Cardiothoracic

LAS VEGAS – The experience at one major heart transplantation center indicates that annual screening dobutamine stress echocardiography to detect cardiac allograft vasculopathy renders annual coronary angiography unnecessary.

“This noninvasive method has very good specificity and is associated with a negative predictive value of 94%-97%. It can be used in our experience in lieu of annual invasive coronary angiography,” Dr. Jerry D. Estep declared at the annual meeting of the Heart Failure Society of America.

Cardiac allograft vasculopathy (CAV) is a unique, highly aggressive form of CAD. After 3 years post transplant it becomes the No. 1 cause of cardiac retransplantation and mortality. Guidelines recommend consideration of annual screening coronary angiography to detect it early to institute aggressive countermeasures. That’s the practice at most transplant centers.

However, at Houston Methodist Hospital, where Dr. Estep is medical director of the heart transplant and LVAD program, annual dobutamine stress echocardiography (DSE) is used instead. Because there is a scarcity of published data on this noninvasive alternative approach, he presented a retrospective study of the Houston transplant center’s experience over a recent 5-year period.

The study included 144 heart transplant recipients who underwent screening DSE for CAV annually for the first 4 years post transplant and coronary angiography at year 5.

During years 1-4, DSE detected CAV in 19% of patients. They didn’t differ in terms of baseline characteristics from those who remained free of this serious complication.

The good news: Ninety-four percent of patients with normal DSEs during years 1-4 had no CAV upon angiography at year 5. Moreover, the 5% who did have CAV at year 5 after earlier negative DSEs had mild to moderate disease.

The investigators documented the performance of annual screening DSE in predicting the development of major adverse cardiac events, defined as readmission for acute coronary syndrome, heart failure, revascularization, repeat heart transplantation, or cardiac death.

Dr. Estep reported having no financial conflicts regarding this study.

[email protected]

LAS VEGAS – The experience at one major heart transplantation center indicates that annual screening dobutamine stress echocardiography to detect cardiac allograft vasculopathy renders annual coronary angiography unnecessary.

“This noninvasive method has very good specificity and is associated with a negative predictive value of 94%-97%. It can be used in our experience in lieu of annual invasive coronary angiography,” Dr. Jerry D. Estep declared at the annual meeting of the Heart Failure Society of America.

Cardiac allograft vasculopathy (CAV) is a unique, highly aggressive form of CAD. After 3 years post transplant it becomes the No. 1 cause of cardiac retransplantation and mortality. Guidelines recommend consideration of annual screening coronary angiography to detect it early to institute aggressive countermeasures. That’s the practice at most transplant centers.

However, at Houston Methodist Hospital, where Dr. Estep is medical director of the heart transplant and LVAD program, annual dobutamine stress echocardiography (DSE) is used instead. Because there is a scarcity of published data on this noninvasive alternative approach, he presented a retrospective study of the Houston transplant center’s experience over a recent 5-year period.

The study included 144 heart transplant recipients who underwent screening DSE for CAV annually for the first 4 years post transplant and coronary angiography at year 5.

During years 1-4, DSE detected CAV in 19% of patients. They didn’t differ in terms of baseline characteristics from those who remained free of this serious complication.

The good news: Ninety-four percent of patients with normal DSEs during years 1-4 had no CAV upon angiography at year 5. Moreover, the 5% who did have CAV at year 5 after earlier negative DSEs had mild to moderate disease.

The investigators documented the performance of annual screening DSE in predicting the development of major adverse cardiac events, defined as readmission for acute coronary syndrome, heart failure, revascularization, repeat heart transplantation, or cardiac death.

Dr. Estep reported having no financial conflicts regarding this study.

[email protected]

LAS VEGAS – The experience at one major heart transplantation center indicates that annual screening dobutamine stress echocardiography to detect cardiac allograft vasculopathy renders annual coronary angiography unnecessary.

“This noninvasive method has very good specificity and is associated with a negative predictive value of 94%-97%. It can be used in our experience in lieu of annual invasive coronary angiography,” Dr. Jerry D. Estep declared at the annual meeting of the Heart Failure Society of America.

Cardiac allograft vasculopathy (CAV) is a unique, highly aggressive form of CAD. After 3 years post transplant it becomes the No. 1 cause of cardiac retransplantation and mortality. Guidelines recommend consideration of annual screening coronary angiography to detect it early to institute aggressive countermeasures. That’s the practice at most transplant centers.

However, at Houston Methodist Hospital, where Dr. Estep is medical director of the heart transplant and LVAD program, annual dobutamine stress echocardiography (DSE) is used instead. Because there is a scarcity of published data on this noninvasive alternative approach, he presented a retrospective study of the Houston transplant center’s experience over a recent 5-year period.

The study included 144 heart transplant recipients who underwent screening DSE for CAV annually for the first 4 years post transplant and coronary angiography at year 5.

During years 1-4, DSE detected CAV in 19% of patients. They didn’t differ in terms of baseline characteristics from those who remained free of this serious complication.

The good news: Ninety-four percent of patients with normal DSEs during years 1-4 had no CAV upon angiography at year 5. Moreover, the 5% who did have CAV at year 5 after earlier negative DSEs had mild to moderate disease.

