Thoracic Surgery News (Archived)

In patients with asymptomatic or minimally symptomatic mitral valve regurgitation as a result of flail mitral leaflets, early surgery yields better survival, lower risk of heart failure, and equivalent rates of atrial fibrillation, compared with watchful waiting, according to a report published online on August 13 in JAMA.

Overall long-term mortality is approximately 40% lower and HF risk approximately 60% lower for early surgery vs. watchful waiting. These benefits persist for up to 20 years and are seen across every important subgroup of patients, said Dr. Rakesh M. Suri of the Mayo Clinic, Rochester, Minn., and his associates.

These are the findings of a series of analyses of data from an international registry of consecutive patients diagnosed in routine clinical practice – the largest study in the world of the comparative effectiveness of early surgery vs. watchful waiting in patients without traditional indications for immediate surgery. The study results "emanate from institutions that together provide a very high rate of mitral valve repair (more than 90%) with low operative mortality, emphasizing that such results might also be achieved in routine practice at many advanced repair centers," the investigators noted.

Despite the safety and efficacy of current surgical correction of flail mitral leaflets, clinicians disagree as to the best approach for patients who have no or minimal HF symptoms, a left ventricular ejection fraction of 60% or more, and a left ventricular end-systolic diameter of 40 mm or more. Those who support watchful waiting consider the consequences of uncorrected mitral regurgitation to be benign, especially when weighed against the potential morbidity and mortality of early surgical intervention. North American guidelines favor early surgery while European guidelines favor watchful waiting.

The Mitral Regurgitation International Database (MIDA) – a registry of patients at two tertiary care centers in France, two in Italy, one in Belgium, and one in the United States – provided an ideal study population to compare the two approaches. For their study, Dr. Suri and his associates examined data for 1,021 of these patients who had been diagnosed in 1980-2004 and followed for up to 25 years (mean follow-up, 10.3 years).

This study included only patients who had no ischemic mitral regurgitation and no significant concomitant aortic valve disease, congenital heart disease, mitral stenosis, or previous valve surgery.

A total of 446 of these patients underwent early surgery (within 30 days of diagnosis) and 575 had watchful waiting at the discretion of their treating physicians. Importantly, 339 (59%) of the watchful-waiting group eventually were advised by their cardiologists to undergo valve repair, at a median of 1.65 years after diagnosis.

Overall, there were 319 deaths during follow-up.

The primary end points of this study were all-cause mortality at 5, 10, and 20 years.

In the initial, unadjusted analysis, survival was 95%, 86%, and 63%, respectively, with early surgery. In contrast, survival was significantly lower with watchful waiting, at 84% at 5 years, 69% at 10 years, and 41% at 20 years, the researchers said (JAMA 2013; 310:609-16).

The large survival benefit with early surgery was confirmed in a multivariable analysis that adjusted for patient age, sex, comorbidities, and the presence of subtle symptoms.

To account for differences between the two study groups in the propensity to undergo surgery, the investigators performed an analysis of the data in a set of 648 patients who were matched for age, comorbidities, and other factors. This analysis also showed a similar and distinct survival advantage with early surgery. Several subgroup analyses also confirmed the results.

Secondary end points were the incidence of heart failure and the onset of new atrial fibrillation during follow-up.

A total of 167 patients had at least one episode of HF. The rates were 7% with early surgery and 23% with watchful waiting at 10 years, and 10% vs. 35% at 20 years, showing a clear advantage for early surgery.

This strong advantage persisted in further analyses of the propensity-matched patients and in all other subgroups examined, at all time points examined.

New-onset AF developed in 227 patients overall. The rate was slightly higher in the early-surgery group during the immediate postoperative period but decreased thereafter and was equivalent between the two study groups at 5, 10, and 20 years.

"Long-term, the results are coherent by all methods used (direct comparison, adjusted comparison, propensity score matching, inverse probability weighing) that early surgical correction of mitral valve regurgitation was associated with a significant survival benefit (total mortality decrement of approximately 40%) and diminished HF risk (reduction of approximately 60%)," Dr. Suri and his associates wrote.

Dr. Suri reported ties to Edwards Lifesciences, Sorin Group, St. Jude Medical, and Abbott.

In patients with asymptomatic or minimally symptomatic mitral valve regurgitation as a result of flail mitral leaflets, early surgery yields better survival, lower risk of heart failure, and equivalent rates of atrial fibrillation, compared with watchful waiting, according to a report published online on August 13 in JAMA.

Overall long-term mortality is approximately 40% lower and HF risk approximately 60% lower for early surgery vs. watchful waiting. These benefits persist for up to 20 years and are seen across every important subgroup of patients, said Dr. Rakesh M. Suri of the Mayo Clinic, Rochester, Minn., and his associates.

These are the findings of a series of analyses of data from an international registry of consecutive patients diagnosed in routine clinical practice – the largest study in the world of the comparative effectiveness of early surgery vs. watchful waiting in patients without traditional indications for immediate surgery. The study results "emanate from institutions that together provide a very high rate of mitral valve repair (more than 90%) with low operative mortality, emphasizing that such results might also be achieved in routine practice at many advanced repair centers," the investigators noted.

Despite the safety and efficacy of current surgical correction of flail mitral leaflets, clinicians disagree as to the best approach for patients who have no or minimal HF symptoms, a left ventricular ejection fraction of 60% or more, and a left ventricular end-systolic diameter of 40 mm or more. Those who support watchful waiting consider the consequences of uncorrected mitral regurgitation to be benign, especially when weighed against the potential morbidity and mortality of early surgical intervention. North American guidelines favor early surgery while European guidelines favor watchful waiting.

The Mitral Regurgitation International Database (MIDA) – a registry of patients at two tertiary care centers in France, two in Italy, one in Belgium, and one in the United States – provided an ideal study population to compare the two approaches. For their study, Dr. Suri and his associates examined data for 1,021 of these patients who had been diagnosed in 1980-2004 and followed for up to 25 years (mean follow-up, 10.3 years).

This study included only patients who had no ischemic mitral regurgitation and no significant concomitant aortic valve disease, congenital heart disease, mitral stenosis, or previous valve surgery.

A total of 446 of these patients underwent early surgery (within 30 days of diagnosis) and 575 had watchful waiting at the discretion of their treating physicians. Importantly, 339 (59%) of the watchful-waiting group eventually were advised by their cardiologists to undergo valve repair, at a median of 1.65 years after diagnosis.

Overall, there were 319 deaths during follow-up.

The primary end points of this study were all-cause mortality at 5, 10, and 20 years.

In the initial, unadjusted analysis, survival was 95%, 86%, and 63%, respectively, with early surgery. In contrast, survival was significantly lower with watchful waiting, at 84% at 5 years, 69% at 10 years, and 41% at 20 years, the researchers said (JAMA 2013; 310:609-16).

The large survival benefit with early surgery was confirmed in a multivariable analysis that adjusted for patient age, sex, comorbidities, and the presence of subtle symptoms.

To account for differences between the two study groups in the propensity to undergo surgery, the investigators performed an analysis of the data in a set of 648 patients who were matched for age, comorbidities, and other factors. This analysis also showed a similar and distinct survival advantage with early surgery. Several subgroup analyses also confirmed the results.

Secondary end points were the incidence of heart failure and the onset of new atrial fibrillation during follow-up.

A total of 167 patients had at least one episode of HF. The rates were 7% with early surgery and 23% with watchful waiting at 10 years, and 10% vs. 35% at 20 years, showing a clear advantage for early surgery.

This strong advantage persisted in further analyses of the propensity-matched patients and in all other subgroups examined, at all time points examined.

New-onset AF developed in 227 patients overall. The rate was slightly higher in the early-surgery group during the immediate postoperative period but decreased thereafter and was equivalent between the two study groups at 5, 10, and 20 years.

"Long-term, the results are coherent by all methods used (direct comparison, adjusted comparison, propensity score matching, inverse probability weighing) that early surgical correction of mitral valve regurgitation was associated with a significant survival benefit (total mortality decrement of approximately 40%) and diminished HF risk (reduction of approximately 60%)," Dr. Suri and his associates wrote.

Dr. Suri reported ties to Edwards Lifesciences, Sorin Group, St. Jude Medical, and Abbott.

