Patrice Wendling

SAN DIEGO – Patients with new-onset, stable chest pain account for millions of stress tests annually in the United States, but randomized data are limited on which test is best and the impact of testing on clinical outcomes.

Results from the prospective PROMISE trial, presented at the annual meeting of the American College of Cardiology, show there is no Holy Grail testing strategy. First-line testing with CT angiography did not reduce hard clinical events compared with functional testing, but did cut the number of patients undergoing an invasive catheterization showing no obstructive coronary artery disease.

Listen here for our interview with ACC president Dr. Patrick O’Gara on how these results will impact patient care and potentially influence current guideline recommendations.

Dr. O’Gara reported no relevant financial conflicts.

[email protected]

SAN DIEGO – Patients with new-onset, stable chest pain account for millions of stress tests annually in the United States, but randomized data are limited on which test is best and the impact of testing on clinical outcomes.

Results from the prospective PROMISE trial, presented at the annual meeting of the American College of Cardiology, show there is no Holy Grail testing strategy. First-line testing with CT angiography did not reduce hard clinical events compared with functional testing, but did cut the number of patients undergoing an invasive catheterization showing no obstructive coronary artery disease.

Listen here for our interview with ACC president Dr. Patrick O’Gara on how these results will impact patient care and potentially influence current guideline recommendations.

Dr. O’Gara reported no relevant financial conflicts.

[email protected]

SAN DIEGO – Patients with new-onset, stable chest pain account for millions of stress tests annually in the United States, but randomized data are limited on which test is best and the impact of testing on clinical outcomes.

Results from the prospective PROMISE trial, presented at the annual meeting of the American College of Cardiology, show there is no Holy Grail testing strategy. First-line testing with CT angiography did not reduce hard clinical events compared with functional testing, but did cut the number of patients undergoing an invasive catheterization showing no obstructive coronary artery disease.

Listen here for our interview with ACC president Dr. Patrick O’Gara on how these results will impact patient care and potentially influence current guideline recommendations.

Dr. O’Gara reported no relevant financial conflicts.

[email protected]

SAN DIEGO – The addition of CT angiography to standard care changed the diagnosis and treatment of one in four patients with stable chest pain in the prospective, randomized SCOT-HEART trial.

CT angiography (CTA) also reduced coronary heart disease deaths or myocardial infarctions by 38% after a median follow-up of 1.7 years, although the finding was of borderline significance (hazard ratio, 0.62; P = .053).

A post-hoc, landmark analysis, however, that accounted for the roughly 6-week delay between the clinic visit and implementation or alteration of therapy based on CTA findings, showed a halving of these outcomes (HR, 0.50; P = .015), chief investigator Dr. David Newby reported at the annual meeting of the American College of Cardiology.

SCOT-HEART (Scottish COmputed Tomography of the Heart trial) involved 4,146 patients referred from chest pain clinics across Scotland for assessment of suspected angina due to coronary artery disease, of whom 47% were diagnosed in the clinic with coronary heart disease and 36% with angina due to coronary heart disease. Patients were then evenly randomized to standard care involving cardiovascular risk assessment with the ASSIGN Score alone or with CTA.

When attending clinicians reviewed the cases at 6 weeks, the diagnosis of coronary heart disease (CHD) changed in 25% of patients assigned CTA vs. only 1% assigned standard care alone and the diagnosis of angina due to CHD changed in 23% vs. 1% (P value < .001 for both), Dr. Newby, from the University of Edinburgh, said.

Clinicians reported that CTA significantly increased the certainty (Relative risk, 2.56; P < .0001) and frequency (RR, 1.09; P = .017) of the diagnosis of CHD and increased the certainty of a diagnosis of angina due to CHD (RR, 1.79; P < .0001), but had no effect on its frequency (RR, 0.93; P = .12).

Overall, 63% of patients had evidence of CHD on CTA, with 25% having obstructive disease.

CTA altered subsequent testing in 15% of patients vs. only 1% with standard care (P < .001). CTA use was associated with the cancellation of 121 functional stress tests and 29 invasive coronary angiography exams. CTA also prompted 94 new angiograms vs. just 8 with standard care, but this was mainly the result of the exclusion or discovery of obstructive coronary heart disease, including triple vessel disease, Dr. Newby observed. CT was associated with a nonsignificant increase in coronary revascularizations (11.2% vs. 9.7%; HR, 1.19; P .06).

The changes in diagnosis and testing were associated with changes in subsequent treatment in 23% of CTA patients vs. 5% of standard care patients overall (P < .001), including recommendations and cancellations for preventive and anti-anginal therapies. The results were also simultaneously published online (Lancet 2015 [doi:10.19016/S0140-6736(15)060291-4]).

The most impressive aspect of SCOT-HEART was the strong trend for improved outcomes in patients for which therapeutic alterations were made, Dr. Eric Peterson, with the Duke University in Durham, N.C., commented.

“This sets the standard for how we perform and evaluate whether CT can improve outcomes for patients,” he said.

In an editorial accompanying the report,, Dr. Pamela Douglas, from the Duke Clinical Research Institute in Durham, N.C., called the finding of reduced death and MI “intriguing,” but urged caution in its interpretation because it was one of 22 secondary end points and the absolute difference between groups was only 16 events (Lancet 2015; [doi: 10.1016/S0140-6736(15)60463-9]). Earlier in the meeting, she reported that the PROMISE trial found no difference in its primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications among chest pain patients evaluated with CTA or functional testing.

Finally, it was noted that radiation exposure in SCOT-HEART (median 4.1 mSv) was substantially lower than that reported in PROMISE, a finding Dr. Newby said he could not explain.

[email protected]

SAN DIEGO – The addition of CT angiography to standard care changed the diagnosis and treatment of one in four patients with stable chest pain in the prospective, randomized SCOT-HEART trial.

CT angiography (CTA) also reduced coronary heart disease deaths or myocardial infarctions by 38% after a median follow-up of 1.7 years, although the finding was of borderline significance (hazard ratio, 0.62; P = .053).

A post-hoc, landmark analysis, however, that accounted for the roughly 6-week delay between the clinic visit and implementation or alteration of therapy based on CTA findings, showed a halving of these outcomes (HR, 0.50; P = .015), chief investigator Dr. David Newby reported at the annual meeting of the American College of Cardiology.

SCOT-HEART (Scottish COmputed Tomography of the Heart trial) involved 4,146 patients referred from chest pain clinics across Scotland for assessment of suspected angina due to coronary artery disease, of whom 47% were diagnosed in the clinic with coronary heart disease and 36% with angina due to coronary heart disease. Patients were then evenly randomized to standard care involving cardiovascular risk assessment with the ASSIGN Score alone or with CTA.

When attending clinicians reviewed the cases at 6 weeks, the diagnosis of coronary heart disease (CHD) changed in 25% of patients assigned CTA vs. only 1% assigned standard care alone and the diagnosis of angina due to CHD changed in 23% vs. 1% (P value < .001 for both), Dr. Newby, from the University of Edinburgh, said.

Clinicians reported that CTA significantly increased the certainty (Relative risk, 2.56; P < .0001) and frequency (RR, 1.09; P = .017) of the diagnosis of CHD and increased the certainty of a diagnosis of angina due to CHD (RR, 1.79; P < .0001), but had no effect on its frequency (RR, 0.93; P = .12).

Overall, 63% of patients had evidence of CHD on CTA, with 25% having obstructive disease.

CTA altered subsequent testing in 15% of patients vs. only 1% with standard care (P < .001). CTA use was associated with the cancellation of 121 functional stress tests and 29 invasive coronary angiography exams. CTA also prompted 94 new angiograms vs. just 8 with standard care, but this was mainly the result of the exclusion or discovery of obstructive coronary heart disease, including triple vessel disease, Dr. Newby observed. CT was associated with a nonsignificant increase in coronary revascularizations (11.2% vs. 9.7%; HR, 1.19; P .06).

The changes in diagnosis and testing were associated with changes in subsequent treatment in 23% of CTA patients vs. 5% of standard care patients overall (P < .001), including recommendations and cancellations for preventive and anti-anginal therapies. The results were also simultaneously published online (Lancet 2015 [doi:10.19016/S0140-6736(15)060291-4]).

The most impressive aspect of SCOT-HEART was the strong trend for improved outcomes in patients for which therapeutic alterations were made, Dr. Eric Peterson, with the Duke University in Durham, N.C., commented.

“This sets the standard for how we perform and evaluate whether CT can improve outcomes for patients,” he said.

In an editorial accompanying the report,, Dr. Pamela Douglas, from the Duke Clinical Research Institute in Durham, N.C., called the finding of reduced death and MI “intriguing,” but urged caution in its interpretation because it was one of 22 secondary end points and the absolute difference between groups was only 16 events (Lancet 2015; [doi: 10.1016/S0140-6736(15)60463-9]). Earlier in the meeting, she reported that the PROMISE trial found no difference in its primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications among chest pain patients evaluated with CTA or functional testing.

Finally, it was noted that radiation exposure in SCOT-HEART (median 4.1 mSv) was substantially lower than that reported in PROMISE, a finding Dr. Newby said he could not explain.

[email protected]

SAN DIEGO – The addition of CT angiography to standard care changed the diagnosis and treatment of one in four patients with stable chest pain in the prospective, randomized SCOT-HEART trial.

CT angiography (CTA) also reduced coronary heart disease deaths or myocardial infarctions by 38% after a median follow-up of 1.7 years, although the finding was of borderline significance (hazard ratio, 0.62; P = .053).

A post-hoc, landmark analysis, however, that accounted for the roughly 6-week delay between the clinic visit and implementation or alteration of therapy based on CTA findings, showed a halving of these outcomes (HR, 0.50; P = .015), chief investigator Dr. David Newby reported at the annual meeting of the American College of Cardiology.

SCOT-HEART (Scottish COmputed Tomography of the Heart trial) involved 4,146 patients referred from chest pain clinics across Scotland for assessment of suspected angina due to coronary artery disease, of whom 47% were diagnosed in the clinic with coronary heart disease and 36% with angina due to coronary heart disease. Patients were then evenly randomized to standard care involving cardiovascular risk assessment with the ASSIGN Score alone or with CTA.