The investigators documented the performance of annual screening DSE in predicting the development of major adverse cardiac events, defined as readmission for acute coronary syndrome, heart failure, revascularization, repeat heart transplantation, or cardiac death.

Dr. Estep reported having no financial conflicts regarding this study.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]

No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.

In its largest randomized controlled trial to date, fenoldopam did not lessen the need for dialysis after cardiac surgery and caused significantly more hypotension than did placebo, investigators reported at the annual congress of the European Society of Intensive Care Medicine.

Acute kidney injury is a common complication of cardiac surgery, and no drugs are known to effectively treat it, said Dr. Tiziana Bove of IRCCS San Raffaele Scientific Institute in Milan. “Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified,” said Dr. Bove and her associates.

The findings were published in JAMA simultaneously with the presentation at the congress ( 2014 Sept 29 [doi: 10.1001/jama.2014.13573]).

Fenoldopam is a selective dopamine receptor D₁ agonist and vasodilator. For the study, 667 patients who had developed early acute kidney injury after cardiac surgery received either an intravenous continuous infusion of fenoldopam at a starting dose of 0.1 mcg/kg per minute or placebo, the investigators said. Rates of dialysis and 30-day mortality were similar between the two groups. In all, 20% of the treatment group received renal replacement therapy, compared with 18% of the placebo group, and 30-day mortality rates were 23% and 22%, respectively, they said. Furthermore, hypotension developed in 26% of treated patients, compared with 15% of the placebo group (P = .001), the researchers said. The study was stopped for futility after an interim analysis, the researchers noted.The Italian Ministry of Health funded the study. Teva supplied the study drug. The authors reported no conflicts of interest.

A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.

If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).

Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.

For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.

"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.

The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.

The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.

Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.

The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.

Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.

In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).

A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.

The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."

The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.

If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).

Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.

For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.

"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.

The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.

The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.

Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.

The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.

Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.

In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).

A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.

The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."

The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

A new clinical practice guideline on cardiovascular evaluation and management of patients undergoing noncardiac surgery adds some clarity around the controversial issue of beta-blocker therapy and updates other aspects of care.

If a patient on beta-blocker medication needs noncardiac surgery, continue the beta-blocker, because there is no evidence of harm from doing so; but you risk doing harm if the drug is stopped, according to the new guideline from the American College of Cardiology (ACC) and the American Heart Association (AHA).

Surgeons will be happy to hear that, said Dr. Lee A. Fleisher, the chair of the guideline-writing committee, because that conforms to one of the Surgical Care Improvement Project’s National Measures.

For patients at elevated risk of a cardiovascular event during noncardiac surgery who are not already on beta-blocker therapy, however, the new guideline steps back from the organization’s 2009 position that beta-blockers not be started, and says instead that it’s not unreasonable to start the drug, with a caveat. Be very cautious and start the drug early enough before surgery that you can titrate it to avoid causing hypotension or a low heart rate.

"Make sure that you’re giving the right amount and monitoring their blood pressure and heart rate," Dr. Fleisher, chair of the guideline writing committee, said in an interview. "Really think once, twice, and thrice about starting a protocol," added Dr. Fleisher, the Robert D. Dripps Professor of Anesthesiology and Critical Care at the University of Pennsylvania, Philadelphia.

The ACC and AHA commissioned a committee to review the evidence for and against beta-blockers in patients undergoing noncardiac surgery. A separate writing committee then considered the evidence review committee’s report, reviewed the literature on other aspects of perioperative care for noncardiac surgery, and compiled a 102-page guideline with a 59-page executive summary.

The "2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery" will be published online on the ACC and AHA websites.

Dr. Fleisher described other highlights of the new guideline pertinent to cardiologists, primary care physicians, or surgeons. For the first time, palliative care has been added as an option that may come out of the preoperative evaluation, he said. Patient categories of high risk and intermediate risk have been lumped together as having "elevated" risk for simplicity’s sake because recommendations for the two separate categories were so similar.

The guideline now endorses two tools to choose from for preoperative risk assessments: the Revised Cardiac Risk Index (RCRI), and the National Surgical Quality Improvement Project risk calculator. "There have been a lot of comments that [the NSQIP] is a very useful tool to have shared decision-making conversations with patients," he said.

Another change applies to patients who receive second- or third-generation coronary stents. Instead of a wait of a year after stent implantation to perform noncardiac surgery, a 6-month wait may be reasonable if the risks of delaying noncardiac surgery outweigh the risks of interrupting dual-antiplatelet therapy for the noncardiac surgery.

In addition, the guideline incorporates findings from the recent POISE-2 study to say that aspirin can be stopped and clonidine is not useful in patients without stents undergoing noncardiac surgery (N. Engl. J. Med. 2014;370:1494-503).

A new statement in the guideline about troponin says to check troponin in high-risk patients with signs or symptoms of trouble but not to include troponin in routine screening.

The recommendations on beta-blockers, however, address the most controversial topic in the guideline, Dr. Fleisher said. "There is a lot of confusing evidence" on the use of beta-blockers, "so we’ve tried to clarify as much as we can."

The ACC and AHA funded the work of the committees. Dr. Fleisher reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a meeting hosted by the Society for Vascular Surgery.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures.

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a meeting hosted by the Society for Vascular Surgery.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures.

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a meeting hosted by the Society for Vascular Surgery.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures.