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A one-size-fits-all fenestrated graft for iliac aneurysms?
CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.
The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.
The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.
"These people do well,extremely well," Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society.
Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.
His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.
"The pros are that it uses an off-the-shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."
Operative details
The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.
Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.
Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.
Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type 3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.
The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).
This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.
Audience reaction
Dr. Rebecca Kelso of the Cleveland Clinic, who co-moderated the session, was enthusiastic about the novel approach.
"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, that has significant implications for being available commercially for everyone."
Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.
"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."
A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.
While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.
Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry.
Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.
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Dr. John F. Eidt |
Vascular surgeons are like cobblers – we try to make the perfect pair of shoes for each customer. While all aneurysm operations are similar in principle, in reality each successful operation depends on a unique blend of surgical skill and experience applied to the individual anatomy of each patient. By combining endovascular and open surgical skills, vascular surgeons are enticed to develop ever more innovative solutions for complex problems. Dr. Kelly should be congratulated for thinking outside the box and applying his imagination and skill to the solution of this common clinical scenario. While I am intrigued by the technique, I will reserve my enthusiastic endorsement because of the relatively high cost and the fact the common iliac artery must be sufficiently large to accommodate the physician-modified bifurcated graft. Others have described the use of a "stacked" Gore Excluder device to achieve a similar result. And the Cook Iliac Branched Device is nearing approval. In the long run, the FDA needs to adopt policies that encourage rather than discourage innovation in the develop- ment of novel surgical treatments. The current onerous IDE process is excessively complex and expensive. Physician-modified endografts fill an important gap in our ability to deliver quality, customized care for every patient. And there is no evidence that innovation in vascular surgery has been harmful to patients. After all, every operation is "physician modified."
Dr. John F. Eidt is a vascular surgeon at the Greenville (South Carolina) Health System, and an associate medical editor of Vascular Specialist.
| | |
Dr. John F. Eidt |
Vascular surgeons are like cobblers – we try to make the perfect pair of shoes for each customer. While all aneurysm operations are similar in principle, in reality each successful operation depends on a unique blend of surgical skill and experience applied to the individual anatomy of each patient. By combining endovascular and open surgical skills, vascular surgeons are enticed to develop ever more innovative solutions for complex problems. Dr. Kelly should be congratulated for thinking outside the box and applying his imagination and skill to the solution of this common clinical scenario. While I am intrigued by the technique, I will reserve my enthusiastic endorsement because of the relatively high cost and the fact the common iliac artery must be sufficiently large to accommodate the physician-modified bifurcated graft. Others have described the use of a "stacked" Gore Excluder device to achieve a similar result. And the Cook Iliac Branched Device is nearing approval. In the long run, the FDA needs to adopt policies that encourage rather than discourage innovation in the develop- ment of novel surgical treatments. The current onerous IDE process is excessively complex and expensive. Physician-modified endografts fill an important gap in our ability to deliver quality, customized care for every patient. And there is no evidence that innovation in vascular surgery has been harmful to patients. After all, every operation is "physician modified."
Dr. John F. Eidt is a vascular surgeon at the Greenville (South Carolina) Health System, and an associate medical editor of Vascular Specialist.
| | |
Dr. John F. Eidt |
Vascular surgeons are like cobblers – we try to make the perfect pair of shoes for each customer. While all aneurysm operations are similar in principle, in reality each successful operation depends on a unique blend of surgical skill and experience applied to the individual anatomy of each patient. By combining endovascular and open surgical skills, vascular surgeons are enticed to develop ever more innovative solutions for complex problems. Dr. Kelly should be congratulated for thinking outside the box and applying his imagination and skill to the solution of this common clinical scenario. While I am intrigued by the technique, I will reserve my enthusiastic endorsement because of the relatively high cost and the fact the common iliac artery must be sufficiently large to accommodate the physician-modified bifurcated graft. Others have described the use of a "stacked" Gore Excluder device to achieve a similar result. And the Cook Iliac Branched Device is nearing approval. In the long run, the FDA needs to adopt policies that encourage rather than discourage innovation in the develop- ment of novel surgical treatments. The current onerous IDE process is excessively complex and expensive. Physician-modified endografts fill an important gap in our ability to deliver quality, customized care for every patient. And there is no evidence that innovation in vascular surgery has been harmful to patients. After all, every operation is "physician modified."
Dr. John F. Eidt is a vascular surgeon at the Greenville (South Carolina) Health System, and an associate medical editor of Vascular Specialist.
CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.
The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.
The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.
"These people do well,extremely well," Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society.
Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.
His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.
"The pros are that it uses an off-the-shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."
Operative details
The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.
Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.
Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.
Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type 3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.
The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).
This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.
Audience reaction
Dr. Rebecca Kelso of the Cleveland Clinic, who co-moderated the session, was enthusiastic about the novel approach.
"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, that has significant implications for being available commercially for everyone."
Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.
"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."
A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.
While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.
Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry.
Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.
CHICAGO – A novel bifurcated covered stent graft limb that uses an off-the-shelf graft can treat large common iliac aneurysms, while preserving good pelvic blood flow.
The alternative endovascular approach has been performed on 15 patients since April 2011, with a success rate of 100%. Bilateral stent grafts were placed in four patients.
The all-male cohort has been able to maintain appropriate exercise tolerance and remains free from erectile dysfunction, pelvic ischemia, buttock claudication, and paralysis.
"These people do well,extremely well," Dr. Patrick Kelly said at the annual meeting of the Midwestern Vascular Surgical Society.
Several iliac branch grafts are currently under investigation, including the Cook Zenith Branch iliac endovascular graft. They promise to preserve flow to the internal iliac artery and thus reduce the potential for ischemic sequelae resulting from iliac embolization. Depending on patient anatomy, however, the internal iliac may become jailed upon deployment of the main body graft, said Dr. Kelly of Sanford Health, Sioux Falls, S.D. The fenestrated systems are also limited by bridging stent technology and the relatively short bridging stent.
His alternative modified bifurcated limb divides the common iliac flow into the internal and external iliac arteries, while excluding the common iliac artery aneurysm.
"The pros are that it uses an off-the-shelf [graft], should be able to handle virtually any anatomy, can be used to treat either existing EVAR or previous open repairs, and has multiple off-ramps, so you don’t jail yourself," he said. "The cons: It requires arm access – although I’m not sure that’s a con – and it requires three stents."
Operative details
The bifurcated limb is created by sewing an 8-mm and 10-mm covered stent graft to the distal end of a standard 16 x 20 x 82-mm stent graft limb. The distal ends of both the 8-mm and 10-mm grafts are left free, allowing flexibility and easier selection of the internal iliac artery, he said.
Once the graft is resheathed using a spiral wire technique, a traditional infrarenal abdominal aneurysm repair is performed. In order to exclude the common iliac aneurysm, the graft is oriented with the 8-mm limb toward the internal iliac and with the distal end of the 8-mm limb being deployed 2-3 cm above the origin of the internal iliac artery. The internal iliac artery is selected from an arm approach, through the 8-mm limb of the bifurcated stent graft limb.
Angiograms are performed and a 3-cm covered, self-expanding bridge stent graft is deployed. The 10-mm limb is used to extend the graft into the external iliac, thus completing exclusion of the common iliac aneurysm, while preserving both the internal and external iliac arteries, Dr. Kelly said.
Thus far, occlusion of the external iliac artery has been reported in one patient, and there were no recurring endoleaks. There was a type 3 endoleak between the main body and bridging stent that was visible on diagnostic angiography, but it resolved after being reballooned and patent flow was established upon completion angiography, Dr. Kelly explained. There was also a retrograde fill that was fixed 1 year postoperatively by extending the limb to obtain a healthy seal.
The average patient age was 65.4 years (range, 46-87 years); fluoroscopy time, 46 minutes (range, 29-91 minutes); and average length of stay 3.1 days (range, 1-9 days).
This compares with an average hospital stay of 4-7 days for the tried-and-true method of open aneurysm repair, which has bleeding rates of 30% or more, colonic ischemia in 20%-30%, and paraplegia in 2%-3%, Dr. Kelly noted.
Audience reaction
Dr. Rebecca Kelso of the Cleveland Clinic, who co-moderated the session, was enthusiastic about the novel approach.
"The potential for it is quite significant, because the other main competitive device he mentioned that’s on the market still has anatomic limitations for use," she said in an interview. "So if he has something that can be used in any patient, no matter what the circumstances, that has significant implications for being available commercially for everyone."
Fellow moderator Dr. Patrick J. Geraghty of Washington University, St. Louis, remarked that while the approach uses a standardized graft, it is somewhat tailored since the length and the diameter of the grafts extending into the external and internal iliac arteries can be chosen separately. That said, the one-size-fits-all approach is particularly appealing because it could simplify treatment planning and reduce treatment delays.
"If you have a patient who is symptomatic and you have an off-the-shelf component, you could potentially treat them within the next 24 hours," he said in an interview. "The current turnaround time for the fenestrated system is about a month or so, so it would shorten treatment delays and might lead to a broader application of the technology."
A potentially shorter hospital length of stay could also reduce hospital costs, Dr. Kelso noted.
While the audience appeared equally enthusiastic about the results, some members questioned whether results on a physician-modified graft without an Investigational Device Exemption (IDE) should be presented at the meeting in light of recent warnings by the U.S. Food and Drug Administration that such interventions involve the use of significant-risk devices and need to be conducted under an IDE. Dr. Kelly responded that he is currently working with the FDA to obtain an IDE.
Earlier this year, the Society of Thoracic Surgeons and the American College of Cardiology became the first medical societies to receive an IDE to study alternative access for transcatheter aortic valve replacement using the STS/ACC TVT Registry.
Dr. Kelly and Dr. Kelso reported having no financial disclosures. Dr. Geraghty disclosed relationships with Cook Medical and Bard/Lutonix.
Fruits, but not vegetables, shown to lower AAA risk
The consumption of fruits, but not vegetables, was associated with a decreased risk of abdominal aortic aneurysm, especially the risk of rupture, according to results of a large database study of two prospective cohorts of Swedish men and women.
"The risk of AAA decreased with increasing consumption of fruit (P =.003), whereas no significant association was observed for vegetable consumption," wrote Dr. Otto Stackelberg and his colleagues at Uppsala (Sweden) University (Circulation 2013;128:795-802).
The study population in the final analysis of the two cohorts consisted of 36,109 women from the Swedish Mammography Cohort (established between 1987 and 1990) and 44,317 men from the Cohort of Swedish Men (established in 1997).
Both cohorts responded in 1997 to extensive questionnaires – identical except for sex-specific questions – that included 96 food-item questions accompanied by other lifestyle factors. Results were linked to the Swedish Inpatient Register and the Swedish National Cause of Death Register to follow outcomes of these patients.
National health coverage in Sweden has been nearly 100% since 1987. All cases of AAA were identified by clinical events, not by general screening. AAA repair was identified via the Nordic Classification of Surgical Procedures. To classify aneurysmal localization and rupture status of AAA repairs, the researchers linked the cohorts to the Swedish Registry for Vascular Surgery (founded in 1987, which accounted for 93.1% of all AAA repairs in Sweden).
Fruit and vegetable consumption was summed from results of the 96 food item questionnaire and converted to daily consumption categories ranging from never to greater than or equal to 3 times daily.
Covariates assessed included education, alcohol consumption, diet, physical activity, waist circumference, and smoking duration and amount. The study population was ethnically homogenous. History of cardiovascular disease, diabetes, hypertension, and hypercholesterolemia was obtained from the Swedish Inpatient Register, the Swedish National Diabetes Register, and the self-reported data from the questionnaire.
During 13 years of follow-up (1998-2010), the researchers found that there were 1,086 primary cases (899 in men; 83%) and 222 cases of ruptured AAA (181 in men; 82%). The mean age for nonruptured AAA was 74 years in men and 76 years in women. For ruptured AAA it was 76 and 78.5 years in men and women, respectively. Cox proportional hazard analysis was used to estimate hazard ratios.
Individuals in the highest quartile of fruit consumption (greater than 2 servings per day) had a 25% lower risk of AAA and a 43% lower risk of ruptured AAA, compared with those in the lowest quartiles of fruit consumption (less than 0.7 servings per day). No association was observed between vegetable consumption and AAA risk. There was no impact of smoking or sex of the individual on the fruit consumption–related AAA risk for both ruptured and nonruptured AAA.
Men and women with a high consumption of fruit and vegetables were more educated; consumed more fish, meat, and whole grains; and were more likely to be leaner and physically active, and less likely to be smokers, according to the researchers. In addition, high consumers of fruit consumed less alcohol, whereas the reverse was true of high consumers of vegetables.
"A diet high in fruits may help to prevent many vascular diseases, and this study provides evidence that a lower risk of AAA will be among the benefits," the researchers concluded.
The study was funded by grants from the Swedish Research Council and the Karolinska Institute. The authors reported they had no disclosures.
So I guess the old adage is correct ... "An apple a day keeps the doctor away," or should I say "An Apple A day keeps the AAA Away?"
Dr. Russell Samson is the Medical Editor of Vascular Specialist.
So I guess the old adage is correct ... "An apple a day keeps the doctor away," or should I say "An Apple A day keeps the AAA Away?"
Dr. Russell Samson is the Medical Editor of Vascular Specialist.
So I guess the old adage is correct ... "An apple a day keeps the doctor away," or should I say "An Apple A day keeps the AAA Away?"
Dr. Russell Samson is the Medical Editor of Vascular Specialist.
The consumption of fruits, but not vegetables, was associated with a decreased risk of abdominal aortic aneurysm, especially the risk of rupture, according to results of a large database study of two prospective cohorts of Swedish men and women.
"The risk of AAA decreased with increasing consumption of fruit (P =.003), whereas no significant association was observed for vegetable consumption," wrote Dr. Otto Stackelberg and his colleagues at Uppsala (Sweden) University (Circulation 2013;128:795-802).
The study population in the final analysis of the two cohorts consisted of 36,109 women from the Swedish Mammography Cohort (established between 1987 and 1990) and 44,317 men from the Cohort of Swedish Men (established in 1997).
Both cohorts responded in 1997 to extensive questionnaires – identical except for sex-specific questions – that included 96 food-item questions accompanied by other lifestyle factors. Results were linked to the Swedish Inpatient Register and the Swedish National Cause of Death Register to follow outcomes of these patients.
National health coverage in Sweden has been nearly 100% since 1987. All cases of AAA were identified by clinical events, not by general screening. AAA repair was identified via the Nordic Classification of Surgical Procedures. To classify aneurysmal localization and rupture status of AAA repairs, the researchers linked the cohorts to the Swedish Registry for Vascular Surgery (founded in 1987, which accounted for 93.1% of all AAA repairs in Sweden).
Fruit and vegetable consumption was summed from results of the 96 food item questionnaire and converted to daily consumption categories ranging from never to greater than or equal to 3 times daily.
Covariates assessed included education, alcohol consumption, diet, physical activity, waist circumference, and smoking duration and amount. The study population was ethnically homogenous. History of cardiovascular disease, diabetes, hypertension, and hypercholesterolemia was obtained from the Swedish Inpatient Register, the Swedish National Diabetes Register, and the self-reported data from the questionnaire.
During 13 years of follow-up (1998-2010), the researchers found that there were 1,086 primary cases (899 in men; 83%) and 222 cases of ruptured AAA (181 in men; 82%). The mean age for nonruptured AAA was 74 years in men and 76 years in women. For ruptured AAA it was 76 and 78.5 years in men and women, respectively. Cox proportional hazard analysis was used to estimate hazard ratios.
Individuals in the highest quartile of fruit consumption (greater than 2 servings per day) had a 25% lower risk of AAA and a 43% lower risk of ruptured AAA, compared with those in the lowest quartiles of fruit consumption (less than 0.7 servings per day). No association was observed between vegetable consumption and AAA risk. There was no impact of smoking or sex of the individual on the fruit consumption–related AAA risk for both ruptured and nonruptured AAA.
Men and women with a high consumption of fruit and vegetables were more educated; consumed more fish, meat, and whole grains; and were more likely to be leaner and physically active, and less likely to be smokers, according to the researchers. In addition, high consumers of fruit consumed less alcohol, whereas the reverse was true of high consumers of vegetables.
"A diet high in fruits may help to prevent many vascular diseases, and this study provides evidence that a lower risk of AAA will be among the benefits," the researchers concluded.
The study was funded by grants from the Swedish Research Council and the Karolinska Institute. The authors reported they had no disclosures.
The consumption of fruits, but not vegetables, was associated with a decreased risk of abdominal aortic aneurysm, especially the risk of rupture, according to results of a large database study of two prospective cohorts of Swedish men and women.
"The risk of AAA decreased with increasing consumption of fruit (P =.003), whereas no significant association was observed for vegetable consumption," wrote Dr. Otto Stackelberg and his colleagues at Uppsala (Sweden) University (Circulation 2013;128:795-802).
The study population in the final analysis of the two cohorts consisted of 36,109 women from the Swedish Mammography Cohort (established between 1987 and 1990) and 44,317 men from the Cohort of Swedish Men (established in 1997).
Both cohorts responded in 1997 to extensive questionnaires – identical except for sex-specific questions – that included 96 food-item questions accompanied by other lifestyle factors. Results were linked to the Swedish Inpatient Register and the Swedish National Cause of Death Register to follow outcomes of these patients.
National health coverage in Sweden has been nearly 100% since 1987. All cases of AAA were identified by clinical events, not by general screening. AAA repair was identified via the Nordic Classification of Surgical Procedures. To classify aneurysmal localization and rupture status of AAA repairs, the researchers linked the cohorts to the Swedish Registry for Vascular Surgery (founded in 1987, which accounted for 93.1% of all AAA repairs in Sweden).
Fruit and vegetable consumption was summed from results of the 96 food item questionnaire and converted to daily consumption categories ranging from never to greater than or equal to 3 times daily.
Covariates assessed included education, alcohol consumption, diet, physical activity, waist circumference, and smoking duration and amount. The study population was ethnically homogenous. History of cardiovascular disease, diabetes, hypertension, and hypercholesterolemia was obtained from the Swedish Inpatient Register, the Swedish National Diabetes Register, and the self-reported data from the questionnaire.
During 13 years of follow-up (1998-2010), the researchers found that there were 1,086 primary cases (899 in men; 83%) and 222 cases of ruptured AAA (181 in men; 82%). The mean age for nonruptured AAA was 74 years in men and 76 years in women. For ruptured AAA it was 76 and 78.5 years in men and women, respectively. Cox proportional hazard analysis was used to estimate hazard ratios.
Individuals in the highest quartile of fruit consumption (greater than 2 servings per day) had a 25% lower risk of AAA and a 43% lower risk of ruptured AAA, compared with those in the lowest quartiles of fruit consumption (less than 0.7 servings per day). No association was observed between vegetable consumption and AAA risk. There was no impact of smoking or sex of the individual on the fruit consumption–related AAA risk for both ruptured and nonruptured AAA.
Men and women with a high consumption of fruit and vegetables were more educated; consumed more fish, meat, and whole grains; and were more likely to be leaner and physically active, and less likely to be smokers, according to the researchers. In addition, high consumers of fruit consumed less alcohol, whereas the reverse was true of high consumers of vegetables.
"A diet high in fruits may help to prevent many vascular diseases, and this study provides evidence that a lower risk of AAA will be among the benefits," the researchers concluded.
The study was funded by grants from the Swedish Research Council and the Karolinska Institute. The authors reported they had no disclosures.
Three Factors Tied to Femoral Artery Aneurysm Outcomes
SAN FRANCISCO - Predictors of acute aneurysm - related complications were aneurysm size of 4 cm or greater, thrombus, and age younger than 60 years, in a study of patients with isolated degenerative femoral artery aneurysms.
"Acute complications have not occurred in patients with FAAs less than 3.5 cm, suggesting that this should be adopted as a new threshold for elective repair," Dr. Gustavo S. Oderich said at the Society for Vascular Surgery Annual Meeting.
Femoral artery aneurysms (FAAs) are rare, affecting 5/100,000 individuals, said Dr. Oderich, a vascular surgeon who practices at the Mayo Clinic, Rochester, Minn. Current indications for repair are symptoms, size greater than 2.5 cm, growth, and thrombus.
