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American Association for Thoracic Surgery (AATS): Annual Meeting
CABG mortality goal elusive without process improvements
MINNEAPOLIS – Achieving a 1% or less operative mortality for primary, isolated coronary artery bypass grafting is feasible only in highly selected patients, according to a multicenter Society for Thoracic Surgery database analysis.
"This goal may only be achievable in less than 60% of CABG patients without other improvements in processes of care," said Dr. Damien LaPar, chief resident in the department of surgery, University of Virginia, Charlottesville.
Dr. Michael J. Mack threw down the gauntlet in his presidential address at the STS annual meeting last year, challenging the surgical community to achieve a CABG mortality rate of 1% or less nationwide in the next 5 years (Ann. Thor. Surg. 2012;94:1044-52).
Operative mortality currently stands at about 2% for CABG versus about 1% for percutaneous coronary intervention (PCI). Use of CABG has fallen off as first-line treatment for coronary artery disease with advances in PCI technology.
Dr. LaPar and his associates used the Society of Thoracic Surgery (STS) database for adult cardiac surgery to analyze the records of 34,416 patients who had undergone CABG from 2001 to 2011 at 17 cardiac surgery centers in Virginia, representing 99% of all cardiac surgeries performed in the state. Multiple logistic regression modeling was used to identify patient populations in which the 1% mortality goal was achievable, relative to the STS Predicted Risk of Mortality (PROM) score.
The patients’ average age was 64 years and 27% were female. The median number of CABG operations performed over the 10-year study period was 544, with an operative mortality of 1.87% (644 deaths), Dr. LaPar reported at the annual meeting of the American Association for Thoracic Surgery.
The STS PROM was highly associated with CABG mortality in both linear (odds ratio 1.89; P less than .0001) and nonlinear (OR 6.59; P less than .0001) models, after adjustment for operative year and surgeon volume.
Upon closer inspection, an STS PROM score of 1.27% or less was found to correlate with a probability of CABG death of 1% or less, he said. The predictive ability of the STS scoring tool appeared to wane, however, for those patients with an estimated risk exceeding 25%.
The investigators then evaluated the risk-adjusted association between mortality and 30 variables used to calculate the STS PROM and process-of-care measures such as internal mammary artery grafting and perioperative/discharge medications.
Several process-of-care, surgeon, and operative factors were correlated with CABG death among all patients, although the relationship was stronger in those at lower risk with an STS PROM score of 1.27% or less, Dr. LaPar said.
Among the 14,687 higher-risk patients with an STS score exceeding 1.27%, the median STS score was significantly higher among decedents than survivors (4.6% vs. 2.4%; P less than .001).
Higher-risk patients who died during CABG were significantly more likely to be older (72.3 years vs. 70.4 years), to have renal dysfunction/dialysis (11.3% vs. 5.3%), peripheral vascular disease (32% vs. 24%), heart failure (37.3% vs. 21%), New York Heart Association class IV (41.6% vs. 26%), and atrial fibrillation (11% vs. 7%), and to have undergone emergent surgery (17% vs. 7.3; all P less than .001).
Higher-risk decedents were also less likely to be on such process measures at discharge as beta-blocker therapy (20% vs. 86%), anti-platelets (21% vs. 94.5%), and lipid-lowering medications (19.5% vs. 85%; all P less than .001), Dr. LaPar said.
"The STS Predicted Risk of Mortality score can be used to strongly identify patients with a threshold value of estimated mortality risk of less than or equal to 1.27% to achieve this [1% mortality] goal," he noted.
During a discussion of the results, some members of the audience raised concerns about whether patients continued on aspirin therapy until the day of surgery or were using tranexamic acid, as these agents could impact interpretation of the results. Dr. LaPar said that aspirin was allowed up to the day of surgery, but that the analyses corrected for this, and that all patients received epsilon-aminocaproic acid (Amicar), not tranexamic acid.
Dr. LaPar reported having no financial disclosures.
MINNEAPOLIS – Achieving a 1% or less operative mortality for primary, isolated coronary artery bypass grafting is feasible only in highly selected patients, according to a multicenter Society for Thoracic Surgery database analysis.
"This goal may only be achievable in less than 60% of CABG patients without other improvements in processes of care," said Dr. Damien LaPar, chief resident in the department of surgery, University of Virginia, Charlottesville.
Dr. Michael J. Mack threw down the gauntlet in his presidential address at the STS annual meeting last year, challenging the surgical community to achieve a CABG mortality rate of 1% or less nationwide in the next 5 years (Ann. Thor. Surg. 2012;94:1044-52).
Operative mortality currently stands at about 2% for CABG versus about 1% for percutaneous coronary intervention (PCI). Use of CABG has fallen off as first-line treatment for coronary artery disease with advances in PCI technology.
Dr. LaPar and his associates used the Society of Thoracic Surgery (STS) database for adult cardiac surgery to analyze the records of 34,416 patients who had undergone CABG from 2001 to 2011 at 17 cardiac surgery centers in Virginia, representing 99% of all cardiac surgeries performed in the state. Multiple logistic regression modeling was used to identify patient populations in which the 1% mortality goal was achievable, relative to the STS Predicted Risk of Mortality (PROM) score.
The patients’ average age was 64 years and 27% were female. The median number of CABG operations performed over the 10-year study period was 544, with an operative mortality of 1.87% (644 deaths), Dr. LaPar reported at the annual meeting of the American Association for Thoracic Surgery.
The STS PROM was highly associated with CABG mortality in both linear (odds ratio 1.89; P less than .0001) and nonlinear (OR 6.59; P less than .0001) models, after adjustment for operative year and surgeon volume.
Upon closer inspection, an STS PROM score of 1.27% or less was found to correlate with a probability of CABG death of 1% or less, he said. The predictive ability of the STS scoring tool appeared to wane, however, for those patients with an estimated risk exceeding 25%.
The investigators then evaluated the risk-adjusted association between mortality and 30 variables used to calculate the STS PROM and process-of-care measures such as internal mammary artery grafting and perioperative/discharge medications.
Several process-of-care, surgeon, and operative factors were correlated with CABG death among all patients, although the relationship was stronger in those at lower risk with an STS PROM score of 1.27% or less, Dr. LaPar said.
Among the 14,687 higher-risk patients with an STS score exceeding 1.27%, the median STS score was significantly higher among decedents than survivors (4.6% vs. 2.4%; P less than .001).
Higher-risk patients who died during CABG were significantly more likely to be older (72.3 years vs. 70.4 years), to have renal dysfunction/dialysis (11.3% vs. 5.3%), peripheral vascular disease (32% vs. 24%), heart failure (37.3% vs. 21%), New York Heart Association class IV (41.6% vs. 26%), and atrial fibrillation (11% vs. 7%), and to have undergone emergent surgery (17% vs. 7.3; all P less than .001).
Higher-risk decedents were also less likely to be on such process measures at discharge as beta-blocker therapy (20% vs. 86%), anti-platelets (21% vs. 94.5%), and lipid-lowering medications (19.5% vs. 85%; all P less than .001), Dr. LaPar said.
"The STS Predicted Risk of Mortality score can be used to strongly identify patients with a threshold value of estimated mortality risk of less than or equal to 1.27% to achieve this [1% mortality] goal," he noted.
During a discussion of the results, some members of the audience raised concerns about whether patients continued on aspirin therapy until the day of surgery or were using tranexamic acid, as these agents could impact interpretation of the results. Dr. LaPar said that aspirin was allowed up to the day of surgery, but that the analyses corrected for this, and that all patients received epsilon-aminocaproic acid (Amicar), not tranexamic acid.
Dr. LaPar reported having no financial disclosures.
