrated, more fluid will cause a bigger fluid backup, leading to more pain, Dr. Nobay said. Only moderate hydration is necessary.

Stones of less than 2 mm pass in 8 days on average; 2–4 mm stones take about 12 days, and those larger than 4 mm pass in an average of 22 days. Patients with stones larger than 7 mm, or those who have failed on pain medications after 2–4 weeks, need an urgent urological consultation.

In the past, surgeons looked only at stones larger than 5 mm for intervention, but the size recently has been increased to 7 mm, Dr. Nobay said.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy. D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures, with no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of these: acute myocardial infarction, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, Dr. Williams and his associates said.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004, with 3,087 of the 3,377 hospitals initially identified as study participants. Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

Of the 18 measures, 17 looked at death in the hospital after acute myocardial infarction; the other 17 assessed processes of care. There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have influenced mortality. There was no significant drop in the mean time to thrombolysis for patients with acute MI or in mean time to give antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to 66% at the high end.

The investigators noted that one potential drawback of the study—its reliance on self-reported data—could introduce bias.

And, they said, the picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy. D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures, with no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of these: acute myocardial infarction, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, Dr. Williams and his associates said.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004, with 3,087 of the 3,377 hospitals initially identified as study participants. Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

Of the 18 measures, 17 looked at death in the hospital after acute myocardial infarction; the other 17 assessed processes of care. There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have influenced mortality. There was no significant drop in the mean time to thrombolysis for patients with acute MI or in mean time to give antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to 66% at the high end.

The investigators noted that one potential drawback of the study—its reliance on self-reported data—could introduce bias.

And, they said, the picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy. D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures, with no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of these: acute myocardial infarction, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, Dr. Williams and his associates said.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004, with 3,087 of the 3,377 hospitals initially identified as study participants. Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

Of the 18 measures, 17 looked at death in the hospital after acute myocardial infarction; the other 17 assessed processes of care. There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have influenced mortality. There was no significant drop in the mean time to thrombolysis for patients with acute MI or in mean time to give antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to 66% at the high end.

The investigators noted that one potential drawback of the study—its reliance on self-reported data—could introduce bias.

And, they said, the picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

Academic hospitals in general and nonacademic hospitals located in the Northeast and Midwest appear to offer greater quality than nonteaching facilities or those in other geographic regions for certain conditions, according to a recent study by Ashish K. Jha, M.D., and colleagues at the Harvard School of Public Health.

The authors found that academic hospitals performed slightly better than nonacademic facilities in treating heart attack and heart failure, but underperformed in the case of pneumonia. Not-for-profit hospitals significantly outscored for-profits in all measures in those conditions, they said.

However, the data do not support the idea that “'good' hospitals are easy to identify or are consistent in their performance across conditions,” the authors pointed out.

The study was the first to use national hospital data submitted as part of the Hospital Quality Alliance (N. Engl. J. Med. 2005;353:265–74).

The HQA is a joint effort of the Centers for Medicare and Medicaid Services, the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association, and consumer groups, including the AARP. Under the Medicare Modernization Act, hospitals have financial incentives to report quarterly to CMS on a specific set of quality indicators. Initial data became publicly available in November 2004, which led Dr. Jha and colleagues to conduct their analysis.

In all, 3,558 hospitals reported on their performance in the first half of 2004, citing quality measures for acute myocardial infarction, heart failure, and pneumonia. To be included, each hospital had to report on at least 25 discharged patients. Of the participating hospitals, 16% were for-profit, 8% were members of the Council of Teaching Hospitals, and 62% were in urban settings.

The authors measured the mean performance for the 3,558 hospitals and variability of performance across the country.

They also sought to determine whether a high level of performance in treating one disease translated into equally good care in the other conditions. They investigated whether profit status, number of beds, geographic area, and academic involvement affected performance.

The heart attack measures included whether aspirin and ?-blockers were given within 24 hours of admission and at discharge and if ACE inhibitors were given to patients with left ventricular systolic dysfunction. For heart failure, the measures included assessment of left ventricular function and whether an ACE inhibitor was given. For pneumonia, hospitals were measured on the timing of initial antibiotics, vaccination, and assessment of oxygenation.

The hospitals' scores reflected the proportion of patients who satisfied the criterion for the performance measure.

Overall, hospitals did best at conducting an oxygenation assessment in pneumonia patients; the mean performance score was 98%, plus or minus 5%. Hospitals had their lowest scores in rates of vaccinations for pneumonia: 43%, plus or minus 27%.

There were huge variations among regions. For the pneumonia composite score, there was a 23% difference between top-ranked Oklahoma City and bottom-ranked San Bernardino, Calif. There was a 12% difference between high and low performers on heart attack, and a 21% difference between the top and bottom for heart failure.

The authors found that high performance scores for acute myocardial infarction predicted equally good performance in heart failure, but not for pneumonia. For instance, 73% of the hospitals that were in the top decile of scores for acute MI were in the top quartile for heart failure, and less than 1% were in the bottom quartile. But only 33% of the hospitals in that top decile for acute MI were in the top quartile for pneumonia.

Limitations of the study include the fact that the investigators limited their evaluation to only 10 measures of the quality of care for 3 clinical conditions, and the results focused on process measures rather than patient outcomes, the authors noted.

Academic hospitals in general and nonacademic hospitals located in the Northeast and Midwest appear to offer greater quality than nonteaching facilities or those in other geographic regions for certain conditions, according to a recent study by Ashish K. Jha, M.D., and colleagues at the Harvard School of Public Health.

The authors found that academic hospitals performed slightly better than nonacademic facilities in treating heart attack and heart failure, but underperformed in the case of pneumonia. Not-for-profit hospitals significantly outscored for-profits in all measures in those conditions, they said.

However, the data do not support the idea that “'good' hospitals are easy to identify or are consistent in their performance across conditions,” the authors pointed out.

The study was the first to use national hospital data submitted as part of the Hospital Quality Alliance (N. Engl. J. Med. 2005;353:265–74).

The HQA is a joint effort of the Centers for Medicare and Medicaid Services, the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association, and consumer groups, including the AARP. Under the Medicare Modernization Act, hospitals have financial incentives to report quarterly to CMS on a specific set of quality indicators. Initial data became publicly available in November 2004, which led Dr. Jha and colleagues to conduct their analysis.

In all, 3,558 hospitals reported on their performance in the first half of 2004, citing quality measures for acute myocardial infarction, heart failure, and pneumonia. To be included, each hospital had to report on at least 25 discharged patients. Of the participating hospitals, 16% were for-profit, 8% were members of the Council of Teaching Hospitals, and 62% were in urban settings.

The authors measured the mean performance for the 3,558 hospitals and variability of performance across the country.

They also sought to determine whether a high level of performance in treating one disease translated into equally good care in the other conditions. They investigated whether profit status, number of beds, geographic area, and academic involvement affected performance.

The heart attack measures included whether aspirin and ?-blockers were given within 24 hours of admission and at discharge and if ACE inhibitors were given to patients with left ventricular systolic dysfunction. For heart failure, the measures included assessment of left ventricular function and whether an ACE inhibitor was given. For pneumonia, hospitals were measured on the timing of initial antibiotics, vaccination, and assessment of oxygenation.

The hospitals' scores reflected the proportion of patients who satisfied the criterion for the performance measure.

Overall, hospitals did best at conducting an oxygenation assessment in pneumonia patients; the mean performance score was 98%, plus or minus 5%. Hospitals had their lowest scores in rates of vaccinations for pneumonia: 43%, plus or minus 27%.

There were huge variations among regions. For the pneumonia composite score, there was a 23% difference between top-ranked Oklahoma City and bottom-ranked San Bernardino, Calif. There was a 12% difference between high and low performers on heart attack, and a 21% difference between the top and bottom for heart failure.

The authors found that high performance scores for acute myocardial infarction predicted equally good performance in heart failure, but not for pneumonia. For instance, 73% of the hospitals that were in the top decile of scores for acute MI were in the top quartile for heart failure, and less than 1% were in the bottom quartile. But only 33% of the hospitals in that top decile for acute MI were in the top quartile for pneumonia.

Limitations of the study include the fact that the investigators limited their evaluation to only 10 measures of the quality of care for 3 clinical conditions, and the results focused on process measures rather than patient outcomes, the authors noted.