In patients with asymptomatic or minimally symptomatic mitral valve regurgitation as a result of flail mitral leaflets, early surgery yields better survival, lower risk of heart failure, and equivalent rates of atrial fibrillation, compared with watchful waiting, according to a report published online on August 13 in JAMA.

Overall long-term mortality is approximately 40% lower and HF risk approximately 60% lower for early surgery vs. watchful waiting. These benefits persist for up to 20 years and are seen across every important subgroup of patients, said Dr. Rakesh M. Suri of the Mayo Clinic, Rochester, Minn., and his associates.

These are the findings of a series of analyses of data from an international registry of consecutive patients diagnosed in routine clinical practice – the largest study in the world of the comparative effectiveness of early surgery vs. watchful waiting in patients without traditional indications for immediate surgery. The study results "emanate from institutions that together provide a very high rate of mitral valve repair (more than 90%) with low operative mortality, emphasizing that such results might also be achieved in routine practice at many advanced repair centers," the investigators noted.

Despite the safety and efficacy of current surgical correction of flail mitral leaflets, clinicians disagree as to the best approach for patients who have no or minimal HF symptoms, a left ventricular ejection fraction of 60% or more, and a left ventricular end-systolic diameter of 40 mm or more. Those who support watchful waiting consider the consequences of uncorrected mitral regurgitation to be benign, especially when weighed against the potential morbidity and mortality of early surgical intervention. North American guidelines favor early surgery while European guidelines favor watchful waiting.

The Mitral Regurgitation International Database (MIDA) – a registry of patients at two tertiary care centers in France, two in Italy, one in Belgium, and one in the United States – provided an ideal study population to compare the two approaches. For their study, Dr. Suri and his associates examined data for 1,021 of these patients who had been diagnosed in 1980-2004 and followed for up to 25 years (mean follow-up, 10.3 years).

This study included only patients who had no ischemic mitral regurgitation and no significant concomitant aortic valve disease, congenital heart disease, mitral stenosis, or previous valve surgery.

A total of 446 of these patients underwent early surgery (within 30 days of diagnosis) and 575 had watchful waiting at the discretion of their treating physicians. Importantly, 339 (59%) of the watchful-waiting group eventually were advised by their cardiologists to undergo valve repair, at a median of 1.65 years after diagnosis.

Overall, there were 319 deaths during follow-up.

The primary end points of this study were all-cause mortality at 5, 10, and 20 years.

In the initial, unadjusted analysis, survival was 95%, 86%, and 63%, respectively, with early surgery. In contrast, survival was significantly lower with watchful waiting, at 84% at 5 years, 69% at 10 years, and 41% at 20 years, the researchers said (JAMA 2013; 310:609-16).

The large survival benefit with early surgery was confirmed in a multivariable analysis that adjusted for patient age, sex, comorbidities, and the presence of subtle symptoms.

To account for differences between the two study groups in the propensity to undergo surgery, the investigators performed an analysis of the data in a set of 648 patients who were matched for age, comorbidities, and other factors. This analysis also showed a similar and distinct survival advantage with early surgery. Several subgroup analyses also confirmed the results.

Secondary end points were the incidence of heart failure and the onset of new atrial fibrillation during follow-up.

A total of 167 patients had at least one episode of HF. The rates were 7% with early surgery and 23% with watchful waiting at 10 years, and 10% vs. 35% at 20 years, showing a clear advantage for early surgery.

This strong advantage persisted in further analyses of the propensity-matched patients and in all other subgroups examined, at all time points examined.

New-onset AF developed in 227 patients overall. The rate was slightly higher in the early-surgery group during the immediate postoperative period but decreased thereafter and was equivalent between the two study groups at 5, 10, and 20 years.

"Long-term, the results are coherent by all methods used (direct comparison, adjusted comparison, propensity score matching, inverse probability weighing) that early surgical correction of mitral valve regurgitation was associated with a significant survival benefit (total mortality decrement of approximately 40%) and diminished HF risk (reduction of approximately 60%)," Dr. Suri and his associates wrote.

Dr. Suri reported ties to Edwards Lifesciences, Sorin Group, St. Jude Medical, and Abbott.

ORLANDO – Mid- and long-term esophageal cancer–free survival rates are similar in patients with early esophageal adenocarcinoma who undergo endoscopic eradication therapy and those who undergo surgical resection, according to findings from a large population-based study.

Of 1,087 patients with early esophageal adenocarcinoma (EAC) who were included in the Surveillance, Epidemiology and End Results (SEER) database, 283 underwent endoscopic eradication therapy (EET), and 804 underwent surgical resection. No significant differences were seen between the groups with respect to 2-year esophageal cancer–free survival (93.5% and 89.6% in the EET and surgery groups, respectively) or 5-year survival (69.3% and 75.8%, respectively), Dr. Sachin Wani reported during a late-breaking abstract session at the annual Digestive Disease Week.

However, the EET group had higher mortality than the surgery group due to non-EAC causes (12.8% vs. 5.7% at 2 years, and 34.8% vs. 12.9% at 5 years), he said. Cardiovascular disease was the most common cause of non-EAC mortality.

Variables significantly associated with mortality were older age (hazard ratio, 1.02), stage T1a disease (compared with T0 disease; HR, 2.71), year of diagnosis (HR, 0.93), and radiation therapy (HR, 5.29), said Dr. Wani of the University of Colorado, Aurora.

Treatment arm was not a predictor of overall survival.

A time-trend analysis showed a significant increase in the proportion of patients with T0 disease undergoing endoscopic eradication therapy. A similar significant increase was noted in patients with stage T1a disease, as well, he said.

Notably, patients undergoing EET were significantly older than those undergoing surgery (70 vs. 63 years), and more likely to be diagnosed with T0 disease (32.5% vs. 23.1% of patients) with well-differentiated histology (33% vs. 24%). They also were less likely to be men, and less likely to receive radiation therapy.

"However, the overall follow-up in the endoscopy arm was shorter than for their surgical counterparts," Dr. Wani noted.

Regional variations were observed in the proportions of patients undergoing EET and surgery, he said.

The differences between the groups, along with the significant differences in non–EAC-related mortality between the treatment groups, highlight selection bias with respect to the therapies offered to patients with EAC, he said.

Patients included in this analysis were adults who had EAC between 1998 and 2009. EAC was defined as carcinoma in situ (T0 disease), or invasive tumor confined to the mucosa, lamina propria, and muscularis mucosae (T1a disease).

The vast majority of patients in the endoscopy arm underwent endoscopic mucosal resection alone; the vast majority in the surgery arm underwent esophagectomy plus partial or total gastrectomy, Dr. Wani said.

Though limited by the use of population-based data that lacked details on recurrences, pathology, staging modalities, and complications and morbidity, this study analyzed one of the largest cohorts of patients with EAC undergoing endoscopic therapy.

The findings are important, because EETs for EAC have gained wide acceptance, and have been endorsed by society guidelines despite a paucity of long-term data examining the differences in outcomes between EET and the gold standard of surgical resection, he said.

Indeed, esophagectomy has traditionally been considered the treatment of choice for EAC, but it is also associated with high morbidity and mortality, even in expert centers, he noted.

"The implications of our study? It really provides a greater degree of confidence in what we do on a daily basis and this whole concept of endoscopic eradication therapy for patients with early esophageal cancer. However we need long-term data – i.e., 5-year data, at least – with newer ablative therapies, such as radiofrequency ablation in combination with endoscopy mucosal resection," he said. Future studies should focus on identifying patient and provider determinants of optimal outcomes, he added.

Dr. Wani reported having no disclosures.

ORLANDO – Mid- and long-term esophageal cancer–free survival rates are similar in patients with early esophageal adenocarcinoma who undergo endoscopic eradication therapy and those who undergo surgical resection, according to findings from a large population-based study.

Of 1,087 patients with early esophageal adenocarcinoma (EAC) who were included in the Surveillance, Epidemiology and End Results (SEER) database, 283 underwent endoscopic eradication therapy (EET), and 804 underwent surgical resection. No significant differences were seen between the groups with respect to 2-year esophageal cancer–free survival (93.5% and 89.6% in the EET and surgery groups, respectively) or 5-year survival (69.3% and 75.8%, respectively), Dr. Sachin Wani reported during a late-breaking abstract session at the annual Digestive Disease Week.

