Thoracic Surgery News (Archived)

MINNEAPOLIS – Sublobar resection and lobectomy resulted in equivalent lung cancer survival and overall recurrence rates in a screen-detected cohort of 348 stage IA non–small cell lung cancer patients.

In all, 7% of patients (4/54) who underwent sublobar resection and 10% of those (29/294) who underwent lobectomy died of lung cancer after a median follow-up of 73 months (P = .64). All-cause mortality was also statistically similar at 17% and 22%, said Dr. Nasser Altorki, professor of cardiothoracic surgery and director of thoracic surgery at New York Presbyterian–Weill Cornell Medical Center in New York.

Although lobectomy has been the standard of care for resection of early-stage non–small cell lung cancer (NSCLC) since 1994, several studies support sublobar resection in patients with small peripheral tumors and the elderly with compromised pulmonary reserve.

The best surgical treatment for younger patients with adequate cardiopulmonary function remains controversial, with two large, ongoing trials in the U.S. and Japan evaluating lobar vs. sublobar resection in this setting. A recent best evidence paper (Interact. CardioVasc. Thorac. Surg. 2012;14:816-20) concluded that lobectomy is still the best surgical option for these patients, citing evidence of lower survival and higher recurrence rates with wedge resections than with anatomic segmentectomies. The two sublobar techniques are often lumped together in comparisons with lobectomy, but are not technically or oncologically the same.

Wedge resection in the current study seemed to be associated with a higher rate of recurrence than segmentectomy, Dr. Altorki said at the annual meeting of the American Association for Thoracic Surgery.

Recurrence occurred in 32 patients after lobectomy and 8 after sublobar resection (11% vs. 15%; P = .40), with all of the sublobar resection recurrences occurring after wedge resection (8/38 or 21% vs. 0%).

"I don’t want to say this is a practice-changing study; however, it is a study that calls for more technical equipoise in our approach to the [surgical] treatment of lung cancer," he said during a discussion of the results. "Clearly, we can apply this operation to patients who would be candidates for both lobectomy and sublobar resection, but it does not extend to those patients, for example, that would have been poor candidates for any surgical resection."

The 348 patients had c1A non–small cell lung cancer that presented as a solid nodule on computed tomography screening and underwent surgery as part of the International Early Lung Cancer Action Program from 1993 to 2011. Comorbidities were similar among the lobectomy and sublobar patients including cardiac disease (6% vs. 11%), chronic obstructive pulmonary disease (15% vs. 26%), and diabetes (9% vs. 7%). Their median age was 63 vs. 65 years, and the median number of pack-years of smoking was 48 vs. 49, respectively.

The lobectomy group had significantly larger tumors (13 mm vs. 11 mm), more frequent sampling of mediastinal nodes (78% vs. 56%), and more resected lymph nodes (mean 8 vs. 5).

The overall rate of hospital mortality in the multicenter study was low at 0.9% (3/348) and "represents what is achievable in screening centers of excellence," Dr. Altorki said.

Ten-year survival was 88% with lobectomy and 90% with sublobar resection (log rank P = .64). There was no difference in patients with tumors less than 2 cm (88% vs. 89%), who represented the majority or 86% of the cohort.

Cox regression analysis, adjusted for the above potential confounders, showed that only age (hazard ratio, 2.9; P less than .0001) and severe emphysema (HR, 4.2; P = .005) significantly predicted survival, whereas sublobar resection did not (HR, 0.8; P = .60), he said.

Invited discussant Dr. Joseph S. Friedberg, chief of thoracic surgery at the University of Pennsylvania Health System-Presbyterian in Philadelphia, expressed surprise that despite undergoing surgery by highly qualified general thoracic surgeons, 70% of sublobar resections were performed as wedge and not segmentectomies, and that more than 40% of sublobar resection patients and nearly a quarter of lobectomy patients did not have one mediastinal node biopsied.

"One would expect, based on the Lung Cancer Study Group analysis and common sense, that some of these patients, especially sublobar resection patients, were understaged and/or undertreated and yet the results are as good as anything in the literature," he said. "How do you reconcile that?"

Dr. Altorki said assessment of the mediastinal field was disappointing and that further education is needed on the prognostic and therapeutic benefits of such assessment, but that the rate far exceeds what is in the published literature. He also speculated that most of the patients were treated by video-assisted thoracic surgery and that mediastinal node assessment may not be as straightforward with VATS as it is with open surgery.

Dr. Altorki said that, going in, many of the surgeons may have thought that a 1- to 1.2-cm tumor may be equally resected with wedge resection and anatomic segmentectomy, and that this "is a job we have to address in ongoing randomized trials."

Dr. Altorki reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

MINNEAPOLIS – Sublobar resection and lobectomy resulted in equivalent lung cancer survival and overall recurrence rates in a screen-detected cohort of 348 stage IA non–small cell lung cancer patients.

In all, 7% of patients (4/54) who underwent sublobar resection and 10% of those (29/294) who underwent lobectomy died of lung cancer after a median follow-up of 73 months (P = .64). All-cause mortality was also statistically similar at 17% and 22%, said Dr. Nasser Altorki, professor of cardiothoracic surgery and director of thoracic surgery at New York Presbyterian–Weill Cornell Medical Center in New York.

Although lobectomy has been the standard of care for resection of early-stage non–small cell lung cancer (NSCLC) since 1994, several studies support sublobar resection in patients with small peripheral tumors and the elderly with compromised pulmonary reserve.

The best surgical treatment for younger patients with adequate cardiopulmonary function remains controversial, with two large, ongoing trials in the U.S. and Japan evaluating lobar vs. sublobar resection in this setting. A recent best evidence paper (Interact. CardioVasc. Thorac. Surg. 2012;14:816-20) concluded that lobectomy is still the best surgical option for these patients, citing evidence of lower survival and higher recurrence rates with wedge resections than with anatomic segmentectomies. The two sublobar techniques are often lumped together in comparisons with lobectomy, but are not technically or oncologically the same.

Wedge resection in the current study seemed to be associated with a higher rate of recurrence than segmentectomy, Dr. Altorki said at the annual meeting of the American Association for Thoracic Surgery.

Recurrence occurred in 32 patients after lobectomy and 8 after sublobar resection (11% vs. 15%; P = .40), with all of the sublobar resection recurrences occurring after wedge resection (8/38 or 21% vs. 0%).

"I don’t want to say this is a practice-changing study; however, it is a study that calls for more technical equipoise in our approach to the [surgical] treatment of lung cancer," he said during a discussion of the results. "Clearly, we can apply this operation to patients who would be candidates for both lobectomy and sublobar resection, but it does not extend to those patients, for example, that would have been poor candidates for any surgical resection."

The 348 patients had c1A non–small cell lung cancer that presented as a solid nodule on computed tomography screening and underwent surgery as part of the International Early Lung Cancer Action Program from 1993 to 2011. Comorbidities were similar among the lobectomy and sublobar patients including cardiac disease (6% vs. 11%), chronic obstructive pulmonary disease (15% vs. 26%), and diabetes (9% vs. 7%). Their median age was 63 vs. 65 years, and the median number of pack-years of smoking was 48 vs. 49, respectively.

The lobectomy group had significantly larger tumors (13 mm vs. 11 mm), more frequent sampling of mediastinal nodes (78% vs. 56%), and more resected lymph nodes (mean 8 vs. 5).

The overall rate of hospital mortality in the multicenter study was low at 0.9% (3/348) and "represents what is achievable in screening centers of excellence," Dr. Altorki said.

Ten-year survival was 88% with lobectomy and 90% with sublobar resection (log rank P = .64). There was no difference in patients with tumors less than 2 cm (88% vs. 89%), who represented the majority or 86% of the cohort.

Cox regression analysis, adjusted for the above potential confounders, showed that only age (hazard ratio, 2.9; P less than .0001) and severe emphysema (HR, 4.2; P = .005) significantly predicted survival, whereas sublobar resection did not (HR, 0.8; P = .60), he said.

Invited discussant Dr. Joseph S. Friedberg, chief of thoracic surgery at the University of Pennsylvania Health System-Presbyterian in Philadelphia, expressed surprise that despite undergoing surgery by highly qualified general thoracic surgeons, 70% of sublobar resections were performed as wedge and not segmentectomies, and that more than 40% of sublobar resection patients and nearly a quarter of lobectomy patients did not have one mediastinal node biopsied.

"One would expect, based on the Lung Cancer Study Group analysis and common sense, that some of these patients, especially sublobar resection patients, were understaged and/or undertreated and yet the results are as good as anything in the literature," he said. "How do you reconcile that?"

Dr. Altorki said assessment of the mediastinal field was disappointing and that further education is needed on the prognostic and therapeutic benefits of such assessment, but that the rate far exceeds what is in the published literature. He also speculated that most of the patients were treated by video-assisted thoracic surgery and that mediastinal node assessment may not be as straightforward with VATS as it is with open surgery.

