Cardiothoracic Surgery

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. The more cases a physician and hospital do, the better the outcomes, according to a review of 55,311 cases in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.

Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.

Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.

“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.

“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.

The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.

Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.

Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.

And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.

No industry funding was reported. Dr. Badhwar had no relevant disclosures.

[email protected]

SOURCE: Badhwar V et al. TCT 2019.

SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. The more cases a physician and hospital do, the better the outcomes, according to a review of 55,311 cases in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.

Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.

Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.

“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.

“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.

The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.

Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.

Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.

And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.

No industry funding was reported. Dr. Badhwar had no relevant disclosures.

[email protected]

SOURCE: Badhwar V et al. TCT 2019.

SAN FRANCISCO – Volume matters when it comes to mitral valve repair/replacement for primary mitral regurgitation. The more cases a physician and hospital do, the better the outcomes, according to a review of 55,311 cases in the Society of Thoracic Surgeons Adult Cardiac Surgery Database.

Investigators “found a clear inflection point at approximately 75 cases” for hospitals and 35 cases for individual surgeons when the curves for successful mitral repair and 30-day operative mortality start to level out. Nationwide, 148 hospitals (14%) in the analysis did 75 or more mitral cases a year, and 303 surgeons (13%) did at least 35.

Lead investigator Vinay Badhwar, MD, professor and chair of cardiovascular and thoracic surgery at West Virginia University, Morgantown, estimated that about 90% of Americans have access to a regional hospital that does at least 25 mitral procedures annually, and about 82% can use a regional hospital that does at least 40. Meanwhile, the rate of mitral valve repair for primary mitral regurgitation was 81% (44,692/55,311) in the study, up from about 60% a decade ago.

“We are getting there; we are getting better,” Dr. Badhwar said at the Transcatheter Cardiovascular Therapeutics annual meeting. By defining volume cut points, he said the findings could be useful in future guidelines to steer referrals to higher-volume centers.

“We really needed these data, because we’ve had so many other pieces pointing to the volume repair rates and technical success, which clearly is related to volume. Now we have the outcome data we’ve been looking for; this ties it together. There really is an impact on patient outcomes,” Robert Bonow, MD, a professor of cardiology at Northwestern University, Chicago, commented.

The team divided annual case volume into quartiles. The lowest hospital quartile did fewer than 11 cases a year, and the highest more than 46. The lowest-quartile surgeons did fewer than 6 cases a year, and the highest more than 20. Lowest-quartile surgeons and hospitals, versus the highest, had higher operative mortality and 30-day morbidity and mortality, and lower 1-year survival.

Patients in the lowest quartile were also more likely to be black or Hispanic (14.8% versus 10.2%); have no insurance (4.0% versus 2.4%); and more severe symptom presentation (31.9% versus 23.8% class III or IV heart failure). The differences were highly statistically significant.

Study moderator Ajay Kirtane, MD, an interventional cardiologist and associate professor of medicine at Columbia University, New York, said there’s a role for advocacy to get more people to high-volume centers. “Just because you live in an area that has a good program doesn’t mean that you are actually going to get referred to that program. We find a lot that it’s advocacy that is important,” especially with the disparities noted in the study. “Not everybody has an advocate who says, ‘Don’t do it here; do it someplace else,’ ” he said at the meeting sponsored by the Cardiovascular Research Foundation.

And not everyone has an advocate to get them to the right surgeon, even if they get to the right program. “There are cardiac procedures that most surgeons can do well. Mitral valve surgery is one of those that should be super specialized,” said cardiothoracic surgeon Michael Mack, MD, director of the cardiovascular service line at Baylor Scott and White Health System, Dallas.

No industry funding was reported. Dr. Badhwar had no relevant disclosures.

[email protected]

SOURCE: Badhwar V et al. TCT 2019.

NEW ORLEANS – Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

NEW ORLEANS – Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

NEW ORLEANS – Race compatibility is a factor that can affect survival and needs to be considered when matching lung transplant candidates to potential donors, results from a large retrospective analysis suggest.

Andrew D. Bowser/MDedge News

Specifically, whites had significantly worse survival when receiving lungs from African American donors in this registry analysis, according to study investigator Alexis Kofi Okoh, MD.

By contrast, donor-to-recipient race compatibility (DRRC) did not affect posttransplant survival among African American or Hispanic patients, said Dr. Okoh, who is with the lung transplant division at the Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J.

While race mismatch has been shown to affect outcomes in kidney, heart, and liver transplant settings, the data for DRRC in lung transplant prior to this analysis generally has been limited to small, single-center studies, according to Dr. Okoh.

