Perioperative Medicine

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

SAN ANTONIO – Preoperative ultrasound assessment had an overall sensitivity of only 8% in the detection of positive sentinel lymph nodes among 2,481 patients with node-positive melanoma in the Multicenter Selective Lymphadenectomy Trial II.

"With a sensitivity of only 8% in this large, multicenter clinical trial, ultrasound is clearly not an effective substitute for sentinel node biopsy to detect metastatic disease and provide accurate staging," Dr. John F. Thompson said at a cancer symposium sponsored by the Society of Surgical Oncology.

As a result of the data, preoperative node field ultrasound has now been removed from the Multicenter Selective Lymphadenectomy Trial II (MSLT II) protocol.

The ongoing phase III MSLT II is designed to determine whether the melanoma-specific survival associated with sentinel lymphadenectomy and postoperative monitoring with serial nodal ultrasound is equivalent to that associated with sentinel lymphadenectomy plus complete lymph node dissection in stage IIa to IIIc melanoma patients with sentinel node (SN) metastases detected by histopathologic or molecular techniques.

Ultrasound has proven value in melanoma follow-up, leading some to suggest that preoperative ultrasound examination of regional nodes could provide accurate staging information and render sentinel node biopsy unnecessary.

To date the literature has been confusing. Some studies suggest high (65%) sensitivity (J. Clin. Oncol. 2009;27:4994-5000), while others suggest much lower (24%) sensitivity (J. Clin. Oncol. 2009;27:5614-9), Dr. Thompson said.

He presented data on 2,481 patients enrolled at 29 centers worldwide from December 2004 to March 2010 who underwent preoperative ultrasound assessment of their regional nodes, followed by sentinel node biopsy. Whether ultrasound was performed before or after the preoperative lymphoscintigraphy was at the discretion of the treating clinician. At 19 centers, excised sentinel nodes were examined pathologically with hematoxylin-eosin stain and immunohistochemistry and, if negative, by reverse transcriptase–polymerase chain reaction (RT-PCR) testing.

Sentinel nodes were removed from 2,788 lymph node fields in the 2,481 patients. Histopathology was positive in 578 fields in 554 patients. Among these, ultrasound was true positive in 46 and false negative in 532.

"Hardly an impressive result," said Dr. Thompson, professor of melanoma and surgical oncology at the University of Sydney and executive director of the Melanoma Institute Australia in North Sydney.

Among the 1,927 patients with 2,210 histologically negative lymph node fields, ultrasound was false positive in 52 and true negative in 1,771.

A total of 387 histologically negative, but RT-PCR–positive sentinel nodes were excluded from the ultrasound analysis because they would be expected to be picked up on ultrasound. However, seven of these cases were in fact reported positive on ultrasound, he said.

Of the remaining 2,401 lymph node fields, the overall sensitivity was 8%, specificity 97%, positive predictive value 47%, and negative predictive value 77%. Sensitivity was the highest at 55% in the axilla, and 0% in the popliteal and epitrochlear areas.

There was, of course, a learning curve with the ultrasound technology, Dr. Thompson noted. Sensitivity nearly doubled from 13% for the first 100 cases to 23% for the subsequent 100 cases. Specificity rose modestly from 93% to 95%.

As observed in other studies, the sensitivity of ultrasound increased with Breslow tumor thickness from just 2.6% for tumors 0-1 mm to 12% for those greater than 4 mm. "The positive predictive value at this stage is up around 81%, so you could perhaps make an argument for using ultrasound in thicker tumors," he said.

Finally, tumor burden data were available for 384 histologically positive sentinel nodes. As expected, the median cross-sectional area was larger at 4.80 mm² for sentinel nodes having ultrasound true-positive results vs. 0.12 mm² for those having ultrasound false-negative results. Significantly larger tumors were missed by ultrasound in the axilla when compared with the groin (P = .004).

"I think we can say that SN biopsy remains the most accurate method of regional node staging for patients with newly diagnosed melanoma," he concluded. "Sufficient accuracy cannot be achieved by assessing SNs using ultrasound alone."

MSLT II is sponsored by the John Wayne Cancer Institute. Dr. Thompson and his coauthors said they had no relevant financial disclosures.

The Centers for Disease Control and Prevention is awarding a total of $10 million to five research groups in the latest round of funding for new research to help reduce healthcare setting–associated infections.

This will be the fourth round of "Prevention Epicenter" funding since the CDC began the program in 1997. The program is intended to discover better ways to deal with difficult health care problems such as antibiotic resistance and hospital infection control. According to CDC estimates, 1 in 20 hospitalized patients will acquire a healthcare-associated infection (HAI).

The CDC names new Prevention Epicenters every 5 years based on peer-reviewed grant applications.

This year’s awardees are: the Chicago Antimicrobial Resistance and Infection Prevention Epicenter (Cook County Health & Hospital System and Rush University Medical Center); the Duke University Prevention Epicenter in Durham, N.C.; the Translation Prevention Research Epicenter (Harvard Pilgrim Health Care) in Wellesley, Mass.; Southeastern Pennsylvania Adult and Pediatric Prevention Epicenter Network (University of Pennsylvania) in Philadelphia; and Washington University and BJC Epi-Center for Prevention of Healthcare Associated Infections in St. Louis.

Strategies the epicenters will be exploring include using combinations of bleach and ultraviolet light to clean hospital rooms, using new tests to distinguish patients who need antibiotics from those who don’t, finding ways to anticipate which medical devices are on the verge of causing an infection in a specific patient, and preventing HAIs by treating patients with probiotics.

In a press release announcing the awards, Dr. John Jernigan, director of CDC’s Office of HAI Prevention Research and Evaluation, said, "The Prevention Epicenter program discovers solutions and refines them so they can work to prevent infections for all healthcare settings. During the past decade, some of our biggest breakthroughs in health care infection prevention have been rooted in research of the Prevention Epicenter program, and we look forward to future advances."

The Centers for Disease Control and Prevention is awarding a total of $10 million to five research groups in the latest round of funding for new research to help reduce healthcare setting–associated infections.

This will be the fourth round of "Prevention Epicenter" funding since the CDC began the program in 1997. The program is intended to discover better ways to deal with difficult health care problems such as antibiotic resistance and hospital infection control. According to CDC estimates, 1 in 20 hospitalized patients will acquire a healthcare-associated infection (HAI).

The CDC names new Prevention Epicenters every 5 years based on peer-reviewed grant applications.

This year’s awardees are: the Chicago Antimicrobial Resistance and Infection Prevention Epicenter (Cook County Health & Hospital System and Rush University Medical Center); the Duke University Prevention Epicenter in Durham, N.C.; the Translation Prevention Research Epicenter (Harvard Pilgrim Health Care) in Wellesley, Mass.; Southeastern Pennsylvania Adult and Pediatric Prevention Epicenter Network (University of Pennsylvania) in Philadelphia; and Washington University and BJC Epi-Center for Prevention of Healthcare Associated Infections in St. Louis.