Most reports of FAAs predate modern imaging. These studies "are limited by the small number of patients, mixed etiology, and short follow-up," Dr. Oderich said. "The purpose of the current study was to review the clinical presentation, management strategies, and outcomes of degenerative FAAs in a larger cohort of patients."
For the study, led by Dr. Peter F. Lawrence of the University of California, Los Angeles, researchers retrospectively studied patients treated for degenerative FAAs between 2002 and 2012 at eight medical centers in the United States. Iatrogenic, anastomotic, and mycotic aneurysms were excluded from the analysis. Endpoints of interest were morbidity and mortality with operative repair; acute aneurysm - related complications including rupture, thrombosis, and embolization; and patient survival.
Dr. Oderich reported on 236 FAAs that occurred in 182 patients. The mean size was 32 cm. Most (81%) were located on the common femoral artery, 14% were located on the superficial femoral artery, and 5% were located on the profunda femoris artery. The majority of patients (88%) had synchronous aneurysms in other locations. The most common locations outside of the femoral artery were the aortic (62%) artery, common iliac arteries (60%), popliteal arteries (47%), and bilateral FAAs (25%).
The mean age of patients was 73 and 94% of patients were male. At presentation 63% of patients were asymptomatic. The most common signs and symptoms were palpable mass (29%), claudication (22%), and local pain (10%).
When the researchers compared symptomatic versus asymptomatic aneurysms, symptomatic aneurysms were larger, had more intraluminal thrombus, and more often affected the profunda femoral artery .Only 12 patients (5%) had acute events, most of them rupture or thrombosis, with a size of 3.5-7 cm in range.
Independent predictors associated with acute aneurysm - related complications were a diameter of 4 cm or greater (P = less than .001), an intraluminal thrombus (P = less than .001), and age younger than 60 (P = .004). Freedom from repair among patients with asymptomatic FAAs was 21% at 5 years, "largely reflecting our practice of indicating the operation for aneurysms greater than 2.5 cm," Dr. Oderich said. The most common indications for repair were pain (34%), intramural thrombus (27%), and size of 2.5 cm or greater (23%).
He reported that 138 patients underwent open repair and 3 patients underwent endovascular treatment of 177 FAAs. The most frequent form of reconstruction was an interposition graft (80%) or bypass (20%). Among the 141 patients who had operative treatment, the 30-day mortality was 1.5%, the morbidity rate was 20%, and the mean length of stay was 7 days. During a mean follow-up of 49 months, there were 35 nonaneurysm-related deaths (27%) and 1 graft-related complication. Patient survival at 5 years was 61%.
"Repair of smaller FAAs may be indicated in patients with intramural thrombus or progressive enlargement," Dr. Oderich concluded. "Current repair of all symptomatic FAAs should remain unchanged. Operative repair was associated with low mortality, morbidity, and durable results."
Decision making when faced with a patient with a degenerative femoral artery aneurysm has always been based on small series. Especially when deciding what size asymptomatic aneurysm is too big to continue to watch, the available data are weak.
The authors pooled a large number of cases from eight institutions to assemble a dataset of 236 FAAs, 25% of which were apparently observed without repair. (Disclaimer: One of my partners contributed data to this series.) They noted that no asymptomatic aneurysm less than 3.5 cm developed an acute complication, and concluded that the threshold for repair of these lesions should rise to at least 3.5 cm in diameter.
Although this report is retrospective and almost certainly contains selection bias, this conclusion seems valid to me at a gut level. I also agree that any symptoms or the presence of significant mural thrombus should prompt repair. Until we are able to capitalize on the capacity of electronic medical records to determine the clinical outcome of patients on the basis of diagnosis rather than what surgical procedure they have had, this is probably the best data we are likely to see regarding the management of FAA.
Dr. Larry W. Kraiss is professor and chief of vascular surgery at the University of Utah, Salt Lake City, and is an associate medical editor of Vascular Specialist.
Decision making when faced with a patient with a degenerative femoral artery aneurysm has always been based on small series. Especially when deciding what size asymptomatic aneurysm is too big to continue to watch, the available data are weak.
The authors pooled a large number of cases from eight institutions to assemble a dataset of 236 FAAs, 25% of which were apparently observed without repair. (Disclaimer: One of my partners contributed data to this series.) They noted that no asymptomatic aneurysm less than 3.5 cm developed an acute complication, and concluded that the threshold for repair of these lesions should rise to at least 3.5 cm in diameter.
Although this report is retrospective and almost certainly contains selection bias, this conclusion seems valid to me at a gut level. I also agree that any symptoms or the presence of significant mural thrombus should prompt repair. Until we are able to capitalize on the capacity of electronic medical records to determine the clinical outcome of patients on the basis of diagnosis rather than what surgical procedure they have had, this is probably the best data we are likely to see regarding the management of FAA.
Dr. Larry W. Kraiss is professor and chief of vascular surgery at the University of Utah, Salt Lake City, and is an associate medical editor of Vascular Specialist.
Decision making when faced with a patient with a degenerative femoral artery aneurysm has always been based on small series. Especially when deciding what size asymptomatic aneurysm is too big to continue to watch, the available data are weak.
The authors pooled a large number of cases from eight institutions to assemble a dataset of 236 FAAs, 25% of which were apparently observed without repair. (Disclaimer: One of my partners contributed data to this series.) They noted that no asymptomatic aneurysm less than 3.5 cm developed an acute complication, and concluded that the threshold for repair of these lesions should rise to at least 3.5 cm in diameter.
Although this report is retrospective and almost certainly contains selection bias, this conclusion seems valid to me at a gut level. I also agree that any symptoms or the presence of significant mural thrombus should prompt repair. Until we are able to capitalize on the capacity of electronic medical records to determine the clinical outcome of patients on the basis of diagnosis rather than what surgical procedure they have had, this is probably the best data we are likely to see regarding the management of FAA.
Dr. Larry W. Kraiss is professor and chief of vascular surgery at the University of Utah, Salt Lake City, and is an associate medical editor of Vascular Specialist.
SAN FRANCISCO - Predictors of acute aneurysm - related complications were aneurysm size of 4 cm or greater, thrombus, and age younger than 60 years, in a study of patients with isolated degenerative femoral artery aneurysms.
"Acute complications have not occurred in patients with FAAs less than 3.5 cm, suggesting that this should be adopted as a new threshold for elective repair," Dr. Gustavo S. Oderich said at the Society for Vascular Surgery Annual Meeting.
Femoral artery aneurysms (FAAs) are rare, affecting 5/100,000 individuals, said Dr. Oderich, a vascular surgeon who practices at the Mayo Clinic, Rochester, Minn. Current indications for repair are symptoms, size greater than 2.5 cm, growth, and thrombus.
Most reports of FAAs predate modern imaging. These studies "are limited by the small number of patients, mixed etiology, and short follow-up," Dr. Oderich said. "The purpose of the current study was to review the clinical presentation, management strategies, and outcomes of degenerative FAAs in a larger cohort of patients."
For the study, led by Dr. Peter F. Lawrence of the University of California, Los Angeles, researchers retrospectively studied patients treated for degenerative FAAs between 2002 and 2012 at eight medical centers in the United States. Iatrogenic, anastomotic, and mycotic aneurysms were excluded from the analysis. Endpoints of interest were morbidity and mortality with operative repair; acute aneurysm - related complications including rupture, thrombosis, and embolization; and patient survival.
Dr. Oderich reported on 236 FAAs that occurred in 182 patients. The mean size was 32 cm. Most (81%) were located on the common femoral artery, 14% were located on the superficial femoral artery, and 5% were located on the profunda femoris artery. The majority of patients (88%) had synchronous aneurysms in other locations. The most common locations outside of the femoral artery were the aortic (62%) artery, common iliac arteries (60%), popliteal arteries (47%), and bilateral FAAs (25%).
The mean age of patients was 73 and 94% of patients were male. At presentation 63% of patients were asymptomatic. The most common signs and symptoms were palpable mass (29%), claudication (22%), and local pain (10%).
When the researchers compared symptomatic versus asymptomatic aneurysms, symptomatic aneurysms were larger, had more intraluminal thrombus, and more often affected the profunda femoral artery .Only 12 patients (5%) had acute events, most of them rupture or thrombosis, with a size of 3.5-7 cm in range.
Independent predictors associated with acute aneurysm - related complications were a diameter of 4 cm or greater (P = less than .001), an intraluminal thrombus (P = less than .001), and age younger than 60 (P = .004). Freedom from repair among patients with asymptomatic FAAs was 21% at 5 years, "largely reflecting our practice of indicating the operation for aneurysms greater than 2.5 cm," Dr. Oderich said. The most common indications for repair were pain (34%), intramural thrombus (27%), and size of 2.5 cm or greater (23%).
He reported that 138 patients underwent open repair and 3 patients underwent endovascular treatment of 177 FAAs. The most frequent form of reconstruction was an interposition graft (80%) or bypass (20%). Among the 141 patients who had operative treatment, the 30-day mortality was 1.5%, the morbidity rate was 20%, and the mean length of stay was 7 days. During a mean follow-up of 49 months, there were 35 nonaneurysm-related deaths (27%) and 1 graft-related complication. Patient survival at 5 years was 61%.
"Repair of smaller FAAs may be indicated in patients with intramural thrombus or progressive enlargement," Dr. Oderich concluded. "Current repair of all symptomatic FAAs should remain unchanged. Operative repair was associated with low mortality, morbidity, and durable results."
SAN FRANCISCO - Predictors of acute aneurysm - related complications were aneurysm size of 4 cm or greater, thrombus, and age younger than 60 years, in a study of patients with isolated degenerative femoral artery aneurysms.
"Acute complications have not occurred in patients with FAAs less than 3.5 cm, suggesting that this should be adopted as a new threshold for elective repair," Dr. Gustavo S. Oderich said at the Society for Vascular Surgery Annual Meeting.
Femoral artery aneurysms (FAAs) are rare, affecting 5/100,000 individuals, said Dr. Oderich, a vascular surgeon who practices at the Mayo Clinic, Rochester, Minn. Current indications for repair are symptoms, size greater than 2.5 cm, growth, and thrombus.