MINNEAPOLIS – Achieving a 1% or less operative mortality for primary, isolated coronary artery bypass grafting is feasible only in highly selected patients, according to a multicenter Society for Thoracic Surgery database analysis.
"This goal may only be achievable in less than 60% of CABG patients without other improvements in processes of care," said Dr. Damien LaPar, chief resident in the department of surgery, University of Virginia, Charlottesville.
Dr. Michael J. Mack threw down the gauntlet in his presidential address at the STS annual meeting last year, challenging the surgical community to achieve a CABG mortality rate of 1% or less nationwide in the next 5 years (Ann. Thor. Surg. 2012;94:1044-52).
Operative mortality currently stands at about 2% for CABG versus about 1% for percutaneous coronary intervention (PCI). Use of CABG has fallen off as first-line treatment for coronary artery disease with advances in PCI technology.
Dr. LaPar and his associates used the Society of Thoracic Surgery (STS) database for adult cardiac surgery to analyze the records of 34,416 patients who had undergone CABG from 2001 to 2011 at 17 cardiac surgery centers in Virginia, representing 99% of all cardiac surgeries performed in the state. Multiple logistic regression modeling was used to identify patient populations in which the 1% mortality goal was achievable, relative to the STS Predicted Risk of Mortality (PROM) score.
The patients’ average age was 64 years and 27% were female. The median number of CABG operations performed over the 10-year study period was 544, with an operative mortality of 1.87% (644 deaths), Dr. LaPar reported at the annual meeting of the American Association for Thoracic Surgery.
The STS PROM was highly associated with CABG mortality in both linear (odds ratio 1.89; P less than .0001) and nonlinear (OR 6.59; P less than .0001) models, after adjustment for operative year and surgeon volume.
Upon closer inspection, an STS PROM score of 1.27% or less was found to correlate with a probability of CABG death of 1% or less, he said. The predictive ability of the STS scoring tool appeared to wane, however, for those patients with an estimated risk exceeding 25%.
The investigators then evaluated the risk-adjusted association between mortality and 30 variables used to calculate the STS PROM and process-of-care measures such as internal mammary artery grafting and perioperative/discharge medications.
Several process-of-care, surgeon, and operative factors were correlated with CABG death among all patients, although the relationship was stronger in those at lower risk with an STS PROM score of 1.27% or less, Dr. LaPar said.
Among the 14,687 higher-risk patients with an STS score exceeding 1.27%, the median STS score was significantly higher among decedents than survivors (4.6% vs. 2.4%; P less than .001).
Higher-risk patients who died during CABG were significantly more likely to be older (72.3 years vs. 70.4 years), to have renal dysfunction/dialysis (11.3% vs. 5.3%), peripheral vascular disease (32% vs. 24%), heart failure (37.3% vs. 21%), New York Heart Association class IV (41.6% vs. 26%), and atrial fibrillation (11% vs. 7%), and to have undergone emergent surgery (17% vs. 7.3; all P less than .001).
Higher-risk decedents were also less likely to be on such process measures at discharge as beta-blocker therapy (20% vs. 86%), anti-platelets (21% vs. 94.5%), and lipid-lowering medications (19.5% vs. 85%; all P less than .001), Dr. LaPar said.
"The STS Predicted Risk of Mortality score can be used to strongly identify patients with a threshold value of estimated mortality risk of less than or equal to 1.27% to achieve this [1% mortality] goal," he noted.
During a discussion of the results, some members of the audience raised concerns about whether patients continued on aspirin therapy until the day of surgery or were using tranexamic acid, as these agents could impact interpretation of the results. Dr. LaPar said that aspirin was allowed up to the day of surgery, but that the analyses corrected for this, and that all patients received epsilon-aminocaproic acid (Amicar), not tranexamic acid.
Dr. LaPar reported having no financial disclosures.
AT THE AATS ANNUAL MEETING
Major finding: The STS PROM was significantly correlated with coronary artery bypass grafting mortality in both linear (odds ratio 1.89; P less than .0001) and nonlinear (OR 6.59; P less than .0001) models, after adjustment for operative year and surgeon volume.
Data source: Retrospective analysis of 34,416 patients who underwent CABG from 2001 to 2011 in STS database.
Disclosures: Dr. LaPar reported having no financial disclosures.
Aortic valve-sparing root surgery durable at 1 year
MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.
Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph Coselli said at the annual meeting of the American Association for Thoracic Surgery.
"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."
In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).
The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (n = 239) or aortic valve–replacing (AVR) (n = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.
"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.
AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).
Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.
At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).
Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.
One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).
At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.
The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).
In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.
Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.
MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.
Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph Coselli said at the annual meeting of the American Association for Thoracic Surgery.
"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."
In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).
The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (n = 239) or aortic valve–replacing (AVR) (n = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.
"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.
AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).
Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.
At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).
Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.
One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).
At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.
The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).
In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.
Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.
MINNEAPOLIS – Despite the complexity of aortic valve–sparing techniques, early outcomes and 1-year survival were similar to those achieved with valve replacing during root replacement surgery in patients with Marfan syndrome in a prospective registry study.
Major adverse valve-related events (MAVREs) at 1 year were also comparable, although there was an increase, of course, in aortic valve regurgitation with valve sparing (7% vs. 0%), Dr. Joseph Coselli said at the annual meeting of the American Association for Thoracic Surgery.
"Follow-up is needed for this particular incident because we don’t know exactly what’s going to happen to these 2-plus aortic regurgitations," he said. "It’s quite possible they may remain stable over a long period of time and don’t represent a failure of the concept."
In an initial report from the international registry, valve-sparing techniques were the most common, and provided comparable 30-day outcomes in 151 patients (J. Thorac. Cardiovasc. Surg. 2009;137:1124-32).
The current analysis involved 316 patients, aged 4-70 years, who underwent aortic valve–sparing (AVS) (n = 239) or aortic valve–replacing (AVR) (n = 63 mechanical and 14 tissue) root replacement surgery at 19 centers between March 2005 and November 2010. The type of operation was determined by clinical factors, and by surgeon and patient preference. AVR surgery was considered the only option in 17% of patients. At 1 year, clinical follow-up was complete in 98% and imaging follow-up in 93%.
"Interestingly, when we started out this particular collection of patients, over 30% were receiving aortic valve replacement, but toward the end of this observational study, late 2010, virtually almost all patients were receiving aortic valve sparing," said Dr. Coselli, chief of adult cardiac surgery at Baylor College of Medicine, Texas Heart Institute, Houston.
AVS patients were younger (33 vs. 39 years); had smaller sinuses of Valsalva (49 vs. 53 mm); and had less acute dissection (3% vs. 9%), chronic dissection (3% vs. 12%), and previous cardiovascular surgery (5% vs. 14%).
Aortic-sparing techniques required significantly longer cardiopulmonary bypass time (195 vs. 152 minutes) and aortic clamp time (156 vs. 115 minutes), but cut ICU time from 46 hours with AVR surgery to 26 hours, ventilator support time from 12 to 8 hours, and hospital length of stay from 7 to 6 days, Dr. Coselli reported.
At 30 days, MAVREs were reported in 6 patients in the AVR group and 15 in the AVS group (P = .4), with no differences in nonstructural dysfunction (1 vs. 7), embolism (1 vs. 3), or bleeding (2 vs. 3 events).
Two AVS patients required early reoperation: One required same-day reintervention because of coronary artery kinking after a Florida sleeve procedure, and the second needed reintervention because of a coronary pseudoaneurysm 6 days after a David-V procedure, he said. Two early deaths occurred, one in each group, but neither was valve related.
One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).
At 1 year, MAVREs occurred in 8 AVR and 35 AVS patients (P = .5). There was no significant difference between AVR and AVS in freedom from valve-related death (1 vs. 2), embolism (2 vs. 4 events), reintervention (0 vs. 1), endocarditis (1 vs. 0), valve thrombosis (0 both), or valve-related morbidity (7 vs. 28), Dr. Coselli said.