However, the EET group had higher mortality than the surgery group due to non-EAC causes (12.8% vs. 5.7% at 2 years, and 34.8% vs. 12.9% at 5 years), he said. Cardiovascular disease was the most common cause of non-EAC mortality.

Variables significantly associated with mortality were older age (hazard ratio, 1.02), stage T1a disease (compared with T0 disease; HR, 2.71), year of diagnosis (HR, 0.93), and radiation therapy (HR, 5.29), said Dr. Wani of the University of Colorado, Aurora.

Treatment arm was not a predictor of overall survival.

A time-trend analysis showed a significant increase in the proportion of patients with T0 disease undergoing endoscopic eradication therapy. A similar significant increase was noted in patients with stage T1a disease, as well, he said.

Notably, patients undergoing EET were significantly older than those undergoing surgery (70 vs. 63 years), and more likely to be diagnosed with T0 disease (32.5% vs. 23.1% of patients) with well-differentiated histology (33% vs. 24%). They also were less likely to be men, and less likely to receive radiation therapy.

"However, the overall follow-up in the endoscopy arm was shorter than for their surgical counterparts," Dr. Wani noted.

Regional variations were observed in the proportions of patients undergoing EET and surgery, he said.

The differences between the groups, along with the significant differences in non–EAC-related mortality between the treatment groups, highlight selection bias with respect to the therapies offered to patients with EAC, he said.

Patients included in this analysis were adults who had EAC between 1998 and 2009. EAC was defined as carcinoma in situ (T0 disease), or invasive tumor confined to the mucosa, lamina propria, and muscularis mucosae (T1a disease).

The vast majority of patients in the endoscopy arm underwent endoscopic mucosal resection alone; the vast majority in the surgery arm underwent esophagectomy plus partial or total gastrectomy, Dr. Wani said.

Though limited by the use of population-based data that lacked details on recurrences, pathology, staging modalities, and complications and morbidity, this study analyzed one of the largest cohorts of patients with EAC undergoing endoscopic therapy.

The findings are important, because EETs for EAC have gained wide acceptance, and have been endorsed by society guidelines despite a paucity of long-term data examining the differences in outcomes between EET and the gold standard of surgical resection, he said.

Indeed, esophagectomy has traditionally been considered the treatment of choice for EAC, but it is also associated with high morbidity and mortality, even in expert centers, he noted.

"The implications of our study? It really provides a greater degree of confidence in what we do on a daily basis and this whole concept of endoscopic eradication therapy for patients with early esophageal cancer. However we need long-term data – i.e., 5-year data, at least – with newer ablative therapies, such as radiofrequency ablation in combination with endoscopy mucosal resection," he said. Future studies should focus on identifying patient and provider determinants of optimal outcomes, he added.

Dr. Wani reported having no disclosures.

ORLANDO – Mid- and long-term esophageal cancer–free survival rates are similar in patients with early esophageal adenocarcinoma who undergo endoscopic eradication therapy and those who undergo surgical resection, according to findings from a large population-based study.

Of 1,087 patients with early esophageal adenocarcinoma (EAC) who were included in the Surveillance, Epidemiology and End Results (SEER) database, 283 underwent endoscopic eradication therapy (EET), and 804 underwent surgical resection. No significant differences were seen between the groups with respect to 2-year esophageal cancer–free survival (93.5% and 89.6% in the EET and surgery groups, respectively) or 5-year survival (69.3% and 75.8%, respectively), Dr. Sachin Wani reported during a late-breaking abstract session at the annual Digestive Disease Week.

However, the EET group had higher mortality than the surgery group due to non-EAC causes (12.8% vs. 5.7% at 2 years, and 34.8% vs. 12.9% at 5 years), he said. Cardiovascular disease was the most common cause of non-EAC mortality.

Variables significantly associated with mortality were older age (hazard ratio, 1.02), stage T1a disease (compared with T0 disease; HR, 2.71), year of diagnosis (HR, 0.93), and radiation therapy (HR, 5.29), said Dr. Wani of the University of Colorado, Aurora.

Treatment arm was not a predictor of overall survival.

A time-trend analysis showed a significant increase in the proportion of patients with T0 disease undergoing endoscopic eradication therapy. A similar significant increase was noted in patients with stage T1a disease, as well, he said.

Notably, patients undergoing EET were significantly older than those undergoing surgery (70 vs. 63 years), and more likely to be diagnosed with T0 disease (32.5% vs. 23.1% of patients) with well-differentiated histology (33% vs. 24%). They also were less likely to be men, and less likely to receive radiation therapy.

"However, the overall follow-up in the endoscopy arm was shorter than for their surgical counterparts," Dr. Wani noted.

Regional variations were observed in the proportions of patients undergoing EET and surgery, he said.

The differences between the groups, along with the significant differences in non–EAC-related mortality between the treatment groups, highlight selection bias with respect to the therapies offered to patients with EAC, he said.

Patients included in this analysis were adults who had EAC between 1998 and 2009. EAC was defined as carcinoma in situ (T0 disease), or invasive tumor confined to the mucosa, lamina propria, and muscularis mucosae (T1a disease).

The vast majority of patients in the endoscopy arm underwent endoscopic mucosal resection alone; the vast majority in the surgery arm underwent esophagectomy plus partial or total gastrectomy, Dr. Wani said.

Though limited by the use of population-based data that lacked details on recurrences, pathology, staging modalities, and complications and morbidity, this study analyzed one of the largest cohorts of patients with EAC undergoing endoscopic therapy.

The findings are important, because EETs for EAC have gained wide acceptance, and have been endorsed by society guidelines despite a paucity of long-term data examining the differences in outcomes between EET and the gold standard of surgical resection, he said.

Indeed, esophagectomy has traditionally been considered the treatment of choice for EAC, but it is also associated with high morbidity and mortality, even in expert centers, he noted.

"The implications of our study? It really provides a greater degree of confidence in what we do on a daily basis and this whole concept of endoscopic eradication therapy for patients with early esophageal cancer. However we need long-term data – i.e., 5-year data, at least – with newer ablative therapies, such as radiofrequency ablation in combination with endoscopy mucosal resection," he said. Future studies should focus on identifying patient and provider determinants of optimal outcomes, he added.

Dr. Wani reported having no disclosures.

MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.

Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph S. Coselli said at the annual meeting of the American Association for Thoracic Surgery.

"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."

In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).

The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (N = 239) or aortic valve–replacing (AVR) (N = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.

"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.

AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).

Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.

At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).

Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.

One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).

At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.

The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).

In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.

Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.

MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.

Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph S. Coselli said at the annual meeting of the American Association for Thoracic Surgery.

"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."

In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).

The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (N = 239) or aortic valve–replacing (AVR) (N = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.

"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.

AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).

Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.

At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).

Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.

One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).

At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.

The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).

In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.

Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.

MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.

Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph S. Coselli said at the annual meeting of the American Association for Thoracic Surgery.

"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."

In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).

The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (N = 239) or aortic valve–replacing (AVR) (N = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.

"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.

AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).

Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.

At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).

Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.

One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).

At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.

The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).

In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.

Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.

DENVER – Uninterrupted warfarin therapy during pacemaker or implantable cardioverter-defibrillator surgery in patients at high thromboembolic risk proved superior to the guideline-recommended practice of discontinuing warfarin and bridging with heparin, according to a large, multicenter, randomized clinical trial.

The primary outcome in the 17-center, 681-patient BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) was the incidence of clinically significant device-pocket hematoma. The rate was 16% in patients randomized to heparin bridging, compared with 3.5% with uninterrupted warfarin, Dr. David H. Birnie reported at the annual meeting of the Heart Rhythm Society.

These results are clearly practice changing. Heparin bridging has been the standard of care. It is recommended in this common clinical scenario in all of the major guidelines, but that’s bound to change as a result of BRUISE CONTROL, predicted Dr. Birnie of the University of Ottawa Heart Institute.

"This trial was a home run. It was unequivocally positive," he commented. "For sure, our clinical practice changed as soon as we saw those results."

Device-pocket hematoma is a "very nasty" complication of cardiac device surgery, Dr. Birnie noted. It is quite painful, can cause device infection, and is difficult to treat. Clinically significant device-pocket hematoma was defined in this trial as a hematoma resulting in prolonged hospitalization for an additional day or more, or interruption of oral anticoagulation for at least 24 hours, and/or requiring additional surgery. All three components of the primary endpoint were significantly less frequent in the uninterrupted warfarin group (see chart).

