Sharon Worcester

NEW ORLEANS – A postpartum educational script about long-acting reversible contraceptive methods appears to increase interest in those methods, but access may be limited for some women, findings from a randomized controlled trial suggest.

Long-acting reversible contraceptive (LARC) use after the 6-week postpartum visit in 400 women who received the "LARC Script" intervention and 400 controls who did not receive the intervention did not differ significantly (17.6% vs. 13.3%, respectively), but interest in LARC use among those not using a LARC method at follow-up did differ significantly between the groups (31.2% vs. 25.8%), Dr. Jennifer H. Tang reported at the annual meeting of the American College of Obstetricians and Gynecologists.

These findings suggest that the LARC Script is effective, but that barriers – such as financial and provider barriers – may be limiting uptake of LARC use, said Dr. Tang of the University of North Carolina at Chapel Hill.

Study subjects were 800 women aged 14-45 years who were recruited post partum between May 2011 and January 2012 and randomized to the intervention and control groups prior to discharge. A 20-item baseline survey lasting about 10 minutes was administered to all participants; the 1-minute intervention consisting of information about LARC was administered to intervention group subjects, with follow-up surveys conducted at 1-2 weeks (to confirm the 6-week visit) and at 6 weeks to assess outcomes.

About 40% of the subjects were Hispanic, median parity was two, and about a third had no insurance. Only a third of subjects were trying to conceive when they became pregnant, and 20% reported using some form of contraceptive to prevent pregnancy when they became pregnant. Most (80%) were not interested in becoming pregnant again, Dr. Tang said.

Approximately 40% of pregnancy intervals in the United States are less than 18 months, and intervals of 18 months or less are associated with poorer pregnancy outcomes. Thus, the findings of this study suggest a need for additional study to identify barriers to LARC access, she said.

"We need to look into reasons why women who want to receive LARC aren’t actually getting it," she said.

This study was funded by the Fellowship in Family Planning. Dr. Tang reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – A postpartum educational script about long-acting reversible contraceptive methods appears to increase interest in those methods, but access may be limited for some women, findings from a randomized controlled trial suggest.

Long-acting reversible contraceptive (LARC) use after the 6-week postpartum visit in 400 women who received the "LARC Script" intervention and 400 controls who did not receive the intervention did not differ significantly (17.6% vs. 13.3%, respectively), but interest in LARC use among those not using a LARC method at follow-up did differ significantly between the groups (31.2% vs. 25.8%), Dr. Jennifer H. Tang reported at the annual meeting of the American College of Obstetricians and Gynecologists.

These findings suggest that the LARC Script is effective, but that barriers – such as financial and provider barriers – may be limiting uptake of LARC use, said Dr. Tang of the University of North Carolina at Chapel Hill.

Study subjects were 800 women aged 14-45 years who were recruited post partum between May 2011 and January 2012 and randomized to the intervention and control groups prior to discharge. A 20-item baseline survey lasting about 10 minutes was administered to all participants; the 1-minute intervention consisting of information about LARC was administered to intervention group subjects, with follow-up surveys conducted at 1-2 weeks (to confirm the 6-week visit) and at 6 weeks to assess outcomes.

About 40% of the subjects were Hispanic, median parity was two, and about a third had no insurance. Only a third of subjects were trying to conceive when they became pregnant, and 20% reported using some form of contraceptive to prevent pregnancy when they became pregnant. Most (80%) were not interested in becoming pregnant again, Dr. Tang said.

Approximately 40% of pregnancy intervals in the United States are less than 18 months, and intervals of 18 months or less are associated with poorer pregnancy outcomes. Thus, the findings of this study suggest a need for additional study to identify barriers to LARC access, she said.

"We need to look into reasons why women who want to receive LARC aren’t actually getting it," she said.

This study was funded by the Fellowship in Family Planning. Dr. Tang reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – A postpartum educational script about long-acting reversible contraceptive methods appears to increase interest in those methods, but access may be limited for some women, findings from a randomized controlled trial suggest.

Long-acting reversible contraceptive (LARC) use after the 6-week postpartum visit in 400 women who received the "LARC Script" intervention and 400 controls who did not receive the intervention did not differ significantly (17.6% vs. 13.3%, respectively), but interest in LARC use among those not using a LARC method at follow-up did differ significantly between the groups (31.2% vs. 25.8%), Dr. Jennifer H. Tang reported at the annual meeting of the American College of Obstetricians and Gynecologists.

These findings suggest that the LARC Script is effective, but that barriers – such as financial and provider barriers – may be limiting uptake of LARC use, said Dr. Tang of the University of North Carolina at Chapel Hill.

Study subjects were 800 women aged 14-45 years who were recruited post partum between May 2011 and January 2012 and randomized to the intervention and control groups prior to discharge. A 20-item baseline survey lasting about 10 minutes was administered to all participants; the 1-minute intervention consisting of information about LARC was administered to intervention group subjects, with follow-up surveys conducted at 1-2 weeks (to confirm the 6-week visit) and at 6 weeks to assess outcomes.

About 40% of the subjects were Hispanic, median parity was two, and about a third had no insurance. Only a third of subjects were trying to conceive when they became pregnant, and 20% reported using some form of contraceptive to prevent pregnancy when they became pregnant. Most (80%) were not interested in becoming pregnant again, Dr. Tang said.

Approximately 40% of pregnancy intervals in the United States are less than 18 months, and intervals of 18 months or less are associated with poorer pregnancy outcomes. Thus, the findings of this study suggest a need for additional study to identify barriers to LARC access, she said.

"We need to look into reasons why women who want to receive LARC aren’t actually getting it," she said.

This study was funded by the Fellowship in Family Planning. Dr. Tang reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – Use of a novel guided educational pamphlet during the immediate postpartum period is feasible and effective for promoting the use of long-acting reversible contraceptive methods, according to findings from a prospective cohort study.

Of 134 study subjects aged 18 years or older, 78% reported a preference regarding contraceptive method at baseline, and the most popular choices were non–long-acting reversible contraceptive (LARC) methods followed by intrauterine devices (IUDs), implants, and injections. Nearly a quarter (23%) of these women changed their minds after the intervention, with 94% of those ultimately choosing a LARC method, Dr. Ariel Cohen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Of the 22% of women who had not decided on a contraceptive method at baseline, more than half selected a method after the intervention, and 82% of those selected a LARC method, with IUD being the most popular choice followed by implant and injection methods, said Dr. Cohen of Baystate Medical Center, Springfield, Mass.

The intervention involved a brief interaction between the subject and a research assistant within 4 days of delivery. The research assistant guided the subject through an eight-page educational pamphlet, which included three sections: an interactive section including six questions about contraceptive preferences, a comparative effectiveness section including a World Health Organization contraceptive comparative effectiveness chart, and an information section that provided more details about each contraceptive method.