The AVS group had significantly more nonstructural dysfunction/structural valve deterioration (23 events vs. 1 event; P = .04), but significantly less bleeding (3 vs. 5 events; P = .01).
In a Cox regression analysis at 1 year, the type of surgery was not associated with overall survival, MAVREs, or any other valve-related outcome, he said.
Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.
AT THE AATS ANNUAL MEETING
Major finding: One-year survival rates were 98% after AVS surgery and 97% after AVR surgery (4 vs. 2 deaths; P = .06).
Data source: Prospective, international, observational registry study in 316 Marfan syndrome patients undergoing aortic root surgery.
Disclosures: Dr. Coselli reported research support from St. Jude Medical; an educational grant, consultancy, and royalties from Vascutek Terumo; and research support, speaking for, and steering committee membership with Medtronic. Two coauthors reported consultant/advisory board participation with Medtronic or Edwards Lifesciences.
Wedge resection in NSCLC: Is 15 mm the magic margin?
MINNEAPOLIS – Increasing the surgical margin length up to 15 mm during wedge resection of small lung cancer tumors significantly lowered the risk of local recurrence among 474 consecutive patients.
No additional benefit was observed, however, beyond 15 mm, said Dr. Kamran Mohiuddin, a surgical research fellow at Brigham and Women’s Hospital, Boston.
Compared with a margin length of 5 mm, the adjusted risk of local recurrence was estimated to be 45% lower with a margin length of 10 mm (hazard ratio, 0.55), 59% lower with a 15-mm margin (HR, 0.41), and 54% lower with a 20-mm margin (HR, 0.46).
"The downward trend flattens out, indicating diminished benefit of increasing the margin length," he said at the annual meeting of the American Association for Thoracic Surgery.
Currently, the data are unclear regarding the optimal margin length for wedge resection of small non–small cell lung cancer (NSCLC) tumors of less than 2 cm. Wedge resections are associated with margins less than 1 cm and a high risk for locoregional recurrence (Ann. Surg. Oncol. 2007;14:2400-5), with a multicenter, prospective study suggesting that the optimal margin length should be larger than the maximum tumor diameter (Ann. Thorac. Surg. 2004;77:415-20).
When asked during a discussion of the analysis whether a more aggressive resection or segmentectomy would be performed if margins are found in the operating room to be inadequate based on the current results, senior author Dr. Scott J. Swanson, an ACS Fellow and director of minimally invasive thoracic surgery at the hospital, said they are taking the results forward into practice, but that it’s unclear whether 15 mm is the optimal number to target.
"Is 15 mm the correct margin? I am not sure we know the answer in all cases, but it is a useful number to keep in the surgeon’s head when we are doing resections for tumors that are 2 cm or less," he said in an interview. "A 15-mm margin seems to be a better target to aim for than margin length to tumor diameter ratio of greater than 1, as suggested by other investigators."
The current analysis included data from all patients, aged 21-85 years, who underwent wedge resection for NSCLC 2 cm or less at their institution between January 2001 and August 2011. Margin length, defined as the distance from the tumor to the closest stapled resection margin, was 0.1-0.5 cm in 36%, 0.6-1.0 cm in 25.5%, 1.1-2.0 cm in 28.5%, and greater than 2 cm in 10%.
The mean tumor size was 1.33 cm, the location of the tumor was the right upper lobe in the majority (36%), and video-assisted thoracic surgery (VATS) was used in 57.5%. The patients’ mean forced expiratory volume in 1 second (FEV1) was 79.8%, and the mean age was 68.5 years.
Perioperative death occurred in 1 patient and at least one major complication in 41 patients, Dr. Mohiuddin said.
The local recurrence rate was 5.8% at 1 year, 11.3% at 2 years, and 16.8% at 3 years. Median follow-up was 3.9 years.
In multivariate regression analysis, increased margin length was significantly associated with a lower risk of local recurrence, with evidence of diminished additional benefit beyond a length of 15 mm (P = .031), he said. The analysis adjusted for FEV1, chronic obstructive pulmonary disease, smoking, diabetes, tumor size, tumor lobe location, location within the hemothorax, surgeon, whether VATS or open surgery was used, and whether or not nodes were sampled.
Dr. Mohiuddin and his coauthors reported having no financial disclosures.
MINNEAPOLIS – Increasing the surgical margin length up to 15 mm during wedge resection of small lung cancer tumors significantly lowered the risk of local recurrence among 474 consecutive patients.
No additional benefit was observed, however, beyond 15 mm, said Dr. Kamran Mohiuddin, a surgical research fellow at Brigham and Women’s Hospital, Boston.
Compared with a margin length of 5 mm, the adjusted risk of local recurrence was estimated to be 45% lower with a margin length of 10 mm (hazard ratio, 0.55), 59% lower with a 15-mm margin (HR, 0.41), and 54% lower with a 20-mm margin (HR, 0.46).
"The downward trend flattens out, indicating diminished benefit of increasing the margin length," he said at the annual meeting of the American Association for Thoracic Surgery.
Currently, the data are unclear regarding the optimal margin length for wedge resection of small non–small cell lung cancer (NSCLC) tumors of less than 2 cm. Wedge resections are associated with margins less than 1 cm and a high risk for locoregional recurrence (Ann. Surg. Oncol. 2007;14:2400-5), with a multicenter, prospective study suggesting that the optimal margin length should be larger than the maximum tumor diameter (Ann. Thorac. Surg. 2004;77:415-20).
When asked during a discussion of the analysis whether a more aggressive resection or segmentectomy would be performed if margins are found in the operating room to be inadequate based on the current results, senior author Dr. Scott J. Swanson, an ACS Fellow and director of minimally invasive thoracic surgery at the hospital, said they are taking the results forward into practice, but that it’s unclear whether 15 mm is the optimal number to target.
"Is 15 mm the correct margin? I am not sure we know the answer in all cases, but it is a useful number to keep in the surgeon’s head when we are doing resections for tumors that are 2 cm or less," he said in an interview. "A 15-mm margin seems to be a better target to aim for than margin length to tumor diameter ratio of greater than 1, as suggested by other investigators."
The current analysis included data from all patients, aged 21-85 years, who underwent wedge resection for NSCLC 2 cm or less at their institution between January 2001 and August 2011. Margin length, defined as the distance from the tumor to the closest stapled resection margin, was 0.1-0.5 cm in 36%, 0.6-1.0 cm in 25.5%, 1.1-2.0 cm in 28.5%, and greater than 2 cm in 10%.
The mean tumor size was 1.33 cm, the location of the tumor was the right upper lobe in the majority (36%), and video-assisted thoracic surgery (VATS) was used in 57.5%. The patients’ mean forced expiratory volume in 1 second (FEV1) was 79.8%, and the mean age was 68.5 years.
Perioperative death occurred in 1 patient and at least one major complication in 41 patients, Dr. Mohiuddin said.
The local recurrence rate was 5.8% at 1 year, 11.3% at 2 years, and 16.8% at 3 years. Median follow-up was 3.9 years.
In multivariate regression analysis, increased margin length was significantly associated with a lower risk of local recurrence, with evidence of diminished additional benefit beyond a length of 15 mm (P = .031), he said. The analysis adjusted for FEV1, chronic obstructive pulmonary disease, smoking, diabetes, tumor size, tumor lobe location, location within the hemothorax, surgeon, whether VATS or open surgery was used, and whether or not nodes were sampled.
Dr. Mohiuddin and his coauthors reported having no financial disclosures.
MINNEAPOLIS – Increasing the surgical margin length up to 15 mm during wedge resection of small lung cancer tumors significantly lowered the risk of local recurrence among 474 consecutive patients.
