In November, Dr. George Andros was honored with the MedStar Georgetown 2013 Distinguished Achievement Award in Diabetic Limb Salvage at this year’s Diabetic Limb Salvage Conference in Washington, D.C. Dr. Andros is pictured with his award between DLS Conference co-chairs Dr. Christopher E. Attinger (left) and Dr. John S. Steinberg (right).

Courtesy Georgetown Diabetic Limb Salvage Conference

Dr. Andros is a founding partner of Los Angeles Vascular Specialists and is founder and medical director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, Calif.

For the last 14 years, Dr. Andros has been co-chair of the Diabetic Foot Global Conference (DFCon), held in Los Angeles. He is also the emeritus medical editor of Vascular Specialist .

In November, Dr. George Andros was honored with the MedStar Georgetown 2013 Distinguished Achievement Award in Diabetic Limb Salvage at this year’s Diabetic Limb Salvage Conference in Washington, D.C. Dr. Andros is pictured with his award between DLS Conference co-chairs Dr. Christopher E. Attinger (left) and Dr. John S. Steinberg (right).

Courtesy Georgetown Diabetic Limb Salvage Conference

Dr. Andros is a founding partner of Los Angeles Vascular Specialists and is founder and medical director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, Calif.

For the last 14 years, Dr. Andros has been co-chair of the Diabetic Foot Global Conference (DFCon), held in Los Angeles. He is also the emeritus medical editor of Vascular Specialist .

In November, Dr. George Andros was honored with the MedStar Georgetown 2013 Distinguished Achievement Award in Diabetic Limb Salvage at this year’s Diabetic Limb Salvage Conference in Washington, D.C. Dr. Andros is pictured with his award between DLS Conference co-chairs Dr. Christopher E. Attinger (left) and Dr. John S. Steinberg (right).

Courtesy Georgetown Diabetic Limb Salvage Conference

Dr. Andros is a founding partner of Los Angeles Vascular Specialists and is founder and medical director of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, Calif.

For the last 14 years, Dr. Andros has been co-chair of the Diabetic Foot Global Conference (DFCon), held in Los Angeles. He is also the emeritus medical editor of Vascular Specialist .

Clinical question

Does the combination of prednisolone and pentoxifylline improve survival in patients with severe alcoholic hepatitis?

Bottom line

Although pentoxifylline and prednisolone have both been demonstrated to be effective individual treatments for alcoholic hepatitis, the combination of both did not improve survival more than prednisolone alone. (LOE = 1b)

Reference

Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: A randomized clinical trial. JAMA 2013;310(10):1033-1041.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Current guidelines recommend the use of either prednisolone or pentoxifylline for the treatment of severe alcoholic hepatitis. The benefit of the combination of these 2 medications in this setting is unclear. These investigators enrolled patients who were current heavy alcohol users and who had biopsy-proven alcoholic hepatitis with a Maddrey score of 32 or more. Patients were randomized, using concealed allocation, to receive prednisolone 40 mg daily plus pentoxifylline 400 mg 3 times daily (n = 133) or prednisolone 40 mg daily plus placebo (n = 137). Treatment lasted for 28 days and follow-up was 100% at 6 months. The patients had a mean age of 51 years and an average Maddrey score in the 50s (indicating severe disease). No significant difference was detected in 6-month survival between the 2 groups in either the intention-to-treat or per-protocol analyses. Overall, there were 82 deaths in the cohort at 6 months -- 40 in the pentoxifylline-prednisolone group and 42 in the placebo-prednisolone group. The risk of hepatorenal syndrome was decreased at 1 month in the combination therapy group as compared with the placebo group (3.1% vs 11.7%; P = .007), but this difference did not remain significant at 6 months. It is important to note, however, that this study was not powered to detect a difference in the incidence of hepatorenal syndrome.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does the combination of prednisolone and pentoxifylline improve survival in patients with severe alcoholic hepatitis?

Bottom line

Although pentoxifylline and prednisolone have both been demonstrated to be effective individual treatments for alcoholic hepatitis, the combination of both did not improve survival more than prednisolone alone. (LOE = 1b)

Reference

Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: A randomized clinical trial. JAMA 2013;310(10):1033-1041.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Current guidelines recommend the use of either prednisolone or pentoxifylline for the treatment of severe alcoholic hepatitis. The benefit of the combination of these 2 medications in this setting is unclear. These investigators enrolled patients who were current heavy alcohol users and who had biopsy-proven alcoholic hepatitis with a Maddrey score of 32 or more. Patients were randomized, using concealed allocation, to receive prednisolone 40 mg daily plus pentoxifylline 400 mg 3 times daily (n = 133) or prednisolone 40 mg daily plus placebo (n = 137). Treatment lasted for 28 days and follow-up was 100% at 6 months. The patients had a mean age of 51 years and an average Maddrey score in the 50s (indicating severe disease). No significant difference was detected in 6-month survival between the 2 groups in either the intention-to-treat or per-protocol analyses. Overall, there were 82 deaths in the cohort at 6 months -- 40 in the pentoxifylline-prednisolone group and 42 in the placebo-prednisolone group. The risk of hepatorenal syndrome was decreased at 1 month in the combination therapy group as compared with the placebo group (3.1% vs 11.7%; P = .007), but this difference did not remain significant at 6 months. It is important to note, however, that this study was not powered to detect a difference in the incidence of hepatorenal syndrome.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does the combination of prednisolone and pentoxifylline improve survival in patients with severe alcoholic hepatitis?

Bottom line

Although pentoxifylline and prednisolone have both been demonstrated to be effective individual treatments for alcoholic hepatitis, the combination of both did not improve survival more than prednisolone alone. (LOE = 1b)

Reference

Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: A randomized clinical trial. JAMA 2013;310(10):1033-1041.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Current guidelines recommend the use of either prednisolone or pentoxifylline for the treatment of severe alcoholic hepatitis. The benefit of the combination of these 2 medications in this setting is unclear. These investigators enrolled patients who were current heavy alcohol users and who had biopsy-proven alcoholic hepatitis with a Maddrey score of 32 or more. Patients were randomized, using concealed allocation, to receive prednisolone 40 mg daily plus pentoxifylline 400 mg 3 times daily (n = 133) or prednisolone 40 mg daily plus placebo (n = 137). Treatment lasted for 28 days and follow-up was 100% at 6 months. The patients had a mean age of 51 years and an average Maddrey score in the 50s (indicating severe disease). No significant difference was detected in 6-month survival between the 2 groups in either the intention-to-treat or per-protocol analyses. Overall, there were 82 deaths in the cohort at 6 months -- 40 in the pentoxifylline-prednisolone group and 42 in the placebo-prednisolone group. The risk of hepatorenal syndrome was decreased at 1 month in the combination therapy group as compared with the placebo group (3.1% vs 11.7%; P = .007), but this difference did not remain significant at 6 months. It is important to note, however, that this study was not powered to detect a difference in the incidence of hepatorenal syndrome.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does preventive percutaneous coronary intervention of noninfarct but stenosed arteries improve outcomes in patients with acute ST-segment elevation myocardial infarction?

Bottom line

Preventive percutaneous coronary intervention (PCI) of noninfarct, stenosed arteries duing treatment for acute ST-segment elevation myocardial infarction (STEMI) is effective in decreasing long-term cardiovascular events. You would need to treat 7 patients with preventive PCI to avoid one such event. (LOE = 1b)

Reference

Wald DS, Morris JK, Wald NJ, et al, for the PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med 2013;369(12):1115-1123.