When attending clinicians reviewed the cases at 6 weeks, the diagnosis of coronary heart disease (CHD) changed in 25% of patients assigned CTA vs. only 1% assigned standard care alone and the diagnosis of angina due to CHD changed in 23% vs. 1% (P value < .001 for both), Dr. Newby, from the University of Edinburgh, said.

Clinicians reported that CTA significantly increased the certainty (Relative risk, 2.56; P < .0001) and frequency (RR, 1.09; P = .017) of the diagnosis of CHD and increased the certainty of a diagnosis of angina due to CHD (RR, 1.79; P < .0001), but had no effect on its frequency (RR, 0.93; P = .12).

Overall, 63% of patients had evidence of CHD on CTA, with 25% having obstructive disease.

CTA altered subsequent testing in 15% of patients vs. only 1% with standard care (P < .001). CTA use was associated with the cancellation of 121 functional stress tests and 29 invasive coronary angiography exams. CTA also prompted 94 new angiograms vs. just 8 with standard care, but this was mainly the result of the exclusion or discovery of obstructive coronary heart disease, including triple vessel disease, Dr. Newby observed. CT was associated with a nonsignificant increase in coronary revascularizations (11.2% vs. 9.7%; HR, 1.19; P .06).

The changes in diagnosis and testing were associated with changes in subsequent treatment in 23% of CTA patients vs. 5% of standard care patients overall (P < .001), including recommendations and cancellations for preventive and anti-anginal therapies. The results were also simultaneously published online (Lancet 2015 [doi:10.19016/S0140-6736(15)060291-4]).

The most impressive aspect of SCOT-HEART was the strong trend for improved outcomes in patients for which therapeutic alterations were made, Dr. Eric Peterson, with the Duke University in Durham, N.C., commented.

“This sets the standard for how we perform and evaluate whether CT can improve outcomes for patients,” he said.

In an editorial accompanying the report,, Dr. Pamela Douglas, from the Duke Clinical Research Institute in Durham, N.C., called the finding of reduced death and MI “intriguing,” but urged caution in its interpretation because it was one of 22 secondary end points and the absolute difference between groups was only 16 events (Lancet 2015; [doi: 10.1016/S0140-6736(15)60463-9]). Earlier in the meeting, she reported that the PROMISE trial found no difference in its primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications among chest pain patients evaluated with CTA or functional testing.

Finally, it was noted that radiation exposure in SCOT-HEART (median 4.1 mSv) was substantially lower than that reported in PROMISE, a finding Dr. Newby said he could not explain.

[email protected]

SAN DIEGO – Initial anatomic testing with CT angiography yielded similar clinical outcomes to functional testing in chest pain patients evaluated for coronary artery disease in the PROMISE study.

After an average of 25 months, the primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications occurred in 3.3% of the CTA patients and 3.0% of the functional-testing patients (adjusted hazard ratio, 1.04; P = .75).

The CTA strategy may offer a slight advantage, however, in terms of fewer invasive catheterizations without evidence of obstructive coronary artery disease (3.4% vs. 4.3%; P = .022) and a higher proportion of catheterizations with obstructive CAD (72.1% vs. 47.5%) getting revascularization (6.2% vs. 3.2%) or coronary artery bypass grafting (72 events vs. 38 events).

“Our results suggest that CTA is a viable alternative to functional testing. These real-world results should inform noninvasive testing choices in clinical care as well as provide guidance to future studies of diagnostic strategies in suspected heart disease,” lead study author Dr. Pamela Douglas reported at the annual meeting of the American College of Cardiology and simultaneously published online (N. Engl. J. Med. 2015 [DOI:10.1056/NEJoa1415516].

Patrice Wendling/Frontline Medical News

PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) enrolled 10,003 symptomatic outpatients requiring nonemergent, noninvasive testing for suspected CAD who were older than 54 years for men or older than 64 years for women with no risk factors, or aged 45-54 years for men and 50-64 years for women with at least one cardiac risk factor.

Patients were randomly assigned to anatomical testing with CTA or functional testing including a nuclear stress test (67%), stress echocardiography (23%), or exercise electrocardiogram (10%). The patients had an average of 2.5 risk cardiovascular risk factors and half were women.

Radiation exposure was higher overall in the CTA group than the functional-testing group (mean 12.0 mSv vs. 10.1 mSv; P < .001), largely because 33% of the functional group had no exposure. Exposure was lower, however, in CTA patients compared with those for whom a nuclear test was specified at randomization as their first intended functional test (12.0 mSv vs. 14.1 mSv; P < .001), Dr. Douglas, from Duke Clinical Research Institute in Durham, N.C., said.

During a discussion of the results, Dr. Elliott Antman, associate dean for clinical and translational research at Harvard University, Boston, said CT angiography can’t officially be described as noninferior to functional testing because PROMISE was designed as a superiority trial with a noninferiority margin that was exceeded by the confidence intervals for the primary end point and questioned how clinicians should use the results.