No additional benefit was observed, however, beyond 15 mm, said Dr. Kamran Mohiuddin, a surgical research fellow at Brigham and Women’s Hospital, Boston.
Compared with a margin length of 5 mm, the adjusted risk of local recurrence was estimated to be 45% lower with a margin length of 10 mm (hazard ratio, 0.55), 59% lower with a 15-mm margin (HR, 0.41), and 54% lower with a 20-mm margin (HR, 0.46).
"The downward trend flattens out, indicating diminished benefit of increasing the margin length," he said at the annual meeting of the American Association for Thoracic Surgery.
Currently, the data are unclear regarding the optimal margin length for wedge resection of small non–small cell lung cancer (NSCLC) tumors of less than 2 cm. Wedge resections are associated with margins less than 1 cm and a high risk for locoregional recurrence (Ann. Surg. Oncol. 2007;14:2400-5), with a multicenter, prospective study suggesting that the optimal margin length should be larger than the maximum tumor diameter (Ann. Thorac. Surg. 2004;77:415-20).
When asked during a discussion of the analysis whether a more aggressive resection or segmentectomy would be performed if margins are found in the operating room to be inadequate based on the current results, senior author Dr. Scott J. Swanson, an ACS Fellow and director of minimally invasive thoracic surgery at the hospital, said they are taking the results forward into practice, but that it’s unclear whether 15 mm is the optimal number to target.
"Is 15 mm the correct margin? I am not sure we know the answer in all cases, but it is a useful number to keep in the surgeon’s head when we are doing resections for tumors that are 2 cm or less," he said in an interview. "A 15-mm margin seems to be a better target to aim for than margin length to tumor diameter ratio of greater than 1, as suggested by other investigators."
The current analysis included data from all patients, aged 21-85 years, who underwent wedge resection for NSCLC 2 cm or less at their institution between January 2001 and August 2011. Margin length, defined as the distance from the tumor to the closest stapled resection margin, was 0.1-0.5 cm in 36%, 0.6-1.0 cm in 25.5%, 1.1-2.0 cm in 28.5%, and greater than 2 cm in 10%.
The mean tumor size was 1.33 cm, the location of the tumor was the right upper lobe in the majority (36%), and video-assisted thoracic surgery (VATS) was used in 57.5%. The patients’ mean forced expiratory volume in 1 second (FEV1) was 79.8%, and the mean age was 68.5 years.
Perioperative death occurred in 1 patient and at least one major complication in 41 patients, Dr. Mohiuddin said.
The local recurrence rate was 5.8% at 1 year, 11.3% at 2 years, and 16.8% at 3 years. Median follow-up was 3.9 years.
In multivariate regression analysis, increased margin length was significantly associated with a lower risk of local recurrence, with evidence of diminished additional benefit beyond a length of 15 mm (P = .031), he said. The analysis adjusted for FEV1, chronic obstructive pulmonary disease, smoking, diabetes, tumor size, tumor lobe location, location within the hemothorax, surgeon, whether VATS or open surgery was used, and whether or not nodes were sampled.
Dr. Mohiuddin and his coauthors reported having no financial disclosures.
AT THE AATS ANNUAL MEETING
Major finding: Compared with a margin length of 5 mm, the adjusted risk of local recurrence was estimated to be 45% lower with a margin length of 10 mm (hazard ratio, 0.55), 59% lower with a margin length of 15 mm (HR, 0.41), and 54% lower with a 20-mm margin (HR, 0.46).
Data source: Retrospective analysis of 474 consecutive patients undergoing pulmonary wedge resection for non–small cell lung cancer tumors up to 2 cm.
Disclosures: Dr. Mohiuddin and his coauthors reported having no financial disclosures.
Survival equivalent with sublobar, lobar resection of stage Ia NSCLC
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 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 done 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.
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 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 done 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.
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 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 done 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.
AT THE AATS ANNUAL MEETING
Major finding: Lung cancer–specific mortality was 7% with sublobar resection and 10% with lobar resection.
Data source: Retrospective analysis of 348 patients with stage IA non–small-cell lung cancer in the prospective International Early Lung Cancer Action Program.
Disclosures: Dr. Altorki reported no relevant financial disclosures.
Fewer graduates, more thoracic surgery board failures
MINNEAPOLIS – The number of residents failing the American Board of Thoracic Surgery exams has risen significantly in the wake of reduced residency hours, a new study confirms.
The change is particularly alarming for the ABTS oral boards, Dr. Susan Moffatt-Bruce reported at the annual meeting of the American Association for Thoracic Surgery.
The failure rate for the oral exams doubled from 14.4% to 28.1% between 2000 to 2005 and 2006 to 2011, the 6 years before and 6 years after the Accreditation Council for Graduate Medical Education imposed an 80-hour residency work week. By 2012, 30% of residents were failing the oral exam.
Of the 903 residents who took the written exam between 2000 and 2005, 10.6% failed, compared with 17.4% of the 672 residents writing the exam between 2006 and 2007. By 2012, however, the success rate reached 85.4%.
Although the percentage failing the written exam was lower than for the oral exams in both time periods, it remained significantly higher from 2006 to 2011 than before the 80-hour work week requirement (12% vs. 21%) said Dr. Moffatt-Bruce, a cardiothoracic surgeon at the Ohio State Medical Center in Columbus.
"There are a decreasing number of trainees, and we will not meet the needs of a growing American population," she said, observing that the shortfall of certified cardiothoracic surgeons could be realized as early as 2020.
Dr. Moffatt-Bruce speculated that the higher failure rate for the oral exams could be the result of a decrease in the number of critical cardiac cases and in experiential learning for thoracic surgery residents, particularly on the weekends and evenings.
"It is very hard to pass an oral exam question about a scenario that you may never have encountered as a resident," she said.
Since 2000, the number of new certificates awarded by the ABTS has decreased steadily from a peak of 126 certificates in 2002 to 93 certificates in 2011. An additional 100 residents would need to be trained to meet the need for cardiothoracic surgeons by 2030, Dr. Moffatt-Bruce said.
She was careful to acknowledge existing efforts by various groups to attract students, such as the 6-year Integrated Cardiothoracic Surgery Residency Program (I-6), but she said additional strategies are needed to improve not only the number of trainees, but also the way in which they learn.
During a discussion of the results, Dr. Edward Verrier, surgical director, Joint Council of Thoracic Surgery Education, said various societies have gotten together and this spring will roll out a completely new content management system for the cardiothoracic surgery curriculum as well as a new curriculum and learning management tool that will help track issues related to competency and various milestones.
"It’s very important to recognize that these issues have been on the table; they’ve been very carefully thought out at the board level, the society level and by some of the other organizations dedicated to education, and we will see significant transitions over the next year," he said.
Dr. Teresa Kieser, a cardiothoracic surgeon with University of Calgary in Canada, said that more than half of medical school graduates in Canada are women, but that perhaps women aren’t choosing cardiothoracic surgery as a career.
Dr. Moffatt-Bruce, who trained in both the U.S. and Canada, agreed there are challenges facing women in cardiothoracic surgery, but said the curriculum needs to be more attractive to everyone and that providing experiences early on in the medical school curriculum and environment will entice residents "to see that this really is a great career choice, that this is the way of the future and that the need is going to be very real. We have to set the burning platform for everyone and we can do that very easily as an association with the various societies."
Dr. Moffatt-Bruce and her coauthors reported having no financial disclosures.
MINNEAPOLIS – The number of residents failing the American Board of Thoracic Surgery exams has risen significantly in the wake of reduced residency hours, a new study confirms.
The change is particularly alarming for the ABTS oral boards, Dr. Susan Moffatt-Bruce reported at the annual meeting of the American Association for Thoracic Surgery.
The failure rate for the oral exams doubled from 14.4% to 28.1% between 2000 to 2005 and 2006 to 2011, the 6 years before and 6 years after the Accreditation Council for Graduate Medical Education imposed an 80-hour residency work week. By 2012, 30% of residents were failing the oral exam.
Of the 903 residents who took the written exam between 2000 and 2005, 10.6% failed, compared with 17.4% of the 672 residents writing the exam between 2006 and 2007. By 2012, however, the success rate reached 85.4%.
Although the percentage failing the written exam was lower than for the oral exams in both time periods, it remained significantly higher from 2006 to 2011 than before the 80-hour work week requirement (12% vs. 21%) said Dr. Moffatt-Bruce, a cardiothoracic surgeon at the Ohio State Medical Center in Columbus.
"There are a decreasing number of trainees, and we will not meet the needs of a growing American population," she said, observing that the shortfall of certified cardiothoracic surgeons could be realized as early as 2020.
Dr. Moffatt-Bruce speculated that the higher failure rate for the oral exams could be the result of a decrease in the number of critical cardiac cases and in experiential learning for thoracic surgery residents, particularly on the weekends and evenings.
"It is very hard to pass an oral exam question about a scenario that you may never have encountered as a resident," she said.
Since 2000, the number of new certificates awarded by the ABTS has decreased steadily from a peak of 126 certificates in 2002 to 93 certificates in 2011. An additional 100 residents would need to be trained to meet the need for cardiothoracic surgeons by 2030, Dr. Moffatt-Bruce said.
She was careful to acknowledge existing efforts by various groups to attract students, such as the 6-year Integrated Cardiothoracic Surgery Residency Program (I-6), but she said additional strategies are needed to improve not only the number of trainees, but also the way in which they learn.
During a discussion of the results, Dr. Edward Verrier, surgical director, Joint Council of Thoracic Surgery Education, said various societies have gotten together and this spring will roll out a completely new content management system for the cardiothoracic surgery curriculum as well as a new curriculum and learning management tool that will help track issues related to competency and various milestones.
"It’s very important to recognize that these issues have been on the table; they’ve been very carefully thought out at the board level, the society level and by some of the other organizations dedicated to education, and we will see significant transitions over the next year," he said.
Dr. Teresa Kieser, a cardiothoracic surgeon with University of Calgary in Canada, said that more than half of medical school graduates in Canada are women, but that perhaps women aren’t choosing cardiothoracic surgery as a career.
Dr. Moffatt-Bruce, who trained in both the U.S. and Canada, agreed there are challenges facing women in cardiothoracic surgery, but said the curriculum needs to be more attractive to everyone and that providing experiences early on in the medical school curriculum and environment will entice residents "to see that this really is a great career choice, that this is the way of the future and that the need is going to be very real. We have to set the burning platform for everyone and we can do that very easily as an association with the various societies."
Dr. Moffatt-Bruce and her coauthors reported having no financial disclosures.
MINNEAPOLIS – The number of residents failing the American Board of Thoracic Surgery exams has risen significantly in the wake of reduced residency hours, a new study confirms.
The change is particularly alarming for the ABTS oral boards, Dr. Susan Moffatt-Bruce reported at the annual meeting of the American Association for Thoracic Surgery.
The failure rate for the oral exams doubled from 14.4% to 28.1% between 2000 to 2005 and 2006 to 2011, the 6 years before and 6 years after the Accreditation Council for Graduate Medical Education imposed an 80-hour residency work week. By 2012, 30% of residents were failing the oral exam.
Of the 903 residents who took the written exam between 2000 and 2005, 10.6% failed, compared with 17.4% of the 672 residents writing the exam between 2006 and 2007. By 2012, however, the success rate reached 85.4%.
Although the percentage failing the written exam was lower than for the oral exams in both time periods, it remained significantly higher from 2006 to 2011 than before the 80-hour work week requirement (12% vs. 21%) said Dr. Moffatt-Bruce, a cardiothoracic surgeon at the Ohio State Medical Center in Columbus.
"There are a decreasing number of trainees, and we will not meet the needs of a growing American population," she said, observing that the shortfall of certified cardiothoracic surgeons could be realized as early as 2020.
Dr. Moffatt-Bruce speculated that the higher failure rate for the oral exams could be the result of a decrease in the number of critical cardiac cases and in experiential learning for thoracic surgery residents, particularly on the weekends and evenings.
"It is very hard to pass an oral exam question about a scenario that you may never have encountered as a resident," she said.
Since 2000, the number of new certificates awarded by the ABTS has decreased steadily from a peak of 126 certificates in 2002 to 93 certificates in 2011. An additional 100 residents would need to be trained to meet the need for cardiothoracic surgeons by 2030, Dr. Moffatt-Bruce said.
She was careful to acknowledge existing efforts by various groups to attract students, such as the 6-year Integrated Cardiothoracic Surgery Residency Program (I-6), but she said additional strategies are needed to improve not only the number of trainees, but also the way in which they learn.
During a discussion of the results, Dr. Edward Verrier, surgical director, Joint Council of Thoracic Surgery Education, said various societies have gotten together and this spring will roll out a completely new content management system for the cardiothoracic surgery curriculum as well as a new curriculum and learning management tool that will help track issues related to competency and various milestones.
"It’s very important to recognize that these issues have been on the table; they’ve been very carefully thought out at the board level, the society level and by some of the other organizations dedicated to education, and we will see significant transitions over the next year," he said.
Dr. Teresa Kieser, a cardiothoracic surgeon with University of Calgary in Canada, said that more than half of medical school graduates in Canada are women, but that perhaps women aren’t choosing cardiothoracic surgery as a career.
Dr. Moffatt-Bruce, who trained in both the U.S. and Canada, agreed there are challenges facing women in cardiothoracic surgery, but said the curriculum needs to be more attractive to everyone and that providing experiences early on in the medical school curriculum and environment will entice residents "to see that this really is a great career choice, that this is the way of the future and that the need is going to be very real. We have to set the burning platform for everyone and we can do that very easily as an association with the various societies."
Dr. Moffatt-Bruce and her coauthors reported having no financial disclosures.
AT THE AATS ANNUAL MEETING
Major finding: The failure rate for ABTS oral exams doubled from 14.4% to 28.1% between 2000-2005 and 2006-2011, the 6 years before and after the 80-hour residency work week.
Data source: Retrospective analysis of ABTS Board scores, both written and oral, from 2000-2011.
Disclosures: Dr. Moffatt-Bruce and her coauthors reported having no financial disclosures.
Ultralow-dose CT bests X-Ray for lung cancer follow-up, but is it enough?
MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.
"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.
Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.
The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.
Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.
The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).
More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.
"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.
Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).
The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.
"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."
Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.
Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.
"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."
Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.
Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.
New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.
"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.
"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.
Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.
Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.
MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.
"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.
Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.
The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.
Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.
The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).
More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.
"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.
Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).
The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.
"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."
Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.
Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.
"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."
Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.
Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.
New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.
"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.
"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.
Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.
Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.
MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.
"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.
Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.
The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.
Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.
The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).
More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.
"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.
Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).
The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.
"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."
Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.
Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.
"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."
Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.
Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.
New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.
"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.
"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.
Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.
Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.
AT THE AATS ANNUAL MEETING
Major finding: Minimal-dose CT detected 94.2% of new or recurrent lung cancer, compared with 21.1% for chest x-ray.
Data source: Prospective study of 311 curative resection patients who underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest x-ray and CT scans were analyzed.
Disclosures: The researchers reported having no study sponsorship or financial disclosures.
Fontan reoperation mortality unexpectedly high in multicenter analysis
MINNEAPOLIS – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.
Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.
When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.
"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.
The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.
The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.
In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.
Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.
Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.
Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).
Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).
The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.
In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).
Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.
Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).
Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.
Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.
MINNEAPOLIS – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.
Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.
When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.
"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.
The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.
The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.
In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.
Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.
Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.
Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).
Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).
The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.
In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).
Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.
Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).
Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.
Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.
MINNEAPOLIS – Early mortality is substantially higher than initially thought for Fontan revision or conversion, the most common reoperation in adults with congenital heart disease.
Discharge mortality was 10.1% among adults undergoing a Fontan redo from 2007 to 2011 in an analysis of the STS-CHSD (Society of Thoracic Surgeons Congenital Heart Surgery Database), encompassing more than 90% of heart surgeries in the United States.
When Fontan conversion was first described in a single-center series, however, discharge mortality was less than 1% (Ann. Thorac. Surg. 2007;84:1457-65), observed Dr. Jeffrey P. Jacobs, chair of the STS-CHSD, and a cardiovascular surgeon with All Children’s Hospital, Johns Hopkins Medicine, St. Petersburg, Fla.
"This point really exemplifies the power of multi-institution data and exemplifies that the published literature reflecting an excellence experience at one center, may not reflect the reality of what is going on across the country or across the world," he said at the annual meeting of the American Association for Thoracic Surgery.
The STS-CHSD includes 108 congenital heart surgery hospitals in North America, 105 in the United States and 3 in Canada, or 84% of programs in the United States.
The investigators identified 92,603 index cardiac operations in the database from 2007-2011, after excluding those with missing data and patients weighing 2,500 g or less undergoing patent ductus arteriosus ligation as their primary procedure.
In all, 30,673 (33%) had one or more prior cardiopulmonary bypass cardiothoracic operation, which was used as a surrogate for reoperation.
Discharge mortality was 3.98% with no prior bypass cardiothoracic operations, 2.38% with one, 1.67% with two, 2.41% with three, 3.31% with four, 4.08% with five, and 5.07% with six or more reoperations, Dr. Jacobs said.
Mean length of stay was 14.8 days for the index procedure and increased in a stepwise manner from 10.8 days with one prior surgery to 14.07 with six or more surgeries.
Fontan (total cavopulmonary connection, external conduit) was the most common reoperation performed among all patients and had the highest discharge mortality whether it was fenestrated (1.8% among 1,870 patients) or nonfenestrated (1.6% among 1,403 patients).
Discharge mortality was lower among all patients for bidirectional cavopulmonary anastomosis (1.3%), pulmonic valve replacement (0.4%), conduit reoperation (0.8%), pacemaker procedure (0.3%), and permanent pacemaker implantation (1.4%).
The number of neonates dying before discharge was alarmingly high for various operations including total anomalous pulmonary venous connection repair (55.6%), pulmonary artery banding (36.4%), and the Norwood procedure (21.6%), but Dr. Jacobs cautioned that these reoperations are very rare events occurring in 18, 11, and 37 cases, respectively.
In contrast, discharge mortality among infants reached a high of 2.6% for a hemi-Fontan reoperation (8 deaths/311 procedures) and was half that for bidirectional cavopulmonary anastomosis, the most common reoperation among infants (29 deaths/2,271 procedures).
Discharge mortality for reoperations among children, aged 1-18 years, in the United States also remained below 2%, he said. The highest rate was 1.7% for a Fontan redo (TCPC, external conduit, fenestrated), the most common operation, performed in 1,852 children.
Finally, there were no double-digit discharge mortality rates among adults, save for the bloated 10.1% reported for Fontan revision or conversion. Rates were low for arrhythmia surgery–atrial surgical ablation (3.4%), right ventricle to pulmonary artery conduit placement (3.3%), permanent pacemaker implantation (2%), conduit reoperation (1.6%), pulmonic valve replacement (0.3%), and pacemaker procedure (0.2%).
Science tells us what we can do, guidelines what we should do, and registries what we are actually doing, Dr. Jacobs concluded.
Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce; STS Task Force on Longitudinal Follow-Up and Linked Registries; and the STS Public Reporting Task Force.
AT THE AATS ANNUAL MEETING
Major finding: Discharge mortality was 10.1% among adults undergoing a Fontan conversion from 2007 to 2011.
Data source: Retrospective analysis of 92,603 index cardiac operations in the Society of Thoracic Surgeons Congenital Heart Surgery Database, including 30,673 reoperations.
Disclosures: Dr. Jacobs is chair of the STS Congenital Heart Surgery Database Taskforce, STS Task Force on Longitudinal Follow-Up and Linked Registries and the STS Public Reporting Task Force.
Less aggressive anticoagulation appears safe after high-risk aortic valve replacement
MINNEAPOLIS – High-risk patients receiving the On-X mechanical aortic valve can be safely managed with less aggressive anticoagulation than currently recommended, interim results of the PROACT trial suggest.*
The lower target international normalized ratio (INR) in the trial resulted in a decline of more than 50% in bleeding events and did not increase the risk of thromboembolism, reported Dr. John Puskas, international principal investigator for PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) and associate chief of cardiothoracic surgery at Emory University in Atlanta.
"This aortic bileaflet mechanical valve may be safely managed in these select patients at an INR of 1.5 to 2.0, with daily low-dose aspirin," he said at the annual meeting of the American Association for Thoracic Surgery.
Current American College of Cardiology and American Heart Association guidelines recommend that warfarin be dosed to achieve an INR of 2.0 to 3.0 after implantation of a bileaflet mechanical valve, and that once-daily aspirin 75-100 mg be added for all patients with mechanical heart valves.
Dr. Puskas and his associates analyzed data from 375 high-risk patients randomly assigned to lower-dose warfarin (INR 1.5-2.0) or to continue standard-dose warfarin (INR 2.0-3.0), 3 months after implantation with the On-X bileaflet mechanical heart valve. All patients received aspirin 81 mg daily. INR was adjusted by rigorous home self-monitoring, with an average of 9 days between readings and at least 96% compliance.
High-risk patients included those with chronic atrial fibrillation, left ventricular ejection fraction less than 30%, ventricular aneurysm, left atrium diameter greater than 50 mm, prior neurological events, on estrogen replacement therapy, hypercoagulability, or inadequate platelet response to aspirin or clopidogrel (Plavix). There were 185 patients in the experimental, test arm and 190 in the control arm. After randomization, 11 test patients had a neurological event (5 strokes, 6 transient ischemic attacks) and crossed over to the control group, per protocol.
After an average follow-up of 3.82 years, patients managed with a lower target INR had a significant benefit compared with controls with respect to number of major bleeding events (10 vs. 25, respectively), minor bleeds (8 vs. 25), total bleeds (18 vs. 50), and all bleeding and thrombus (38 vs. 64), Dr. Puskas said. The corresponding rate ratios (RRs) were 0.45, 0.36, 0.40, and 0.66.
There was no difference between groups in the composite primary endpoint of major bleed, stroke, transient ischemic attack, thromboembolic events and thrombosis (30 events vs. 39 events; RR, 0.86; P = .54), he said.
Specifically, hemorrhagic stroke occurred in 1 test patient and 2 controls (RR, 0.56) and ischemic stroke in 5 patients in each group (RR, 1.12), he said.
Valve-related mortality was also similar in the test and control groups (5 deaths vs. 4 deaths), as was total mortality (10 vs. 11), Dr. Puskas said.
Invited discussant Dr. A. Pieter Kappetein, a member of the RE-ALIGN trial steering committee and professor of thoracic surgery at Erasmus Medical Center in Rotterdam, the Netherlands, said the number of patients in the analysis was extremely low and questioned the validity of combining bleeding and thromboembolic events in the primary endpoint.
"In this study, you mix the efficacy endpoint with the safety endpoints," he said, observing that they move in opposite directions.