Strategies the epicenters will be exploring include using combinations of bleach and ultraviolet light to clean hospital rooms, using new tests to distinguish patients who need antibiotics from those who don’t, finding ways to anticipate which medical devices are on the verge of causing an infection in a specific patient, and preventing HAIs by treating patients with probiotics.

In a press release announcing the awards, Dr. John Jernigan, director of CDC’s Office of HAI Prevention Research and Evaluation, said, "The Prevention Epicenter program discovers solutions and refines them so they can work to prevent infections for all healthcare settings. During the past decade, some of our biggest breakthroughs in health care infection prevention have been rooted in research of the Prevention Epicenter program, and we look forward to future advances."

The Centers for Disease Control and Prevention is awarding a total of $10 million to five research groups in the latest round of funding for new research to help reduce healthcare setting–associated infections.

This will be the fourth round of "Prevention Epicenter" funding since the CDC began the program in 1997. The program is intended to discover better ways to deal with difficult health care problems such as antibiotic resistance and hospital infection control. According to CDC estimates, 1 in 20 hospitalized patients will acquire a healthcare-associated infection (HAI).

The CDC names new Prevention Epicenters every 5 years based on peer-reviewed grant applications.

This year’s awardees are: the Chicago Antimicrobial Resistance and Infection Prevention Epicenter (Cook County Health & Hospital System and Rush University Medical Center); the Duke University Prevention Epicenter in Durham, N.C.; the Translation Prevention Research Epicenter (Harvard Pilgrim Health Care) in Wellesley, Mass.; Southeastern Pennsylvania Adult and Pediatric Prevention Epicenter Network (University of Pennsylvania) in Philadelphia; and Washington University and BJC Epi-Center for Prevention of Healthcare Associated Infections in St. Louis.

Strategies the epicenters will be exploring include using combinations of bleach and ultraviolet light to clean hospital rooms, using new tests to distinguish patients who need antibiotics from those who don’t, finding ways to anticipate which medical devices are on the verge of causing an infection in a specific patient, and preventing HAIs by treating patients with probiotics.

In a press release announcing the awards, Dr. John Jernigan, director of CDC’s Office of HAI Prevention Research and Evaluation, said, "The Prevention Epicenter program discovers solutions and refines them so they can work to prevent infections for all healthcare settings. During the past decade, some of our biggest breakthroughs in health care infection prevention have been rooted in research of the Prevention Epicenter program, and we look forward to future advances."

SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.

"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."

According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.

"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.

Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.

At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."

No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.

"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."

Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."

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

SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.

"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."

According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.

"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.

Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.

At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."

No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.

"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."

Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."

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

SAN DIEGO – Oral anticoagulation with warfarin is routinely discontinued before venous surgery to avoid potential bleeding complications, but results from a single-center study suggest that endovenous laser therapy can be safely performed in patients taking warfarin.

"Cessation of warfarin therapy may necessitate an alternative form of bridging anticoagulation before and after the intervention in order to minimize the risk of perioperative thromboembolic complications from preexisting medical conditions," Dr. Paul J. Riesenman said at the annual meeting of the American Venous Forum. "This practice adds cost and complexity to the operative planning. But in many patients, minimizing the perioperative time period off the anticoagulation may be required to safely perform the procedure."

According to Dr. Riesenman, a vascular surgery fellow at Emory University in Atlanta, endovenous laser therapy is minimally invasive and "bleeding complications are uncommonly reported." Noninterruption of warfarin therapy in these patients could simplify preoperative planning and minimize the risk of perioperative complications.

"One of the unknowns of this practice is how the presence of therapeutic anticoagulation may affect the success of the ablative procedure," he noted.

Between September 2004 and July 2010, 518 patients underwent 770 lower-extremity EVLT (endovenous laser therapy) procedures. Of these, five patients ranging in age from 31 to 69 years underwent 12 separate EVLT procedures without interruption of warfarin therapy. The great saphenous vein was targeted in eight procedures, and the small saphenous vein in the remaining four. Concomitant procedures included phlebectomies during five interventions and ultrasound-guided sclerotherapy during an additional five procedures.

At Emory, EVLT is routinely done in an office setting using a 55- or 80-cm inducer sheath placed in the target vessel. "We use an 810-nm wavelength system run on continuous operating mode at 14 W," Dr. Riesenman said. "Once successful ablation of the target vessel is confirmed by ultrasound and any additional venous interventions are performed, a two-layer compression bandage is applied and the patient receives a 20- to 30–mm Hg compression stocking. Follow-up with ultrasound is performed at 1 and 8 weeks."

No intraprocedural bleeding complications were observed in the five patients, and no excessive ecchymosis was documented at 1-week follow-up. Successful ablation of the target vessels was confirmed by ultrasound at 1 and 8 weeks in all patients.

"Most patients reported significant resolution of their symptoms, although one patient did report severe lower extremity pain during her 8-week follow-up," Dr. Riesenman said. "At that follow-up, there were no concerning ultrasound or physical exam findings. Interestingly, she did inquire about having her contralateral extremity treated at that time."

Although he acknowledged that the study is a "small, limited case series," Dr. Riesenman concluded that EVLT "can be safely and effectively performed on patients undergoing oral anticoagulation therapy with warfarin. We recommend that warfarin not routinely be interrupted when patients undergo this procedure."

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

Patients who quit smoking shortly before undergoing surgery are not at increased risk of postoperative complications, compared with those who continue to smoke, according to a report published online March 14 in the Archives of Internal Medicine.

"Until some new evidence of harm emerges, firm advice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time," said Katie Myers of Queen Mary, University of London, and her associates.

Publication of a study in 1989 with 39 subjects suggested that "stopping smoking leads to a decrease in coughing and an increase in sputum production." Although that article did not actually show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery "to minimize the increase in pulmonary complications in recent quitters."

Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as "high quality" the three studies that also used biochemical testing to validate subjects’ self-report of their smoking status.

These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.

Only one of the nine studies showed a significant effect of smoking cessation, and that was in favor of recent quitting. When the results were pooled, there was "no beneficial or detrimental effect of quitting within 8 weeks before surgery, compared with continued smoking," the researchers said.

The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications.

"In conclusion, there is currently no suggestion, either from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications," the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archinternmed.2011.97]).

The reluctance to allow or encourage smoking cessation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has directly examined mucociliary clearance in surgical patients shortly after smoking cessation, and that study found no significant difference between surgical patients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

"No data are available on the effects of only a few days’ abstinence from smoking. Early abstinence generates more intense withdrawal discomfort, but there is no clear rationale to expect this to translate into postoperative complications," they added.

However, they acknowledged that their study is limited by its observational nature and by the small number of studies available for review that have evaluated this issue. "Our findings are necessarily tentative and may be modified when more data become available," the researchers said.