“If you do have the option, [race compatibility] should highly be considered, because it clearly has an impact on outcomes,” Dr. Okoh said in an interview here at the annual meeting of the American College of Chest Physicians.

Considering the race of both donor and recipient is especially important now that the lung transplant population is becoming more ethnically diverse, he added.

The study was based on an analysis of 19,504 lung transplant recipients in the prospectively maintained United Network for Organ Sharing (UNOS) database during 2006-2018. In that cohort, 16,485 recipients were white, 1,787 were African American, and 1,232 were Hispanic.

Race-matched donor organs were used in two-thirds (66.2%) of white recipients, about one-quarter (26.8%) of African American recipients, and one-third (33.0%) of Hispanic recipients.

Overall, survival post–lung transplant was significantly poorer among recipients who did not receive a race-matched organ in Kaplan-Meier survival estimates, Dr. Okoh said, though, that this effect was diminished after they adjusted for patient baseline characteristics (P = 0.2809).

For African American recipients, the unadjusted and adjusted survival estimates were no different regardless of donor race, and likewise, there were no apparent survival differences between Hispanic recipients who received race matched or mismatched organs.

Survival among white recipients, however, was significantly affected by race of the recipient, with decreased survival estimates noted even after adjustment for patient characteristics, according to Dr. Okoh’s presentation.

Results of regression analysis showed that white recipient/African American donor was the only race mismatch to significantly affect survival, Dr. Okoh said in the interview.

The posttransplant survival hazard ratios (and 95% confidence intervals) reported by Dr. Okoh with a no race mismatch serving as reference were 1.15 (1.08-1.23) for whites with African American donors, and 1.09 (1.01-1.18) for whites with Hispanic donors.

Dr. Okoh and coinvestigators reported no relevant conflicts in relation to their study.

SOURCE: Okoh A et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.220.

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[email protected]

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[email protected]

PARIS – The risk of infective endocarditis following transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis proved to be the same as after surgical replacement in a French national propensity score–matched study.

This finding from what is believed to be the largest-ever study of infective endocarditis following TAVR will come as a surprise to many physicians. It’s easy to mistakenly assume the risk of this feared complication is lower – and perhaps even negligible – in TAVR patients since the procedure doesn’t involve a significant surgical wound, it’s briefer, the hospital length of stay is shorter, and recovery time is markedly less than with surgical aortic valve replacement (SAVR).

Not so, Laurent Fauchier, MD, PhD, said in presenting the study findings at the annual congress of the European Society of Cardiology.

“Do not think there is a lower risk of infective endocarditis. Be aware, be careful, and provide appropriate antibiotic prophylaxis, just as surgeons do in SAVR. Don’t think, as I did, that with TAVR with no pacemaker implantation there is no risk of infective endocarditis. The TAVR valve is a device, it’s a prosthesis, and the risk is very similar to that of surgery,” advised Dr. Fauchier, a cardiologist at Francois Rabelais University in Tours, France.

He presented a study of all of the nearly 108,000 patients who underwent isolated TAVR or SAVR in France during 2010-2018. The data source was the French national administrative hospital discharge record system. Since the TAVR patients were overall markedly older and sicker than the SAVR patients, especially during the first years of the study, he and his coinvestigators performed propensity score matching using 30 variables, which enabled them to narrow the field of inquiry down to a carefully selected study population of 16,291 TAVR patients and an equal number of closely similar SAVR patients.

A total of 1,070 cases of infective endocarditis occurred during a mean follow-up of just over 2 years. The rate of hospital admission for this complication was 1.89% per year in the TAVR group and similar at 1.71% per year in the SAVR cohort.

Of note, all-cause mortality in TAVR patients who developed infective endocarditis was 1.32-fold greater than it was in SAVR patients with infective endocarditis, a statistically significant difference. The explanation for the increased mortality risk in the TAVR group probably has to do at least in part with an inability on the part of the investigators to fully capture and control for the TAVR group’s greater frailty, according to the cardiologist.

Risk factors for infective endocarditis shared in common by TAVR and SAVR patients included male gender, a higher Charlson Comorbidity Index score, and a greater frailty index. The main predictors unique to the TAVR patients were atrial fibrillation, anemia, and tricuspid regurgitation. And although pacemaker and defibrillator implantation were risk factors for infective endocarditis in the SAVR patients, it wasn’t predictive of increased risk in the TAVR population. Dr. Fauchier called this finding “quite reassuring” given that roughly 20% of the TAVR group received a pacemaker.

