ACS Surgery News

SAN FRANCISCO – Inclacumab, an inhibitor of the P-selectin pathway, may be a novel treatment for reducing myocardial damage after percutaneous coronary intervention for non–ST-elevation myocardial infarction, based on results from a phase-II study.

The trial, SELECT-ACS, is best viewed as a proof-of-concept study utilizing a reduction in biomarkers of myocardial damage as the endpoint, Dr. Jean-Claude Tardif said at the annual meeting of the American College of Cardiology.

Periprocedural myocardial damage, albeit often mild in nature, is common in PCI patients and is due in part to platelet activation and inflammation. The clinical relevance of post-PCI changes in biomarkers of myocardial damage is uncertain. What is clear from SELECT-ACS is that inclacumab is biologically active in NSTEMI patients. Future phase III studies with hard clinical endpoints conducted in patients with or without PCI will be critical to determining the drug’s relevance, he said.

In addition, the results of the ongoing SELECT-CABG study, in which the effects of inclacumab are being studied in patients undergoing surgical revascularization, will be presented later this year, according to Dr. Tardif, professor of medicine and director of research at the Montreal Heart Institute.

Inclacumab is a human recombinant monoclonal antibody that is a highly specific P-selectin antagonist. P-selectin is a cell adhesion molecule known to play a critical role in communication between activated platelets, WBCs, and the arterial wall. In animal studies, P-selectin inhibition reduces platelet stickiness, macrophage accumulation, and neointimal formation after injury.

"The P-selectin pathway is really at the crossroads of thrombosis and inflammation," Dr. Tardif explained. "It’s probably important to see this drug, inclacumab, not only as an antithrombotic but as an anti-inflammatory agent."

In SELECT-ACS, 544 patients with NSTEMI scheduled for coronary angiography and possible PCI were randomized to receive a single 1-hour-long infusion of inclacumab at 5 or 20 mg/kg or a placebo infusion up to 24 hours before their procedure. Most patients received the infusion just a few hours before angiography.

The primary study endpoint in SELECT-ACS was change in troponin I level from baseline at 16 and 24 hours post-PCI, compared with placebo. Thus, the analysis was restricted to the 322 study participants who underwent PCI. The medically managed SELECT-ACS participants treated with inclacumab will be the subject of a future report.

In the inclacumab 20 mg/kg group, the drop in troponin I was 22% greater than seen in placebo-treated controls at 16 hours and 24% greater at 24 hours. Peak troponin I level was reduced by 24% relative to placebo, and the area under the curve over a 24-hour span was reduced by 34%.

In addition, the decrease in creatine kinase MB (CK-MB) fraction was 16% greater with inclacumab 20 mg/kg than with placebo at 16 hours, and it also showed a 17% greater decrease at 24 hours. The incidence of a CK-MB rise greater than three times the upper limit of normal within the first 24 hours following PCI was 8.9% with inclacumab 20 mg/kg, compared with 18% with placebo. Moreover, soluble P-selectin levels were 22% lower in the inclacumab 20 mg/kg group than in controls.

Inclacumab at 5 mg/kg had no effect.

The pattern and intensity of adverse events were similar in the inclacumab and placebo groups. Given the dual antithrombotic and anti-inflammatory effects of P-selectin inhibition, it’s encouraging to note that the inclacumab-treated patients had no increase in bleeding or infections, Dr. Tardif said.

The study was funded by F. Hoffmann-La Roche. Dr. Tardif reported having no relevant financial interests.

Simultaneous with Dr. Tardif’s presentation of the SELECT-ACS findings in San Francisco, the study was published online (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jaac.2013.03.003]).

[email protected]

SAN FRANCISCO – Inclacumab, an inhibitor of the P-selectin pathway, may be a novel treatment for reducing myocardial damage after percutaneous coronary intervention for non–ST-elevation myocardial infarction, based on results from a phase-II study.

The trial, SELECT-ACS, is best viewed as a proof-of-concept study utilizing a reduction in biomarkers of myocardial damage as the endpoint, Dr. Jean-Claude Tardif said at the annual meeting of the American College of Cardiology.

Periprocedural myocardial damage, albeit often mild in nature, is common in PCI patients and is due in part to platelet activation and inflammation. The clinical relevance of post-PCI changes in biomarkers of myocardial damage is uncertain. What is clear from SELECT-ACS is that inclacumab is biologically active in NSTEMI patients. Future phase III studies with hard clinical endpoints conducted in patients with or without PCI will be critical to determining the drug’s relevance, he said.

In addition, the results of the ongoing SELECT-CABG study, in which the effects of inclacumab are being studied in patients undergoing surgical revascularization, will be presented later this year, according to Dr. Tardif, professor of medicine and director of research at the Montreal Heart Institute.

Inclacumab is a human recombinant monoclonal antibody that is a highly specific P-selectin antagonist. P-selectin is a cell adhesion molecule known to play a critical role in communication between activated platelets, WBCs, and the arterial wall. In animal studies, P-selectin inhibition reduces platelet stickiness, macrophage accumulation, and neointimal formation after injury.

"The P-selectin pathway is really at the crossroads of thrombosis and inflammation," Dr. Tardif explained. "It’s probably important to see this drug, inclacumab, not only as an antithrombotic but as an anti-inflammatory agent."

In SELECT-ACS, 544 patients with NSTEMI scheduled for coronary angiography and possible PCI were randomized to receive a single 1-hour-long infusion of inclacumab at 5 or 20 mg/kg or a placebo infusion up to 24 hours before their procedure. Most patients received the infusion just a few hours before angiography.

The primary study endpoint in SELECT-ACS was change in troponin I level from baseline at 16 and 24 hours post-PCI, compared with placebo. Thus, the analysis was restricted to the 322 study participants who underwent PCI. The medically managed SELECT-ACS participants treated with inclacumab will be the subject of a future report.

In the inclacumab 20 mg/kg group, the drop in troponin I was 22% greater than seen in placebo-treated controls at 16 hours and 24% greater at 24 hours. Peak troponin I level was reduced by 24% relative to placebo, and the area under the curve over a 24-hour span was reduced by 34%.

In addition, the decrease in creatine kinase MB (CK-MB) fraction was 16% greater with inclacumab 20 mg/kg than with placebo at 16 hours, and it also showed a 17% greater decrease at 24 hours. The incidence of a CK-MB rise greater than three times the upper limit of normal within the first 24 hours following PCI was 8.9% with inclacumab 20 mg/kg, compared with 18% with placebo. Moreover, soluble P-selectin levels were 22% lower in the inclacumab 20 mg/kg group than in controls.

Inclacumab at 5 mg/kg had no effect.

The pattern and intensity of adverse events were similar in the inclacumab and placebo groups. Given the dual antithrombotic and anti-inflammatory effects of P-selectin inhibition, it’s encouraging to note that the inclacumab-treated patients had no increase in bleeding or infections, Dr. Tardif said.

The study was funded by F. Hoffmann-La Roche. Dr. Tardif reported having no relevant financial interests.

Simultaneous with Dr. Tardif’s presentation of the SELECT-ACS findings in San Francisco, the study was published online (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jaac.2013.03.003]).

[email protected]

SAN FRANCISCO – Inclacumab, an inhibitor of the P-selectin pathway, may be a novel treatment for reducing myocardial damage after percutaneous coronary intervention for non–ST-elevation myocardial infarction, based on results from a phase-II study.