Dr. Altorki said that, going in, many of the surgeons may have thought that a 1- to 1.2-cm tumor may be equally resected with wedge resection and anatomic segmentectomy, and that this "is a job we have to address in ongoing randomized trials."

Dr. Altorki reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

MINNEAPOLIS – Sublobar resection and lobectomy resulted in equivalent lung cancer survival and overall recurrence rates in a screen-detected cohort of 348 stage IA non–small cell lung cancer patients.

In all, 7% of patients (4/54) who underwent sublobar resection and 10% of those (29/294) who underwent lobectomy died of lung cancer after a median follow-up of 73 months (P = .64). All-cause mortality was also statistically similar at 17% and 22%, said Dr. Nasser Altorki, professor of cardiothoracic surgery and director of thoracic surgery at New York Presbyterian–Weill Cornell Medical Center in New York.

Although lobectomy has been the standard of care for resection of early-stage non–small cell lung cancer (NSCLC) since 1994, several studies support sublobar resection in patients with small peripheral tumors and the elderly with compromised pulmonary reserve.

The best surgical treatment for younger patients with adequate cardiopulmonary function remains controversial, with two large, ongoing trials in the U.S. and Japan evaluating lobar vs. sublobar resection in this setting. A recent best evidence paper (Interact. CardioVasc. Thorac. Surg. 2012;14:816-20) concluded that lobectomy is still the best surgical option for these patients, citing evidence of lower survival and higher recurrence rates with wedge resections than with anatomic segmentectomies. The two sublobar techniques are often lumped together in comparisons with lobectomy, but are not technically or oncologically the same.

Wedge resection in the current study seemed to be associated with a higher rate of recurrence than segmentectomy, Dr. Altorki said at the annual meeting of the American Association for Thoracic Surgery.

Recurrence occurred in 32 patients after lobectomy and 8 after sublobar resection (11% vs. 15%; P = .40), with all of the sublobar resection recurrences occurring after wedge resection (8/38 or 21% vs. 0%).

"I don’t want to say this is a practice-changing study; however, it is a study that calls for more technical equipoise in our approach to the [surgical] treatment of lung cancer," he said during a discussion of the results. "Clearly, we can apply this operation to patients who would be candidates for both lobectomy and sublobar resection, but it does not extend to those patients, for example, that would have been poor candidates for any surgical resection."

The 348 patients had c1A non–small cell lung cancer that presented as a solid nodule on computed tomography screening and underwent surgery as part of the International Early Lung Cancer Action Program from 1993 to 2011. Comorbidities were similar among the lobectomy and sublobar patients including cardiac disease (6% vs. 11%), chronic obstructive pulmonary disease (15% vs. 26%), and diabetes (9% vs. 7%). Their median age was 63 vs. 65 years, and the median number of pack-years of smoking was 48 vs. 49, respectively.

The lobectomy group had significantly larger tumors (13 mm vs. 11 mm), more frequent sampling of mediastinal nodes (78% vs. 56%), and more resected lymph nodes (mean 8 vs. 5).

The overall rate of hospital mortality in the multicenter study was low at 0.9% (3/348) and "represents what is achievable in screening centers of excellence," Dr. Altorki said.

Ten-year survival was 88% with lobectomy and 90% with sublobar resection (log rank P = .64). There was no difference in patients with tumors less than 2 cm (88% vs. 89%), who represented the majority or 86% of the cohort.

Cox regression analysis, adjusted for the above potential confounders, showed that only age (hazard ratio, 2.9; P less than .0001) and severe emphysema (HR, 4.2; P = .005) significantly predicted survival, whereas sublobar resection did not (HR, 0.8; P = .60), he said.

Invited discussant Dr. Joseph S. Friedberg, chief of thoracic surgery at the University of Pennsylvania Health System-Presbyterian in Philadelphia, expressed surprise that despite undergoing surgery by highly qualified general thoracic surgeons, 70% of sublobar resections were performed as wedge and not segmentectomies, and that more than 40% of sublobar resection patients and nearly a quarter of lobectomy patients did not have one mediastinal node biopsied.

"One would expect, based on the Lung Cancer Study Group analysis and common sense, that some of these patients, especially sublobar resection patients, were understaged and/or undertreated and yet the results are as good as anything in the literature," he said. "How do you reconcile that?"

Dr. Altorki said assessment of the mediastinal field was disappointing and that further education is needed on the prognostic and therapeutic benefits of such assessment, but that the rate far exceeds what is in the published literature. He also speculated that most of the patients were treated by video-assisted thoracic surgery and that mediastinal node assessment may not be as straightforward with VATS as it is with open surgery.

Dr. Altorki said that, going in, many of the surgeons may have thought that a 1- to 1.2-cm tumor may be equally resected with wedge resection and anatomic segmentectomy, and that this "is a job we have to address in ongoing randomized trials."

Dr. Altorki reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

INDIANAPOLIS - Transthoracic esophagectomy for esophageal cancer provides significantly lower in-hospital mortality and major morbidity rates than does transhiatal esophagectomy, according to an analysis of a large multiyear national database.

Further, in-hospital outcomes of esophagectomy didn?t differ significantly between high-volume centers ? in this study, defined as those doing 10 or more cases per year ? and low-volume centers, Dr. Mehraneh D. Jafari reported at the annual meeting of the American Surgical Association.

That finding was met with skepticism, and discussants were quick to argue that study limitations make it difficult to draw any meaningful conclusions from the data. For one thing, speakers contended that defining a high-volume center based upon an institutional threshold of 10 or more cases per year sets the bar far too low given that a single dedicated esophageal surgery specialist might easily perform 50 or more esophagectomies annually.

Dr. Jafari presented an analysis of 11,473 transthoracic and 3,717 transhiatal esophagectomies performed for esophageal cancer. The data came from the Nationwide Inpatient Sample (NIS) during 2001-2010. The NIS records data on in-hospital outcomes for a nationally representative sample composed of roughly 20% of the country?s hospital discharges each year.

The number of esophagectomies rose steadily by an average of 4% annually during the study years, reflecting the substantial national increase in cases of esophageal cancer. The growing case count, expected to reach an estimated 18,000 cases of esophageal cancer nationwide in 2013, has been attributed to rising rates of gastroesophageal reflux disease, Barrett?s esophagus, and obesity. Transthoracic esophagectomy, used in 76% of cases, remained the preferred operative strategy throughout the study years.

In-hospital outcomes were markedly better in patients who had transthoracic esophagectomy. After adjustment for potential confounding variables in a multivariate analysis, transhiatal esophagectomy recipients had a 67% increased risk of in-hospital mortality and a 39% greater risk of serious complications, including a 37% increased risk of pulmonary complications. However, anastomotic leak rates were similar with both operations, according to Dr. Jafari of the University of California, Irvine.

The referral rate to high-volume esophagectomy centers climbed steadily over time, rising from 22% of all cases in 2001 to 58% in 2010.

The 35 high-volume centers performed an average of 16 cases per year. In contrast, the 484 low-volume centers averaged 2 cases per year. In-hospital mortality among the 9,386 patients treated in low-volume centers averaged 7.6% compared with 4.3% for patients in high-volume centers. Overall in-hospital serious morbidity rates were greater in the low-volume centers as well: 47% versus 41%. While these raw differences were statistically significant, a risk-adjusted multivariate analysis found no significant outcome differences between low- and high-volume centers.

Discussant Dr. Michael J. Zinner noted that in an earlier study he and his coworkers showed that an institutional threshold of roughly 30 esophagectomies per year is required to discriminate between low- and high-volume centers in terms of in-hospital mortality. So why define high-volume centers as those doing a mere 10 cases per year? asked Dr. Zinner, chairman of the department of surgery at Brigham and Women?s Hospital and professor of surgery at Harvard Medical School, Boston.

"The problem here is if you establish 30 cases per year as the threshold for a high-volume center, I can tell you there are probably less than 20 centers in the whole U.S. capable of doing that volume. That?s a real issue, because then how are patients who live in a remote region going to get care at one of those centers?" replied Dr. Jafari?s senior coauthor Dr. Ninh T. Nguyen, professor and vice-chair of surgery at UC Irvine.

"I think instead we should try to lift all boats: Develop a national esophageal center network to identify the qualities reflective of better outcomes in the high-volume centers and introduce those factors at low-volume centers. This way we?re not impeding access to care for our patients," he continued.

Dr. Nguyen said that in-hospital surgical morbidity rates in the NIS need to be taken with a grain of salt, as the accuracy of coding for complications is "rather low." The development of minimally invasive techniques for intrathoracic anastomosis has transformed transthoracic esophagectomy into a procedure with an improved complication profile.

"I switched to transthoracic esophagectomy 5 years ago. One reason was development of the minimally invasive approach. As a result, we?re not scared of a chest anastomosis like we used to be. When patients undergoing transthoracic esophagectomy with thoracotomy had a leak in the chest they had a very high risk for mortality. That?s not the case anymore. We have not observed any mortality associated with a leak in the chest for many, many years now," he said.