One of Ms. Myers’ associates is supported by the U.K. Center for Tobacco Control Studies. Two associates reported ties to GlaxoSmithKline, Novartis, Pfizer Global, and Johnson & Johnson, which manufacture smoking cessation products.

Patients who quit smoking shortly before undergoing surgery are not at increased risk of postoperative complications, compared with those who continue to smoke, according to a report published online March 14 in the Archives of Internal Medicine.

"Until some new evidence of harm emerges, firm advice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time," said Katie Myers of Queen Mary, University of London, and her associates.

Publication of a study in 1989 with 39 subjects suggested that "stopping smoking leads to a decrease in coughing and an increase in sputum production." Although that article did not actually show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery "to minimize the increase in pulmonary complications in recent quitters."

Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as "high quality" the three studies that also used biochemical testing to validate subjects’ self-report of their smoking status.

These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.

Only one of the nine studies showed a significant effect of smoking cessation, and that was in favor of recent quitting. When the results were pooled, there was "no beneficial or detrimental effect of quitting within 8 weeks before surgery, compared with continued smoking," the researchers said.

The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications.

"In conclusion, there is currently no suggestion, either from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications," the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archinternmed.2011.97]).

The reluctance to allow or encourage smoking cessation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has directly examined mucociliary clearance in surgical patients shortly after smoking cessation, and that study found no significant difference between surgical patients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

"No data are available on the effects of only a few days’ abstinence from smoking. Early abstinence generates more intense withdrawal discomfort, but there is no clear rationale to expect this to translate into postoperative complications," they added.

However, they acknowledged that their study is limited by its observational nature and by the small number of studies available for review that have evaluated this issue. "Our findings are necessarily tentative and may be modified when more data become available," the researchers said.

One of Ms. Myers’ associates is supported by the U.K. Center for Tobacco Control Studies. Two associates reported ties to GlaxoSmithKline, Novartis, Pfizer Global, and Johnson & Johnson, which manufacture smoking cessation products.

Patients who quit smoking shortly before undergoing surgery are not at increased risk of postoperative complications, compared with those who continue to smoke, according to a report published online March 14 in the Archives of Internal Medicine.

"Until some new evidence of harm emerges, firm advice to stop smoking and an offer of smoking cessation treatment to those who need it can be provided to presurgical patients at any time," said Katie Myers of Queen Mary, University of London, and her associates.

Publication of a study in 1989 with 39 subjects suggested that "stopping smoking leads to a decrease in coughing and an increase in sputum production." Although that article did not actually show a significant effect of smoking cessation on postoperative complications, it has continued to influence routine practice; in fact, some treatment guidelines recommend against smoking cessation in the 2 months prior to surgery "to minimize the increase in pulmonary complications in recent quitters."

Ms. Myers and her colleagues reviewed the literature for all studies that allowed comparisons of postoperative complications in patients who stopped smoking 8 weeks or less before undergoing surgery (recent quitters) and patients who continued to smoke. They then performed a meta-analysis of the nine studies that did so, rating as "high quality" the three studies that also used biochemical testing to validate subjects’ self-report of their smoking status.

These studies involved 889 subjects, including 448 recent quitters and 441 continuing smokers.

Only one of the nine studies showed a significant effect of smoking cessation, and that was in favor of recent quitting. When the results were pooled, there was "no beneficial or detrimental effect of quitting within 8 weeks before surgery, compared with continued smoking," the researchers said.

The results were the same in an analysis of the three high-quality studies, and likewise when the analysis was restricted to only pulmonary postoperative complications.

"In conclusion, there is currently no suggestion, either from any single study or from combinations of studies, that quitting smoking shortly before surgery increases postoperative complications," the investigators said (Arch. Intern. Med. 2011 [doi:10.1001/archinternmed.2011.97]).

The reluctance to allow or encourage smoking cessation shortly before surgery is based on unconfirmed assumptions. Only one study in the literature has directly examined mucociliary clearance in surgical patients shortly after smoking cessation, and that study found no significant difference between surgical patients who had recently quit and those who continued to smoke, Ms. Myers and her associates noted.

"No data are available on the effects of only a few days’ abstinence from smoking. Early abstinence generates more intense withdrawal discomfort, but there is no clear rationale to expect this to translate into postoperative complications," they added.

However, they acknowledged that their study is limited by its observational nature and by the small number of studies available for review that have evaluated this issue. "Our findings are necessarily tentative and may be modified when more data become available," the researchers said.

One of Ms. Myers’ associates is supported by the U.K. Center for Tobacco Control Studies. Two associates reported ties to GlaxoSmithKline, Novartis, Pfizer Global, and Johnson & Johnson, which manufacture smoking cessation products.

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study reported at the annual meeting of the Society for Maternal-Fetal Medicine, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

"Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines," said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1-2 g for all adults, large or small.

"Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients’ weight or BMI," Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks’ gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m²), obese (30-39.9 kg/m²), or extremely obese (greater than or equal to 40 kg/m²).

All were given 2 g of cefazolin 30-60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were racially/ethnically diverse: 31% were white, 21% were African American, 41% were Hispanic, and 7% were Asian. They were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m² in the lean, obese, and extremely obese groups, respectively.

The mean concentration of cefazolin in adipose tissue collected at incision was 9.4 mcg/g in lean women, Dr. Pevzner reported. In comparison, it was 6.4 mcg/g, or 32% lower, in obese women (P = .009) and 4.4 mcg/g, or 53% lower, in extremely obese women (P less than .001).

Regression analysis showed that the higher the women’s BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = –0.67, P less than .001).

None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint. And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4 mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. "As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used," he said. Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

"Larger prospective and perhaps randomized studies are needed to confirm the current findings from a clinical standpoint and answer some of these lingering questions," he concluded.

Dr. Pevzner said he did not have any relevant financial disclosures.

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study reported at the annual meeting of the Society for Maternal-Fetal Medicine, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

"Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines," said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1-2 g for all adults, large or small.

"Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients’ weight or BMI," Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks’ gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m²), obese (30-39.9 kg/m²), or extremely obese (greater than or equal to 40 kg/m²).

All were given 2 g of cefazolin 30-60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were racially/ethnically diverse: 31% were white, 21% were African American, 41% were Hispanic, and 7% were Asian. They were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m² in the lean, obese, and extremely obese groups, respectively.

The mean concentration of cefazolin in adipose tissue collected at incision was 9.4 mcg/g in lean women, Dr. Pevzner reported. In comparison, it was 6.4 mcg/g, or 32% lower, in obese women (P = .009) and 4.4 mcg/g, or 53% lower, in extremely obese women (P less than .001).

Regression analysis showed that the higher the women’s BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = –0.67, P less than .001).