Academic hospitals in general and nonacademic hospitals located in the Northeast and Midwest appear to offer greater quality than nonteaching facilities or those in other geographic regions for certain conditions, according to a recent study by Ashish K. Jha, M.D., and colleagues at the Harvard School of Public Health.

The authors found that academic hospitals performed slightly better than nonacademic facilities in treating heart attack and heart failure, but underperformed in the case of pneumonia. Not-for-profit hospitals significantly outscored for-profits in all measures in those conditions, they said.

However, the data do not support the idea that “'good' hospitals are easy to identify or are consistent in their performance across conditions,” the authors pointed out.

The study was the first to use national hospital data submitted as part of the Hospital Quality Alliance (N. Engl. J. Med. 2005;353:265–74).

The HQA is a joint effort of the Centers for Medicare and Medicaid Services, the Joint Commission on Accreditation of Healthcare Organizations, the American Hospital Association, and consumer groups, including the AARP. Under the Medicare Modernization Act, hospitals have financial incentives to report quarterly to CMS on a specific set of quality indicators. Initial data became publicly available in November 2004, which led Dr. Jha and colleagues to conduct their analysis.

In all, 3,558 hospitals reported on their performance in the first half of 2004, citing quality measures for acute myocardial infarction, heart failure, and pneumonia. To be included, each hospital had to report on at least 25 discharged patients. Of the participating hospitals, 16% were for-profit, 8% were members of the Council of Teaching Hospitals, and 62% were in urban settings.

The authors measured the mean performance for the 3,558 hospitals and variability of performance across the country.

They also sought to determine whether a high level of performance in treating one disease translated into equally good care in the other conditions. They investigated whether profit status, number of beds, geographic area, and academic involvement affected performance.

The heart attack measures included whether aspirin and ?-blockers were given within 24 hours of admission and at discharge and if ACE inhibitors were given to patients with left ventricular systolic dysfunction. For heart failure, the measures included assessment of left ventricular function and whether an ACE inhibitor was given. For pneumonia, hospitals were measured on the timing of initial antibiotics, vaccination, and assessment of oxygenation.

The hospitals' scores reflected the proportion of patients who satisfied the criterion for the performance measure.

Overall, hospitals did best at conducting an oxygenation assessment in pneumonia patients; the mean performance score was 98%, plus or minus 5%. Hospitals had their lowest scores in rates of vaccinations for pneumonia: 43%, plus or minus 27%.

There were huge variations among regions. For the pneumonia composite score, there was a 23% difference between top-ranked Oklahoma City and bottom-ranked San Bernardino, Calif. There was a 12% difference between high and low performers on heart attack, and a 21% difference between the top and bottom for heart failure.

The authors found that high performance scores for acute myocardial infarction predicted equally good performance in heart failure, but not for pneumonia. For instance, 73% of the hospitals that were in the top decile of scores for acute MI were in the top quartile for heart failure, and less than 1% were in the bottom quartile. But only 33% of the hospitals in that top decile for acute MI were in the top quartile for pneumonia.

Limitations of the study include the fact that the investigators limited their evaluation to only 10 measures of the quality of care for 3 clinical conditions, and the results focused on process measures rather than patient outcomes, the authors noted.

Although the SB Charité III artificial lumbar disk has been available commercially in Europe since 1987 and in the United States since last November, some surgeons are reluctant to adopt the technology. And some American insurers still regard it as experimental.

The Food and Drug Administration approved the disk for 18− to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. Contraindications include spondylothesis and osteoporosis.

Several surgeons, however, say they are cautious because few long-term outcomes have been published on the disk's durability, and few data support its hypothetical advantage: By preserving motion at the affected level, it will protect adjacent levels from further degeneration.

The SB Charité III was developed by two orthopedic surgeons in Berlin. Eventually, after a third design revision, the technology was acquired in 2003 by DePuy Spine, a division of Johnson & Johnson.

According to DePuy, 200,000 Americans undergo spinal fusion for degenerative disk disease each year. Surgeons say that so far, few patients seem to be candidates for the disk. “There are no real good indications for this product,” said Greg Graziano, M.D., a professor in the departments of neurosurgery and orthopedic surgery at the University of Michigan.

Dr. Graziano told this newspaper that he believes the ideal candidate is someone who is young, has arthritic degenerative changes, and exhibits minimal posterior arthritis. A patient who needs spinal canal work or decompression surgery isn't suitable, he said.

The University of Michigan Hospital told insurers it was willing to reduce the surgical costs for 20 patients as a means of getting the procedure off the ground at the facility, Dr. Graziano said. But the disk itself is still in the $11,000-$12,000 range, and insurers have balked, he said.

In April, the Blue Cross and Blue Shield (BCBS) Association's Technology Evaluation Center issued a report stating that “current evidence supporting the effectiveness of the artificial vertebral disk is insufficient.” The organization said there were methodologic flaws with the single randomized study used to win FDA approval, and it noted that the study only proved noninferiority to fusion with a Bagby and Kuslich (BAK) cage.

The technology assessments are meant as scientific opinions—although they sometimes form the basis for coverage decisions, a BCBS spokeswoman said. Individual BCBS plans are not under any obligation to follow the recommendations, she added.

DePuy Spine is working with the BCBS plans to provide further evidence that it is a superior technology, said Richard Toselli, M.D., vice president for research and development at the company. In an interview, Dr. Toselli said that several individual BCBS plans, along with Aetna, Kaiser Permanente, and 62 small regional carriers, are paying for implantation of the Charité disk.

“Some evidence shows that it's as good as standard fusion and perhaps better, but we don't know that yet,” Ziya Gokaslan, M.D., vice chairman of the department of neurosurgery at Johns Hopkins Hospital in Baltimore, told this newspaper. Dr. Gokaslan said he has not yet implanted a Charité disk at Hopkins, but he has participated in the implantation of the device in Germany and Brazil.

“I think there is use for this device, and I think there are potential benefits down the line,” he said. But he added, “We do not know the long-term complications of the implantation of this device,” such as whether the plastic core will wear out. If early hip and knee implants are any indication, revisions and replacements could be required within 15–20 years of the original implantations, he said.

DePuy acknowledged that getting at the Charité disk for a revision can be difficult. The company said that if the disk has migrated from the disk space, it needs to be removed through an anterior approach and replaced with another disk or via a fusion done either anteriorly and/or posteriorly. “If the device has not migrated, and the patient continues to complain of pain, then the revision strategy is to do a posterior fusion alone and leave the disk in place,” Dr. Toselli said.

But the company said there's no indication the disks will have a short life span and that there have been few reports of complications in the 10,000 devices implanted worldwide. Dr. Toselli also cited a 10-year follow-up report on 100 cases, published in 2002 by one of the Charité pioneers, J.P. Lemaire, M.D. In that study, “no significant migration of the polyethylene” occurred in any of the implants, and there were only 2 cases (2%) of adjacent functional overload (Rachis [The Spinal Column] 2002;14:271–85). Overall, 62% of the patients had excellent results.

Surgeons need more experience in choosing the correct disk size and placing it properly. “There's an art to placing these things,” Dr. Graziano said, adding that “the reproducibility between surgeons is not there yet.”

DePuy has trained about 2,200 surgeons at its Center for Spine Arthroplasty at the Endo-Surgery Institute in Cincinnati. Surgeons can also train with or observe colleagues who have Charité experience at 50 regional sites.

Dr. Gokaslan and Dr. Graziano agree that artificial disks are at the stage interbody fusion cages were 10 years ago. An initial burst of enthusiasm was followed by the recognition that cages were not a panacea.

“It took 5 years to figure out who should get cages and who shouldn't,” Dr. Graziano said.

Although patients are asking for the Charité disks, surgeons will likely resist the pressure, Dr. Gokaslan said. “It's hard to change the habits of surgeons when there is no serious evidence showing this is better than what they've done in the past,” he said.

Although the SB Charité III artificial lumbar disk has been available commercially in Europe since 1987 and in the United States since last November, some surgeons are reluctant to adopt the technology. And some American insurers still regard it as experimental.

The Food and Drug Administration approved the disk for 18− to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. Contraindications include spondylothesis and osteoporosis.

Several surgeons, however, say they are cautious because few long-term outcomes have been published on the disk's durability, and few data support its hypothetical advantage: By preserving motion at the affected level, it will protect adjacent levels from further degeneration.

