Vascular

MILWAUKEE – Although female gender is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003).

Patrice Wendling/IMNG Medical Media

On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the meeting.

He highlighted a recent prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no gender differences, however, for any of these outcomes following elective open repair or emergency EVAR or surgery (Vasc. Surg. 2012;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002), Dr. Gloviczki said.

High-risk patients, defined by an SVS comorbidity score of more than 10, however, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group.

Dr. Gloviczki noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

He noted that Mayo Clinic performed its first EVAR in 1996, and that today, 63% of patients with an aneurysm undergo endovascular repair.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki and his coauthors reported no relevant conflicts of interest.

MILWAUKEE – Although female gender is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003).

Patrice Wendling/IMNG Medical Media

On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the meeting.

He highlighted a recent prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no gender differences, however, for any of these outcomes following elective open repair or emergency EVAR or surgery (Vasc. Surg. 2012;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002), Dr. Gloviczki said.

High-risk patients, defined by an SVS comorbidity score of more than 10, however, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group.

Dr. Gloviczki noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

He noted that Mayo Clinic performed its first EVAR in 1996, and that today, 63% of patients with an aneurysm undergo endovascular repair.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki and his coauthors reported no relevant conflicts of interest.

MILWAUKEE – Although female gender is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003).

Patrice Wendling/IMNG Medical Media

On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the meeting.

He highlighted a recent prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no gender differences, however, for any of these outcomes following elective open repair or emergency EVAR or surgery (Vasc. Surg. 2012;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002), Dr. Gloviczki said.

High-risk patients, defined by an SVS comorbidity score of more than 10, however, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group.

Dr. Gloviczki noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

He noted that Mayo Clinic performed its first EVAR in 1996, and that today, 63% of patients with an aneurysm undergo endovascular repair.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki and his coauthors reported no relevant conflicts of interest.

MILWAUKEE – Less invasive lower-extremity endovascular interventions do not reduce hospital readmissions among patients with peripheral artery disease, according to an analysis of the Cerner Health Facts database.

The 30-day readmission rate was 13.9% for patients who underwent open surgery and 15.3% for those who had an endovascular procedure.

Lead author Dr. Todd Vogel expressed surprise that the two approaches were relatively equal, adding that, "I thought with endo, we’re doing less, they’d come back more."

Patrice Wendling/IMNG Medical Media

The common practice of staging lower-limb endovascular interventions is creating concerns that use of hospital readmissions as a quality outcome measure for reimbursement may not accurately identify planned readmissions or quality of care.

Session moderator Dr. Patrick Geraghty said in an interview that lower-extremity intervention outcomes "are probably the most complex and difficult to define outcomes issue for all of vascular surgery," as compared with carotid and aortic aneurysms, and that this is already reflected in efforts proposed by the National Surgical Quality Improvement Program (NSQIP) and the Centers for Medicare and Medicaid Services (CMS).

"Lower-extremity readmission is going to be a real hot-button discussion because we already know it’s substantial," he said. "If I do a stent graft for someone with leg ischemia and the flow improves and they go home on post-op day 1, and I bring them back 10 days later for a planned debridement of a toe ulcer that we’d been looking at, was that bad? Was that poor care, something I should be penalized for?

"Or was it just good care, but it didn’t fit into CMS’s box of everything should be done within one admission and that any readmission is therefore bad?"

The current analysis is unique in that utilizes electronic medical record (EMR) data to provide real-world outcomes for lower-limb interventions, said Dr. Geraghty, a vascular surgeon with Barnes-Jewish Hospital in St. Louis.

"I think we’re seeing here maybe the first fruits of good EMR design, and it’s a prod for surgeons to look into EMR design and ask whether we can design EMR notes for vascular follow-up in the ER such that we pull good EMR data over great numbers of patients," he said at the annual meeting of the Midwestern Vascular Surgical Society.

Dr. Vogel said that the Cerner database is not as population based as Medicare, capturing observational patient EMR data on more than 84 million admissions and ambulatory visits at roughly 187 participating hospitals, albeit primarily urban. Cerner is the second largest EMR in the United States after Epic.

The analysis encompassed 1,458 elective first admissions with a diagnosis of peripheral artery disease (PAD) undergoing a lower-extremity procedure from October 2008 to December 2010. Of these, 777 had open surgery and 681 an endovascular procedure.

Intermittent claudication was the most common indication for any procedure, present in 56.2% of open and 43.8% of endovascular patients.

The overall readmission rate at 30 days was surprisingly high at 14.5%, and was also unexpectedly high for for those with claudication, at 10.2% in the open and 11.3% in the endovascular group, said Dr. Vogel, chief of vascular surgery at the University of Missouri Hospitals and Clinics, Columbia.

"The frightening number to think about is that, in the claudicant group, we have a 10% readmission rate within 30 days," he said, noting that rates were very similar between groups. "So that’s a number we should all begin to think about."

As expected, readmission rates in the open and endovascular groups increased with disease severity. Rates for rest pain and gangrene were 14% vs. 18.2%, and 22% vs. 24%, respectively.

In bivariate analysis, blacks were significantly more likely to be readmitted 30 days after discharge (odds ratio, 1.56), as were patients discharged to a skilled nursing facility or nursing home (OR, 2.59), he said.

There was a nonsignificant trend toward higher readmissions at teaching hospitals (OR, 1.20), while a hospital stay of more than 7 days was a strong, significant predictor of 30-day readmission (OR, 2.54).

Readmissions also were increased in patients with a Charlson Comorbidity Index score of 3-5 (OR, 1.56) or score of 6-10 (OR, 1.90), diabetes (OR, 1.41), or sepsis (OR, 2.99), he said.

The risk of 30-day readmission was increased more than fivefold among patients with poor liver function, as indicated by total bilirubin levels greater than 2 mg/dL (OR, 5.15) or AST over 100 U/L (OR, 5.56). Risk was also more than twofold higher among patients with renal disease, as indicated by hemoglobin (nadir) less than 8 g/dL (OR, 2.17) and serum creatinine of at least 2 mg/dL (OR, 2.07), as well as those dispensed a staggering 30 medications or more (OR, 2.63), Dr. Vogel reported.

Notably, patients with cardiac troponin levels above 0.2 mg/dL were not at significantly higher risk of readmission (OR, 1.75), although those with a white blood cell count greater than 15,000/mcL were (OR, 2.1), which goes along with the finding of sepsis, he said.

In multivariate logistic regression analysis adjusting for age, disease severity, and race, PAD severity dropped out but male gender (OR, 1.39), Charlson Comorbidity Index (OR 1.12), length of stay (OR, 1.25), AST (OR 2.89), and more than 30 dispensed medications (OR, 1.84) remained significant.

"I think these are the things we’re going to have to look at if we’re going to really address readmissions," Dr. Vogel said.

He highlighted a new algorithm created at the Dartmouth-Hitchcock Medical Center that describes strategies for both predicting and preventing readmissions in vascular surgery (J. Vasc. Surg. 2012 56:556-62).

"It’s fun to describe all this, but the next step is to create change," he added.

During a discussion of the study, Dr. Vogel said that it was possible to calculate specialty-specific readmission rates but that such an analysis had not been performed yet.

Patrice Wendling/IMNG Medical Media

Society for Vascular Surgery (SVS) President Peter Gloviczki then rose from the audience to say that such an analysis is very important in light of a recent Medicare database analysis reporting that endovascular lower-extremity revascularization performed by vascular specialists results in higher costs, longer hospital stays, and more repeat revascularization procedures and amputations than the same procedure performed by interventional radiologists (J. Vasc. Interv. Radiol. 2012:23:3-9).