In light of such large-scale trials as ARISTOTLE and RELY, he asked whether PROACT should be considered a pilot trial and whether a new trial, designed with roughly 8,000 patients, should be performed that would also include newer anticoagulation agents to adequately evaluate reduced anticoagulation in mechanical valves.
"Is it not potentially dangerous if we do not know what the increase is for thrombosis and follow your conclusions?" he added.
Dr. Puskas said he shared Dr. Kappetein’s concern about the noninferiority design of the trial and that it was a topic of great discussion with the Food and Drug Administration (FDA). He also agreed that thrombotic events and bleeding events move in the opposite direction.
"What we are really looking for is to determine the sweet spot where those two curves intersect," he said. "While it is theoretically and intellectually correct to say that thrombosis is the efficacy issue and hemorrhage is the safety issue, we are obliged to combine those for two reasons.
"The first is practical; no company will sponsor an 8,000-patient trial, and second, this is, in fact, a trade-off in the minds of patients and clinicians. So, it is a relevant clinical endpoint – the unholy composite, if you will – of thrombosis and hemorrhage."
Finally, a member of the audience asked whether the results would hold up with standard management because universal point-of-care home testing is not the "real world" in the United States.
Dr. Puskas replied that it is in Scandinavia and other parts of the world, and admonished American clinicians, including himself, "to catch up to what should be standard of care." He noted that, based on the roughly 53,000 INR readings in PROACT, controlling INR within your range was more important in terms of adverse events, particularly hemorrhagic events, than what arm patients were assigned to.
"Home monitoring is available, it’s not high tech and it’s much easier for patients," he said. "To be perfectly blunt, there’s really no excuse for us not using it uniformly in America. Quite frankly, it is a conflict of interest between local caregivers and their patients’ well-being.
"There is a small revenue stream to cardiology offices and primary care doctors running Coumadin clinics, and that is keeping us in the system that we have now rather than home monitoring through bigger, centralized Coumadin clinics."
Dr. Puskas did not report data on PROACT’s low-risk arm managed with clopidogrel 75 mg/day plus aspirin 325 mg/day, or a third arm managed on warfarin at an INR of 2.0-2.5 plus aspirin 81 mg/day. The low-risk data will not be available for at least one more year, although the investigators are in discussion with the FDA about a possible interim analysis, he said in an interview.
The evaluable high-risk patients were 79% male, 93% were in sinus rhythm preoperatively, and concomitant procedures included coronary artery bypass grafting in 27%, aortic aneurysm repair in 14%, and other procedures in 25%. Their average age was 55 years.
Life Technologies sponsored the study. Dr. Puskas reported having no financial relationship with Life Technologies.
Correction, 6/18/2013: An earlier version of this article stated that the On-X aortic valve is investigational. This was a misstatement. The valve itself has been approved in the United States since 2001. The PROACT trial applications of lowered INR and an aspirin/Plavix regimen are not approved.
MINNEAPOLIS – High-risk patients receiving the On-X mechanical aortic valve can be safely managed with less aggressive anticoagulation than currently recommended, interim results of the PROACT trial suggest.*
The lower target international normalized ratio (INR) in the trial resulted in a decline of more than 50% in bleeding events and did not increase the risk of thromboembolism, reported Dr. John Puskas, international principal investigator for PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) and associate chief of cardiothoracic surgery at Emory University in Atlanta.
"This aortic bileaflet mechanical valve may be safely managed in these select patients at an INR of 1.5 to 2.0, with daily low-dose aspirin," he said at the annual meeting of the American Association for Thoracic Surgery.
Current American College of Cardiology and American Heart Association guidelines recommend that warfarin be dosed to achieve an INR of 2.0 to 3.0 after implantation of a bileaflet mechanical valve, and that once-daily aspirin 75-100 mg be added for all patients with mechanical heart valves.
Dr. Puskas and his associates analyzed data from 375 high-risk patients randomly assigned to lower-dose warfarin (INR 1.5-2.0) or to continue standard-dose warfarin (INR 2.0-3.0), 3 months after implantation with the On-X bileaflet mechanical heart valve. All patients received aspirin 81 mg daily. INR was adjusted by rigorous home self-monitoring, with an average of 9 days between readings and at least 96% compliance.
High-risk patients included those with chronic atrial fibrillation, left ventricular ejection fraction less than 30%, ventricular aneurysm, left atrium diameter greater than 50 mm, prior neurological events, on estrogen replacement therapy, hypercoagulability, or inadequate platelet response to aspirin or clopidogrel (Plavix). There were 185 patients in the experimental, test arm and 190 in the control arm. After randomization, 11 test patients had a neurological event (5 strokes, 6 transient ischemic attacks) and crossed over to the control group, per protocol.
After an average follow-up of 3.82 years, patients managed with a lower target INR had a significant benefit compared with controls with respect to number of major bleeding events (10 vs. 25, respectively), minor bleeds (8 vs. 25), total bleeds (18 vs. 50), and all bleeding and thrombus (38 vs. 64), Dr. Puskas said. The corresponding rate ratios (RRs) were 0.45, 0.36, 0.40, and 0.66.
There was no difference between groups in the composite primary endpoint of major bleed, stroke, transient ischemic attack, thromboembolic events and thrombosis (30 events vs. 39 events; RR, 0.86; P = .54), he said.
Specifically, hemorrhagic stroke occurred in 1 test patient and 2 controls (RR, 0.56) and ischemic stroke in 5 patients in each group (RR, 1.12), he said.
Valve-related mortality was also similar in the test and control groups (5 deaths vs. 4 deaths), as was total mortality (10 vs. 11), Dr. Puskas said.
Invited discussant Dr. A. Pieter Kappetein, a member of the RE-ALIGN trial steering committee and professor of thoracic surgery at Erasmus Medical Center in Rotterdam, the Netherlands, said the number of patients in the analysis was extremely low and questioned the validity of combining bleeding and thromboembolic events in the primary endpoint.
"In this study, you mix the efficacy endpoint with the safety endpoints," he said, observing that they move in opposite directions.
In light of such large-scale trials as ARISTOTLE and RELY, he asked whether PROACT should be considered a pilot trial and whether a new trial, designed with roughly 8,000 patients, should be performed that would also include newer anticoagulation agents to adequately evaluate reduced anticoagulation in mechanical valves.
"Is it not potentially dangerous if we do not know what the increase is for thrombosis and follow your conclusions?" he added.
Dr. Puskas said he shared Dr. Kappetein’s concern about the noninferiority design of the trial and that it was a topic of great discussion with the Food and Drug Administration (FDA). He also agreed that thrombotic events and bleeding events move in the opposite direction.
"What we are really looking for is to determine the sweet spot where those two curves intersect," he said. "While it is theoretically and intellectually correct to say that thrombosis is the efficacy issue and hemorrhage is the safety issue, we are obliged to combine those for two reasons.
"The first is practical; no company will sponsor an 8,000-patient trial, and second, this is, in fact, a trade-off in the minds of patients and clinicians. So, it is a relevant clinical endpoint – the unholy composite, if you will – of thrombosis and hemorrhage."
Finally, a member of the audience asked whether the results would hold up with standard management because universal point-of-care home testing is not the "real world" in the United States.
Dr. Puskas replied that it is in Scandinavia and other parts of the world, and admonished American clinicians, including himself, "to catch up to what should be standard of care." He noted that, based on the roughly 53,000 INR readings in PROACT, controlling INR within your range was more important in terms of adverse events, particularly hemorrhagic events, than what arm patients were assigned to.
"Home monitoring is available, it’s not high tech and it’s much easier for patients," he said. "To be perfectly blunt, there’s really no excuse for us not using it uniformly in America. Quite frankly, it is a conflict of interest between local caregivers and their patients’ well-being.