Study design

Randomized controlled trial (single-blinded)

Funding source

Foundation

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

This study enrolled 465 patients with acute STEMI who received successful PCI to the infarct artery and were noted to have stenosis greater than 50% in other noninfarct coronary arteries during angiography. Patients with history of, or indications for, coronary artery bypass grafting and those in cardiogenic shock were excluded. Using concealed allocation, the investigators randomized patients to receive no further PCI or immediate preventive PCI to noninfarct arteries. The 2 groups had similar comorbidities and a mean age of 62 years. The use of drug-eluting stents and medical therapy after discharge were also similar between groups. The primary outcome was the composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. Mean follow-up was 2 years and analysis was by intention to treat. The trial was stopped early because of highly significant results favoring preventive PCI. Overall, there was a 9% event rate in the preventive PCI group as compared with 23% in the other group (hazard ratio = 0.35; 95% CI, 0.21-0.58; P < .001). The individual components of the primary outcome showed similar results, although the reduction in cardiac death was not statistically significant (P = .07). As expected, the procedure time and contrast volume used were higher in the preventive PCI group, but the complication rates, including contrast-induced nephropathy, did not differ between groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does preventive percutaneous coronary intervention of noninfarct but stenosed arteries improve outcomes in patients with acute ST-segment elevation myocardial infarction?

Bottom line

Preventive percutaneous coronary intervention (PCI) of noninfarct, stenosed arteries duing treatment for acute ST-segment elevation myocardial infarction (STEMI) is effective in decreasing long-term cardiovascular events. You would need to treat 7 patients with preventive PCI to avoid one such event. (LOE = 1b)

Reference

Wald DS, Morris JK, Wald NJ, et al, for the PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med 2013;369(12):1115-1123.

Study design

Randomized controlled trial (single-blinded)

Funding source

Foundation

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

This study enrolled 465 patients with acute STEMI who received successful PCI to the infarct artery and were noted to have stenosis greater than 50% in other noninfarct coronary arteries during angiography. Patients with history of, or indications for, coronary artery bypass grafting and those in cardiogenic shock were excluded. Using concealed allocation, the investigators randomized patients to receive no further PCI or immediate preventive PCI to noninfarct arteries. The 2 groups had similar comorbidities and a mean age of 62 years. The use of drug-eluting stents and medical therapy after discharge were also similar between groups. The primary outcome was the composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. Mean follow-up was 2 years and analysis was by intention to treat. The trial was stopped early because of highly significant results favoring preventive PCI. Overall, there was a 9% event rate in the preventive PCI group as compared with 23% in the other group (hazard ratio = 0.35; 95% CI, 0.21-0.58; P < .001). The individual components of the primary outcome showed similar results, although the reduction in cardiac death was not statistically significant (P = .07). As expected, the procedure time and contrast volume used were higher in the preventive PCI group, but the complication rates, including contrast-induced nephropathy, did not differ between groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does preventive percutaneous coronary intervention of noninfarct but stenosed arteries improve outcomes in patients with acute ST-segment elevation myocardial infarction?

Bottom line

Preventive percutaneous coronary intervention (PCI) of noninfarct, stenosed arteries duing treatment for acute ST-segment elevation myocardial infarction (STEMI) is effective in decreasing long-term cardiovascular events. You would need to treat 7 patients with preventive PCI to avoid one such event. (LOE = 1b)

Reference

Wald DS, Morris JK, Wald NJ, et al, for the PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med 2013;369(12):1115-1123.

Study design

Randomized controlled trial (single-blinded)

Funding source

Foundation

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

This study enrolled 465 patients with acute STEMI who received successful PCI to the infarct artery and were noted to have stenosis greater than 50% in other noninfarct coronary arteries during angiography. Patients with history of, or indications for, coronary artery bypass grafting and those in cardiogenic shock were excluded. Using concealed allocation, the investigators randomized patients to receive no further PCI or immediate preventive PCI to noninfarct arteries. The 2 groups had similar comorbidities and a mean age of 62 years. The use of drug-eluting stents and medical therapy after discharge were also similar between groups. The primary outcome was the composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. Mean follow-up was 2 years and analysis was by intention to treat. The trial was stopped early because of highly significant results favoring preventive PCI. Overall, there was a 9% event rate in the preventive PCI group as compared with 23% in the other group (hazard ratio = 0.35; 95% CI, 0.21-0.58; P < .001). The individual components of the primary outcome showed similar results, although the reduction in cardiac death was not statistically significant (P = .07). As expected, the procedure time and contrast volume used were higher in the preventive PCI group, but the complication rates, including contrast-induced nephropathy, did not differ between groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

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.

Patrice Wendling/IMNG Medical Media

"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.

[email protected]

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.

Patrice Wendling/IMNG Medical Media

"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.

[email protected]

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.

Patrice Wendling/IMNG Medical Media

"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.

[email protected]

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society.

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

Patrice Wendling/IMNG Medical Media

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

[email protected]

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society.

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

Patrice Wendling/IMNG Medical Media

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

[email protected]

CHICAGO – Patients undergoing carotid endarterectomy with cervical block anesthesia had fewer hemodynamic fluctuations and required less vasoactive medications than those under general anesthesia in a retrospective evaluation.

"Under cervical block anesthesia, carotid endarterectomy can be performed with a better hemodynamic profile," Dr. Marika Y. Gassner, a resident with Henry Ford Macomb Hospital, Clinton Township, Mich., said at the annual meeting of the Midwestern Vascular Surgical Society.

The practice switched in 2003 from using general anesthesia for the majority of carotid endarterectomy to performing more than 90% of cases under local cervical block anesthesia (CBA). Exceptions include patients who are extremely nervous, unable to communicate in English, or who have plaque extending above C2.

Patrice Wendling/IMNG Medical Media

The investigators organized the retrospective cohort study after initial observations suggested patients under CBA had less intraoperative hypotension or fluctuations in mean arterial pressure below 65 mm Hg. Vasoactive therapy demands were also lower. For example, anesthesia records showed that several doses of beta-blockers and ephedrine were required for a patient under general anesthesia, while a patient under CBA had only a single dose of midazolam (Versed) early in the procedure, she said.

Other advantages of CBA include continuous feedback on neurologic status/cerebral perfusion, endotracheal intubation not required, shorter operative times, and reduced use of shunts, Dr. Gassner said.

The analysis included 651 patients who underwent carotid endarterectomy by a single surgeon at two suburban teaching hospitals, with 397 under general anesthesia (GA) and 254 under CBA.

The CBA and GA groups were similar in age (71.26 vs. 70.97 years) and incidence of coronary artery disease (57% vs. 56%), hypertension (77% vs. 75%), and renal failure (3.5% vs. 4.0%). The GA group, however, had significantly more females (39% vs. 46.6%), and a higher incidence of chronic obstructive pulmonary disease (16% vs. 23%), nicotine abuse, (50% vs. 63%), and symptomatic patients (41.3% vs. 54%).

The incidence of intraoperative hypotension (systolic BP less than 100 mm HG) was 0.52% with CBA and 17.84% with GA (P less than .001), Dr. Gassner said.

Mean arterial pressure changes of 20% or more per patient occurred in 20% and 41%, respectively (P less than .001).

Vasopressors were required during surgery in 51.13% of the GA group and 36.22% of the CBA group (P = .0002), and antihypertensive medications in 64% and 73.6% (P = .0085). Drugs from both categories were required by significantly fewer CBA patients (22.5% vs. 33.75%; P = .045), she said.