The investigators reported having no conflicts of interest.

bjancin@frontlinemedcom.com

INDIANAPOLIS - Transthoracic esophagectomy for esophageal cancer provides significantly lower in-hospital mortality and major morbidity rates than does transhiatal esophagectomy, according to an analysis of a large multiyear national database.

Further, in-hospital outcomes of esophagectomy didn?t differ significantly between high-volume centers ? in this study, defined as those doing 10 or more cases per year ? and low-volume centers, Dr. Mehraneh D. Jafari reported at the annual meeting of the American Surgical Association.

That finding was met with skepticism, and discussants were quick to argue that study limitations make it difficult to draw any meaningful conclusions from the data. For one thing, speakers contended that defining a high-volume center based upon an institutional threshold of 10 or more cases per year sets the bar far too low given that a single dedicated esophageal surgery specialist might easily perform 50 or more esophagectomies annually.

Dr. Jafari presented an analysis of 11,473 transthoracic and 3,717 transhiatal esophagectomies performed for esophageal cancer. The data came from the Nationwide Inpatient Sample (NIS) during 2001-2010. The NIS records data on in-hospital outcomes for a nationally representative sample composed of roughly 20% of the country?s hospital discharges each year.

The number of esophagectomies rose steadily by an average of 4% annually during the study years, reflecting the substantial national increase in cases of esophageal cancer. The growing case count, expected to reach an estimated 18,000 cases of esophageal cancer nationwide in 2013, has been attributed to rising rates of gastroesophageal reflux disease, Barrett?s esophagus, and obesity. Transthoracic esophagectomy, used in 76% of cases, remained the preferred operative strategy throughout the study years.

In-hospital outcomes were markedly better in patients who had transthoracic esophagectomy. After adjustment for potential confounding variables in a multivariate analysis, transhiatal esophagectomy recipients had a 67% increased risk of in-hospital mortality and a 39% greater risk of serious complications, including a 37% increased risk of pulmonary complications. However, anastomotic leak rates were similar with both operations, according to Dr. Jafari of the University of California, Irvine.

The referral rate to high-volume esophagectomy centers climbed steadily over time, rising from 22% of all cases in 2001 to 58% in 2010.

The 35 high-volume centers performed an average of 16 cases per year. In contrast, the 484 low-volume centers averaged 2 cases per year. In-hospital mortality among the 9,386 patients treated in low-volume centers averaged 7.6% compared with 4.3% for patients in high-volume centers. Overall in-hospital serious morbidity rates were greater in the low-volume centers as well: 47% versus 41%. While these raw differences were statistically significant, a risk-adjusted multivariate analysis found no significant outcome differences between low- and high-volume centers.

Discussant Dr. Michael J. Zinner noted that in an earlier study he and his coworkers showed that an institutional threshold of roughly 30 esophagectomies per year is required to discriminate between low- and high-volume centers in terms of in-hospital mortality. So why define high-volume centers as those doing a mere 10 cases per year? asked Dr. Zinner, chairman of the department of surgery at Brigham and Women?s Hospital and professor of surgery at Harvard Medical School, Boston.

"The problem here is if you establish 30 cases per year as the threshold for a high-volume center, I can tell you there are probably less than 20 centers in the whole U.S. capable of doing that volume. That?s a real issue, because then how are patients who live in a remote region going to get care at one of those centers?" replied Dr. Jafari?s senior coauthor Dr. Ninh T. Nguyen, professor and vice-chair of surgery at UC Irvine.

"I think instead we should try to lift all boats: Develop a national esophageal center network to identify the qualities reflective of better outcomes in the high-volume centers and introduce those factors at low-volume centers. This way we?re not impeding access to care for our patients," he continued.

Dr. Nguyen said that in-hospital surgical morbidity rates in the NIS need to be taken with a grain of salt, as the accuracy of coding for complications is "rather low." The development of minimally invasive techniques for intrathoracic anastomosis has transformed transthoracic esophagectomy into a procedure with an improved complication profile.

"I switched to transthoracic esophagectomy 5 years ago. One reason was development of the minimally invasive approach. As a result, we?re not scared of a chest anastomosis like we used to be. When patients undergoing transthoracic esophagectomy with thoracotomy had a leak in the chest they had a very high risk for mortality. That?s not the case anymore. We have not observed any mortality associated with a leak in the chest for many, many years now," he said.

The investigators reported having no conflicts of interest.

bjancin@frontlinemedcom.com

INDIANAPOLIS - Transthoracic esophagectomy for esophageal cancer provides significantly lower in-hospital mortality and major morbidity rates than does transhiatal esophagectomy, according to an analysis of a large multiyear national database.

Further, in-hospital outcomes of esophagectomy didn?t differ significantly between high-volume centers ? in this study, defined as those doing 10 or more cases per year ? and low-volume centers, Dr. Mehraneh D. Jafari reported at the annual meeting of the American Surgical Association.

That finding was met with skepticism, and discussants were quick to argue that study limitations make it difficult to draw any meaningful conclusions from the data. For one thing, speakers contended that defining a high-volume center based upon an institutional threshold of 10 or more cases per year sets the bar far too low given that a single dedicated esophageal surgery specialist might easily perform 50 or more esophagectomies annually.

Dr. Jafari presented an analysis of 11,473 transthoracic and 3,717 transhiatal esophagectomies performed for esophageal cancer. The data came from the Nationwide Inpatient Sample (NIS) during 2001-2010. The NIS records data on in-hospital outcomes for a nationally representative sample composed of roughly 20% of the country?s hospital discharges each year.

The number of esophagectomies rose steadily by an average of 4% annually during the study years, reflecting the substantial national increase in cases of esophageal cancer. The growing case count, expected to reach an estimated 18,000 cases of esophageal cancer nationwide in 2013, has been attributed to rising rates of gastroesophageal reflux disease, Barrett?s esophagus, and obesity. Transthoracic esophagectomy, used in 76% of cases, remained the preferred operative strategy throughout the study years.

In-hospital outcomes were markedly better in patients who had transthoracic esophagectomy. After adjustment for potential confounding variables in a multivariate analysis, transhiatal esophagectomy recipients had a 67% increased risk of in-hospital mortality and a 39% greater risk of serious complications, including a 37% increased risk of pulmonary complications. However, anastomotic leak rates were similar with both operations, according to Dr. Jafari of the University of California, Irvine.

The referral rate to high-volume esophagectomy centers climbed steadily over time, rising from 22% of all cases in 2001 to 58% in 2010.

The 35 high-volume centers performed an average of 16 cases per year. In contrast, the 484 low-volume centers averaged 2 cases per year. In-hospital mortality among the 9,386 patients treated in low-volume centers averaged 7.6% compared with 4.3% for patients in high-volume centers. Overall in-hospital serious morbidity rates were greater in the low-volume centers as well: 47% versus 41%. While these raw differences were statistically significant, a risk-adjusted multivariate analysis found no significant outcome differences between low- and high-volume centers.

Discussant Dr. Michael J. Zinner noted that in an earlier study he and his coworkers showed that an institutional threshold of roughly 30 esophagectomies per year is required to discriminate between low- and high-volume centers in terms of in-hospital mortality. So why define high-volume centers as those doing a mere 10 cases per year? asked Dr. Zinner, chairman of the department of surgery at Brigham and Women?s Hospital and professor of surgery at Harvard Medical School, Boston.

"The problem here is if you establish 30 cases per year as the threshold for a high-volume center, I can tell you there are probably less than 20 centers in the whole U.S. capable of doing that volume. That?s a real issue, because then how are patients who live in a remote region going to get care at one of those centers?" replied Dr. Jafari?s senior coauthor Dr. Ninh T. Nguyen, professor and vice-chair of surgery at UC Irvine.

"I think instead we should try to lift all boats: Develop a national esophageal center network to identify the qualities reflective of better outcomes in the high-volume centers and introduce those factors at low-volume centers. This way we?re not impeding access to care for our patients," he continued.

Dr. Nguyen said that in-hospital surgical morbidity rates in the NIS need to be taken with a grain of salt, as the accuracy of coding for complications is "rather low." The development of minimally invasive techniques for intrathoracic anastomosis has transformed transthoracic esophagectomy into a procedure with an improved complication profile.

"I switched to transthoracic esophagectomy 5 years ago. One reason was development of the minimally invasive approach. As a result, we?re not scared of a chest anastomosis like we used to be. When patients undergoing transthoracic esophagectomy with thoracotomy had a leak in the chest they had a very high risk for mortality. That?s not the case anymore. We have not observed any mortality associated with a leak in the chest for many, many years now," he said.

The investigators reported having no conflicts of interest.

bjancin@frontlinemedcom.com

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

Kcentra (Prothrombin Complex Concentrate, Human), manufactured by CSL Behring of King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding.Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA [vitamin K antagonist] anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S- e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

Kcentra (Prothrombin Complex Concentrate, Human), manufactured by CSL Behring of King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding.Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA [vitamin K antagonist] anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S- e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

The Food and Drug Administration has approved a new agent for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding.

Kcentra (Prothrombin Complex Concentrate, Human), manufactured by CSL Behring of King of Prussia, Pa., is a nonactivated 4-factor prothrombin complex concentrate (PCC). It contains the coagulation factors that are low in warfarin-treated patients: factors II (prothrombin), VII, IX, and X. The product also contains antithrombotic proteins C and S. Fresh frozen plasma is the only FDA-approved product for reversing warfarin-induced acute bleeding.Like plasma, Kcentra is used with administration of vitamin K to reverse the anticoagulation effect and stop bleeding. Unlike plasma, Kcentra can be given quickly because it does not require thawing or determination of blood type.

"The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA [vitamin K antagonist] anticoagulation," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation."

The American College of Chest Physicians endorsed use of PCC for rapid reversal of VKA-associated bleeding in its 2012 consensus guidelines on anticoagulant therapy (CHEST 2012;141(Suppl):e152S- e184S).

"Kcentra has been shown to restore the decreased vitamin K–dependent clotting factors significantly faster than plasma in patients on warfarin," Dr. Ravi Sarode, the coordinating investigator for the pivotal Kcentra trial and director of transfusion medicine and hemostasis reference laboratory at the University of Texas Southwestern Medical Center, said in a statement issued by CSL Behring.

According to the company, 3-4 million people in the United States each year receive warfarin to prevent clots after a stroke, heart attack, heart valve surgery, or deep vein thrombosis/pulmonary embolism, or for atrial fibrillation. Severe bleeding is possible, however, because of the warfarin-induced clotting factor deficiency. CSL Behring said that some 29,000 emergency department visits annually are for warfarin-associated bleeding.

The FDA said that Kcentra will carry a boxed warning on the risk of blood clots. Patients should be monitored for signs and symptoms of thromboembolic events. "Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance," said the FDA. The warning further states that Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months, and as such might not be suitable in patients who had any of those events in the 3 months before starting therapy.

Kcentra, made from pooled plasma of healthy donors, is processed to minimize risk of transmitting viral and other diseases, the agency said. It is marketed as Beriplex or Confidex in 25 countries.

Dr. Sarode received compensation as coordinating principal investigator of the study.

aault@frontlinemedcom.com

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule, which was released April 26.

The Medicare proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures.

Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget.

At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement.

"This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, which was also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program.

The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first of the two domains are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate.

CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain being used to get a total score under the new program includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well.

Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," he added.

"Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff," according to Mr. Johnson

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

mschneider@frontlinemedcom.com

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule, which was released April 26.

The Medicare proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures.

Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget.

At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement.

"This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, which was also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program.

The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first of the two domains are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate.

CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain being used to get a total score under the new program includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well.

Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," he added.

"Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff," according to Mr. Johnson

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

mschneider@frontlinemedcom.com

The penalties are going up in Medicare’s hospital readmission reduction program.

Starting on Oct. 1, hospitals could face up to a 2% cut in Medicare payments if their 30-day readmission rates for acute myocardial infarction, heart failure, and pneumonia are too high. The program started on Oct. 1, 2012, with a 1% cap on penalties.

The penalty increase was outlined in Medicare’s proposed fiscal year 2014 inpatient prospective payment system rule, which was released April 26.

The Medicare proposal also outlines the government’s plans to expand the readmission reduction program to include two new readmission measures.

Starting on Oct. 1, 2014, the program would also include readmissions associated with an acute exacerbation of chronic obstructive pulmonary disease, as well as readmissions for elective total hip or knee arthroplasty.

The inclusion of COPD for fiscal year 2015 was expected since that condition was specifically highlighted by Congress in the Affordable Care Act (ACA), which created the readmission reduction program. However, lawmakers had also recommended adding coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and other vascular conditions, which are not included in the Centers for Medicare and Medicaid Services (CMS) proposal.

The reasons for the switch were largely due to cost and volume, according to the proposal rule.

In 2005, annual hospital charges totaled $3.95 billion for primary total hip arthroplasty and $7.42 billion for total knee arthroplasty. When combined, the two procedures represent the largest procedures cost in the Medicare budget.

At the same time, inpatient admissions for PCI and other vascular conditions have been declining, according to Medicare officials, as more of those services are being shifted to hospital outpatient departments.

The fiscal 2014 payment proposal also includes a revised methodology for calculating hospital readmission rates in an effort to do a better job of accounting for certain planned readmissions.

The change is a mixed bag for hospitals, according to the Premier healthcare alliance. While the revised methodology will likely result in a more accurate payment calculation, it fails to take into consideration socioeconomic and community factors.

"Hospitals that serve high percentages of lower-income patients will be disproportionately penalized for circumstances outside their control," Blair Childs, senior vice president of public affairs at Premier, said in a statement.

"This places additional financial burdens on already stressed local health care systems in these communities."

The Medicare program is also moving forward with the Hospital-Acquired Condition Reduction Program, which was also created by the ACA.

The new program, which begins on Oct. 1, 2014, levies a 1% penalty on hospitals that rank in the lowest-performing quartile for eight hospital-acquired conditions. The proposed rule includes the quality measures, scoring methodology, and correction process that are planned for the program.

During the first year, officials plan to use quality measures that are calculated using claims data or are part of the Inpatient Quality Reporting program.

The eight measures are divided into two domains. Hospitals will receive a score for each measure, which will then be used to calculate a domain score. The two domains will be weighted equally to get a total score under the program, according to CMS.

The measures in the first of the two domains are pressure ulcer rate; volume of foreign object left in the body; iatrogenic pneumothorax rate; postoperative physiologic and metabolic derangement rate; postoperative pulmonary embolism or deep vein thrombosis rate; and accidental puncture and laceration rate.

CMS is also considering the use of a composite patient safety indicator measure set as an alternative to the first domain.

The second domain being used to get a total score under the new program includes two health care–associated infection measures: central line–associated bloodstream infection and catheter-associated urinary tract infection.

CMS plans to account for risk factors such as age, gender, and comorbidities when calculating the measure rates.

There are no surprises in the conditions chosen for the new program, said Erik Johnson, senior vice president at Avalere Health. However, the fact that CMS officials chose to include eight measures at the start of the program indicates how serious they are about hospital-acquired conditions, he said.

Mr. Johnson predicted that hospitals will take these quality programs seriously as well.

Through the combination of the hospital-acquired condition program, the readmission reduction program, value-based purchasing, and a few other programs, hospitals now have at least 7% of their Medicare payments at risk based on performance on quality measures, he said.

"It’s already starting to move behaviors," he added.

"Hospitals are by and large making a good-faith effort to get better at all of those things. But there are going to be winners and losers, and the losers may end up losing big on a lot of this stuff," according to Mr. Johnson

CMS will accept public comments on the proposal until June 25 at www.regulations.gov. The agency is scheduled to release its final rule by Aug. 1.

mschneider@frontlinemedcom.com

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the AATS Mitral Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the AATS Mitral Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.

NEW YORK – After following more than 400 patients who underwent mitral valve replacement for almost 25 years, French investigators have found that the Carpentier-Edwards Perimount Pericardial prosthetic has an expected durability of more than 16 years, with a low incidence of valve-related complications. The findings were presented by Dr. Thierry Bourguignon as one of the Plenary "Top 10" abstracts at the AATS Mitral Conclave.

"This is a great study. This very-long-term data has been missing for the Carpentier-Edwards Perimount bioprosthetic," said session moderator Dr. David H. Adams of Mount Sinai Medical Center in New York.

In this prospective study, investigators followed 404 patients who underwent mitral valve replacement between August 1984 and March 2011; 46 of these patients eventually needed a second bioprosthesis. Patients were asked to complete yearly clinical questionnaires and undergo an echocardiographic study. Their mean age was 68 years, but the range was 22-89 years. Almost one-fifth of the group was aged 60 years or younger. The mean follow-up time was 7.2 years, although it ranged from 0 to 24.8 years. Ten patients were lost during follow-up, yielding almost a 98% completion rate. Fifty-seven percent were New York Heart Association (NYHA) class III or IV.

The operative mortality rate was 3.3%. A total of 188 patients had late death (5.8%/valve-year). Forty of the deaths were valve related, including 5 due to thromboembolism, 4 to hemorrhage, 4 to endocarditis, 4 to structural valve dysfunction (SVD), and 23 to sudden death. Valve-related survival was more than 60% at 20 years post surgery. Risk factors affecting late survival were age at implant (hazard ratio, 1.06; P less than .001) and preoperative NYHA class III or IV (HR, 1.86; P less than .001).

"Valve-related events, including endocarditis, thromboembolism, and bleeding, were rare," said Dr. Bourguignon, a cardiovascular surgeon at Trousseau Hospital in Chambray Les Tours, France. There were no cases of valve thrombosis.

Seventy-six patients had an SVD, which was defined by echocardiography as severe mitral regurgitation and/or having a mean gradient of more than 8 mm Hg, even if patients were asymptomatic. Of these, 63 were reoperated and 13 died before reoperation. Three-quarters of the valves failed due to calcification, while 20% had late leaflet tears and 4% had mixed problems.

For the entire group, it took an average of 16.6 years before an SVD occurred, although freedom from SVD differed according to age at surgery. Older patients fared better. After 16.6 years, 75% of those over age 70 were expected to be free from SVD, while the rates were lower for those between 60 and 70 years (52%) and those under age 60 (40%). Older patients were also less likely to need the valve removed due to SVD.

What should a surgeon tell a patient about the risk of needing another operation to replace a failing mitral valve bioprosthetic? Using competing risk analysis, the authors predict that, for example, a 60-year-old patient at time of surgery will have a 20% chance of requiring reoperation due to an SVD after 11.9 years.

"In our experience, the CE Perimount valve is a reliable choice for patients older than 60, depending on the accepted risk of reoperation," said Dr. Bourguignon. Addressing a question from the audience, Dr. Bourguignon suggested that although the 25-year data were not available as yet for aortic valve replacements, preliminary findings indicate aortic valve replacement with bioprosthetics lasts longer than mitral valve replacement. At his hospital, patients under age 60 generally receive mechanical valves.

The conclave was sponsored by the American Association for Thoracic Surgery.

Dr. Bourguignon has a financial relationship with Edwards Lifesciences.

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

mschneider@frontlinemedcom.com

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

mschneider@frontlinemedcom.com

President Obama is proposing to cut more than $370 billion from the Medicare program over the next decade, a move aimed at reducing the federal deficit and putting the program on firmer financial footing.

The president’s fiscal year 2014 budget proposal, sent to Congress April 10, includes cuts for physicians, drug companies, hospitals, and long-term facilities, as well as increased cost-sharing for some Medicare beneficiaries.

The part of the budget with the potential to have the biggest impact on doctors is the increased authority for the Independent Payment Advisory Board (IPAB). The 15-member board was created under the Affordable Care Act (ACA) and is charged with recommending to Congress how to reduce spending growth in Medicare. Under current law, IPAB would make recommendations only if the projected Medicare per capita growth rate exceeded the gross domestic product (GDP) plus 1%. In the president’s budget proposal, that target would be triggered early, when Medicare spending was projected to exceed GDP plus 0.5%.

This change is projected to save the federal government $4.1 billion over the next decade.

The bulk of the Medicare savings will come from proposals to cut payments to drug companies, long-term care facilities, and increases in cost sharing by beneficiaries.

For instance, the administration estimates it will save about $123 billion over 10 years by allowing the Medicare Part D program to pay the lower Medicaid rate for prescription drugs for its low-income beneficiaries.

A change involving post–acute care providers would save $79 billion. The administration wants to reduce the market basket updates for inpatient rehabilitation facilities, long-term care hospitals, skilled nursing facilities, and home health agencies by 1.1% starting in 2014 and running through 2023.

Beneficiaries also would contribute more for their Medicare premiums under the Obama budget proposal. Starting in 2017, certain Medicare beneficiaries will pay more for their Part B and D premiums, which is expected to generate $50 billion in savings over 10 years.

The budget also includes about $22.1 billion in cuts to Medicaid over 10 years.

The budget also includes a little good news for physicians: It assumes that the Congress will eliminate the Sustainable Growth Rate (SGR) formula used in setting Medicare physician payments.

The American Medical Association praised the administration for its commitment to move toward new ways to pay for health care.

"The President’s proposals align with many of the principles developed by the AMA and 110 other physician organizations on transitioning Medicare to include an array of accountable payment models," Dr. Jeremy A. Lazarus, AMA president, said in a statement. "It is critical for physicians to have a period of stability and the flexibility to choose options that will help them lower costs and improve the quality of care for their patients. We are encouraged that the president and members of Congress are focused this year on eliminating this failed formula and strengthening Medicare for patients now and in the future."

The cost-cutting proposals aren’t new; President Obama included some of them in last year’s budget proposal. He also called for cuts to Medicare when negotiating for a deficit reduction deal with House Speaker John Boehner (R-Ohio) late last year.

President Obama said his proposed budget would lower the federal deficit in a "balanced way," allowing more targeted cuts to replace the across-the-board budget cuts set out in the sequester, which took effect in March. Overall, the Obama administration estimates that the new budget would achieve $1.8 trillion in deficit reduction over the next 10 years.

But the budget is already getting a cool reception from Republicans on Capitol Hill. House Budget Committee Chairman Paul Ryan (R-Wisc.) said that after eliminating the sequester, there is only about $119 billion in deficit reduction over the next decade in the president’s proposed budget.

"I’m disappointed by the president’s proposal because it merely ratifies the status quo," Rep. Ryan said in a statement. "It doesn’t break new ground; it goes over old ground."

Both the House and the Senate have already passed their own budget proposals for fiscal year 2014.

In addition to the Medicare and Medicaid cuts, the President’s budget offers some targeted increases.

For instance, the Centers for Medicare and Medicaid Services is seeking about $1.5 billion in new funding to help support operations and outreach related to the ACA’s health insurance exchanges. The funds would support the federally operated exchanges and offer assistance to states that are running their own exchanges. The exchanges will open for enrollment on Oct. 1, 2013, the first day of fiscal year 2014. Coverage under the exchanges is set to begin on Jan. 1, 2014.

Health and Human Services Secretary Kathleen Sebelius said she is hopeful that Congress will come through with the money to help launch the new program. "We intend to implement the law," she said during a press conference April 10.

The budget also includes funding for mental health. The proposal invests $130 million to add 5,000 mental health professionals to the behavioral health workforce. The money will also fund Project AWARE (Advancing Wellness and Resilience in Education), which trains teachers to detect and respond to mental illness in their students.

The Centers for Disease Control and Prevention would get an additional $30 million to track gun violence and research ways to prevent it under the budget proposal sent to Congress.

The American Psychiatric Association supported the administration’s effort to identify at-risk individuals early through Project AWARE. But the APA said in a statement that it was concerned that the effort to expand the supply of mental health professionals seems to stop at nonphysician providers.

"We recognize the growing need for mental health providers; however, providing a small amount of training to lesser-qualified health professionals at the expense of utilizing veteran medical psychiatrists will only serve to exacerbate the problem we are trying to solve," the APA wrote. "As a nation, we should ensure that patients have access to the full range of services, from physician care to hospital care to outpatient clinics and long-term follow-up."

The National Institutes of Health would receive a $471 million funding increase over its fiscal year 2012 funding, bringing its total budget to $31.1 billion. That includes about $40 billion toward an effort to map the human brain. The agency will also invest $80 million to speed up drug development and the testing of new therapies for Alzheimer’s disease.

mschneider@frontlinemedcom.com

SAN FRANCISCO - Off-pump coronary artery bypass graft surgery offered no advantages over on-pump CABG in any major end points at 1 year of follow-up in two major prospective randomized trials totaling more than 7,000 patients.

Among the key 1-year outcomes - which didn't differ between off- and on-pump CABG patients in the GOPCABE and CORONARY trials - were death, MI, stroke, neurocognitive function, quality of life, renal failure, and repeat revascularization, investigators reported at the annual meeting of the American College of Cardiology.

A third randomized trial presented at the same session of the ACC meeting did find a significant outcome advantage favoring off-pump CABG in high-operative-risk patients at 1 year. However, experts discounted this Czech study because it was small, single center, reported only 30-day results, and the advantage found for off-pump surgery hinged on an outdated and inadequate definition of MI.

The new study findings signal a striking fall from grace for off-pump CABG. Not long ago, this technique, while controversial, was viewed by many as a progressive development within heart surgery, one that would revitalize a mature operation whose annual case numbers were declining in the face of stiff competition from percutaneous coronary intervention by cardiologists. Off-pump CABG was an innovation designed to avoid the perioperative complications related to aortic cross-clamping and the heart-lung machine, including the lingering neurocognitive dysfunction known informally in surgical circles as "pump head."

However, the resounding lack of any demonstrable advantages for off-pump CABG in the two large trials presented in San Francisco left analysts scratching their heads as to the role remaining for this beating heart surgical technique, which is more difficult to learn and perform skillfully than on-pump bypass.

Discussant Dr. Michael J. Mack, a cardiac surgeon, voiced a similar sentiment. "I was an early advocate of off-pump surgery. But as a card-carrying off-pump bypass surgeon, it's getting harder and harder for me to maintain enthusiasm for a potential benefit from this," declared Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex. He noted that the CORONARY and GOPCABE trials follow upon the earlier ROOBY (Randomized On/Off Bypass) trial, which actually showed worse outcomes in the off-pump group. ROOBY enrolled 2,203 Veterans Affairs patients, with the off-pump CABG group having a significantly higher 1-year rate of the primary composite endpoint comprising death, nonfatal MI, or repeat revascularization, along with worse graft patency (N. Engl. J. Med. 2009;361:1827-37).

