Mark S. Lesney

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

CHICAGO – Results from a follow-up analysis of patients in the randomized DECREASE III trial showed that there is an apparent "legacy" effect of perioperative statin therapy, resulting in improved long-term survival, compared with statin initiation after vascular surgery.

Ischemic cardiac events are a major cause of perioperative morbidity and mortality in noncardiac surgery (including vascular surgery), with an estimated 10%-40% of perioperative deaths ascribed to myocardial infarction (MI), according to the original report by Dr. Don Poldermans and the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) III researchers. Statins, which are associated with improved plaque stability, were plausible candidates to reduce perioperative MI. And in fact, results of the original DECREASE III study showed that in high-risk patients who undergo major vascular surgery, fluvastatin XL reduced myocardial ischemia and the combined end point of cardiovascular death and MI.

Dr. Olaf Schouten from the Erasmus University Medical Center, Rotterdam, the Netherlands, discussed a further analysis of the DECREASE III population at the Vascular Annual Meeting. The investigators examined a total of 497 patients who were randomized to placebo (247 patients) or fluvastatin (250) in the double-blinded trial.

The patients had been started on treatment a median of 34 days prior to surgery. At the end of the DECREASE III study period (30 days after surgery), all patients were prescribed lifelong statins as recommended by current guidelines. The current study relied on all-cause death data obtained from a civil service registry for a median follow-up of 4.8 years, during which time 129 patients died.

Perioperative statin use was associated with a significant reduction of perioperative cardiovascular events (hazard ratio, 0.55), according to Dr. Schouten. In a multivariate analysis that adjusted for possible confounders including cardiovascular risk factors, type and site of vascular surgery, and age, preoperative statin initiation was still significantly associated with an improved long-term outcome (HR, 0.59).

"The randomized DECREASE III trial showed that perioperative statin use is associated with a significant reduction of perioperative cardiovascular events," according to Dr. Schouten. But it appears that statin therapy also results in a long-term survival benefit, compared with postoperative initiation of statin therapy, he added.

"This ‘legacy’ effect might be due to the prevention of perioperative myocardial damage, as patients with myocardial damage had a significantly higher risk of death during follow-up," Dr. Schouten speculated.

"The main message of our study is that all vascular surgery patients eligible for statin therapy [that is, without contraindications] should be prescribed statins at the first, preoperative, and outpatient clinic visit," said Dr. Schouten in an interview. He pointed out that statin therapy is safe in the perioperative period, with no significant side effects; it improves perioperative cardiac outcome; and it is associated with a long-term survival benefit.

"So prescribe statins as soon as possible, keep them on statins in the perioperative period, and keep them on [lifelong statins] after surgery," Dr. Schouten concluded.

Dr. Schouten stated that he had nothing to disclose.

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

The Cardiothoracic Surgery Research Program is an intramural research program within the National Heart, Lung, and Blood Institute at the NIH in Bethesda Md. The Director of the laboratory is Dr. Keith A. Horvath,

Currently the program focuses on three major research areas, represented by sections: cell-based therapy, bioengineering, and transplantation. In their 2010 quadrennial report, the group detailed 4 years of significant translational research"representing the return of cardiothoracic research to the NHLBI after a hiatus since 1990," according to Dr. Horvath.

The Cellular Biology Section is focused on cell-based therapy for myocardial ischemia using adult bone-marrow-derived mesenchymal stem cells (BMSCs).

Their research aims are focused on a large animal model to test the effects of BMSCs on chronic myocardial ischemia, to study the fate and differentiation of BMSCs after administration, and to further investigate gene expression patterns of BMSCs under both normoxic and hypoxic conditions.

The group has already demonstrated the benefits of direct injection of autologous BMSCs in to chronically ischemic myocardium.

Direct injection of autologous BMSCs into the ischemic myocardium showed regional ventricular wall thickening demonstrating significant improvement after cell treatment, whereas saline treated animals showed no improvement compared to baseline as assessed by echocardiography.

Global function was also improved following BMSC injection and increased vascularity was found in the BMSC group compared to saline injected controls.