The SB Charité III was developed by two orthopedic surgeons in Berlin. Eventually, after a third design revision, the technology was acquired in 2003 by DePuy Spine, a division of Johnson & Johnson.

According to DePuy, 200,000 Americans undergo spinal fusion for degenerative disk disease each year. Surgeons say that so far, few patients seem to be candidates for the disk. “There are no real good indications for this product,” said Greg Graziano, M.D., a professor in the departments of neurosurgery and orthopedic surgery at the University of Michigan.

Dr. Graziano told this newspaper that he believes the ideal candidate is someone who is young, has arthritic degenerative changes, and exhibits minimal posterior arthritis. A patient who needs spinal canal work or decompression surgery isn't suitable, he said.

The University of Michigan Hospital told insurers it was willing to reduce the surgical costs for 20 patients as a means of getting the procedure off the ground at the facility, Dr. Graziano said. But the disk itself is still in the $11,000-$12,000 range, and insurers have balked, he said.

In April, the Blue Cross and Blue Shield (BCBS) Association's Technology Evaluation Center issued a report stating that “current evidence supporting the effectiveness of the artificial vertebral disk is insufficient.” The organization said there were methodologic flaws with the single randomized study used to win FDA approval, and it noted that the study only proved noninferiority to fusion with a Bagby and Kuslich (BAK) cage.

The technology assessments are meant as scientific opinions—although they sometimes form the basis for coverage decisions, a BCBS spokeswoman said. Individual BCBS plans are not under any obligation to follow the recommendations, she added.

DePuy Spine is working with the BCBS plans to provide further evidence that it is a superior technology, said Richard Toselli, M.D., vice president for research and development at the company. In an interview, Dr. Toselli said that several individual BCBS plans, along with Aetna, Kaiser Permanente, and 62 small regional carriers, are paying for implantation of the Charité disk.

“Some evidence shows that it's as good as standard fusion and perhaps better, but we don't know that yet,” Ziya Gokaslan, M.D., vice chairman of the department of neurosurgery at Johns Hopkins Hospital in Baltimore, told this newspaper. Dr. Gokaslan said he has not yet implanted a Charité disk at Hopkins, but he has participated in the implantation of the device in Germany and Brazil.

“I think there is use for this device, and I think there are potential benefits down the line,” he said. But he added, “We do not know the long-term complications of the implantation of this device,” such as whether the plastic core will wear out. If early hip and knee implants are any indication, revisions and replacements could be required within 15–20 years of the original implantations, he said.

DePuy acknowledged that getting at the Charité disk for a revision can be difficult. The company said that if the disk has migrated from the disk space, it needs to be removed through an anterior approach and replaced with another disk or via a fusion done either anteriorly and/or posteriorly. “If the device has not migrated, and the patient continues to complain of pain, then the revision strategy is to do a posterior fusion alone and leave the disk in place,” Dr. Toselli said.

But the company said there's no indication the disks will have a short life span and that there have been few reports of complications in the 10,000 devices implanted worldwide. Dr. Toselli also cited a 10-year follow-up report on 100 cases, published in 2002 by one of the Charité pioneers, J.P. Lemaire, M.D. In that study, “no significant migration of the polyethylene” occurred in any of the implants, and there were only 2 cases (2%) of adjacent functional overload (Rachis [The Spinal Column] 2002;14:271–85). Overall, 62% of the patients had excellent results.

Surgeons need more experience in choosing the correct disk size and placing it properly. “There's an art to placing these things,” Dr. Graziano said, adding that “the reproducibility between surgeons is not there yet.”

DePuy has trained about 2,200 surgeons at its Center for Spine Arthroplasty at the Endo-Surgery Institute in Cincinnati. Surgeons can also train with or observe colleagues who have Charité experience at 50 regional sites.

Dr. Gokaslan and Dr. Graziano agree that artificial disks are at the stage interbody fusion cages were 10 years ago. An initial burst of enthusiasm was followed by the recognition that cages were not a panacea.

“It took 5 years to figure out who should get cages and who shouldn't,” Dr. Graziano said.

Although patients are asking for the Charité disks, surgeons will likely resist the pressure, Dr. Gokaslan said. “It's hard to change the habits of surgeons when there is no serious evidence showing this is better than what they've done in the past,” he said.

Although the SB Charité III artificial lumbar disk has been available commercially in Europe since 1987 and in the United States since last November, some surgeons are reluctant to adopt the technology. And some American insurers still regard it as experimental.

The Food and Drug Administration approved the disk for 18− to 60-year-old patients with degenerative disk disease at one level, either L4/L5 or L5/S1. Contraindications include spondylothesis and osteoporosis.

Several surgeons, however, say they are cautious because few long-term outcomes have been published on the disk's durability, and few data support its hypothetical advantage: By preserving motion at the affected level, it will protect adjacent levels from further degeneration.

The SB Charité III was developed by two orthopedic surgeons in Berlin. Eventually, after a third design revision, the technology was acquired in 2003 by DePuy Spine, a division of Johnson & Johnson.

According to DePuy, 200,000 Americans undergo spinal fusion for degenerative disk disease each year. Surgeons say that so far, few patients seem to be candidates for the disk. “There are no real good indications for this product,” said Greg Graziano, M.D., a professor in the departments of neurosurgery and orthopedic surgery at the University of Michigan.

Dr. Graziano told this newspaper that he believes the ideal candidate is someone who is young, has arthritic degenerative changes, and exhibits minimal posterior arthritis. A patient who needs spinal canal work or decompression surgery isn't suitable, he said.

The University of Michigan Hospital told insurers it was willing to reduce the surgical costs for 20 patients as a means of getting the procedure off the ground at the facility, Dr. Graziano said. But the disk itself is still in the $11,000-$12,000 range, and insurers have balked, he said.

In April, the Blue Cross and Blue Shield (BCBS) Association's Technology Evaluation Center issued a report stating that “current evidence supporting the effectiveness of the artificial vertebral disk is insufficient.” The organization said there were methodologic flaws with the single randomized study used to win FDA approval, and it noted that the study only proved noninferiority to fusion with a Bagby and Kuslich (BAK) cage.

The technology assessments are meant as scientific opinions—although they sometimes form the basis for coverage decisions, a BCBS spokeswoman said. Individual BCBS plans are not under any obligation to follow the recommendations, she added.

DePuy Spine is working with the BCBS plans to provide further evidence that it is a superior technology, said Richard Toselli, M.D., vice president for research and development at the company. In an interview, Dr. Toselli said that several individual BCBS plans, along with Aetna, Kaiser Permanente, and 62 small regional carriers, are paying for implantation of the Charité disk.

“Some evidence shows that it's as good as standard fusion and perhaps better, but we don't know that yet,” Ziya Gokaslan, M.D., vice chairman of the department of neurosurgery at Johns Hopkins Hospital in Baltimore, told this newspaper. Dr. Gokaslan said he has not yet implanted a Charité disk at Hopkins, but he has participated in the implantation of the device in Germany and Brazil.

“I think there is use for this device, and I think there are potential benefits down the line,” he said. But he added, “We do not know the long-term complications of the implantation of this device,” such as whether the plastic core will wear out. If early hip and knee implants are any indication, revisions and replacements could be required within 15–20 years of the original implantations, he said.

DePuy acknowledged that getting at the Charité disk for a revision can be difficult. The company said that if the disk has migrated from the disk space, it needs to be removed through an anterior approach and replaced with another disk or via a fusion done either anteriorly and/or posteriorly. “If the device has not migrated, and the patient continues to complain of pain, then the revision strategy is to do a posterior fusion alone and leave the disk in place,” Dr. Toselli said.

But the company said there's no indication the disks will have a short life span and that there have been few reports of complications in the 10,000 devices implanted worldwide. Dr. Toselli also cited a 10-year follow-up report on 100 cases, published in 2002 by one of the Charité pioneers, J.P. Lemaire, M.D. In that study, “no significant migration of the polyethylene” occurred in any of the implants, and there were only 2 cases (2%) of adjacent functional overload (Rachis [The Spinal Column] 2002;14:271–85). Overall, 62% of the patients had excellent results.

Surgeons need more experience in choosing the correct disk size and placing it properly. “There's an art to placing these things,” Dr. Graziano said, adding that “the reproducibility between surgeons is not there yet.”