The causative microorganisms for infective endocarditis were essentially the same in the TAVR and SAVR groups, simplifying antimicrobial prophylaxis decision making.

Dr. Fauchier reported having no financial conflicts regarding the study, conducted free of commercial support. He serves as a consultant to and/or on speakers’ bureaus for Bayer, BMS Pfizer, Boehringer Ingelheim, Medtronic, and Novartis.

[email protected]

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

LAS VEGAS – The Melody transcatheter pulmonary valve showed durable efficacy out to 5 years after placement in a mandated U.S. postapproval study that followed 65 patients, a majority of whom were children or teenagers.

Mitchel L. Zoler/MDedge News

After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)

The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.

The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).

“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.

The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”

The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).

The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.

Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.

The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.

Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.

Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.

The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.

[email protected]

LAS VEGAS – The Melody transcatheter pulmonary valve showed durable efficacy out to 5 years after placement in a mandated U.S. postapproval study that followed 65 patients, a majority of whom were children or teenagers.

Mitchel L. Zoler/MDedge News

After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)

The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.

The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).

“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.

The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”

The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).

The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.

Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.

The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.

Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.

Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.

The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.

[email protected]

LAS VEGAS – The Melody transcatheter pulmonary valve showed durable efficacy out to 5 years after placement in a mandated U.S. postapproval study that followed 65 patients, a majority of whom were children or teenagers.

Mitchel L. Zoler/MDedge News

After 5 years, 69% of the replacement valve recipients had no valvular hemodynamic dysfunction, compared with a 67% rate among patients enrolled in the original Investigational Device Exemption (IDE) study that led to Food and Drug Administration marketing approval for the Melody valve in 2010 under a humanitarian device exemption. (Full approval followed in 2017.)

The 5-year rate of any reintervention, including explants, was 78% in the postapproval study, again similar to the 76% rate reported in the IDE study after a median 4.5 year follow-up (Circulation. 2015 Jun 2;131[22]:1960-70), Aimee K. Armstrong, MD, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

The new 5-year postapproval study findings “confirm that the hemodynamic effectiveness achieved by real-world providers is equivalent to the historical control established in the IDE study,” concluded Dr. Armstrong, professor of pediatrics at the Ohio State University and director of cardiac catheterization and interventional therapies at Nationwide Children’s Hospital, both in Columbus.

The postapproval study ran at 10 U.S. centers, none of which were among the five U.S. centers that ran the IDE study. Today, the Melody transcatheter pulmonary valve “is very commonly used” at many additional U.S. sites, Dr. Armstrong said in an interview. And the outcomes achieved using the valve likely surpass those seen in the IDE and postapproval studies because of innovations in technique, such as more routine use of “prestenting,” placing a stent in the vascular site where the pulmonary valve conduit will sit to address stenosis at this location and prevent subsequent conduit fracture (JACC Cardiovasc Interv. 2017 Sep;10[17]:1760-2).

“In 2010 [when the postapproval study began], we didn’t understand the importance of prestenting the way we do now. In 2010, I did not prestent every patient; now I do,” she said. The results reported by Dr. Armstrong included a 5% cumulative rate of major stent fractures in the Melody devices.

The postapproval study results also documented a concerning 4.5% annualized incidence of endocarditis among pulmonary valve recipients, with a nearly 300% increased rate of endocarditis among patients aged 12 years or younger, compared with older patients. Dr. Armstrong cautioned that this age association may be confounded by other factors, such as a residual pressure gradient in the right ventricular outflow tract of 15 mm Hg or greater. “We are discovering that we need to reduce the pressure gradient as much as we can, to perhaps less than 15 mm Hg, to reduce endocarditis, and that is something we did not know even a year ago. Practice is still evolving.”

The Melody Transcatheter Pulmonary Valve Postapproval Study performed cardiac catheterization for valve placement in 121 patients, and successfully implanted the valve for at least 24 hours in 99 of these patients. Patient age ranged from 5 to 45 years, with a median of 17 years; two-thirds were boys or men. The median age of the patients in the postapproval study was about 2 years younger than in the IDE study. Dr. Armstrong and her associates had previously published the 1-year outcomes from the postapproval study (JACC Cardiovasc Interv. 2014 Nov;7[11]:1254-62).

The enrolled patients usually needed a new right ventricular outflow tract because of a congenital heart defect, such as tetralogy of Fallot with pulmonary atresia and truncus arteriosus. Patients also included those who underwent a Ross operation. These patients often receive surgical placement of a right ventricular-to-pulmonary artery conduit, which can over time develop stenosis, insufficiency, or both because of calcification, intimal proliferation, and graft degeneration.