BMSCs isolated from transgenic pigs designed to express enhanced green fluorescent proteins as the donors showed that allogeneic injection of the green BMSCs is safe, with no observable side effects or signs of graft versus host disease were observed.

The green cells were found migrating from the injected area into deeper layers of myocardium over the course of 1 to 6 weeks. By immunofluorescent staining, the green cells were associated with smooth muscle actin or vWF positive cells, suggesting that the transplanted cells were contributing to the formation of new vessels.

They found no evidence that these cells were associated with the new generation of cardiac myocytes, which suggests that the benefits of this therapy may be due to angiogenesis not the regeneration of cardiac myocytes. Gene profiling of the cells before and after transplantation showed that genes such as VEGF, HIF1-a, PDGF, ANGPT2 and CXCL14 were significantly up-regulated.

A clinical trial will be conducted at the NIH Heart Center at Suburban Hospital, Bethesda, and will follow the direct injection of BSMCs into ischemic areas in patients after coronary artery bypass grafting (CABG) or transmyocardial revascularization.

The Transplantation Section at CSRP has focused on developing a clinically relevant large animal cardiac xenotransplantation model, using genetically engineered pig hearts place in baboons.

Efforts are being focused on appropriate immunosuppression through drugs, stem cell, and genetic-engineering of donor hearts. These research efforts involve a working collaboration with Mayo Clinic, University of Pittsburgh, University of Maryland, Beth Israel Hospital, NIH Swine Center in Missouri, and Revivicor.

The Bioengineering Section is focused on developing and applying engineering technologies with devices, imaging and robotics with the goal of achieving "state-of-the-art minimally invasive cardiac operations.

"By enhancing precision and consistency, these novel procedures will improve clinical outcomes and expand the cohort of patients that can be treated."

The current work focuses on beating heart aortic valve replacement under real-time MRI guidance. Feasibility studies have been completed and long term animal studies are underway.

Active and passive markers have been added to the prostheses and delivery device to aid visualization and allow placement of the valve with the precision achieved in an open surgical procedure in 1/100th the time. The current goal is to translate this work into a clinical trial.

This column will keep track of these and other research efforts conducted by the CSRP, especially as they move from preclinical to clinical applications of their advanced research.☐

The Cardiothoracic Surgery Research Program is an intramural research program within the National Heart, Lung, and Blood Institute at the NIH in Bethesda Md. The Director of the laboratory is Dr. Keith A. Horvath,

Currently the program focuses on three major research areas, represented by sections: cell-based therapy, bioengineering, and transplantation. In their 2010 quadrennial report, the group detailed 4 years of significant translational research"representing the return of cardiothoracic research to the NHLBI after a hiatus since 1990," according to Dr. Horvath.

The Cellular Biology Section is focused on cell-based therapy for myocardial ischemia using adult bone-marrow-derived mesenchymal stem cells (BMSCs).

Their research aims are focused on a large animal model to test the effects of BMSCs on chronic myocardial ischemia, to study the fate and differentiation of BMSCs after administration, and to further investigate gene expression patterns of BMSCs under both normoxic and hypoxic conditions.

The group has already demonstrated the benefits of direct injection of autologous BMSCs in to chronically ischemic myocardium.

Direct injection of autologous BMSCs into the ischemic myocardium showed regional ventricular wall thickening demonstrating significant improvement after cell treatment, whereas saline treated animals showed no improvement compared to baseline as assessed by echocardiography.

Global function was also improved following BMSC injection and increased vascularity was found in the BMSC group compared to saline injected controls.

BMSCs isolated from transgenic pigs designed to express enhanced green fluorescent proteins as the donors showed that allogeneic injection of the green BMSCs is safe, with no observable side effects or signs of graft versus host disease were observed.

The green cells were found migrating from the injected area into deeper layers of myocardium over the course of 1 to 6 weeks. By immunofluorescent staining, the green cells were associated with smooth muscle actin or vWF positive cells, suggesting that the transplanted cells were contributing to the formation of new vessels.