“What I can say to the next patient is that they can be incredibly assured about their overall prognosis, which is a nontrivial thing to say that they have a very, very low likelihood of a bad event in the next 2 years no matter what we do,” Dr. Douglas responded. “I can offer a test choice that will have no difference in major health events like death or nonfatal MI, but I can offer a test that potentially has lower radiation and has a better triage function to the cath lab where you have less likelihood of ending up in the cath lab not needing to be there because you do not have obstructive disease.”

Though PROMISE may influence practice, it is unclear whether the noninferiority issue will impact its ability to change U.S. guidelines, which currently include a IIb recommendation that CTA be considered in the evaluation of patients with chest pain.

“Technically two randomized controlled trials are needed before you get evidence level A, but we have 10,000 patients who were well studied here, so I would anticipate a big change actually in the guidelines from a use criteria, but we shall see,” Dr. Douglas said.

[email protected]

SAN DIEGO – Initial anatomic testing with CT angiography yielded similar clinical outcomes to functional testing in chest pain patients evaluated for coronary artery disease in the PROMISE study.

After an average of 25 months, the primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications occurred in 3.3% of the CTA patients and 3.0% of the functional-testing patients (adjusted hazard ratio, 1.04; P = .75).

The CTA strategy may offer a slight advantage, however, in terms of fewer invasive catheterizations without evidence of obstructive coronary artery disease (3.4% vs. 4.3%; P = .022) and a higher proportion of catheterizations with obstructive CAD (72.1% vs. 47.5%) getting revascularization (6.2% vs. 3.2%) or coronary artery bypass grafting (72 events vs. 38 events).

“Our results suggest that CTA is a viable alternative to functional testing. These real-world results should inform noninvasive testing choices in clinical care as well as provide guidance to future studies of diagnostic strategies in suspected heart disease,” lead study author Dr. Pamela Douglas reported at the annual meeting of the American College of Cardiology and simultaneously published online (N. Engl. J. Med. 2015 [DOI:10.1056/NEJoa1415516].

Patrice Wendling/Frontline Medical News

PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) enrolled 10,003 symptomatic outpatients requiring nonemergent, noninvasive testing for suspected CAD who were older than 54 years for men or older than 64 years for women with no risk factors, or aged 45-54 years for men and 50-64 years for women with at least one cardiac risk factor.

Patients were randomly assigned to anatomical testing with CTA or functional testing including a nuclear stress test (67%), stress echocardiography (23%), or exercise electrocardiogram (10%). The patients had an average of 2.5 risk cardiovascular risk factors and half were women.

Radiation exposure was higher overall in the CTA group than the functional-testing group (mean 12.0 mSv vs. 10.1 mSv; P < .001), largely because 33% of the functional group had no exposure. Exposure was lower, however, in CTA patients compared with those for whom a nuclear test was specified at randomization as their first intended functional test (12.0 mSv vs. 14.1 mSv; P < .001), Dr. Douglas, from Duke Clinical Research Institute in Durham, N.C., said.

During a discussion of the results, Dr. Elliott Antman, associate dean for clinical and translational research at Harvard University, Boston, said CT angiography can’t officially be described as noninferior to functional testing because PROMISE was designed as a superiority trial with a noninferiority margin that was exceeded by the confidence intervals for the primary end point and questioned how clinicians should use the results.

“What I can say to the next patient is that they can be incredibly assured about their overall prognosis, which is a nontrivial thing to say that they have a very, very low likelihood of a bad event in the next 2 years no matter what we do,” Dr. Douglas responded. “I can offer a test choice that will have no difference in major health events like death or nonfatal MI, but I can offer a test that potentially has lower radiation and has a better triage function to the cath lab where you have less likelihood of ending up in the cath lab not needing to be there because you do not have obstructive disease.”

Though PROMISE may influence practice, it is unclear whether the noninferiority issue will impact its ability to change U.S. guidelines, which currently include a IIb recommendation that CTA be considered in the evaluation of patients with chest pain.

“Technically two randomized controlled trials are needed before you get evidence level A, but we have 10,000 patients who were well studied here, so I would anticipate a big change actually in the guidelines from a use criteria, but we shall see,” Dr. Douglas said.

[email protected]

SAN DIEGO – Initial anatomic testing with CT angiography yielded similar clinical outcomes to functional testing in chest pain patients evaluated for coronary artery disease in the PROMISE study.

After an average of 25 months, the primary composite end point of all-cause death, nonfatal myocardial infarction, unstable angina hospitalization, and major cardiovascular procedural complications occurred in 3.3% of the CTA patients and 3.0% of the functional-testing patients (adjusted hazard ratio, 1.04; P = .75).

The CTA strategy may offer a slight advantage, however, in terms of fewer invasive catheterizations without evidence of obstructive coronary artery disease (3.4% vs. 4.3%; P = .022) and a higher proportion of catheterizations with obstructive CAD (72.1% vs. 47.5%) getting revascularization (6.2% vs. 3.2%) or coronary artery bypass grafting (72 events vs. 38 events).

“Our results suggest that CTA is a viable alternative to functional testing. These real-world results should inform noninvasive testing choices in clinical care as well as provide guidance to future studies of diagnostic strategies in suspected heart disease,” lead study author Dr. Pamela Douglas reported at the annual meeting of the American College of Cardiology and simultaneously published online (N. Engl. J. Med. 2015 [DOI:10.1056/NEJoa1415516].

Patrice Wendling/Frontline Medical News

PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) enrolled 10,003 symptomatic outpatients requiring nonemergent, noninvasive testing for suspected CAD who were older than 54 years for men or older than 64 years for women with no risk factors, or aged 45-54 years for men and 50-64 years for women with at least one cardiac risk factor.

Patients were randomly assigned to anatomical testing with CTA or functional testing including a nuclear stress test (67%), stress echocardiography (23%), or exercise electrocardiogram (10%). The patients had an average of 2.5 risk cardiovascular risk factors and half were women.

Radiation exposure was higher overall in the CTA group than the functional-testing group (mean 12.0 mSv vs. 10.1 mSv; P < .001), largely because 33% of the functional group had no exposure. Exposure was lower, however, in CTA patients compared with those for whom a nuclear test was specified at randomization as their first intended functional test (12.0 mSv vs. 14.1 mSv; P < .001), Dr. Douglas, from Duke Clinical Research Institute in Durham, N.C., said.

During a discussion of the results, Dr. Elliott Antman, associate dean for clinical and translational research at Harvard University, Boston, said CT angiography can’t officially be described as noninferior to functional testing because PROMISE was designed as a superiority trial with a noninferiority margin that was exceeded by the confidence intervals for the primary end point and questioned how clinicians should use the results.

“What I can say to the next patient is that they can be incredibly assured about their overall prognosis, which is a nontrivial thing to say that they have a very, very low likelihood of a bad event in the next 2 years no matter what we do,” Dr. Douglas responded. “I can offer a test choice that will have no difference in major health events like death or nonfatal MI, but I can offer a test that potentially has lower radiation and has a better triage function to the cath lab where you have less likelihood of ending up in the cath lab not needing to be there because you do not have obstructive disease.”

Though PROMISE may influence practice, it is unclear whether the noninferiority issue will impact its ability to change U.S. guidelines, which currently include a IIb recommendation that CTA be considered in the evaluation of patients with chest pain.

“Technically two randomized controlled trials are needed before you get evidence level A, but we have 10,000 patients who were well studied here, so I would anticipate a big change actually in the guidelines from a use criteria, but we shall see,” Dr. Douglas said.

[email protected]

LAKE BUENA VISTA, FLA. – Modifying the Centers for Disease Control and Prevention’s outpatient fall prevention program STEADI for inpatient use did not prevent further falls in elderly patients hospitalized for fall injuries.

The intervention was associated, however, with a “clear reduction in median length of stay and hospital charges,” Dr. Alexander Eastman, M.P.H., said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

STEADI(Stopping Elderly Accidents, Deaths and Injuries) is a CDC–funded program. It has six core domains – fall history, medical conditions, medications, gait/balance, vision limitation, and postural hypotension – and includes standardized gait and balance assessments and a fall-prevention checklist.

Dr. Eastman and other members of a multidisciplinary team at the University of Texas Southwestern Medical Center in Dallas used the same checklist principle to create a modified version of the STEADI program (mSTEADI) for inpatient use. Their patient assessment was associated with delivery of therapeutic interventions, and the gait and posture testing and therapies were adapted for use with injured patients.

Data were then prospectively collected for 1 year from 218 patients, aged older than 65 years, who were admitted for falls at the level 1 trauma center and enrolled in the mSTEADI program. Their results were compared with data from 196 historical controls from the same period the year before mSTEADI was introduced. The two groups were well matched with respect to median age (77 years vs. 76 years); mean Injury Severity Score (12.1 vs. 11.8); and Abbreviated Injury Scale (AIS) head, face, chest, or abdomen scores. mSTEADI patients had a slightly higher mean AIS extremity score (2.7 vs. 2.5; P value = .014).

After a year, however, the mSTEADI group and the historical controls had the same in-house fall rate, 4.1%. The fall recidivism rate was 2.1% for the mSTEADI group and 2.8% for the controls, an insignificant difference, Dr. Eastman said.

The mSTEADI group, however, was discharged a day earlier (5 days vs. 6 days; P <.01), was more likely to be discharged directly home (54.5% vs. 46.8%; P <.01), and had lower overall hospital charges ($45,538 vs. $60,585; P = .02).

Limitations of the study were the use of retrospective controls and the very real possibility of selection bias in a group receiving intensive assessment and therapy, Dr. Eastman said. Discussant Dr. Stephanie Bonne of Washington University, St. Louis, asked whether the researchers were confident they captured all subsequent falls when calculating recidivism in such a large urban setting and whether the findings of shorter hospital stay and more discharges home would prompt them to recommend mSTEADI for enhancing rehabilitation protocols rather than for preventing repeated falls.

Dr. Eastman said that the combination of medical and emergency medical services records probably captured geriatric patients returning to the hospital with an injury from a fall since Southwestern is the EMS medical director for Dallas and 15 surrounding municipalities.

“As far as the decreased length of stay, I think there’s no question that increased focus on your rehabilitation efforts results in this unintended benefit of getting more patients home,” he added. “That’s a very real, tangible benefit to this program, but I’m not sure you have to incorporate all the other stuff that the mSTEADI program brings rather than breaking out just those specific portions of the program that are rehab focused and then really going out and studying in-hospital falls and fall recidivists to see what other phases are potential targets for intervention.”