Performing device surgery in patients on uninterrupted warfarin with a median international normalized ratio (INR) of 2.3 was not associated with any increase in major perioperative bleeding or other surgical or thromboembolic complications. And patient satisfaction surveys indicated subjects greatly preferred having their procedure without stopping their warfarin.

BRUISE CONTROL was planned as a definitive 1,000-patient clinical trial. However, the Data and Safety Monitoring Board halted the study after an interim analysis involving the first 681 subjects.

Of note, this was a study restricted to patients at high stroke risk – greater than 5% annually – as defined by the presence of atrial fibrillation and a CHADS₂ score of 3 or more or the presence of a mechanical heart valve.

Dr. Birnie said that although it seems counterintuitive to have less bleeding when cardiac device surgery is performed on a fully anticoagulated patient, as occurred in BRUISE CONTROL, he and his coinvestigators have an explanatory hypothesis: "When bleeding occurs in a fully anticoagulated patient, the operator can readily see it and address it. On the contrary, with bridging you get hemostasis at the time of surgery, but you may have missed a tiny little thing, and then 24 hours later when you start up your heparin bridging again, that’s when the bleeding occurs. It’s a physiologically plausible explanation," he said.

In a multivariate analysis, neither the use of pressure dressings, nor the use of sandbags, nor injection of antibleeding agents into the device pocket before closure had any significant impact on the incidence of clinically significant hematomas. Only three factors did: uninterrupted warfarin therapy, which reduced the risk by 84%; aspirin therapy, which doubled the risk; and the presence of diabetes mellitus, which was inexplicably associated with a 52% reduction in hematoma risk.

Each year roughly 1.6 million people worldwide undergo pacemaker or implantable cardioverter-defibrillator (ICD) implantation. Up to one-third of them are on long-term oral anticoagulation, most commonly with warfarin.

Dr. Birnie stressed that the BRUISE CONTROL findings have no relevance to patients on one of the new oral anticoagulants.

"The whole risk/benefit ratio of the new agents is completely different from warfarin. Their onset and offset of action is hours as opposed to the 5 days for warfarin," he noted.

With that point in mind, he and his coinvestigators have just started the BRUISE CONTROL-2 trial, which is examining whether it’s better to stop the new agents around the time of device surgery or continue the medication uninterrupted.

Simultaneous with Dr. Birnie’s presentation of the BRUISE CONTROL data in Denver, the study results were published online (N. Engl. J. Med. 2013 May 9 [doi: 10.1056/NEJMoa1302946]).

BRUISE CONTROL was funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario. Dr. Birnie reported having no conflicts of interest.

bjancin@frontlinemedcom.com

DENVER – Uninterrupted warfarin therapy during pacemaker or implantable cardioverter-defibrillator surgery in patients at high thromboembolic risk proved superior to the guideline-recommended practice of discontinuing warfarin and bridging with heparin, according to a large, multicenter, randomized clinical trial.

The primary outcome in the 17-center, 681-patient BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) was the incidence of clinically significant device-pocket hematoma. The rate was 16% in patients randomized to heparin bridging, compared with 3.5% with uninterrupted warfarin, Dr. David H. Birnie reported at the annual meeting of the Heart Rhythm Society.

These results are clearly practice changing. Heparin bridging has been the standard of care. It is recommended in this common clinical scenario in all of the major guidelines, but that’s bound to change as a result of BRUISE CONTROL, predicted Dr. Birnie of the University of Ottawa Heart Institute.

"This trial was a home run. It was unequivocally positive," he commented. "For sure, our clinical practice changed as soon as we saw those results."

Device-pocket hematoma is a "very nasty" complication of cardiac device surgery, Dr. Birnie noted. It is quite painful, can cause device infection, and is difficult to treat. Clinically significant device-pocket hematoma was defined in this trial as a hematoma resulting in prolonged hospitalization for an additional day or more, or interruption of oral anticoagulation for at least 24 hours, and/or requiring additional surgery. All three components of the primary endpoint were significantly less frequent in the uninterrupted warfarin group (see chart).

Performing device surgery in patients on uninterrupted warfarin with a median international normalized ratio (INR) of 2.3 was not associated with any increase in major perioperative bleeding or other surgical or thromboembolic complications. And patient satisfaction surveys indicated subjects greatly preferred having their procedure without stopping their warfarin.

BRUISE CONTROL was planned as a definitive 1,000-patient clinical trial. However, the Data and Safety Monitoring Board halted the study after an interim analysis involving the first 681 subjects.

Of note, this was a study restricted to patients at high stroke risk – greater than 5% annually – as defined by the presence of atrial fibrillation and a CHADS₂ score of 3 or more or the presence of a mechanical heart valve.

Dr. Birnie said that although it seems counterintuitive to have less bleeding when cardiac device surgery is performed on a fully anticoagulated patient, as occurred in BRUISE CONTROL, he and his coinvestigators have an explanatory hypothesis: "When bleeding occurs in a fully anticoagulated patient, the operator can readily see it and address it. On the contrary, with bridging you get hemostasis at the time of surgery, but you may have missed a tiny little thing, and then 24 hours later when you start up your heparin bridging again, that’s when the bleeding occurs. It’s a physiologically plausible explanation," he said.

In a multivariate analysis, neither the use of pressure dressings, nor the use of sandbags, nor injection of antibleeding agents into the device pocket before closure had any significant impact on the incidence of clinically significant hematomas. Only three factors did: uninterrupted warfarin therapy, which reduced the risk by 84%; aspirin therapy, which doubled the risk; and the presence of diabetes mellitus, which was inexplicably associated with a 52% reduction in hematoma risk.

Each year roughly 1.6 million people worldwide undergo pacemaker or implantable cardioverter-defibrillator (ICD) implantation. Up to one-third of them are on long-term oral anticoagulation, most commonly with warfarin.

Dr. Birnie stressed that the BRUISE CONTROL findings have no relevance to patients on one of the new oral anticoagulants.

"The whole risk/benefit ratio of the new agents is completely different from warfarin. Their onset and offset of action is hours as opposed to the 5 days for warfarin," he noted.

With that point in mind, he and his coinvestigators have just started the BRUISE CONTROL-2 trial, which is examining whether it’s better to stop the new agents around the time of device surgery or continue the medication uninterrupted.

Simultaneous with Dr. Birnie’s presentation of the BRUISE CONTROL data in Denver, the study results were published online (N. Engl. J. Med. 2013 May 9 [doi: 10.1056/NEJMoa1302946]).

BRUISE CONTROL was funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario. Dr. Birnie reported having no conflicts of interest.

bjancin@frontlinemedcom.com

DENVER – Uninterrupted warfarin therapy during pacemaker or implantable cardioverter-defibrillator surgery in patients at high thromboembolic risk proved superior to the guideline-recommended practice of discontinuing warfarin and bridging with heparin, according to a large, multicenter, randomized clinical trial.

The primary outcome in the 17-center, 681-patient BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) was the incidence of clinically significant device-pocket hematoma. The rate was 16% in patients randomized to heparin bridging, compared with 3.5% with uninterrupted warfarin, Dr. David H. Birnie reported at the annual meeting of the Heart Rhythm Society.

These results are clearly practice changing. Heparin bridging has been the standard of care. It is recommended in this common clinical scenario in all of the major guidelines, but that’s bound to change as a result of BRUISE CONTROL, predicted Dr. Birnie of the University of Ottawa Heart Institute.

"This trial was a home run. It was unequivocally positive," he commented. "For sure, our clinical practice changed as soon as we saw those results."

Device-pocket hematoma is a "very nasty" complication of cardiac device surgery, Dr. Birnie noted. It is quite painful, can cause device infection, and is difficult to treat. Clinically significant device-pocket hematoma was defined in this trial as a hematoma resulting in prolonged hospitalization for an additional day or more, or interruption of oral anticoagulation for at least 24 hours, and/or requiring additional surgery. All three components of the primary endpoint were significantly less frequent in the uninterrupted warfarin group (see chart).