They found no evidence that these cells were associated with the new generation of cardiac myocytes, which suggests that the benefits of this therapy may be due to angiogenesis not the regeneration of cardiac myocytes. Gene profiling of the cells before and after transplantation showed that genes such as VEGF, HIF1-a, PDGF, ANGPT2 and CXCL14 were significantly up-regulated.

A clinical trial will be conducted at the NIH Heart Center at Suburban Hospital, Bethesda, and will follow the direct injection of BSMCs into ischemic areas in patients after coronary artery bypass grafting (CABG) or transmyocardial revascularization.

The Transplantation Section at CSRP has focused on developing a clinically relevant large animal cardiac xenotransplantation model, using genetically engineered pig hearts place in baboons.

Efforts are being focused on appropriate immunosuppression through drugs, stem cell, and genetic-engineering of donor hearts. These research efforts involve a working collaboration with Mayo Clinic, University of Pittsburgh, University of Maryland, Beth Israel Hospital, NIH Swine Center in Missouri, and Revivicor.

The Bioengineering Section is focused on developing and applying engineering technologies with devices, imaging and robotics with the goal of achieving "state-of-the-art minimally invasive cardiac operations.

"By enhancing precision and consistency, these novel procedures will improve clinical outcomes and expand the cohort of patients that can be treated."

The current work focuses on beating heart aortic valve replacement under real-time MRI guidance. Feasibility studies have been completed and long term animal studies are underway.

Active and passive markers have been added to the prostheses and delivery device to aid visualization and allow placement of the valve with the precision achieved in an open surgical procedure in 1/100th the time. The current goal is to translate this work into a clinical trial.

This column will keep track of these and other research efforts conducted by the CSRP, especially as they move from preclinical to clinical applications of their advanced research.☐

The Cardiothoracic Surgery Research Program is an intramural research program within the National Heart, Lung, and Blood Institute at the NIH in Bethesda Md. The Director of the laboratory is Dr. Keith A. Horvath,

Currently the program focuses on three major research areas, represented by sections: cell-based therapy, bioengineering, and transplantation. In their 2010 quadrennial report, the group detailed 4 years of significant translational research"representing the return of cardiothoracic research to the NHLBI after a hiatus since 1990," according to Dr. Horvath.

The Cellular Biology Section is focused on cell-based therapy for myocardial ischemia using adult bone-marrow-derived mesenchymal stem cells (BMSCs).

Their research aims are focused on a large animal model to test the effects of BMSCs on chronic myocardial ischemia, to study the fate and differentiation of BMSCs after administration, and to further investigate gene expression patterns of BMSCs under both normoxic and hypoxic conditions.

The group has already demonstrated the benefits of direct injection of autologous BMSCs in to chronically ischemic myocardium.

Direct injection of autologous BMSCs into the ischemic myocardium showed regional ventricular wall thickening demonstrating significant improvement after cell treatment, whereas saline treated animals showed no improvement compared to baseline as assessed by echocardiography.

Global function was also improved following BMSC injection and increased vascularity was found in the BMSC group compared to saline injected controls.

BMSCs isolated from transgenic pigs designed to express enhanced green fluorescent proteins as the donors showed that allogeneic injection of the green BMSCs is safe, with no observable side effects or signs of graft versus host disease were observed.

The green cells were found migrating from the injected area into deeper layers of myocardium over the course of 1 to 6 weeks. By immunofluorescent staining, the green cells were associated with smooth muscle actin or vWF positive cells, suggesting that the transplanted cells were contributing to the formation of new vessels.

They found no evidence that these cells were associated with the new generation of cardiac myocytes, which suggests that the benefits of this therapy may be due to angiogenesis not the regeneration of cardiac myocytes. Gene profiling of the cells before and after transplantation showed that genes such as VEGF, HIF1-a, PDGF, ANGPT2 and CXCL14 were significantly up-regulated.

A clinical trial will be conducted at the NIH Heart Center at Suburban Hospital, Bethesda, and will follow the direct injection of BSMCs into ischemic areas in patients after coronary artery bypass grafting (CABG) or transmyocardial revascularization.