Subjects were asked about their predelivery method of choice, and were called at 3 months and 6 months post partum for a follow-up evaluation.

The initial intervention took a mean of 8 minutes, and the research assistant had little difficulty obtaining the necessary time and privacy with the subjects, Dr. Cohen noted.

Mean age of the women was 24 years. Most identified as white or Hispanic, most (58%) had at least one other child (median parity, 2), and 84% had a 12th grade education or less.

The findings are important because although ACOG recommends that contraceptive counseling be provided during the intrapartum period, many physicians delay contraception discussion until the postpartum visit, Dr. Cohen said.

"However, research has shown that patients who are at the highest risk for unintended pregnancy have up to a 50% no-show rate at the postpartum visit," she said.

The immediate postpartum period provides a unique opportunity for contraceptive counseling, she added.

"Not only is the patient a captive audience ... she’s also highly motivated to avoid a rapid repeat pregnancy," she said.

Based on these findings, it appears this educational tool would be useful prior to discharge, if administered by either a physician or trained nurse or medical assistant, she said, noting that plans are underway to validate the tool by developing a pre- and posttest and conducting a randomized study, she said.

Dr. Cohen reported having no disclosures.

NEW ORLEANS – Use of a novel guided educational pamphlet during the immediate postpartum period is feasible and effective for promoting the use of long-acting reversible contraceptive methods, according to findings from a prospective cohort study.

Of 134 study subjects aged 18 years or older, 78% reported a preference regarding contraceptive method at baseline, and the most popular choices were non–long-acting reversible contraceptive (LARC) methods followed by intrauterine devices (IUDs), implants, and injections. Nearly a quarter (23%) of these women changed their minds after the intervention, with 94% of those ultimately choosing a LARC method, Dr. Ariel Cohen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Of the 22% of women who had not decided on a contraceptive method at baseline, more than half selected a method after the intervention, and 82% of those selected a LARC method, with IUD being the most popular choice followed by implant and injection methods, said Dr. Cohen of Baystate Medical Center, Springfield, Mass.

The intervention involved a brief interaction between the subject and a research assistant within 4 days of delivery. The research assistant guided the subject through an eight-page educational pamphlet, which included three sections: an interactive section including six questions about contraceptive preferences, a comparative effectiveness section including a World Health Organization contraceptive comparative effectiveness chart, and an information section that provided more details about each contraceptive method.

Subjects were asked about their predelivery method of choice, and were called at 3 months and 6 months post partum for a follow-up evaluation.

The initial intervention took a mean of 8 minutes, and the research assistant had little difficulty obtaining the necessary time and privacy with the subjects, Dr. Cohen noted.

Mean age of the women was 24 years. Most identified as white or Hispanic, most (58%) had at least one other child (median parity, 2), and 84% had a 12th grade education or less.

The findings are important because although ACOG recommends that contraceptive counseling be provided during the intrapartum period, many physicians delay contraception discussion until the postpartum visit, Dr. Cohen said.

"However, research has shown that patients who are at the highest risk for unintended pregnancy have up to a 50% no-show rate at the postpartum visit," she said.

The immediate postpartum period provides a unique opportunity for contraceptive counseling, she added.

"Not only is the patient a captive audience ... she’s also highly motivated to avoid a rapid repeat pregnancy," she said.

Based on these findings, it appears this educational tool would be useful prior to discharge, if administered by either a physician or trained nurse or medical assistant, she said, noting that plans are underway to validate the tool by developing a pre- and posttest and conducting a randomized study, she said.

Dr. Cohen reported having no disclosures.

NEW ORLEANS – Use of a novel guided educational pamphlet during the immediate postpartum period is feasible and effective for promoting the use of long-acting reversible contraceptive methods, according to findings from a prospective cohort study.

Of 134 study subjects aged 18 years or older, 78% reported a preference regarding contraceptive method at baseline, and the most popular choices were non–long-acting reversible contraceptive (LARC) methods followed by intrauterine devices (IUDs), implants, and injections. Nearly a quarter (23%) of these women changed their minds after the intervention, with 94% of those ultimately choosing a LARC method, Dr. Ariel Cohen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Of the 22% of women who had not decided on a contraceptive method at baseline, more than half selected a method after the intervention, and 82% of those selected a LARC method, with IUD being the most popular choice followed by implant and injection methods, said Dr. Cohen of Baystate Medical Center, Springfield, Mass.

The intervention involved a brief interaction between the subject and a research assistant within 4 days of delivery. The research assistant guided the subject through an eight-page educational pamphlet, which included three sections: an interactive section including six questions about contraceptive preferences, a comparative effectiveness section including a World Health Organization contraceptive comparative effectiveness chart, and an information section that provided more details about each contraceptive method.

Subjects were asked about their predelivery method of choice, and were called at 3 months and 6 months post partum for a follow-up evaluation.

The initial intervention took a mean of 8 minutes, and the research assistant had little difficulty obtaining the necessary time and privacy with the subjects, Dr. Cohen noted.

Mean age of the women was 24 years. Most identified as white or Hispanic, most (58%) had at least one other child (median parity, 2), and 84% had a 12th grade education or less.

The findings are important because although ACOG recommends that contraceptive counseling be provided during the intrapartum period, many physicians delay contraception discussion until the postpartum visit, Dr. Cohen said.

"However, research has shown that patients who are at the highest risk for unintended pregnancy have up to a 50% no-show rate at the postpartum visit," she said.

The immediate postpartum period provides a unique opportunity for contraceptive counseling, she added.

"Not only is the patient a captive audience ... she’s also highly motivated to avoid a rapid repeat pregnancy," she said.

Based on these findings, it appears this educational tool would be useful prior to discharge, if administered by either a physician or trained nurse or medical assistant, she said, noting that plans are underway to validate the tool by developing a pre- and posttest and conducting a randomized study, she said.

Dr. Cohen reported having no disclosures.

CHARLESTON, S.C. – Cure rates and patient satisfaction following vaginal prolapse repair were high at 3-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to findings from a prospective randomized trial.

The findings raise questions about the long-term value of vaginal mesh repairs because subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients, Dr. Robert E. Gutman reported at the annual meeting of the Society of Gynecologic Surgeons.

Of 65 women who were enrolled in the trial before enrollment was halted because of a 15.6% mesh exposure rate, 51 – including 25 in the mesh group and 26 in the no mesh group – had quality of life data available for the planned 3-year final analysis, and 41 had 2- or 3-year pelvic organ prolapse quantification (POP-Q) examination information available.

No differences were noted between the groups with respect to POP-Q stage or individual POP-Q points at 3 years, and the majority in both the mesh and no mesh groups (90% and 86%, respectively) improved in stage from baseline, said Dr. Gutman of MedStar Washington Hospital Center and of the department of obstetrics and gynecology and urology at Georgetown University, both in Washington.

Furthermore, no differences were seen between the groups with respect to symptomatic improvement as assessed by the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), including subscale scores. Also, cure rates – using a variety of definitions for cure – did not differ between the groups.