"There is a small revenue stream to cardiology offices and primary care doctors running Coumadin clinics, and that is keeping us in the system that we have now rather than home monitoring through bigger, centralized Coumadin clinics."
Dr. Puskas did not report data on PROACT’s low-risk arm managed with clopidogrel 75 mg/day plus aspirin 325 mg/day, or a third arm managed on warfarin at an INR of 2.0-2.5 plus aspirin 81 mg/day. The low-risk data will not be available for at least one more year, although the investigators are in discussion with the FDA about a possible interim analysis, he said in an interview.
The evaluable high-risk patients were 79% male, 93% were in sinus rhythm preoperatively, and concomitant procedures included coronary artery bypass grafting in 27%, aortic aneurysm repair in 14%, and other procedures in 25%. Their average age was 55 years.
Life Technologies sponsored the study. Dr. Puskas reported having no financial relationship with Life Technologies.
Correction, 6/18/2013: An earlier version of this article stated that the On-X aortic valve is investigational. This was a misstatement. The valve itself has been approved in the United States since 2001. The PROACT trial applications of lowered INR and an aspirin/Plavix regimen are not approved.
MINNEAPOLIS – High-risk patients receiving the On-X mechanical aortic valve can be safely managed with less aggressive anticoagulation than currently recommended, interim results of the PROACT trial suggest.*
The lower target international normalized ratio (INR) in the trial resulted in a decline of more than 50% in bleeding events and did not increase the risk of thromboembolism, reported Dr. John Puskas, international principal investigator for PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial) and associate chief of cardiothoracic surgery at Emory University in Atlanta.
"This aortic bileaflet mechanical valve may be safely managed in these select patients at an INR of 1.5 to 2.0, with daily low-dose aspirin," he said at the annual meeting of the American Association for Thoracic Surgery.
Current American College of Cardiology and American Heart Association guidelines recommend that warfarin be dosed to achieve an INR of 2.0 to 3.0 after implantation of a bileaflet mechanical valve, and that once-daily aspirin 75-100 mg be added for all patients with mechanical heart valves.
Dr. Puskas and his associates analyzed data from 375 high-risk patients randomly assigned to lower-dose warfarin (INR 1.5-2.0) or to continue standard-dose warfarin (INR 2.0-3.0), 3 months after implantation with the On-X bileaflet mechanical heart valve. All patients received aspirin 81 mg daily. INR was adjusted by rigorous home self-monitoring, with an average of 9 days between readings and at least 96% compliance.
High-risk patients included those with chronic atrial fibrillation, left ventricular ejection fraction less than 30%, ventricular aneurysm, left atrium diameter greater than 50 mm, prior neurological events, on estrogen replacement therapy, hypercoagulability, or inadequate platelet response to aspirin or clopidogrel (Plavix). There were 185 patients in the experimental, test arm and 190 in the control arm. After randomization, 11 test patients had a neurological event (5 strokes, 6 transient ischemic attacks) and crossed over to the control group, per protocol.
After an average follow-up of 3.82 years, patients managed with a lower target INR had a significant benefit compared with controls with respect to number of major bleeding events (10 vs. 25, respectively), minor bleeds (8 vs. 25), total bleeds (18 vs. 50), and all bleeding and thrombus (38 vs. 64), Dr. Puskas said. The corresponding rate ratios (RRs) were 0.45, 0.36, 0.40, and 0.66.
There was no difference between groups in the composite primary endpoint of major bleed, stroke, transient ischemic attack, thromboembolic events and thrombosis (30 events vs. 39 events; RR, 0.86; P = .54), he said.
Specifically, hemorrhagic stroke occurred in 1 test patient and 2 controls (RR, 0.56) and ischemic stroke in 5 patients in each group (RR, 1.12), he said.
Valve-related mortality was also similar in the test and control groups (5 deaths vs. 4 deaths), as was total mortality (10 vs. 11), Dr. Puskas said.
Invited discussant Dr. A. Pieter Kappetein, a member of the RE-ALIGN trial steering committee and professor of thoracic surgery at Erasmus Medical Center in Rotterdam, the Netherlands, said the number of patients in the analysis was extremely low and questioned the validity of combining bleeding and thromboembolic events in the primary endpoint.
"In this study, you mix the efficacy endpoint with the safety endpoints," he said, observing that they move in opposite directions.
In light of such large-scale trials as ARISTOTLE and RELY, he asked whether PROACT should be considered a pilot trial and whether a new trial, designed with roughly 8,000 patients, should be performed that would also include newer anticoagulation agents to adequately evaluate reduced anticoagulation in mechanical valves.
"Is it not potentially dangerous if we do not know what the increase is for thrombosis and follow your conclusions?" he added.
Dr. Puskas said he shared Dr. Kappetein’s concern about the noninferiority design of the trial and that it was a topic of great discussion with the Food and Drug Administration (FDA). He also agreed that thrombotic events and bleeding events move in the opposite direction.
"What we are really looking for is to determine the sweet spot where those two curves intersect," he said. "While it is theoretically and intellectually correct to say that thrombosis is the efficacy issue and hemorrhage is the safety issue, we are obliged to combine those for two reasons.
"The first is practical; no company will sponsor an 8,000-patient trial, and second, this is, in fact, a trade-off in the minds of patients and clinicians. So, it is a relevant clinical endpoint – the unholy composite, if you will – of thrombosis and hemorrhage."
Finally, a member of the audience asked whether the results would hold up with standard management because universal point-of-care home testing is not the "real world" in the United States.
Dr. Puskas replied that it is in Scandinavia and other parts of the world, and admonished American clinicians, including himself, "to catch up to what should be standard of care." He noted that, based on the roughly 53,000 INR readings in PROACT, controlling INR within your range was more important in terms of adverse events, particularly hemorrhagic events, than what arm patients were assigned to.
"Home monitoring is available, it’s not high tech and it’s much easier for patients," he said. "To be perfectly blunt, there’s really no excuse for us not using it uniformly in America. Quite frankly, it is a conflict of interest between local caregivers and their patients’ well-being.
"There is a small revenue stream to cardiology offices and primary care doctors running Coumadin clinics, and that is keeping us in the system that we have now rather than home monitoring through bigger, centralized Coumadin clinics."
Dr. Puskas did not report data on PROACT’s low-risk arm managed with clopidogrel 75 mg/day plus aspirin 325 mg/day, or a third arm managed on warfarin at an INR of 2.0-2.5 plus aspirin 81 mg/day. The low-risk data will not be available for at least one more year, although the investigators are in discussion with the FDA about a possible interim analysis, he said in an interview.
The evaluable high-risk patients were 79% male, 93% were in sinus rhythm preoperatively, and concomitant procedures included coronary artery bypass grafting in 27%, aortic aneurysm repair in 14%, and other procedures in 25%. Their average age was 55 years.
Life Technologies sponsored the study. Dr. Puskas reported having no financial relationship with Life Technologies.
Correction, 6/18/2013: An earlier version of this article stated that the On-X aortic valve is investigational. This was a misstatement. The valve itself has been approved in the United States since 2001. The PROACT trial applications of lowered INR and an aspirin/Plavix regimen are not approved.
AT THE AATS ANNUAL MEETING
Major finding: The composite primary endpoint of major bleed, stroke, transient ischemic attack, thromboembolic events, and thrombosis occurred in 30 patients managed with less aggressive anticoagulation and in 39 managed with standard warfarin anticoagulation (rate ratio, 0.86; P = .54).
Data source: Interim analysis of 375 high-risk aortic valve replacement patients in the Prospective Randomized On-X Anticoagulation Trial.
Disclosures: Life Technologies sponsored the study. Dr. Puskas reported having no financial relationship with Life Technologies.