The Transplantation Section at CSRP has focused on developing a clinically relevant large animal cardiac xenotransplantation model, using genetically engineered pig hearts place in baboons.

Efforts are being focused on appropriate immunosuppression through drugs, stem cell, and genetic-engineering of donor hearts. These research efforts involve a working collaboration with Mayo Clinic, University of Pittsburgh, University of Maryland, Beth Israel Hospital, NIH Swine Center in Missouri, and Revivicor.

The Bioengineering Section is focused on developing and applying engineering technologies with devices, imaging and robotics with the goal of achieving "state-of-the-art minimally invasive cardiac operations.

"By enhancing precision and consistency, these novel procedures will improve clinical outcomes and expand the cohort of patients that can be treated."

The current work focuses on beating heart aortic valve replacement under real-time MRI guidance. Feasibility studies have been completed and long term animal studies are underway.

Active and passive markers have been added to the prostheses and delivery device to aid visualization and allow placement of the valve with the precision achieved in an open surgical procedure in 1/100th the time. The current goal is to translate this work into a clinical trial.

This column will keep track of these and other research efforts conducted by the CSRP, especially as they move from preclinical to clinical applications of their advanced research.☐

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, conducted a study of 2,218 consecutive patients undergoing isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)–endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases), according to Dr. Kurlansky.

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The public policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure. The information gathered from a better understanding of quality outcomes in this study, he said, may help inform efforts to improve other complex procedures.

Dr. Kurlansky reported that he had no disclosures relevant to this presentation.

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year-period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene. Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures.

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year-period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene. Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures.

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year-period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene. Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – The rate of neurologic events in aortic stenosis patients at high risk for surgery was higher in those treated with transcatheter aortic valve replacement than in those who underwent open replacement in the PARTNER trial, and patients who had the procedure transapically had the greatest incidence.

However, the rates of neurologic events were low in all groups in the PARTNER (Placement of Aortic Transcatheter Valves) trial, Dr. D. Craig Miller of Stanford (Calif.) University reported at the meeting.

Photo credit: Catherine Harrell/Elsevier Global Medical News

The neurologic substudy compared the risk of neurologic complications in 657 high-risk symptomatic patients with critical aortic stenosis receiving transcatheter aortic valve replacement (TAVR) or open replacement (AVR), as well as the difference between using a transapical or a transfemoral approach.

The PARTNER investigators ran two parallel trials in 1,057 patients with severe, symptomatic aortic stenosis: Cohort A comprised 699 patients at high risk for AVR, while cohort B comprised 358 inoperable patients.

Cohort B patients were randomized to either TAVR, using a transfemoral approach, or medical therapy. Results demonstrated superior survival and quality of life following TAVR compared with standard medical therapy; however, stroke occurred significantly more frequently with TAVR (N. Engl. J. Med. 2010;363:1597-607).

Cohort A patients were first assessed for suitability for either a transfemoral or transapical approach in TAVR, then randomized within those groups to either TAVR or AVR. Dr. Miller presented the neurologic outcomes of cohort A.

The main results of the cohort A trial, reported in April by Dr. Craig Smith, chief of cardiothoracic surgery at New York–Presbyterian Hospital/Columbia University Medical Center in New York, at the American College of Cardiology annual meeting, showed that all-cause mortality at 30 days favored (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% and 27%, respectively). The difference at 1 year reached the trial’s prespecified noninferiority margin with a P value of .001. But again, neurologic complications occurred more frequently after TAVR.

Stroke was a major secondary end point and was defined as a focal deficit lasting greater than 24 hours or a focal deficit lasting greater than 24 hours with positive neuron-imaging studies. Each event was adjudicated in a blinded review by an independent clinical events committee and subclassified (ischemic, hemorrhagic, or undetermined etiology).

There were 47 patients who had 49 neurologic events, and most (72%) were ischemic.

There was, however, a statistically significant difference in all neurologic events between AVR and TAVR at 30 days (2.4% vs. 5.5%, respectively) and 1 year (4.3% vs. 8.3%).