Performing device surgery in patients on uninterrupted warfarin with a median international normalized ratio (INR) of 2.3 was not associated with any increase in major perioperative bleeding or other surgical or thromboembolic complications. And patient satisfaction surveys indicated subjects greatly preferred having their procedure without stopping their warfarin.

BRUISE CONTROL was planned as a definitive 1,000-patient clinical trial. However, the Data and Safety Monitoring Board halted the study after an interim analysis involving the first 681 subjects.

Of note, this was a study restricted to patients at high stroke risk – greater than 5% annually – as defined by the presence of atrial fibrillation and a CHADS₂ score of 3 or more or the presence of a mechanical heart valve.

Dr. Birnie said that although it seems counterintuitive to have less bleeding when cardiac device surgery is performed on a fully anticoagulated patient, as occurred in BRUISE CONTROL, he and his coinvestigators have an explanatory hypothesis: "When bleeding occurs in a fully anticoagulated patient, the operator can readily see it and address it. On the contrary, with bridging you get hemostasis at the time of surgery, but you may have missed a tiny little thing, and then 24 hours later when you start up your heparin bridging again, that’s when the bleeding occurs. It’s a physiologically plausible explanation," he said.

In a multivariate analysis, neither the use of pressure dressings, nor the use of sandbags, nor injection of antibleeding agents into the device pocket before closure had any significant impact on the incidence of clinically significant hematomas. Only three factors did: uninterrupted warfarin therapy, which reduced the risk by 84%; aspirin therapy, which doubled the risk; and the presence of diabetes mellitus, which was inexplicably associated with a 52% reduction in hematoma risk.

Each year roughly 1.6 million people worldwide undergo pacemaker or implantable cardioverter-defibrillator (ICD) implantation. Up to one-third of them are on long-term oral anticoagulation, most commonly with warfarin.

Dr. Birnie stressed that the BRUISE CONTROL findings have no relevance to patients on one of the new oral anticoagulants.

"The whole risk/benefit ratio of the new agents is completely different from warfarin. Their onset and offset of action is hours as opposed to the 5 days for warfarin," he noted.

With that point in mind, he and his coinvestigators have just started the BRUISE CONTROL-2 trial, which is examining whether it’s better to stop the new agents around the time of device surgery or continue the medication uninterrupted.

Simultaneous with Dr. Birnie’s presentation of the BRUISE CONTROL data in Denver, the study results were published online (N. Engl. J. Med. 2013 May 9 [doi: 10.1056/NEJMoa1302946]).

BRUISE CONTROL was funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario. Dr. Birnie reported having no conflicts of interest.

bjancin@frontlinemedcom.com

DENVER – After a failed first ablation procedure for paroxysmal atrial fibrillation, redo ablation proved more effective than did antiarrhythmic drug therapy in a randomized trial, Dr. Jonathan Steinberg reported at the annual meeting of the Heart Rhythm Society.

The success rate of a first ablation procedure in patients with symptomatic paroxysmal AF is typically about 60%. The question of what to do for the 40% who are nonresponders has been unclear, with no prior randomized clinical trial evidence available to guide decisions, noted Dr. Steinberg of Columbia University, New York.

The study comprised 154 patients with recurrent symptomatic paroxysmal AF 3 months after an initial ablation procedure involving only pulmonary vein isolation. All participants received an implantable loop recorder to track atrial arrhythmic events.

They were then randomized to redo ablation limited to reisolation of the pulmonary vein, which was successfully accomplished in all instances, or to guideline-based antiarrhythmic drug therapy. The choice of drug was left to individual investigator discretion. The three options were propafenone at 450-900 mg/day, sotalol at 160-320 mg/day, or flecainide at 200-400 mg/day. Propafenone was selected in the majority of cases, at an average dose of 579 mg/day.

The average AF burden as measured by implantable loop recorder at randomization was 15%. The primary study endpoint was AF burden at 36 months of follow-up, which was 5.6% in the redo-ablation group compared with 18.8% in the antiarrhythmic drug group.

Secondary endpoints uniformly favored redo ablation as well (see graphic).

Data from the implantable loop recorders was evaluated every 3 months during 3 years of follow-up. As early as 3 months into the study, the group given antiarrhythmic drugs had an AF burden of 3.3%, significantly higher than the 1.9% rate seen in the redo-ablation group.

Thereafter, the drug therapy group experienced a gradual increase in AF burden throughout the first 12-15 months, followed by a much more substantial increase during the remainder of the study.

"The redo-ablation group had a different pattern" of AF burden, Dr. Steinberg observed. "It was low throughout the first 12-15 months, with just a slight increase, and it then rose only gradually over time until the 36-month end of the study."

Freedom from any atrial tachy-arrhythmia at 1 year was 30% in the antiarrhythmic drug therapy group and 75% in the redo-ablation group. By 3 years, 12% of those in the drug therapy group were free of atrial tachyarrhythmias as were 58% in the redo-ablation group.

Complications in the redo-ablation group consisted of two cases of cardiac tamponade. In contrast, 49 patients, or 64%, in the antiarrhythmic drug therapy group discontinued medication because of intolerance or ineffectiveness.

Session cochair Dr. Gordon Tomaselli of Johns Hopkins University, Baltimore, said that in light of the potential proarrhythmic effects of virtually all antiarrhythmic drugs, it would have been useful to include a no-antiarrhythmic drug control group in the study.

Dr. Steinberg reported having no conflicts of interest.

bjancin@frontlinemedcom.com

DENVER – After a failed first ablation procedure for paroxysmal atrial fibrillation, redo ablation proved more effective than did antiarrhythmic drug therapy in a randomized trial, Dr. Jonathan Steinberg reported at the annual meeting of the Heart Rhythm Society.

The success rate of a first ablation procedure in patients with symptomatic paroxysmal AF is typically about 60%. The question of what to do for the 40% who are nonresponders has been unclear, with no prior randomized clinical trial evidence available to guide decisions, noted Dr. Steinberg of Columbia University, New York.

The study comprised 154 patients with recurrent symptomatic paroxysmal AF 3 months after an initial ablation procedure involving only pulmonary vein isolation. All participants received an implantable loop recorder to track atrial arrhythmic events.

They were then randomized to redo ablation limited to reisolation of the pulmonary vein, which was successfully accomplished in all instances, or to guideline-based antiarrhythmic drug therapy. The choice of drug was left to individual investigator discretion. The three options were propafenone at 450-900 mg/day, sotalol at 160-320 mg/day, or flecainide at 200-400 mg/day. Propafenone was selected in the majority of cases, at an average dose of 579 mg/day.

The average AF burden as measured by implantable loop recorder at randomization was 15%. The primary study endpoint was AF burden at 36 months of follow-up, which was 5.6% in the redo-ablation group compared with 18.8% in the antiarrhythmic drug group.

Secondary endpoints uniformly favored redo ablation as well (see graphic).

Data from the implantable loop recorders was evaluated every 3 months during 3 years of follow-up. As early as 3 months into the study, the group given antiarrhythmic drugs had an AF burden of 3.3%, significantly higher than the 1.9% rate seen in the redo-ablation group.

Thereafter, the drug therapy group experienced a gradual increase in AF burden throughout the first 12-15 months, followed by a much more substantial increase during the remainder of the study.

"The redo-ablation group had a different pattern" of AF burden, Dr. Steinberg observed. "It was low throughout the first 12-15 months, with just a slight increase, and it then rose only gradually over time until the 36-month end of the study."

Freedom from any atrial tachy-arrhythmia at 1 year was 30% in the antiarrhythmic drug therapy group and 75% in the redo-ablation group. By 3 years, 12% of those in the drug therapy group were free of atrial tachyarrhythmias as were 58% in the redo-ablation group.

Complications in the redo-ablation group consisted of two cases of cardiac tamponade. In contrast, 49 patients, or 64%, in the antiarrhythmic drug therapy group discontinued medication because of intolerance or ineffectiveness.

Session cochair Dr. Gordon Tomaselli of Johns Hopkins University, Baltimore, said that in light of the potential proarrhythmic effects of virtually all antiarrhythmic drugs, it would have been useful to include a no-antiarrhythmic drug control group in the study.

Dr. Steinberg reported having no conflicts of interest.

bjancin@frontlinemedcom.com

DENVER – After a failed first ablation procedure for paroxysmal atrial fibrillation, redo ablation proved more effective than did antiarrhythmic drug therapy in a randomized trial, Dr. Jonathan Steinberg reported at the annual meeting of the Heart Rhythm Society.