The trial, SELECT-ACS, is best viewed as a proof-of-concept study utilizing a reduction in biomarkers of myocardial damage as the endpoint, Dr. Jean-Claude Tardif said at the annual meeting of the American College of Cardiology.

Periprocedural myocardial damage, albeit often mild in nature, is common in PCI patients and is due in part to platelet activation and inflammation. The clinical relevance of post-PCI changes in biomarkers of myocardial damage is uncertain. What is clear from SELECT-ACS is that inclacumab is biologically active in NSTEMI patients. Future phase III studies with hard clinical endpoints conducted in patients with or without PCI will be critical to determining the drug’s relevance, he said.

In addition, the results of the ongoing SELECT-CABG study, in which the effects of inclacumab are being studied in patients undergoing surgical revascularization, will be presented later this year, according to Dr. Tardif, professor of medicine and director of research at the Montreal Heart Institute.

Inclacumab is a human recombinant monoclonal antibody that is a highly specific P-selectin antagonist. P-selectin is a cell adhesion molecule known to play a critical role in communication between activated platelets, WBCs, and the arterial wall. In animal studies, P-selectin inhibition reduces platelet stickiness, macrophage accumulation, and neointimal formation after injury.

"The P-selectin pathway is really at the crossroads of thrombosis and inflammation," Dr. Tardif explained. "It’s probably important to see this drug, inclacumab, not only as an antithrombotic but as an anti-inflammatory agent."

In SELECT-ACS, 544 patients with NSTEMI scheduled for coronary angiography and possible PCI were randomized to receive a single 1-hour-long infusion of inclacumab at 5 or 20 mg/kg or a placebo infusion up to 24 hours before their procedure. Most patients received the infusion just a few hours before angiography.

The primary study endpoint in SELECT-ACS was change in troponin I level from baseline at 16 and 24 hours post-PCI, compared with placebo. Thus, the analysis was restricted to the 322 study participants who underwent PCI. The medically managed SELECT-ACS participants treated with inclacumab will be the subject of a future report.

In the inclacumab 20 mg/kg group, the drop in troponin I was 22% greater than seen in placebo-treated controls at 16 hours and 24% greater at 24 hours. Peak troponin I level was reduced by 24% relative to placebo, and the area under the curve over a 24-hour span was reduced by 34%.

In addition, the decrease in creatine kinase MB (CK-MB) fraction was 16% greater with inclacumab 20 mg/kg than with placebo at 16 hours, and it also showed a 17% greater decrease at 24 hours. The incidence of a CK-MB rise greater than three times the upper limit of normal within the first 24 hours following PCI was 8.9% with inclacumab 20 mg/kg, compared with 18% with placebo. Moreover, soluble P-selectin levels were 22% lower in the inclacumab 20 mg/kg group than in controls.

Inclacumab at 5 mg/kg had no effect.

The pattern and intensity of adverse events were similar in the inclacumab and placebo groups. Given the dual antithrombotic and anti-inflammatory effects of P-selectin inhibition, it’s encouraging to note that the inclacumab-treated patients had no increase in bleeding or infections, Dr. Tardif said.

The study was funded by F. Hoffmann-La Roche. Dr. Tardif reported having no relevant financial interests.

Simultaneous with Dr. Tardif’s presentation of the SELECT-ACS findings in San Francisco, the study was published online (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jaac.2013.03.003]).

[email protected]

SCOTTSDALE, ARIZ. – Despite thromboprophylaxis, burn patients become hypercoagulable during recovery, putting them at increased risk of venous thromboembolism, a small, prospective study has shown.

"The hypercoagulable state is likely multifactorial, and we believe that additional prophylaxis and monitoring may be needed," Dr. Robert Van Haren said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Patrice Wendling/IMNG Medical Media

Hypercoagulability has long been known to contribute to venous thromboembolism (VTE), but it’s only more recently that the increased incidence of thromboembolic complications in burn patients has been appreciated.

A study using duplex ultrasound screening reported that 23% of burn patients developed deep venous thrombosis at an average of 6.7 days after admission (J. Burn Care Rehabil. 2002;23:439-43).

More recent work reports that such in-hospital risk factors as number of operations, pneumonia, and central venous access are significantly associated with VTE after thermal injury (J. Burn Care Res. 2012;33:84-8).

Dr. Van Haren and his colleagues at the University of Miami used thromboelastography (TEG) and coagulation tests to analyze blood samples drawn from indwelling catheters upon admission and at 1 week in 24 patients. All patients were placed on unfractionated or low-molecular-weight heparin at admission.

Their median age was 49 years, 88% were male, and the median total body surface area burned was 29%. Inhalation injuries also were present in 17%.

TEG values were within normal limits at admission for clotting time (R = 11.5 minutes), initial clot formation (K = 2.8 minutes), clot kinetics (alpha angle = 54.6 degrees), and clot strength (maximum amplitude = 62.5 mm).

Repeat TEG at 1 week in 16 patients who remained hospitalized revealed significantly decreased R (8.3 minutes) and K (2.0 minutes) times, and elevated alpha angle (65.5 degrees) and maximum amplitude (73.1 mm; all statistically significant, P less than .05).

"All of these changes demonstrate that these patients became more hypercoagulable at week 1," said Dr. Van Haren, a 4th-year general surgery resident.

Coagulation tests were generally supportive of TEG findings. From admission to week 1, significant decreases were observed in median prothrombin time (17.4 seconds vs. 15.7 seconds; P = .013) and international normalized ratio (1.47 vs. 1.28; P = .013). At the same time, significant elevations occurred in protein C activity (75% vs. 93%; P = .017), protein S activity (69% vs. 76%; P = .030), antithrombin III (62% vs. 88%; P = .005), and fibrinogen (524 mg/dL vs. 676 mg/dL; P = .047).

The changes suggest a procoagulant state, and cannot be attributed to hemoconcentration, as fluid balance was more positive and hematocrit was lower on repeat samples, Dr. Van Haren reported.

The only in-hospital risk factor significant for hypercoagulability at 1 week was a pre-TEG operation, he said. Men, however, were more likely to be hypercoagulable than women.

Two patients, both male, developed a deep venous thrombosis. Contrary to previous studies, the only predictive markers of VTE were decreased partial thromboplastin time and fibrinogen and elevated prothrombin fragment 1 + 2.

During the discussion period after Dr. Van Haren’s presentation, audience members asked why hypercoagulability was evaluated at 1 week, since hypercoagulability has been shown to develop quite rapidly in trauma patients. Other questions addressed whether clinicians should use the data to increase thromboprophylaxis or begin dosing based on body mass index in burn patients.

Dr. Van Haren said the 1-week time point was somewhat arbitrary, and plans to look at earlier time periods in another cohort to determine exactly when the transition to hypercoagulability occurs. "I think the most interesting thing would be to see if you can guide your thromboprophylaxis based on TEG, and use it to titrate your dose to see if it will result in decreases in VTE rates."

The study was funded in part by grants from the Office of Naval Research and U.S. Army. Dr. Van Haren and his coauthors reported no relevant financial conflicts.

[email protected]

SCOTTSDALE, ARIZ. – Despite thromboprophylaxis, burn patients become hypercoagulable during recovery, putting them at increased risk of venous thromboembolism, a small, prospective study has shown.