None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint. And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4 mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. "As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used," he said. Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

"Larger prospective and perhaps randomized studies are needed to confirm the current findings from a clinical standpoint and answer some of these lingering questions," he concluded.

Dr. Pevzner said he did not have any relevant financial disclosures.

SAN FRANCISCO – As women grow heavier, tailoring antibiotic dose to weight or body mass index may be critical for preventing surgical site infections after cesarean deliveries, a study has shown.

In the prospective cohort study reported at the annual meeting of the Society for Maternal-Fetal Medicine, all 29 women undergoing a cesarean were given the same standard fixed dose of cefazolin before their surgery. Concentrations of the antibiotic in adipose tissue collected at the start of the surgery were one-third lower in obese women and one-half lower in extremely obese women than those in their lean counterparts. Perhaps most importantly, some of the heavier women had tissue concentrations below those believed to be necessary for preventing antibiotic resistance.

"Based on the current findings, a considerable proportion of obese women undergoing cesarean delivery do not have adequate antimicrobial protection for the duration of the procedure, following current guidelines," said Dr. Leo Pevzner, an ob.gyn. at the University of California, Irvine.

The National Surgical Infection Prevention Project has endorsed tailoring antibiotic dose to weight or body mass index (BMI), but data on appropriate prophylactic doses in adults are limited, he noted. Hence, recommendations still call for an intravenous dose of 1-2 g for all adults, large or small.

"Current obesity trends, along with evolutionary changes in bacterial resistance, portend a questionable utility of existing prophylaxis regimens and have the potential to drastically increase the rates of surgical site infections if no attempts are made to address antimicrobial dosing based on patients’ weight or BMI," Dr. Pevzner commented.

The investigators enrolled in the study women with a singleton pregnancy who were scheduled for a cesarean delivery at term (greater than 37 weeks’ gestation). Any who had received antibiotics in the previous week or who had chronic hypertension or pregestational diabetes were excluded.

On the basis of their BMI, the women were classified as lean (less than 30 kg/m²), obese (30-39.9 kg/m²), or extremely obese (greater than or equal to 40 kg/m²).

All were given 2 g of cefazolin 30-60 minutes before skin incision for the cesarean surgery. The investigators collected adipose tissue at the time of skin incision (initial) and again just before closure (final), as well as myometrial tissue after delivery and blood at the end of the procedure.

The concentration of cefazolin in all samples was assessed in a blinded manner with a microbiologic plate assay performed in triplicate, using plates seeded with Streptococcus sanguis. Zones of inhibition were measured in millimeters.

The study participants were racially/ethnically diverse: 31% were white, 21% were African American, 41% were Hispanic, and 7% were Asian. They were 30 years old, on average. The mean BMI was 27, 34, and 45 kg/m² in the lean, obese, and extremely obese groups, respectively.

The mean concentration of cefazolin in adipose tissue collected at incision was 9.4 mcg/g in lean women, Dr. Pevzner reported. In comparison, it was 6.4 mcg/g, or 32% lower, in obese women (P = .009) and 4.4 mcg/g, or 53% lower, in extremely obese women (P less than .001).

Regression analysis showed that the higher the women’s BMI, the lower the concentration of the antibiotic in their initial adipose tissue sample (r = –0.67, P less than .001).

None of the lean women had an adipose concentration of cefazolin below 4 mcg/g, the theoretic breakpoint for preventing resistance, according to Dr. Pevzner.

But eight women – four obese and four extremely obese – had an initial or a final adipose concentration below this breakpoint. And three women – all extremely obese – had both initial and final adipose concentrations below this breakpoint.

The concentrations of cefazolin in the final adipose tissue, myometrial tissue, and serum also decreased with increasing BMI category, but these differences were not statistically significant, Dr. Pevzner reported.

Among the 25 women with follow-up, 2 developed surgical site infections requiring antibiotic therapy. Both were in the extremely obese group, and both had initial and final adipose cefazolin concentrations below the 4 mcg/g threshold.

The study was small, Dr. Pevzner acknowledged. "As such, there is not enough information to reach a conclusion regarding the weight or BMI above which a higher dose of antibiotics should be used," he said. Also, the impact of multiple gestations and maternal diseases, such as hypertension and diabetes, in this setting is unknown.

"Larger prospective and perhaps randomized studies are needed to confirm the current findings from a clinical standpoint and answer some of these lingering questions," he concluded.

Dr. Pevzner said he did not have any relevant financial disclosures.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. "We wanted to look at metabolic syndrome’s effect on these outcomes," said Dr. Smolock of the DeBakey Heart and Vascular Center.

"This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome," said study discussant Dr. Scott L. Stevens. "Of note, mortality was not increased among those with metabolic syndrome." Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

"Primary patency decreased as well significantly over 5 years in those with metabolic syndrome," Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality "could speak to this being a local procedure, not [one] done under general anesthesia." He added, "I hope some of that has to do with our risk-reduction strategies preoperatively."

"What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?" Dr. Stevens asked.

"Our beta blocker, statin, and aspirin use were not at levels we wanted," Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. "I don’t think this is because of small or poor targets," Dr. Smolock said. "The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically."

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. "We wanted to look at metabolic syndrome’s effect on these outcomes," said Dr. Smolock of the DeBakey Heart and Vascular Center.

"This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome," said study discussant Dr. Scott L. Stevens. "Of note, mortality was not increased among those with metabolic syndrome." Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

"Primary patency decreased as well significantly over 5 years in those with metabolic syndrome," Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality "could speak to this being a local procedure, not [one] done under general anesthesia." He added, "I hope some of that has to do with our risk-reduction strategies preoperatively."

"What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?" Dr. Stevens asked.

"Our beta blocker, statin, and aspirin use were not at levels we wanted," Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. "I don’t think this is because of small or poor targets," Dr. Smolock said. "The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically."

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

NAPLES, FLA. – Presence of metabolic syndrome is a risk factor for poor outcomes during superficial femoral artery interventions, according to a retrospective database study.

Although approximately half of patients with peripheral artery disease also have metabolic syndrome, its impact on peripheral interventions is not unknown, Dr. Christopher J. Smolock said at the annual meeting of the Southern Association for Vascular Surgery.

To find out more, Dr. Smolock and his associates reviewed a database of 870 patients who underwent endovascular treatment for symptomatic superficial femoral artery (SFA) disease. In this study, 46% of patients met criteria for metabolic syndrome, the average age was 67 years, and 64% were men.

A total 1,006 limbs of these patients were treated between 1999 and 2009 at the DeBakey Heart and Vascular Center at the Methodist Hospital in Houston. The researchers compared patient factors at presentation and outcomes between patients without metabolic syndrome (542 treated limbs) and patients with the syndrome (464 treated limbs).

Limbs in the metabolic syndrome group were significantly more likely to come from women (44% vs. 31%), to come from patients with critical ischemia symptoms of pain at rest and tissue loss (54% vs. 38%), and to feature more advanced SFA lesions (51% vs. 31%), compared with limbs in the group without metabolic syndrome.