In the current study presented by Dr. Miller, a hazard analysis showed that there was an early high-peaking hazard phase and a later constant hazard phase for the likelihood of neurologic events.

In the early hazard phase, TAVR was a significant risk factor for neurologic events, compared with AVR, as was a smaller aortic valve area (AVA) index in the TAVR group.

In the late constant hazard phase, significant risk factors were patient- and disease-related. They included higher New York Heart Association functional class, stroke or TIA within 6-12 months, and nontransfemoral TAVR assessment.

Dr. Miller emphasized that there were "remarkably low 30-day mortality rates in these very elderly, very-high-risk aortic stenosis patients in both arms of the study." All neurologic events occurred more frequently in the TAVR arm compared with the AVR arm at 30 days and 1 year. In the more favorable transfemoral stratum, the rate of neurologic events was about threefold higher in the transfemoral TAVR group, at 4.6%, compared with the open AVR control group, at 1.4%, at 30 days, which persisted out to 1 year (6.1% and 1.9%, respectively). He also stated that "major stroke rates at 30 days were also very low (AVR, 2.3%; TAVR, 3.8%)." But he cautioned that the number of major strokes (29) was too small to support robust statistical hazard analysis or parametric modeling.

He emphasized that the higher observed incidence of neurologic events in the nontransfemoral candidate stratum reflected the patient substrate, and was not related to the transapical TAVR or AVR procedures per se.

Overall, taking the competing hazard of death into consideration, which is a strong force in these elderly patients with many comorbidities, the likelihood of being alive and having sustained a neurologic event was lowest in AVR patients in the transfemoral stratum, and highest in the transapical TAVR group, he concluded.

The PARTNER Trial was sponsored by Edwards Lifesciences. Dr. Miller is a consultant for Medtronic Cardiovascular and St. Jude Medical. He is a faculty member on the PARTNER U.S. Pivotal Trial Executive Committee and the Stanford Principal Investigator for the PARTNER Trial.

PHILADELPHIA – Although mortality on the waiting list is still a problem, long-term survival after lung transplantation of patients with pulmonary arterial hypertension has improved significantly over time, a study has shown.

In the study, pulmonary arterial hypertension (PAH) was classified as idiopathic (iPAH) or associated with congenital heart diseases or connective tissue diseases. Patients were divided into 1997-2004 and 2005-2010 cohorts.

Out of 2,918 patients referred to the program between January 1997 and September 2010, 316 (11%) presented with PAH (World Health Organization Group 1). In these patients, PAH was classified as iPAH (123 patients), congenital (77 patients), connective (102 patients), and other (14). The number of referrals was similar between 1997-2004 and 2005-2010. Follow-up was completed until September 2010 for all patients.

Among the 100 PAH patients listed for lung transplantation (LT), 57 underwent bilateral LT and 22 had heart LT. Eighteen patients on the waiting list died, and three are still waiting. The waiting list mortality was higher for patients with connective tissue diseases, Dr. Marc de Perrot said at the annual meeting of the American Association for Thoracic Surgery.

No patient with iPAH has died on the waiting list since 2005; 25% died before that time, he and his associates at Toronto General Hospital found.

After LT, the 30-day mortality decreased from 24% in the first cohort to 6% in the second, a significant difference. The 10-year survival was 56% after bilateral LT and 49% after heart LT, a nonsignificant difference.

However, the 10-year survival was significantly worse for iPAH patients at 42% vs. 70% for the remaining patients (P = .01). The 10-year survival was best for connective tissue disease (69%) and congenital (70%) patients.

Lung transplantation is a viable option for about a third of the patients presenting with PAH, according to Dr. de Perrot. He added that extracorporeal life support may help reduce the waiting list mortality, particularly for iPAH patients. Overall, the 30-day mortality for patients after lung transplantation has improved significantly over time.

"Patients with connective tissue diseases have a high mortality on the waiting list, but enjoy excellent long-term survival after transplant," Dr. de Perrot concluded.

Dr. de Perrot reported receiving speaker and teaching honoraria from Actelion.

PHILADELPHIA – Although mortality on the waiting list is still a problem, long-term survival after lung transplantation of patients with pulmonary arterial hypertension has improved significantly over time, a study has shown.