DePuy has trained about 2,200 surgeons at its Center for Spine Arthroplasty at the Endo-Surgery Institute in Cincinnati. Surgeons can also train with or observe colleagues who have Charité experience at 50 regional sites.

Dr. Gokaslan and Dr. Graziano agree that artificial disks are at the stage interbody fusion cages were 10 years ago. An initial burst of enthusiasm was followed by the recognition that cages were not a panacea.

“It took 5 years to figure out who should get cages and who shouldn't,” Dr. Graziano said.

Although patients are asking for the Charité disks, surgeons will likely resist the pressure, Dr. Gokaslan said. “It's hard to change the habits of surgeons when there is no serious evidence showing this is better than what they've done in the past,” he said.

WASHINGTON — The investigational drug-eluting stent Endeavor did not do as well as the Cypher stent in measures of in-segment late lumen loss, according to study results presented at a symposium sponsored by the Cardiovascular Research Foundation.

The ENDEAVOR III trial compared the Endeavor, which is coated with a sirolimus-like drug called ABT-578, and the sirolimus-eluting Cypher. The Endeavor is manufactured by Medtronic Inc., and the Cypher by Cordis Corp.

The study of 436 patients “validates the angiographic and clinical outcomes seen in ENDEAVOR II,” said David E. Kandzari, M.D., the study's co-principal investigator. Dr. Kandzari, of Duke University Medical Center in Durham, N.C., disclosed no conflicts of interest.

The Endeavor was recently approved in Europe based on the preceding ENDEAVOR II results. But in ENDEAVOR III, the stent did not meet the noninferiority target for the primary end point, which was in-segment late lumen loss based on qualitative coronary angiography at 8 months.

The 282 patients in the Endeavor arm had an in-segment late loss of 0.34 mm that was consistent with results in ENDEAVOR II. But the results missed the 0.20-mm or less margin of difference from Cypher, which was needed to establish noninferiority. The 94 patients in the Cypher arm had a late loss of 0.13 mm, making for a 0.21-mm difference.

There was angiographic follow-up in 87.3% of the Endeavor patients and in 83.2% of the Cypher patients.

“In this trial, it wasn't that the Endeavor fared unexpectedly worse, but that we saw more favorable outcomes than expected with the Cypher in terms of late loss,” Dr. Kandzari told reporters in a briefing. The significance of late loss on clinical outcomes still has to be determined, he added.

“In real-world clinical practice, the most meaningful outcome is a clinical event—in particular, target vessel revascularization,” he said. At 9 months, those data looked favorable for the Endeavor, he said, adding that they were concordant with ENDEAVOR II data.

The secondary outcomes for Cypher and Endeavor were similar. The need for target vessel revascularization at 9 months was 6% for the Endeavor and 5.3% for the Cypher. Target lesion revascularization was 6.3% for the Endeavor, compared with 3.5% for the Cypher, but with only 113 patients in the Cypher group, the study was not powered for statistical significance, said Dr. Kandzari.

In ENDEAVOR III, target vessel failure was somewhat higher at 12%, compared with 9.5% in ENDEAVOR II, but similar to that seen with Cypher, at 11.5%.

At 9 months, the overall rate of major adverse cardiac events was 7.6% for the Endeavor arm and 7.1% for the Cypher arm. There were two deaths from noncardiac causes in the Endeavor group, compared with none in the Cypher arm. There was no stent thrombosis, according to Dr. Kandzari.

Scott Ward, president of Medtronic Vascular, said the company will continue development of the stent and has started enrollment for ENDEAVOR IV, an 80-center study of 1,548 patients, in which Endeavor will be compared with Boston Scientific Corp.'s paclitaxel-eluting Taxus stent.

Mr. Ward said he believed that the late loss issue will not be a deal-breaker for FDA approval. Regulators are more interested in evaluating how often patients have to come back to be revascularized, he told reporters.

However, in a discussion, Patrick Serruys, M.D., a professor of interventional cardiology at Erasmus University Medical Center in Rotterdam, the Netherlands, said the late-loss problem was significant with Endeavor and that it might become more important in high-risk patients.

Medtronic representatives said the manufacturer expects Food and Drug Administration approval by late 2007.

WASHINGTON — The investigational drug-eluting stent Endeavor did not do as well as the Cypher stent in measures of in-segment late lumen loss, according to study results presented at a symposium sponsored by the Cardiovascular Research Foundation.

The ENDEAVOR III trial compared the Endeavor, which is coated with a sirolimus-like drug called ABT-578, and the sirolimus-eluting Cypher. The Endeavor is manufactured by Medtronic Inc., and the Cypher by Cordis Corp.

The study of 436 patients “validates the angiographic and clinical outcomes seen in ENDEAVOR II,” said David E. Kandzari, M.D., the study's co-principal investigator. Dr. Kandzari, of Duke University Medical Center in Durham, N.C., disclosed no conflicts of interest.

The Endeavor was recently approved in Europe based on the preceding ENDEAVOR II results. But in ENDEAVOR III, the stent did not meet the noninferiority target for the primary end point, which was in-segment late lumen loss based on qualitative coronary angiography at 8 months.

The 282 patients in the Endeavor arm had an in-segment late loss of 0.34 mm that was consistent with results in ENDEAVOR II. But the results missed the 0.20-mm or less margin of difference from Cypher, which was needed to establish noninferiority. The 94 patients in the Cypher arm had a late loss of 0.13 mm, making for a 0.21-mm difference.

There was angiographic follow-up in 87.3% of the Endeavor patients and in 83.2% of the Cypher patients.

“In this trial, it wasn't that the Endeavor fared unexpectedly worse, but that we saw more favorable outcomes than expected with the Cypher in terms of late loss,” Dr. Kandzari told reporters in a briefing. The significance of late loss on clinical outcomes still has to be determined, he added.

“In real-world clinical practice, the most meaningful outcome is a clinical event—in particular, target vessel revascularization,” he said. At 9 months, those data looked favorable for the Endeavor, he said, adding that they were concordant with ENDEAVOR II data.

The secondary outcomes for Cypher and Endeavor were similar. The need for target vessel revascularization at 9 months was 6% for the Endeavor and 5.3% for the Cypher. Target lesion revascularization was 6.3% for the Endeavor, compared with 3.5% for the Cypher, but with only 113 patients in the Cypher group, the study was not powered for statistical significance, said Dr. Kandzari.

In ENDEAVOR III, target vessel failure was somewhat higher at 12%, compared with 9.5% in ENDEAVOR II, but similar to that seen with Cypher, at 11.5%.

At 9 months, the overall rate of major adverse cardiac events was 7.6% for the Endeavor arm and 7.1% for the Cypher arm. There were two deaths from noncardiac causes in the Endeavor group, compared with none in the Cypher arm. There was no stent thrombosis, according to Dr. Kandzari.

Scott Ward, president of Medtronic Vascular, said the company will continue development of the stent and has started enrollment for ENDEAVOR IV, an 80-center study of 1,548 patients, in which Endeavor will be compared with Boston Scientific Corp.'s paclitaxel-eluting Taxus stent.

Mr. Ward said he believed that the late loss issue will not be a deal-breaker for FDA approval. Regulators are more interested in evaluating how often patients have to come back to be revascularized, he told reporters.

However, in a discussion, Patrick Serruys, M.D., a professor of interventional cardiology at Erasmus University Medical Center in Rotterdam, the Netherlands, said the late-loss problem was significant with Endeavor and that it might become more important in high-risk patients.

Medtronic representatives said the manufacturer expects Food and Drug Administration approval by late 2007.

WASHINGTON — The investigational drug-eluting stent Endeavor did not do as well as the Cypher stent in measures of in-segment late lumen loss, according to study results presented at a symposium sponsored by the Cardiovascular Research Foundation.

The ENDEAVOR III trial compared the Endeavor, which is coated with a sirolimus-like drug called ABT-578, and the sirolimus-eluting Cypher. The Endeavor is manufactured by Medtronic Inc., and the Cypher by Cordis Corp.

The study of 436 patients “validates the angiographic and clinical outcomes seen in ENDEAVOR II,” said David E. Kandzari, M.D., the study's co-principal investigator. Dr. Kandzari, of Duke University Medical Center in Durham, N.C., disclosed no conflicts of interest.

The Endeavor was recently approved in Europe based on the preceding ENDEAVOR II results. But in ENDEAVOR III, the stent did not meet the noninferiority target for the primary end point, which was in-segment late lumen loss based on qualitative coronary angiography at 8 months.