There were no deaths in either group. Postoperative complications were higher in the GA than the CBA group including myocardial infarction (4 vs. 0 events), stroke (6 vs. 0 events), hematoma (7 vs. 2 events), and return to the OR (7 vs. 0 events). The difference did not reach statistical significance because of the sample size, Dr. Gassner said.

Earlier in the presentation, she observed that there was no difference in the primary composite endpoint of stroke, myocardial infarction, or death at 30 days in the randomized GALA (general anaesthesia vs. local anaesthesia for carotid surgery) trial conducted at 95 centers in 24 countries (Lancet 2008;372:2132-42).

"If they couldn’t find it [a survival advantage] in GALA with 3,500 patients, we couldn’t find it here," Dr. Gassner said, adding that a randomized trial powered to look at late mortality is needed.

The group has no current plans to conduct such a study or a cost analysis, although a subsequent analysis of the GALA data revealed a cost savings of about $283 favoring carotid endarterectomy using local anesthesia (Br. J. Surg. 2010;97:1218-25).

Dr. Gassner and her coauthors reported having no financial disclosures.

[email protected]

Let’s face it, most of us when we entered into pediatrics envisioned bouncing babies, adorable toddlers, and snotty-nosed children drawing us pictures that adorned the walls of our office. Never did we imagine sitting in a room across from a stone-faced teenage girl to talk about birth control.

But, reality quickly sets in, and staying up to date with the latest recommendation on birth control is imperative or you need to make the proper referral. Knowing the laws of your state about birth control, which govern your ability to administer contraception without parental consent, is vital. The Guttmacher website gives you a concise list for each state. Parental involvement is always encouraged, but may be the obstacle that prevents the patient from having the discussion.

Abstinence is the only foolproof way to avoid pregnancy, yet many of us forget to discuss it during our conversation. With statistics like 40% of teens report to having engaged in some level of sexual activity by age 15, it is not far-fetched to believe that there are teens who just assume all of their peers are having sex (Hatcher, R.A., et al. Contraceptive Technology, 20th revised ed. New York: Ardent Media, 2011). It is important that teens know that the majority of teens are not having sex, and saying "No" is an option. But teens will need support and help in developing the skills to incorporate abstinence into their relationships.

Discussing the health risk of sexually transmitted infections (STIs) and the possibility of infertility has a strong impact. Being clear on the risks of contracting human papillomavirus with the subsequent risk of cervical cancer associated with having multiple sexual partners, as well as the risk of contracting an incurable disease such as HIV, can be very persuasive.

Discussing condoms, how they protect against sexually transmitted diseases, and the value of dual protection is also important.

With pregnancy rates lower than 1% with perfect and typical use, long-acting reversible contraceptive (LARC) methods "are the best reversible methods for preventing unintended pregnancy, rapid repeat pregnancy, and abortion in young women," according to the American College of Obstetricians and Gynecologists committee opinion No. 539, written by the Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group (Obstet. Gynecol. 2012;120:983-8). Complications of these methods – intrauterine devices (IUDs) and the contraceptive implant – are rare and are similar in adolescents and older women, yet LARCs are underused in the younger age group.

An IUD is a LARC that eliminates the need for the teen to remember to take an oral contraceptive. Mirena is one such IUD that has little to no side effects, and is easily placed and removed. It can be used to control dysmenorrhea and abnormal uterine bleeding/heavy menstrual bleeding as well.

Skyla is the newest intrauterine system on the market. Compared with Mirena, which has been available since 2000, the new system uses less levonorgestrel (14 vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use.

In the past, IUDs were discouraged because there was a fear that there was an increased risk of infection and pelvic inflammatory disease (PID) with their use. However, more recent research shows that there is only a slightly increased risk of PID at the time of insertion, and there is no increased risk of STIs or infertility associated with using IUDs. They have become increasingly popular for adolescents, and should be given as an option.

The contraceptive implant (Nexplanon), which is approved for 3 years of use, is another form of LARC.

The use of oral contraceptives is a common option, although challenging for the already-preoccupied teen. The birth control pill has a failure rate of 0.3% when used correctly, but that increases to 8% when used in its typical fashion, according to the U.S. Medical Eligibility Criteria for Contraceptive Use (MMWR 2010;59:1-88). Many parents express concerns regarding the safety of OCs because of all the media advertisements for lawsuits. The reality is they are safe. The risk of deep vein thrombosis is low in women younger than 35 years who are nonsmokers, without hypertension, and who are not obese. Starting with an ultralow dose of estrogen minimizes side effects. If a patient begins to have breakthrough bleeding, switching to a triphasic pill helps reduce those episodes.

The Minipill (a progestin-only contraceptive) and Depo-Provera (a progestogen-only injection) are options for women who cannot tolerate estrogen, but the downsides are that their use can increase acne and appetite (which can lead to weight gain). Depo-Provera use also has been shown to lead to significant bone density loss if used greater than 2 years. These contraceptives are all reasonable options for a teen who demonstrates a high level of responsibility.

A talk on contraception would not be complete without including information about emergency contraception. It is important to let teens know that if there is a risk of pregnancy, taking emergency contraception within 3-5 days can prevent them from becoming pregnant. In June 2013, the Food and Drug Administration removed the requirement for minors to have a script to receive Plan B. My Way and Next Choice still require a prescription. Other options such as ella (ulipristal acetate, available by prescription) are hormone free, have fewer side effects, and have been shown to be more effective than hormones in preventing pregnancy.

In 2012, the American Academy of Pediatrics released a policy statement on emergency contraception, which stated: "All adolescents, males and females, ... should be counseled on emergency contraception as part of routine anticipatory guidance in the context of a discussion on sexual safety and family planning regardless of current intentions of sexual behavior" (Pediatrics 2012;130:1174-82).

All of the oral emergency contraception methods are significantly less effective in obese women, and obese women are four times more likely to get pregnant despite using these methods. The copper IUD has been shown to be the most effective form of emergency contraception regardless of weight and offers continuous protection. But, it should be noted that using the copper IUD for this purpose is an off-label use in the United States.

Knowledge is power, and sharing this little bit of information can be life changing for a teen who is considering being sexually active.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

Let’s face it, most of us when we entered into pediatrics envisioned bouncing babies, adorable toddlers, and snotty-nosed children drawing us pictures that adorned the walls of our office. Never did we imagine sitting in a room across from a stone-faced teenage girl to talk about birth control.

But, reality quickly sets in, and staying up to date with the latest recommendation on birth control is imperative or you need to make the proper referral. Knowing the laws of your state about birth control, which govern your ability to administer contraception without parental consent, is vital. The Guttmacher website gives you a concise list for each state. Parental involvement is always encouraged, but may be the obstacle that prevents the patient from having the discussion.

Abstinence is the only foolproof way to avoid pregnancy, yet many of us forget to discuss it during our conversation. With statistics like 40% of teens report to having engaged in some level of sexual activity by age 15, it is not far-fetched to believe that there are teens who just assume all of their peers are having sex (Hatcher, R.A., et al. Contraceptive Technology, 20th revised ed. New York: Ardent Media, 2011). It is important that teens know that the majority of teens are not having sex, and saying "No" is an option. But teens will need support and help in developing the skills to incorporate abstinence into their relationships.