He went on to say that the controversial paper, which was sharply rebuked by past SVS President Richard Cambria, failed to define indications for the interventions or major vs. minor amputations.

"I think if your data show, not necessarily the outcome, but the case mix of the specialties and what we believe is the severity of disease that vascular surgeons take care of compared to radiologists, that would be very good because that is a way to answer with data, and not with rhetoric," Dr. Gloviczki said.

Dr. Vogel agreed that vascular surgeons, as a rule, treat sicker patients with heavier disease burden, subsequently leading to these various secondary outcomes, and that the Medicare analysis failed to adequately process the data.

"It was a very jaded view," he said.

Session comoderator Dr. Melina Kibbe, a vascular surgeon with Northwestern Memorial Hospital in Chicago, said that the current analysis is the first to use the Cerner database and "that this could be why we’re seeing different outcomes than what other people have reported because this is a more real-world database."

She went on to say that using lower-extremity readmissions as a quality measure is highly problematic because care of these patients, much like that for those with cancer, is often staged and extends for years.

Those thoughts were echoed by the newly elected president of the Midwestern Vascular Surgical Society, Dr. Timothy Kresowik. In an interview, he said, "I’d stay away from lower extremity to begin with. I think it’s just a terrible area to try to do performance measures, especially short-term performance measures, because the important thing to remember about lower-extremity bypass is the real issues are long term."

Dr. Vogel, Dr. Geraghty, Dr. Gloviczki, Dr. Kibbe, and Dr. Kresowik reported having no relevant conflicts of interest.

MILWAUKEE – Less invasive lower-extremity endovascular interventions do not reduce hospital readmissions among patients with peripheral artery disease, according to an analysis of the Cerner Health Facts database.

The 30-day readmission rate was 13.9% for patients who underwent open surgery and 15.3% for those who had an endovascular procedure.

Lead author Dr. Todd Vogel expressed surprise that the two approaches were relatively equal, adding that, "I thought with endo, we’re doing less, they’d come back more."

Patrice Wendling/IMNG Medical Media

The common practice of staging lower-limb endovascular interventions is creating concerns that use of hospital readmissions as a quality outcome measure for reimbursement may not accurately identify planned readmissions or quality of care.

Session moderator Dr. Patrick Geraghty said in an interview that lower-extremity intervention outcomes "are probably the most complex and difficult to define outcomes issue for all of vascular surgery," as compared with carotid and aortic aneurysms, and that this is already reflected in efforts proposed by the National Surgical Quality Improvement Program (NSQIP) and the Centers for Medicare and Medicaid Services (CMS).

"Lower-extremity readmission is going to be a real hot-button discussion because we already know it’s substantial," he said. "If I do a stent graft for someone with leg ischemia and the flow improves and they go home on post-op day 1, and I bring them back 10 days later for a planned debridement of a toe ulcer that we’d been looking at, was that bad? Was that poor care, something I should be penalized for?

"Or was it just good care, but it didn’t fit into CMS’s box of everything should be done within one admission and that any readmission is therefore bad?"

The current analysis is unique in that utilizes electronic medical record (EMR) data to provide real-world outcomes for lower-limb interventions, said Dr. Geraghty, a vascular surgeon with Barnes-Jewish Hospital in St. Louis.

"I think we’re seeing here maybe the first fruits of good EMR design, and it’s a prod for surgeons to look into EMR design and ask whether we can design EMR notes for vascular follow-up in the ER such that we pull good EMR data over great numbers of patients," he said at the annual meeting of the Midwestern Vascular Surgical Society.

Dr. Vogel said that the Cerner database is not as population based as Medicare, capturing observational patient EMR data on more than 84 million admissions and ambulatory visits at roughly 187 participating hospitals, albeit primarily urban. Cerner is the second largest EMR in the United States after Epic.

The analysis encompassed 1,458 elective first admissions with a diagnosis of peripheral artery disease (PAD) undergoing a lower-extremity procedure from October 2008 to December 2010. Of these, 777 had open surgery and 681 an endovascular procedure.

Intermittent claudication was the most common indication for any procedure, present in 56.2% of open and 43.8% of endovascular patients.

The overall readmission rate at 30 days was surprisingly high at 14.5%, and was also unexpectedly high for for those with claudication, at 10.2% in the open and 11.3% in the endovascular group, said Dr. Vogel, chief of vascular surgery at the University of Missouri Hospitals and Clinics, Columbia.

"The frightening number to think about is that, in the claudicant group, we have a 10% readmission rate within 30 days," he said, noting that rates were very similar between groups. "So that’s a number we should all begin to think about."

As expected, readmission rates in the open and endovascular groups increased with disease severity. Rates for rest pain and gangrene were 14% vs. 18.2%, and 22% vs. 24%, respectively.

In bivariate analysis, blacks were significantly more likely to be readmitted 30 days after discharge (odds ratio, 1.56), as were patients discharged to a skilled nursing facility or nursing home (OR, 2.59), he said.

There was a nonsignificant trend toward higher readmissions at teaching hospitals (OR, 1.20), while a hospital stay of more than 7 days was a strong, significant predictor of 30-day readmission (OR, 2.54).

Readmissions also were increased in patients with a Charlson Comorbidity Index score of 3-5 (OR, 1.56) or score of 6-10 (OR, 1.90), diabetes (OR, 1.41), or sepsis (OR, 2.99), he said.

The risk of 30-day readmission was increased more than fivefold among patients with poor liver function, as indicated by total bilirubin levels greater than 2 mg/dL (OR, 5.15) or AST over 100 U/L (OR, 5.56). Risk was also more than twofold higher among patients with renal disease, as indicated by hemoglobin (nadir) less than 8 g/dL (OR, 2.17) and serum creatinine of at least 2 mg/dL (OR, 2.07), as well as those dispensed a staggering 30 medications or more (OR, 2.63), Dr. Vogel reported.

Notably, patients with cardiac troponin levels above 0.2 mg/dL were not at significantly higher risk of readmission (OR, 1.75), although those with a white blood cell count greater than 15,000/mcL were (OR, 2.1), which goes along with the finding of sepsis, he said.

In multivariate logistic regression analysis adjusting for age, disease severity, and race, PAD severity dropped out but male gender (OR, 1.39), Charlson Comorbidity Index (OR 1.12), length of stay (OR, 1.25), AST (OR 2.89), and more than 30 dispensed medications (OR, 1.84) remained significant.

"I think these are the things we’re going to have to look at if we’re going to really address readmissions," Dr. Vogel said.

He highlighted a new algorithm created at the Dartmouth-Hitchcock Medical Center that describes strategies for both predicting and preventing readmissions in vascular surgery (J. Vasc. Surg. 2012 56:556-62).

"It’s fun to describe all this, but the next step is to create change," he added.

During a discussion of the study, Dr. Vogel said that it was possible to calculate specialty-specific readmission rates but that such an analysis had not been performed yet.

Patrice Wendling/IMNG Medical Media

Society for Vascular Surgery (SVS) President Peter Gloviczki then rose from the audience to say that such an analysis is very important in light of a recent Medicare database analysis reporting that endovascular lower-extremity revascularization performed by vascular specialists results in higher costs, longer hospital stays, and more repeat revascularization procedures and amputations than the same procedure performed by interventional radiologists (J. Vasc. Interv. Radiol. 2012:23:3-9).