Because the translation of the STEADI program to mSTEADI may have missed “some intangible associated with in-house falls,” an additional study of inpatient falls (iSTEADI) is being planned, as are home visits by Dallas paramedics to assess fall risk for every fall patient discharged from their institution, Dr. Eastman said.

[email protected]

LAKE BUENA VISTA, FLA. – Modifying the Centers for Disease Control and Prevention’s outpatient fall prevention program STEADI for inpatient use did not prevent further falls in elderly patients hospitalized for fall injuries.

The intervention was associated, however, with a “clear reduction in median length of stay and hospital charges,” Dr. Alexander Eastman, M.P.H., said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

STEADI(Stopping Elderly Accidents, Deaths and Injuries) is a CDC–funded program. It has six core domains – fall history, medical conditions, medications, gait/balance, vision limitation, and postural hypotension – and includes standardized gait and balance assessments and a fall-prevention checklist.

Dr. Eastman and other members of a multidisciplinary team at the University of Texas Southwestern Medical Center in Dallas used the same checklist principle to create a modified version of the STEADI program (mSTEADI) for inpatient use. Their patient assessment was associated with delivery of therapeutic interventions, and the gait and posture testing and therapies were adapted for use with injured patients.

Data were then prospectively collected for 1 year from 218 patients, aged older than 65 years, who were admitted for falls at the level 1 trauma center and enrolled in the mSTEADI program. Their results were compared with data from 196 historical controls from the same period the year before mSTEADI was introduced. The two groups were well matched with respect to median age (77 years vs. 76 years); mean Injury Severity Score (12.1 vs. 11.8); and Abbreviated Injury Scale (AIS) head, face, chest, or abdomen scores. mSTEADI patients had a slightly higher mean AIS extremity score (2.7 vs. 2.5; P value = .014).

After a year, however, the mSTEADI group and the historical controls had the same in-house fall rate, 4.1%. The fall recidivism rate was 2.1% for the mSTEADI group and 2.8% for the controls, an insignificant difference, Dr. Eastman said.

The mSTEADI group, however, was discharged a day earlier (5 days vs. 6 days; P <.01), was more likely to be discharged directly home (54.5% vs. 46.8%; P <.01), and had lower overall hospital charges ($45,538 vs. $60,585; P = .02).

Limitations of the study were the use of retrospective controls and the very real possibility of selection bias in a group receiving intensive assessment and therapy, Dr. Eastman said. Discussant Dr. Stephanie Bonne of Washington University, St. Louis, asked whether the researchers were confident they captured all subsequent falls when calculating recidivism in such a large urban setting and whether the findings of shorter hospital stay and more discharges home would prompt them to recommend mSTEADI for enhancing rehabilitation protocols rather than for preventing repeated falls.

Dr. Eastman said that the combination of medical and emergency medical services records probably captured geriatric patients returning to the hospital with an injury from a fall since Southwestern is the EMS medical director for Dallas and 15 surrounding municipalities.

“As far as the decreased length of stay, I think there’s no question that increased focus on your rehabilitation efforts results in this unintended benefit of getting more patients home,” he added. “That’s a very real, tangible benefit to this program, but I’m not sure you have to incorporate all the other stuff that the mSTEADI program brings rather than breaking out just those specific portions of the program that are rehab focused and then really going out and studying in-hospital falls and fall recidivists to see what other phases are potential targets for intervention.”

Because the translation of the STEADI program to mSTEADI may have missed “some intangible associated with in-house falls,” an additional study of inpatient falls (iSTEADI) is being planned, as are home visits by Dallas paramedics to assess fall risk for every fall patient discharged from their institution, Dr. Eastman said.

[email protected]

LAKE BUENA VISTA, FLA. – Modifying the Centers for Disease Control and Prevention’s outpatient fall prevention program STEADI for inpatient use did not prevent further falls in elderly patients hospitalized for fall injuries.

The intervention was associated, however, with a “clear reduction in median length of stay and hospital charges,” Dr. Alexander Eastman, M.P.H., said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

STEADI(Stopping Elderly Accidents, Deaths and Injuries) is a CDC–funded program. It has six core domains – fall history, medical conditions, medications, gait/balance, vision limitation, and postural hypotension – and includes standardized gait and balance assessments and a fall-prevention checklist.

Dr. Eastman and other members of a multidisciplinary team at the University of Texas Southwestern Medical Center in Dallas used the same checklist principle to create a modified version of the STEADI program (mSTEADI) for inpatient use. Their patient assessment was associated with delivery of therapeutic interventions, and the gait and posture testing and therapies were adapted for use with injured patients.

Data were then prospectively collected for 1 year from 218 patients, aged older than 65 years, who were admitted for falls at the level 1 trauma center and enrolled in the mSTEADI program. Their results were compared with data from 196 historical controls from the same period the year before mSTEADI was introduced. The two groups were well matched with respect to median age (77 years vs. 76 years); mean Injury Severity Score (12.1 vs. 11.8); and Abbreviated Injury Scale (AIS) head, face, chest, or abdomen scores. mSTEADI patients had a slightly higher mean AIS extremity score (2.7 vs. 2.5; P value = .014).