The success rate of a first ablation procedure in patients with symptomatic paroxysmal AF is typically about 60%. The question of what to do for the 40% who are nonresponders has been unclear, with no prior randomized clinical trial evidence available to guide decisions, noted Dr. Steinberg of Columbia University, New York.

The study comprised 154 patients with recurrent symptomatic paroxysmal AF 3 months after an initial ablation procedure involving only pulmonary vein isolation. All participants received an implantable loop recorder to track atrial arrhythmic events.

They were then randomized to redo ablation limited to reisolation of the pulmonary vein, which was successfully accomplished in all instances, or to guideline-based antiarrhythmic drug therapy. The choice of drug was left to individual investigator discretion. The three options were propafenone at 450-900 mg/day, sotalol at 160-320 mg/day, or flecainide at 200-400 mg/day. Propafenone was selected in the majority of cases, at an average dose of 579 mg/day.

The average AF burden as measured by implantable loop recorder at randomization was 15%. The primary study endpoint was AF burden at 36 months of follow-up, which was 5.6% in the redo-ablation group compared with 18.8% in the antiarrhythmic drug group.

Secondary endpoints uniformly favored redo ablation as well (see graphic).

Data from the implantable loop recorders was evaluated every 3 months during 3 years of follow-up. As early as 3 months into the study, the group given antiarrhythmic drugs had an AF burden of 3.3%, significantly higher than the 1.9% rate seen in the redo-ablation group.

Thereafter, the drug therapy group experienced a gradual increase in AF burden throughout the first 12-15 months, followed by a much more substantial increase during the remainder of the study.

"The redo-ablation group had a different pattern" of AF burden, Dr. Steinberg observed. "It was low throughout the first 12-15 months, with just a slight increase, and it then rose only gradually over time until the 36-month end of the study."

Freedom from any atrial tachy-arrhythmia at 1 year was 30% in the antiarrhythmic drug therapy group and 75% in the redo-ablation group. By 3 years, 12% of those in the drug therapy group were free of atrial tachyarrhythmias as were 58% in the redo-ablation group.

Complications in the redo-ablation group consisted of two cases of cardiac tamponade. In contrast, 49 patients, or 64%, in the antiarrhythmic drug therapy group discontinued medication because of intolerance or ineffectiveness.

Session cochair Dr. Gordon Tomaselli of Johns Hopkins University, Baltimore, said that in light of the potential proarrhythmic effects of virtually all antiarrhythmic drugs, it would have been useful to include a no-antiarrhythmic drug control group in the study.

Dr. Steinberg reported having no conflicts of interest.

bjancin@frontlinemedcom.com

About one-third of patients with Barrett’s esophagus can expect recurrence of intestinal metaplasia by 2 years after obtaining complete remission with radiofrequency ablation.

The finding highlights the importance of frequent endoscopic surveillance in these patients, even after remission is achieved, wrote Dr. Milli Gupta and colleagues in the July issue of Gastroenterology.

In the study, Dr. Gupta, of the Mayo Clinic, Rochester, Minn., and her associates looked at 448 patients with Barrett’s treated with radiofrequency ablation (RFA) at three different tertiary referral centers (doi: .1053/j.gastro.2013.03.008).

The data were collected from patients treated and followed up in these centers from January 2003 to November 2011 as part of the Barrett’s Esophagus Translational Research Network consortium.

The patients’ mean age was 64 years, 85% were men, and the mean length of Barrett’s esophagus that was treated was 4.1 cm, the authors reported.

Looking at the indication for RFA, 11% had intramucosal esophageal adenocarcinoma, 60% had high-grade dysplasia, 15% had low-grade dysplasia, and 14% had nondysplastic BE.

Slightly more than half (55%) of patients also underwent endoscopic mucosal resection before RFA, and 1% had received cryotherapy.

After RFA, the authors found that by 1 year, roughly 26% of patients achieved complete remission of intestinal metaplasia (CRIM), defined as two negative endoscopies and histology clear of intestinal metaplasia.

That figure climbed to 56% by 2 years, and to 71% by 3 years, with 29% of patients receiving one RFA treatment session, 35% receiving two sessions, and the remaining percentage of patients undergoing 3-10 sessions before remission.

Adverse events occurred in 6.5% of patients, with stricture formation being the most common, followed by bleeding, mucosal tears, and hospitalizations for dysrhythmias.

However, using a Kaplan-Meier survival curve, they found that after CRIM was attained, 20% of patients would have recurrence of intestinal metaplasia by 1 year. Similarly, by 2 years after attainment of CRIM, the rate of recurrence was 33%.

"By 3 years, recurrences continued to occur, but precise estimates were difficult to establish because of the small number of at-risk subjects (n = 11), which made estimates of recurrence less precise," Dr. Gupta and her colleagues wrote.

According to the authors, the most common type of recurrence was intestinal metaplasia without dysplasia, which was seen in 78% of patients who recurred after CRIM.

The remaining patients who recurred (22%) developed dysplastic Barrett’s esophagus, with 11% showing high-grade dysplasia, 8% showing low-grade dysplasia, and 3% developing cancer.

There were no discernable endoscopic or patient factors associated with time to recurrence on univariate and multivariate analyses, the authors added.

"Despite the ability of RFA to achieve CRIM, recurrence of intestinal metaplasia and dysplasia appears to occur in a substantial proportion of subjects," wrote Dr. Gupta.

She pointed out that current recommendations call for intense surveillance at 3- to 6-month intervals, and if no recurrence is found, "surveillance generally is decreased to 6- to 12-month intervals."

However, "until predictive biomarkers are identified and available for clinical practice, endoscopic surveillance directed at the gastroesophageal junction and original BE [Barrett’s esophagus] segment should be continued."

Dr. Gupta had no conflicts of interest. Several of her coauthors disclosed financial relationships with drug makers, including the makers of therapies for Barrett’s esophagus. The study was funded by a grant from the National Institutes of Health. The Barrett’s Esophagus Translational Research Network consortium is funded by the National Cancer Institute.

About one-third of patients with Barrett’s esophagus can expect recurrence of intestinal metaplasia by 2 years after obtaining complete remission with radiofrequency ablation.

The finding highlights the importance of frequent endoscopic surveillance in these patients, even after remission is achieved, wrote Dr. Milli Gupta and colleagues in the July issue of Gastroenterology.

In the study, Dr. Gupta, of the Mayo Clinic, Rochester, Minn., and her associates looked at 448 patients with Barrett’s treated with radiofrequency ablation (RFA) at three different tertiary referral centers (doi: .1053/j.gastro.2013.03.008).

The data were collected from patients treated and followed up in these centers from January 2003 to November 2011 as part of the Barrett’s Esophagus Translational Research Network consortium.

The patients’ mean age was 64 years, 85% were men, and the mean length of Barrett’s esophagus that was treated was 4.1 cm, the authors reported.

Looking at the indication for RFA, 11% had intramucosal esophageal adenocarcinoma, 60% had high-grade dysplasia, 15% had low-grade dysplasia, and 14% had nondysplastic BE.

Slightly more than half (55%) of patients also underwent endoscopic mucosal resection before RFA, and 1% had received cryotherapy.

After RFA, the authors found that by 1 year, roughly 26% of patients achieved complete remission of intestinal metaplasia (CRIM), defined as two negative endoscopies and histology clear of intestinal metaplasia.

That figure climbed to 56% by 2 years, and to 71% by 3 years, with 29% of patients receiving one RFA treatment session, 35% receiving two sessions, and the remaining percentage of patients undergoing 3-10 sessions before remission.

Adverse events occurred in 6.5% of patients, with stricture formation being the most common, followed by bleeding, mucosal tears, and hospitalizations for dysrhythmias.

However, using a Kaplan-Meier survival curve, they found that after CRIM was attained, 20% of patients would have recurrence of intestinal metaplasia by 1 year. Similarly, by 2 years after attainment of CRIM, the rate of recurrence was 33%.

"By 3 years, recurrences continued to occur, but precise estimates were difficult to establish because of the small number of at-risk subjects (n = 11), which made estimates of recurrence less precise," Dr. Gupta and her colleagues wrote.