Discussing the health risk of sexually transmitted infections (STIs) and the possibility of infertility has a strong impact. Being clear on the risks of contracting human papillomavirus with the subsequent risk of cervical cancer associated with having multiple sexual partners, as well as the risk of contracting an incurable disease such as HIV, can be very persuasive.

Discussing condoms, how they protect against sexually transmitted diseases, and the value of dual protection is also important.

With pregnancy rates lower than 1% with perfect and typical use, long-acting reversible contraceptive (LARC) methods "are the best reversible methods for preventing unintended pregnancy, rapid repeat pregnancy, and abortion in young women," according to the American College of Obstetricians and Gynecologists committee opinion No. 539, written by the Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group (Obstet. Gynecol. 2012;120:983-8). Complications of these methods – intrauterine devices (IUDs) and the contraceptive implant – are rare and are similar in adolescents and older women, yet LARCs are underused in the younger age group.

An IUD is a LARC that eliminates the need for the teen to remember to take an oral contraceptive. Mirena is one such IUD that has little to no side effects, and is easily placed and removed. It can be used to control dysmenorrhea and abnormal uterine bleeding/heavy menstrual bleeding as well.

Skyla is the newest intrauterine system on the market. Compared with Mirena, which has been available since 2000, the new system uses less levonorgestrel (14 vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use.

In the past, IUDs were discouraged because there was a fear that there was an increased risk of infection and pelvic inflammatory disease (PID) with their use. However, more recent research shows that there is only a slightly increased risk of PID at the time of insertion, and there is no increased risk of STIs or infertility associated with using IUDs. They have become increasingly popular for adolescents, and should be given as an option.

The contraceptive implant (Nexplanon), which is approved for 3 years of use, is another form of LARC.

The use of oral contraceptives is a common option, although challenging for the already-preoccupied teen. The birth control pill has a failure rate of 0.3% when used correctly, but that increases to 8% when used in its typical fashion, according to the U.S. Medical Eligibility Criteria for Contraceptive Use (MMWR 2010;59:1-88). Many parents express concerns regarding the safety of OCs because of all the media advertisements for lawsuits. The reality is they are safe. The risk of deep vein thrombosis is low in women younger than 35 years who are nonsmokers, without hypertension, and who are not obese. Starting with an ultralow dose of estrogen minimizes side effects. If a patient begins to have breakthrough bleeding, switching to a triphasic pill helps reduce those episodes.

The Minipill (a progestin-only contraceptive) and Depo-Provera (a progestogen-only injection) are options for women who cannot tolerate estrogen, but the downsides are that their use can increase acne and appetite (which can lead to weight gain). Depo-Provera use also has been shown to lead to significant bone density loss if used greater than 2 years. These contraceptives are all reasonable options for a teen who demonstrates a high level of responsibility.

A talk on contraception would not be complete without including information about emergency contraception. It is important to let teens know that if there is a risk of pregnancy, taking emergency contraception within 3-5 days can prevent them from becoming pregnant. In June 2013, the Food and Drug Administration removed the requirement for minors to have a script to receive Plan B. My Way and Next Choice still require a prescription. Other options such as ella (ulipristal acetate, available by prescription) are hormone free, have fewer side effects, and have been shown to be more effective than hormones in preventing pregnancy.

In 2012, the American Academy of Pediatrics released a policy statement on emergency contraception, which stated: "All adolescents, males and females, ... should be counseled on emergency contraception as part of routine anticipatory guidance in the context of a discussion on sexual safety and family planning regardless of current intentions of sexual behavior" (Pediatrics 2012;130:1174-82).

All of the oral emergency contraception methods are significantly less effective in obese women, and obese women are four times more likely to get pregnant despite using these methods. The copper IUD has been shown to be the most effective form of emergency contraception regardless of weight and offers continuous protection. But, it should be noted that using the copper IUD for this purpose is an off-label use in the United States.

Knowledge is power, and sharing this little bit of information can be life changing for a teen who is considering being sexually active.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

Let’s face it, most of us when we entered into pediatrics envisioned bouncing babies, adorable toddlers, and snotty-nosed children drawing us pictures that adorned the walls of our office. Never did we imagine sitting in a room across from a stone-faced teenage girl to talk about birth control.

But, reality quickly sets in, and staying up to date with the latest recommendation on birth control is imperative or you need to make the proper referral. Knowing the laws of your state about birth control, which govern your ability to administer contraception without parental consent, is vital. The Guttmacher website gives you a concise list for each state. Parental involvement is always encouraged, but may be the obstacle that prevents the patient from having the discussion.

Abstinence is the only foolproof way to avoid pregnancy, yet many of us forget to discuss it during our conversation. With statistics like 40% of teens report to having engaged in some level of sexual activity by age 15, it is not far-fetched to believe that there are teens who just assume all of their peers are having sex (Hatcher, R.A., et al. Contraceptive Technology, 20th revised ed. New York: Ardent Media, 2011). It is important that teens know that the majority of teens are not having sex, and saying "No" is an option. But teens will need support and help in developing the skills to incorporate abstinence into their relationships.

Discussing the health risk of sexually transmitted infections (STIs) and the possibility of infertility has a strong impact. Being clear on the risks of contracting human papillomavirus with the subsequent risk of cervical cancer associated with having multiple sexual partners, as well as the risk of contracting an incurable disease such as HIV, can be very persuasive.

Discussing condoms, how they protect against sexually transmitted diseases, and the value of dual protection is also important.

With pregnancy rates lower than 1% with perfect and typical use, long-acting reversible contraceptive (LARC) methods "are the best reversible methods for preventing unintended pregnancy, rapid repeat pregnancy, and abortion in young women," according to the American College of Obstetricians and Gynecologists committee opinion No. 539, written by the Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group (Obstet. Gynecol. 2012;120:983-8). Complications of these methods – intrauterine devices (IUDs) and the contraceptive implant – are rare and are similar in adolescents and older women, yet LARCs are underused in the younger age group.

An IUD is a LARC that eliminates the need for the teen to remember to take an oral contraceptive. Mirena is one such IUD that has little to no side effects, and is easily placed and removed. It can be used to control dysmenorrhea and abnormal uterine bleeding/heavy menstrual bleeding as well.

Skyla is the newest intrauterine system on the market. Compared with Mirena, which has been available since 2000, the new system uses less levonorgestrel (14 vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use.

In the past, IUDs were discouraged because there was a fear that there was an increased risk of infection and pelvic inflammatory disease (PID) with their use. However, more recent research shows that there is only a slightly increased risk of PID at the time of insertion, and there is no increased risk of STIs or infertility associated with using IUDs. They have become increasingly popular for adolescents, and should be given as an option.

The contraceptive implant (Nexplanon), which is approved for 3 years of use, is another form of LARC.

The use of oral contraceptives is a common option, although challenging for the already-preoccupied teen. The birth control pill has a failure rate of 0.3% when used correctly, but that increases to 8% when used in its typical fashion, according to the U.S. Medical Eligibility Criteria for Contraceptive Use (MMWR 2010;59:1-88). Many parents express concerns regarding the safety of OCs because of all the media advertisements for lawsuits. The reality is they are safe. The risk of deep vein thrombosis is low in women younger than 35 years who are nonsmokers, without hypertension, and who are not obese. Starting with an ultralow dose of estrogen minimizes side effects. If a patient begins to have breakthrough bleeding, switching to a triphasic pill helps reduce those episodes.

The Minipill (a progestin-only contraceptive) and Depo-Provera (a progestogen-only injection) are options for women who cannot tolerate estrogen, but the downsides are that their use can increase acne and appetite (which can lead to weight gain). Depo-Provera use also has been shown to lead to significant bone density loss if used greater than 2 years. These contraceptives are all reasonable options for a teen who demonstrates a high level of responsibility.

A talk on contraception would not be complete without including information about emergency contraception. It is important to let teens know that if there is a risk of pregnancy, taking emergency contraception within 3-5 days can prevent them from becoming pregnant. In June 2013, the Food and Drug Administration removed the requirement for minors to have a script to receive Plan B. My Way and Next Choice still require a prescription. Other options such as ella (ulipristal acetate, available by prescription) are hormone free, have fewer side effects, and have been shown to be more effective than hormones in preventing pregnancy.

In 2012, the American Academy of Pediatrics released a policy statement on emergency contraception, which stated: "All adolescents, males and females, ... should be counseled on emergency contraception as part of routine anticipatory guidance in the context of a discussion on sexual safety and family planning regardless of current intentions of sexual behavior" (Pediatrics 2012;130:1174-82).

All of the oral emergency contraception methods are significantly less effective in obese women, and obese women are four times more likely to get pregnant despite using these methods. The copper IUD has been shown to be the most effective form of emergency contraception regardless of weight and offers continuous protection. But, it should be noted that using the copper IUD for this purpose is an off-label use in the United States.

Knowledge is power, and sharing this little bit of information can be life changing for a teen who is considering being sexually active.

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

CHICAGO - Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date. Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

Patrice Wendling/IMNG Medical News

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the Midwestern Vascular Surgical Society.

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244). Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service?s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... We need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they?re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

Dr. Engelbert had no conflicts.

[email protected]

CHICAGO - Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date. Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

Patrice Wendling/IMNG Medical News

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the Midwestern Vascular Surgical Society.

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244). Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service?s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... We need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they?re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

Dr. Engelbert had no conflicts.

[email protected]

CHICAGO - Lower-extremity revascularization or amputation was among the strongest predictors of 30-day vascular surgery readmission in what is being described as the largest single-center review in this setting to date. Lower-extremity revascularization and amputations made up 63% of unplanned readmissions, though rates for endovascular lower-extremity revascularization were almost half that of open revascularization (8.2% vs. 15%).

Notably, below-knee amputations fared the worst, with a 30-day unplanned readmission rate of 24%, compared with 13.3% for above-knee amputations and 16.4% for foot amputation.

Patrice Wendling/IMNG Medical News

"Amputations and open lower-extremity revascularization had the highest rates of readmission in this analysis and therefore we need to focus our efforts and find additional postoperative [management] strategies for these two subgroups," Dr. Travis L. Engelbert said at the annual meeting of the Midwestern Vascular Surgical Society.

The analysis involved 2,505 patients who underwent vascular surgery at the University of Wisconsin Hospitals and Clinics in Madison from 2009 to mid-2013. The overall readmission rate was 9.7% (n = 244). Of these, 147 patients (60.2%) were readmitted to the vascular surgery service.

The most common readmitting diagnosis was wound complication or infection in 37%, said Dr. Engelbert, a vascular surgeon at the university.

Patients whose index admission was urgent rather than elective had significantly higher readmission rates (14.6% vs. 6.9%; P less than .001), as did those living remotely rather than inside Dane County, where the university is located (12% vs. 8.8%; P = .02).

Not surprisingly, higher illness severity, as calculated using the 3M APR DRG software, was significantly associated with readmission (15.6% high vs. 4.3% low severity; P less than .001).

Patients who were readmitted had a longer initial length of stay (8.5 days vs. 6.1 days; P less than .01), and were more likely to have an ICU admission (18.3% vs. 9.5% without ICU stay; P less than .05), he reported.

Based on insurance status, patients covered by Medicaid (16.8%) and Medicare (10%) were most likely to have an unplanned readmission, followed by fee-for-service patients (9.5%), self-pay (8%), and HMO (5.5%) patients (P = .02).

Dr. Engelbert observed that vascular surgery outcomes have come under scrutiny and that there has been some discussion of cutbacks in Medicare reimbursement given its high rates of readmission.

"This is already starting to happen for certain medical patient populations and if this were to happen, it would significantly affect a vascular service?s practice because a majority of our patients are covered by Medicare and have a higher readmission rate," he said.

The analysis suggests that vascular surgeons may also want to pay closer attention to discharge destination for their patients. Readmission rates were about three times higher for patients discharged to a rehabilitation facility or skilled nursing facility than for those discharged home (19.2% and 16.2% vs. 6.2%; P less than .01).

"The discharge destination matters," Dr. Engelbert said. "... We need to have improved coordination between hospitals and postdischarge destinations. And, we also might need to look at how these patients are cared for and if they are discharged to the appropriate level of care when they?re discharged to these skilled nursing and rehabilitation facilities."

The effects of discharge destination (odds ratio, 1.54 skilled nursing facility), index length of stay (OR, 1.03), insurance (OR, 0.43 HMO), and lower-extremity revascularization or amputation (OR, 2.35) persisted in multivariable logistic regression analysis that controlled for age, sex, race, proximity to hospital, clinic follow-up time, urgent vs. elective admission, insurance type, procedure type, length of stay, and discharge destination.

Dr. Engelbert had no conflicts.

[email protected]

Two young men went camping in the wilderness. One of them went off to gather firewood. He returned an hour later, staggering, badly battered, very bloody and with his clothes in tatters. His friend asked what happened. "I ran into a blacksnake" was the reply. "Everyone knows that blacksnakes are harmless," his friend retorted. "They are not so harmless if they make you jump off a cliff."

How does this story apply to vascular surgery and vascular disease patients? It is very relevant to the management of asymptomatic carotid stenosis, small aneurysms, or nondisabling intermittent claudication -- all conditions that are not dangerous and in most cases cause no serious harm.

Let's look first at asymptomatic carotid stenosis. A healthy, totally asymptomatic 58-year-old man with no cardiovascular risk factors undergoes a carotid screening exam by a commercial mobile laboratory service. He is told that he has a moderate carotid stenosis and a proper carotid duplex is recommended. This is obtained in the office of a "vascular specialist," and it shows that the patient has a "50%-60% narrowing of his left internal carotid artery." The vascular specialist advises him to have a "minimally invasive" carotid stent placed. This is performed in the local hospital by the vascular specialist. The patient has a "minor stroke" with near complete recovery within 2 months except for some persistent difficulty with fine movements of his right hand and some difficulty finding words. Although the man is able to keep his job, he is not as skilled at it as he was.

This patient is a victim of the blacksnake phenomenon. Although his carotid stenosis had more than a 95% chance of causing him no future harm, he suffered a somewhat disabling stroke that he would not have had if he had not undergone the screening exam. In other words the detection of the lesion and its unnecessary invasive treatment lead to a problem that otherwise would not have occurred.

Another example of a potential blacksnake phenomenon occurred in a 74-year-old retired hand surgeon with a 4.1-cm (diameter) abdominal aortic aneurysm. In 2004 this patient saw a vascular surgeon who was then chief of service at a major university center that was just beginning to perform EVAR. The patient had favorable anatomy for EVAR, and the vascular surgeon apparently wished to increase his limited experience with the procedure. The patient was advised to have the EVAR procedure "as soon as possible." He sought a second opinion and was advised to have his aneurysm observed periodically. Ten years later the patient remains well, and the aneurysm still has a diameter of 4.1 cm. If this patient had had an urgent EVAR in 2004 and had had any complication, it would have been a clear example of the blacksnake phenomenon. The fact-based second opinion and the patient's willingness to follow the appropriately conservative option spared him any exposure to the risk of treating a largely harmless condition. Harm from the blacksnake phenomenon was avoided.

Another patient who was spared exposure to the blacksnake phenomenon was a 58-year-old hypertensive hyperlipidemic smoker who had had a coronary artery bypass and who sought a second opinion for treatment of two block left calf claudication. The patient had had three endovascular procedures by a "vascular specialist" for a long superficial femoral artery occlusion which was causing the same symptom. All three interventions had failed, and a bypass had been suggested by the same specialist. The second opinion work-up revealed that the patient shockingly had not been placed on statins, had not been advised to stop smoking, and was not being treated for his hypertension by his intervening vascular specialist or the cardiologist who had referred the patient for his three interventions. Nor had he been told that his uncorrected femoral artery occlusion posed little risk to his limb or his life. The vascular surgeon providing the second opinion advised no treatment for the femoral occlusion, but placed the patient on statins, anti-hypertensives, and other medical measures. Had the patient undergone a fourth intervention or a bypass for the femoral occlusion, his risks would have been substantial. Avoiding these risks spared the patient the likelihood of being victimized by the blacksnake phenomenon.

All these cases are real. Yet all are examples of an actual or potential blacksnake phenomenon which can and does occur commonly in our system of vascular care. These cases emphasize that patients can be harmed by the blacksnake phenomenon, which results from the benign natural history of many vascular lesions which are better left uncorrected. Fixing such lesions simply because they exist and are detected causes more harm than benefit to patients. Many self-appointed vascular specialists are not fully aware of this benign natural history. Others, it seems, choose to ignore it, perhaps for bad motives. However, it behooves all specialists that treat non-coronary vascular disease to be aware of the natural history of various lesions and conditions, so that they do not treat patients with them unnecessarily or for the wrong reasons.

Moreover, they must be aware of and utilize optimal medical treatments for these lesions and conditions. In that way patients can be spared exposure to the blacksnake phenomenon, and real vascular specialists can provide the best overall care for their patients.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Two young men went camping in the wilderness. One of them went off to gather firewood. He returned an hour later, staggering, badly battered, very bloody and with his clothes in tatters. His friend asked what happened. "I ran into a blacksnake" was the reply. "Everyone knows that blacksnakes are harmless," his friend retorted. "They are not so harmless if they make you jump off a cliff."

How does this story apply to vascular surgery and vascular disease patients? It is very relevant to the management of asymptomatic carotid stenosis, small aneurysms, or nondisabling intermittent claudication -- all conditions that are not dangerous and in most cases cause no serious harm.

Let's look first at asymptomatic carotid stenosis. A healthy, totally asymptomatic 58-year-old man with no cardiovascular risk factors undergoes a carotid screening exam by a commercial mobile laboratory service. He is told that he has a moderate carotid stenosis and a proper carotid duplex is recommended. This is obtained in the office of a "vascular specialist," and it shows that the patient has a "50%-60% narrowing of his left internal carotid artery." The vascular specialist advises him to have a "minimally invasive" carotid stent placed. This is performed in the local hospital by the vascular specialist. The patient has a "minor stroke" with near complete recovery within 2 months except for some persistent difficulty with fine movements of his right hand and some difficulty finding words. Although the man is able to keep his job, he is not as skilled at it as he was.

This patient is a victim of the blacksnake phenomenon. Although his carotid stenosis had more than a 95% chance of causing him no future harm, he suffered a somewhat disabling stroke that he would not have had if he had not undergone the screening exam. In other words the detection of the lesion and its unnecessary invasive treatment lead to a problem that otherwise would not have occurred.

Another example of a potential blacksnake phenomenon occurred in a 74-year-old retired hand surgeon with a 4.1-cm (diameter) abdominal aortic aneurysm. In 2004 this patient saw a vascular surgeon who was then chief of service at a major university center that was just beginning to perform EVAR. The patient had favorable anatomy for EVAR, and the vascular surgeon apparently wished to increase his limited experience with the procedure. The patient was advised to have the EVAR procedure "as soon as possible." He sought a second opinion and was advised to have his aneurysm observed periodically. Ten years later the patient remains well, and the aneurysm still has a diameter of 4.1 cm. If this patient had had an urgent EVAR in 2004 and had had any complication, it would have been a clear example of the blacksnake phenomenon. The fact-based second opinion and the patient's willingness to follow the appropriately conservative option spared him any exposure to the risk of treating a largely harmless condition. Harm from the blacksnake phenomenon was avoided.

Another patient who was spared exposure to the blacksnake phenomenon was a 58-year-old hypertensive hyperlipidemic smoker who had had a coronary artery bypass and who sought a second opinion for treatment of two block left calf claudication. The patient had had three endovascular procedures by a "vascular specialist" for a long superficial femoral artery occlusion which was causing the same symptom. All three interventions had failed, and a bypass had been suggested by the same specialist. The second opinion work-up revealed that the patient shockingly had not been placed on statins, had not been advised to stop smoking, and was not being treated for his hypertension by his intervening vascular specialist or the cardiologist who had referred the patient for his three interventions. Nor had he been told that his uncorrected femoral artery occlusion posed little risk to his limb or his life. The vascular surgeon providing the second opinion advised no treatment for the femoral occlusion, but placed the patient on statins, anti-hypertensives, and other medical measures. Had the patient undergone a fourth intervention or a bypass for the femoral occlusion, his risks would have been substantial. Avoiding these risks spared the patient the likelihood of being victimized by the blacksnake phenomenon.

All these cases are real. Yet all are examples of an actual or potential blacksnake phenomenon which can and does occur commonly in our system of vascular care. These cases emphasize that patients can be harmed by the blacksnake phenomenon, which results from the benign natural history of many vascular lesions which are better left uncorrected. Fixing such lesions simply because they exist and are detected causes more harm than benefit to patients. Many self-appointed vascular specialists are not fully aware of this benign natural history. Others, it seems, choose to ignore it, perhaps for bad motives. However, it behooves all specialists that treat non-coronary vascular disease to be aware of the natural history of various lesions and conditions, so that they do not treat patients with them unnecessarily or for the wrong reasons.

Moreover, they must be aware of and utilize optimal medical treatments for these lesions and conditions. In that way patients can be spared exposure to the blacksnake phenomenon, and real vascular specialists can provide the best overall care for their patients.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Two young men went camping in the wilderness. One of them went off to gather firewood. He returned an hour later, staggering, badly battered, very bloody and with his clothes in tatters. His friend asked what happened. "I ran into a blacksnake" was the reply. "Everyone knows that blacksnakes are harmless," his friend retorted. "They are not so harmless if they make you jump off a cliff."

How does this story apply to vascular surgery and vascular disease patients? It is very relevant to the management of asymptomatic carotid stenosis, small aneurysms, or nondisabling intermittent claudication -- all conditions that are not dangerous and in most cases cause no serious harm.

Let's look first at asymptomatic carotid stenosis. A healthy, totally asymptomatic 58-year-old man with no cardiovascular risk factors undergoes a carotid screening exam by a commercial mobile laboratory service. He is told that he has a moderate carotid stenosis and a proper carotid duplex is recommended. This is obtained in the office of a "vascular specialist," and it shows that the patient has a "50%-60% narrowing of his left internal carotid artery." The vascular specialist advises him to have a "minimally invasive" carotid stent placed. This is performed in the local hospital by the vascular specialist. The patient has a "minor stroke" with near complete recovery within 2 months except for some persistent difficulty with fine movements of his right hand and some difficulty finding words. Although the man is able to keep his job, he is not as skilled at it as he was.