"The hypercoagulable state is likely multifactorial, and we believe that additional prophylaxis and monitoring may be needed," Dr. Robert Van Haren said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Patrice Wendling/IMNG Medical Media

Hypercoagulability has long been known to contribute to venous thromboembolism (VTE), but it’s only more recently that the increased incidence of thromboembolic complications in burn patients has been appreciated.

A study using duplex ultrasound screening reported that 23% of burn patients developed deep venous thrombosis at an average of 6.7 days after admission (J. Burn Care Rehabil. 2002;23:439-43).

More recent work reports that such in-hospital risk factors as number of operations, pneumonia, and central venous access are significantly associated with VTE after thermal injury (J. Burn Care Res. 2012;33:84-8).

Dr. Van Haren and his colleagues at the University of Miami used thromboelastography (TEG) and coagulation tests to analyze blood samples drawn from indwelling catheters upon admission and at 1 week in 24 patients. All patients were placed on unfractionated or low-molecular-weight heparin at admission.

Their median age was 49 years, 88% were male, and the median total body surface area burned was 29%. Inhalation injuries also were present in 17%.

TEG values were within normal limits at admission for clotting time (R = 11.5 minutes), initial clot formation (K = 2.8 minutes), clot kinetics (alpha angle = 54.6 degrees), and clot strength (maximum amplitude = 62.5 mm).

Repeat TEG at 1 week in 16 patients who remained hospitalized revealed significantly decreased R (8.3 minutes) and K (2.0 minutes) times, and elevated alpha angle (65.5 degrees) and maximum amplitude (73.1 mm; all statistically significant, P less than .05).

"All of these changes demonstrate that these patients became more hypercoagulable at week 1," said Dr. Van Haren, a 4th-year general surgery resident.

Coagulation tests were generally supportive of TEG findings. From admission to week 1, significant decreases were observed in median prothrombin time (17.4 seconds vs. 15.7 seconds; P = .013) and international normalized ratio (1.47 vs. 1.28; P = .013). At the same time, significant elevations occurred in protein C activity (75% vs. 93%; P = .017), protein S activity (69% vs. 76%; P = .030), antithrombin III (62% vs. 88%; P = .005), and fibrinogen (524 mg/dL vs. 676 mg/dL; P = .047).

The changes suggest a procoagulant state, and cannot be attributed to hemoconcentration, as fluid balance was more positive and hematocrit was lower on repeat samples, Dr. Van Haren reported.

The only in-hospital risk factor significant for hypercoagulability at 1 week was a pre-TEG operation, he said. Men, however, were more likely to be hypercoagulable than women.

Two patients, both male, developed a deep venous thrombosis. Contrary to previous studies, the only predictive markers of VTE were decreased partial thromboplastin time and fibrinogen and elevated prothrombin fragment 1 + 2.

During the discussion period after Dr. Van Haren’s presentation, audience members asked why hypercoagulability was evaluated at 1 week, since hypercoagulability has been shown to develop quite rapidly in trauma patients. Other questions addressed whether clinicians should use the data to increase thromboprophylaxis or begin dosing based on body mass index in burn patients.

Dr. Van Haren said the 1-week time point was somewhat arbitrary, and plans to look at earlier time periods in another cohort to determine exactly when the transition to hypercoagulability occurs. "I think the most interesting thing would be to see if you can guide your thromboprophylaxis based on TEG, and use it to titrate your dose to see if it will result in decreases in VTE rates."

The study was funded in part by grants from the Office of Naval Research and U.S. Army. Dr. Van Haren and his coauthors reported no relevant financial conflicts.

[email protected]

SCOTTSDALE, ARIZ. – Despite thromboprophylaxis, burn patients become hypercoagulable during recovery, putting them at increased risk of venous thromboembolism, a small, prospective study has shown.

"The hypercoagulable state is likely multifactorial, and we believe that additional prophylaxis and monitoring may be needed," Dr. Robert Van Haren said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Patrice Wendling/IMNG Medical Media

Hypercoagulability has long been known to contribute to venous thromboembolism (VTE), but it’s only more recently that the increased incidence of thromboembolic complications in burn patients has been appreciated.

A study using duplex ultrasound screening reported that 23% of burn patients developed deep venous thrombosis at an average of 6.7 days after admission (J. Burn Care Rehabil. 2002;23:439-43).

More recent work reports that such in-hospital risk factors as number of operations, pneumonia, and central venous access are significantly associated with VTE after thermal injury (J. Burn Care Res. 2012;33:84-8).

Dr. Van Haren and his colleagues at the University of Miami used thromboelastography (TEG) and coagulation tests to analyze blood samples drawn from indwelling catheters upon admission and at 1 week in 24 patients. All patients were placed on unfractionated or low-molecular-weight heparin at admission.

Their median age was 49 years, 88% were male, and the median total body surface area burned was 29%. Inhalation injuries also were present in 17%.

TEG values were within normal limits at admission for clotting time (R = 11.5 minutes), initial clot formation (K = 2.8 minutes), clot kinetics (alpha angle = 54.6 degrees), and clot strength (maximum amplitude = 62.5 mm).

Repeat TEG at 1 week in 16 patients who remained hospitalized revealed significantly decreased R (8.3 minutes) and K (2.0 minutes) times, and elevated alpha angle (65.5 degrees) and maximum amplitude (73.1 mm; all statistically significant, P less than .05).

"All of these changes demonstrate that these patients became more hypercoagulable at week 1," said Dr. Van Haren, a 4th-year general surgery resident.

Coagulation tests were generally supportive of TEG findings. From admission to week 1, significant decreases were observed in median prothrombin time (17.4 seconds vs. 15.7 seconds; P = .013) and international normalized ratio (1.47 vs. 1.28; P = .013). At the same time, significant elevations occurred in protein C activity (75% vs. 93%; P = .017), protein S activity (69% vs. 76%; P = .030), antithrombin III (62% vs. 88%; P = .005), and fibrinogen (524 mg/dL vs. 676 mg/dL; P = .047).

The changes suggest a procoagulant state, and cannot be attributed to hemoconcentration, as fluid balance was more positive and hematocrit was lower on repeat samples, Dr. Van Haren reported.

The only in-hospital risk factor significant for hypercoagulability at 1 week was a pre-TEG operation, he said. Men, however, were more likely to be hypercoagulable than women.

Two patients, both male, developed a deep venous thrombosis. Contrary to previous studies, the only predictive markers of VTE were decreased partial thromboplastin time and fibrinogen and elevated prothrombin fragment 1 + 2.

During the discussion period after Dr. Van Haren’s presentation, audience members asked why hypercoagulability was evaluated at 1 week, since hypercoagulability has been shown to develop quite rapidly in trauma patients. Other questions addressed whether clinicians should use the data to increase thromboprophylaxis or begin dosing based on body mass index in burn patients.

Dr. Van Haren said the 1-week time point was somewhat arbitrary, and plans to look at earlier time periods in another cohort to determine exactly when the transition to hypercoagulability occurs. "I think the most interesting thing would be to see if you can guide your thromboprophylaxis based on TEG, and use it to titrate your dose to see if it will result in decreases in VTE rates."

The study was funded in part by grants from the Office of Naval Research and U.S. Army. Dr. Van Haren and his coauthors reported no relevant financial conflicts.

[email protected]

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.

The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.

At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.

No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.

All stent fractures were type 1, with no incidents of type II-V fractures, he reported.

Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.

Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.

All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.

The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.

The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.

The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.

In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.

Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.

In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.

The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.