After a year, however, the mSTEADI group and the historical controls had the same in-house fall rate, 4.1%. The fall recidivism rate was 2.1% for the mSTEADI group and 2.8% for the controls, an insignificant difference, Dr. Eastman said.

The mSTEADI group, however, was discharged a day earlier (5 days vs. 6 days; P <.01), was more likely to be discharged directly home (54.5% vs. 46.8%; P <.01), and had lower overall hospital charges ($45,538 vs. $60,585; P = .02).

Limitations of the study were the use of retrospective controls and the very real possibility of selection bias in a group receiving intensive assessment and therapy, Dr. Eastman said. Discussant Dr. Stephanie Bonne of Washington University, St. Louis, asked whether the researchers were confident they captured all subsequent falls when calculating recidivism in such a large urban setting and whether the findings of shorter hospital stay and more discharges home would prompt them to recommend mSTEADI for enhancing rehabilitation protocols rather than for preventing repeated falls.

Dr. Eastman said that the combination of medical and emergency medical services records probably captured geriatric patients returning to the hospital with an injury from a fall since Southwestern is the EMS medical director for Dallas and 15 surrounding municipalities.

“As far as the decreased length of stay, I think there’s no question that increased focus on your rehabilitation efforts results in this unintended benefit of getting more patients home,” he added. “That’s a very real, tangible benefit to this program, but I’m not sure you have to incorporate all the other stuff that the mSTEADI program brings rather than breaking out just those specific portions of the program that are rehab focused and then really going out and studying in-hospital falls and fall recidivists to see what other phases are potential targets for intervention.”

Because the translation of the STEADI program to mSTEADI may have missed “some intangible associated with in-house falls,” an additional study of inpatient falls (iSTEADI) is being planned, as are home visits by Dallas paramedics to assess fall risk for every fall patient discharged from their institution, Dr. Eastman said.

[email protected]

CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.

“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).

Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.

Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.

To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.

Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.

It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.

After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).

The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.

Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.

In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).

Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.

Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.

The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.

An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.

“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”

CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.

“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”

The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.

[email protected]

CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.

“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).

Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.

Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.

To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.

Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.

It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.

After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).

The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.

Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.

In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).

Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.

Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.

The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.

An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.

“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”

CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.

“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”

The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.

[email protected]

CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.

“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).

Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.

Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.

To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.

Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.

It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.

After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).

The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.

Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.

In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).

Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.

Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.

The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.

An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.

“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”

CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.

“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”

The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.

[email protected]

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

[email protected]

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

[email protected]

CHICAGO – Patients who underwent modified laparoscopic Sugarbaker parastomal hernia repair were a third less likely to experience recurrence as those repaired with other surgical techniques in a multicenter, retrospective study in 62 patients.

The recurrence rate was 16.6% for the modified Sugarbaker technique, compared with 61% for keyhole repair, 69.2% for ostomy relocation, and 33.3% for open repair (P value < .001). Median follow-up was 16.6 months, 19.6 months, 16.4 months, and 27.2 months (P = .748).

In an adjusted Cox proportional hazards regression model, the Sugarbaker technique (hazard ratio, 0.28; P = .021) and body mass index (HR, 1.09; P = .013) were the only significant predictors of time to hernia recurrence.

Using the Kaplan-Meier method, 80% of Sugarbaker patients would be recurrence free at 2 years vs. about 60% of those in the other groups (log-rank P = .021), Mr. Francis DeAsis, a research assistant from NorthShore University Health in Evanston, Ill., reported at the annual meeting of the Central Surgical Association.

The findings are in keeping with prior Sugarbaker studies involving 177 repairs between 2005 and 2013, reporting recurrence rates between 4% and 20% and morbidity of 12%-43%, he said.

Morbidity was 40% among the 25 Sugarbaker repairs in the current analysis, significantly lower than that in the Keyhole, relocation, and open repair groups (40% vs. 83.3%, 61.5%, 83.3%; P = .005).

“Based on our results and others, we’d like to suggest that the Sugarbaker approach should be the primary option for treating parastomal hernia,” Mr. DeAsis said.

The study provides “further proof that no other technique available results in a durable repair compared to the Sugarbaker technique for these challenging hernias,” senior study author Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore, said in an interview.

The Sugarbaker technique typically involves a laparoscopic mesh sublay over the fascial defect and lateralization of the stoma limb. Modifications at NorthShore included use of polytetrafluoroethylene mesh with a 5-cm overlap of the defect and, if possible, primary closure of the defect. A catheter is occasionally used to identify the correct ostomy limb, but most importantly, a laparoscopic approach is utilized in order to decrease wound infections and quicken the return to daily activities, Dr. Ujiki said. “We also avoid cautery and diligently look for other incidental hernias at the prevision incisions.”

Ileus (> 3 days) was the most common complication in all groups: Sugarbaker (4/25), keyhole (9/18), relocation (3/13), and open (1/6). Only one death occurred; in the open group.

Discussant Dr. Matthew Goldblatt, with the Medical College of Wisconsin in Milwaukee, questioned how many patients also had ventral hernias and whether this was a complicating factor in ileus or length of stay and whether the fascia was closed primarily during keyhole repair or the mesh simply placed as a bridge, as this can impact failure rates.