GOPCABE and CORONARY were designed in part to answer critics of ROOBY, who have argued that the VA trial used insufficiently experienced off-pump CABG surgeons and featured a patient population at too low an operative risk to detect a signal of benefit favoring off-pump surgery. The GOPCABE (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) study involved 2,539 patients aged 75 years or older randomized at 12 German centers. A total of 60% of patients had triple-vessel disease, and no one was excluded from the trial because of left ventricular function or coronary artery anatomy. Participating surgeons were highly experienced. Those who performed off-pump CABG in the study had previously done an average of 514 of them, while the on-pump surgeons had done an average of 1,378 of those operations.

"We wanted to have the best off-pump vs. the best on-pump surgeons, like in a competition," explained Dr. Anno Diegeler, a surgeon at the Bad Neustadt (Germany) Heart Center.

He and his coinvestigators conducted GOPCABE because they believed it would be easier to show advantages for off-pump CABG in a population at high operative risk, such as elderly patients with many comorbidities. Indeed, the study hypothesis was that the off-pump group would show a robust 30% reduction in the primary endpoint, a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 1 year.

That didn't happen. The 30-day rate of the primary endpoint was 7.8% in the off-pump group and 8.2% with on-pump CABG, while the 1-year rates were 13.1% and 14.0%, respectively. None of the individual components of the composite endpoint differed significantly between the groups, either.

Neurocognitive function wasn't measured in GOPCABE, but it was in CORONARY (the CABG Off or On Pump Revascularization Study), which involved 4,752 randomized patients in 19 countries.

Dr. Andre Lamy presented the 1-year results. The primary endpoint was a composite of death, MI, stroke, or new renal failure requiring dialysis. The rate was 12.1% in patients in the off-pump group and similar at 13.3% in the on-pump group. As in GOPCABE, the surgeons participating in CORONARY were highly proficient. They had to have at least 2 years' experience as a staff cardiac surgeon and at least 100 prior cases of whichever operation they were assigned to. The vast majority met that standard for both procedures.

Quality of life and neurocognitive tests showed significant difference between the two groups.

However, neurocognitive testing was declared optional because it's so time consuming, and many patients opted out. For example, only 1,273 of the original 4,752 patients returned to take the Montreal Cognitive Assessment at 1 year, noted Dr. Lamy, a heart surgeon at the Population Health Research Institute at McMaster University in Hamilton, Ont.

Discussant Dr. Bernard Gersh zeroed in on the incomplete neurocognitive testing. "I think this is really a significant limitation. There's a huge bias. If there's any advantage to off-pump CABG, it may be in neurocognitive dysfunction," commented Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

In response to questioning as to where off-pump CABG fits into clinical practice in light of the disappointing CORONARY and GOPCABE findings, Dr. Diegeler said he remains convinced that some high-operative-risk patients - those with aortic calcification or other evidence of generalized vascular disease - do benefit preferentially from off-pump surgery when performed by expert surgeons.

Dr. Lamy said a post hoc analysis of the CORONARY data showed that low-operative-risk patients as defined by a EuroScore of 0-2 tended to do better with on- than off-pump CABG, while the converse was true in those with moderate- or high-risk scores.

"In my personal practice now, my low-risk patients go on-pump and my moderate- and high-risk patients go off-pump," he added.

Dr. Jan Hlavicka presented the results of the PRAGUE-6 trial, in which 206 patients at high operative risk  - a EuroScore of 6 or greater - were randomized to off- or on-pump CABG at Charles University, Prague. The operations were performed by five surgeons proficient in both procedures. The 30-day primary composite endpoint comprising death, MI, stroke, or new renal failure requiring dialysis occurred in 20.6% of the on-pump group, compared with 9.2% of off-pump patients.

The off-pump group required significantly fewer RBC transfusions. There were no significant differences between the two groups in terms of average hospital length of stay, wound infection rates, or total hospital costs.

Dr. Gersh noted that the only significant difference between the two groups in the individual components of the primary endpoint was in acute MI rates: 12.1% in the on- vs. 4.1% in the off-pump CABG group. He took issue with the Czech investigators? use of the 2004 Society of Thoracic Surgeons definition of acute MI. That's not sufficiently stringent. It surely captures many patients who don't really have an acute MI. The data should be reanalyzed using a contemporary definition which requires new Q waves, he added.

Dr. Hlavicka, Dr. Lamy, and Dr. Diegeler declared no conflicts.

bjancin@frontlinemedcom.com

SAN FRANCISCO - Off-pump coronary artery bypass graft surgery offered no advantages over on-pump CABG in any major end points at 1 year of follow-up in two major prospective randomized trials totaling more than 7,000 patients.

Among the key 1-year outcomes - which didn't differ between off- and on-pump CABG patients in the GOPCABE and CORONARY trials - were death, MI, stroke, neurocognitive function, quality of life, renal failure, and repeat revascularization, investigators reported at the annual meeting of the American College of Cardiology.

A third randomized trial presented at the same session of the ACC meeting did find a significant outcome advantage favoring off-pump CABG in high-operative-risk patients at 1 year. However, experts discounted this Czech study because it was small, single center, reported only 30-day results, and the advantage found for off-pump surgery hinged on an outdated and inadequate definition of MI.

The new study findings signal a striking fall from grace for off-pump CABG. Not long ago, this technique, while controversial, was viewed by many as a progressive development within heart surgery, one that would revitalize a mature operation whose annual case numbers were declining in the face of stiff competition from percutaneous coronary intervention by cardiologists. Off-pump CABG was an innovation designed to avoid the perioperative complications related to aortic cross-clamping and the heart-lung machine, including the lingering neurocognitive dysfunction known informally in surgical circles as "pump head."

However, the resounding lack of any demonstrable advantages for off-pump CABG in the two large trials presented in San Francisco left analysts scratching their heads as to the role remaining for this beating heart surgical technique, which is more difficult to learn and perform skillfully than on-pump bypass.

Discussant Dr. Michael J. Mack, a cardiac surgeon, voiced a similar sentiment. "I was an early advocate of off-pump surgery. But as a card-carrying off-pump bypass surgeon, it's getting harder and harder for me to maintain enthusiasm for a potential benefit from this," declared Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex. He noted that the CORONARY and GOPCABE trials follow upon the earlier ROOBY (Randomized On/Off Bypass) trial, which actually showed worse outcomes in the off-pump group. ROOBY enrolled 2,203 Veterans Affairs patients, with the off-pump CABG group having a significantly higher 1-year rate of the primary composite endpoint comprising death, nonfatal MI, or repeat revascularization, along with worse graft patency (N. Engl. J. Med. 2009;361:1827-37).

GOPCABE and CORONARY were designed in part to answer critics of ROOBY, who have argued that the VA trial used insufficiently experienced off-pump CABG surgeons and featured a patient population at too low an operative risk to detect a signal of benefit favoring off-pump surgery. The GOPCABE (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) study involved 2,539 patients aged 75 years or older randomized at 12 German centers. A total of 60% of patients had triple-vessel disease, and no one was excluded from the trial because of left ventricular function or coronary artery anatomy. Participating surgeons were highly experienced. Those who performed off-pump CABG in the study had previously done an average of 514 of them, while the on-pump surgeons had done an average of 1,378 of those operations.

"We wanted to have the best off-pump vs. the best on-pump surgeons, like in a competition," explained Dr. Anno Diegeler, a surgeon at the Bad Neustadt (Germany) Heart Center.

He and his coinvestigators conducted GOPCABE because they believed it would be easier to show advantages for off-pump CABG in a population at high operative risk, such as elderly patients with many comorbidities. Indeed, the study hypothesis was that the off-pump group would show a robust 30% reduction in the primary endpoint, a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 1 year.

That didn't happen. The 30-day rate of the primary endpoint was 7.8% in the off-pump group and 8.2% with on-pump CABG, while the 1-year rates were 13.1% and 14.0%, respectively. None of the individual components of the composite endpoint differed significantly between the groups, either.

Neurocognitive function wasn't measured in GOPCABE, but it was in CORONARY (the CABG Off or On Pump Revascularization Study), which involved 4,752 randomized patients in 19 countries.

Dr. Andre Lamy presented the 1-year results. The primary endpoint was a composite of death, MI, stroke, or new renal failure requiring dialysis. The rate was 12.1% in patients in the off-pump group and similar at 13.3% in the on-pump group. As in GOPCABE, the surgeons participating in CORONARY were highly proficient. They had to have at least 2 years' experience as a staff cardiac surgeon and at least 100 prior cases of whichever operation they were assigned to. The vast majority met that standard for both procedures.

Quality of life and neurocognitive tests showed significant difference between the two groups.

However, neurocognitive testing was declared optional because it's so time consuming, and many patients opted out. For example, only 1,273 of the original 4,752 patients returned to take the Montreal Cognitive Assessment at 1 year, noted Dr. Lamy, a heart surgeon at the Population Health Research Institute at McMaster University in Hamilton, Ont.