For example, based on a POP-Q stage of 1 or less as a definition of cure, 45% and 43% of those in the mesh and no mesh groups, respectively, were cured. When no prolapse beyond the hymen was used as a definition, 85% and 71% were cured When absence of bulge symptoms (a "no" answer to item 3 on the PFDI) was used as a definition, 92% and 81% were cured. The differences between the groups for these and other definitions – including a rating of very much better or much better on the Patient Global Impression of Improvement Index (PGI-I), having no prolapse reoperation, and composite outcomes using various combinations of these definitions – were not statistically significant, Dr. Gutman said.

Of note, no new mesh exposures occurred between the previously reported 1-year analysis (three cases required surgical excision before 1 year) and the 3-year analysis. The only prolapse reoperation after 1 year was in a woman who also had a reoperation prior to the 1-year analysis, he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Also of note, the anatomic cure rate was lowest for the anterior compartment, and this did not differ between the mesh and no mesh groups.

Patients included in the study were women with stage 2-4 prolapse who were randomized to the mesh or no mesh group at baseline. Three-month and 1-year outcomes were previously reported.

Although the study is underpowered because of the early halting of enrollment, and is limited by the substantial number of patients lost to follow-up, it also has several strengths, including the long-term follow-up, multicenter design, and robust definitions of cure.

Therefore, the findings of a similar cure rate in the mesh and no mesh groups, excellent quality of life improvements in both groups, a mesh exposure rate of 15.6%, and a finding of only one new mesh exposure between 1- and 3-year follow-up, suggest that a "balanced approach is really required for vaginal mesh repairs, including a thorough patient consent," Dr. Gutman concluded.

He reported having no relevant financial disclosures.

obnews@frontlinemedcom.com

CHARLESTON, S.C. – Cure rates and patient satisfaction following vaginal prolapse repair were high at 3-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to findings from a prospective randomized trial.

The findings raise questions about the long-term value of vaginal mesh repairs because subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients, Dr. Robert E. Gutman reported at the annual meeting of the Society of Gynecologic Surgeons.

Of 65 women who were enrolled in the trial before enrollment was halted because of a 15.6% mesh exposure rate, 51 – including 25 in the mesh group and 26 in the no mesh group – had quality of life data available for the planned 3-year final analysis, and 41 had 2- or 3-year pelvic organ prolapse quantification (POP-Q) examination information available.

No differences were noted between the groups with respect to POP-Q stage or individual POP-Q points at 3 years, and the majority in both the mesh and no mesh groups (90% and 86%, respectively) improved in stage from baseline, said Dr. Gutman of MedStar Washington Hospital Center and of the department of obstetrics and gynecology and urology at Georgetown University, both in Washington.

Furthermore, no differences were seen between the groups with respect to symptomatic improvement as assessed by the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), including subscale scores. Also, cure rates – using a variety of definitions for cure – did not differ between the groups.

For example, based on a POP-Q stage of 1 or less as a definition of cure, 45% and 43% of those in the mesh and no mesh groups, respectively, were cured. When no prolapse beyond the hymen was used as a definition, 85% and 71% were cured When absence of bulge symptoms (a "no" answer to item 3 on the PFDI) was used as a definition, 92% and 81% were cured. The differences between the groups for these and other definitions – including a rating of very much better or much better on the Patient Global Impression of Improvement Index (PGI-I), having no prolapse reoperation, and composite outcomes using various combinations of these definitions – were not statistically significant, Dr. Gutman said.

Of note, no new mesh exposures occurred between the previously reported 1-year analysis (three cases required surgical excision before 1 year) and the 3-year analysis. The only prolapse reoperation after 1 year was in a woman who also had a reoperation prior to the 1-year analysis, he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Also of note, the anatomic cure rate was lowest for the anterior compartment, and this did not differ between the mesh and no mesh groups.

Patients included in the study were women with stage 2-4 prolapse who were randomized to the mesh or no mesh group at baseline. Three-month and 1-year outcomes were previously reported.

Although the study is underpowered because of the early halting of enrollment, and is limited by the substantial number of patients lost to follow-up, it also has several strengths, including the long-term follow-up, multicenter design, and robust definitions of cure.

Therefore, the findings of a similar cure rate in the mesh and no mesh groups, excellent quality of life improvements in both groups, a mesh exposure rate of 15.6%, and a finding of only one new mesh exposure between 1- and 3-year follow-up, suggest that a "balanced approach is really required for vaginal mesh repairs, including a thorough patient consent," Dr. Gutman concluded.

He reported having no relevant financial disclosures.

obnews@frontlinemedcom.com

CHARLESTON, S.C. – Cure rates and patient satisfaction following vaginal prolapse repair were high at 3-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to findings from a prospective randomized trial.

The findings raise questions about the long-term value of vaginal mesh repairs because subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients, Dr. Robert E. Gutman reported at the annual meeting of the Society of Gynecologic Surgeons.

Of 65 women who were enrolled in the trial before enrollment was halted because of a 15.6% mesh exposure rate, 51 – including 25 in the mesh group and 26 in the no mesh group – had quality of life data available for the planned 3-year final analysis, and 41 had 2- or 3-year pelvic organ prolapse quantification (POP-Q) examination information available.

No differences were noted between the groups with respect to POP-Q stage or individual POP-Q points at 3 years, and the majority in both the mesh and no mesh groups (90% and 86%, respectively) improved in stage from baseline, said Dr. Gutman of MedStar Washington Hospital Center and of the department of obstetrics and gynecology and urology at Georgetown University, both in Washington.

Furthermore, no differences were seen between the groups with respect to symptomatic improvement as assessed by the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), including subscale scores. Also, cure rates – using a variety of definitions for cure – did not differ between the groups.

For example, based on a POP-Q stage of 1 or less as a definition of cure, 45% and 43% of those in the mesh and no mesh groups, respectively, were cured. When no prolapse beyond the hymen was used as a definition, 85% and 71% were cured When absence of bulge symptoms (a "no" answer to item 3 on the PFDI) was used as a definition, 92% and 81% were cured. The differences between the groups for these and other definitions – including a rating of very much better or much better on the Patient Global Impression of Improvement Index (PGI-I), having no prolapse reoperation, and composite outcomes using various combinations of these definitions – were not statistically significant, Dr. Gutman said.

Of note, no new mesh exposures occurred between the previously reported 1-year analysis (three cases required surgical excision before 1 year) and the 3-year analysis. The only prolapse reoperation after 1 year was in a woman who also had a reoperation prior to the 1-year analysis, he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Also of note, the anatomic cure rate was lowest for the anterior compartment, and this did not differ between the mesh and no mesh groups.

Patients included in the study were women with stage 2-4 prolapse who were randomized to the mesh or no mesh group at baseline. Three-month and 1-year outcomes were previously reported.