Claudication was a presentation for 46% of the limbs in the group with metabolic syndrome versus 62% of limbs in the non–metabolic syndrome group.

The investigators compared 30-day mortality and morbidity between these groups. In addition, they assessed the 5-year rates for primary and secondary patency; freedom from recurrent symptoms; and limb salvage. "We wanted to look at metabolic syndrome’s effect on these outcomes," said Dr. Smolock of the DeBakey Heart and Vascular Center.

"This addresses the important topic of outcomes with SFA interventions in those with metabolic syndrome," said study discussant Dr. Scott L. Stevens. "Of note, mortality was not increased among those with metabolic syndrome." Dr. Stevens is a vascular surgeon at the University of Tennessee Medical Center in Knoxville.

There was no significant difference in 30-day mortality: 0.2% in the metabolic syndrome group and the 1.3% in the nonsyndrome group.

A lower percentage of the metabolic syndrome group, 67% vs. 73%, experienced freedom from recurrent symptoms over 5 years.

"Primary patency decreased as well significantly over 5 years in those with metabolic syndrome," Dr. Smolock said. The study revealed 56% of the metabolic syndrome group had 5-year primary patency, compared with 66% in unaffected group; 71% vs. 78% had assisted primary patency; and 71% vs. 78% had secondary patency. Secondary patency decreased also, but there was no significant difference between groups, he added.

Because critical ischemia more often affected the group with metabolic syndrome, the rate of limb amputation was higher in this group (22% versus 13% of the unaffected group at 5 years).

Dr. Stevens asked why the metabolic group experienced significantly higher morbidity but not mortality, compared with the unaffected group. This might be because the mortality figures were calculated for only the first 30 days and not over the 5 years, Dr. Smolock said. In addition, the low 30-day mortality "could speak to this being a local procedure, not [one] done under general anesthesia." He added, "I hope some of that has to do with our risk-reduction strategies preoperatively."

"What changes have you made in your practice to reduce risk factors in those patients with metabolic syndrome?" Dr. Stevens asked.

"Our beta blocker, statin, and aspirin use were not at levels we wanted," Dr. Smolock replied. So use of these agents is now prescribed for all patients without a contraindication, he said.

Dr. Stevens also asked if metabolic syndrome might just be a surrogate for patients with smaller arteries and/or more plaque. "I don’t think this is because of small or poor targets," Dr. Smolock said. "The SVS [Society for Vascular Surgery] runoff score was equal between the groups. Diabetes is a risk in and of itself for small or poor targets, but it’s not something we could see anatomically."

Metabolic syndrome was defined in this study using the National Heart, Lung and Blood Institute/American Heart Association criteria. Therefore, patients had to have three or more of the following: systolic blood pressure of 130 mm Hg or greater/diastolic blood pressure of 85 mm Hg or greater; triglycerides of 150 mg/dL or greater; HDL cholesterol of 50 mg/dL or lower for women or 40 mg/dL or lower for men; fasting blood glucose of 110 mg/dL or greater; or body mass index of 30 kg/m2 or greater.

Dr. Smolock said that he had no relevant disclosures.

NAPLES, FLA. – Selective lumbar spinal drainage is worthwhile to reduce adverse neurologic outcomes for patients who develop symptoms of spinal cord ischemia after thoracic aortic endograft repair, according to a retrospective study.

Although surgeons who perform open aortic repair commonly employ perioperative lumbar spinal drainage, there is no consensus regarding drain placement for spinal cord ischemia (SCI) that is associated with thoracic endovascular aorta repair (TEVAR), Charles J. Keith said at the annual meeting of the Southern Association for Vascular Surgery.

Mr. Keith, a medical student at the University of Alabama at Birmingham, and his associates reviewed 10 years of experience at their institution to compare outcomes between drained and nondrained patients. Of 266 TEVAR interventions in 239 patients, of whom 167 (70%) were men, between January 2000 and June 2010, 16 (7% of cases) developed SCI within 30 days.

History of stroke, infrarenal pathology, and a longer aortic coverage in centimeters were significant risk factors for SCI in this patient population, Mr. Keith said. There were 147 interventions that involved aneurysms in the study, accounting for just more than half of the aortic pathology treated.

Left subclavian artery stent graft coverage was required in 80 interventions (30%), but it was not significantly associated with SCI.

Study discussant Dr. Peter H. Lin asked about routine or prophylactic drainage for patients with these risk factors. "Use of prophylactic drainage is supported by some, but we would have deployed an extra 105 unnecessary drains in this population," Mr. Keith replied. "There are risks associated with drainage, such as epidural hematoma, as was experienced by one of our patients."

Patients who developed SCI were three times more likely to die within 1 year, compared with non-SCI patients (odds ratio, 3.0).

Focus your efforts on complete symptom recovery after TEVAR and perform frequent neurologic assessments of high-risk patients, Mr. Keith said. These actions will minimize time to drain placement when indicated, improve symptom resolution, and increase 1-year survival.

In all, 10 of the 16 SCI cases were drained. There were no significant differences in terms of risk factors or demographics between drained and nondrained patients. Of the 10 drained cases, three patients experienced complete neurologic symptom resolution, four had partial resolution, and three had no resolution. Of the six patients who were not drained, four experienced complete resolution and two experienced no resolution.

Another aim of the study was to evaluate a drainage protocol adopted at their institution. Since 2007, all patients receive a neurologic evaluation post TEVAR. If they show any symptoms of neurologic deficit, their mean arterial pressure is increased to greater than 110 mm Hg, and the frequency of neurologic exams increases to hourly. Also, a lumbar drain is immediately placed if they have a major deficit and within 3 hours if minor symptoms persist postoperatively.

Although patients who experienced SCI after TEVAR had diminished outcomes, compared with non-SCI patients, the study supports the use of a spinal drainage protocol to improve neurologic outcomes in a select patient population, Mr. Keith said.

There are reports that support the use of steroids to reduce swelling and spinal cord edema, said Dr. Lin of the division of vascular and endovascular therapy at Baylor College of Medicine, Houston.

"Steroids are not included in our protocol, but it’s definitely something to consider," Mr. Keith said.

Dr. Lin asked if the study findings have changed the treatment approach at the University of Alabama. Mr. Keith deferred to Dr. William D. Jordan Jr., a coauthor of the study and moderator of this session at the meeting.

"We seek input from neurologic surgeons and anesthesia to help us place the drains in a more timely fashion," said Dr. Jordan, chief of vascular surgery at the University of Alabama.

A meeting attendee commented that that approach might work at the University of Alabama, but what if feedback from neurosurgery or anesthesia is not available in a timely fashion at another institution?

"In some places, they place a drain the night before in the ICU. If that works at your institution, fine," Dr. Jordan said.