He went on to say that the controversial paper, which was sharply rebuked by past SVS President Richard Cambria, failed to define indications for the interventions or major vs. minor amputations.

"I think if your data show, not necessarily the outcome, but the case mix of the specialties and what we believe is the severity of disease that vascular surgeons take care of compared to radiologists, that would be very good because that is a way to answer with data, and not with rhetoric," Dr. Gloviczki said.

Dr. Vogel agreed that vascular surgeons, as a rule, treat sicker patients with heavier disease burden, subsequently leading to these various secondary outcomes, and that the Medicare analysis failed to adequately process the data.

"It was a very jaded view," he said.

Session comoderator Dr. Melina Kibbe, a vascular surgeon with Northwestern Memorial Hospital in Chicago, said that the current analysis is the first to use the Cerner database and "that this could be why we’re seeing different outcomes than what other people have reported because this is a more real-world database."

She went on to say that using lower-extremity readmissions as a quality measure is highly problematic because care of these patients, much like that for those with cancer, is often staged and extends for years.

Those thoughts were echoed by the newly elected president of the Midwestern Vascular Surgical Society, Dr. Timothy Kresowik. In an interview, he said, "I’d stay away from lower extremity to begin with. I think it’s just a terrible area to try to do performance measures, especially short-term performance measures, because the important thing to remember about lower-extremity bypass is the real issues are long term."

Dr. Vogel, Dr. Geraghty, Dr. Gloviczki, Dr. Kibbe, and Dr. Kresowik reported having no relevant conflicts of interest.

MILWAUKEE – Less invasive lower-extremity endovascular interventions do not reduce hospital readmissions among patients with peripheral artery disease, according to an analysis of the Cerner Health Facts database.

The 30-day readmission rate was 13.9% for patients who underwent open surgery and 15.3% for those who had an endovascular procedure.

Lead author Dr. Todd Vogel expressed surprise that the two approaches were relatively equal, adding that, "I thought with endo, we’re doing less, they’d come back more."

Patrice Wendling/IMNG Medical Media

The common practice of staging lower-limb endovascular interventions is creating concerns that use of hospital readmissions as a quality outcome measure for reimbursement may not accurately identify planned readmissions or quality of care.

Session moderator Dr. Patrick Geraghty said in an interview that lower-extremity intervention outcomes "are probably the most complex and difficult to define outcomes issue for all of vascular surgery," as compared with carotid and aortic aneurysms, and that this is already reflected in efforts proposed by the National Surgical Quality Improvement Program (NSQIP) and the Centers for Medicare and Medicaid Services (CMS).

"Lower-extremity readmission is going to be a real hot-button discussion because we already know it’s substantial," he said. "If I do a stent graft for someone with leg ischemia and the flow improves and they go home on post-op day 1, and I bring them back 10 days later for a planned debridement of a toe ulcer that we’d been looking at, was that bad? Was that poor care, something I should be penalized for?

"Or was it just good care, but it didn’t fit into CMS’s box of everything should be done within one admission and that any readmission is therefore bad?"

The current analysis is unique in that utilizes electronic medical record (EMR) data to provide real-world outcomes for lower-limb interventions, said Dr. Geraghty, a vascular surgeon with Barnes-Jewish Hospital in St. Louis.

"I think we’re seeing here maybe the first fruits of good EMR design, and it’s a prod for surgeons to look into EMR design and ask whether we can design EMR notes for vascular follow-up in the ER such that we pull good EMR data over great numbers of patients," he said at the annual meeting of the Midwestern Vascular Surgical Society.

Dr. Vogel said that the Cerner database is not as population based as Medicare, capturing observational patient EMR data on more than 84 million admissions and ambulatory visits at roughly 187 participating hospitals, albeit primarily urban. Cerner is the second largest EMR in the United States after Epic.

The analysis encompassed 1,458 elective first admissions with a diagnosis of peripheral artery disease (PAD) undergoing a lower-extremity procedure from October 2008 to December 2010. Of these, 777 had open surgery and 681 an endovascular procedure.

Intermittent claudication was the most common indication for any procedure, present in 56.2% of open and 43.8% of endovascular patients.

The overall readmission rate at 30 days was surprisingly high at 14.5%, and was also unexpectedly high for for those with claudication, at 10.2% in the open and 11.3% in the endovascular group, said Dr. Vogel, chief of vascular surgery at the University of Missouri Hospitals and Clinics, Columbia.

"The frightening number to think about is that, in the claudicant group, we have a 10% readmission rate within 30 days," he said, noting that rates were very similar between groups. "So that’s a number we should all begin to think about."

As expected, readmission rates in the open and endovascular groups increased with disease severity. Rates for rest pain and gangrene were 14% vs. 18.2%, and 22% vs. 24%, respectively.

In bivariate analysis, blacks were significantly more likely to be readmitted 30 days after discharge (odds ratio, 1.56), as were patients discharged to a skilled nursing facility or nursing home (OR, 2.59), he said.

There was a nonsignificant trend toward higher readmissions at teaching hospitals (OR, 1.20), while a hospital stay of more than 7 days was a strong, significant predictor of 30-day readmission (OR, 2.54).

Readmissions also were increased in patients with a Charlson Comorbidity Index score of 3-5 (OR, 1.56) or score of 6-10 (OR, 1.90), diabetes (OR, 1.41), or sepsis (OR, 2.99), he said.

The risk of 30-day readmission was increased more than fivefold among patients with poor liver function, as indicated by total bilirubin levels greater than 2 mg/dL (OR, 5.15) or AST over 100 U/L (OR, 5.56). Risk was also more than twofold higher among patients with renal disease, as indicated by hemoglobin (nadir) less than 8 g/dL (OR, 2.17) and serum creatinine of at least 2 mg/dL (OR, 2.07), as well as those dispensed a staggering 30 medications or more (OR, 2.63), Dr. Vogel reported.

Notably, patients with cardiac troponin levels above 0.2 mg/dL were not at significantly higher risk of readmission (OR, 1.75), although those with a white blood cell count greater than 15,000/mcL were (OR, 2.1), which goes along with the finding of sepsis, he said.

In multivariate logistic regression analysis adjusting for age, disease severity, and race, PAD severity dropped out but male gender (OR, 1.39), Charlson Comorbidity Index (OR 1.12), length of stay (OR, 1.25), AST (OR 2.89), and more than 30 dispensed medications (OR, 1.84) remained significant.

"I think these are the things we’re going to have to look at if we’re going to really address readmissions," Dr. Vogel said.

He highlighted a new algorithm created at the Dartmouth-Hitchcock Medical Center that describes strategies for both predicting and preventing readmissions in vascular surgery (J. Vasc. Surg. 2012 56:556-62).

"It’s fun to describe all this, but the next step is to create change," he added.

During a discussion of the study, Dr. Vogel said that it was possible to calculate specialty-specific readmission rates but that such an analysis had not been performed yet.

Patrice Wendling/IMNG Medical Media

Society for Vascular Surgery (SVS) President Peter Gloviczki then rose from the audience to say that such an analysis is very important in light of a recent Medicare database analysis reporting that endovascular lower-extremity revascularization performed by vascular specialists results in higher costs, longer hospital stays, and more repeat revascularization procedures and amputations than the same procedure performed by interventional radiologists (J. Vasc. Interv. Radiol. 2012:23:3-9).

He went on to say that the controversial paper, which was sharply rebuked by past SVS President Richard Cambria, failed to define indications for the interventions or major vs. minor amputations.