Most reports of FAAs predate modern imaging. These studies "are limited by the small number of patients, mixed etiology, and short follow-up," Dr. Oderich said. "The purpose of the current study was to review the clinical presentation, management strategies, and outcomes of degenerative FAAs in a larger cohort of patients."
For the study, led by Dr. Peter F. Lawrence of the University of California, Los Angeles, researchers retrospectively studied patients treated for degenerative FAAs between 2002 and 2012 at eight medical centers in the United States. Iatrogenic, anastomotic, and mycotic aneurysms were excluded from the analysis. Endpoints of interest were morbidity and mortality with operative repair; acute aneurysm - related complications including rupture, thrombosis, and embolization; and patient survival.
Dr. Oderich reported on 236 FAAs that occurred in 182 patients. The mean size was 32 cm. Most (81%) were located on the common femoral artery, 14% were located on the superficial femoral artery, and 5% were located on the profunda femoris artery. The majority of patients (88%) had synchronous aneurysms in other locations. The most common locations outside of the femoral artery were the aortic (62%) artery, common iliac arteries (60%), popliteal arteries (47%), and bilateral FAAs (25%).
The mean age of patients was 73 and 94% of patients were male. At presentation 63% of patients were asymptomatic. The most common signs and symptoms were palpable mass (29%), claudication (22%), and local pain (10%).
When the researchers compared symptomatic versus asymptomatic aneurysms, symptomatic aneurysms were larger, had more intraluminal thrombus, and more often affected the profunda femoral artery .Only 12 patients (5%) had acute events, most of them rupture or thrombosis, with a size of 3.5-7 cm in range.
Independent predictors associated with acute aneurysm - related complications were a diameter of 4 cm or greater (P = less than .001), an intraluminal thrombus (P = less than .001), and age younger than 60 (P = .004). Freedom from repair among patients with asymptomatic FAAs was 21% at 5 years, "largely reflecting our practice of indicating the operation for aneurysms greater than 2.5 cm," Dr. Oderich said. The most common indications for repair were pain (34%), intramural thrombus (27%), and size of 2.5 cm or greater (23%).
He reported that 138 patients underwent open repair and 3 patients underwent endovascular treatment of 177 FAAs. The most frequent form of reconstruction was an interposition graft (80%) or bypass (20%). Among the 141 patients who had operative treatment, the 30-day mortality was 1.5%, the morbidity rate was 20%, and the mean length of stay was 7 days. During a mean follow-up of 49 months, there were 35 nonaneurysm-related deaths (27%) and 1 graft-related complication. Patient survival at 5 years was 61%.
"Repair of smaller FAAs may be indicated in patients with intramural thrombus or progressive enlargement," Dr. Oderich concluded. "Current repair of all symptomatic FAAs should remain unchanged. Operative repair was associated with low mortality, morbidity, and durable results."
AT THE SVS ANNUAL MEETING
Major finding: Among patients treated for isolated degenerative femoral artery aneurysms, independent predictors associated with acute aneurysm–related complications were a diameter of 4 cm or greater (P = less than .001), an intraluminal thrombus (P = less than .001), and age younger than 60 (P = .004).
Data source: A retrospective study of 182 patients in the United States who were treated for 236 femoral artery aneurysms that occurred between 2002 and 2012.
Disclosures: Dr. Oderich disclosed that he has served as a consultant to W.L. Gore and Cook Medical.
One-third of perioperative EVAR deaths occurred after discharge
SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.
"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.
Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."
In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.
Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.
Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.
Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).
Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.
The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).
The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).
"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."
Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."
Dr. Gupta said that he had no relevant financial disclosures to make.
Dr. Gupta and his colleagues have assessed postprocedure complications after elective EVAR based upon review of the NSQIP database, and concluded that earlier follow-up of high-risk patients might identify and prevent some of the complications. This study is limited by the database nature of the review. This study also does not provide us with data as to the size of the AAA in the high risk patients.
Most of the complications leading to increased risk of mortality were postoperative issues, such as renal failure or MI, which could not be identified at the time of procedure, or the time of discharge. The only identifiable preoperative risk factors for adverse outcomes were preoperative heart failure, admission from a skilled nursing facility and increasing age. While changing the timing of follow-up might be appropriate for the high-risk patients, other considerations would be changing to more percutaneous procedures , and use of other adjuncts, such as antibiotic irrigations or Prevena (negative pressure wound therapy for intact skin) to decrease the wound infection rates for those undergoing femoral exploration for EVAR. Further, any intervention on the elderly, especially nursing home patients, needs to be thoroughly considered, as EVAR is most often a preventive operation, assuming fitness and appropriate longevity remains for the patient.
The findings from this study are important, but mostly, should serve as a caution to properly assess patients to determine who will potentially benefit from EVAR, and which patients might be best managed by observation alone.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
Dr. Gupta and his colleagues have assessed postprocedure complications after elective EVAR based upon review of the NSQIP database, and concluded that earlier follow-up of high-risk patients might identify and prevent some of the complications. This study is limited by the database nature of the review. This study also does not provide us with data as to the size of the AAA in the high risk patients.
Most of the complications leading to increased risk of mortality were postoperative issues, such as renal failure or MI, which could not be identified at the time of procedure, or the time of discharge. The only identifiable preoperative risk factors for adverse outcomes were preoperative heart failure, admission from a skilled nursing facility and increasing age. While changing the timing of follow-up might be appropriate for the high-risk patients, other considerations would be changing to more percutaneous procedures , and use of other adjuncts, such as antibiotic irrigations or Prevena (negative pressure wound therapy for intact skin) to decrease the wound infection rates for those undergoing femoral exploration for EVAR. Further, any intervention on the elderly, especially nursing home patients, needs to be thoroughly considered, as EVAR is most often a preventive operation, assuming fitness and appropriate longevity remains for the patient.
The findings from this study are important, but mostly, should serve as a caution to properly assess patients to determine who will potentially benefit from EVAR, and which patients might be best managed by observation alone.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
Dr. Gupta and his colleagues have assessed postprocedure complications after elective EVAR based upon review of the NSQIP database, and concluded that earlier follow-up of high-risk patients might identify and prevent some of the complications. This study is limited by the database nature of the review. This study also does not provide us with data as to the size of the AAA in the high risk patients.
Most of the complications leading to increased risk of mortality were postoperative issues, such as renal failure or MI, which could not be identified at the time of procedure, or the time of discharge. The only identifiable preoperative risk factors for adverse outcomes were preoperative heart failure, admission from a skilled nursing facility and increasing age. While changing the timing of follow-up might be appropriate for the high-risk patients, other considerations would be changing to more percutaneous procedures , and use of other adjuncts, such as antibiotic irrigations or Prevena (negative pressure wound therapy for intact skin) to decrease the wound infection rates for those undergoing femoral exploration for EVAR. Further, any intervention on the elderly, especially nursing home patients, needs to be thoroughly considered, as EVAR is most often a preventive operation, assuming fitness and appropriate longevity remains for the patient.
The findings from this study are important, but mostly, should serve as a caution to properly assess patients to determine who will potentially benefit from EVAR, and which patients might be best managed by observation alone.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.
"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.
Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."
In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.
Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.
Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.
Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).
Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.
The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).
The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).
"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."
Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."
Dr. Gupta said that he had no relevant financial disclosures to make.
SAN FRANCISCO – One-third of perioperative deaths and complications after elective endovascular repair of abdominal aortic aneurysms occur post discharge, results from a large analysis showed.
"Improved predischarge surveillance and close postdischarge follow-up of identified high-risk patients may further improve 30-day outcomes after EVAR," Dr. Prateek K. Gupta said at the Society for Vascular Surgery annual meeting.
Outcome improvement in the field of aortic surgery, specifically endovascular repair of abdominal aortic aneurysms, "has received much attention," said Dr. Gupta of the department of surgery at the University of Wisconsin Hospital and Clinics, Madison. "With EVAR, the index hospital stay after aortic surgery has decreased significantly, leaving a need for better understanding of postdischarge outcomes, which is necessary to improve quality and reduce readmission rates with implementation of targeted outpatient interventions."
In an effort to examine postdischarge 30-day outcomes after elective EVAR, Dr. Gupta and his associates identified 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010. The primary outcome of interest was postdischarge mortality, while the secondary outcome was postdischarge overall morbidity. The researchers performed univariate and multiple logistic regression analysis to assess factors associated with the primary and secondary study outcomes.
Of the 11,229 patient 83% were male and their mean age was 75 years. Dr. Gupta reported that 117 patients died within 30 days of EVAR, for a rate of 1%. Of these deaths, 31% occurred after hospital discharge, and the median time to death was 9 days. At the same time, 1,204 patients experienced complications within 30 days of EVAR, for a rate of 11%. Of these, 500 (40%) occurred post discharge, and the median time for a complication to occur was 3 days.
Only 20% of patients (7/36) who died post discharge experienced an in-hospital complication. Compared with patients who did not develop a postdischarge complication, those who had more than a sixfold likelihood of reoperation (20.4% vs. 3.1%, respectively; P less than .0001) and death (3.0% vs. 0.2%; P less than .0001) within 30 days of surgery.
Multivariable analysis revealed the following factors that were independently and significantly associated with postdischarge mortality: preoperative heart failure (adjusted odds ratio, 4.7), admission from a skilled nursing facility (AOR, 2.2), increase in age per year (AOR, 1.09), postdischarge renal failure requiring dialysis (AOR, 72.5), postdischarge cardiac arrest/MI (AOR, 46.6), and postdischarge pneumonia (AOR, 26.5).
Dr. Gupta reported that the 30-day postdischarge rate among patients admitted from a nursing facility or acute care was 2.5%. "In contrast to patients who survived after EVAR, patients who died post discharge were more likely to have been admitted from a nursing facility or acute care (13.9% vs. 1.8%; P less than .0001)," he said.
The 30-day post-discharge mortality was highest among patients who had postdischarge renal failure (27%),postdischarge MI (19%), and postdischarge pneumonia (15%).
The researchers also found that patients with a history of peripheral artery disease (PAD) had a significantly higher post-discharge complication rate after EVAR (7.1% vs. 4.3%; P = .001). This also correlated with a higher wound infection rate (3.2% vs. 1.7%; P = .01). A previous cardiac surgery also predisposed patients toward a higher overall postdischarge complication rate (5.3% vs. 4.2%; P = .007).