Another attendee asked about the 3-hour window before drain placement. Dr. Jordan replied, "We are basically telling anesthesia: ‘We need these [patients] awake to make sure they are kicking their legs.’ That is why we chose 3 hours for recovery, but we can often tell within 1 hour if the [patient] is moving."

There is no consensus on measures to prevent SCI, Mr. Keith said. In addition to lumbar drainage, others report use of vasopressors to increase mean arterial pressure and predeployment aortic occlusion to detect diminished spinal cord evoked potentials.

Mr. Keith and Dr. Lin said that they had no relevant disclosures. Dr. Jordan had multiple disclosures, including being a consultant, speaker, and advisor for Abbott Vascular; an advisor for LeMaitre Vascular; a speaker and advisor for Medtronic; and a consultant and speaker for W.L. Gore.

NAPLES, FLA. – Selective lumbar spinal drainage is worthwhile to reduce adverse neurologic outcomes for patients who develop symptoms of spinal cord ischemia after thoracic aortic endograft repair, according to a retrospective study.

Although surgeons who perform open aortic repair commonly employ perioperative lumbar spinal drainage, there is no consensus regarding drain placement for spinal cord ischemia (SCI) that is associated with thoracic endovascular aorta repair (TEVAR), Charles J. Keith said at the annual meeting of the Southern Association for Vascular Surgery.

Mr. Keith, a medical student at the University of Alabama at Birmingham, and his associates reviewed 10 years of experience at their institution to compare outcomes between drained and nondrained patients. Of 266 TEVAR interventions in 239 patients, of whom 167 (70%) were men, between January 2000 and June 2010, 16 (7% of cases) developed SCI within 30 days.

History of stroke, infrarenal pathology, and a longer aortic coverage in centimeters were significant risk factors for SCI in this patient population, Mr. Keith said. There were 147 interventions that involved aneurysms in the study, accounting for just more than half of the aortic pathology treated.

Left subclavian artery stent graft coverage was required in 80 interventions (30%), but it was not significantly associated with SCI.

Study discussant Dr. Peter H. Lin asked about routine or prophylactic drainage for patients with these risk factors. "Use of prophylactic drainage is supported by some, but we would have deployed an extra 105 unnecessary drains in this population," Mr. Keith replied. "There are risks associated with drainage, such as epidural hematoma, as was experienced by one of our patients."

Patients who developed SCI were three times more likely to die within 1 year, compared with non-SCI patients (odds ratio, 3.0).

Focus your efforts on complete symptom recovery after TEVAR and perform frequent neurologic assessments of high-risk patients, Mr. Keith said. These actions will minimize time to drain placement when indicated, improve symptom resolution, and increase 1-year survival.

In all, 10 of the 16 SCI cases were drained. There were no significant differences in terms of risk factors or demographics between drained and nondrained patients. Of the 10 drained cases, three patients experienced complete neurologic symptom resolution, four had partial resolution, and three had no resolution. Of the six patients who were not drained, four experienced complete resolution and two experienced no resolution.

Another aim of the study was to evaluate a drainage protocol adopted at their institution. Since 2007, all patients receive a neurologic evaluation post TEVAR. If they show any symptoms of neurologic deficit, their mean arterial pressure is increased to greater than 110 mm Hg, and the frequency of neurologic exams increases to hourly. Also, a lumbar drain is immediately placed if they have a major deficit and within 3 hours if minor symptoms persist postoperatively.

Although patients who experienced SCI after TEVAR had diminished outcomes, compared with non-SCI patients, the study supports the use of a spinal drainage protocol to improve neurologic outcomes in a select patient population, Mr. Keith said.

There are reports that support the use of steroids to reduce swelling and spinal cord edema, said Dr. Lin of the division of vascular and endovascular therapy at Baylor College of Medicine, Houston.

"Steroids are not included in our protocol, but it’s definitely something to consider," Mr. Keith said.

Dr. Lin asked if the study findings have changed the treatment approach at the University of Alabama. Mr. Keith deferred to Dr. William D. Jordan Jr., a coauthor of the study and moderator of this session at the meeting.

"We seek input from neurologic surgeons and anesthesia to help us place the drains in a more timely fashion," said Dr. Jordan, chief of vascular surgery at the University of Alabama.

A meeting attendee commented that that approach might work at the University of Alabama, but what if feedback from neurosurgery or anesthesia is not available in a timely fashion at another institution?

"In some places, they place a drain the night before in the ICU. If that works at your institution, fine," Dr. Jordan said.

Another attendee asked about the 3-hour window before drain placement. Dr. Jordan replied, "We are basically telling anesthesia: ‘We need these [patients] awake to make sure they are kicking their legs.’ That is why we chose 3 hours for recovery, but we can often tell within 1 hour if the [patient] is moving."

There is no consensus on measures to prevent SCI, Mr. Keith said. In addition to lumbar drainage, others report use of vasopressors to increase mean arterial pressure and predeployment aortic occlusion to detect diminished spinal cord evoked potentials.

Mr. Keith and Dr. Lin said that they had no relevant disclosures. Dr. Jordan had multiple disclosures, including being a consultant, speaker, and advisor for Abbott Vascular; an advisor for LeMaitre Vascular; a speaker and advisor for Medtronic; and a consultant and speaker for W.L. Gore.

NAPLES, FLA. – Selective lumbar spinal drainage is worthwhile to reduce adverse neurologic outcomes for patients who develop symptoms of spinal cord ischemia after thoracic aortic endograft repair, according to a retrospective study.

Although surgeons who perform open aortic repair commonly employ perioperative lumbar spinal drainage, there is no consensus regarding drain placement for spinal cord ischemia (SCI) that is associated with thoracic endovascular aorta repair (TEVAR), Charles J. Keith said at the annual meeting of the Southern Association for Vascular Surgery.

Mr. Keith, a medical student at the University of Alabama at Birmingham, and his associates reviewed 10 years of experience at their institution to compare outcomes between drained and nondrained patients. Of 266 TEVAR interventions in 239 patients, of whom 167 (70%) were men, between January 2000 and June 2010, 16 (7% of cases) developed SCI within 30 days.

History of stroke, infrarenal pathology, and a longer aortic coverage in centimeters were significant risk factors for SCI in this patient population, Mr. Keith said. There were 147 interventions that involved aneurysms in the study, accounting for just more than half of the aortic pathology treated.

Left subclavian artery stent graft coverage was required in 80 interventions (30%), but it was not significantly associated with SCI.

Study discussant Dr. Peter H. Lin asked about routine or prophylactic drainage for patients with these risk factors. "Use of prophylactic drainage is supported by some, but we would have deployed an extra 105 unnecessary drains in this population," Mr. Keith replied. "There are risks associated with drainage, such as epidural hematoma, as was experienced by one of our patients."