In the study, pulmonary arterial hypertension (PAH) was classified as idiopathic (iPAH) or associated with congenital heart diseases or connective tissue diseases. Patients were divided into 1997-2004 and 2005-2010 cohorts.

Out of 2,918 patients referred to the program between January 1997 and September 2010, 316 (11%) presented with PAH (World Health Organization Group 1). In these patients, PAH was classified as iPAH (123 patients), congenital (77 patients), connective (102 patients), and other (14). The number of referrals was similar between 1997-2004 and 2005-2010. Follow-up was completed until September 2010 for all patients.

Among the 100 PAH patients listed for lung transplantation (LT), 57 underwent bilateral LT and 22 had heart LT. Eighteen patients on the waiting list died, and three are still waiting. The waiting list mortality was higher for patients with connective tissue diseases, Dr. Marc de Perrot said at the annual meeting of the American Association for Thoracic Surgery.

No patient with iPAH has died on the waiting list since 2005; 25% died before that time, he and his associates at Toronto General Hospital found.

After LT, the 30-day mortality decreased from 24% in the first cohort to 6% in the second, a significant difference. The 10-year survival was 56% after bilateral LT and 49% after heart LT, a nonsignificant difference.

However, the 10-year survival was significantly worse for iPAH patients at 42% vs. 70% for the remaining patients (P = .01). The 10-year survival was best for connective tissue disease (69%) and congenital (70%) patients.

Lung transplantation is a viable option for about a third of the patients presenting with PAH, according to Dr. de Perrot. He added that extracorporeal life support may help reduce the waiting list mortality, particularly for iPAH patients. Overall, the 30-day mortality for patients after lung transplantation has improved significantly over time.

"Patients with connective tissue diseases have a high mortality on the waiting list, but enjoy excellent long-term survival after transplant," Dr. de Perrot concluded.

Dr. de Perrot reported receiving speaker and teaching honoraria from Actelion.

PHILADELPHIA – Although mortality on the waiting list is still a problem, long-term survival after lung transplantation of patients with pulmonary arterial hypertension has improved significantly over time, a study has shown.

In the study, pulmonary arterial hypertension (PAH) was classified as idiopathic (iPAH) or associated with congenital heart diseases or connective tissue diseases. Patients were divided into 1997-2004 and 2005-2010 cohorts.

Out of 2,918 patients referred to the program between January 1997 and September 2010, 316 (11%) presented with PAH (World Health Organization Group 1). In these patients, PAH was classified as iPAH (123 patients), congenital (77 patients), connective (102 patients), and other (14). The number of referrals was similar between 1997-2004 and 2005-2010. Follow-up was completed until September 2010 for all patients.

Among the 100 PAH patients listed for lung transplantation (LT), 57 underwent bilateral LT and 22 had heart LT. Eighteen patients on the waiting list died, and three are still waiting. The waiting list mortality was higher for patients with connective tissue diseases, Dr. Marc de Perrot said at the annual meeting of the American Association for Thoracic Surgery.

No patient with iPAH has died on the waiting list since 2005; 25% died before that time, he and his associates at Toronto General Hospital found.

After LT, the 30-day mortality decreased from 24% in the first cohort to 6% in the second, a significant difference. The 10-year survival was 56% after bilateral LT and 49% after heart LT, a nonsignificant difference.

However, the 10-year survival was significantly worse for iPAH patients at 42% vs. 70% for the remaining patients (P = .01). The 10-year survival was best for connective tissue disease (69%) and congenital (70%) patients.

Lung transplantation is a viable option for about a third of the patients presenting with PAH, according to Dr. de Perrot. He added that extracorporeal life support may help reduce the waiting list mortality, particularly for iPAH patients. Overall, the 30-day mortality for patients after lung transplantation has improved significantly over time.

"Patients with connective tissue diseases have a high mortality on the waiting list, but enjoy excellent long-term survival after transplant," Dr. de Perrot concluded.

Dr. de Perrot reported receiving speaker and teaching honoraria from Actelion.