Although the study is underpowered because of the early halting of enrollment, and is limited by the substantial number of patients lost to follow-up, it also has several strengths, including the long-term follow-up, multicenter design, and robust definitions of cure.

Therefore, the findings of a similar cure rate in the mesh and no mesh groups, excellent quality of life improvements in both groups, a mesh exposure rate of 15.6%, and a finding of only one new mesh exposure between 1- and 3-year follow-up, suggest that a "balanced approach is really required for vaginal mesh repairs, including a thorough patient consent," Dr. Gutman concluded.

He reported having no relevant financial disclosures.

obnews@frontlinemedcom.com

CHARLESTON, S.C. – Single-incision mini-slings for the treatment of stress urinary incontinence are associated with higher failure and reoperation rates than are retropubic midurethral slings, according to findings from a survey and review of medical records of more than 200 patients.

At a mean follow-up of 21 months, 71 of 93 (76%) women who underwent a single-incision mini-sling procedure reported treatment failure, defined as overall incontinence, compared with 70 of 109 (64%) women who underwent a retropubic midurethral sling procedure, Dr. Annetta M. Madsen reported at the annual meeting of the Society of Gynecologic Surgeons.

After adjustment for body mass index and follow-up time, which differed between the groups, the odds ratio for treatment failure in the mini-sling vs. retropubic midurethral sling group was 1.84, which trended toward statistical significance, said Dr. Madsen of the Mayo Clinic, Rochester, Minn.

The secondary outcomes of postoperative stress-specific incontinence occurred in 47% and 29% of the mini-sling and retropubic midurethral sling groups, respectively. This difference did reach statistical significance (adjusted odds ratio, 2.4). There was no significant difference between the groups with respect to de novo urge.

As for other secondary endpoints, the mini-sling group had significantly reduced odds of reporting global improvement and patient satisfaction, and significantly increased odds of surgery for recurrent or persistent stress urinary incontinence (SUI), compared with the retropubic midurethral sling group, but the retropubic midurethral sling group had a higher reoperation rate for mesh erosion, Dr. Madsen said.

There was no difference in urethrolysis between the groups.

Study participants were women with a mean age of 60 years with SUI or stress-predominant mixed urinary incontinence, who underwent a sling procedure between January, 2008, and December, 2009. Treatment failure was defined by a score of greater than 0 on the International Consultation on Incontinence Questionnaire, an affirmative response to questions about stress incontinence on the questionnaire, or a need for a repeat anti-incontinence procedure.

The mini-sling and retropubic midurethral sling groups were similar with respect to most demographics – with the exception of BMI and duration of follow-up, and also were similar with respect to baseline urodynamics, Dr. Madsen noted.

Although retropubic and transobturator midurethral slings have been shown to have similar efficacy, it has remained unknown how single-incision mini-slings compare with these types of slings, she said.

These findings suggest that the retropubic midurethral sling is associated with higher risk of mesh exposure and reoperation for mesh complications, but with lower rates of stress-specific incontinence, higher global impression of improvement and patient satisfaction, and similar rates of overall urethrolysis and reoperation rates for any indication, Dr. Madsen concluded.

She reported having no disclosures. The meeting was jointly sponsored by the American College of Surgeons.

CHARLESTON, S.C. – Single-incision mini-slings for the treatment of stress urinary incontinence are associated with higher failure and reoperation rates than are retropubic midurethral slings, according to findings from a survey and review of medical records of more than 200 patients.

At a mean follow-up of 21 months, 71 of 93 (76%) women who underwent a single-incision mini-sling procedure reported treatment failure, defined as overall incontinence, compared with 70 of 109 (64%) women who underwent a retropubic midurethral sling procedure, Dr. Annetta M. Madsen reported at the annual meeting of the Society of Gynecologic Surgeons.

After adjustment for body mass index and follow-up time, which differed between the groups, the odds ratio for treatment failure in the mini-sling vs. retropubic midurethral sling group was 1.84, which trended toward statistical significance, said Dr. Madsen of the Mayo Clinic, Rochester, Minn.

The secondary outcomes of postoperative stress-specific incontinence occurred in 47% and 29% of the mini-sling and retropubic midurethral sling groups, respectively. This difference did reach statistical significance (adjusted odds ratio, 2.4). There was no significant difference between the groups with respect to de novo urge.

As for other secondary endpoints, the mini-sling group had significantly reduced odds of reporting global improvement and patient satisfaction, and significantly increased odds of surgery for recurrent or persistent stress urinary incontinence (SUI), compared with the retropubic midurethral sling group, but the retropubic midurethral sling group had a higher reoperation rate for mesh erosion, Dr. Madsen said.

There was no difference in urethrolysis between the groups.

Study participants were women with a mean age of 60 years with SUI or stress-predominant mixed urinary incontinence, who underwent a sling procedure between January, 2008, and December, 2009. Treatment failure was defined by a score of greater than 0 on the International Consultation on Incontinence Questionnaire, an affirmative response to questions about stress incontinence on the questionnaire, or a need for a repeat anti-incontinence procedure.

The mini-sling and retropubic midurethral sling groups were similar with respect to most demographics – with the exception of BMI and duration of follow-up, and also were similar with respect to baseline urodynamics, Dr. Madsen noted.

Although retropubic and transobturator midurethral slings have been shown to have similar efficacy, it has remained unknown how single-incision mini-slings compare with these types of slings, she said.

These findings suggest that the retropubic midurethral sling is associated with higher risk of mesh exposure and reoperation for mesh complications, but with lower rates of stress-specific incontinence, higher global impression of improvement and patient satisfaction, and similar rates of overall urethrolysis and reoperation rates for any indication, Dr. Madsen concluded.

She reported having no disclosures. The meeting was jointly sponsored by the American College of Surgeons.

CHARLESTON, S.C. – Single-incision mini-slings for the treatment of stress urinary incontinence are associated with higher failure and reoperation rates than are retropubic midurethral slings, according to findings from a survey and review of medical records of more than 200 patients.

At a mean follow-up of 21 months, 71 of 93 (76%) women who underwent a single-incision mini-sling procedure reported treatment failure, defined as overall incontinence, compared with 70 of 109 (64%) women who underwent a retropubic midurethral sling procedure, Dr. Annetta M. Madsen reported at the annual meeting of the Society of Gynecologic Surgeons.

After adjustment for body mass index and follow-up time, which differed between the groups, the odds ratio for treatment failure in the mini-sling vs. retropubic midurethral sling group was 1.84, which trended toward statistical significance, said Dr. Madsen of the Mayo Clinic, Rochester, Minn.

The secondary outcomes of postoperative stress-specific incontinence occurred in 47% and 29% of the mini-sling and retropubic midurethral sling groups, respectively. This difference did reach statistical significance (adjusted odds ratio, 2.4). There was no significant difference between the groups with respect to de novo urge.

As for other secondary endpoints, the mini-sling group had significantly reduced odds of reporting global improvement and patient satisfaction, and significantly increased odds of surgery for recurrent or persistent stress urinary incontinence (SUI), compared with the retropubic midurethral sling group, but the retropubic midurethral sling group had a higher reoperation rate for mesh erosion, Dr. Madsen said.

There was no difference in urethrolysis between the groups.

Study participants were women with a mean age of 60 years with SUI or stress-predominant mixed urinary incontinence, who underwent a sling procedure between January, 2008, and December, 2009. Treatment failure was defined by a score of greater than 0 on the International Consultation on Incontinence Questionnaire, an affirmative response to questions about stress incontinence on the questionnaire, or a need for a repeat anti-incontinence procedure.

The mini-sling and retropubic midurethral sling groups were similar with respect to most demographics – with the exception of BMI and duration of follow-up, and also were similar with respect to baseline urodynamics, Dr. Madsen noted.

Although retropubic and transobturator midurethral slings have been shown to have similar efficacy, it has remained unknown how single-incision mini-slings compare with these types of slings, she said.

These findings suggest that the retropubic midurethral sling is associated with higher risk of mesh exposure and reoperation for mesh complications, but with lower rates of stress-specific incontinence, higher global impression of improvement and patient satisfaction, and similar rates of overall urethrolysis and reoperation rates for any indication, Dr. Madsen concluded.

She reported having no disclosures. The meeting was jointly sponsored by the American College of Surgeons.

NEW ORLEANS – A telephone call made at 4 weeks postpartum to reinforce counseling about contraception did not increase the use of highly effective contraception at 6 months, according to findings from a randomized controlled study involving 258 women.

However, the rates of highly effective contraceptive use at 6 months were fairly high, at 71% and 67% in the intervention and control groups, respectively, and the study identified three factors associated with contraceptive use, Dr. Michelle M. Isley reported at the annual meeting of the American College of Obstetricians and Gynecologists.

On multivariate analysis, an intention to use a highly effective contraceptive method at 1-2 days postpartum was positively associated with use of such a contraceptive method at 6 months. A plan to breast-feed for a longer period of time, and a history of miscarriage were each negatively associated with the use of a highly effective contraceptive method at 6 months, said Dr. Isley of Ohio State University, Columbus.

The finding that an intention to use contraception was associated with actual use at 6 months has possible implications for patient counseling, she said. "This suggests that counseling in the prenatal period is valuable."

Dr. Isley noted, however, that 60% of study participants said their provider had talked to them about contraception prior to delivery. "I think we could do better here."

The finding of a negative association between plans to breast-feed for a longer period and use of contraception at 6 months suggests there may be a perception that birth control is not safe to use during breast-feeding. A simple educational intervention about birth control methods that are safe and effective during breast-feeding could be useful in these cases, Dr. Isley said.

Women planning to breast-feed may also be counting on reduced fertility during lactation.

"If women are relying on lactational amenorrhea for their birth control, then I think we ought to provide better, more thorough information about this method so that women can use it more effectively," she said.

As for the findings of a negative association between prior miscarriage and contraceptive use at 6 months postpartum, it is possible that these women believe their fertility is decreased, but more research is needed to clarify this association, she noted.

Study subjects had a mean age of 29 years and were enrolled and randomized at 1-2 days postpartum. Each woman completed a baseline questionnaire on demographic information and contraceptive use intentions. Those randomized to the intervention group received a phone call at 4 weeks postpartum from a study staff member, who readdressed the importance of postpartum contraception, answered basic questions about contraception, and encouraged the woman to attend her postpartum visit.

Contraceptive methods considered to be highly effective in this study were reversible methods including pills, patch, injection, implants, and intrauterine devices. The intervention and control groups did not differ significantly with respect to baseline characteristics.

The results underscore the importance of finding new and inventive ways of providing postpartum contraception, Dr. Isley said.

"As we all are aware, unintended pregnancy is a prevalent public health problem," she said, noting that improving the postpartum use of highly effective contraceptive methods can decrease unintended pregnancy and provide women with a method for controlling the timing of pregnancy.

"More efforts need to be made to figure out how to talk to women about birth control and how to promote these highly effective methods so that ultimately we can decrease mistimed and unintended pregnancies," she said.

Dr. Isley reported having no disclosures.

NEW ORLEANS – A telephone call made at 4 weeks postpartum to reinforce counseling about contraception did not increase the use of highly effective contraception at 6 months, according to findings from a randomized controlled study involving 258 women.

However, the rates of highly effective contraceptive use at 6 months were fairly high, at 71% and 67% in the intervention and control groups, respectively, and the study identified three factors associated with contraceptive use, Dr. Michelle M. Isley reported at the annual meeting of the American College of Obstetricians and Gynecologists.

On multivariate analysis, an intention to use a highly effective contraceptive method at 1-2 days postpartum was positively associated with use of such a contraceptive method at 6 months. A plan to breast-feed for a longer period of time, and a history of miscarriage were each negatively associated with the use of a highly effective contraceptive method at 6 months, said Dr. Isley of Ohio State University, Columbus.

The finding that an intention to use contraception was associated with actual use at 6 months has possible implications for patient counseling, she said. "This suggests that counseling in the prenatal period is valuable."

Dr. Isley noted, however, that 60% of study participants said their provider had talked to them about contraception prior to delivery. "I think we could do better here."

The finding of a negative association between plans to breast-feed for a longer period and use of contraception at 6 months suggests there may be a perception that birth control is not safe to use during breast-feeding. A simple educational intervention about birth control methods that are safe and effective during breast-feeding could be useful in these cases, Dr. Isley said.

Women planning to breast-feed may also be counting on reduced fertility during lactation.

"If women are relying on lactational amenorrhea for their birth control, then I think we ought to provide better, more thorough information about this method so that women can use it more effectively," she said.

As for the findings of a negative association between prior miscarriage and contraceptive use at 6 months postpartum, it is possible that these women believe their fertility is decreased, but more research is needed to clarify this association, she noted.

Study subjects had a mean age of 29 years and were enrolled and randomized at 1-2 days postpartum. Each woman completed a baseline questionnaire on demographic information and contraceptive use intentions. Those randomized to the intervention group received a phone call at 4 weeks postpartum from a study staff member, who readdressed the importance of postpartum contraception, answered basic questions about contraception, and encouraged the woman to attend her postpartum visit.

Contraceptive methods considered to be highly effective in this study were reversible methods including pills, patch, injection, implants, and intrauterine devices. The intervention and control groups did not differ significantly with respect to baseline characteristics.

The results underscore the importance of finding new and inventive ways of providing postpartum contraception, Dr. Isley said.

"As we all are aware, unintended pregnancy is a prevalent public health problem," she said, noting that improving the postpartum use of highly effective contraceptive methods can decrease unintended pregnancy and provide women with a method for controlling the timing of pregnancy.

"More efforts need to be made to figure out how to talk to women about birth control and how to promote these highly effective methods so that ultimately we can decrease mistimed and unintended pregnancies," she said.

Dr. Isley reported having no disclosures.

NEW ORLEANS – A telephone call made at 4 weeks postpartum to reinforce counseling about contraception did not increase the use of highly effective contraception at 6 months, according to findings from a randomized controlled study involving 258 women.

However, the rates of highly effective contraceptive use at 6 months were fairly high, at 71% and 67% in the intervention and control groups, respectively, and the study identified three factors associated with contraceptive use, Dr. Michelle M. Isley reported at the annual meeting of the American College of Obstetricians and Gynecologists.

On multivariate analysis, an intention to use a highly effective contraceptive method at 1-2 days postpartum was positively associated with use of such a contraceptive method at 6 months. A plan to breast-feed for a longer period of time, and a history of miscarriage were each negatively associated with the use of a highly effective contraceptive method at 6 months, said Dr. Isley of Ohio State University, Columbus.

The finding that an intention to use contraception was associated with actual use at 6 months has possible implications for patient counseling, she said. "This suggests that counseling in the prenatal period is valuable."

Dr. Isley noted, however, that 60% of study participants said their provider had talked to them about contraception prior to delivery. "I think we could do better here."

The finding of a negative association between plans to breast-feed for a longer period and use of contraception at 6 months suggests there may be a perception that birth control is not safe to use during breast-feeding. A simple educational intervention about birth control methods that are safe and effective during breast-feeding could be useful in these cases, Dr. Isley said.

Women planning to breast-feed may also be counting on reduced fertility during lactation.

"If women are relying on lactational amenorrhea for their birth control, then I think we ought to provide better, more thorough information about this method so that women can use it more effectively," she said.

As for the findings of a negative association between prior miscarriage and contraceptive use at 6 months postpartum, it is possible that these women believe their fertility is decreased, but more research is needed to clarify this association, she noted.

Study subjects had a mean age of 29 years and were enrolled and randomized at 1-2 days postpartum. Each woman completed a baseline questionnaire on demographic information and contraceptive use intentions. Those randomized to the intervention group received a phone call at 4 weeks postpartum from a study staff member, who readdressed the importance of postpartum contraception, answered basic questions about contraception, and encouraged the woman to attend her postpartum visit.

Contraceptive methods considered to be highly effective in this study were reversible methods including pills, patch, injection, implants, and intrauterine devices. The intervention and control groups did not differ significantly with respect to baseline characteristics.

The results underscore the importance of finding new and inventive ways of providing postpartum contraception, Dr. Isley said.

"As we all are aware, unintended pregnancy is a prevalent public health problem," she said, noting that improving the postpartum use of highly effective contraceptive methods can decrease unintended pregnancy and provide women with a method for controlling the timing of pregnancy.

"More efforts need to be made to figure out how to talk to women about birth control and how to promote these highly effective methods so that ultimately we can decrease mistimed and unintended pregnancies," she said.

Dr. Isley reported having no disclosures.

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com

NEW ORLEANS – Maternal body mass index does not affect the efficacy of low-dose aspirin for preventing preeclampsia or preterm birth, according to a secondary analysis of data from the National Institute of Child Health and Human Development’s Maternal-Fetal Medicine Units Network trial.

In the large randomized controlled trial, aspirin was not found to be of benefit for preventing preeclampsia; however, some meta-analyses have suggested a modest benefit, Dr. Jessica Cantu noted at the annual meeting of the American College of Obstetricians and Gynecologists. In one meta-analysis of individual patient data from 31 studies that included more than 32,000 women, aspirin-treated patients had a 10% relative risk reduction, compared with controls, she said.

In fact, aspirin is the only intervention that has shown any potential benefit for preventing preeclampsia, which occurs in 5%-8% of pregnancies and causes 18% of maternal deaths, said Dr. Cantu of the University of Alabama at Birmingham.

"So why is it that the randomized controlled trials have not shown benefit? Potential reasons are that the aspirin dose used was small in these trials, ranging from 50 to 150 mg/day. Second, the contradictory results may lie in the timing of initiation, with more recent data suggesting benefit when aspirin is initiated at less than 16 weeks’ gestation. Finally, maternal obesity is a potential reason for the lack of significant benefit in clinical trials," she said.

Since obese women are at increased risk for preeclampsia, and since obesity and preeclampsia share certain pathophysiological features, including endothelial dysfunction, oxidative stress, and an increased state of inflammation, it seems plausible that obese pregnant women might benefit the most from low-dose aspirin therapy.

"On the other hand, study dose of low-dose aspirin may be too small to have an effect on these women," she said.

To take a closer look at the impact of body mass index on outcomes in the Maternal-Fetal Medicine Units Network trial, which included women at high risk for preeclampsia, a secondary analysis of data from 2,479 women in that trial was performed to determine if outcomes varied by BMI class.

No significant differences were seen in the relative risk of preeclampsia between those with a BMI of 30 or less and those with a BMI of greater than 30 when aspirin was initiated at 13-26 weeks’ gestation. There also was no difference between the groups with respect to the rate of delivery prior to 37 weeks’ gestation.

Even after additional analyses were performed to compare outcomes in obese and nonobese patients from each of four high-risk subgroups of patients in the study, and when patients were further stratified into four BMI subgroups (normal, overweight, obese, and morbidly obese) the effects of aspirin therapy did not differ based on BMI class.

This study is limited by the fact that it involves a secondary analysis of data. Also, the timing of initiation of aspirin therapy may have contributed to the overall lack of an effect, Dr. Cantu said.

"These limitations notwithstanding, we conclude that there is no effect of maternal BMI on aspirin efficacy for the prevention of preeclampsia or preterm birth," she said.

Dr. Cantu reported having no disclosures.

obnews@frontlinemedcom.com

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

sboschert@frontlinemedcom.com

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

sboschert@frontlinemedcom.com

MIAMI BEACH – The extent of vascular disease, not the presence of diabetes or the cause of the ulceration, should drive the decision to intervene in a patient with a "diabetic foot," according to Dr. Joshua Beckman.

"When do I intervene on a diabetic foot? When I intervene on all feet: when there’s inadequate blood flow to heal the lesion," he said at the International Symposium on Endovascular Therapy 2013.

When lesions are detected in diabetic patients with PAD, assess for ankle pressures and determine ankle brachial index regardless of whether the lesion is neuropathic, he advised, explaining that, "even if you have a neuropathic initiation for your ulcer, if you have a low perfusion pressure, particularly under 50 mmHg, you’re not going to heal that lesion no matter how it was started."

"I always assess patients, whether I think the lesion is a neuropathic one or not, for the ankle pressures and do ankle brachial index and, assuming it’s low, I refer for revascularization based on the same criteria I would everybody else," said Dr. Beckman of Harvard Medical School, Boston.

That said, up to one-third of patients with diabetes have peripheral artery disease, and its presence is an independent predictor of adverse outcomes. "In fact, the combination of PAD and diabetes represents the group of people in the United States that has the most amputations, and their risk may be 20-fold that of people without both PAD and diabetes," he noted.

Indeed, the risk of amputation is much greater in diabetic patients, regardless of the care they receive, Dr. Beckman said, citing a study of 136 lower-extremity angiograms in patients with PAD. The odds ratios for amputation and death at 4.5 years’ follow-up were 5.4 for those with diabetes and 3.1 for those without diabetes (Diabetes Care 2001;24:1433-7).

Additionally, in a study of 1,244 men with claudication, the risk of ischemic ulceration was 4-fold higher in diabetic patients than in nondiabetic patients. Ankle brachial indices ranged from 0.9 to 0.1, and there was no point at which a diabetic patient was not worse off than a nondiabetic patient, he said. The risk in a diabetic patient with an ankle brachial index of 0.9 was equal to the risk in a nondiabetic patient with an ankle brachial index of 0.1 (J. Vasc. Surg. 2001;34:962-70).

Diabetic patients also can have a number of other initiators of diabetic foot ulceration, including neuropathy, bone deformity, callus, penetrating injury, and ill-fitting shoes. In combination, these factors can be especially problematic, he said.

Also, the extensor muscle abnormality that can result from motor neuropathy can change foot morphology, thereby increasing pressure on areas such as the ball of the foot, where ulcers are common.

Furthermore, a patient with neuropathy can walk around for a long time without recognizing a problem that an individual with normal nerve function wouldn’t tolerate. "A diabetic patient can have a bad shoe that rubs all day and not appreciate it," Dr. Beckman said.

With PAD, there are a "whole host of issues we never deal with in the nondiabetic patient that really accelerate the pathway toward ischemic ulceration and critical limb ischemia," he said. "Diabetes is a risk multiplier. It makes things worse, and it’s far more involved in the initiation [of ulceration] than in the decision whether to fix somebody."

Further underscoring the importance of such follow-up is a study of 533 diabetic patients hospitalized for critical limb ischemia. Nearly 50% of them developed critical limb ischemia in the contralateral limb at 6-year follow-up (Diabetes Res. Clin. Prac. 2007;77:445-50).

"So this is a group of people who need not only exquisite care, but exquisite surveillance, because it is very likely that, over time, they will come back to your office with the same problem in the other foot. I’m not recommending intervention or surgery in the asymptomatic foot, but I am suggesting you should probably never let them go, and have routine follow-ups where you look at their feet every time," he said.

Dr. Beckman reported having no disclosures relevant to his talk.

sboschert@frontlinemedcom.com

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

CHARLESTON, S.C. – Mechanical bowel preparation prior to vaginal pelvic organ prolapse surgery offers no advantage over lack of any bowel preparation, with respect to surgeons’ assessment of acceptability, according to findings from a single-blind randomized trial involving 150 women.

Furthermore, the use of mechanical bowel preparation prior to surgery was associated with decreased patient satisfaction, Dr. Alicia C. Ballard reported at the annual meeting of the Society of Gynecologic Surgeons.

Surgeons’ acceptability, based on a rating of excellent or good in terms of bowel cleansing, was similar at 81.3% and 88% for 75 patients who underwent mechanical bowel preparation and 75 control subjects who received no bowel preparation. There also were no significant differences between the groups in intraoperative visualization, stooling, or difficulty in bowel handling, said Dr. Ballard of the University of Alabama at Birmingham.

Patient satisfaction was 61.3% in the bowel preparation group, compared with 89.3% in the control group. Patients in the bowel preparation group also were more likely to be willing to try a different form of bowel preparation (84.3% vs. 64.4%), she noted.

Study subjects were adult women scheduled to undergo vaginal prolapse surgery – with a planned apical suspension and posterior colporrhaphy – at a single center between January 2011 and August 2012. Those randomized to the intervention group were placed on a clear-liquid diet and administered saline enemas at 4 p.m. and 6 p.m. on the day prior to surgery. Those assigned to the control group continued on their regular diet. Both groups were instructed to take nothing by mouth after 12 a.m. on the day of the surgery.

The four participating surgeons were blinded as to patient allocation, and rated their acceptability of the bowel preparation using a 4-point Likert scale.

"Overall, surgeons assessed the bowel to be acceptably cleansed [excellent or good rating], with no differences noted between the intervention and control groups," Dr. Ballard said at the meeting, which was jointly sponsored by the American College of Surgeons.

In fact, bowel cleansing was assessed as "fair" or "poor" in more patients in the intervention group than the control group (14.7% vs. 9.3%), although this difference was not statistically significant.

Also, intraoperative assessment of the rectal vault showed no differences between the groups in the presence of gas or stool.

The findings are important given that 5 million women underwent prolapse procedures in the United States between 1976 and 2006, and that mechanical bowel preparation is commonly applied preoperatively - despite a lack of clear evidence that it is necessary or beneficial, Dr. Ballard said.

Although limited by the single-site design, this study has several strengths, including a robust sample size, randomization, and a well-defined surgical cohort that included patients undergoing concomitant apical suspension and posterior repair. It is also strengthened by the inclusion of both surgeon and patient assessments.

Therefore, the findings challenge the role of mechanical bowel preparation for vaginal prolapse surgery.

"Routine use of mechanical bowel preparation should be reconsidered," Dr. Ballard concluded.

She reported having no relevant financial disclosures.

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – At 2 years, the Endurant stent graft was durable for abdominal aortic aneurysm, based on findings from a registry of nearly 1,300 patients.

Freedom from aneurysm-related death was 98% in the 500 registry participants who were followed for at least 2 years, reported Dr. Dittmar Böckler, of University Hospital Heidelberg, Germany.

Procedural success was nearly 98% in 1,263 participants in the ENGAGE Global Registry of patients treated with Medtronic’s Endurant system. The findings offer encouragement about "real world" endovascular aneurysm repair (EVAR) and new-generation EVAR devices, Dr. Böckler said at the International Symposium on Endovascular Therapy 2013.

Procedural success was based on a composite of technical success (99%), freedom from intraoperative death (100%), and freedom from type I and III endoleaks (98.6%). Also, there was freedom from reinterventions at 1 year (95%) in all 1,236 patients and at 2 years (93%) in the 500 patients who have been followed that long.

The risk of any type of second procedure was 5.6% at 1 year and 1.6% at 2 years. The risk of a second procedure for an endoleak was 1.4% at 1 year and 1.8% at 2 years. The total endoleak rate was a "remarkably low" 9.7% at 1 year and 9.1% at 2 years, he said.

No stent migration occurred at either time point. Sac enlargement, which is known to increase the long-term risk of aneurysm rupture, was rare, occurring in 3.4% of patients at 1 year and 2.9% at 2 years, Dr. Böckler said.