The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.

Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.

Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

An estimated 55 million U.S. adults – or 30% of those aged 19-64 years – were without health insurance coverage at some point last year, according to the Commonwealth Fund’s biennial survey of health insurance.

Another 30 million (16%) were considered underinsured because their out-of-pocket health care costs were high relative to income.

Many uninsured and underinsured adults also faced significant medical debt or had trouble affording health care visits and prescriptions, according to the report.

"The costs of health care and health coverage in the United States have been on an unsustainable upward trajectory over several decades, straining family and government budgets," Dr. David Blumenthal, president of the Commonwealth Fund, said during a press conference April 25.

When it comes to young adults, those aged 19-25 years, the rate of uninsurance has actually fallen – from 48% in 2010 to 41% in 2012. The researchers said the Affordable Care Act (ACA), which includes a provision allowing adults under age 26 to stay on their parents’ health plan if they can’t gain employer-sponsored insurance, is likely the reason behind the upswing in coverage in this group.

Other Americans are likely to gain coverage starting in January 2014, when most of the insurance coverage expansions of the ACA begin to take effect, Dr. Blumenthal said.

"Our expectation is that we will begin to see positive changes in our health care system when the major coverage provisions of the law launch in 2014," Dr. Blumenthal said. "But the changes won’t happen overnight."

Of the 55 million adults who were uninsured in the 2012 survey, about 87% would be eligible either for Medicaid or for a federal subsidy to help with the purchase of insurance under the ACA, according to the Commonwealth Fund. However, not everyone who is eligible for the benefits will take advantage of them because either they do not know they are eligible, they can’t find a premium they can afford, or they choose not to enroll. Also, following the Supreme Court decision on the ACA in 2012, states are not required to expand their Medicaid programs up to 133% of the federal poverty level, so there is likely to be patchwork of Medicaid coverage across the country.

In the meantime, U.S. adults who are uninsured or underinsured are having problems accessing care and paying medical bills.

The survey found that 43% of U.S. adults were missing out on necessary care due to cost, up from 37% in 2003. For instance, some people reported that they didn’t visit a doctor when they were sick, skipped recommended tests, or failed to fill prescriptions because of concerns about the cost.

The cost of health care was a significant barrier to access for Americans who were uninsured or underinsured. But it was also a problem for some adults with adequate insurance. Among those with adequate insurance, 28% reported cost-related problems.

Medical debt also continues to be a problem. In 2012, 41% of U.S. adults reported problems paying their medical bills or said they were paying off medical debt over time. Of those adults who had trouble paying their medical bills, 42% said they had received a lower credit rating as a result and 37% reported that they had used all of their savings in an attempt to pay off their medical bills.

The findings are based on a telephone survey conducted from April 26 to Aug. 19, 2012, of a nationally representative sample of more than 4,400 adults aged 19-64 years.

[email protected]

SAN DIEGO – The total recurrence rate of ovarian dermoid cysts in a pediatric and adolescent population following cystectomy is 11%, and evidence of recurrence that requires a second operative management is 3%.

Moreover, the method of surgical intervention – laparoscopy or laparotomy – does not appear to influence the rate of cyst recurrence, Erin Rogers reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dermoid cysts can represent up to 70% of benign ovarian tumors in women under age 30, said Ms. Rogers, a medical student at Queens University, Kingston, Ontario, Canada. "They have a slow growth rate and on average have been seen to grow at 1.8 mm per year."

The general presentation is an asymptomatic woman who has dermoid cysts that are discovered incidentally through imaging for other reasons. However, some patients can present with abdominal pain or an abdominal mass, she said.

The preferred way to image dermoid cysts is by ultrasound. Clinicians "manage them expectantly if they’re small and not growing that quickly," Ms. Rogers said. "Expectant management involves routine imaging every 6-12 months. Surgery is generally indicated if the cysts reach 4-5 cm in size or if they grow at a rate greater than 2 cm per year. Surgical management includes cystectomy or laparoscopy."

In a study conducted at the Hospital for Sick Children in Toronto, Ms. Rogers and her associates set out to determine the rate of dermoid cyst recurrence after cystectomy in a pediatric/adolescent population; evaluate if the mode of surgery impacts the rate of recurrence; and develop a postsurgical follow-up protocol for dermoid cysts. They retrospectively evaluated 66 patients under age 18 treated with dermoid cystectomy at the hospital between January 2003 and June 2012. Data collected included follow-up information, imaging, and demographic information. Recurrence was defined as any evidence of dermoid cyst on postoperative imaging.

The average age of patients at the time of surgery was 13 years, and the initial cyst size was an average of 8 cm. More than half of patients (61%) underwent laparoscopy, and the rest underwent laparotomy. The follow-up for patients "was quite varied," she said. "This is because the management of these patients is at the discretion of the managing physician." More than one-third of patients (39%) were followed with a single postoperative visit and no ultrasound imaging; 9% were followed with a single follow-up visit and ultrasound; and 53% were followed annually with a follow-up visit and ultrasound.

Seven of the 66 patients had a recurrence (11%). Of the patients with a recurrence, 5 were treated expectantly with imaging alone and 2 were followed with a second operation.

Recurrence occurred in 15% of patients treated with laparoscopy and 4% of patients treated with laparotomy, a difference that did not reach significance (P = .23). However, about 5% of patients who were treated initially with a laparoscopic procedure showed evidence of recurrence that required a second surgery, while none who were treated with a laparotomy showed evidence of recurrence that required a second surgery.

Based on the study results, Ms. Rogers and her associates propose that dermoid cysts treated with cystectomy should involve a single follow-up visit with an ultrasound 12 months postoperatively. "At that time, if there is no dermoid cyst on ultrasound, these patients can be discharged to the care of their family physician or pediatrician and advised to seek medical attention if they have any symptoms that may suggest recurrence," she said. If a dermoid cyst or a cyst of unknown origin is seen on ultrasound, "we suggest that they be followed with a second ultrasound in 3-6 months. If there is no evidence of a dermoid cyst at that time, that cyst can be presumed to have been a functional cyst, and patients can seek medical attention as needed. However, if a dermoid cyst is seen on ultrasound, we suggest they be treated expectantly, with repeat ultrasounds every 6-12 months. We can consider surgery if they become symptomatic or seem to grow at a rapid rate."

Ms. Rogers said that she had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – The total recurrence rate of ovarian dermoid cysts in a pediatric and adolescent population following cystectomy is 11%, and evidence of recurrence that requires a second operative management is 3%.

Moreover, the method of surgical intervention – laparoscopy or laparotomy – does not appear to influence the rate of cyst recurrence, Erin Rogers reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dermoid cysts can represent up to 70% of benign ovarian tumors in women under age 30, said Ms. Rogers, a medical student at Queens University, Kingston, Ontario, Canada. "They have a slow growth rate and on average have been seen to grow at 1.8 mm per year."

The general presentation is an asymptomatic woman who has dermoid cysts that are discovered incidentally through imaging for other reasons. However, some patients can present with abdominal pain or an abdominal mass, she said.

The preferred way to image dermoid cysts is by ultrasound. Clinicians "manage them expectantly if they’re small and not growing that quickly," Ms. Rogers said. "Expectant management involves routine imaging every 6-12 months. Surgery is generally indicated if the cysts reach 4-5 cm in size or if they grow at a rate greater than 2 cm per year. Surgical management includes cystectomy or laparoscopy."