"I think if your data show, not necessarily the outcome, but the case mix of the specialties and what we believe is the severity of disease that vascular surgeons take care of compared to radiologists, that would be very good because that is a way to answer with data, and not with rhetoric," Dr. Gloviczki said.

Dr. Vogel agreed that vascular surgeons, as a rule, treat sicker patients with heavier disease burden, subsequently leading to these various secondary outcomes, and that the Medicare analysis failed to adequately process the data.

"It was a very jaded view," he said.

Session comoderator Dr. Melina Kibbe, a vascular surgeon with Northwestern Memorial Hospital in Chicago, said that the current analysis is the first to use the Cerner database and "that this could be why we’re seeing different outcomes than what other people have reported because this is a more real-world database."

She went on to say that using lower-extremity readmissions as a quality measure is highly problematic because care of these patients, much like that for those with cancer, is often staged and extends for years.

Those thoughts were echoed by the newly elected president of the Midwestern Vascular Surgical Society, Dr. Timothy Kresowik. In an interview, he said, "I’d stay away from lower extremity to begin with. I think it’s just a terrible area to try to do performance measures, especially short-term performance measures, because the important thing to remember about lower-extremity bypass is the real issues are long term."

Dr. Vogel, Dr. Geraghty, Dr. Gloviczki, Dr. Kibbe, and Dr. Kresowik reported having no relevant conflicts of interest.

MILWAUKEE – The risk for worse outcomes following carotid-artery stenting may extend to even younger Medicare-age patients than previously reported by such pivotal trials as CREST, a provocative population study suggests.

The rate of the composite primary end point of death, stroke, or cardiac complications was 5.2% for carotid angioplasty and stenting (CAS) and 3.6% for carotid endarterectomy (CEA) among patients younger than age 65 years, and was 6.3% vs. 4.5% among patients aged 65 years or older, who comprised 76% of the study cohort (both P values less than .0001).

Patrice Wendling/IMNG Medical Media

Rates of the primary end point were similar between the carotid stenting and endarterectomy groups among asymptomatic patients aged 65 years or older (4.1% vs. 3.8%; P = .25), but were significantly higher in symptomatic patients age 65 years or older who received stenting (22.5% vs. 12.5%; P less than .0001).

This finding was driven by significantly higher rates of all three individual components of the primary end point: death (5.1% vs. 2.2%), stroke (12.5% vs. 7.6%), and cardiac complications (7.5% v s. 4.2%), "which is a little bit different than what we thought, compared with the CREST trial," lead author Dr. Jeffrey Jim said at the annual Midwestern Vascular Surgical Society meeting.

In the lead-in phase of CREST (Carotid Revascularization Endarterectomy vs. Stent Trial), octogenarians were found to be at higher risk of in-hospital death and stroke post CAS, but not myocardial infarction (J. Vasc. Surg. 2004;40:1106-11).

Subsequent CREST analyses have identified an interaction between age and carotid stenting efficacy, with the crossover at an age of approximately 70 years (N. Engl. J. Med. 2010;363:11-23).

The current results appear to move that threshold to an even younger age, just as the Centers for Medicare and Medicaid Services starts reconsidering the national coverage decision for carotid-artery stenting. Although he did not present the data, Dr. Jim noted that hospital costs also were higher for stenting patients.

Patrice Wendling/IMNG Medical Media

"Our results show that carotid angioplasty and stenting was associated with a higher rate of adverse outcomes and increased charges among patients of Medicare age, and really don’t support the widespread use of carotid stenting over CEA in this general population," Dr. Jim said.

Session moderator Dr. Patrick Geraghty, a vascular surgeon with Barnes–Jewish Health in St. Louis, said the difference in MI rates between arms "basically turns the CREST findings on their head," and asked whether cardiac troponin levels were tracked equally in both arms.

Dr. Jim responded that such tracking wasn’t possible with the Nationwide Inpatient Sample (NIS) database used for the analysis, and that it’s unknown whether one hospital called a troponin level of 0.15 ng/mL a troponin leak, while another coded that as an MI. Anatomic information and operative details also were not available.

The analysis was based on 678,081 hospitalizations for CEA and CAS from 2005 to 2009, the latest available data in the NIS, a comprehensive, inpatient database developed as part of the Healthcare Cost and Utilization Project and designed to approximate a 20% sample of U.S. hospitals.

The 595,813 CEA patients were more likely to be asymptomatic, whereas the 82,268 CAS patients were more likely to be male, medically high risk, treated at a teaching hospital, and an emergent/urgent admission.

The average age was 71 years in the CEA group and 70 years in the CAS group. Three-fourths of both groups had Medicare insurance coverage.

In the entire study cohort, the composite primary end point occurred in 6% of the carotid stenting group and 4.3% of the endarterectomy group (P less than .0001), said Dr. Jim, a vascular specialist at Washington University School of Medicine, St. Louis.

Patients who underwent carotid stenting experienced significantly higher rates of each individual component of the primary end point: death (1.1% vs. 0.5%), stroke (2% vs. 1%) and cardiac complications (3.6% vs. 3.1%).

Independent predictors of the primary end point were CAS, symptomatic stenosis, and medical high risk, defined as a patient age 80 years or older, or a patient who had renal failure, severe chronic lung disease, recent MI, coronary bypass/valve surgery within 30 days, unstable angina, or class III/IV heart failure.

Dr. Jim and Dr. Geraghty reported having no relevant conflicts of interest.

MILWAUKEE – The risk for worse outcomes following carotid-artery stenting may extend to even younger Medicare-age patients than previously reported by such pivotal trials as CREST, a provocative population study suggests.

The rate of the composite primary end point of death, stroke, or cardiac complications was 5.2% for carotid angioplasty and stenting (CAS) and 3.6% for carotid endarterectomy (CEA) among patients younger than age 65 years, and was 6.3% vs. 4.5% among patients aged 65 years or older, who comprised 76% of the study cohort (both P values less than .0001).

Patrice Wendling/IMNG Medical Media

Rates of the primary end point were similar between the carotid stenting and endarterectomy groups among asymptomatic patients aged 65 years or older (4.1% vs. 3.8%; P = .25), but were significantly higher in symptomatic patients age 65 years or older who received stenting (22.5% vs. 12.5%; P less than .0001).

This finding was driven by significantly higher rates of all three individual components of the primary end point: death (5.1% vs. 2.2%), stroke (12.5% vs. 7.6%), and cardiac complications (7.5% v s. 4.2%), "which is a little bit different than what we thought, compared with the CREST trial," lead author Dr. Jeffrey Jim said at the annual Midwestern Vascular Surgical Society meeting.

In the lead-in phase of CREST (Carotid Revascularization Endarterectomy vs. Stent Trial), octogenarians were found to be at higher risk of in-hospital death and stroke post CAS, but not myocardial infarction (J. Vasc. Surg. 2004;40:1106-11).

Subsequent CREST analyses have identified an interaction between age and carotid stenting efficacy, with the crossover at an age of approximately 70 years (N. Engl. J. Med. 2010;363:11-23).

The current results appear to move that threshold to an even younger age, just as the Centers for Medicare and Medicaid Services starts reconsidering the national coverage decision for carotid-artery stenting. Although he did not present the data, Dr. Jim noted that hospital costs also were higher for stenting patients.

Patrice Wendling/IMNG Medical Media

"Our results show that carotid angioplasty and stenting was associated with a higher rate of adverse outcomes and increased charges among patients of Medicare age, and really don’t support the widespread use of carotid stenting over CEA in this general population," Dr. Jim said.