The 282 patients in the Endeavor arm had an in-segment late loss of 0.34 mm that was consistent with results in ENDEAVOR II. But the results missed the 0.20-mm or less margin of difference from Cypher, which was needed to establish noninferiority. The 94 patients in the Cypher arm had a late loss of 0.13 mm, making for a 0.21-mm difference.

There was angiographic follow-up in 87.3% of the Endeavor patients and in 83.2% of the Cypher patients.

“In this trial, it wasn't that the Endeavor fared unexpectedly worse, but that we saw more favorable outcomes than expected with the Cypher in terms of late loss,” Dr. Kandzari told reporters in a briefing. The significance of late loss on clinical outcomes still has to be determined, he added.

“In real-world clinical practice, the most meaningful outcome is a clinical event—in particular, target vessel revascularization,” he said. At 9 months, those data looked favorable for the Endeavor, he said, adding that they were concordant with ENDEAVOR II data.

The secondary outcomes for Cypher and Endeavor were similar. The need for target vessel revascularization at 9 months was 6% for the Endeavor and 5.3% for the Cypher. Target lesion revascularization was 6.3% for the Endeavor, compared with 3.5% for the Cypher, but with only 113 patients in the Cypher group, the study was not powered for statistical significance, said Dr. Kandzari.

In ENDEAVOR III, target vessel failure was somewhat higher at 12%, compared with 9.5% in ENDEAVOR II, but similar to that seen with Cypher, at 11.5%.

At 9 months, the overall rate of major adverse cardiac events was 7.6% for the Endeavor arm and 7.1% for the Cypher arm. There were two deaths from noncardiac causes in the Endeavor group, compared with none in the Cypher arm. There was no stent thrombosis, according to Dr. Kandzari.

Scott Ward, president of Medtronic Vascular, said the company will continue development of the stent and has started enrollment for ENDEAVOR IV, an 80-center study of 1,548 patients, in which Endeavor will be compared with Boston Scientific Corp.'s paclitaxel-eluting Taxus stent.

Mr. Ward said he believed that the late loss issue will not be a deal-breaker for FDA approval. Regulators are more interested in evaluating how often patients have to come back to be revascularized, he told reporters.

However, in a discussion, Patrick Serruys, M.D., a professor of interventional cardiology at Erasmus University Medical Center in Rotterdam, the Netherlands, said the late-loss problem was significant with Endeavor and that it might become more important in high-risk patients.

Medtronic representatives said the manufacturer expects Food and Drug Administration approval by late 2007.

WASHINGTON — Leaders from emergency medicine, hospital and nursing organizations, and insurance companies are looking for ways to make the public—and legislators—more aware of emergency department crowding and its potential impact on patient safety.

At a roundtable meeting convened by the American College of Emergency Physicians, the agenda also included discussion of what could be done to help stem the growing tide of “boarding” of patients and diversions away from overcrowded emergency departments (EDs).

The meeting was also attended by representatives from the American Hospital Association, the Federation of American Hospitals, the Joint Commission on Accreditation of Healthcare Organizations, the Emergency Nurses Association, and CareFirst BlueCross BlueShield.

Just ahead of the meeting, ACEP issued a survey showing that 69% of Americans believed that EDs are approaching a crisis situation because of overcrowding.

There were 114 million ED visits in 2003, the largest number of visits ever, and an increase of 2 million visits per year from 1993, said Robert Suter, M.D., quoting statistics from the Centers for Disease Control and Prevention.

The number of EDs declined by 14% over the same time period.

The most significant contributor to overcrowding is the practice of boarding, in which patients who've been designated as inpatients aren't admitted because of a backup in the hospital, said Dr. Suter, an associate professor at the University of Texas Southwestern Medical Center. They end up waiting in ED hallways or acute beds. In the poll, 77% of those surveyed said boarding should only be used as a last resort in extreme cases, such as a natural disaster or epidemic.

The backlog of ED patients often leads hospitals to divert ambulances to other facilities. Of the poll respondents, 55% said they were concerned about diversion; 35% of emergency medicine physicians said diversion was happening at their practice location. Hospitals are reporting a similar crowding crunch. In the AHA's 2005 Survey of Hospital Leaders, 69% of urban hospitals, 33% of rural hospitals, 79% of teaching hospitals, and 43% of nonteaching hospitals report that their EDs are at or over capacity, said Carolyn Steinberg, vice president of health trend analysis at the AHA.

Among all hospitals, 40% said they had been on diversion in the last year; 70% of urban hospitals and 74% of teaching hospitals had to divert ambulances.

The main reason for diversion was a lack of critical care beds, cited by 44% of hospitals. Other reasons cited included: an overcrowded ED (23%), a lack of general acute care beds (13%), staff shortages (9%), and a lack of specialty physician coverage (5%).

Patient boarding threatens the safety of patients and workers, and puts patients in undignified and unacceptable positions, said Bruce Auerbach, M.D., vice president and chief of emergency and ambulatory services at Sturdy Memorial Hospital in Attleboro, Mass. The roundtable group agreed on some operational solutions for hospitals, including creating a protocol for how to cope when an ED is at full capacity; creating observation or discharge holding units to help manage patient flow; working with administration to better manage the flow of inpatient elective surgery; and creating a community-wide diversion strategy so that the practice is used sparingly.

Diversion should not be eliminated entirely, the attendees agreed, in that it allows psychological relief for staff who are under stress and is sometimes necessary—for instance, with large numbers of casualties from natural disasters or accidents.

The attendees also urged policymakers to fully fund Medicaid, provide better access to quality care for the mentally ill, consider more pay-for-performance-based incentives, and increase EDs' spending from Homeland Security Department funds.

WASHINGTON — Leaders from emergency medicine, hospital and nursing organizations, and insurance companies are looking for ways to make the public—and legislators—more aware of emergency department crowding and its potential impact on patient safety.

At a roundtable meeting convened by the American College of Emergency Physicians, the agenda also included discussion of what could be done to help stem the growing tide of “boarding” of patients and diversions away from overcrowded emergency departments (EDs).

The meeting was also attended by representatives from the American Hospital Association, the Federation of American Hospitals, the Joint Commission on Accreditation of Healthcare Organizations, the Emergency Nurses Association, and CareFirst BlueCross BlueShield.

Just ahead of the meeting, ACEP issued a survey showing that 69% of Americans believed that EDs are approaching a crisis situation because of overcrowding.

There were 114 million ED visits in 2003, the largest number of visits ever, and an increase of 2 million visits per year from 1993, said Robert Suter, M.D., quoting statistics from the Centers for Disease Control and Prevention.

The number of EDs declined by 14% over the same time period.

The most significant contributor to overcrowding is the practice of boarding, in which patients who've been designated as inpatients aren't admitted because of a backup in the hospital, said Dr. Suter, an associate professor at the University of Texas Southwestern Medical Center. They end up waiting in ED hallways or acute beds. In the poll, 77% of those surveyed said boarding should only be used as a last resort in extreme cases, such as a natural disaster or epidemic.

The backlog of ED patients often leads hospitals to divert ambulances to other facilities. Of the poll respondents, 55% said they were concerned about diversion; 35% of emergency medicine physicians said diversion was happening at their practice location. Hospitals are reporting a similar crowding crunch. In the AHA's 2005 Survey of Hospital Leaders, 69% of urban hospitals, 33% of rural hospitals, 79% of teaching hospitals, and 43% of nonteaching hospitals report that their EDs are at or over capacity, said Carolyn Steinberg, vice president of health trend analysis at the AHA.

Among all hospitals, 40% said they had been on diversion in the last year; 70% of urban hospitals and 74% of teaching hospitals had to divert ambulances.

The main reason for diversion was a lack of critical care beds, cited by 44% of hospitals. Other reasons cited included: an overcrowded ED (23%), a lack of general acute care beds (13%), staff shortages (9%), and a lack of specialty physician coverage (5%).

Patient boarding threatens the safety of patients and workers, and puts patients in undignified and unacceptable positions, said Bruce Auerbach, M.D., vice president and chief of emergency and ambulatory services at Sturdy Memorial Hospital in Attleboro, Mass. The roundtable group agreed on some operational solutions for hospitals, including creating a protocol for how to cope when an ED is at full capacity; creating observation or discharge holding units to help manage patient flow; working with administration to better manage the flow of inpatient elective surgery; and creating a community-wide diversion strategy so that the practice is used sparingly.