According to the authors, the most common type of recurrence was intestinal metaplasia without dysplasia, which was seen in 78% of patients who recurred after CRIM.

The remaining patients who recurred (22%) developed dysplastic Barrett’s esophagus, with 11% showing high-grade dysplasia, 8% showing low-grade dysplasia, and 3% developing cancer.

There were no discernable endoscopic or patient factors associated with time to recurrence on univariate and multivariate analyses, the authors added.

"Despite the ability of RFA to achieve CRIM, recurrence of intestinal metaplasia and dysplasia appears to occur in a substantial proportion of subjects," wrote Dr. Gupta.

She pointed out that current recommendations call for intense surveillance at 3- to 6-month intervals, and if no recurrence is found, "surveillance generally is decreased to 6- to 12-month intervals."

However, "until predictive biomarkers are identified and available for clinical practice, endoscopic surveillance directed at the gastroesophageal junction and original BE [Barrett’s esophagus] segment should be continued."

Dr. Gupta had no conflicts of interest. Several of her coauthors disclosed financial relationships with drug makers, including the makers of therapies for Barrett’s esophagus. The study was funded by a grant from the National Institutes of Health. The Barrett’s Esophagus Translational Research Network consortium is funded by the National Cancer Institute.

About one-third of patients with Barrett’s esophagus can expect recurrence of intestinal metaplasia by 2 years after obtaining complete remission with radiofrequency ablation.

The finding highlights the importance of frequent endoscopic surveillance in these patients, even after remission is achieved, wrote Dr. Milli Gupta and colleagues in the July issue of Gastroenterology.

In the study, Dr. Gupta, of the Mayo Clinic, Rochester, Minn., and her associates looked at 448 patients with Barrett’s treated with radiofrequency ablation (RFA) at three different tertiary referral centers (doi: .1053/j.gastro.2013.03.008).

The data were collected from patients treated and followed up in these centers from January 2003 to November 2011 as part of the Barrett’s Esophagus Translational Research Network consortium.

The patients’ mean age was 64 years, 85% were men, and the mean length of Barrett’s esophagus that was treated was 4.1 cm, the authors reported.

Looking at the indication for RFA, 11% had intramucosal esophageal adenocarcinoma, 60% had high-grade dysplasia, 15% had low-grade dysplasia, and 14% had nondysplastic BE.

Slightly more than half (55%) of patients also underwent endoscopic mucosal resection before RFA, and 1% had received cryotherapy.

After RFA, the authors found that by 1 year, roughly 26% of patients achieved complete remission of intestinal metaplasia (CRIM), defined as two negative endoscopies and histology clear of intestinal metaplasia.

That figure climbed to 56% by 2 years, and to 71% by 3 years, with 29% of patients receiving one RFA treatment session, 35% receiving two sessions, and the remaining percentage of patients undergoing 3-10 sessions before remission.

Adverse events occurred in 6.5% of patients, with stricture formation being the most common, followed by bleeding, mucosal tears, and hospitalizations for dysrhythmias.

However, using a Kaplan-Meier survival curve, they found that after CRIM was attained, 20% of patients would have recurrence of intestinal metaplasia by 1 year. Similarly, by 2 years after attainment of CRIM, the rate of recurrence was 33%.

"By 3 years, recurrences continued to occur, but precise estimates were difficult to establish because of the small number of at-risk subjects (n = 11), which made estimates of recurrence less precise," Dr. Gupta and her colleagues wrote.

According to the authors, the most common type of recurrence was intestinal metaplasia without dysplasia, which was seen in 78% of patients who recurred after CRIM.

The remaining patients who recurred (22%) developed dysplastic Barrett’s esophagus, with 11% showing high-grade dysplasia, 8% showing low-grade dysplasia, and 3% developing cancer.

There were no discernable endoscopic or patient factors associated with time to recurrence on univariate and multivariate analyses, the authors added.

"Despite the ability of RFA to achieve CRIM, recurrence of intestinal metaplasia and dysplasia appears to occur in a substantial proportion of subjects," wrote Dr. Gupta.

She pointed out that current recommendations call for intense surveillance at 3- to 6-month intervals, and if no recurrence is found, "surveillance generally is decreased to 6- to 12-month intervals."

However, "until predictive biomarkers are identified and available for clinical practice, endoscopic surveillance directed at the gastroesophageal junction and original BE [Barrett’s esophagus] segment should be continued."

Dr. Gupta had no conflicts of interest. Several of her coauthors disclosed financial relationships with drug makers, including the makers of therapies for Barrett’s esophagus. The study was funded by a grant from the National Institutes of Health. The Barrett’s Esophagus Translational Research Network consortium is funded by the National Cancer Institute.

MINNEAPOLIS – A single high dose of human recombinant erythropoietin given 2 days before heart surgery reduced blood transfusions by 65%, without substantially increasing mortality or morbidity in the prospective, randomized SHOT trial.

Patients who received 80,000 IU of erythropoietin (Eprex) in a single bolus plus iron supplementation until discharge needed 0.39 blood units/patient, compared with 1.12 units/patient for those receiving standard care involving thromboelastography and tranexamic acid (P less than .001; risk ratio, 0.338).

IMNG Medical Media/Martin Allred

All-cause mortality at 45 days postoperative was 3.0% with erythropoietin and 3.33%
without it (P = .26), Dr. Luca Weltert said at the annual meeting of the American Association for Thoracic Surgery.

The investigators undertook the SHOT (Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery) trial because their original erythropoietin protocol proved too compli- cated for everyday use. The protocol was incorporated
into the 2012 Society of
Thoracic Surgeons and Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines, but consisted of five different doses of erythropoietin in 5 days, totaling 52,000 IU, he explained.

Invited discussant Dr. Victor Ferraris, of the Lexington (Ky.) Veterans Affairs Medical Center, questioned whether the high dose of erythropoietin increased thromboembolic events, in light of the black box warnings added to erythropoiesis-stimulating agents due to an increased risk for thromboembolic events in patients with malignancy and an increased risk of serious cardiovascular events in patients with chronic kidney disease when the hemoglobin level exceeds 12 g/dL.

Thromboembolic events were not significantly different between groups, and the trial did not include cancer patients, said Dr. Weltert of the European Hospital in Rome.

Major nonfatal adverse events at 45 days were reported in 4.33% of erythropoietin and 5.67% of control patients (P = .13). Specifically, there were no differences in neurologic complications (4 vs. 5 events, respectively), long-term wound infection (4 in both groups), deep vein thrombosis (2 vs. 5), onset of acute hypertension (1 vs. 2), and new-onset renal failure (2 vs. 1).

Attendees continued this line of questioning, asking how reliable the negative finding is and whether the investigators could have missed a population with a positive result. The efficacy endpoint was based on a minimal sample size of 400 patients, and the trial enrolled 600 consecutive "all comers," Dr. Weltert said, but he added that 3,000 - 4,000 patients would be needed for the safety endpoint, "so the samples are ridiculously small to really state strongly that there is no harm for a subgroup."

The two study arms were well matched, with 35% of all patients undergoing coronary artery bypass grafting, 31% valve surgery, roughly 20% repair of the ascending aorta, and other in about 14%. The mean logistic EuroScore was 9.94 in the erythropoietin group and 10.12 in the control group, and the mean ages were 72.9 and 70.4 years, respectively.

Mean hemoglobin levels on day 4 postoperative was significantly higher in the erythropoietin group than in controls (10.21 vs. 9.01 g/dL; P = .02), Dr. Weltert said.

There were no significant differences between the erythropoietin and control groups in intensive care unit stay (2.71 vs. 2.60 days, respectively), perioperative myocardial infarction (7 vs. 7), cardiac tamponade (3 vs. 5), or need for reintubation (13 vs. 15).

An attendee asked whether hemoglobin levels drifted between days 3 and 4 postoperatively, as this can confound the decision to transfuse after cardiac surgery, and whether the investigators looked at another potential confounder, hemoglobin trigger, since no less than five randomized controlled trials have shown that a hemoglobin level of 7-8 g/dL should be used as a transfusion trigger.

Dr. Weltert said the team picked day 4 to check hemoglobin levels for practical reasons because that’s the day when you see the biggest drift and that the erythropoietin group fared better. He went on to say, "The trigger is extremely important, and I think it will be the very next step in bloodless surgery."