This patient is a victim of the blacksnake phenomenon. Although his carotid stenosis had more than a 95% chance of causing him no future harm, he suffered a somewhat disabling stroke that he would not have had if he had not undergone the screening exam. In other words the detection of the lesion and its unnecessary invasive treatment lead to a problem that otherwise would not have occurred.

Another example of a potential blacksnake phenomenon occurred in a 74-year-old retired hand surgeon with a 4.1-cm (diameter) abdominal aortic aneurysm. In 2004 this patient saw a vascular surgeon who was then chief of service at a major university center that was just beginning to perform EVAR. The patient had favorable anatomy for EVAR, and the vascular surgeon apparently wished to increase his limited experience with the procedure. The patient was advised to have the EVAR procedure "as soon as possible." He sought a second opinion and was advised to have his aneurysm observed periodically. Ten years later the patient remains well, and the aneurysm still has a diameter of 4.1 cm. If this patient had had an urgent EVAR in 2004 and had had any complication, it would have been a clear example of the blacksnake phenomenon. The fact-based second opinion and the patient's willingness to follow the appropriately conservative option spared him any exposure to the risk of treating a largely harmless condition. Harm from the blacksnake phenomenon was avoided.

Another patient who was spared exposure to the blacksnake phenomenon was a 58-year-old hypertensive hyperlipidemic smoker who had had a coronary artery bypass and who sought a second opinion for treatment of two block left calf claudication. The patient had had three endovascular procedures by a "vascular specialist" for a long superficial femoral artery occlusion which was causing the same symptom. All three interventions had failed, and a bypass had been suggested by the same specialist. The second opinion work-up revealed that the patient shockingly had not been placed on statins, had not been advised to stop smoking, and was not being treated for his hypertension by his intervening vascular specialist or the cardiologist who had referred the patient for his three interventions. Nor had he been told that his uncorrected femoral artery occlusion posed little risk to his limb or his life. The vascular surgeon providing the second opinion advised no treatment for the femoral occlusion, but placed the patient on statins, anti-hypertensives, and other medical measures. Had the patient undergone a fourth intervention or a bypass for the femoral occlusion, his risks would have been substantial. Avoiding these risks spared the patient the likelihood of being victimized by the blacksnake phenomenon.

All these cases are real. Yet all are examples of an actual or potential blacksnake phenomenon which can and does occur commonly in our system of vascular care. These cases emphasize that patients can be harmed by the blacksnake phenomenon, which results from the benign natural history of many vascular lesions which are better left uncorrected. Fixing such lesions simply because they exist and are detected causes more harm than benefit to patients. Many self-appointed vascular specialists are not fully aware of this benign natural history. Others, it seems, choose to ignore it, perhaps for bad motives. However, it behooves all specialists that treat non-coronary vascular disease to be aware of the natural history of various lesions and conditions, so that they do not treat patients with them unnecessarily or for the wrong reasons.

Moreover, they must be aware of and utilize optimal medical treatments for these lesions and conditions. In that way patients can be spared exposure to the blacksnake phenomenon, and real vascular specialists can provide the best overall care for their patients.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

The TOPCAT study, reported at the recent American Heart Association meeting in Dallas, examined the murky world of our understanding of heart failure occurring in patients with preserved left ventricular ejection fraction.

That seeming paradox has been the subject of physiologic and therapeutic controversy for some time. The realization that at least half of the patients admitted to the hospital with heart failure have normal or even supernormal left ventricular ejection fraction (HFpEF) has raised the therapeutic importance of this clinical entity. Of even more importance is the fact that patients with HFpEF exhibit morbidity and mortality similar to those heart failure patients with reduced left ventricular ejection fraction (HFrEF).

In an epidemiologic study in Olmsted County, Minnesota (N. Engl. J. Med. 2006;355:251-9), the 1-year mortality was 29% for HFpEF and 32% for HFrEF. Patients with HFpEF were more likely to be female (65.7% vs. 34.6%) and to have hypertension and atrial fibrillation than were those with HFrEF (62.7% vs. 48% and 41.3% vs. 28.5%, respectively).

Although we have significantly impacted mortality in patients who have HFrEF with the use of cardiac resynchronization therapy, implantable cardiac defibrillators, and medical therapy with beta-blockers and renin angiotensin inhibitors, we have failed to modify clinical outcomes in patients with HFpEF.

This has not been for a lack of trying. Several randomized clinical trials have been conducted with all of the drugs currently being used for HFrEF without any definitive results. An important problem in treating this population has been the heterogeneity of patients and multiple comorbidities, including chronic renal and pulmonary disease, acute hypertension, and atrial fibrillation that patients with HFpEF experience with the acute event. In addition, many of these patients are already receiving a multiplicity of concurrent therapies that have been approved for HFrEF for management.

Our understanding of the pathophysiology of HFpEF also remains cloudy. Both left and right ventricular hypertrophy with concomitant decrease in ventricular diastolic relaxation is the common observed echocardiographic abnormality. We have not as yet developed therapy for the treatment of diastolic dysfunction. Aldosterone antagonists, previously shown to be beneficial in patients with HFrEF, have emerged as likely candidates to improve HFpEF. Small clinical studies have shown improvement in diastolic function in elderly patients with hypertension and chronic renal disease. Consequently, the National Heart, Lung, and Blood Institute embarked on the TOPCAT study in 2006.

TOPCAT randomized 3,345 symptomatic heart failure patients who had a heart failure hospitalization in the previous year and with evidence of fluid retention, a left ventricular ejection fraction of more than 45%, controlled systolic blood pressure of less than 140 mm Hg, and elevated brain natriuretic peptide to treatment with placebo or spironolactone at 25 or 50 mg daily. A history of hypertension was present in 91%, coronary artery disease in 57%, atrial fibrillation in 35%, chronic renal disease in 35%, and diabetes in 32%. Patients included in the study had a mean LVEF of 56%; two thirds were in New York Heart Association class II and one third were in NYHA class III.

Over 80% of patients were receiving an ACE inhibitor or angiotensin receptor blocker, beta-blockers, and a diuretic. The mean dose of spironolactone was 25 mg. There was no significant difference in the primary outcome of cardiovascular death, nonfatal hospitalization or resuscitated cardiac arrest in the placebo and treated groups (20.4% and 18.6%, respectively). There was a significant decrease in heart failure hospitalization in the placebo compared to spironolactone patients (14.2% vs. 12.0%; P = .042). Both hyperkalemia greater than 5.5 mmol/L and an increase in serum creatinine were observed in the treated patients.

The striking observation in this trial, as it has been in previous trials, is the disparity between the epidemiologic mortality and the randomized controlled trial experience: 29% annual mortality in Olmsted County, compared with the 10.2% three-year mortality in TOPCAT. It appears that we are studying two separate diseases. And we are. After all the exclusion criteria included in the design of TOPCAT, we are unable to encapsulate the population at risk in this complex heart failure syndrome.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The TOPCAT study, reported at the recent American Heart Association meeting in Dallas, examined the murky world of our understanding of heart failure occurring in patients with preserved left ventricular ejection fraction.