In a study conducted at the Hospital for Sick Children in Toronto, Ms. Rogers and her associates set out to determine the rate of dermoid cyst recurrence after cystectomy in a pediatric/adolescent population; evaluate if the mode of surgery impacts the rate of recurrence; and develop a postsurgical follow-up protocol for dermoid cysts. They retrospectively evaluated 66 patients under age 18 treated with dermoid cystectomy at the hospital between January 2003 and June 2012. Data collected included follow-up information, imaging, and demographic information. Recurrence was defined as any evidence of dermoid cyst on postoperative imaging.

The average age of patients at the time of surgery was 13 years, and the initial cyst size was an average of 8 cm. More than half of patients (61%) underwent laparoscopy, and the rest underwent laparotomy. The follow-up for patients "was quite varied," she said. "This is because the management of these patients is at the discretion of the managing physician." More than one-third of patients (39%) were followed with a single postoperative visit and no ultrasound imaging; 9% were followed with a single follow-up visit and ultrasound; and 53% were followed annually with a follow-up visit and ultrasound.

Seven of the 66 patients had a recurrence (11%). Of the patients with a recurrence, 5 were treated expectantly with imaging alone and 2 were followed with a second operation.

Recurrence occurred in 15% of patients treated with laparoscopy and 4% of patients treated with laparotomy, a difference that did not reach significance (P = .23). However, about 5% of patients who were treated initially with a laparoscopic procedure showed evidence of recurrence that required a second surgery, while none who were treated with a laparotomy showed evidence of recurrence that required a second surgery.

Based on the study results, Ms. Rogers and her associates propose that dermoid cysts treated with cystectomy should involve a single follow-up visit with an ultrasound 12 months postoperatively. "At that time, if there is no dermoid cyst on ultrasound, these patients can be discharged to the care of their family physician or pediatrician and advised to seek medical attention if they have any symptoms that may suggest recurrence," she said. If a dermoid cyst or a cyst of unknown origin is seen on ultrasound, "we suggest that they be followed with a second ultrasound in 3-6 months. If there is no evidence of a dermoid cyst at that time, that cyst can be presumed to have been a functional cyst, and patients can seek medical attention as needed. However, if a dermoid cyst is seen on ultrasound, we suggest they be treated expectantly, with repeat ultrasounds every 6-12 months. We can consider surgery if they become symptomatic or seem to grow at a rapid rate."

Ms. Rogers said that she had no relevant financial conflicts to disclose.

[email protected]

SAN DIEGO – The total recurrence rate of ovarian dermoid cysts in a pediatric and adolescent population following cystectomy is 11%, and evidence of recurrence that requires a second operative management is 3%.

Moreover, the method of surgical intervention – laparoscopy or laparotomy – does not appear to influence the rate of cyst recurrence, Erin Rogers reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Dermoid cysts can represent up to 70% of benign ovarian tumors in women under age 30, said Ms. Rogers, a medical student at Queens University, Kingston, Ontario, Canada. "They have a slow growth rate and on average have been seen to grow at 1.8 mm per year."

The general presentation is an asymptomatic woman who has dermoid cysts that are discovered incidentally through imaging for other reasons. However, some patients can present with abdominal pain or an abdominal mass, she said.

The preferred way to image dermoid cysts is by ultrasound. Clinicians "manage them expectantly if they’re small and not growing that quickly," Ms. Rogers said. "Expectant management involves routine imaging every 6-12 months. Surgery is generally indicated if the cysts reach 4-5 cm in size or if they grow at a rate greater than 2 cm per year. Surgical management includes cystectomy or laparoscopy."

In a study conducted at the Hospital for Sick Children in Toronto, Ms. Rogers and her associates set out to determine the rate of dermoid cyst recurrence after cystectomy in a pediatric/adolescent population; evaluate if the mode of surgery impacts the rate of recurrence; and develop a postsurgical follow-up protocol for dermoid cysts. They retrospectively evaluated 66 patients under age 18 treated with dermoid cystectomy at the hospital between January 2003 and June 2012. Data collected included follow-up information, imaging, and demographic information. Recurrence was defined as any evidence of dermoid cyst on postoperative imaging.

The average age of patients at the time of surgery was 13 years, and the initial cyst size was an average of 8 cm. More than half of patients (61%) underwent laparoscopy, and the rest underwent laparotomy. The follow-up for patients "was quite varied," she said. "This is because the management of these patients is at the discretion of the managing physician." More than one-third of patients (39%) were followed with a single postoperative visit and no ultrasound imaging; 9% were followed with a single follow-up visit and ultrasound; and 53% were followed annually with a follow-up visit and ultrasound.

Seven of the 66 patients had a recurrence (11%). Of the patients with a recurrence, 5 were treated expectantly with imaging alone and 2 were followed with a second operation.

Recurrence occurred in 15% of patients treated with laparoscopy and 4% of patients treated with laparotomy, a difference that did not reach significance (P = .23). However, about 5% of patients who were treated initially with a laparoscopic procedure showed evidence of recurrence that required a second surgery, while none who were treated with a laparotomy showed evidence of recurrence that required a second surgery.

Based on the study results, Ms. Rogers and her associates propose that dermoid cysts treated with cystectomy should involve a single follow-up visit with an ultrasound 12 months postoperatively. "At that time, if there is no dermoid cyst on ultrasound, these patients can be discharged to the care of their family physician or pediatrician and advised to seek medical attention if they have any symptoms that may suggest recurrence," she said. If a dermoid cyst or a cyst of unknown origin is seen on ultrasound, "we suggest that they be followed with a second ultrasound in 3-6 months. If there is no evidence of a dermoid cyst at that time, that cyst can be presumed to have been a functional cyst, and patients can seek medical attention as needed. However, if a dermoid cyst is seen on ultrasound, we suggest they be treated expectantly, with repeat ultrasounds every 6-12 months. We can consider surgery if they become symptomatic or seem to grow at a rapid rate."

Ms. Rogers said that she had no relevant financial conflicts to disclose.

[email protected]

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

CHARLESTON, S.C. – Obese women are at greater risk of complications from hysterectomy than are nonobese women, but the difference is primarily related to minor complications, according to findings from a large retrospective cohort study.

Of 907 women who underwent hysterectomy at a single center between July 2006 and January 2009, 267 (29%) were obese. Overall, 154 of the patients had at least one complication. After the investigators adjusted for race, prior cesarean section, malignancy, concomitant procedures, and previous surgeries, the obese women were found to be significantly more likely than the nonobese women to experience any complication (adjusted odds ratio, 1.62), Dr. Kristen A. Matteson reported at the annual meeting of the Society of Gynecologic Surgeons.

However, this was secondary to an increased odds of minor complications (adjusted OR, 1.69), not major complications (adjusted OR, 1.06), according to Dr. Matteson of the Women and Infants Hospital of Rhode Island and Brown University, both in Providence, R.I.

In the 142 obese women in the study who underwent hysterectomy for benign indications, but had no concomitant procedures, the minor complication rate was greatest with abdominal hysterectomy (23.3%), followed by laparoscopic hysterectomy (12.6%). No complications occurred in those who underwent vaginal hysterectomy, but the differences between the groups with respect to minor complications were not statistically significant.

"No difference was seen in major complication rates in this subgroup," Dr. Matteson said at the meeting, which was jointly sponsored by the American College of Surgeons.