Diversion should not be eliminated entirely, the attendees agreed, in that it allows psychological relief for staff who are under stress and is sometimes necessary—for instance, with large numbers of casualties from natural disasters or accidents.

The attendees also urged policymakers to fully fund Medicaid, provide better access to quality care for the mentally ill, consider more pay-for-performance-based incentives, and increase EDs' spending from Homeland Security Department funds.

WASHINGTON — Leaders from emergency medicine, hospital and nursing organizations, and insurance companies are looking for ways to make the public—and legislators—more aware of emergency department crowding and its potential impact on patient safety.

At a roundtable meeting convened by the American College of Emergency Physicians, the agenda also included discussion of what could be done to help stem the growing tide of “boarding” of patients and diversions away from overcrowded emergency departments (EDs).

The meeting was also attended by representatives from the American Hospital Association, the Federation of American Hospitals, the Joint Commission on Accreditation of Healthcare Organizations, the Emergency Nurses Association, and CareFirst BlueCross BlueShield.

Just ahead of the meeting, ACEP issued a survey showing that 69% of Americans believed that EDs are approaching a crisis situation because of overcrowding.

There were 114 million ED visits in 2003, the largest number of visits ever, and an increase of 2 million visits per year from 1993, said Robert Suter, M.D., quoting statistics from the Centers for Disease Control and Prevention.

The number of EDs declined by 14% over the same time period.

The most significant contributor to overcrowding is the practice of boarding, in which patients who've been designated as inpatients aren't admitted because of a backup in the hospital, said Dr. Suter, an associate professor at the University of Texas Southwestern Medical Center. They end up waiting in ED hallways or acute beds. In the poll, 77% of those surveyed said boarding should only be used as a last resort in extreme cases, such as a natural disaster or epidemic.

The backlog of ED patients often leads hospitals to divert ambulances to other facilities. Of the poll respondents, 55% said they were concerned about diversion; 35% of emergency medicine physicians said diversion was happening at their practice location. Hospitals are reporting a similar crowding crunch. In the AHA's 2005 Survey of Hospital Leaders, 69% of urban hospitals, 33% of rural hospitals, 79% of teaching hospitals, and 43% of nonteaching hospitals report that their EDs are at or over capacity, said Carolyn Steinberg, vice president of health trend analysis at the AHA.

Among all hospitals, 40% said they had been on diversion in the last year; 70% of urban hospitals and 74% of teaching hospitals had to divert ambulances.

The main reason for diversion was a lack of critical care beds, cited by 44% of hospitals. Other reasons cited included: an overcrowded ED (23%), a lack of general acute care beds (13%), staff shortages (9%), and a lack of specialty physician coverage (5%).

Patient boarding threatens the safety of patients and workers, and puts patients in undignified and unacceptable positions, said Bruce Auerbach, M.D., vice president and chief of emergency and ambulatory services at Sturdy Memorial Hospital in Attleboro, Mass. The roundtable group agreed on some operational solutions for hospitals, including creating a protocol for how to cope when an ED is at full capacity; creating observation or discharge holding units to help manage patient flow; working with administration to better manage the flow of inpatient elective surgery; and creating a community-wide diversion strategy so that the practice is used sparingly.

Diversion should not be eliminated entirely, the attendees agreed, in that it allows psychological relief for staff who are under stress and is sometimes necessary—for instance, with large numbers of casualties from natural disasters or accidents.

The attendees also urged policymakers to fully fund Medicaid, provide better access to quality care for the mentally ill, consider more pay-for-performance-based incentives, and increase EDs' spending from Homeland Security Department funds.

CHICAGO — Perioperative mortality and long-term survival of patients with cirrhosis and hepatocellular carcinoma can be predicted using the Model for End-Stage Liver Disease, said Swee Teh, M.D., at the annual meeting of the Society for Surgery of the Alimentary Tract.

Typically, the Child-Turcotte-Pugh score is used most often to predict survival in patients being considered for resection, said Dr. Teh. He and his colleagues at the Mayo Clinic, Rochester, Minn., wanted to determine if the Model for End-Stage Liver Disease (MELD) score could predict perioperative mortality.

The MELD was developed by the United Network for Organ Sharing as a means of ranking patients waiting for a liver transplant and was used regularly starting in early 2002. Scores range from 6 (less ill) to 40 (gravely ill) and rely on three lab tests: bilirubin, international normalized ratio of prothrombin time, and creatinine.

Dr. Teh and his colleagues reviewed the charts of all patients who had a resection for hepatocellular carcinoma between January 1993 and December 2003, and analyzed perioperative mortality and long-term survival, applying both the Child-Turcotte-Pugh and MELD scores. Child-Turcotte-Pugh scores are categorized by three groups: the least sick patients are in class A and have 5–6 points; the moderately ill are in class B, with 7–9 points; and the more severely ill are in class C, with 10–15 points.

There were 82 patients with both cirrhosis and hepatocellular carcinoma (62 male and 20 female). The mean age was 62.1 years for all patients. Overall, 32% of the patients were stage I; 26%, stage II; and 42%, stage III.

The Child-Turcotte-Pugh score for the patients ranged from 5 to 9. Thirty-seven patients had a MELD score of less than 8, and 45 had a MELD of greater than 9 (with a range of 9–15).

The higher MELD scores tended to be associated with greater resection and lower survival. Fifty-nine of the patients had a minor resection, defined as less than three segments (29 had a MELD of less than 8, and 30 had a MELD of greater than 9); and 23 patients had a resection of more than four segments (with 8 having a MELD of 8 or less and 15 with a MELD of 9 or more).

There were 13 perioperative deaths. There appeared to be no correlation between the Child-Turcotte-Pugh score and death during surgery, said Dr. Teh. But all 13 patients who died had a MELD score greater than 9, he said.

At 30 days post resection, none of the patients with a MELD of less than 8 had died, compared with 29% of those with a MELD of greater than 9. The differences between the scores continued to be significant at 1, 3, and 5 years, at which point there was 51% survival among patients with a MELD of less than 8, and 24% among those with a MELD of greater than 9.

Dr. Teh said that because the study appeared to show that MELD is a strong predictor of perioperative mortality and long-term survival, his group recommends resection in patients with scores of less than 8 and organ transplants in those with a 9 or higher score.

Kevin Behrns, M.D., of the University of North Carolina at Chapel Hill, who discussed the paper at the meeting, said Dr. Teh's work showed that “MELD is predictive not only of perioperative mortality but also of survival” and that it is “more predictive than the Child-Turcotte-Pugh” score.

CHICAGO — Perioperative mortality and long-term survival of patients with cirrhosis and hepatocellular carcinoma can be predicted using the Model for End-Stage Liver Disease, said Swee Teh, M.D., at the annual meeting of the Society for Surgery of the Alimentary Tract.

Typically, the Child-Turcotte-Pugh score is used most often to predict survival in patients being considered for resection, said Dr. Teh. He and his colleagues at the Mayo Clinic, Rochester, Minn., wanted to determine if the Model for End-Stage Liver Disease (MELD) score could predict perioperative mortality.

The MELD was developed by the United Network for Organ Sharing as a means of ranking patients waiting for a liver transplant and was used regularly starting in early 2002. Scores range from 6 (less ill) to 40 (gravely ill) and rely on three lab tests: bilirubin, international normalized ratio of prothrombin time, and creatinine.

Dr. Teh and his colleagues reviewed the charts of all patients who had a resection for hepatocellular carcinoma between January 1993 and December 2003, and analyzed perioperative mortality and long-term survival, applying both the Child-Turcotte-Pugh and MELD scores. Child-Turcotte-Pugh scores are categorized by three groups: the least sick patients are in class A and have 5–6 points; the moderately ill are in class B, with 7–9 points; and the more severely ill are in class C, with 10–15 points.

There were 82 patients with both cirrhosis and hepatocellular carcinoma (62 male and 20 female). The mean age was 62.1 years for all patients. Overall, 32% of the patients were stage I; 26%, stage II; and 42%, stage III.

The Child-Turcotte-Pugh score for the patients ranged from 5 to 9. Thirty-seven patients had a MELD score of less than 8, and 45 had a MELD of greater than 9 (with a range of 9–15).