"Usually, patients undergoing EVAR are followed up at 2 weeks for wound evaluation, or at 1 month with a CT scan," Dr. Gupta said. "In the present study, the median occurrence for most of the postdischarge complications was within the first 10 days after surgery. The interquartile range was 11-22 days for the diagnosis of a wound infection after EVAR. These data suggest that earlier follow-up of high-risk patients may help identify and possibly prevent some of these complications and subsequently decrease readmissions. A standardized protocol for triage and surveillance of high-risk patients post EVAR is needed."
Limitations of the study include that fact that causality could not be determined because it was a retrospective analysis. "In addition, the timing of the operation is not specified in NSQIP," so it could either be a predischarge event or it could have occurred on readmission, Dr. Gupta said. "Data on readmission is not available from the 2005-2010 data sets."
Dr. Gupta said that he had no relevant financial disclosures to make.
AT THE SVS ANNUAL MEETING
Major finding: Following endovascular repair of abdominal aortic aneurysms, 31% of deaths and 40% of complications occurred after hospital discharge.
Data source: An analysis of 11,229 patients from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database who underwent an elective EVAR for AAA between 2005 and 2010.
Disclosures: Dr. Gupta said that he had no relevant financial conflicts to disclose.
Oxygen debt key in multiple organ dysfunction
SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.
At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."
The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.
The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."
Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."
Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."
Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.
Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."
Dr. Hollier had no disclosures.
SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.
At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."
The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.
The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."
Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."
Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."
Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.
Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."
Dr. Hollier had no disclosures.
SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.
At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."
The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.
The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."
Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."
Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."
Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.
Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."
Dr. Hollier had no disclosures.
EXPERT ANALYSIS FROM THE VASCULAR ANNUAL MEETING
Medicare-funded EVAR can mean unmet surgery costs
SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.
"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."
Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.
"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.
Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.
"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."
Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.
Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."
He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."
Dr. Stone said that he had no relevant financial conflicts to disclose.
Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.
As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.
As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.
As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.
Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.
SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.
"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."
Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.
"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.
Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.
"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."
Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.
Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."
He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."
Dr. Stone said that he had no relevant financial conflicts to disclose.
SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.
"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."
Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.
"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.
Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.
"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."
Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.
Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."
He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."
Dr. Stone said that he had no relevant financial conflicts to disclose.
AT THE VASCULAR ANNUAL MEETING
Major finding: In a study of DRG 238 remunerated EVAR, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.
Data source: A retrospectively examination of the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at Dartmouth-Hitchcock Medical Center between April 2011 and March 2012.
Disclosures: Dr. Stone said that he had no relevant financial conflicts to disclose.
Pooled data allow fine-tuning of AAA surveillance times
Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in JAMA.
"By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.
Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.
The researchers reviewed the literature for data sets with 100 or more patients who had repeated ultrasound measurements of their AAAs over time. This yielded 18 data sets with 15,471 subjects with AAA diameters between 3.0 and 5.4 cm.
The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women. Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm. Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.
Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.
"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7" (JAMA 2013;309:806-13).
However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.
The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. "The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," the researchers wrote.
A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have operative mortality and a poorer outcome at hospital discharge.
This study was supported by the U.K. National Institute for Health Research. The authors had no conflicts.
This meta-analysis derived from a literature sample of more than 15,000 patients largely confirms the empirically determined recommendations in the SVS practice guidelines for care of patients with AAA published in 2009.
| Dr. Larry Kraiss |
One strategy outlined by Dr. Thompson et al. in the meta-analysis proposes surveillance at 2-year intervals for AAA 3.0-3.9 cm, 1-year intervals for AAA 4.0-4.9 cm, and 6-month intervals for AAA 5.0-5.4 cm. The SVS practice guidelines recommend 3-year intervals for AAA 3.0-3.4 cm, 1-year interval for AAA 3.5-4.4 cm, and 6-month intervals for AAA 4.5-5.4 cm. The authors also acknowledge that their findings have questionable applicability to women with small AAA.
Of course, vascular surgeons treat individuals who may or may not behave like the average patient from this group of 15,000. Patients with small AAA have varying levels of anxiety and co-morbidities that must be accounted for when making decisions when to re-image the known small AAA. This account of the report does not mention whether there were subgroups of patients whose AAA grew more rapidly and might merit more frequent surveillance. Active smokers and those with COPD are often seen as having more rapid rates of AAA growth.
The report offers vascular surgeons additional evidence to reassure their patients that commonly practiced surveillance intervals are not too long and that the likelihood that a given AAA will dramatically increase its chances of rupture over the recommended interval is low. This report should not be used by payers to trump the vascular surgeon’s clinical judgment.
Dr. Larry Kraiss is Professor and Chief of Vascular Surgery, University of Utah, Salt Lake City, and is an associate medical editor for Vascular Specialist.
This meta-analysis derived from a literature sample of more than 15,000 patients largely confirms the empirically determined recommendations in the SVS practice guidelines for care of patients with AAA published in 2009.
| Dr. Larry Kraiss |
One strategy outlined by Dr. Thompson et al. in the meta-analysis proposes surveillance at 2-year intervals for AAA 3.0-3.9 cm, 1-year intervals for AAA 4.0-4.9 cm, and 6-month intervals for AAA 5.0-5.4 cm. The SVS practice guidelines recommend 3-year intervals for AAA 3.0-3.4 cm, 1-year interval for AAA 3.5-4.4 cm, and 6-month intervals for AAA 4.5-5.4 cm. The authors also acknowledge that their findings have questionable applicability to women with small AAA.
Of course, vascular surgeons treat individuals who may or may not behave like the average patient from this group of 15,000. Patients with small AAA have varying levels of anxiety and co-morbidities that must be accounted for when making decisions when to re-image the known small AAA. This account of the report does not mention whether there were subgroups of patients whose AAA grew more rapidly and might merit more frequent surveillance. Active smokers and those with COPD are often seen as having more rapid rates of AAA growth.
The report offers vascular surgeons additional evidence to reassure their patients that commonly practiced surveillance intervals are not too long and that the likelihood that a given AAA will dramatically increase its chances of rupture over the recommended interval is low. This report should not be used by payers to trump the vascular surgeon’s clinical judgment.
Dr. Larry Kraiss is Professor and Chief of Vascular Surgery, University of Utah, Salt Lake City, and is an associate medical editor for Vascular Specialist.
This meta-analysis derived from a literature sample of more than 15,000 patients largely confirms the empirically determined recommendations in the SVS practice guidelines for care of patients with AAA published in 2009.
| Dr. Larry Kraiss |
One strategy outlined by Dr. Thompson et al. in the meta-analysis proposes surveillance at 2-year intervals for AAA 3.0-3.9 cm, 1-year intervals for AAA 4.0-4.9 cm, and 6-month intervals for AAA 5.0-5.4 cm. The SVS practice guidelines recommend 3-year intervals for AAA 3.0-3.4 cm, 1-year interval for AAA 3.5-4.4 cm, and 6-month intervals for AAA 4.5-5.4 cm. The authors also acknowledge that their findings have questionable applicability to women with small AAA.
Of course, vascular surgeons treat individuals who may or may not behave like the average patient from this group of 15,000. Patients with small AAA have varying levels of anxiety and co-morbidities that must be accounted for when making decisions when to re-image the known small AAA. This account of the report does not mention whether there were subgroups of patients whose AAA grew more rapidly and might merit more frequent surveillance. Active smokers and those with COPD are often seen as having more rapid rates of AAA growth.
The report offers vascular surgeons additional evidence to reassure their patients that commonly practiced surveillance intervals are not too long and that the likelihood that a given AAA will dramatically increase its chances of rupture over the recommended interval is low. This report should not be used by payers to trump the vascular surgeon’s clinical judgment.
Dr. Larry Kraiss is Professor and Chief of Vascular Surgery, University of Utah, Salt Lake City, and is an associate medical editor for Vascular Specialist.
Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in JAMA.
"By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.
Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.
The researchers reviewed the literature for data sets with 100 or more patients who had repeated ultrasound measurements of their AAAs over time. This yielded 18 data sets with 15,471 subjects with AAA diameters between 3.0 and 5.4 cm.
The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women. Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm. Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.
Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.
"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7" (JAMA 2013;309:806-13).
However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.
The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. "The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," the researchers wrote.
A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have operative mortality and a poorer outcome at hospital discharge.
This study was supported by the U.K. National Institute for Health Research. The authors had no conflicts.
Information pooled in a meta-analysis of 18 data sets may allow clinicians to fine-tune the ultrasonographic surveillance of small abdominal aortic aneurysms, according to a report in JAMA.
"By pooling results from 18 studies, we quantified AAA growth rates and the AAA rupture risk as a function of aortic diameter. Our intent was to provide an objective basis for selecting surveillance intervals for patients with small AAAs," said Simon G. Thompson, D.Sc., of the cardiovascular epidemiology unit, department of public health and primary care, University of Cambridge (England), and his associates.
Their findings suggest that the overall number and frequency of surveillance scans can be reduced, at least for men. However, the picture is still unclear for women, and more research is required before specific recommendations can be made, the investigators said.
The researchers reviewed the literature for data sets with 100 or more patients who had repeated ultrasound measurements of their AAAs over time. This yielded 18 data sets with 15,471 subjects with AAA diameters between 3.0 and 5.4 cm.
The 13,728 men and 1,743 women were followed for an average of 1-8 years. There were "relatively few" AAA ruptures: 178 among men and 50 among women. Among men, a 3-cm AAA took a mean of 7.4 years to have a 10% chance of reaching 5.5 cm, a 4-cm AAA took a mean of 3.2 years to have a 10% chance of reaching 5.5 cm, and a 5-cm AAA took a mean of 0.7 years to have a 10% chance of reaching 5.5 cm. Similarly, rupture rates among men approximately doubled for every 0.5-cm increase in AAA diameter. For AAAs with diameters of 3.0-4.5 cm, the average time to reach a rupture risk of 1% was at least 2 years.
Based on the lower 95% confidence limits, the risk of rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.