Patients who developed SCI were three times more likely to die within 1 year, compared with non-SCI patients (odds ratio, 3.0).

Focus your efforts on complete symptom recovery after TEVAR and perform frequent neurologic assessments of high-risk patients, Mr. Keith said. These actions will minimize time to drain placement when indicated, improve symptom resolution, and increase 1-year survival.

In all, 10 of the 16 SCI cases were drained. There were no significant differences in terms of risk factors or demographics between drained and nondrained patients. Of the 10 drained cases, three patients experienced complete neurologic symptom resolution, four had partial resolution, and three had no resolution. Of the six patients who were not drained, four experienced complete resolution and two experienced no resolution.

Another aim of the study was to evaluate a drainage protocol adopted at their institution. Since 2007, all patients receive a neurologic evaluation post TEVAR. If they show any symptoms of neurologic deficit, their mean arterial pressure is increased to greater than 110 mm Hg, and the frequency of neurologic exams increases to hourly. Also, a lumbar drain is immediately placed if they have a major deficit and within 3 hours if minor symptoms persist postoperatively.

Although patients who experienced SCI after TEVAR had diminished outcomes, compared with non-SCI patients, the study supports the use of a spinal drainage protocol to improve neurologic outcomes in a select patient population, Mr. Keith said.

There are reports that support the use of steroids to reduce swelling and spinal cord edema, said Dr. Lin of the division of vascular and endovascular therapy at Baylor College of Medicine, Houston.

"Steroids are not included in our protocol, but it’s definitely something to consider," Mr. Keith said.

Dr. Lin asked if the study findings have changed the treatment approach at the University of Alabama. Mr. Keith deferred to Dr. William D. Jordan Jr., a coauthor of the study and moderator of this session at the meeting.

"We seek input from neurologic surgeons and anesthesia to help us place the drains in a more timely fashion," said Dr. Jordan, chief of vascular surgery at the University of Alabama.

A meeting attendee commented that that approach might work at the University of Alabama, but what if feedback from neurosurgery or anesthesia is not available in a timely fashion at another institution?

"In some places, they place a drain the night before in the ICU. If that works at your institution, fine," Dr. Jordan said.

Another attendee asked about the 3-hour window before drain placement. Dr. Jordan replied, "We are basically telling anesthesia: ‘We need these [patients] awake to make sure they are kicking their legs.’ That is why we chose 3 hours for recovery, but we can often tell within 1 hour if the [patient] is moving."

There is no consensus on measures to prevent SCI, Mr. Keith said. In addition to lumbar drainage, others report use of vasopressors to increase mean arterial pressure and predeployment aortic occlusion to detect diminished spinal cord evoked potentials.

Mr. Keith and Dr. Lin said that they had no relevant disclosures. Dr. Jordan had multiple disclosures, including being a consultant, speaker, and advisor for Abbott Vascular; an advisor for LeMaitre Vascular; a speaker and advisor for Medtronic; and a consultant and speaker for W.L. Gore.

SAN DIEGO – An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the annual meeting of the Society of Thoracic Surgeons.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.

SAN DIEGO – An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the annual meeting of the Society of Thoracic Surgeons.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.

SAN DIEGO – An interval between neoadjuvant chemoradiation and esophagectomy that extends beyond 8 weeks is not associated with increased perioperative complications, increased pathological complete response, or change in overall survival, results from a long-term single-center study showed.

"For patients who have not yet recovered from neoadjuvant chemoradiation, it is safe to delay surgery to allow them to improve their performance status," Dr. Jae Y. Kim said at the annual meeting of the Society of Thoracic Surgeons.

Traditionally, he said, surgery has been recommended within 8 weeks after completing neoadjuvant chemoradiation for esophageal cancer, yet many patients choose to delay their surgery.

Some patients have not yet recovered from chemoradiation, while others are delayed for personal or logistical reasons, explained Dr. Kim, a thoracic surgery fellow at the University of Texas M.D. Anderson Cancer Center, Houston. "The impact of this delay on outcomes is unknown." Radiation-induced tumor necrosis increases over time, he said, and there is evidence from rectal cancer that a longer interval may increase the rate of pathological complete response. "On the other hand, there are theoretical concerns that this delay may lead to increased radiation fibrosis and cause a more difficult operation. It is also possible that a delay would allow for tumor regrowth."

In an effort to determine whether an increased interval between chemoradiation and surgery is associated with risk of major perioperative complications or overall survival, Dr. Kim and his associates conducted a retrospective study of 266 patients with esophageal cancer followed by neoadjuvant chemoradiation who were treated at M.D. Anderson in 2002-2008. They divided the patients into two groups: a "short-interval" group of 150 who underwent esophagectomy within 8 weeks of chemoradiation, and a "delayed" group of 116 who underwent esophagectomy more than 8 weeks following chemoradiation.

"Most patients were clustered around 4-11 weeks," Dr. Kim said. "No patient had surgery more than 46 weeks after completing neoadjuvant chemoradiation."

The median interval from completion of neoadjuvant therapy to surgery was 46 days in the short-interval group and 76 days in the delayed group. In both groups, more than 95% of patients were staged with PET-CT and endoscopic ultrasound.

The researchers compared the two groups in terms of perioperative complications, rate of pathological complete response, and overall survival.

The two groups were similar in 18 of 22 baseline characteristics examined, but they were different in four areas. Compared with their counterparts in the short-interval group, the patients in the delayed group were slightly older (mean age, 60 years vs. 57 years, respectively), had more coronary artery disease (17% vs. 7%), had less adenocarcinoma histology (87% vs. 97%), and weighed less (53% with a body mass index of 25 kg/m2 or greater vs. 75% of their counterparts in the short-interval group).

By any objective measure used to gauge the difficulty of the operation, the two groups were similar, including mean OR time (390 minutes in the short-interval group vs. 398 minutes in the delayed group), mean number of lymph nodes removed (21% vs. 20%), and mean estimated blood loss (505 mL vs. 478 mL).

The rates of major complications also were similar between the two groups, including perioperative mortality (2% in the short-interval group vs. 3% in the delayed group), median length of stay (11 days in each group), and rate of anastomotic leak (11% vs. 16%).

The rate of pathological complete response was similar between the two groups (21% vs. 23%).

Overall 5-year survival in the short-interval group was 46%, compared with 36% in the delayed-surgery group, a nonsignificant difference. Disease-free 5-year survival in the short-interval group was 44%, compared with 36% in the delayed group.

"The timing of surgery, both as a continuous and a dichotomous variable, was not associated" with perioperative complication or death, pathological complete response, or overall survival, Dr. Kim added.

On multivariable analysis, older age, more involved lymph nodes, and advanced pathological stage were independently associated with decreased survival.

The researchers performed a subgroup analysis of patients with adenocarcinoma histology and found that the results were similar.