Session moderator Dr. Patrick Geraghty, a vascular surgeon with Barnes–Jewish Health in St. Louis, said the difference in MI rates between arms "basically turns the CREST findings on their head," and asked whether cardiac troponin levels were tracked equally in both arms.

Dr. Jim responded that such tracking wasn’t possible with the Nationwide Inpatient Sample (NIS) database used for the analysis, and that it’s unknown whether one hospital called a troponin level of 0.15 ng/mL a troponin leak, while another coded that as an MI. Anatomic information and operative details also were not available.

The analysis was based on 678,081 hospitalizations for CEA and CAS from 2005 to 2009, the latest available data in the NIS, a comprehensive, inpatient database developed as part of the Healthcare Cost and Utilization Project and designed to approximate a 20% sample of U.S. hospitals.

The 595,813 CEA patients were more likely to be asymptomatic, whereas the 82,268 CAS patients were more likely to be male, medically high risk, treated at a teaching hospital, and an emergent/urgent admission.

The average age was 71 years in the CEA group and 70 years in the CAS group. Three-fourths of both groups had Medicare insurance coverage.

In the entire study cohort, the composite primary end point occurred in 6% of the carotid stenting group and 4.3% of the endarterectomy group (P less than .0001), said Dr. Jim, a vascular specialist at Washington University School of Medicine, St. Louis.

Patients who underwent carotid stenting experienced significantly higher rates of each individual component of the primary end point: death (1.1% vs. 0.5%), stroke (2% vs. 1%) and cardiac complications (3.6% vs. 3.1%).

Independent predictors of the primary end point were CAS, symptomatic stenosis, and medical high risk, defined as a patient age 80 years or older, or a patient who had renal failure, severe chronic lung disease, recent MI, coronary bypass/valve surgery within 30 days, unstable angina, or class III/IV heart failure.

Dr. Jim and Dr. Geraghty reported having no relevant conflicts of interest.

MILWAUKEE – The risk for worse outcomes following carotid-artery stenting may extend to even younger Medicare-age patients than previously reported by such pivotal trials as CREST, a provocative population study suggests.

The rate of the composite primary end point of death, stroke, or cardiac complications was 5.2% for carotid angioplasty and stenting (CAS) and 3.6% for carotid endarterectomy (CEA) among patients younger than age 65 years, and was 6.3% vs. 4.5% among patients aged 65 years or older, who comprised 76% of the study cohort (both P values less than .0001).

Patrice Wendling/IMNG Medical Media

Rates of the primary end point were similar between the carotid stenting and endarterectomy groups among asymptomatic patients aged 65 years or older (4.1% vs. 3.8%; P = .25), but were significantly higher in symptomatic patients age 65 years or older who received stenting (22.5% vs. 12.5%; P less than .0001).

This finding was driven by significantly higher rates of all three individual components of the primary end point: death (5.1% vs. 2.2%), stroke (12.5% vs. 7.6%), and cardiac complications (7.5% v s. 4.2%), "which is a little bit different than what we thought, compared with the CREST trial," lead author Dr. Jeffrey Jim said at the annual Midwestern Vascular Surgical Society meeting.

In the lead-in phase of CREST (Carotid Revascularization Endarterectomy vs. Stent Trial), octogenarians were found to be at higher risk of in-hospital death and stroke post CAS, but not myocardial infarction (J. Vasc. Surg. 2004;40:1106-11).

Subsequent CREST analyses have identified an interaction between age and carotid stenting efficacy, with the crossover at an age of approximately 70 years (N. Engl. J. Med. 2010;363:11-23).

The current results appear to move that threshold to an even younger age, just as the Centers for Medicare and Medicaid Services starts reconsidering the national coverage decision for carotid-artery stenting. Although he did not present the data, Dr. Jim noted that hospital costs also were higher for stenting patients.

Patrice Wendling/IMNG Medical Media

"Our results show that carotid angioplasty and stenting was associated with a higher rate of adverse outcomes and increased charges among patients of Medicare age, and really don’t support the widespread use of carotid stenting over CEA in this general population," Dr. Jim said.

Session moderator Dr. Patrick Geraghty, a vascular surgeon with Barnes–Jewish Health in St. Louis, said the difference in MI rates between arms "basically turns the CREST findings on their head," and asked whether cardiac troponin levels were tracked equally in both arms.

Dr. Jim responded that such tracking wasn’t possible with the Nationwide Inpatient Sample (NIS) database used for the analysis, and that it’s unknown whether one hospital called a troponin level of 0.15 ng/mL a troponin leak, while another coded that as an MI. Anatomic information and operative details also were not available.

The analysis was based on 678,081 hospitalizations for CEA and CAS from 2005 to 2009, the latest available data in the NIS, a comprehensive, inpatient database developed as part of the Healthcare Cost and Utilization Project and designed to approximate a 20% sample of U.S. hospitals.

The 595,813 CEA patients were more likely to be asymptomatic, whereas the 82,268 CAS patients were more likely to be male, medically high risk, treated at a teaching hospital, and an emergent/urgent admission.

The average age was 71 years in the CEA group and 70 years in the CAS group. Three-fourths of both groups had Medicare insurance coverage.

In the entire study cohort, the composite primary end point occurred in 6% of the carotid stenting group and 4.3% of the endarterectomy group (P less than .0001), said Dr. Jim, a vascular specialist at Washington University School of Medicine, St. Louis.

Patients who underwent carotid stenting experienced significantly higher rates of each individual component of the primary end point: death (1.1% vs. 0.5%), stroke (2% vs. 1%) and cardiac complications (3.6% vs. 3.1%).

Independent predictors of the primary end point were CAS, symptomatic stenosis, and medical high risk, defined as a patient age 80 years or older, or a patient who had renal failure, severe chronic lung disease, recent MI, coronary bypass/valve surgery within 30 days, unstable angina, or class III/IV heart failure.

Dr. Jim and Dr. Geraghty reported having no relevant conflicts of interest.

SAN DIEGO – The 30-day periprocedural outcomes in patients who underwent carotid artery stenting with closed-cell design stents were not significantly inferior to outcomes of those treated with carotid endarterectomy, a large meta-analysis demonstrated.

However, patients who underwent carotid endarterectomy (CEA) had significantly better 30-day periprocedural outcomes, compared with those who underwent carotid artery stenting (CAS) with open-cell design stents.

Doug Brunk/IMNG Medical Media

"A number of randomized clinical trials and meta-analyses have consistently showed the higher risk of periprocedural stroke in patients undergoing stenting when compared to endarterectomy," Dr. Mohammed A. Almekhlafi said at the annual meeting of the Society of Neurointerventional Surgery. "One of the factors that has been implicated as a determinant of periprocedural neurological events is the stent cell design. The small free-cell area between the struts of a closed-cell stent theoretically provides better scaffolding of the vessel wall and superior plaque stabilization compared to the larger uncovered gaps in open-cell stents."

Dr. Almekhlafi, an interventional neurology fellow at the University of Calgary (Alta.), and his associates set out to investigate the impact of stent cell design on the outcome of randomized controlled trials comparing CAS vs. CEA. The stent cell design was divided into closed (meaning all stent struts are interconnected) or open (meaning not all stent-struts are interconnected). The primary outcome was a composite of the 30-day risk of stroke or death.

The final analysis included 4,949 patients from nine randomized clinical trials. Of these, 807 underwent CAS with closed-cell stenting, 1,657 underwent CAS with open-cell stenting, and 2,485 underwent CEA.