"For a U.S. patient with a 3.0-cm AAA detected by screening, this would reduce the average number of surveillance scans from approximately 15 to 7" (JAMA 2013;309:806-13).
However, if the lower 95% prediction limits of the estimates were applied (to acknowledge that the population in each study might have different growth and rupture rates), the risk of rupture in men would be less than 1% if surveillance intervals were extended to 2 years for AAAs measuring 3.0-3.9 cm, to 1 year for those measuring 4.0-4.9 cm, and to 6 months for those measuring 5.0-5.4 cm. This would result in a lesser average reduction in the number of surveillance scans from 15 to 10.
The rate of rupture was four times higher for women than for men, even though the rate of AAA growth was similar. "The clinical implication is that a lower AAA diameter threshold for surgery should be adopted for women, a recommendation already made by the joint council of the American Association for Vascular Surgery and the Society for Vascular Surgery," the researchers wrote.
A threshold of 4.5 cm rather than 5.5 cm might be more appropriate for women, but this decision must be weighed against the evidence that women have operative mortality and a poorer outcome at hospital discharge.
This study was supported by the U.K. National Institute for Health Research. The authors had no conflicts.
Major Finding: The risk of AAA rupture in men would be less than 1% if surveillance intervals were extended to 3 years for AAAs measuring 3.0-3.9 cm, to 2 years for those measuring 4.0-4.4 cm, and to 1 year for those measuring 4.5-5.4 cm.
Data Source: A meta-analysis of 18 studies each involving at least 100 patients who had AAAs of 3.0-5.4 cm in diameter and who had serial ultrasound measurements of the lesions for an average of 1-8 years.
Disclosures: This study was supported by the U.K. National Institute for Health Research’s Health Technology Assessment Programme. The authors reported that they had no relevant financial conflicts, although individual members had participated in aneurysm clinical trials.
Post-EVAR Survival For Women on Par With Men
MILWAUKEE – Although female sex 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). 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 annual meeting. of the Midwestern Vascular Society.
He highlighted a 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 sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;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 of 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).
High-risk patients, defined by an SVS comorbidity score greater than 10, 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. He 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.
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 reported no conflicts.
I was impressed with Dr. Gloviczki’s report of the Mayo Clinic experience with 1002 consecutive EVAR procedures. Covering nearly 15 years of consecutive patient accrual in their AAA Registry, it spans virtually the entire EVAR era from the early learning curve phase through adjustments in devices, indications and practice up to 2011. Notable were exemplary 1% and 12.5% 30-day mortality rates for elective and ruptured AAA, respectively. Patients with SVS comorbidity scores <10 had an incredibly low operative mortality rate of 0.18% after elective EVAR compared to 2.33% for the higher-risk cohort.
| Dr. Donaldson |
A relatively low proportion (13%) of women were treated. In distinction to some series, the Mayo experience did not reveal a clear difference (P = 0.09) in early and late mortality rates for women and men after elective EVAR despite a significant increase in risk for complications and reinterventions among women. Even if larger cohorts of women add strength to the mortality findings, the message is clear that women are special. As Dr. Gloviczki mentioned, the overall complication rate of 24% among the 131 women likely relates in part to access problems via small and diseased iliac arteries, consistent with the experience of many of us. Other anatomic features more common in women such as increased tortuosity of the aortic neck related to vertebral compression and collapse may deserve research. The Mayo report should serve to reinforce an element of caution with regard to selection and management of women who appear to be candidates for EVAR.
Dr. Magruder C. Donaldson is Chairman of Surgery at Metrowest Medical Center in Framingham, Mass., and an associate medical editor for Vascular Specialist.
I was impressed with Dr. Gloviczki’s report of the Mayo Clinic experience with 1002 consecutive EVAR procedures. Covering nearly 15 years of consecutive patient accrual in their AAA Registry, it spans virtually the entire EVAR era from the early learning curve phase through adjustments in devices, indications and practice up to 2011. Notable were exemplary 1% and 12.5% 30-day mortality rates for elective and ruptured AAA, respectively. Patients with SVS comorbidity scores <10 had an incredibly low operative mortality rate of 0.18% after elective EVAR compared to 2.33% for the higher-risk cohort.
| Dr. Donaldson |
A relatively low proportion (13%) of women were treated. In distinction to some series, the Mayo experience did not reveal a clear difference (P = 0.09) in early and late mortality rates for women and men after elective EVAR despite a significant increase in risk for complications and reinterventions among women. Even if larger cohorts of women add strength to the mortality findings, the message is clear that women are special. As Dr. Gloviczki mentioned, the overall complication rate of 24% among the 131 women likely relates in part to access problems via small and diseased iliac arteries, consistent with the experience of many of us. Other anatomic features more common in women such as increased tortuosity of the aortic neck related to vertebral compression and collapse may deserve research. The Mayo report should serve to reinforce an element of caution with regard to selection and management of women who appear to be candidates for EVAR.
Dr. Magruder C. Donaldson is Chairman of Surgery at Metrowest Medical Center in Framingham, Mass., and an associate medical editor for Vascular Specialist.
I was impressed with Dr. Gloviczki’s report of the Mayo Clinic experience with 1002 consecutive EVAR procedures. Covering nearly 15 years of consecutive patient accrual in their AAA Registry, it spans virtually the entire EVAR era from the early learning curve phase through adjustments in devices, indications and practice up to 2011. Notable were exemplary 1% and 12.5% 30-day mortality rates for elective and ruptured AAA, respectively. Patients with SVS comorbidity scores <10 had an incredibly low operative mortality rate of 0.18% after elective EVAR compared to 2.33% for the higher-risk cohort.
| Dr. Donaldson |
A relatively low proportion (13%) of women were treated. In distinction to some series, the Mayo experience did not reveal a clear difference (P = 0.09) in early and late mortality rates for women and men after elective EVAR despite a significant increase in risk for complications and reinterventions among women. Even if larger cohorts of women add strength to the mortality findings, the message is clear that women are special. As Dr. Gloviczki mentioned, the overall complication rate of 24% among the 131 women likely relates in part to access problems via small and diseased iliac arteries, consistent with the experience of many of us. Other anatomic features more common in women such as increased tortuosity of the aortic neck related to vertebral compression and collapse may deserve research. The Mayo report should serve to reinforce an element of caution with regard to selection and management of women who appear to be candidates for EVAR.
Dr. Magruder C. Donaldson is Chairman of Surgery at Metrowest Medical Center in Framingham, Mass., and an associate medical editor for Vascular Specialist.
MILWAUKEE – Although female sex 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). 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 annual meeting. of the Midwestern Vascular Society.
He highlighted a 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 sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;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 of 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).
High-risk patients, defined by an SVS comorbidity score greater than 10, 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. He 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.
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 reported no conflicts.
MILWAUKEE – Although female sex 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). 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 annual meeting. of the Midwestern Vascular Society.
He highlighted a 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 sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;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 of 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).
High-risk patients, defined by an SVS comorbidity score greater than 10, 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. He 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.
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 reported no conflicts.
Major Finding: Death rates were similar between women and men at 30 days (2.5% vs. 1.5%) as were rates for combined early or late death (hazard ratio 1.1 vs. 1.0).
Data Source: The study is a database review of 1,002 consecutive patients in the Mayo Clinic AAA Registry.
Disclosures: Dr. Gloviczki and his coauthors reported no relevant conflicts of interest.
General Residents See Fewer Aortic Surgeries
MILWAUKEE – General surgery residents in a community-based residency program experienced a significant 49% decline in open aortic surgeries over the last decade, an analysis showed.
In 2000-2001, residents were exposed to 20-25 open aortic cases per year, but now get in on 8-15 cases per year, said Dr. Adam Rothermel, a third-year general surgery resident at Mount Carmel Hospital in Columbus, Ohio, where the analysis was conducted.
"Open aortic cases are difficult to find, and our residents, as a whole, would agree that we're not coming out with good enough experience with these cases," he said at the annual meeting of the Midwestern Vascular Surgical Society.
The results reflect the exponential shift from open vascular surgery to endovascular procedures over the last decade, as well as the more recent implementation of the 80-hour resident work week.
The total number of carotid endarterectomy, infrainguinal bypass, and open aortic cases for the entire hospital decreased by 55%, 30%, and 71%, respectively, over the study period of 2000 to 2011.
Total resident cases over the same period were unchanged for carotid endarterectomy (77 vs. 84 cases), trended downward for infrainguinal bypass (62 vs. 52 cases), and were significantly lower for open aortic cases (43 vs. 8 cases) according to a review of resident case logs, Dr. Rothermel said.
He pointed out that a significant portion of vascular surgery in the United States is still performed by general surgeons, citing surveys showing that general surgeons performed 59% of the vascular procedures in the United States in 1985 (J. Vasc. Surg. 1987;6:611-21) and 49% in 1992 (J. Vasc. Surg. 1996:23:172-81).
Session moderator Dr. Jean E. Starr, medical director of endovascular services at Ohio State University Medical Center in Columbus, said the current results parallel what's found nationally. She went on to ask what the findings imply for general surgery residents when they've finished training, and how this will reflect on patient practice in light of general surgeons performing half of vascular surgeries in the United States.
"When you get out of your general surgery training from a community based program and are expected then, going into say a rural center, to perform these operations, you have to give pause," Dr. Rothermel replied.
"I don't think I have a good way to fix the problem at this point, but I think we need to be aware of the trend."
Audience member Dr. Joseph Giglia, principal investigator for the laparoscopic aortic surgery program at the University of Cincinnati Medical Center, countered by asking whether the findings really matter given that open aortic cases are decreasing significantly across the country.
He pointed out that the latest survey data were 20 years old, and submitted that general surgeons no longer perform 50% of vascular surgeries in the United States.
"I think these cases are important for our primary vascular residents to participate in," Dr. Giglia said.
"I think there has to be a sea change, a real shift in the paradigm about who's doing these cases and what we're going to do in the future."
Dr. Rothermel agreed that another survey should be conducted to better reflect current practice trends.
If vascular surgeons are to pick up the bulk of the caseload, however, efforts to recruit medical students to the specialty may need to be enhanced.