Patients included in the study were all those who underwent laparoscopic hysterectomy at the Women and Infants Hospital during the study period, as well as a random subset of women who underwent abdominal and vaginal hysterectomies, who were selected as comparators. Obesity was determined based on body mass index and according to World Health Organization guidelines.

Minor complications included conversion to laparotomy, wound cellulitis, need for transfusion, prolonged surgery, and length of hospitalization above the 90th percentile. Major complications included bowel injury, blood vessel injury, trocar site hernia, pelvic hematoma, vaginal nonhealing, need for reoperation, pelvic infection, urinary tract infection, sepsis, and thromboembolic event.

The findings are important given that approximately 600,000 hysterectomies are performed in the United States each year, according to the Centers for Disease Control and Prevention, and given that the prevalence of obesity is skyrocketing, Dr. Matteson said, explaining that a better understanding of the complications associated with hysterectomy in obese women could facilitate patient counseling about the risks.

Dr. Matteson reported having no relevant financial disclosures.

NATIONAL HARBOR, MD. – Small surgical margins can mean big trouble for patients with breast cancer, said investigators at the annual Society of Surgical Oncology Cancer Symposium.

A retrospective study of outcomes for 2,377 women who underwent either breast-conserving therapy or mastectomy revealed that margins less than 2 mm resulted in a substantial risk of residual disease for all patients, reported Dr. Erin Garvey, a general surgery resident at Mayo Clinic Arizona in Phoenix.

"A policy of re-excision for margins less than 2 mm, coupled with a standardized multidisciplinary approach to breast cancer surgery, results in excellent re-excision and 5-year local recurrence rates. The local recurrence rate is higher, however, for those patients who complete breast-conserving therapy, thus warranting appropriate patient counseling regarding re-excision options and long-term outcome expectations," she said.

In a separate study, investigators from the University of Texas M.D. Anderson Cancer Center, Houston, reported 10-year follow-up data for women who opted for mastectomy to treat ductal carcinoma in situ (DCIS). They found that the incidence of local-regional recurrence (LRR) increased as the surgical margins shrank, and that close margins were the only independent predictor of LRR, reported Dr. Elizabeth FitzSullivan, a surgery fellow at M.D. Anderson.

"However, the local-regional recurrence rate in these patients is so low that routine postmastectomy radiation therapy is not warranted," she said.

No accord on margins

Despite multiple studies and meta-analyses, there is no standard for acceptable margin width in breast cancer, and surveys of both surgeons and radiation oncologists have shown wide variations in preferred margin widths, Dr. Garvey said.

Her group hypothesized that patients with invasive ductal carcinoma without an extensive in situ component who had surgical margins of at least 1 mm would have no evidence of residual disease on re-excision.

To test the idea, they took a retrospective look at records from a prospective database on 2,377 patients who underwent a total of 2,520 procedures from January 2000 through May 2012.

Of this group, 1,498 (63%) underwent lumpectomy, and 180 (12%) required re-excision surgery: 10% who had breast-conserving surgery alone, and 2% whose surgeries were converted to mastectomies. Of the 158 patients who had completed breast-conserving therapy following re-excision, 50 (32%) had residual disease, as did 20 of the 27 patients whose procedures were converted to mastectomies.

Of the 37% (879) who had up-front mastectomies, 2% (19) had re-excision, and of this group, 5 patients had residual disease.

In all, 40% of patients with positive margins had residual disease, compared with 38% of those with margins from 0.1 to 0.9 mm, and 33% for those with margins from 1.0 to 1.9 mm.

In univariate analysis, the presence of residual disease on re-excision did not show any significant association with age, race, menopausal status, width of the closest final margin, hormone receptor status, tumor histology, triple-negative disease, or the presence of angiolymphatic invasion. There was a trend, albeit nonsignificant, toward an association between residual disease and more than one margin narrower than 2 mm, Dr. Garvey noted.

At a median follow-up of 43 months (range, 0-140 months), 5-year local recurrence rates were 1.9% for patients who had breast-conserving therapy, and 1.1% for those who had mastectomy.

Patients who underwent breast-conserving therapy without re-excision had a 5-year local recurrence rate of 1.8%, compared with 4.3% for those who required re-excision, and 0% for those whose procedures were converted to mastectomy.

There was a nonsignificant trend toward higher local recurrence rates for breast-conserving therapy in patients who had re-excisions, which became significant when those patients who had conversion to mastectomy were excluded, with a hazard ratio compared with no re-excision of 2.56 (P = .04).

Narrower margins, larger risk

Dr. FitzSullivan and her M.D. Anderson colleagues reviewed the records of 810 women treated with mastectomy for DCIS from 1996 to 2009. They looked at the final width of histologic margins, defining disease-free margins as those of 3 mm or greater.

In all, 4 patients had positive margins, 59 had margins of 1 mm or smaller, and 35 had margins from 1.1 to 2.9 mm.

In multivariate analysis, independent predictors of close or positive margins were pathologic tumor size of 1.5 cm or greater (odds ratio, 5.11; P = .001), multicentric disease (OR, 5.44; P = .026), and the presence of necrosis (OR, 2.5; P = .003). Neither age, postmenopausal status, skin-sparing mastectomy, nor immediate breast reconstruction were significantly associated with close or positive margins, however.

None of seven patients who underwent postmastectomy radiotherapy had local-regional recurrences. Of the 803 patients who did not receive postsurgery radiation, 10-year LRR rates were 1%, consisting of 7 cases of invasive disease and 1 of DICS. Five patients had surgical management, and the remaining 3 had no further treatment.

When the researchers stratified the local recurrence rates by margin status, they saw that 5% of patients with margins of 1 mm or smaller had LRRs within 10 years, as did 3.6% of those with margins from 1.1 to 2.9 mm, compared with just 0.07% of those with disease-free margins (P less than .001). There was no difference in LRR between the two narrow-margin groups.

Among 546 patients with an intact contralateral breast, the 10-year rate of contralateral breast disease was 6.4%.

On univariate analysis, significant predictors of LRR included margin status (P = .002), multicentric disease (P = .005), and necrosis (P = .005). On multivariate analysis, however, only margin status remained significant, with an HR of 8.0 (P = .006).

Dr. FitzSullivan said that the low rate of LRR of DCIS treated with mastectomy and close surgical margins, compared with the rate of contralateral breast cancer, suggests that routine postmastectomy radiation therapy is not warranted, and should be reserved only for those patients with close or positive surgical margins that cannot be surgically excised.

Each study was internally funded. Dr. Garvey and Dr. FitzSullivan reported having no financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Small surgical margins can mean big trouble for patients with breast cancer, said investigators at the annual Society of Surgical Oncology Cancer Symposium.

A retrospective study of outcomes for 2,377 women who underwent either breast-conserving therapy or mastectomy revealed that margins less than 2 mm resulted in a substantial risk of residual disease for all patients, reported Dr. Erin Garvey, a general surgery resident at Mayo Clinic Arizona in Phoenix.

"A policy of re-excision for margins less than 2 mm, coupled with a standardized multidisciplinary approach to breast cancer surgery, results in excellent re-excision and 5-year local recurrence rates. The local recurrence rate is higher, however, for those patients who complete breast-conserving therapy, thus warranting appropriate patient counseling regarding re-excision options and long-term outcome expectations," she said.