Discussant Dr. Bernard Gersh zeroed in on the incomplete neurocognitive testing. "I think this is really a significant limitation. There's a huge bias. If there's any advantage to off-pump CABG, it may be in neurocognitive dysfunction," commented Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

In response to questioning as to where off-pump CABG fits into clinical practice in light of the disappointing CORONARY and GOPCABE findings, Dr. Diegeler said he remains convinced that some high-operative-risk patients - those with aortic calcification or other evidence of generalized vascular disease - do benefit preferentially from off-pump surgery when performed by expert surgeons.

Dr. Lamy said a post hoc analysis of the CORONARY data showed that low-operative-risk patients as defined by a EuroScore of 0-2 tended to do better with on- than off-pump CABG, while the converse was true in those with moderate- or high-risk scores.

"In my personal practice now, my low-risk patients go on-pump and my moderate- and high-risk patients go off-pump," he added.

Dr. Jan Hlavicka presented the results of the PRAGUE-6 trial, in which 206 patients at high operative risk  - a EuroScore of 6 or greater - were randomized to off- or on-pump CABG at Charles University, Prague. The operations were performed by five surgeons proficient in both procedures. The 30-day primary composite endpoint comprising death, MI, stroke, or new renal failure requiring dialysis occurred in 20.6% of the on-pump group, compared with 9.2% of off-pump patients.

The off-pump group required significantly fewer RBC transfusions. There were no significant differences between the two groups in terms of average hospital length of stay, wound infection rates, or total hospital costs.

Dr. Gersh noted that the only significant difference between the two groups in the individual components of the primary endpoint was in acute MI rates: 12.1% in the on- vs. 4.1% in the off-pump CABG group. He took issue with the Czech investigators? use of the 2004 Society of Thoracic Surgeons definition of acute MI. That's not sufficiently stringent. It surely captures many patients who don't really have an acute MI. The data should be reanalyzed using a contemporary definition which requires new Q waves, he added.

Dr. Hlavicka, Dr. Lamy, and Dr. Diegeler declared no conflicts.

bjancin@frontlinemedcom.com

SAN FRANCISCO - Off-pump coronary artery bypass graft surgery offered no advantages over on-pump CABG in any major end points at 1 year of follow-up in two major prospective randomized trials totaling more than 7,000 patients.

Among the key 1-year outcomes - which didn't differ between off- and on-pump CABG patients in the GOPCABE and CORONARY trials - were death, MI, stroke, neurocognitive function, quality of life, renal failure, and repeat revascularization, investigators reported at the annual meeting of the American College of Cardiology.

A third randomized trial presented at the same session of the ACC meeting did find a significant outcome advantage favoring off-pump CABG in high-operative-risk patients at 1 year. However, experts discounted this Czech study because it was small, single center, reported only 30-day results, and the advantage found for off-pump surgery hinged on an outdated and inadequate definition of MI.

The new study findings signal a striking fall from grace for off-pump CABG. Not long ago, this technique, while controversial, was viewed by many as a progressive development within heart surgery, one that would revitalize a mature operation whose annual case numbers were declining in the face of stiff competition from percutaneous coronary intervention by cardiologists. Off-pump CABG was an innovation designed to avoid the perioperative complications related to aortic cross-clamping and the heart-lung machine, including the lingering neurocognitive dysfunction known informally in surgical circles as "pump head."

However, the resounding lack of any demonstrable advantages for off-pump CABG in the two large trials presented in San Francisco left analysts scratching their heads as to the role remaining for this beating heart surgical technique, which is more difficult to learn and perform skillfully than on-pump bypass.

Discussant Dr. Michael J. Mack, a cardiac surgeon, voiced a similar sentiment. "I was an early advocate of off-pump surgery. But as a card-carrying off-pump bypass surgeon, it's getting harder and harder for me to maintain enthusiasm for a potential benefit from this," declared Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex. He noted that the CORONARY and GOPCABE trials follow upon the earlier ROOBY (Randomized On/Off Bypass) trial, which actually showed worse outcomes in the off-pump group. ROOBY enrolled 2,203 Veterans Affairs patients, with the off-pump CABG group having a significantly higher 1-year rate of the primary composite endpoint comprising death, nonfatal MI, or repeat revascularization, along with worse graft patency (N. Engl. J. Med. 2009;361:1827-37).

GOPCABE and CORONARY were designed in part to answer critics of ROOBY, who have argued that the VA trial used insufficiently experienced off-pump CABG surgeons and featured a patient population at too low an operative risk to detect a signal of benefit favoring off-pump surgery. The GOPCABE (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) study involved 2,539 patients aged 75 years or older randomized at 12 German centers. A total of 60% of patients had triple-vessel disease, and no one was excluded from the trial because of left ventricular function or coronary artery anatomy. Participating surgeons were highly experienced. Those who performed off-pump CABG in the study had previously done an average of 514 of them, while the on-pump surgeons had done an average of 1,378 of those operations.

"We wanted to have the best off-pump vs. the best on-pump surgeons, like in a competition," explained Dr. Anno Diegeler, a surgeon at the Bad Neustadt (Germany) Heart Center.

He and his coinvestigators conducted GOPCABE because they believed it would be easier to show advantages for off-pump CABG in a population at high operative risk, such as elderly patients with many comorbidities. Indeed, the study hypothesis was that the off-pump group would show a robust 30% reduction in the primary endpoint, a composite of death, stroke, myocardial infarction, repeat revascularization, or new renal-replacement therapy at 1 year.

That didn't happen. The 30-day rate of the primary endpoint was 7.8% in the off-pump group and 8.2% with on-pump CABG, while the 1-year rates were 13.1% and 14.0%, respectively. None of the individual components of the composite endpoint differed significantly between the groups, either.

Neurocognitive function wasn't measured in GOPCABE, but it was in CORONARY (the CABG Off or On Pump Revascularization Study), which involved 4,752 randomized patients in 19 countries.

Dr. Andre Lamy presented the 1-year results. The primary endpoint was a composite of death, MI, stroke, or new renal failure requiring dialysis. The rate was 12.1% in patients in the off-pump group and similar at 13.3% in the on-pump group. As in GOPCABE, the surgeons participating in CORONARY were highly proficient. They had to have at least 2 years' experience as a staff cardiac surgeon and at least 100 prior cases of whichever operation they were assigned to. The vast majority met that standard for both procedures.

Quality of life and neurocognitive tests showed significant difference between the two groups.

However, neurocognitive testing was declared optional because it's so time consuming, and many patients opted out. For example, only 1,273 of the original 4,752 patients returned to take the Montreal Cognitive Assessment at 1 year, noted Dr. Lamy, a heart surgeon at the Population Health Research Institute at McMaster University in Hamilton, Ont.

Discussant Dr. Bernard Gersh zeroed in on the incomplete neurocognitive testing. "I think this is really a significant limitation. There's a huge bias. If there's any advantage to off-pump CABG, it may be in neurocognitive dysfunction," commented Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

In response to questioning as to where off-pump CABG fits into clinical practice in light of the disappointing CORONARY and GOPCABE findings, Dr. Diegeler said he remains convinced that some high-operative-risk patients - those with aortic calcification or other evidence of generalized vascular disease - do benefit preferentially from off-pump surgery when performed by expert surgeons.

Dr. Lamy said a post hoc analysis of the CORONARY data showed that low-operative-risk patients as defined by a EuroScore of 0-2 tended to do better with on- than off-pump CABG, while the converse was true in those with moderate- or high-risk scores.

"In my personal practice now, my low-risk patients go on-pump and my moderate- and high-risk patients go off-pump," he added.

Dr. Jan Hlavicka presented the results of the PRAGUE-6 trial, in which 206 patients at high operative risk  - a EuroScore of 6 or greater - were randomized to off- or on-pump CABG at Charles University, Prague. The operations were performed by five surgeons proficient in both procedures. The 30-day primary composite endpoint comprising death, MI, stroke, or new renal failure requiring dialysis occurred in 20.6% of the on-pump group, compared with 9.2% of off-pump patients.

The off-pump group required significantly fewer RBC transfusions. There were no significant differences between the two groups in terms of average hospital length of stay, wound infection rates, or total hospital costs.

Dr. Gersh noted that the only significant difference between the two groups in the individual components of the primary endpoint was in acute MI rates: 12.1% in the on- vs. 4.1% in the off-pump CABG group. He took issue with the Czech investigators? use of the 2004 Society of Thoracic Surgeons definition of acute MI. That's not sufficiently stringent. It surely captures many patients who don't really have an acute MI. The data should be reanalyzed using a contemporary definition which requires new Q waves, he added.

Dr. Hlavicka, Dr. Lamy, and Dr. Diegeler declared no conflicts.

bjancin@frontlinemedcom.com

NATIONAL HARBOR, MD. - Seeing is believing, especially when enhanced visualization of tumors during surgery helps improve chances for complete resection, investigators said at the annual Society of Surgical Oncology Cancer Symposium.

With near-infrared (NIR) fluorescence imaging and a portable camera that can be used in an operating room, surgeons can eliminate some of the guesswork involved in identifying involved surgical margins or lymph nodes, researchers from the United States and the Netherlands reported in oral and poster sessions.