A recent survey of 338 medical students showed that 236 first- and second-year students had no clinical exposure to vascular surgery, while only 38 of the 102 third-year students had been exposed to vascular surgery after completing a general surgery rotation (Ann. Vasc. Surg. 2012 July 25 [doi:10.1016/j.avsg.2012.02.012]).
Nearly half (49%) of first- and second-year students said that they would consider vascular surgery, however, with another 19% willing to do so if the length of training were reduced, according to the survey.
Dr. Rothermel and Dr. Starr reported no conflicts of interest.
While it is true that general surgeons continue to perform a significant number of vascular operations, these procedures are largely limited to dialysis access and trauma. Based on surgical operative logs of surgeons seeking recertification by the American Board of Surgery, it appears that complex vascular procedures, including open abdominal aneurysms, are increasingly the domain of certified vascular surgeons. With available evidence supporting the relationship between surgical volume and outcome, this is a trend that is likely here to stay. The SCORE curriculum acknowledges this reality by not recommending substantial open vascular operative experience for general surgery residents other than dialysis access, amputations, and vascular trauma.
| Dr. John F. Eidt |
A more significant issue is the fact that vascular surgery residents are also reporting decreased experience with open abdominal surgery.
To some extent, the downward trend in open infrarenal AAA has been mitigated by an increase in a variety of complex debranching and hybrid procedures. Nonetheless, there is concern that current vascular residents may have insufficient operative experience with selected open complex procedures. One response has been growing interest in the development of robust surgical simulation.
While computer-based patient-specific simulation is on the horizon, it is extremely expensive, not universally available and still suffers from limitations in realism.
It is important to recognize that surgical simulation spans a broad spectrum including fundamental skills, cognitive task analysis, partial task trainers, open and endovascular models, crisis management and team training, in addition to high-end endovascular simulation.
The APDVS is actively developing and validating a series of fundamental endovascular skills modeled on the highly successful Fundamentals of Laparoscopic Surgery (FLS). One of the key features of FLS is that trainees must participate in deliberate practice in order to achieve established performance criteria.
Endovascular simulation has suffered from a lack of standardized metrics of performance and has sometimes been considered nothing more than advanced video games with little relationship to actual surgery.
In order to maximize the value of every open operative experience, it is expected that trainees will be required to achieve specified metrics of endovascular proficiency before progressing to more advanced activities including operations.
The 0+5 programs have proven remarkably popular with medical students as there are more than three applicants for each position. Still, despite the popularity, the total applicant pool represents less than 0.5% of the more than 18,000 graduating U.S. medical students.
Clearly, we must continue to provide pathways to vascular experience for medical students including suture labs, surgical simulation, research opportunities, and elective rotations. Finally, there is growing evidence that we are not training enough vascular surgeons to meet the needs of the aging population.
The addition of 40 new 0+5 residency positions over the past few years has resulted in a transient increase in the total number of first- year positions to approximately 160. But the cap on graduate medical education funding may require some programs to discontinue their 5+2 slots. Unless additional funding is forthcoming, the growth of vascular surgery as a specialty may be severely restricted. Clearly, these challenges represent opportunities for novel and creative solutions.
Dr. John F. Eidt is at the University of South Carolina School of Medicine Greenville, and is an associate medical editor for Vascular Specialist.
While it is true that general surgeons continue to perform a significant number of vascular operations, these procedures are largely limited to dialysis access and trauma. Based on surgical operative logs of surgeons seeking recertification by the American Board of Surgery, it appears that complex vascular procedures, including open abdominal aneurysms, are increasingly the domain of certified vascular surgeons. With available evidence supporting the relationship between surgical volume and outcome, this is a trend that is likely here to stay. The SCORE curriculum acknowledges this reality by not recommending substantial open vascular operative experience for general surgery residents other than dialysis access, amputations, and vascular trauma.
| Dr. John F. Eidt |
A more significant issue is the fact that vascular surgery residents are also reporting decreased experience with open abdominal surgery.
To some extent, the downward trend in open infrarenal AAA has been mitigated by an increase in a variety of complex debranching and hybrid procedures. Nonetheless, there is concern that current vascular residents may have insufficient operative experience with selected open complex procedures. One response has been growing interest in the development of robust surgical simulation.
While computer-based patient-specific simulation is on the horizon, it is extremely expensive, not universally available and still suffers from limitations in realism.
It is important to recognize that surgical simulation spans a broad spectrum including fundamental skills, cognitive task analysis, partial task trainers, open and endovascular models, crisis management and team training, in addition to high-end endovascular simulation.
The APDVS is actively developing and validating a series of fundamental endovascular skills modeled on the highly successful Fundamentals of Laparoscopic Surgery (FLS). One of the key features of FLS is that trainees must participate in deliberate practice in order to achieve established performance criteria.
Endovascular simulation has suffered from a lack of standardized metrics of performance and has sometimes been considered nothing more than advanced video games with little relationship to actual surgery.
In order to maximize the value of every open operative experience, it is expected that trainees will be required to achieve specified metrics of endovascular proficiency before progressing to more advanced activities including operations.
The 0+5 programs have proven remarkably popular with medical students as there are more than three applicants for each position. Still, despite the popularity, the total applicant pool represents less than 0.5% of the more than 18,000 graduating U.S. medical students.
Clearly, we must continue to provide pathways to vascular experience for medical students including suture labs, surgical simulation, research opportunities, and elective rotations. Finally, there is growing evidence that we are not training enough vascular surgeons to meet the needs of the aging population.
The addition of 40 new 0+5 residency positions over the past few years has resulted in a transient increase in the total number of first- year positions to approximately 160. But the cap on graduate medical education funding may require some programs to discontinue their 5+2 slots. Unless additional funding is forthcoming, the growth of vascular surgery as a specialty may be severely restricted. Clearly, these challenges represent opportunities for novel and creative solutions.
Dr. John F. Eidt is at the University of South Carolina School of Medicine Greenville, and is an associate medical editor for Vascular Specialist.
While it is true that general surgeons continue to perform a significant number of vascular operations, these procedures are largely limited to dialysis access and trauma. Based on surgical operative logs of surgeons seeking recertification by the American Board of Surgery, it appears that complex vascular procedures, including open abdominal aneurysms, are increasingly the domain of certified vascular surgeons. With available evidence supporting the relationship between surgical volume and outcome, this is a trend that is likely here to stay. The SCORE curriculum acknowledges this reality by not recommending substantial open vascular operative experience for general surgery residents other than dialysis access, amputations, and vascular trauma.
| Dr. John F. Eidt |
A more significant issue is the fact that vascular surgery residents are also reporting decreased experience with open abdominal surgery.
To some extent, the downward trend in open infrarenal AAA has been mitigated by an increase in a variety of complex debranching and hybrid procedures. Nonetheless, there is concern that current vascular residents may have insufficient operative experience with selected open complex procedures. One response has been growing interest in the development of robust surgical simulation.
While computer-based patient-specific simulation is on the horizon, it is extremely expensive, not universally available and still suffers from limitations in realism.
It is important to recognize that surgical simulation spans a broad spectrum including fundamental skills, cognitive task analysis, partial task trainers, open and endovascular models, crisis management and team training, in addition to high-end endovascular simulation.
The APDVS is actively developing and validating a series of fundamental endovascular skills modeled on the highly successful Fundamentals of Laparoscopic Surgery (FLS). One of the key features of FLS is that trainees must participate in deliberate practice in order to achieve established performance criteria.
Endovascular simulation has suffered from a lack of standardized metrics of performance and has sometimes been considered nothing more than advanced video games with little relationship to actual surgery.
In order to maximize the value of every open operative experience, it is expected that trainees will be required to achieve specified metrics of endovascular proficiency before progressing to more advanced activities including operations.
The 0+5 programs have proven remarkably popular with medical students as there are more than three applicants for each position. Still, despite the popularity, the total applicant pool represents less than 0.5% of the more than 18,000 graduating U.S. medical students.
Clearly, we must continue to provide pathways to vascular experience for medical students including suture labs, surgical simulation, research opportunities, and elective rotations. Finally, there is growing evidence that we are not training enough vascular surgeons to meet the needs of the aging population.
The addition of 40 new 0+5 residency positions over the past few years has resulted in a transient increase in the total number of first- year positions to approximately 160. But the cap on graduate medical education funding may require some programs to discontinue their 5+2 slots. Unless additional funding is forthcoming, the growth of vascular surgery as a specialty may be severely restricted. Clearly, these challenges represent opportunities for novel and creative solutions.
Dr. John F. Eidt is at the University of South Carolina School of Medicine Greenville, and is an associate medical editor for Vascular Specialist.
MILWAUKEE – General surgery residents in a community-based residency program experienced a significant 49% decline in open aortic surgeries over the last decade, an analysis showed.
In 2000-2001, residents were exposed to 20-25 open aortic cases per year, but now get in on 8-15 cases per year, said Dr. Adam Rothermel, a third-year general surgery resident at Mount Carmel Hospital in Columbus, Ohio, where the analysis was conducted.
"Open aortic cases are difficult to find, and our residents, as a whole, would agree that we're not coming out with good enough experience with these cases," he said at the annual meeting of the Midwestern Vascular Surgical Society.
The results reflect the exponential shift from open vascular surgery to endovascular procedures over the last decade, as well as the more recent implementation of the 80-hour resident work week.
The total number of carotid endarterectomy, infrainguinal bypass, and open aortic cases for the entire hospital decreased by 55%, 30%, and 71%, respectively, over the study period of 2000 to 2011.
Total resident cases over the same period were unchanged for carotid endarterectomy (77 vs. 84 cases), trended downward for infrainguinal bypass (62 vs. 52 cases), and were significantly lower for open aortic cases (43 vs. 8 cases) according to a review of resident case logs, Dr. Rothermel said.
He pointed out that a significant portion of vascular surgery in the United States is still performed by general surgeons, citing surveys showing that general surgeons performed 59% of the vascular procedures in the United States in 1985 (J. Vasc. Surg. 1987;6:611-21) and 49% in 1992 (J. Vasc. Surg. 1996:23:172-81).
Session moderator Dr. Jean E. Starr, medical director of endovascular services at Ohio State University Medical Center in Columbus, said the current results parallel what's found nationally. She went on to ask what the findings imply for general surgery residents when they've finished training, and how this will reflect on patient practice in light of general surgeons performing half of vascular surgeries in the United States.