As for EVAR treatment failure, the conversion rate was "very acceptable" at 0.6% and 0.8% at 1 and 2 years, respectively, and the rupture rate was 0.2% at 1 year and remained the same at 2 years, he noted.

Stent graft occlusion occurred in 3.5% at 1 year and in 2.7% at 2 years. Similar patency was seen in 150 patients from the Endurant U.S. Investigational Device Exemption (IDE) trial; at 2 years, 3.1% of patients in that trial had occlusions.

The ENGAGE findings compare favorably with those of other studies of EVAR, including the DREAM (Dutch Randomized Endovascular Aneurysm Management) study and the OVER (Open Vs. Endovascular Repair) trial, he said.

Of note, the need for secondary intervention was halved with the Endurant system; it was 6.4% in ENGAGE and 6.1% in Endurant U.S. IDE, compared with 13.7% in OVER and 12% in DREAM.

"The clinical effectiveness of EVAR is well established," Dr. Böckler said, citing the outcomes of numerous EVAR trials. The 2-year outcomes begin to address the remaining concerns and questions, including whether outcomes are durable, whether performance outside of controlled trials will match that seen in trials, whether newer technology will perform as well as or better than older technology, and whether it will perform as well in real-world settings and in different populations and practices.

The registry – a multicenter, postmarket, noninterventional, nonrandomized prospective study – includes 1,263 patients enrolled between March 2009 and April 2011 to assess real-world safety and clinical performance of the Endurant stent graft system. Patients will be followed for 5 years. ENGAGE is the largest contemporary EVAR registry for a single manufacturer’s stent, and it includes a database that can be pooled and compared with other available stent graft data, according to Dr. Böckler.

Of note, the registry participants include a challenging patient population: 16% had symptomatic abdominal aortic aneurysms, 10.6% were classed as ASA (American Society of Anesthesiologists) IV (having severe systemic disease that is a constant threat to life), and 10.5% were female patients with narrow access arteries.

Although more patients and additional follow-up are needed to prove long-term efficacy, these 2-year findings demonstrate that real-world EVAR practice with the Endurant stent graft system provides very good and durable results, Dr. Böckler said. "EVAR is getting better with the new-generation devices."

Dr. Böckler has served as a consultant, advisory board member, or speaker for Endologix, Endomax, Gore, Medtronic, Siemens, and Maquet. He has received research or grant support from Gore, Maquet, Medtronic, and Siemens.

cardionews@frontlinemedcom.com

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.

MIAMI BEACH – When the "wire and catheter" approach fails, crossing devices come into play for recanalizing vessels during endovascular interventions, according to Dr. John Rundback.

Specialized crossing devices may improve the ability to treat chronic total occlusions (CTOs), including calcified and long, complex lesions that can be very difficult to cross, particularly in the infrapopliteal region, said Dr. Rundback, medical director of the Interventional Institute at Holy Name Medical Center, Briarcliff Manor, N.Y.

Courtesy Holy Name Medical Center

When it comes to specialized crossing devices, there is a whole spectrum available, and many are relatively new on the market, so experience with them is limited, Dr. Rundback said at the International Symposium on Endovascular Therapy 2013.

The goal with each, however, is to remain intraluminal and to maximize the interventional options, he said, noting that goal is particularly relevant with the advent of drug-eluting balloons.

Although the data are sparse, and these devices – which are generally used in patients who have failed traditional wire and catheter crossing – have not been compared to wire and catheter techniques in a rigorous fashion, it is nonetheless clear that there are cases in which these devices will be needed.

"You have to sort of pick one or two and keep them in your lab, and gain familiarity," he said.

The approved and emerging devices he discussed include the Viance and Enteer peripheral CTO crossing devices (Covidien), the Crosser CTO device (Bard Peripheral Vascular), the Wildcat and Kittycat CTO devices (Avinger), and the TruePath crossing device (Boston Scientific).

Viance and Enteer

The Viance crossing catheter is a high-speed rotating recanalization device, and the Enteer reentry system is a unique reentry catheter. The two were studied together as a novel overall strategy, Dr. Rundback explained.

In a study involving 66 patients, which led to the recent approval of the device, CTO lesion lengths were reasonably long, much like those Dr. Runback said he sees in his practice. However, moderate to severe calcification was present in only 42% of patients, which is less than he generally sees, and a fair amount of tortuosity was present in 50%-60% of patients.

About two-thirds of the cases involved the superficial femoral artery (SFA), and the remaining cases were in the tibial circulation. Overall, the approach was safe, and the success rate was 85%, Dr. Rundback said.

The Crosser

The latest version of this device, approved in the United States for both coronary and peripheral indications, involves a dedicated hydraulic vibrational system that provides translational force through the lumen.

"It’s the one we tend to use the most in our practice, and our junior associates have had great success with this device," Dr. Rundback noted.

The Crosser device is unique in that it establishes a luminal plane where you often don’t see anything, and moves quite smoothly and easily through the lumen, he said.

In the PATRIOT (Peripheral Approach to Recanalization in Occluded Totals) study of this device, 85 guide wire–refractory peripheral CTO patients were treated with a high technical success rate of 84% and no perforations.

Most cases involved the SFA, but about a third were popliteal or below. Lesion length was reasonable (average, 117.5 mm), and about 75% of patients had old, calcified lesions.

Treatment was quick, taking only about 2 minutes on average.

"That has been our experience as well. These actually work very quickly to reestablish straight-line flow," he said, noting that it is important to be cautious, nonetheless.

"You can get extraluminal without knowing it. [The technique] requires a certain amount of practice and tactile feedback to become familiar with the utility of these devices," he said.

Wildcat and Kittycat

These devices are rotating crossing devices (Kittycat is a small-vessel device) that have shown promise in trials.

In the CONNECT (Chronic Total Occlusion Crossing with the Wildcat Catheter) trial, the technical success rate was 89%, and safety was greater than 95% in patients with an average lesion length of 174 mm, about half of whom had moderately calcified lesions.

The newest incarnations of these rotating crossing devices use optical coherence technology that allows visualization of the lumen as the occlusion is traversed.

Dr. Rundback said he has no personal experience with these devices, but said that the prospect of visualizing the position within the lumen "does have some sort of empirical appeal and may provide real, true benefit in terms of staying in the lumen."

TruePath

This FDA-approved crossing device uses a high-speed, rotating diamond-studded burr to advance through lesions.

It is entirely self-contained and easy to use, Dr. Rundback said, noting that the device uses a feedback system involving red lights and beeping sounds that are activated when resistance is encountered in the system. This provides audible, visible, and tactile feedback to help avoid going extraluminal.

In the ReOpen study of 85 patients with a mean occlusion length of 166 mm who failed guide-wire treatment, the technical success rate was 80% and the device was safe, he said.

Dr. Rundback reported having no relevant financial disclosures.