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In 8 years, TMVR means more procedures
NEW YORK – Since the commercialization of transcatheter mitral valve repair, the share of these procedures among all mitral operations has grown exponentially and has also contributed to an increase in the number of overall mitral procedures, including surgical repair, according to an analysis of a national German database reported at the American Association for Thoracic Surgery Mitral Conclave here.
Transcatheter mitral valve repair (TMVR) using the MitraClip device (Abbott Vascular) was first commercialized in Germany in 2008, and in the years since the share of TMVR procedures among all mitral operations increased from 0.3% to 18.1% in 2015 throughout Germany, said Lenard Conradi, MD, surgical director of minimally-invasive and transcatheter heart valve procedures at the University Heart Center Hamburg.
The goal of the study was to gain insights into how cardiothoracic surgeons in Germany and at Dr. Conradi’s center in particular were approaching TMVR and what types of patients were having the procedure, Dr. Conradi said.
“While the EuroSCORE I of patients we operated on didn’t change at all between these two time frames, there were subtle changes in the patients that we operated on,” he said. “Before the commercialization of TMVR, we tended to have a ratio of organic vs. functional MR [mitral regurgitation] of 50-50; after commercialization of TMVR, many of the functional MR patients were allocated to TMVR.”
Dr. Conradi noted the profile of patients who had mitral valve repair also changed once the transcatheter approach became available. “Ischemic disease with coronary artery disease, previous infarction, or previous cardiac surgery – mostly coronary artery bypass grafting – were much less prevalent in this surgery population after TMVR became available,” he said.
The study also found that 30-day mortality declined from 7% to 4% during the study period. “That was probably due to more adequate patient selection because we had a more appropriate treatment that we could offer these high-risk patients as an alternative to high-risk surgical approaches,” Dr. Conradi said.
The analysis stratified procedure volumes and growth by four age groups: younger than 65 years; 65-74; 75-84; and greater than ore equal to 85. Older patients were more likely to have TMVR. Surgical procedure volumes increased most in the less than 65 group and least in the greater than or equal to 85 group.
In Germany, transcatheter mitral valve procedures are reimbursed at a higher rate than surgical procedures, but that doesn’t fully explain the uptake in TMVR, Dr. Conradi said. “The patients receiving the transcatheter approach vs. surgery still differ fundamentally, but the addition of an interventional program decreases the surgical patient’s mean risk profile and thus optimizes surgical results,” he said. “I think this can only happen if surgeons are closely involved. The indications will broaden for these therapies. There’s no doubt about that.”
Dr. Conradi disclosed receiving travel support and lecture fees from Abbott Vascular.
NEW YORK – Since the commercialization of transcatheter mitral valve repair, the share of these procedures among all mitral operations has grown exponentially and has also contributed to an increase in the number of overall mitral procedures, including surgical repair, according to an analysis of a national German database reported at the American Association for Thoracic Surgery Mitral Conclave here.
Transcatheter mitral valve repair (TMVR) using the MitraClip device (Abbott Vascular) was first commercialized in Germany in 2008, and in the years since the share of TMVR procedures among all mitral operations increased from 0.3% to 18.1% in 2015 throughout Germany, said Lenard Conradi, MD, surgical director of minimally-invasive and transcatheter heart valve procedures at the University Heart Center Hamburg.
The goal of the study was to gain insights into how cardiothoracic surgeons in Germany and at Dr. Conradi’s center in particular were approaching TMVR and what types of patients were having the procedure, Dr. Conradi said.
“While the EuroSCORE I of patients we operated on didn’t change at all between these two time frames, there were subtle changes in the patients that we operated on,” he said. “Before the commercialization of TMVR, we tended to have a ratio of organic vs. functional MR [mitral regurgitation] of 50-50; after commercialization of TMVR, many of the functional MR patients were allocated to TMVR.”
Dr. Conradi noted the profile of patients who had mitral valve repair also changed once the transcatheter approach became available. “Ischemic disease with coronary artery disease, previous infarction, or previous cardiac surgery – mostly coronary artery bypass grafting – were much less prevalent in this surgery population after TMVR became available,” he said.
The study also found that 30-day mortality declined from 7% to 4% during the study period. “That was probably due to more adequate patient selection because we had a more appropriate treatment that we could offer these high-risk patients as an alternative to high-risk surgical approaches,” Dr. Conradi said.