In a separate study, investigators from the University of Texas M.D. Anderson Cancer Center, Houston, reported 10-year follow-up data for women who opted for mastectomy to treat ductal carcinoma in situ (DCIS). They found that the incidence of local-regional recurrence (LRR) increased as the surgical margins shrank, and that close margins were the only independent predictor of LRR, reported Dr. Elizabeth FitzSullivan, a surgery fellow at M.D. Anderson.

"However, the local-regional recurrence rate in these patients is so low that routine postmastectomy radiation therapy is not warranted," she said.

No accord on margins

Despite multiple studies and meta-analyses, there is no standard for acceptable margin width in breast cancer, and surveys of both surgeons and radiation oncologists have shown wide variations in preferred margin widths, Dr. Garvey said.

Her group hypothesized that patients with invasive ductal carcinoma without an extensive in situ component who had surgical margins of at least 1 mm would have no evidence of residual disease on re-excision.

To test the idea, they took a retrospective look at records from a prospective database on 2,377 patients who underwent a total of 2,520 procedures from January 2000 through May 2012.

Of this group, 1,498 (63%) underwent lumpectomy, and 180 (12%) required re-excision surgery: 10% who had breast-conserving surgery alone, and 2% whose surgeries were converted to mastectomies. Of the 158 patients who had completed breast-conserving therapy following re-excision, 50 (32%) had residual disease, as did 20 of the 27 patients whose procedures were converted to mastectomies.

Of the 37% (879) who had up-front mastectomies, 2% (19) had re-excision, and of this group, 5 patients had residual disease.

In all, 40% of patients with positive margins had residual disease, compared with 38% of those with margins from 0.1 to 0.9 mm, and 33% for those with margins from 1.0 to 1.9 mm.

In univariate analysis, the presence of residual disease on re-excision did not show any significant association with age, race, menopausal status, width of the closest final margin, hormone receptor status, tumor histology, triple-negative disease, or the presence of angiolymphatic invasion. There was a trend, albeit nonsignificant, toward an association between residual disease and more than one margin narrower than 2 mm, Dr. Garvey noted.

At a median follow-up of 43 months (range, 0-140 months), 5-year local recurrence rates were 1.9% for patients who had breast-conserving therapy, and 1.1% for those who had mastectomy.

Patients who underwent breast-conserving therapy without re-excision had a 5-year local recurrence rate of 1.8%, compared with 4.3% for those who required re-excision, and 0% for those whose procedures were converted to mastectomy.

There was a nonsignificant trend toward higher local recurrence rates for breast-conserving therapy in patients who had re-excisions, which became significant when those patients who had conversion to mastectomy were excluded, with a hazard ratio compared with no re-excision of 2.56 (P = .04).

Narrower margins, larger risk

Dr. FitzSullivan and her M.D. Anderson colleagues reviewed the records of 810 women treated with mastectomy for DCIS from 1996 to 2009. They looked at the final width of histologic margins, defining disease-free margins as those of 3 mm or greater.

In all, 4 patients had positive margins, 59 had margins of 1 mm or smaller, and 35 had margins from 1.1 to 2.9 mm.

In multivariate analysis, independent predictors of close or positive margins were pathologic tumor size of 1.5 cm or greater (odds ratio, 5.11; P = .001), multicentric disease (OR, 5.44; P = .026), and the presence of necrosis (OR, 2.5; P = .003). Neither age, postmenopausal status, skin-sparing mastectomy, nor immediate breast reconstruction were significantly associated with close or positive margins, however.

None of seven patients who underwent postmastectomy radiotherapy had local-regional recurrences. Of the 803 patients who did not receive postsurgery radiation, 10-year LRR rates were 1%, consisting of 7 cases of invasive disease and 1 of DICS. Five patients had surgical management, and the remaining 3 had no further treatment.

When the researchers stratified the local recurrence rates by margin status, they saw that 5% of patients with margins of 1 mm or smaller had LRRs within 10 years, as did 3.6% of those with margins from 1.1 to 2.9 mm, compared with just 0.07% of those with disease-free margins (P less than .001). There was no difference in LRR between the two narrow-margin groups.

Among 546 patients with an intact contralateral breast, the 10-year rate of contralateral breast disease was 6.4%.

On univariate analysis, significant predictors of LRR included margin status (P = .002), multicentric disease (P = .005), and necrosis (P = .005). On multivariate analysis, however, only margin status remained significant, with an HR of 8.0 (P = .006).

Dr. FitzSullivan said that the low rate of LRR of DCIS treated with mastectomy and close surgical margins, compared with the rate of contralateral breast cancer, suggests that routine postmastectomy radiation therapy is not warranted, and should be reserved only for those patients with close or positive surgical margins that cannot be surgically excised.

Each study was internally funded. Dr. Garvey and Dr. FitzSullivan reported having no financial disclosures.

[email protected]

NATIONAL HARBOR, MD. – Small surgical margins can mean big trouble for patients with breast cancer, said investigators at the annual Society of Surgical Oncology Cancer Symposium.

A retrospective study of outcomes for 2,377 women who underwent either breast-conserving therapy or mastectomy revealed that margins less than 2 mm resulted in a substantial risk of residual disease for all patients, reported Dr. Erin Garvey, a general surgery resident at Mayo Clinic Arizona in Phoenix.

"A policy of re-excision for margins less than 2 mm, coupled with a standardized multidisciplinary approach to breast cancer surgery, results in excellent re-excision and 5-year local recurrence rates. The local recurrence rate is higher, however, for those patients who complete breast-conserving therapy, thus warranting appropriate patient counseling regarding re-excision options and long-term outcome expectations," she said.

In a separate study, investigators from the University of Texas M.D. Anderson Cancer Center, Houston, reported 10-year follow-up data for women who opted for mastectomy to treat ductal carcinoma in situ (DCIS). They found that the incidence of local-regional recurrence (LRR) increased as the surgical margins shrank, and that close margins were the only independent predictor of LRR, reported Dr. Elizabeth FitzSullivan, a surgery fellow at M.D. Anderson.

"However, the local-regional recurrence rate in these patients is so low that routine postmastectomy radiation therapy is not warranted," she said.

No accord on margins

Despite multiple studies and meta-analyses, there is no standard for acceptable margin width in breast cancer, and surveys of both surgeons and radiation oncologists have shown wide variations in preferred margin widths, Dr. Garvey said.

Her group hypothesized that patients with invasive ductal carcinoma without an extensive in situ component who had surgical margins of at least 1 mm would have no evidence of residual disease on re-excision.

To test the idea, they took a retrospective look at records from a prospective database on 2,377 patients who underwent a total of 2,520 procedures from January 2000 through May 2012.

Of this group, 1,498 (63%) underwent lumpectomy, and 180 (12%) required re-excision surgery: 10% who had breast-conserving surgery alone, and 2% whose surgeries were converted to mastectomies. Of the 158 patients who had completed breast-conserving therapy following re-excision, 50 (32%) had residual disease, as did 20 of the 27 patients whose procedures were converted to mastectomies.

Of the 37% (879) who had up-front mastectomies, 2% (19) had re-excision, and of this group, 5 patients had residual disease.

In all, 40% of patients with positive margins had residual disease, compared with 38% of those with margins from 0.1 to 0.9 mm, and 33% for those with margins from 1.0 to 1.9 mm.

In univariate analysis, the presence of residual disease on re-excision did not show any significant association with age, race, menopausal status, width of the closest final margin, hormone receptor status, tumor histology, triple-negative disease, or the presence of angiolymphatic invasion. There was a trend, albeit nonsignificant, toward an association between residual disease and more than one margin narrower than 2 mm, Dr. Garvey noted.