The higher MELD scores tended to be associated with greater resection and lower survival. Fifty-nine of the patients had a minor resection, defined as less than three segments (29 had a MELD of less than 8, and 30 had a MELD of greater than 9); and 23 patients had a resection of more than four segments (with 8 having a MELD of 8 or less and 15 with a MELD of 9 or more).

There were 13 perioperative deaths. There appeared to be no correlation between the Child-Turcotte-Pugh score and death during surgery, said Dr. Teh. But all 13 patients who died had a MELD score greater than 9, he said.

At 30 days post resection, none of the patients with a MELD of less than 8 had died, compared with 29% of those with a MELD of greater than 9. The differences between the scores continued to be significant at 1, 3, and 5 years, at which point there was 51% survival among patients with a MELD of less than 8, and 24% among those with a MELD of greater than 9.

Dr. Teh said that because the study appeared to show that MELD is a strong predictor of perioperative mortality and long-term survival, his group recommends resection in patients with scores of less than 8 and organ transplants in those with a 9 or higher score.

Kevin Behrns, M.D., of the University of North Carolina at Chapel Hill, who discussed the paper at the meeting, said Dr. Teh's work showed that “MELD is predictive not only of perioperative mortality but also of survival” and that it is “more predictive than the Child-Turcotte-Pugh” score.

CHICAGO — Perioperative mortality and long-term survival of patients with cirrhosis and hepatocellular carcinoma can be predicted using the Model for End-Stage Liver Disease, said Swee Teh, M.D., at the annual meeting of the Society for Surgery of the Alimentary Tract.

Typically, the Child-Turcotte-Pugh score is used most often to predict survival in patients being considered for resection, said Dr. Teh. He and his colleagues at the Mayo Clinic, Rochester, Minn., wanted to determine if the Model for End-Stage Liver Disease (MELD) score could predict perioperative mortality.

The MELD was developed by the United Network for Organ Sharing as a means of ranking patients waiting for a liver transplant and was used regularly starting in early 2002. Scores range from 6 (less ill) to 40 (gravely ill) and rely on three lab tests: bilirubin, international normalized ratio of prothrombin time, and creatinine.

Dr. Teh and his colleagues reviewed the charts of all patients who had a resection for hepatocellular carcinoma between January 1993 and December 2003, and analyzed perioperative mortality and long-term survival, applying both the Child-Turcotte-Pugh and MELD scores. Child-Turcotte-Pugh scores are categorized by three groups: the least sick patients are in class A and have 5–6 points; the moderately ill are in class B, with 7–9 points; and the more severely ill are in class C, with 10–15 points.

There were 82 patients with both cirrhosis and hepatocellular carcinoma (62 male and 20 female). The mean age was 62.1 years for all patients. Overall, 32% of the patients were stage I; 26%, stage II; and 42%, stage III.

The Child-Turcotte-Pugh score for the patients ranged from 5 to 9. Thirty-seven patients had a MELD score of less than 8, and 45 had a MELD of greater than 9 (with a range of 9–15).

The higher MELD scores tended to be associated with greater resection and lower survival. Fifty-nine of the patients had a minor resection, defined as less than three segments (29 had a MELD of less than 8, and 30 had a MELD of greater than 9); and 23 patients had a resection of more than four segments (with 8 having a MELD of 8 or less and 15 with a MELD of 9 or more).

There were 13 perioperative deaths. There appeared to be no correlation between the Child-Turcotte-Pugh score and death during surgery, said Dr. Teh. But all 13 patients who died had a MELD score greater than 9, he said.

At 30 days post resection, none of the patients with a MELD of less than 8 had died, compared with 29% of those with a MELD of greater than 9. The differences between the scores continued to be significant at 1, 3, and 5 years, at which point there was 51% survival among patients with a MELD of less than 8, and 24% among those with a MELD of greater than 9.

Dr. Teh said that because the study appeared to show that MELD is a strong predictor of perioperative mortality and long-term survival, his group recommends resection in patients with scores of less than 8 and organ transplants in those with a 9 or higher score.

Kevin Behrns, M.D., of the University of North Carolina at Chapel Hill, who discussed the paper at the meeting, said Dr. Teh's work showed that “MELD is predictive not only of perioperative mortality but also of survival” and that it is “more predictive than the Child-Turcotte-Pugh” score.

Radical prostatectomy for locally advanced prostate cancer, which generally results in better outcomes than radiation therapy alone, is not often offered. But a 15-year survival rate of 80%—better than for radiation therapy, and equivalent to stage 2 surgery results—was achieved in men with clinical T3 disease who had the procedure, according to results of a long-term study at the Mayo Clinic, Rochester, Minn.

Many men with clinical T3 disease are told they can't be helped by surgery and are often referred to the clinic for second opinions, senior investigator Horst Zincke, M.D., director of urooncologic surgery at the clinic, told FAMILY PRACTICE NEWS.

Principal investigator John Ward, M.D., now of the Naval Medical Center, Portsmouth, Va., along with Dr. Zincke and other colleagues, conducted a retrospective study of 5,652 men who had radical prostatectomy for confirmed prostate cancer from 1987 to 1997 (a period when prostate-specific antigen [PSA] testing came into use).

Of those, 15% (842) had the surgery for clinical stage T3. Median follow-up was 10.3 years. Survival was compared with men who had prostatectomy for stage 2 disease during the same period as well as with published results for radiation therapy (BJU Int. 2005;95:751–6).

Reports in the literature indicate a 79% survival at 5 years for T3 disease treated with radiation alone, Dr. Zincke said in the interview. And, he and his colleagues noted, studies have also shown that cancer can persist in 14%–91% of men given radiotherapy.

The Mayo study found that survival rates with surgery were 95% at 5 years, 90% at 10 years, and 79% at 15 years. During those same periods, 85%, 73%, and 67% of patients, respectively, were free of local or systemic disease recurrence after surgery.

Although 21% of T3 patients were given neoadjuvant hormone therapy, that intervention had little impact on the grade, stage, or rates of margin positivity, and did not affect progression-free or cancer-specific survival, the authors said.

The fact that survival, complication, and incontinence rates were similar to those for surgery for T2 disease, including a 75% rate of erectile dysfunction, reflected “the infrequent use of a nerve-sparing technique,” the authors reported. Perioperative mortality was the same as for T2 patients.

Experts continue to debate T3 disease management, and surgery has declined significantly in the United States; only about 6% of T3 patients undergo radical prostatectomy, according to the authors. At the Mayo Clinic, the number of patients receiving the procedure has dropped from 25.3% of T3 patients in 1987 to 2.8% in 2001. The decline may partly be due to overstaging by PSA results—in this study, 27% were clinically overstaged, the authors said.

And surgeons have gotten more wary of operating when they believe the cancer is extracapsular, Dr. Zincke said.

While the Mayo results were good, they may not be repeated everywhere, he said. The best candidates are patients in their 40s to 60s who have early extracapsular disease, Dr. Zincke said. With those men, “we know we can take the cancer out without causing increased morbidity,” he said.

Radical prostatectomy for locally advanced prostate cancer, which generally results in better outcomes than radiation therapy alone, is not often offered. But a 15-year survival rate of 80%—better than for radiation therapy, and equivalent to stage 2 surgery results—was achieved in men with clinical T3 disease who had the procedure, according to results of a long-term study at the Mayo Clinic, Rochester, Minn.

Many men with clinical T3 disease are told they can't be helped by surgery and are often referred to the clinic for second opinions, senior investigator Horst Zincke, M.D., director of urooncologic surgery at the clinic, told FAMILY PRACTICE NEWS.

Principal investigator John Ward, M.D., now of the Naval Medical Center, Portsmouth, Va., along with Dr. Zincke and other colleagues, conducted a retrospective study of 5,652 men who had radical prostatectomy for confirmed prostate cancer from 1987 to 1997 (a period when prostate-specific antigen [PSA] testing came into use).

Of those, 15% (842) had the surgery for clinical stage T3. Median follow-up was 10.3 years. Survival was compared with men who had prostatectomy for stage 2 disease during the same period as well as with published results for radiation therapy (BJU Int. 2005;95:751–6).

Reports in the literature indicate a 79% survival at 5 years for T3 disease treated with radiation alone, Dr. Zincke said in the interview. And, he and his colleagues noted, studies have also shown that cancer can persist in 14%–91% of men given radiotherapy.