Dr. Almekhlafi reported that the primary outcome was significantly lower among patients in the CEA arm, compared with those in the CAS open-cell design arm (odds ratio, 1.84; P = .003). The primary outcome was lower among patients in the CEA arm, compared with those in the CAS closed-cell design arm, although this difference did not reach statistical significance (OR, 1.54; P = .29).

When the researchers limited their analysis to risk of 30-day periprocedural stroke, this outcome remained nonsignificant among patients in the CEA arm, compared with those in the CAS closed-cell design arm (OR 2.92; P = .22). However, the risk of 30-day periprocedural stroke remained significantly higher among patients in the CAS open-cell design arm, compared with those in the CEA arm (OR, 1.97; P = .0007).

"Uncertainty still exists regarding the impact of stent characteristics on CAS outcome," Dr. Almekhlafi said. "The size of the emboli might also be relevant."

He acknowledged certain limitations of the study, including the fact that trials included in this analysis did not randomize patients to open vs. closed stents, and that trials using the closed-design stents recruited fewer patients than did those using open-cell stents.

Dr. Almekhlafi said that he had no relevant financial disclosures to make.

SAN DIEGO – The 30-day periprocedural outcomes in patients who underwent carotid artery stenting with closed-cell design stents were not significantly inferior to outcomes of those treated with carotid endarterectomy, a large meta-analysis demonstrated.

However, patients who underwent carotid endarterectomy (CEA) had significantly better 30-day periprocedural outcomes, compared with those who underwent carotid artery stenting (CAS) with open-cell design stents.

Doug Brunk/IMNG Medical Media

"A number of randomized clinical trials and meta-analyses have consistently showed the higher risk of periprocedural stroke in patients undergoing stenting when compared to endarterectomy," Dr. Mohammed A. Almekhlafi said at the annual meeting of the Society of Neurointerventional Surgery. "One of the factors that has been implicated as a determinant of periprocedural neurological events is the stent cell design. The small free-cell area between the struts of a closed-cell stent theoretically provides better scaffolding of the vessel wall and superior plaque stabilization compared to the larger uncovered gaps in open-cell stents."

Dr. Almekhlafi, an interventional neurology fellow at the University of Calgary (Alta.), and his associates set out to investigate the impact of stent cell design on the outcome of randomized controlled trials comparing CAS vs. CEA. The stent cell design was divided into closed (meaning all stent struts are interconnected) or open (meaning not all stent-struts are interconnected). The primary outcome was a composite of the 30-day risk of stroke or death.

The final analysis included 4,949 patients from nine randomized clinical trials. Of these, 807 underwent CAS with closed-cell stenting, 1,657 underwent CAS with open-cell stenting, and 2,485 underwent CEA.

Dr. Almekhlafi reported that the primary outcome was significantly lower among patients in the CEA arm, compared with those in the CAS open-cell design arm (odds ratio, 1.84; P = .003). The primary outcome was lower among patients in the CEA arm, compared with those in the CAS closed-cell design arm, although this difference did not reach statistical significance (OR, 1.54; P = .29).

When the researchers limited their analysis to risk of 30-day periprocedural stroke, this outcome remained nonsignificant among patients in the CEA arm, compared with those in the CAS closed-cell design arm (OR 2.92; P = .22). However, the risk of 30-day periprocedural stroke remained significantly higher among patients in the CAS open-cell design arm, compared with those in the CEA arm (OR, 1.97; P = .0007).

"Uncertainty still exists regarding the impact of stent characteristics on CAS outcome," Dr. Almekhlafi said. "The size of the emboli might also be relevant."

He acknowledged certain limitations of the study, including the fact that trials included in this analysis did not randomize patients to open vs. closed stents, and that trials using the closed-design stents recruited fewer patients than did those using open-cell stents.

Dr. Almekhlafi said that he had no relevant financial disclosures to make.

SAN DIEGO – The 30-day periprocedural outcomes in patients who underwent carotid artery stenting with closed-cell design stents were not significantly inferior to outcomes of those treated with carotid endarterectomy, a large meta-analysis demonstrated.

However, patients who underwent carotid endarterectomy (CEA) had significantly better 30-day periprocedural outcomes, compared with those who underwent carotid artery stenting (CAS) with open-cell design stents.

Doug Brunk/IMNG Medical Media

"A number of randomized clinical trials and meta-analyses have consistently showed the higher risk of periprocedural stroke in patients undergoing stenting when compared to endarterectomy," Dr. Mohammed A. Almekhlafi said at the annual meeting of the Society of Neurointerventional Surgery. "One of the factors that has been implicated as a determinant of periprocedural neurological events is the stent cell design. The small free-cell area between the struts of a closed-cell stent theoretically provides better scaffolding of the vessel wall and superior plaque stabilization compared to the larger uncovered gaps in open-cell stents."

Dr. Almekhlafi, an interventional neurology fellow at the University of Calgary (Alta.), and his associates set out to investigate the impact of stent cell design on the outcome of randomized controlled trials comparing CAS vs. CEA. The stent cell design was divided into closed (meaning all stent struts are interconnected) or open (meaning not all stent-struts are interconnected). The primary outcome was a composite of the 30-day risk of stroke or death.

The final analysis included 4,949 patients from nine randomized clinical trials. Of these, 807 underwent CAS with closed-cell stenting, 1,657 underwent CAS with open-cell stenting, and 2,485 underwent CEA.

Dr. Almekhlafi reported that the primary outcome was significantly lower among patients in the CEA arm, compared with those in the CAS open-cell design arm (odds ratio, 1.84; P = .003). The primary outcome was lower among patients in the CEA arm, compared with those in the CAS closed-cell design arm, although this difference did not reach statistical significance (OR, 1.54; P = .29).

When the researchers limited their analysis to risk of 30-day periprocedural stroke, this outcome remained nonsignificant among patients in the CEA arm, compared with those in the CAS closed-cell design arm (OR 2.92; P = .22). However, the risk of 30-day periprocedural stroke remained significantly higher among patients in the CAS open-cell design arm, compared with those in the CEA arm (OR, 1.97; P = .0007).

"Uncertainty still exists regarding the impact of stent characteristics on CAS outcome," Dr. Almekhlafi said. "The size of the emboli might also be relevant."

He acknowledged certain limitations of the study, including the fact that trials included in this analysis did not randomize patients to open vs. closed stents, and that trials using the closed-design stents recruited fewer patients than did those using open-cell stents.

Dr. Almekhlafi said that he had no relevant financial disclosures to make.

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

A new model demonstrated that at least one additional screening for abdominal aortic aneurysm was more cost effective in dollars per quality-adjusted life-year than was the single screening currently mandated for select populations in countries like the United States and England.

Previous decision models agreed that the optimal AAA screening protocol is a once-in-a-lifetime scan that is performed in men at age 65. However, none of these models examined the additional benefit of rescreening individuals whose aortic diameters approached but did not exceed the defined aneurysm threshold.

Dr. Rikke Søgaard and his colleagues developed their new model to determine if there was an optimal rescreening schedule for patients. They tested four screening strategies (no screening, once per lifetime screening, twice per lifetime screening with a 5-year interval, and lifetime screening every 5 years) for a hypothetical cohort of 100,000 men aged 65 years who were taken from the general population. Each individual was assigned to one of the four strategies. The researchers then compared the estimated lifetime costs and benefits of the four AAA strategies for this population.