In early human trials, a small, portable infrared camera has been successful at identifying dye-impregnated tumors -- including noncontiguous pockets of malignancy -- during surgery to resect squamous cell carcinomas and adenocarcinomas of the lung, reported Dr. Sunil Singhal, an ACS Fellow of the department of surgery at the University of Pennsylvania, Philadelphia.

Courtesy Dr. Sunil Singhal

"Even in this day and age, surgeons leave behind disease in 40% of the cases, and in about a quarter of those cases the tumor was within 2 centimeters of where the surgeon was working," Dr. Singhal said.

To improve the odds, he and his colleagues have been investigating optical contrast agents that can be delivered safely to tumors and cause them to fluoresce under light in the NIR portion of the spectrum. In preclinical studies with dogs, they found that indocyanine green had the right combination of toxicity, photostability, pharmacokinetics, and cost. The dye, currently used in retinal angiography, has an emission profile that makes it easy for observers to discriminate between the fluorescing dye and blood or tissues, Dr. Singhal said.

They also developed an intraoperative device, dubbed the "FloCam" which consists of a light source and NIR camera that sits above the patient and sends images to a computer monitor showing the operation in NIR.

In animal studies, the system found evidence of residual disease that was not visible to the naked eye or on x-ray microtomography. On pathologic examination, they saw that the dye was "remarkably precise in delineating margins from normal surrounding tissues," particularly in tumors with neovascular features.

Dr. Singhal said that the imaging technique has been effective at identifying tumor sites during surgery in 36 of 38 patients in early human trials, failing only for 1 patient with melanoma, and for 1 with a sarcoma.

One patient was a 64-year-old nonsmoking man who presented with a cough and was found to have a 2.5-cm right upper lobe lung tumor. Evaluation of the mediastinum with imaging and pathology samples was negative for malignancy, but during surgery, the dye highlighted previously undetected tumor hotspots in the right lower lobe.

Green hybrid

In a separate study, investigators in the Netherlands reported on improved intraoperative sentinel node identification and harvesting using a novel hybrid radiopharmaceutical tracer combining indocyanine green with technetium-99m in a nanocolloid suspension.

They found that in 96 patients with malignant melanomas of the head and neck, trunk, or extremities, the hybrid tracer, facilitated both preoperative SPECT/CT imaging and intraoperative radio- and fluorescence-guide sentinel node biopsy in all patients.

"The hybrid tracer was found to be particularly useful for the detection of sentinel nodes in the neck, and for sentinel nodes that failed to accumulate patent blue dye," wrote Dr. Oscar R. Brouwer from the division of nuclear medicine at the Netherlands Cancer Institute in Amsterdam, and colleagues in a scientific poster.

Dr. Singhal and Dr. Brouwer both reported that they had no disclosures.

NATIONAL HARBOR, MD. - Seeing is believing, especially when enhanced visualization of tumors during surgery helps improve chances for complete resection, investigators said at the annual Society of Surgical Oncology Cancer Symposium.

With near-infrared (NIR) fluorescence imaging and a portable camera that can be used in an operating room, surgeons can eliminate some of the guesswork involved in identifying involved surgical margins or lymph nodes, researchers from the United States and the Netherlands reported in oral and poster sessions.

In early human trials, a small, portable infrared camera has been successful at identifying dye-impregnated tumors -- including noncontiguous pockets of malignancy -- during surgery to resect squamous cell carcinomas and adenocarcinomas of the lung, reported Dr. Sunil Singhal, an ACS Fellow of the department of surgery at the University of Pennsylvania, Philadelphia.

Courtesy Dr. Sunil Singhal

"Even in this day and age, surgeons leave behind disease in 40% of the cases, and in about a quarter of those cases the tumor was within 2 centimeters of where the surgeon was working," Dr. Singhal said.

To improve the odds, he and his colleagues have been investigating optical contrast agents that can be delivered safely to tumors and cause them to fluoresce under light in the NIR portion of the spectrum. In preclinical studies with dogs, they found that indocyanine green had the right combination of toxicity, photostability, pharmacokinetics, and cost. The dye, currently used in retinal angiography, has an emission profile that makes it easy for observers to discriminate between the fluorescing dye and blood or tissues, Dr. Singhal said.

They also developed an intraoperative device, dubbed the "FloCam" which consists of a light source and NIR camera that sits above the patient and sends images to a computer monitor showing the operation in NIR.

In animal studies, the system found evidence of residual disease that was not visible to the naked eye or on x-ray microtomography. On pathologic examination, they saw that the dye was "remarkably precise in delineating margins from normal surrounding tissues," particularly in tumors with neovascular features.

Dr. Singhal said that the imaging technique has been effective at identifying tumor sites during surgery in 36 of 38 patients in early human trials, failing only for 1 patient with melanoma, and for 1 with a sarcoma.

One patient was a 64-year-old nonsmoking man who presented with a cough and was found to have a 2.5-cm right upper lobe lung tumor. Evaluation of the mediastinum with imaging and pathology samples was negative for malignancy, but during surgery, the dye highlighted previously undetected tumor hotspots in the right lower lobe.

Green hybrid

In a separate study, investigators in the Netherlands reported on improved intraoperative sentinel node identification and harvesting using a novel hybrid radiopharmaceutical tracer combining indocyanine green with technetium-99m in a nanocolloid suspension.

They found that in 96 patients with malignant melanomas of the head and neck, trunk, or extremities, the hybrid tracer, facilitated both preoperative SPECT/CT imaging and intraoperative radio- and fluorescence-guide sentinel node biopsy in all patients.

"The hybrid tracer was found to be particularly useful for the detection of sentinel nodes in the neck, and for sentinel nodes that failed to accumulate patent blue dye," wrote Dr. Oscar R. Brouwer from the division of nuclear medicine at the Netherlands Cancer Institute in Amsterdam, and colleagues in a scientific poster.

Dr. Singhal and Dr. Brouwer both reported that they had no disclosures.

NATIONAL HARBOR, MD. - Seeing is believing, especially when enhanced visualization of tumors during surgery helps improve chances for complete resection, investigators said at the annual Society of Surgical Oncology Cancer Symposium.

With near-infrared (NIR) fluorescence imaging and a portable camera that can be used in an operating room, surgeons can eliminate some of the guesswork involved in identifying involved surgical margins or lymph nodes, researchers from the United States and the Netherlands reported in oral and poster sessions.

In early human trials, a small, portable infrared camera has been successful at identifying dye-impregnated tumors -- including noncontiguous pockets of malignancy -- during surgery to resect squamous cell carcinomas and adenocarcinomas of the lung, reported Dr. Sunil Singhal, an ACS Fellow of the department of surgery at the University of Pennsylvania, Philadelphia.

Courtesy Dr. Sunil Singhal

"Even in this day and age, surgeons leave behind disease in 40% of the cases, and in about a quarter of those cases the tumor was within 2 centimeters of where the surgeon was working," Dr. Singhal said.

To improve the odds, he and his colleagues have been investigating optical contrast agents that can be delivered safely to tumors and cause them to fluoresce under light in the NIR portion of the spectrum. In preclinical studies with dogs, they found that indocyanine green had the right combination of toxicity, photostability, pharmacokinetics, and cost. The dye, currently used in retinal angiography, has an emission profile that makes it easy for observers to discriminate between the fluorescing dye and blood or tissues, Dr. Singhal said.

They also developed an intraoperative device, dubbed the "FloCam" which consists of a light source and NIR camera that sits above the patient and sends images to a computer monitor showing the operation in NIR.

In animal studies, the system found evidence of residual disease that was not visible to the naked eye or on x-ray microtomography. On pathologic examination, they saw that the dye was "remarkably precise in delineating margins from normal surrounding tissues," particularly in tumors with neovascular features.

Dr. Singhal said that the imaging technique has been effective at identifying tumor sites during surgery in 36 of 38 patients in early human trials, failing only for 1 patient with melanoma, and for 1 with a sarcoma.

One patient was a 64-year-old nonsmoking man who presented with a cough and was found to have a 2.5-cm right upper lobe lung tumor. Evaluation of the mediastinum with imaging and pathology samples was negative for malignancy, but during surgery, the dye highlighted previously undetected tumor hotspots in the right lower lobe.

Green hybrid

In a separate study, investigators in the Netherlands reported on improved intraoperative sentinel node identification and harvesting using a novel hybrid radiopharmaceutical tracer combining indocyanine green with technetium-99m in a nanocolloid suspension.

They found that in 96 patients with malignant melanomas of the head and neck, trunk, or extremities, the hybrid tracer, facilitated both preoperative SPECT/CT imaging and intraoperative radio- and fluorescence-guide sentinel node biopsy in all patients.

"The hybrid tracer was found to be particularly useful for the detection of sentinel nodes in the neck, and for sentinel nodes that failed to accumulate patent blue dye," wrote Dr. Oscar R. Brouwer from the division of nuclear medicine at the Netherlands Cancer Institute in Amsterdam, and colleagues in a scientific poster.

Dr. Singhal and Dr. Brouwer both reported that they had no disclosures.