At a median follow-up of 43 months (range, 0-140 months), 5-year local recurrence rates were 1.9% for patients who had breast-conserving therapy, and 1.1% for those who had mastectomy.

Patients who underwent breast-conserving therapy without re-excision had a 5-year local recurrence rate of 1.8%, compared with 4.3% for those who required re-excision, and 0% for those whose procedures were converted to mastectomy.

There was a nonsignificant trend toward higher local recurrence rates for breast-conserving therapy in patients who had re-excisions, which became significant when those patients who had conversion to mastectomy were excluded, with a hazard ratio compared with no re-excision of 2.56 (P = .04).

Narrower margins, larger risk

Dr. FitzSullivan and her M.D. Anderson colleagues reviewed the records of 810 women treated with mastectomy for DCIS from 1996 to 2009. They looked at the final width of histologic margins, defining disease-free margins as those of 3 mm or greater.

In all, 4 patients had positive margins, 59 had margins of 1 mm or smaller, and 35 had margins from 1.1 to 2.9 mm.

In multivariate analysis, independent predictors of close or positive margins were pathologic tumor size of 1.5 cm or greater (odds ratio, 5.11; P = .001), multicentric disease (OR, 5.44; P = .026), and the presence of necrosis (OR, 2.5; P = .003). Neither age, postmenopausal status, skin-sparing mastectomy, nor immediate breast reconstruction were significantly associated with close or positive margins, however.

None of seven patients who underwent postmastectomy radiotherapy had local-regional recurrences. Of the 803 patients who did not receive postsurgery radiation, 10-year LRR rates were 1%, consisting of 7 cases of invasive disease and 1 of DICS. Five patients had surgical management, and the remaining 3 had no further treatment.

When the researchers stratified the local recurrence rates by margin status, they saw that 5% of patients with margins of 1 mm or smaller had LRRs within 10 years, as did 3.6% of those with margins from 1.1 to 2.9 mm, compared with just 0.07% of those with disease-free margins (P less than .001). There was no difference in LRR between the two narrow-margin groups.

Among 546 patients with an intact contralateral breast, the 10-year rate of contralateral breast disease was 6.4%.

On univariate analysis, significant predictors of LRR included margin status (P = .002), multicentric disease (P = .005), and necrosis (P = .005). On multivariate analysis, however, only margin status remained significant, with an HR of 8.0 (P = .006).

Dr. FitzSullivan said that the low rate of LRR of DCIS treated with mastectomy and close surgical margins, compared with the rate of contralateral breast cancer, suggests that routine postmastectomy radiation therapy is not warranted, and should be reserved only for those patients with close or positive surgical margins that cannot be surgically excised.

Each study was internally funded. Dr. Garvey and Dr. FitzSullivan reported having no financial disclosures.

[email protected]

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

[email protected]

On Twitter @aliciaault

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

[email protected]

On Twitter @aliciaault

BETHESDA, MD. – Surgery is curative in half of patients with refractory temporal lobe epilepsy, yet it is still highly underused – in part because of misperceptions about the risks and benefits, according to Dr. Edward F. Chang.

Dr. Chang, assistant professor of neurological surgery and physiology at the University of California, San Francisco, said that numerous studies have shown that 60%-70% of patients are free of seizures 1 year after surgery and that at least half have seizure freedom over the long term. Also, there are "well-documented quality of life improvements," he said at the meeting sponsored by the National Institute of Neurological Disorders and Stroke.

Sixty percent of people with epilepsy have focal seizures, and the temporal lobe form is the most common type of epilepsy that is characterized by focal seizures, according to NINDS. The Epilepsy Foundation estimates that there are at least 200,000 new cases of epilepsy (any type) in the United States each year.

Based on the totality of the evidence, in 2003 the American Academy of Neurology, the American Epilepsy Society, and the American Association of Neurological Surgeons jointly published a guideline statement (Neurology 2003;60:538-47), urging referral of refractory patients for surgery.

But physicians are still not heeding that guidance, said Dr. Chang. His own survey of clinicians (Neurology 2012;78:1200-6) showed that there had been no increase in surgery in a 5-year period after the joint recommendation. Dr. Chang characterized that as "very depressing in terms of how we are using evidence," especially since there has been an increasing burden of epilepsy. In some cases, patients have lived with epilepsy for 20-30 years before being referred for surgery, he said.

Surgery is safe and effective and the side effects are predictable, he noted, adding that the number needed to treat for one patient with refractory temporal lobe epilepsy to become free of disabling seizures is only two – a number that parallels the use of antibiotics for pneumonia.

"We are below the standard of care," Dr. Chang said. Clinicians and patients shy away from surgery because "of the idea that brain surgery is too dangerous," he said. And physicians don’t understand the data. Drug and device makers also are "spending millions of dollars a year telling patients there are other options," he said, but if "we address this basic utilization problem we’d see an immediate and substantial reduction ... in the burden of epilepsy worldwide."

There have been several advances in surgical technique in the last few years that might make neurologists and patients – who might be spooked by looking at photos and videos of temporal lobe surgery on the Internet – more comfortable. For instance, there are transcortical approaches, which use a small incision to go through the white matter to the hippocampus. With the subtemporal approach, "you don’t have to go through any lateral cortex at all," he noted.

"Even for relatively large lesions that are quite deep in the brain we can actually do these minimally invasive approaches by just going underneath the lateral temporal cortex and selectively removing the hippocampus," Dr. Chang said.

On the horizon, there are nonsurgical minimally invasive techniques under development that have the potential to yield outcomes similar to surgery, he added. NINDS is funding a pivotal trial of stereotactic radiosurgery. The device selectively delivers radiation to the hippocampus and mesial lobe and spares the lateral temporal areas en route. Overall, it is fairly safe, but some patients have severe swelling as long as a year after the procedure and most have no effect for at least a year.

Another approach under study is using MRI to guide laser thermoablation. "A lot of us are quite excited about this," Dr. Chang said. The MRI allows the clinician to accurately place the laser and study how much the tissue is heated, which can help researchers determine whether there is damage and if it might be irreversible.

Finally, there is MRI-guided focused ultrasound, which uses the same principles as radiosurgery to target structures deep in the brain, he said. The procedure is currently in phase III trials for essential tremor.

There is, however, "a lot of irrational exuberance with these technologies," he pointed out.

It is not clear how to validate them, especially since clinicians are currently struggling with how to validate different surgical approaches. A big issue for the surgery trials is that it is difficult to recruit patients. Many have said that they don’t want to participate because they don’t want to be randomized.

Researchers also are trying to better understand epileptogenesis and how to reduce procedural side effects, including how to predict effects on cognitive function. To get there, "we need to understand more about how human cognition works," Dr. Chang said. Brain-mapping studies are showing that most aspects of cognition are not centered in one specific, focused area.

"Just like we’re thinking now that seizures are part of a distributed network, we also need to understand comorbidities and morbidity from surgical approaches in the same kind of framework," he said.

Until surgery is better used and studied, it is unlikely that neurology can move forward to truly understand the safety and effectiveness of the minimally invasive approaches, Dr. Chang said.

Dr. Chang has received grants from the National Institutes of Health and the Esther A. and Joseph Klingenstein Fund.

[email protected]

On Twitter @aliciaault