The analysis stratified procedure volumes and growth by four age groups: younger than 65 years; 65-74; 75-84; and greater than ore equal to 85. Older patients were more likely to have TMVR. Surgical procedure volumes increased most in the less than 65 group and least in the greater than or equal to 85 group.
In Germany, transcatheter mitral valve procedures are reimbursed at a higher rate than surgical procedures, but that doesn’t fully explain the uptake in TMVR, Dr. Conradi said. “The patients receiving the transcatheter approach vs. surgery still differ fundamentally, but the addition of an interventional program decreases the surgical patient’s mean risk profile and thus optimizes surgical results,” he said. “I think this can only happen if surgeons are closely involved. The indications will broaden for these therapies. There’s no doubt about that.”
Dr. Conradi disclosed receiving travel support and lecture fees from Abbott Vascular.
NEW YORK – Since the commercialization of transcatheter mitral valve repair, the share of these procedures among all mitral operations has grown exponentially and has also contributed to an increase in the number of overall mitral procedures, including surgical repair, according to an analysis of a national German database reported at the American Association for Thoracic Surgery Mitral Conclave here.
Transcatheter mitral valve repair (TMVR) using the MitraClip device (Abbott Vascular) was first commercialized in Germany in 2008, and in the years since the share of TMVR procedures among all mitral operations increased from 0.3% to 18.1% in 2015 throughout Germany, said Lenard Conradi, MD, surgical director of minimally-invasive and transcatheter heart valve procedures at the University Heart Center Hamburg.
The goal of the study was to gain insights into how cardiothoracic surgeons in Germany and at Dr. Conradi’s center in particular were approaching TMVR and what types of patients were having the procedure, Dr. Conradi said.
“While the EuroSCORE I of patients we operated on didn’t change at all between these two time frames, there were subtle changes in the patients that we operated on,” he said. “Before the commercialization of TMVR, we tended to have a ratio of organic vs. functional MR [mitral regurgitation] of 50-50; after commercialization of TMVR, many of the functional MR patients were allocated to TMVR.”
Dr. Conradi noted the profile of patients who had mitral valve repair also changed once the transcatheter approach became available. “Ischemic disease with coronary artery disease, previous infarction, or previous cardiac surgery – mostly coronary artery bypass grafting – were much less prevalent in this surgery population after TMVR became available,” he said.
The study also found that 30-day mortality declined from 7% to 4% during the study period. “That was probably due to more adequate patient selection because we had a more appropriate treatment that we could offer these high-risk patients as an alternative to high-risk surgical approaches,” Dr. Conradi said.
The analysis stratified procedure volumes and growth by four age groups: younger than 65 years; 65-74; 75-84; and greater than ore equal to 85. Older patients were more likely to have TMVR. Surgical procedure volumes increased most in the less than 65 group and least in the greater than or equal to 85 group.
In Germany, transcatheter mitral valve procedures are reimbursed at a higher rate than surgical procedures, but that doesn’t fully explain the uptake in TMVR, Dr. Conradi said. “The patients receiving the transcatheter approach vs. surgery still differ fundamentally, but the addition of an interventional program decreases the surgical patient’s mean risk profile and thus optimizes surgical results,” he said. “I think this can only happen if surgeons are closely involved. The indications will broaden for these therapies. There’s no doubt about that.”
Dr. Conradi disclosed receiving travel support and lecture fees from Abbott Vascular.
AT THE AATS MITRAL CONCLAVE 2017
Key clinical point: Since its commercialization, transcatheter mitral valve repair (TMVR) has accounted for an increasing share of all mitral surgeries in Germany and driven greater mitral surgery volume overall.
Major finding: Volume of surgical mitral valve procedures increased 70% overall and TMVR procedures 57% in Germany since 2008.
Data source: Analysis of data from German Federal statistics office.
Disclosures: Dr. Conradi reported receiving travel support and lecture fees from Abbott Vascular.
Novel Lotus valve outperforms CoreValve in REPRISE III
PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.
“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.
The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.
REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.
REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.
The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.
The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.
“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”
The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.
The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.
The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.
The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.
REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.
[email protected]
PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.
“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.
The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.
REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.
REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.
The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.
The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.
“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”
The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.
The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.
The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.
The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.
REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.
[email protected]
PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.
A key finding was that the Lotus valve group had a 1-year rate of moderate or greater PVL of just 2% as assessed in a central core lab, compared with an 11% rate in patients randomized to the classic CoreValve or the subsequent-generation Evolut R device, he observed.
“With the Lotus valve there was no or only trace PVL in over 85% of patients. This is probably even more important than the low rate of moderate or severe PVL. The valve really does result in virtually no PVL in the vast majority of patients. That’s unique to this platform,” the cardiologist said in an interview.
The unprecedented low rate of moderate or severe PVL at 1 year postprocedure is attributable to the polymer seal delivered via the Lotus system for that express purpose, he explained.
REPRISE III was the first large randomized comparative clinical trial featuring two TAVR valves, an event that reflects the rapid expansion of the field. All previous major trials had compared TAVR with surgical aortic valve replacement.
REPRISE III randomized 912 TAVR patients at 55 centers 2:1 to the Lotus valve in its 23-, 25-, or 27-mm configurations or to a CoreValve at 26, 29, or 31 mm. Roughly half of the CoreValve group got the newer repositionable and retrievable Evolut R valve, while the earlier enrollees received the nonrepositionable classic CoreValve.
The Lotus valve group proved noninferior to the CoreValve recipients for the primary safety endpoint, a 30-day composite of all-cause mortality, stroke, major or life-threatening bleeding, major vascular complications, and stage 2 or 3 acute kidney injury. The rates were 20.3% in the Lotus arm and 17.2% with CoreValve.
The 1-year rate of disabling stroke was 3.6% in the Lotus group versus 7.3% in the CoreValve group. Dr. Feldman downplayed the importance of this difference, even though it was statistically significant. The Lotus valve performed as expected, but the disabling stroke rate in the CoreValve group was higher than in earlier studies for reasons unknown, most likely simply the play of chance, he said.
“I think the real message here is that the Lotus valve performed very well,” the cardiologist said. “There have been concerns that repositioning the valve into a better position during the deployment process might create excess stroke. It appears clear that’s not the case.”
The ability to reposition the Lotus device resulted in a significantly lower rate of repeat procedures at 1 year: 0.2% versus 2% with the CoreValve, as well as zero cases of aortic valve malposition and valve-in-valve deployment.
The need for a new pacemaker within 30 days after TAVR was strikingly more common in the Lotus valve group: 36%, compared with 20% with the CoreValve. Dr. Feldman attributed the high new pacemaker rate in the Lotus arm partly to the operators’ limited experience with the novel valve along with the fact that REPRISE III used a first-iteration device deployment mechanism. An improved deployment mechanism designed to minimize problematic contact with the left ventricular outflow tract was developed too late for inclusion in the trial. But in a recent European study using this proprietary deployment system, known as Depth Guard, the new pacemaker rate was below 20%.
The learning curve for the new Lotus valve system is “not at all challenging,” according to the cardiologist. He noted that U.S. operators participating in REPRISE III, who had no prior experience with the device, were allowed only two initial cases in order to gain experience; after that, every patient counted in the clinical trial results.
The REPRISE III results will be offered to the Food and Drug Administration to support regulatory approval of the device in high-surgical-risk patients. Dr. Feldman said Boston Scientific plans to conduct an additional clinical trial of the Lotus valve, this time in intermediate-risk patients, with the goal of gaining an expanded indication. This, too, will be a head-to-head comparison with a commercially available TAVR valve, probably the Edwards Sapien 3 valve.
REPRISE III was sponsored by Boston Scientific. Dr. Feldman reported serving as a consultant to that company, Abbott, and Edwards Lifesciences, and having received institutional research grants from those companies as well.
[email protected]
AT EUROPCR
Key clinical point:
Major finding: The rate of the 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak was 17% in patients randomized to the investigational Lotus transcatheter aortic valve replacement system, compared with 29% in recipients of the CoreValve.
Data source: REPRISE III, a prospective, multicenter, international clinical trial randomized 912 patients with severe aortic stenosis who were at high surgical risk to TAVR with the investigational Lotus valve or a commercially available CoreValve.
Disclosures: REPRISE III was sponsored by Boston Scientific. The study presenter reported serving as a consultant to that company as well as for Abbott and Edwards Lifesciences. He has also received institutional research grants from those companies.
VIDEO: Sutureless aortic valve shows promise in IDE trial
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).
The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
VIDEO: Surgery use declines for non–small cell lung cancer
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
Time to reexamine surgery for nonlocalized bronchiectasis
Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.
“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).
The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.
The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.
The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.
Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.
The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).
Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).
Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.
But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”
The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.
Dr. Dai and his coauthors had no financial relationships to disclose.
The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”
Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.
To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.
Dr. Milman and Dr. Ng had no financial relationships to disclose.
The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”
Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.
To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.
Dr. Milman and Dr. Ng had no financial relationships to disclose.
The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”
Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.
To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.
Dr. Milman and Dr. Ng had no financial relationships to disclose.
Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.
“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).
The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.
The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.
The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.
Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.
The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).
Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).
Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.
But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”
The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.
Dr. Dai and his coauthors had no financial relationships to disclose.
Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.
“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).
The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.
The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.
The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.
Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.
The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).
Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).
Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.
But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”
The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.
Dr. Dai and his coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Lobectomy for nonlocalized bronchiectasis can improve symptoms significantly.
Major finding: Among 37 patients who had lobectomy, 62.2% were asymptomatic after surgery.
Data source: Single-center retrospective review of 37 patients who had lobectomy for nonlocalized bronchiectasis from January 2010 to December 2013.
Disclosure: Dr. Dai and his coauthors had no financial relationships to disclose.
Orbital, over rotational, atherectomy holds survival edge in elderly, obese
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
WASHINGTON – Orbital atherectomy (OA) was associated with a lower risk of in-hospital mortality than rotational atherectomy (RA) in female, obese, and elderly study groups, according to data from a prospective observational study.
Each procedure was employed to treat coronary artery calcifications (CAC) in the elderly and the obese prior to percutaneous interventions (PCI).
The data comparing OA with RA in these populations were drawn from the Clinical Outcomes of Atherectomy Prior to PCI (COAP) study, for which Perwaiz M. Meraj, MD, director of structural heart and peripheral vascular disease at the North Shore-LIJ Hospital, Manhasset, N.Y., served as the senior author.
Each set of data, as well as a third set of data comparing OA to RA in female patients, was presented separately at CRT 2017, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In the comparison of OA to RA in the elderly, a substudy known as COAP-75, the focus was on patients 75 years of age or older who underwent either OA or RA to remove calcified coronary lesions within the context of PCI. As with the obese and female subgroups, the elderly patients in this study were drawn from 35,590 patients who underwent PCI at one of five tertiary care hospitals in a recent 5-year period.
Of the 310 elderly patients undergoing atherectomy, 117 were treated with OA and 193 with RA. The median lesion lengths and diameters were not significantly different between the two groups. Although OA was less likely to be performed through femoral access (53% vs. 68.9%; P = .005), no other measured differences in procedure were significant, with one exception: Fluoroscopy exposure was of shorter duration in the OA, versus the RA, arm (24.0 minutes vs. 29.4 minutes; P = .005).
On univariate analysis, the lower rate of in-hospital deaths for OA did not reach statistical significance (0% vs. 1.55%; P = .176), but the difference was significant on multivariate-adjusted analysis (P = .034).
There were also higher numerical rates of perforation, tamponade, heart failure, and red blood cell transfusion in the RA group, versus the OA group, but only the latter was significant (P = .002) on multivariate-adjusted analysis.
In contrast, there was a higher rate of MI among those treated with OA, rather than RA (17.1% vs. 13.5%), which was not significant on univariate analysis (P = .573) but did reach significance on adjusted-multivariate analysis (P = .008).
Overall, the authors suggested that both OA and RA are safe procedures, but the mortality reduction suggests a potential relative advantage for OA.
Similar conclusions were reached in the substudy of patients with obesity, called COAP-BMI. In that study, 222 patients were evaluated, of which 91 were treated with OA and 131 were treated with RA.
In-hospital mortality was 0% in the group treated with OA, compared with 3.05% in the group treated with RA (P = .004). The rate of in-hospital major adverse cardiovascular events was also significantly lower in the OA group (15.4% vs. 16.3%; P = .007).
“The rate of secondary outcomes for myocardial infarction and stroke were similar between groups, as were individual procedural safety endpoints, including dissection, perforation, tamponade, or heart failure,” reported Evan Shlofmitz, MD, a cardiology fellow at Northwell Health, Manhasset, N.Y., who collaborated with Dr. Meraj and presented the data at the meeting.
As with the study in the elderly, for which Dr. Shlofmitz was also a coauthor, the study in the obese is the first to compare OA and RA, he noted.
In a third substudy, called COAP-Female, OA and RA were compared in 247 women with CAC who were undergoing PCI.
Again, in-hospital mortality rates were higher in those treated with RA, compared with OA, but the difference was not significant (0.79% vs. 0%; P = .254). There were also no significant differences in any secondary outcomes, including MI, or in any procedural complications, such as rates of dissection, perforation, or major bleeding.
The only significant difference identified in the study was a lower fluoroscopy time in those treated with OA relative to RA (21.3 minutes vs. 27.6 minutes; P = .001).
Although fluoroscopy time was not a primary endpoint, “a reduction in radiation exposure has important ramifications for both patients and operators,” Dr. Shlofmitz noted. He suggested that objective data on outcomes in females is needed, because this group has been “severely underrepresented in atherectomy trials.”
Overall, the substudies reinforce a large body of evidence that atherectomy is safe and effective for achieving revascularization in patients undergoing PCI who have CAC, Dr. Shlofmitz concluded. However, the significant mortality advantage for OA relative to RA in the elderly and the obese suggests that the approaches may not be interchangeable.
Dr. Shlofmitz reported no financial relationships to disclose.
AT CRT 2017
Key clinical point: Orbital atherectomy was associated with better survival than rotational atherectomy in elderly and obese patients requiring percutaneous interventions.
Major finding: In-hospital mortality was significantly lower after orbital atherectomy, compared with rotational atherectomy, in both the elderly (0% vs. 1.55%; P = .034) and the obese (0% vs. 3.05%; P = .004).
Data source: A nonrandomized, prospective, multicenter study.
Disclosures: Dr. Shlofmitz reported no financial relationships to disclose.
Study boosts surgical left atrial appendage occlusion
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
At ACC 17
Key clinical point:
Major finding: The ancillary surgical procedure was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality at 1 year, compared with no appendage closure.
Data source: A retrospective comparative effectiveness study using the Society of Thoracic Surgeons database of more than 10,000 Medicare recipients with atrial fibrillation who underwent cardiac surgery, 37% of whom underwent surgical left atrial appendage occlusion during their primary operation.
Disclosures: The presenter reported having no financial conflicts. The Burroughs Welcome Fund and the Food and Drug Administration funded the study.
VIDEO: Postop troponin T spike flags high mortality risk
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A rise in the blood level of troponin T immediately after patients underwent noncardiac surgery identified a high risk group with a 30-day mortality rate nearly fivefold higher than that of patients who did not have a postoperative troponin T spike, according to a prospective study of more than 21,000 patients.
For 93% of the patients who have these perioperative spikes in troponin T, a marker of myocardial ischemia, the increased level was the only indicator of a heart problem, P.J. Devereaux, MD, said at the annual meeting of the American College of Cardiology. The painkillers that patients receive following surgery generally mask the chest discomfort they might otherwise feel from their heart damage, he explained. The clinical condition is called myocardial injury after noncardiac surgery.
“We’re seeing more older patients with a high burden of vascular disease undergoing surgery, and surgery is a very significant stress, so a large proportion of these patients will have [myocardial injury after noncardiac surgery] and that affects 30-day survival,” said Dr. Devereaux, professor and director of cardiology at McMaster University in Hamilton, Ont.
Based on the new findings, he recommended performing a baseline assessment of troponin T levels in patients scheduled for noncardiac surgery if they are at least 65 years of age, or if they are age 45-64 years with known vascular disease, followed by repeat testing 1 and 2 days after surgery to check whether a spike in the measure had occurred. The high sensitivity troponin T (hsTnT) test he used in the study is relatively costly (and received Food and Drug Administration approval for U.S. marketing in January 2017), but Dr. Devereaux believed that, used in this way, the cost for testing would be reasonable, given its powerful ability to identify high-risk patients and relative to the cost of other screening tools routinely used in U.S. medical practice.
“It looks very cost-effective,” he said in a video interview.
If the baseline and two follow-up measures of hsTnT showed a postoperative level of at least 20 ng/L that rose above the baseline level by at least 5 ng/L, or if the postoperative level was at least 65 ng/L, Dr. Devereaux recommended starting daily treatment with aspirin and a statin to try to contain any perioperative myocardial damage the patient may have, and follow with comprehensive assessment of the patient by a cardiologist or other internal medicine physician.
“Given the risks associated with a rise in hsTnT in this study, Dr. Devereaux’s recommendations are very reasonable until we collect more data on this,” said Frank W. Sellke, MD, professor of surgery and chief of cardiothoracic surgery at Brown Medical School and the Lifespan Hospitals in Providence, R.I. “What was surprising was how few patients had symptoms” of myocardial ischemia. “You can’t do hsTnT measurements on every patient who goes in for a hernia operation; it’s not practical. But his findings are fairly compelling, and hopefully the cost of this testing will come down,” Dr. Sellke said in an interview.
In the multicenter study of 21,842 patients, 24% had a postoperative hsTnT level of 20 ng/L or greater, including 5% with a level of 65 ng/L or greater. The 30-day mortality rate was 3% among those with a perioperative level of 20-64 ng/L, 9% among patients with perioperative hsTnT levels of 65-999 ng/L, and 30% among the 54 patients (0.2% of the study group) with perioperative levels that reached 1,000 ng/L or greater. Dr. Devereaux reported.
This iteration of the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION) enrolled patients who were at least 45 years of age and underwent noncardiac surgery at 23 centers in 13 countries, including the United States and Canada. All patients underwent hsTnT testing 6-12 hours after surgery and 1, 2, and 3 days after surgery, but only 40% also had a baseline measurement before their surgery began. Full 30-day follow-up occurred for 21,050. The patients’ average age was 63 years. The most common surgery was “low-risk,” in 35%, followed by “major” general surgery in 20%, and “major” orthopedic surgery in 16%. At 30 days, 266 patients (1.2%) had died.
These findings “help define a cutoff for hsTnT that will be clinically useful to change practice,” said Athena Poppas, MD, a cardiologist and director of the Cardiovascular Institute at Rhode Island Hospital in Providence. Dr. Poppas was a designated discussant for Dr. Devereaux’s report at the meeting.
In January 2017, the Canadian Cardiovascular Society issued guidelines for perioperative cardiac risk assessment and management for patients undergoing noncardiac surgery (Can J Cardiol. 2017 Jan;33[1]:17-32). Dr. Devereaux was a member of the writing panel for these guidelines. This is what the guidelines said about using troponin T measurements:
“We recommend obtaining daily troponin measurements for 48-72 hours after noncardiac surgery in patients with a baseline risk greater than 5% for cardiovascular death or nonfatal myocardial infarction at 30 days after surgery (i.e., patients with an elevated NT-proBNP/BNP measurement before surgery or, if there is no NT-proBNP/BNP measurement before surgery, in those who have an RCRI [revised cardiac risk index] score of 1 or greater, age 45-64 years with significant cardiovascular disease, or age 65 years or older).”
The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim. Dr. Sellke and Dr. Poppas had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT ACC 17
Key clinical point:
Major finding: A postoperative high sensitivity troponin T rise of 5 ng/L or more linked with a 4.7-fold increase in 30-day mortality.
Data source: VISION, a prospective, multicenter observational study of 21,842 patients undergoing noncardiac surgery.
Disclosures: The VISION study is sponsored by Roche Diagnostics, which markets the high sensitivity troponin T assay used in the study. Dr. Devereaux has received research funding from Roche Diagnostics and from Abbott Diagnostics and Boehringer Ingelheim.
Intensive ventilation precedes lesser pulmonary complications
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
High PEEP “not only recruits collapsed lung tissue, but can also lead to lung overdistension. If lung collapse is extensive, as in patients with ARDS [acute respiratory distress syndrome], and maybe also in patients with postoperative ARDS, the balance between benefit (i.e., recruitment of lung tissue), and harm (i.e., lung overdistension), tips toward benefit. If there is very little lung collapse, as in critically ill patients without ARDS or patients during surgery, this balance could go in the other direction.”
The clinical trial by Leme and his colleagues “provides another brick in the evidence wall of lung protection. However, it remains unclear which patients benefit most from ventilation with a high [positive end-expiratory pressure] level.”
Ary Serpa Neto, MD, MSc, PhD, and Marcus J. Schultz, MD, PhD, are at the Academic Medical Center, Amsterdam. They reported having no conflicts of interest. These comments are from their editorial (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2570).
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Addition of 10 cm H2O to positive end-expiratory volume (PEEP) during mechanical ventilation was followed by significantly lessened pulmonary complications in hospitalized patients who developed hypoxemia after cardiac surgery, participating in a single-center, randomized trial.
This “intensive” alveolar recruitment strategy yielded a median pulmonary complications score of 1.7 (interquartile range, 1.0-2.0), compared with 2.0 (IQR, 1.5-3.0) among patients who underwent ventilation with a PEEP of 20 cm H2O, Alcino Costa Leme, RRT, PhD, said at the International Symposium on Intensive Care and Emergency Medicine. The report was published simultaneously online March 21 in JAMA.
Intensive alveolar recruitment nearly doubled the odds of a lower pulmonary complications score (common odds ratio, 1.9; 95% confidence interval, 1.2-2.8; P = .003), Dr. Leme and his associates reported.
The study comprised 320 adults who developed hypoxemia immediately after undergoing elective cardiac surgery at the Heart Institute (Incor) of the University of São Paulo. The median age of the patients was 62 years, and none had a history of lung disease. Pulmonary complications were scored between 0 (no signs or symptoms) and 5 (death), the investigators noted (JAMA. 2017 Mar 21. doi: 10.1001/jama.2017.2297).
The intensive alveolar recruitment strategy consisted of three 60-second cycles of lung inflation with a positive end-expiratory pressure (PEEP) of 30 cm H2O, pressure-controlled ventilation, driving pressure of 15 cm H2O, respiratory rate of 15/min, inspiratory time of 1.5 seconds, and FIO2 of 0.40. Between and after inflations, patients received assist-controlled or pressure-controlled ventilation, with driving pressures set to achieve a tidal volume of 6 mL/kg of predicted body weight, an inspiratory time of 1 second, PEEP of 13 cm H2O, and minimum respiratory rate to maintain PaCO2 between 35 and 45 mm Hg.
The “moderate strategy” consisted of three 30-second inflations under continuous positive airway pressure mode at 20 cm H2O and FIO2 of 0.60. Between and after inflations, patients received assist or control volume-controlled ventilation (decelerating-flow waveform), tidal volume of 6 mL/kg of predicted body weight, inspiratory time of 1 second, PEEP of 8 cm H2O, and FIO2 of 0.60, at a minimum respiratory rate that maintained PaCO2 at 35-45 mm Hg.
“[The] use of an intensive alveolar recruitment strategy compared with a moderate recruitment strategy resulted in less severe pulmonary complications during the hospital stay,” the investigators wrote. On average, intensively managed patients had shorter stays in the hospital (10.9 vs. 12.4 days; P = .04) and in the intensive care unit (3.8 vs. 4.8 days; P = .01) than did moderately managed patients. Intensive management also was associated with lower rates of hospital mortality and barotrauma, but the differences in these less common outcomes did not reach statistical significance.
“To our knowledge, this is the first study to show a significant effect of lung recruitment maneuvers on clinical outcomes, which objectively resulted in modest reductions in ICU and hospital length of stay,” the researchers wrote. “This is especially noteworthy considering that the control group was also receiving protective lung ventilation with low [tidal volume] and moderate PEEP levels. Thus, the major difference between treatment groups was the intensity of lung recruitment.”
FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
FROM ISICEM
Key clinical point: Intensive lung recruitment during mechanical ventilation of hypoxemic cardiac surgery patients was followed by less severe pulmonary complications, compared with moderate lung recruitment.
Major finding: Compared with moderate alveolar recruitment, intensive recruitment nearly doubled the odds that patients had a lower pulmonary complications score (odds ratio, 1.9; 95% confidence interval, 1.2 to 2.8; P = .003).
Data source: A single-center randomized trial of 320 adults with no history of pulmonary disease who developed hypoxemia after undergoing elective cardiac surgery.
Disclosures: FAPESP (Fundação de Amparo e Pesquisa do Estado de São Paulo) and FINEP (Financiadora de Estudos e Projetos) provided partial funding. Dr. Leme had no disclosures. Senior author Marcelo Britto Passos Amato, MD, PhD, disclosed research funding from Covidien/Medtronics, Dixtal Biomedica Ltd, and Timpel SA.
Can better operations improve CABG in women?
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
As with other long-term analyses, the answer in this study “is in the shadows as opposed to the spotlight,” George L. Hicks Jr., MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2017;153[3]:580-1).
Dr. Hicks of the University of Rochester (N.Y.) noted key limitations of the study: use of all-cause mortality, substandard use of bilateral– or single–internal thoracic artery grafting, little data about postdischarge cholesterol levels, diabetes incidence, or blood pressure, among others. However, “the authors raise the banner for the continued need for increased use of arterial revascularization with the eventual hope that the Arterial Revascularization Trial will reinforce the survival benefits manifested by that strategy,” he said.
Reducing risks and not changing the type of operation will even out the differences in postoperative survival between genders, he indicated. “Furthermore, the extension of similar therapies – for example, [bilateral–internal thoracic artery] or all-arterial grafting and improved long-term risk modification in both men and women – may improve the inequality but not eliminate the differences until we know that both men and women come from the same planet,” he said.
Dr. Hicks reported having no relevant financial relationships to disclose.
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
Worse outcomes after cardiovascular arterial bypass grafting (CABG) in women have been attributed to a number of clinical and nonclinical factors: older age, delayed diagnosis and treatment, more comorbidities, smaller body size, underuse of arterial grafts, and referral bias. However, a team of Cleveland Clinic researchers reported that women were less likely than men to have bilateral–internal thoracic artery (ITA) grafting and complete revascularization, both of which are linked to better long-term survival.
“Women had less favorable preoperative characteristics than men but received fewer bilateral-ITA grafts and less all-arterial grafting as part of their revascularization strategy,” Tamer Attia, MD, MSc, and his coauthors said in the study published in the Journal of Thoracic and Cardiovascular Surgery. They also found that women were more likely to die in the hospital after CABG and had lower risk-adjusted long-term survival than men (2017 March;153:571-9).
Survival was lowest in women who were not completely revascularized and had no ITA grafting, while survival was highest in men who were completely revascularized and had bilateral grafting, Dr. Attia and coauthors said.
The researchers’ goal was to use extensive risk adjustment to evaluate how differences in revascularization strategies influenced survival of men and women after CABG. They analyzed 57,943 primary, isolated CABG procedures performed at Cleveland Clinic from 1972 to 2011, including 11,009 procedures in women.
The researchers identified differences between sexes in three key areas: revascularization strategies, in-hospital outcomes, and time-related survival.
With regard to revascularization strategies, while men were significantly more likely to have incomplete revascularization than were women, women received significantly fewer arterial grafts (8.4% vs. 9.3% for men). This included fewer bilateral-ITA grafts and radial artery grafts, less use of total arterial revascularization, and greater use of saphenous vein grafts (SVGs) to the left anterior descending artery. Women were also significantly more likely to receive only SVGs for revascularization (32% vs. 30% for men; P less than .0001). Most operations for both women and men were done with cardiopulmonary bypass, but significantly more women had off-pump procedures (5.4% vs. 2.9%).
In the hospital after operations, women were significantly more prone to postoperative deep sternal–wound infections and septicemias, as well as strokes and renal failure, including dialysis-dependent renal failure. Women also had higher rates of new-onset atrial fibrillation (15% vs. 13% in men), and higher rates of mechanical ventilation for more than 24 hours (13% vs. 9.2%). Women spent more time in the ICU and hospital overall, and their in-hospital death rate was more than double that of men (2.7% vs. 1.1%).
Women also had shorter long-term survival, “and this has persisted since the beginning of CABG at Cleveland Clinic,” Dr. Attia and coauthors said. What’s more, the survival gap between women in the study and women in the general population post CABG was wider than that in men. “After we adjusted for patient and revascularization strategy differences, female sex remained an independent risk factor for death overall and both early and late after CABG.”
Incomplete revascularization had greater consequences for women than for men. At 10 years, 58% of women with incomplete revascularization survived, vs. 70% of men. At 20 years, the rates were 25% for women and 35% for men. “Use of ITA grafts was associated with better survival than use of SVGs alone and was best when bilateral-ITA grafting was performed,” Dr. Attia and coauthors said. However, the study determined that bilateral grafting seems less effective in women long-term. “Hence, a patient’s sex deserves special consideration in operative planning.”
Many questions about CABG in women remain: Identifying which female patients would benefit from more meticulous conduit harvesting, from better coronary artery selection, and from bilateral-ITA grafting and which are less susceptible to sternal would infections could increase appropriate use of bilateral-ITA grafting, the researchers noted. “The difference in effectiveness of bilateral-ITA grafting needs to be considered in women at elevated risk for bilateral-ITA harvesting complications.”
Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Survival rates after CABG are worse for women than for men.
Major finding: In both men and women, complete revascularization and use of bilateral-ITA grafting achieve better long-term survival than incomplete revascularization and single-ITA grafting.
Data source: Analysis of 57,943 adults who had primary isolated CABG from 1972 to 2011 at Cleveland Clinic.
Disclosure: Coauthor Ellen Mayer Sabik, MD, is a principal investigator for Abbott Laboratories and is on the scientific advisory board of Medtronic. Dr. Attia and all other coauthors reported having no relevant financial disclosures.