Dr. Ujiki responded that some patients had concomitant ventral hernias and that they simply used a larger piece of mesh to cover both hernias. Primary closure was not part of the keyhole repair early in the 10-year series, spanning 2004 to 2014, but ultimately was performed in about half of patients in the keyhole group.

“I don’t think that there’s going to be a difference between the two in terms of recurrence, but I can’t say for sure,” he added.

At this point, the group does not use prophylactic mesh placement at the time the ostomy is created, to avoid infections.

Finally, the audience asked whether the investigators are willing to accept a 16% recurrence rate, a fourfold increase over the best reported result with a modified Sugarbaker technique.

“With these hernia repairs, to me a 16% recurrence rate is outstanding and I think it will only get better,” Dr. Ujiki said.

The series includes every patient on which they’ve performed a Sugarbaker and thus, represents their learning curve, which may not be the case with other series, he noted.

Dr. Ujiki left the audience with two bits of advice to hasten the learning curve: leave at least 5 cm of overlap because the mesh will shrink down and keep the stitches close to the mesh without cutting off the bowel.

[email protected]

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]

CHICAGO – The next generation of hybrid carotid stents is slowly breathing life into the stagnant field of carotid artery stenting.

The new hybrid stents combine the flexibility of a traditional open-cell, nitinol stent with the stabilization typically offered by a closed-cell stent design. The initial clinical experience is limited, but shows promising results against embolization, Dr. Claudio Schönholz said at a symposium on vascular surgery sponsored by Northwestern University.

Last year, Dr. Schönholz and his colleagues at the Medical University of South Carolina in Charleston reported the first-in-man use of the investigational Gore Carotid Stent (W.L. Gore & Associates) (J. Endovasc. Thera. 2014 Aug;21:601-4).

As part of the Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy (SCAFFOLD) study, the team has successfully treated another four patients with no evidence of peri- or postprocedural neurological events. This included a case with such severe high-grade stenosis and slow flow that the external carotid artery was not even visible on imaging before the stent was placed, Dr. Schönholz said.

The Food and Drug Administration recently reviewed unreleased data for the first 100 patients enrolled in SCAFFOLD and given the green light for the multicenter, 312-patient study to resume with the start of the new year, he said.

Medtronic’s Cristallo Ideale hybrid stent is already approved outside the United States and was associated with no major neurological events and two cases of transient ischemic attack in 124 patients treated at four expert centers in Italy and Germany in the Cristallo study (J. Endovasc. Ther. 2008;15:186-92).

A more recent retrospective study revealed only one minor stroke in the perioperative period and during the first 30 days in 68 patients with symptomatic carotid stenosis treated by Turkish surgeons with the Cristallo Ideale stent and a proximal protection device (MO.MA, Invatec s.r.l., Medtronic, Italy) (Int. Angiol. 2014 Nov. 14. [Epub ahead of print]).

Better patient selection, increased operator experience, and use of embolic protection devices has reduced neurological events associated with carotid artery stenting, but embolization still occurs after protection devices are removed due to plaque protrusion through the stent struts, Dr. Schönholz said.

The unique design of the hybrid stents “may prevent plaque protrusion, eliminating peri- and postprocedural events,” he said.

The Cristallo Ideale hybrid stent is a nitinol-based stent that has a closed-cell portion at its center and an open-cell configuration on the distal and proximal sections.

In contrast, the Gore Carotid Stent has a closed-cell component throughout the entire device length that is created by placing an expanded polytetrafluoroethylene lattice with 500-micron pores over an open-cell frame. Once combined, both the stent frame and lattice are coated on all surfaces with Carmeda Bioactive Surface (CBAS) heparin. It’s action is limited only to the device surface and has no systemic anticoagulation effects, said Dr. Schönholz, who disclosed serving on Gore’s scientific advisory board.

The open-cell frame allows a high degree of flexibility and conformity to the native anatomy, while the stent lattice provides a high degree of plaque scaffolding that can reduce plaque prolapse, he said. The lattice also reduces the amount of emboli released during and after stent deployment and stabilizes the stent frame by resisting elongation as well as “fish-scaling,” or the misalignment of stent struts that protrude into the vessel wall, particularly when stents are deployed in tortuous anatomy.

When asked during a discussion whether the same results couldn’t be achieved by simply putting in another covered stent like a Viabahn, Dr. Schönholz replied that the Gore Stent isn’t a true covered stent because the 500-micron pores allow perfusion to be maintained to the external carotid artery. “It was intended to prevent plaque profusion, but at the same time allowing perfusion of the external carotid,” he said.

So far, the investigators have not incorporated intravascular ultrasound during stent placement, as it was not part of the SCAFFOLD protocol, but this will likely be used once the device is approved, he added.

Course director Dr. Mark K. Eskandari, chief of vascular surgery at Northwestern University in Chicago, said the results show that “carotid stenting isn’t dead yet and we can persevere. Advances in technology, both in regards to mechanical embolic protection devices and stent design systems, continue to improve the already great results of carotid artery stenting.”

[email protected]