"When you get out of your general surgery training from a community based program and are expected then, going into say a rural center, to perform these operations, you have to give pause," Dr. Rothermel replied.
"I don't think I have a good way to fix the problem at this point, but I think we need to be aware of the trend."
Audience member Dr. Joseph Giglia, principal investigator for the laparoscopic aortic surgery program at the University of Cincinnati Medical Center, countered by asking whether the findings really matter given that open aortic cases are decreasing significantly across the country.
He pointed out that the latest survey data were 20 years old, and submitted that general surgeons no longer perform 50% of vascular surgeries in the United States.
"I think these cases are important for our primary vascular residents to participate in," Dr. Giglia said.
"I think there has to be a sea change, a real shift in the paradigm about who's doing these cases and what we're going to do in the future."
Dr. Rothermel agreed that another survey should be conducted to better reflect current practice trends.
If vascular surgeons are to pick up the bulk of the caseload, however, efforts to recruit medical students to the specialty may need to be enhanced.
A recent survey of 338 medical students showed that 236 first- and second-year students had no clinical exposure to vascular surgery, while only 38 of the 102 third-year students had been exposed to vascular surgery after completing a general surgery rotation (Ann. Vasc. Surg. 2012 July 25 [doi:10.1016/j.avsg.2012.02.012]).
Nearly half (49%) of first- and second-year students said that they would consider vascular surgery, however, with another 19% willing to do so if the length of training were reduced, according to the survey.
Dr. Rothermel and Dr. Starr reported no conflicts of interest.
MILWAUKEE – General surgery residents in a community-based residency program experienced a significant 49% decline in open aortic surgeries over the last decade, an analysis showed.
In 2000-2001, residents were exposed to 20-25 open aortic cases per year, but now get in on 8-15 cases per year, said Dr. Adam Rothermel, a third-year general surgery resident at Mount Carmel Hospital in Columbus, Ohio, where the analysis was conducted.
"Open aortic cases are difficult to find, and our residents, as a whole, would agree that we're not coming out with good enough experience with these cases," he said at the annual meeting of the Midwestern Vascular Surgical Society.
The results reflect the exponential shift from open vascular surgery to endovascular procedures over the last decade, as well as the more recent implementation of the 80-hour resident work week.
The total number of carotid endarterectomy, infrainguinal bypass, and open aortic cases for the entire hospital decreased by 55%, 30%, and 71%, respectively, over the study period of 2000 to 2011.
Total resident cases over the same period were unchanged for carotid endarterectomy (77 vs. 84 cases), trended downward for infrainguinal bypass (62 vs. 52 cases), and were significantly lower for open aortic cases (43 vs. 8 cases) according to a review of resident case logs, Dr. Rothermel said.
He pointed out that a significant portion of vascular surgery in the United States is still performed by general surgeons, citing surveys showing that general surgeons performed 59% of the vascular procedures in the United States in 1985 (J. Vasc. Surg. 1987;6:611-21) and 49% in 1992 (J. Vasc. Surg. 1996:23:172-81).
Session moderator Dr. Jean E. Starr, medical director of endovascular services at Ohio State University Medical Center in Columbus, said the current results parallel what's found nationally. She went on to ask what the findings imply for general surgery residents when they've finished training, and how this will reflect on patient practice in light of general surgeons performing half of vascular surgeries in the United States.
"When you get out of your general surgery training from a community based program and are expected then, going into say a rural center, to perform these operations, you have to give pause," Dr. Rothermel replied.
"I don't think I have a good way to fix the problem at this point, but I think we need to be aware of the trend."
Audience member Dr. Joseph Giglia, principal investigator for the laparoscopic aortic surgery program at the University of Cincinnati Medical Center, countered by asking whether the findings really matter given that open aortic cases are decreasing significantly across the country.
He pointed out that the latest survey data were 20 years old, and submitted that general surgeons no longer perform 50% of vascular surgeries in the United States.
"I think these cases are important for our primary vascular residents to participate in," Dr. Giglia said.
"I think there has to be a sea change, a real shift in the paradigm about who's doing these cases and what we're going to do in the future."
Dr. Rothermel agreed that another survey should be conducted to better reflect current practice trends.
If vascular surgeons are to pick up the bulk of the caseload, however, efforts to recruit medical students to the specialty may need to be enhanced.
A recent survey of 338 medical students showed that 236 first- and second-year students had no clinical exposure to vascular surgery, while only 38 of the 102 third-year students had been exposed to vascular surgery after completing a general surgery rotation (Ann. Vasc. Surg. 2012 July 25 [doi:10.1016/j.avsg.2012.02.012]).
Nearly half (49%) of first- and second-year students said that they would consider vascular surgery, however, with another 19% willing to do so if the length of training were reduced, according to the survey.
Dr. Rothermel and Dr. Starr reported no conflicts of interest.
Major Finding: General surgery residents in a community-based program experienced a significant 49% decline in open aortic surgeries from 2000 to 2011.
Data Source: Review of all carotid endarterectomy, femoro-popliteal bypass, and open aortic surgeries performed at a community hospital and by residents from 2000 to 2011.
Disclosures: Dr. Rothermel and Dr. Starr reported no conflicts of interest.
Stents Fixed Dialysis Graft/Fistula Pseudoaneurysms
LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.
"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.
Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.
A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.
"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.
Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.
However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.
Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.
"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.
A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.
One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).
The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.
Ms. Kinning and Dr. Kinning said they had no relevant disclosures.
We have also been using this technique to salvage these grafts and fistulae. It is especially useful as a stop-gap measure. We have our own outpatient in-office suite and so we can treat a patient who comes to the office exsanguinating, place the graft, control the hemorrhage and then electively work the patient up for further treatment as necessary.
Dr. Russell H. Samson is Clinical Associate Professor of Surgery (Vascular) Florida State University Medical School, and Attending Vascular Surgeon, Sarasota Vascular Specialists. He is also an associate medical editor for Vascular Specialist.
We have also been using this technique to salvage these grafts and fistulae. It is especially useful as a stop-gap measure. We have our own outpatient in-office suite and so we can treat a patient who comes to the office exsanguinating, place the graft, control the hemorrhage and then electively work the patient up for further treatment as necessary.
Dr. Russell H. Samson is Clinical Associate Professor of Surgery (Vascular) Florida State University Medical School, and Attending Vascular Surgeon, Sarasota Vascular Specialists. He is also an associate medical editor for Vascular Specialist.
We have also been using this technique to salvage these grafts and fistulae. It is especially useful as a stop-gap measure. We have our own outpatient in-office suite and so we can treat a patient who comes to the office exsanguinating, place the graft, control the hemorrhage and then electively work the patient up for further treatment as necessary.
Dr. Russell H. Samson is Clinical Associate Professor of Surgery (Vascular) Florida State University Medical School, and Attending Vascular Surgeon, Sarasota Vascular Specialists. He is also an associate medical editor for Vascular Specialist.
LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.
"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.
Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.
A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.
"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.
Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.
However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.
Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.
"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.
A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.
One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).
The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.
Ms. Kinning and Dr. Kinning said they had no relevant disclosures.
LAS VEGAS -- Percutaneous covered stents safely and effectively bypass and seal off pseudoaneurysms in arteriovenous grafts and fistulas, preventing rupture, prolonging hemodialysis access, and eliminating the need for open surgical repair, a prospective study of 24 patients has found.
"Endograft exclusion of PSAs [pseudoaneurysms] is a practical approach to solving a not uncommonly encountered clinical problem in this complex patient population. Patients avoid complications related to [surgery], and are able to maintain an uninterrupted dialysis pattern" without the use of a central venous catheter, lead investigator Alison Kinning said at the annual meeting of the Society for Clinical Vascular Surgery.
Twenty of the patients had arteriovenous grafts, four had arteriovenous fistulas, and all had at least one pseudoaneurysm. The patients were stented with Fluency e-polytetrafluoroethylene–covered nitinol stents using a bareback technique.
A 6-French sheath was placed after removal of the stent delivery catheter, and angioplasty was used in order to pleat out and fix the stent in place, with angioplasty for outflow stenosis also done as needed. Blood was drawn out of the aneurysm after the stent was in place in order to relieve skin tension.
"We allowed immediate [dialysis] cannulation, including the stented segment, following endograft placement. We did mark the center of the stent so as to avoid cannulation [of its ends]," noted Ms. Kinning, a third-year medical student at the American University of the Caribbean in St. Maarten.
Primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up. The mean duration of patency was 17.6 months, and the longest duration of patency was 6 years, 4 months.
However, after 2 months one patient asked to have the stent removed because of pain, and two patients were restented after their initial stents fractured.
Five stented grafts had to be removed after a mean of 2.4 months because of infection. The cause of the infections is uncertain, but these probably occurred because of repeated cannulations, diabetes, poor personal hygiene, or other factors.
"Sometimes, the infection may have already started [before stenting], but you’ve at least prevented the [graft] from rupturing. Sometimes the stent will help you control an emergent or threatening situation and give you time to plan a repair or bypass if needed," said coauthor Dr. Wayne Kinning, a vascular surgeon in Flint, Mich., and Ms. Kinning’s father.
A handful of other studies have supported the use of stents in order to treat pseudoaneurysms.
One such study found that infections were associated with skin erosion over the aneurysm. In this retrospective review of medical records by Dr. Aamir Shah, patients with a PSA underwent endovascular repair using a stent graft. The indications for repair included PSA with symptoms, PSA with skin erosion, PSA with failed hemodialysis, and PSA after balloon angioplasty of a stenosis. (J. Vasc. Surg. 2012 [doi:10.1016/j.jjvs.2011.10.126]).
The procedure "probably will become increasingly recommended. I think that’s the shift that’s happening," said Dr. Kinning.
Ms. Kinning and Dr. Kinning said they had no relevant disclosures.
Major Finding: Following stenting of hemodialysis graft pseudoaneurysms, primary assisted patency was 100% in the 20 patients who completed a 2-month follow-up and in the 13 who completed a 6-month follow-up.
Data Source: A prospective series of 24 patients was studied.
Disclosures: Ms. Kinning and Dr. Kinning said they had no relevant financial disclosures.