The investigators did compare costs for the two strategies, with standard care ringing up at 336 euros (U.S.$434), vs. 297 euros (U.S.$383) for the erythropoietin protocol (P = .05).

The European Hospital sponsored the study. Dr. Weltert reported no relevant disclosures.

pwendling@frontlinemedcom.com

MINNEAPOLIS – A single high dose of human recombinant erythropoietin given 2 days before heart surgery reduced blood transfusions by 65%, without substantially increasing mortality or morbidity in the prospective, randomized SHOT trial.

Patients who received 80,000 IU of erythropoietin (Eprex) in a single bolus plus iron supplementation until discharge needed 0.39 blood units/patient, compared with 1.12 units/patient for those receiving standard care involving thromboelastography and tranexamic acid (P less than .001; risk ratio, 0.338).

IMNG Medical Media/Martin Allred

All-cause mortality at 45 days postoperative was 3.0% with erythropoietin and 3.33%
without it (P = .26), Dr. Luca Weltert said at the annual meeting of the American Association for Thoracic Surgery.

The investigators undertook the SHOT (Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery) trial because their original erythropoietin protocol proved too compli- cated for everyday use. The protocol was incorporated
into the 2012 Society of
Thoracic Surgeons and Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines, but consisted of five different doses of erythropoietin in 5 days, totaling 52,000 IU, he explained.

Invited discussant Dr. Victor Ferraris, of the Lexington (Ky.) Veterans Affairs Medical Center, questioned whether the high dose of erythropoietin increased thromboembolic events, in light of the black box warnings added to erythropoiesis-stimulating agents due to an increased risk for thromboembolic events in patients with malignancy and an increased risk of serious cardiovascular events in patients with chronic kidney disease when the hemoglobin level exceeds 12 g/dL.

Thromboembolic events were not significantly different between groups, and the trial did not include cancer patients, said Dr. Weltert of the European Hospital in Rome.

Major nonfatal adverse events at 45 days were reported in 4.33% of erythropoietin and 5.67% of control patients (P = .13). Specifically, there were no differences in neurologic complications (4 vs. 5 events, respectively), long-term wound infection (4 in both groups), deep vein thrombosis (2 vs. 5), onset of acute hypertension (1 vs. 2), and new-onset renal failure (2 vs. 1).

Attendees continued this line of questioning, asking how reliable the negative finding is and whether the investigators could have missed a population with a positive result. The efficacy endpoint was based on a minimal sample size of 400 patients, and the trial enrolled 600 consecutive "all comers," Dr. Weltert said, but he added that 3,000 - 4,000 patients would be needed for the safety endpoint, "so the samples are ridiculously small to really state strongly that there is no harm for a subgroup."

The two study arms were well matched, with 35% of all patients undergoing coronary artery bypass grafting, 31% valve surgery, roughly 20% repair of the ascending aorta, and other in about 14%. The mean logistic EuroScore was 9.94 in the erythropoietin group and 10.12 in the control group, and the mean ages were 72.9 and 70.4 years, respectively.

Mean hemoglobin levels on day 4 postoperative was significantly higher in the erythropoietin group than in controls (10.21 vs. 9.01 g/dL; P = .02), Dr. Weltert said.

There were no significant differences between the erythropoietin and control groups in intensive care unit stay (2.71 vs. 2.60 days, respectively), perioperative myocardial infarction (7 vs. 7), cardiac tamponade (3 vs. 5), or need for reintubation (13 vs. 15).

An attendee asked whether hemoglobin levels drifted between days 3 and 4 postoperatively, as this can confound the decision to transfuse after cardiac surgery, and whether the investigators looked at another potential confounder, hemoglobin trigger, since no less than five randomized controlled trials have shown that a hemoglobin level of 7-8 g/dL should be used as a transfusion trigger.

Dr. Weltert said the team picked day 4 to check hemoglobin levels for practical reasons because that’s the day when you see the biggest drift and that the erythropoietin group fared better. He went on to say, "The trigger is extremely important, and I think it will be the very next step in bloodless surgery."

The investigators did compare costs for the two strategies, with standard care ringing up at 336 euros (U.S.$434), vs. 297 euros (U.S.$383) for the erythropoietin protocol (P = .05).

The European Hospital sponsored the study. Dr. Weltert reported no relevant disclosures.

pwendling@frontlinemedcom.com

MINNEAPOLIS – A single high dose of human recombinant erythropoietin given 2 days before heart surgery reduced blood transfusions by 65%, without substantially increasing mortality or morbidity in the prospective, randomized SHOT trial.

Patients who received 80,000 IU of erythropoietin (Eprex) in a single bolus plus iron supplementation until discharge needed 0.39 blood units/patient, compared with 1.12 units/patient for those receiving standard care involving thromboelastography and tranexamic acid (P less than .001; risk ratio, 0.338).

IMNG Medical Media/Martin Allred

All-cause mortality at 45 days postoperative was 3.0% with erythropoietin and 3.33%
without it (P = .26), Dr. Luca Weltert said at the annual meeting of the American Association for Thoracic Surgery.

The investigators undertook the SHOT (Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery) trial because their original erythropoietin protocol proved too compli- cated for everyday use. The protocol was incorporated
into the 2012 Society of
Thoracic Surgeons and Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines, but consisted of five different doses of erythropoietin in 5 days, totaling 52,000 IU, he explained.

Invited discussant Dr. Victor Ferraris, of the Lexington (Ky.) Veterans Affairs Medical Center, questioned whether the high dose of erythropoietin increased thromboembolic events, in light of the black box warnings added to erythropoiesis-stimulating agents due to an increased risk for thromboembolic events in patients with malignancy and an increased risk of serious cardiovascular events in patients with chronic kidney disease when the hemoglobin level exceeds 12 g/dL.

Thromboembolic events were not significantly different between groups, and the trial did not include cancer patients, said Dr. Weltert of the European Hospital in Rome.

Major nonfatal adverse events at 45 days were reported in 4.33% of erythropoietin and 5.67% of control patients (P = .13). Specifically, there were no differences in neurologic complications (4 vs. 5 events, respectively), long-term wound infection (4 in both groups), deep vein thrombosis (2 vs. 5), onset of acute hypertension (1 vs. 2), and new-onset renal failure (2 vs. 1).

Attendees continued this line of questioning, asking how reliable the negative finding is and whether the investigators could have missed a population with a positive result. The efficacy endpoint was based on a minimal sample size of 400 patients, and the trial enrolled 600 consecutive "all comers," Dr. Weltert said, but he added that 3,000 - 4,000 patients would be needed for the safety endpoint, "so the samples are ridiculously small to really state strongly that there is no harm for a subgroup."

The two study arms were well matched, with 35% of all patients undergoing coronary artery bypass grafting, 31% valve surgery, roughly 20% repair of the ascending aorta, and other in about 14%. The mean logistic EuroScore was 9.94 in the erythropoietin group and 10.12 in the control group, and the mean ages were 72.9 and 70.4 years, respectively.

Mean hemoglobin levels on day 4 postoperative was significantly higher in the erythropoietin group than in controls (10.21 vs. 9.01 g/dL; P = .02), Dr. Weltert said.

There were no significant differences between the erythropoietin and control groups in intensive care unit stay (2.71 vs. 2.60 days, respectively), perioperative myocardial infarction (7 vs. 7), cardiac tamponade (3 vs. 5), or need for reintubation (13 vs. 15).

An attendee asked whether hemoglobin levels drifted between days 3 and 4 postoperatively, as this can confound the decision to transfuse after cardiac surgery, and whether the investigators looked at another potential confounder, hemoglobin trigger, since no less than five randomized controlled trials have shown that a hemoglobin level of 7-8 g/dL should be used as a transfusion trigger.

Dr. Weltert said the team picked day 4 to check hemoglobin levels for practical reasons because that’s the day when you see the biggest drift and that the erythropoietin group fared better. He went on to say, "The trigger is extremely important, and I think it will be the very next step in bloodless surgery."

The investigators did compare costs for the two strategies, with standard care ringing up at 336 euros (U.S.$434), vs. 297 euros (U.S.$383) for the erythropoietin protocol (P = .05).

The European Hospital sponsored the study. Dr. Weltert reported no relevant disclosures.

pwendling@frontlinemedcom.com