The model used microsimulation of 6-month cycles to provide detailed epidemiologic results for each of the strategies, based on key events (detection, symptoms, rupture, and death) during a simulated lifetime. Apart from rupture rates taken from a systematic review, parameter estimates were the result of original analyses composed of a combination of research registries from two Danish screening trials, the Danish Vascular Registry, and national registries for causes of death.

Assuming a 12% per year incidental detection rate of aneurysms measuring 55 mm and larger, the model predicted that 2,469 men would be detected with a clinically relevant aneurysm. A single rescreening after 5 years of individuals without initial aneurysms who had an initial aortic diameter of 25-29 mm would detect an additional 452 men per 100,000 of those originally screened, whereas lifetime rescreening every 5 years thereafter would detect a total of 794 men with a clinically relevant aneurysm per 100,000.

Most of these aneurysms were smaller than the threshold for surgery, but appropriate for watchful waiting with rescreening, according to Dr. Søgaard of the University of Southern Denmark, Odense, and his colleagues.

The researchers found that elective surgeries would increase from 861 to 1,390 with a once-per-lifetime screening, to 1,496 for a single rescreening after 5 years, and to 1,530 with rescreening every 5 years for life. The rate of aneurysm-related mortality dropped with initial screening from 788 to 538 per 100,000, further falling to 520 and 511 for the single rescreening and the lifetime rescreening, respectively. "This decrease was the result of replacing acute surgery with elective surgery," the researchers stated (BMJ 2012 July 5 [doi:10.1136/bmj.e4276]).

The cost effectiveness of rescreening had not previously been studied, according to the authors. They determined that according to their model, there was a 92% probability that any rescreening protocol would be cost effective if it were at or below a threshold of £20,000 (24,790 euros and $31,460) per quality-adjusted life-year. They estimated that the incremental cost effectiveness was £10,013 per QALY, well under the threshold.

However, Dr. Søgaard and his colleagues also pointed out that substantial uncertainty surrounded this ratio, and "with an average incremental cost-effectiveness ratio of lifetime rescreening of £29,680, the optimal screening strategy is indeterminate"

"This study has policy relevance for two different scenarios. In Denmark, where no national guidance has been issued, it suggests that screening will be cost effective. In England and Scotland, where screening is currently being implemented (as is also the case in the United States), this study supports further consideration of rescreening, at least once," the researchers concluded.

The study was funded by the Health Research Fund of Central Denmark Region and the Research Fund of Viborg Hospital. The researchers disclosed financial support from these two agencies but no other relevant disclosures.

NATIONAL HARBOR, MD. – Covered stents may reduce the recurrence of chronic mesenteric ischemia and the need for reintervention in patients undergoing primary interventions, according to Dr. Gustavo S. Oderich.

Freedom from symptom recurrence among primary intervention patients was 92% for those with covered stents, compared with 47% for those with bare metal stents (BMS), he reported at the Vascular Annual Meeting. This difference was significant.

Similarly, freedom from reintervention was 91% at 5 years for the covered-stent group, compared with 54% for the BMS group, also a significant difference.

The findings come from a review of patients who were treated for chronic mesenteric ischemia (CMI) using BMS or covered stents (2000-2010). End points included freedom from symptom recurrence, reintervention, and primary and secondary patency rates.

"Mesenteric angioplasty and stenting [have been] plagued by high rates of restenosis and reinterventions in the range of 30%-60% in different reports," said Dr. Oderich, professor of vascular and endovascular surgery at the Mayo Clinic in Rochester, Minn. Covered stents have been shown to lower restenosis rates when used for renal alignment in fenestrated endografts and for the treatment of failing arteriovenous grafts.

The researchers compared BMS and iCast covered stents (Atrium USA) to determine if covered stents could also reduce restenosis in patients with CMI.

In all, 352 patients were treated for CMI, of which 247 had endovascular revascularization. The researchers included 191 patients in the primary intervention group; of these, 149 (78%) had BMS, 42 patients had covered stents, and 22 patients had angioplasty alone. (The angioplasty-alone patients were excluded from the study.) The primary intervention population included 191 patients; the reintervention population included 36 patients who had undergone open primary intervention.

The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation, but the BMS patients tended to have greater rates of chronic pulmonary disease. The anatomical and procedural variables – including extent of disease, type of approach, number of vessels treated, and stent length and diameter – were also similar, as were early outcomes.

Technical success (defined as successful stent implantation without local complications or stenosis less than 30%) was 95% and 98% for the BMS and covered-stent groups, respectively. Mortality was 3% and 0% for the BMS and covered stent groups, respectively.

The primary patency rate at 5 years was 92% for those with covered stents, compared with 47% for those with BMS, in the primary intervention group. There was no difference in secondary patency rates between the two groups. The average follow-up for the cohort was 29 months.

Multivariate analysis of the primary intervention group showed that the use of a covered stent was a protective factor for loss of primary patency, symptom recurrence, and reintervention.

Other independent predictors of loss of primary patency included age, female sex, and current smoking history. For symptom recurrence, other independent predictors included female sex and current smoking history. For reintervention, age and female sex were independent predictors.

Covered stents also were associated with less recurrence and fewer reinterventions in patients undergoing reintervention for mesenteric chronic ischemia. The reintervention group included 15 patients who were treated with BMS and 21 patients treated with covered stents. The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation. In all, 16 vessels were treated with BMS and 22 with covered stents. The two groups had similar approaches, number of vessels treated, and stent dimensions – with the exception of a slight trend toward longer stents in the covered-stent group.

Dr. Oderich reported that he is the principal investigator of a clinical trial sponsored by Cook Medical.

NATIONAL HARBOR, MD. – Covered stents may reduce the recurrence of chronic mesenteric ischemia and the need for reintervention in patients undergoing primary interventions, according to Dr. Gustavo S. Oderich.

Freedom from symptom recurrence among primary intervention patients was 92% for those with covered stents, compared with 47% for those with bare metal stents (BMS), he reported at the Vascular Annual Meeting. This difference was significant.

Similarly, freedom from reintervention was 91% at 5 years for the covered-stent group, compared with 54% for the BMS group, also a significant difference.

The findings come from a review of patients who were treated for chronic mesenteric ischemia (CMI) using BMS or covered stents (2000-2010). End points included freedom from symptom recurrence, reintervention, and primary and secondary patency rates.

"Mesenteric angioplasty and stenting [have been] plagued by high rates of restenosis and reinterventions in the range of 30%-60% in different reports," said Dr. Oderich, professor of vascular and endovascular surgery at the Mayo Clinic in Rochester, Minn. Covered stents have been shown to lower restenosis rates when used for renal alignment in fenestrated endografts and for the treatment of failing arteriovenous grafts.

The researchers compared BMS and iCast covered stents (Atrium USA) to determine if covered stents could also reduce restenosis in patients with CMI.

In all, 352 patients were treated for CMI, of which 247 had endovascular revascularization. The researchers included 191 patients in the primary intervention group; of these, 149 (78%) had BMS, 42 patients had covered stents, and 22 patients had angioplasty alone. (The angioplasty-alone patients were excluded from the study.) The primary intervention population included 191 patients; the reintervention population included 36 patients who had undergone open primary intervention.

The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation, but the BMS patients tended to have greater rates of chronic pulmonary disease. The anatomical and procedural variables – including extent of disease, type of approach, number of vessels treated, and stent length and diameter – were also similar, as were early outcomes.

Technical success (defined as successful stent implantation without local complications or stenosis less than 30%) was 95% and 98% for the BMS and covered-stent groups, respectively. Mortality was 3% and 0% for the BMS and covered stent groups, respectively.

The primary patency rate at 5 years was 92% for those with covered stents, compared with 47% for those with BMS, in the primary intervention group. There was no difference in secondary patency rates between the two groups. The average follow-up for the cohort was 29 months.

Multivariate analysis of the primary intervention group showed that the use of a covered stent was a protective factor for loss of primary patency, symptom recurrence, and reintervention.

Other independent predictors of loss of primary patency included age, female sex, and current smoking history. For symptom recurrence, other independent predictors included female sex and current smoking history. For reintervention, age and female sex were independent predictors.

Covered stents also were associated with less recurrence and fewer reinterventions in patients undergoing reintervention for mesenteric chronic ischemia. The reintervention group included 15 patients who were treated with BMS and 21 patients treated with covered stents. The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation. In all, 16 vessels were treated with BMS and 22 with covered stents. The two groups had similar approaches, number of vessels treated, and stent dimensions – with the exception of a slight trend toward longer stents in the covered-stent group.

Dr. Oderich reported that he is the principal investigator of a clinical trial sponsored by Cook Medical.

NATIONAL HARBOR, MD. – Covered stents may reduce the recurrence of chronic mesenteric ischemia and the need for reintervention in patients undergoing primary interventions, according to Dr. Gustavo S. Oderich.

Freedom from symptom recurrence among primary intervention patients was 92% for those with covered stents, compared with 47% for those with bare metal stents (BMS), he reported at the Vascular Annual Meeting. This difference was significant.

Similarly, freedom from reintervention was 91% at 5 years for the covered-stent group, compared with 54% for the BMS group, also a significant difference.

The findings come from a review of patients who were treated for chronic mesenteric ischemia (CMI) using BMS or covered stents (2000-2010). End points included freedom from symptom recurrence, reintervention, and primary and secondary patency rates.

"Mesenteric angioplasty and stenting [have been] plagued by high rates of restenosis and reinterventions in the range of 30%-60% in different reports," said Dr. Oderich, professor of vascular and endovascular surgery at the Mayo Clinic in Rochester, Minn. Covered stents have been shown to lower restenosis rates when used for renal alignment in fenestrated endografts and for the treatment of failing arteriovenous grafts.

The researchers compared BMS and iCast covered stents (Atrium USA) to determine if covered stents could also reduce restenosis in patients with CMI.

In all, 352 patients were treated for CMI, of which 247 had endovascular revascularization. The researchers included 191 patients in the primary intervention group; of these, 149 (78%) had BMS, 42 patients had covered stents, and 22 patients had angioplasty alone. (The angioplasty-alone patients were excluded from the study.) The primary intervention population included 191 patients; the reintervention population included 36 patients who had undergone open primary intervention.

The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation, but the BMS patients tended to have greater rates of chronic pulmonary disease. The anatomical and procedural variables – including extent of disease, type of approach, number of vessels treated, and stent length and diameter – were also similar, as were early outcomes.

Technical success (defined as successful stent implantation without local complications or stenosis less than 30%) was 95% and 98% for the BMS and covered-stent groups, respectively. Mortality was 3% and 0% for the BMS and covered stent groups, respectively.

The primary patency rate at 5 years was 92% for those with covered stents, compared with 47% for those with BMS, in the primary intervention group. There was no difference in secondary patency rates between the two groups. The average follow-up for the cohort was 29 months.

Multivariate analysis of the primary intervention group showed that the use of a covered stent was a protective factor for loss of primary patency, symptom recurrence, and reintervention.

Other independent predictors of loss of primary patency included age, female sex, and current smoking history. For symptom recurrence, other independent predictors included female sex and current smoking history. For reintervention, age and female sex were independent predictors.

Covered stents also were associated with less recurrence and fewer reinterventions in patients undergoing reintervention for mesenteric chronic ischemia. The reintervention group included 15 patients who were treated with BMS and 21 patients treated with covered stents. The two groups were similar in terms of demographics, cardiovascular risk factors, and clinical presentation. In all, 16 vessels were treated with BMS and 22 with covered stents. The two groups had similar approaches, number of vessels treated, and stent dimensions – with the exception of a slight trend toward longer stents in the covered-stent group.

Dr. Oderich reported that he is the principal investigator of a clinical trial sponsored by Cook Medical.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.

Surgeons are more reluctant to withdraw life support if they made an error during surgery. This is especially true after an elective procedure, according to an extended analysis of a recent scenario-based survey of 2,100 surgeons who were involved in high-risk operations.

The survey included a series of questions regarding specialty-specific scenarios for 700 vascular surgeons (elective and emergent thoracoabdominal aortic aneurysm repair), 700 cardiothoracic surgeons (elective and emergent ascending aortic aneurysm repair), and 700 neurosurgeons (elective and emergent calcified right middle cerebral artery aneurysm clipping), according to Dr. Margaret L. Schwarze of the University of Wisconsin, Madison, and colleagues.

In the case of the vascular and the cardiac surgeons, the complication was the same: The "patient has weakness in left arm and leg when she awakes from anesthesia." The surgical error for the vascular surgeons was inadvertent placement of the proximal clamp so that it occluded the left carotid artery; for the cardiac surgeons, it was inadvertent dislodging of the arterial cannula. For both vascular and cardiac procedures, the non–error-caused complication resulted from unexplained intraoperative stroke.

The three specialties were chosen based on the presumption of routine high-risk operations, according to a report published online ahead of print in the Annals of Surgery (2012;256:10-15).

This analysis follows an earlier report in the Annals of Surgery by these same authors, who used these same survey data to determine that the majority of these surgeons performing high-risk operations did not discuss advanced directives with their patients, and 54% were unlikely to operate on these patients if they were aware of such directives prior to surgery (Ann. Surg. 2012;255:418-23).

Of the original 2,100 surveys that were sent out, 912 were completed and returned, with roughly equal percentages (54%-56%) for each specialty.

Multivariate analysis showed that surgeons who faced complications after emergency surgery that were not clearly the result of surgeon error were nearly twice as likely to agree to withdraw life-sustaining support, compared with surgeons evaluating elective procedures that had a complication resulting from surgeon error (odds ratio, 1.95). In addition, the odds of withdrawing life support were significantly greater among surgeons who were not optimistic about the patient’s future quality of life (OR, 1.75) and among those who were not concerned that the patients did not accurately value their future health state (OR, 1.59), compared with their counterparts, according to the authors.

"Iatrogenic complications that clearly derive from technical errors during elective procedures may pose considerable guilt and emotional burden upon surgeons," the authors speculated. "It is understandable that such factors should weigh on the surgeon. However, our findings call into question the degree to which these factors may unduly interfere with a patient’s ability to control his or her health care decisions."

In addition, "our data suggest that the commission of an error in surgical technique and prognostic optimism may present a challenge to patient autonomy. ... [This] suggests the importance of efforts to alleviate surgeons’ emotional strain while simultaneously respecting the fierce ethic of responsibility that surgeons possess for patients’ outcomes."

When a patient experiences a life-threatening complication and requests withdrawal of life-supporting therapy postoperatively, surgeons may be unlikely to do so without delay, according to the authors. "These decisions may be influenced by both the timing of surgery and whether the complication was the result of explicit technical error. In addition, these nonclinical factors may be associated with surgeons’ optimism about the patient’s postoperative quality of life," they concluded.

The authors reported that they had no financial disclosures.