Dr. Kim said that he had no relevant financial disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

NAPLES, FLA. – An exponential increase in ambulatory endovascular procedures for peripheral arterial disease is occurring in Florida, and it mirrors a nationwide trend, Dr. Michael S. Hong said at the annual meeting of the Southern Association for Vascular Surgery.

This shift to more ambulatory-based interventions is leading to decreases in open bypass procedures and major amputations, he said. This finding is from a study of discharges for peripheral arterial disease from Florida hospitals since 2000 and from ambulatory centers since 2004.

Approximately four out of five endovascular interventions for claudication, for example, are now performed in an ambulatory setting in Florida (approximately 8,000 vs. 2,000 done in a hospital setting), Dr. Hong said.

"With critical limb ischemia, the number of endovascular ambulatory interventions is much less than [that for] claudication, but we see an increase in the absolute number and in the proportion done in an ambulatory setting over time," said Dr. Hong, a research resident in the department of surgery at the University of Florida, Gainesville.

At the same time, inpatient procedures are still increasing for critical limb ischemia, Dr. Hong said. "Inpatient endovascular procedures are predominantly now for more advanced peripheral arterial disease."

"Interventionists might consider these more dangerous and hence want to perform them more in the hospital," said study discussant Dr. Russell H. Samson, a vascular surgeon at Doctors Hospital of Sarasota (Fla.). In addition, critical limb ischemia repairs "are very equipment intensive and the equipment is expensive."

Importantly, overall patient safety has not been compromised with a move toward more outpatient procedures, Dr. Hong said. "From our data, with only two deaths and 20 transferred, ... this shift to the ambulatory setting has not compromised patient safety."

He and his associates reviewed 10 years of ICD-9 inpatient codes and 6 years of outpatient CPT codes for endovascular angioplasty, atherectomy, and peripheral stent procedures. They also assessed ICD-9 codes for open bypasses.

Among the findings is that lower extremity bypass procedures in the state dropped from 5,294 in 2000 to 3,636 in 2008, a 31% decrease.

In just 5 years (2004-2008), ambulatory endovascular procedures grew from 3,014 to an estimated 6,670, which Dr. Hong described as "an exponential increase." (The 2008 figure is an annual projection based on data available from the first three quarters of that year.)

In 2008, the number of endovascular interventions in both settings exceeded the number of open bypasses by nearly threefold (12,419 vs. 3,636). Although hospital-based endovascular procedures increased from 2,698 to 5,748 in 2008, "inpatient management ... numbers seem to have plateaued over the last several years," Dr. Hong said.

Dr. Samson commented, "There is a shift for performing these procedures from hospitals to outpatient settings. However, only 3% are being done in freestanding facilities and the rest are at centers affiliated with hospitals." Dr. Hong confirmed that 97% of the ambulatory endovascular interventions were performed at hospital-affiliated centers, but added that some were done at freestanding cardiac catheter centers.

The researchers also assessed amputation numbers and trends. They found a 43% decrease in major amputations (defined as above knee to the ankle), from 2,833 in 2000 to 1,609 in 2008. At the same time, the number of minor amputations (from the forefoot to toe) remained relatively stable, from 1,354 to 1,362. "If you put them together with major amputations, the overall rate is down," Dr. Hong said.

Not surprisingly, the overall shift to ambulatory interventions was associated with "substantially lower charges overall," Dr. Hong said. The total mean charge for open bypass was $62,946, compared with $57,995 for hospital-based endovascular interventions and $32,719 for ambulatory endovascular procedures. Total charges increased each year by approximately 21% in the hospital setting and by 10% in the ambulatory setting, he added.

One potential study limitation is the reliance on coder input into the AHCA (Agency for Health Care Administration) database. "But there is nothing here to suggest any significant adverse problems so far," Dr. Hong said.

Another limitation of the study is that cost-to-charge ratios vary by hospital, Dr. Hong said. He added, however, that "a comparison between procedures still provides a good estimate of relative costs." Because AHCA is an administrative database, there was no clinical information on ankle brachial index or TASC (TransAtlantic Inter-Society Consensus) lesion classification. Also, it is unknown if the deidentified data included patients who underwent multiple procedures.

Dr. Hong and Dr. Samson said that they had no relevant disclosures.

The Food and Drug Administration on Feb. 4 gave clearance to an application for Apple’s iPad and iPhone that will allow physicians to review radiology images in the absence of a standard workstation.

Photo credit: Image supplied by MIM Software Inc.

The FDA cleared the app, named Mobile MIM, for viewing images and making diagnoses using computed tomography, magnetic resonance imaging, and nuclear medicine technology such as positron emission tomography.

The app can measure distance on the image as well as image intensity; it can also display measurement lines, regions of interest, and annotations.

The FDA noted that the luminance displayed by a mobile device can vary greatly, even among identical models. The image’s luminance also can vary based on ambient lighting. The app includes an interactive contrast test that will allow a user to determine whether he or she can properly distinguish subtle differences in contrast.

The Mobile MIM app was created by Cleveland-based MIM Software Inc. The company said on its Web site that the Mobile MIM should be available in Apple’s App Store the week of Feb. 7.

The Food and Drug Administration on Feb. 4 gave clearance to an application for Apple’s iPad and iPhone that will allow physicians to review radiology images in the absence of a standard workstation.

Photo credit: Image supplied by MIM Software Inc.

The FDA cleared the app, named Mobile MIM, for viewing images and making diagnoses using computed tomography, magnetic resonance imaging, and nuclear medicine technology such as positron emission tomography.

The app can measure distance on the image as well as image intensity; it can also display measurement lines, regions of interest, and annotations.

The FDA noted that the luminance displayed by a mobile device can vary greatly, even among identical models. The image’s luminance also can vary based on ambient lighting. The app includes an interactive contrast test that will allow a user to determine whether he or she can properly distinguish subtle differences in contrast.

The Mobile MIM app was created by Cleveland-based MIM Software Inc. The company said on its Web site that the Mobile MIM should be available in Apple’s App Store the week of Feb. 7.

The Food and Drug Administration on Feb. 4 gave clearance to an application for Apple’s iPad and iPhone that will allow physicians to review radiology images in the absence of a standard workstation.

Photo credit: Image supplied by MIM Software Inc.

The FDA cleared the app, named Mobile MIM, for viewing images and making diagnoses using computed tomography, magnetic resonance imaging, and nuclear medicine technology such as positron emission tomography.

The app can measure distance on the image as well as image intensity; it can also display measurement lines, regions of interest, and annotations.

The FDA noted that the luminance displayed by a mobile device can vary greatly, even among identical models. The image’s luminance also can vary based on ambient lighting. The app includes an interactive contrast test that will allow a user to determine whether he or she can properly distinguish subtle differences in contrast.

The Mobile MIM app was created by Cleveland-based MIM Software Inc. The company said on its Web site that the Mobile MIM should be available in Apple’s App Store the week of Feb. 7.