The Mayo study found that survival rates with surgery were 95% at 5 years, 90% at 10 years, and 79% at 15 years. During those same periods, 85%, 73%, and 67% of patients, respectively, were free of local or systemic disease recurrence after surgery.

Although 21% of T3 patients were given neoadjuvant hormone therapy, that intervention had little impact on the grade, stage, or rates of margin positivity, and did not affect progression-free or cancer-specific survival, the authors said.

The fact that survival, complication, and incontinence rates were similar to those for surgery for T2 disease, including a 75% rate of erectile dysfunction, reflected “the infrequent use of a nerve-sparing technique,” the authors reported. Perioperative mortality was the same as for T2 patients.

Experts continue to debate T3 disease management, and surgery has declined significantly in the United States; only about 6% of T3 patients undergo radical prostatectomy, according to the authors. At the Mayo Clinic, the number of patients receiving the procedure has dropped from 25.3% of T3 patients in 1987 to 2.8% in 2001. The decline may partly be due to overstaging by PSA results—in this study, 27% were clinically overstaged, the authors said.

And surgeons have gotten more wary of operating when they believe the cancer is extracapsular, Dr. Zincke said.

While the Mayo results were good, they may not be repeated everywhere, he said. The best candidates are patients in their 40s to 60s who have early extracapsular disease, Dr. Zincke said. With those men, “we know we can take the cancer out without causing increased morbidity,” he said.

Radical prostatectomy for locally advanced prostate cancer, which generally results in better outcomes than radiation therapy alone, is not often offered. But a 15-year survival rate of 80%—better than for radiation therapy, and equivalent to stage 2 surgery results—was achieved in men with clinical T3 disease who had the procedure, according to results of a long-term study at the Mayo Clinic, Rochester, Minn.

Many men with clinical T3 disease are told they can't be helped by surgery and are often referred to the clinic for second opinions, senior investigator Horst Zincke, M.D., director of urooncologic surgery at the clinic, told FAMILY PRACTICE NEWS.

Principal investigator John Ward, M.D., now of the Naval Medical Center, Portsmouth, Va., along with Dr. Zincke and other colleagues, conducted a retrospective study of 5,652 men who had radical prostatectomy for confirmed prostate cancer from 1987 to 1997 (a period when prostate-specific antigen [PSA] testing came into use).

Of those, 15% (842) had the surgery for clinical stage T3. Median follow-up was 10.3 years. Survival was compared with men who had prostatectomy for stage 2 disease during the same period as well as with published results for radiation therapy (BJU Int. 2005;95:751–6).

Reports in the literature indicate a 79% survival at 5 years for T3 disease treated with radiation alone, Dr. Zincke said in the interview. And, he and his colleagues noted, studies have also shown that cancer can persist in 14%–91% of men given radiotherapy.

The Mayo study found that survival rates with surgery were 95% at 5 years, 90% at 10 years, and 79% at 15 years. During those same periods, 85%, 73%, and 67% of patients, respectively, were free of local or systemic disease recurrence after surgery.

Although 21% of T3 patients were given neoadjuvant hormone therapy, that intervention had little impact on the grade, stage, or rates of margin positivity, and did not affect progression-free or cancer-specific survival, the authors said.

The fact that survival, complication, and incontinence rates were similar to those for surgery for T2 disease, including a 75% rate of erectile dysfunction, reflected “the infrequent use of a nerve-sparing technique,” the authors reported. Perioperative mortality was the same as for T2 patients.

Experts continue to debate T3 disease management, and surgery has declined significantly in the United States; only about 6% of T3 patients undergo radical prostatectomy, according to the authors. At the Mayo Clinic, the number of patients receiving the procedure has dropped from 25.3% of T3 patients in 1987 to 2.8% in 2001. The decline may partly be due to overstaging by PSA results—in this study, 27% were clinically overstaged, the authors said.

And surgeons have gotten more wary of operating when they believe the cancer is extracapsular, Dr. Zincke said.

While the Mayo results were good, they may not be repeated everywhere, he said. The best candidates are patients in their 40s to 60s who have early extracapsular disease, Dr. Zincke said. With those men, “we know we can take the cancer out without causing increased morbidity,” he said.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy.D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures and that there was no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of the following conditions: acute MI, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, the authors wrote.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004—a total of 3,087 out of the 3,377 hospitals initially identified as study participants.

Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

One of the measures looked at death in the hospital after acute myocardial infarction, and the other 17 assessed processes of care.

There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have had an impact on mortality. And there was no significant improvement in the mean time to thrombolysis for patients with acute MI or in mean time to administration of antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities, the investigators said.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to a high of 66% at the highest performing facilities.

One potential drawback of the study was its reliance on self-reported data, which could introduce bias. And, they said, the data should not be viewed as static. The picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy.D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures and that there was no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of the following conditions: acute MI, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, the authors wrote.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004—a total of 3,087 out of the 3,377 hospitals initially identified as study participants.

Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

One of the measures looked at death in the hospital after acute myocardial infarction, and the other 17 assessed processes of care.

There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have had an impact on mortality. And there was no significant improvement in the mean time to thrombolysis for patients with acute MI or in mean time to administration of antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities, the investigators said.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to a high of 66% at the highest performing facilities.

One potential drawback of the study was its reliance on self-reported data, which could introduce bias. And, they said, the data should not be viewed as static. The picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

A set of process measures established by the Joint Commission on Accreditation of Healthcare Organizations has helped hospitals to improve performance, according to a study of the first 2 years of implementation.

The study, by Scott C. Williams, Psy.D., and his colleagues at the commission, found that improvements were made in 15 of 18 standardized measures and that there was no deterioration of quality in any of those areas (N. Engl. J. Med. 2005;353:255–64).

In 2002, the commission began measuring performance in the 18 measures at 3,377 of 4,644 hospitals accredited by the organization. Nonparticipating hospitals either did not offer the services being measured or had an average daily census of fewer than 10 patients. The facilities could choose to submit data on at least two of the following conditions: acute MI, heart failure, pneumonia, and pregnancy and related conditions.

They did not track the pregnancy measures, as two of the measures applied to rare events, and the third, vaginal birth after cesarean section, is controversial, the authors wrote.

The study covered hospitals that submitted data from the third quarter of 2002 to the second quarter of 2004—a total of 3,087 out of the 3,377 hospitals initially identified as study participants.

Of those, 1,473 submitted data on heart attack measures, 1,946 on heart failure, and 1,797 on pneumonia.

One of the measures looked at death in the hospital after acute myocardial infarction, and the other 17 assessed processes of care.

There was no improvement in the death measure, but the authors said most of the improvements in the process measures being assessed would not have had an impact on mortality. And there was no significant improvement in the mean time to thrombolysis for patients with acute MI or in mean time to administration of antibiotics for pneumonia.

For acute MI, researchers looked at measures such as whether aspirin was given within 24 hours of admission and prescribed at discharge, whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction, and the mean time from arrival to thrombolysis or percutaneous coronary intervention.

For heart failure, hospitals were tracked on whether they had given patients smoking cessation counseling and discharge instructions on medication, diet, weight, and worsening of symptoms, and whether an ACE inhibitor was prescribed at discharge for patients with left ventricular systolic dysfunction.

For pneumonia, the commission monitored whether there was an oxygenation assessment within 24 hours of admission and whether pneumococcal screening, vaccination, or both had been given at discharge, or if blood specimens were cultured before starting an antibiotic.

By the end of the study period, more than 90% of MI patients at most hospitals received aspirin at admission. Although only 74% of patients received ACE inhibitors at discharge at the lowest performing hospitals, 83% received them at the highest performing facilities, the investigators said.

The biggest improvement was seen in offering smoking cessation counseling. Rates went from a range of 1%–7% at the lowest performing hospitals at baseline to a range of 57%–68% at the study's end. At high-performing facilities, however, rates dropped from an 80%–98% range at baseline to a range of 74%–85% at the end.

Even after improvement, pneumococcal vaccination rates were still low, ranging from 35% in the lowest performing hospitals to a high of 66% at the highest performing facilities.

One potential drawback of the study was its reliance on self-reported data, which could introduce bias. And, they said, the data should not be viewed as static. The picture could change as public reporting of hospital data becomes more prevalent and pay for performance spreads.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is not known, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is not known, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is not known, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.