That seeming paradox has been the subject of physiologic and therapeutic controversy for some time. The realization that at least half of the patients admitted to the hospital with heart failure have normal or even supernormal left ventricular ejection fraction (HFpEF) has raised the therapeutic importance of this clinical entity. Of even more importance is the fact that patients with HFpEF exhibit morbidity and mortality similar to those heart failure patients with reduced left ventricular ejection fraction (HFrEF).

In an epidemiologic study in Olmsted County, Minnesota (N. Engl. J. Med. 2006;355:251-9), the 1-year mortality was 29% for HFpEF and 32% for HFrEF. Patients with HFpEF were more likely to be female (65.7% vs. 34.6%) and to have hypertension and atrial fibrillation than were those with HFrEF (62.7% vs. 48% and 41.3% vs. 28.5%, respectively).

Although we have significantly impacted mortality in patients who have HFrEF with the use of cardiac resynchronization therapy, implantable cardiac defibrillators, and medical therapy with beta-blockers and renin angiotensin inhibitors, we have failed to modify clinical outcomes in patients with HFpEF.

This has not been for a lack of trying. Several randomized clinical trials have been conducted with all of the drugs currently being used for HFrEF without any definitive results. An important problem in treating this population has been the heterogeneity of patients and multiple comorbidities, including chronic renal and pulmonary disease, acute hypertension, and atrial fibrillation that patients with HFpEF experience with the acute event. In addition, many of these patients are already receiving a multiplicity of concurrent therapies that have been approved for HFrEF for management.

Our understanding of the pathophysiology of HFpEF also remains cloudy. Both left and right ventricular hypertrophy with concomitant decrease in ventricular diastolic relaxation is the common observed echocardiographic abnormality. We have not as yet developed therapy for the treatment of diastolic dysfunction. Aldosterone antagonists, previously shown to be beneficial in patients with HFrEF, have emerged as likely candidates to improve HFpEF. Small clinical studies have shown improvement in diastolic function in elderly patients with hypertension and chronic renal disease. Consequently, the National Heart, Lung, and Blood Institute embarked on the TOPCAT study in 2006.

TOPCAT randomized 3,345 symptomatic heart failure patients who had a heart failure hospitalization in the previous year and with evidence of fluid retention, a left ventricular ejection fraction of more than 45%, controlled systolic blood pressure of less than 140 mm Hg, and elevated brain natriuretic peptide to treatment with placebo or spironolactone at 25 or 50 mg daily. A history of hypertension was present in 91%, coronary artery disease in 57%, atrial fibrillation in 35%, chronic renal disease in 35%, and diabetes in 32%. Patients included in the study had a mean LVEF of 56%; two thirds were in New York Heart Association class II and one third were in NYHA class III.

Over 80% of patients were receiving an ACE inhibitor or angiotensin receptor blocker, beta-blockers, and a diuretic. The mean dose of spironolactone was 25 mg. There was no significant difference in the primary outcome of cardiovascular death, nonfatal hospitalization or resuscitated cardiac arrest in the placebo and treated groups (20.4% and 18.6%, respectively). There was a significant decrease in heart failure hospitalization in the placebo compared to spironolactone patients (14.2% vs. 12.0%; P = .042). Both hyperkalemia greater than 5.5 mmol/L and an increase in serum creatinine were observed in the treated patients.

The striking observation in this trial, as it has been in previous trials, is the disparity between the epidemiologic mortality and the randomized controlled trial experience: 29% annual mortality in Olmsted County, compared with the 10.2% three-year mortality in TOPCAT. It appears that we are studying two separate diseases. And we are. After all the exclusion criteria included in the design of TOPCAT, we are unable to encapsulate the population at risk in this complex heart failure syndrome.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The TOPCAT study, reported at the recent American Heart Association meeting in Dallas, examined the murky world of our understanding of heart failure occurring in patients with preserved left ventricular ejection fraction.

That seeming paradox has been the subject of physiologic and therapeutic controversy for some time. The realization that at least half of the patients admitted to the hospital with heart failure have normal or even supernormal left ventricular ejection fraction (HFpEF) has raised the therapeutic importance of this clinical entity. Of even more importance is the fact that patients with HFpEF exhibit morbidity and mortality similar to those heart failure patients with reduced left ventricular ejection fraction (HFrEF).

In an epidemiologic study in Olmsted County, Minnesota (N. Engl. J. Med. 2006;355:251-9), the 1-year mortality was 29% for HFpEF and 32% for HFrEF. Patients with HFpEF were more likely to be female (65.7% vs. 34.6%) and to have hypertension and atrial fibrillation than were those with HFrEF (62.7% vs. 48% and 41.3% vs. 28.5%, respectively).

Although we have significantly impacted mortality in patients who have HFrEF with the use of cardiac resynchronization therapy, implantable cardiac defibrillators, and medical therapy with beta-blockers and renin angiotensin inhibitors, we have failed to modify clinical outcomes in patients with HFpEF.

This has not been for a lack of trying. Several randomized clinical trials have been conducted with all of the drugs currently being used for HFrEF without any definitive results. An important problem in treating this population has been the heterogeneity of patients and multiple comorbidities, including chronic renal and pulmonary disease, acute hypertension, and atrial fibrillation that patients with HFpEF experience with the acute event. In addition, many of these patients are already receiving a multiplicity of concurrent therapies that have been approved for HFrEF for management.

Our understanding of the pathophysiology of HFpEF also remains cloudy. Both left and right ventricular hypertrophy with concomitant decrease in ventricular diastolic relaxation is the common observed echocardiographic abnormality. We have not as yet developed therapy for the treatment of diastolic dysfunction. Aldosterone antagonists, previously shown to be beneficial in patients with HFrEF, have emerged as likely candidates to improve HFpEF. Small clinical studies have shown improvement in diastolic function in elderly patients with hypertension and chronic renal disease. Consequently, the National Heart, Lung, and Blood Institute embarked on the TOPCAT study in 2006.

TOPCAT randomized 3,345 symptomatic heart failure patients who had a heart failure hospitalization in the previous year and with evidence of fluid retention, a left ventricular ejection fraction of more than 45%, controlled systolic blood pressure of less than 140 mm Hg, and elevated brain natriuretic peptide to treatment with placebo or spironolactone at 25 or 50 mg daily. A history of hypertension was present in 91%, coronary artery disease in 57%, atrial fibrillation in 35%, chronic renal disease in 35%, and diabetes in 32%. Patients included in the study had a mean LVEF of 56%; two thirds were in New York Heart Association class II and one third were in NYHA class III.

Over 80% of patients were receiving an ACE inhibitor or angiotensin receptor blocker, beta-blockers, and a diuretic. The mean dose of spironolactone was 25 mg. There was no significant difference in the primary outcome of cardiovascular death, nonfatal hospitalization or resuscitated cardiac arrest in the placebo and treated groups (20.4% and 18.6%, respectively). There was a significant decrease in heart failure hospitalization in the placebo compared to spironolactone patients (14.2% vs. 12.0%; P = .042). Both hyperkalemia greater than 5.5 mmol/L and an increase in serum creatinine were observed in the treated patients.

The striking observation in this trial, as it has been in previous trials, is the disparity between the epidemiologic mortality and the randomized controlled trial experience: 29% annual mortality in Olmsted County, compared with the 10.2% three-year mortality in TOPCAT. It appears that we are studying two separate diseases. And we are. After all the exclusion criteria included in the design of TOPCAT, we are unable to encapsulate the population at risk in this complex heart failure syndrome.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.