Multiple conduit reoperations to restore right ventricular outflow tract function are usually needed over a patient’s lifetime because of conduit degeneration. This makes a transcatheter procedure in a child or adolescent an attractive option because the prosthetic conduit will need replacement relatively quickly, and the transcatheter approach avoids an episode of open-heart surgery.

The Melody system is not the only transcatheter option for treating a leak or stenosis in a right ventricular outflow tract. The Sapien XT Transcatheter Heart Valve, marketed by Edwards, has FDA labeling for replacement of a dysfunctional right ventricular outflow tract.

Because the Sapien XT system was designed for replacing an aortic valve it’s challenging to place the conduit in the pulmonary valve position, Dr. Armstrong said. Operators find the Sapien 3 valve, a more modern design of the XT model that’s also primarily intended for aortic valve replacement, easier to position than the XT for pulmonary valve replacement, but Sapien 3 does not have FDA labeling for the right ventricular outflow tract indication. The Sapien valves are attractive because they don’t fracture, but Melody is easier to place and operators can reduce the fracture risk by prestenting, she noted.

Overall, the 5-year results from the postapproval study represented success, because 78% of patients who received the Melody device avoided any further interventions during follow-up. “That’s a big deal to a 12, 15, or 18 year old,” said Dr. Armstrong. “A surgically placed valve won’t last long in a teen, so it’s nice to do something noninvasively. It’s great if you can delay surgery for a few years” and avoid having the patient grow out of a surgically placed conduit or developing lots of calcification in the conduit during a growth spurt.

The postapproval study was funded by Medtronic, the company that sells the Melody valve. Dr. Armstrong has received research funding from Medtronic as well as Abbott, Edwards, and Siemens, and she has been a consultant to Abbott.

[email protected]

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

NEW ORLEANS – Results of the largest-ever analysis of TAVR in patients with bicuspid aortic stenosis indicate that key 30-day and 1-year outcomes are similar to those of propensity-matched TAVR patients with tricuspid disease, Raj R. Makkar, MD, said at the annual meeting of the American College of Cardiology.

“Select bicuspid anatomy is amenable to TAVR with current-generation, balloon-expandable TAVR technology with acceptable clinical outcomes. These data provide an argument for TAVR to be a reasonable alternative for bicuspid AS [aortic stenosis] patients who are at intermediate or high risk for surgical aortic valve replacement, which are the patients that are enrolled in this registry, and provide a sound basis to conduct a randomized clinical trial in young patients with bicuspid AS who are at low risk for surgery,” declared Dr. Makkar, director of interventional cardiology and the cardiac catheterization laboratory at Cedars-Sinai Medical Center in Los Angeles.

The landmark randomized trials of TAVR versus SAVR (surgical aortic valve replacement) that established TAVR as the preferred treatment for patients with severe aortic stenosis who are at high, intermediate, or low surgical risk systematically excluded patients with bicuspid AS, even though bicuspid anatomy is common, particularly in younger patients with AS.

Despite the absence of supportive randomized trial data, TAVR is being done for bicuspid AS. To learn how patients with bicuspid disease have fared, Dr. Makkar and coinvestigators analyzed the real-world Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry of all patients who underwent TAVR with the balloon-expandable Sapien 3 stent in the United States during 2015-2018. They compared outcomes in 2,691 patients with high or intermediate surgical risk who underwent TAVR for bicuspid AS to an equal number of patients who had TAVR for tricuspid disease, with the two groups being propensity-matched across 25 variables.

Key outcomes were reassuringly similar in the two groups. For example, 30-day and 1-year all-cause mortality rates were 2.6% and 10.8% in patients with bicuspid valves and similar, at 2.5% and 12.1%, in those with tricuspid AS. Paravalvular leak rates at 30 days and 1 year were similar in the two groups. The Kansas City Cardiomyopathy Questionnaire scores, reflecting quality of life, improved dramatically – by nearly 30 points – from pre-TAVR baseline in both groups. The proportion of patients who were New York Heart Association functional class III or IV improved from nearly 85% at baseline to about 8% at 30 days and 1 year, again with no significant difference between the bicuspid and tricuspid AS groups. And there were other benefits, too.

“Despite the concerns regarding optimal expansion of these valves in a bicuspid anatomy, what we observed here was a significant and similar reduction in mean gradients and increase in valve area, both in the bicuspid and tricuspid AS patients. So there was no impact of bicuspid anatomy as seen here in terms of valve hemodynamics,” according to the cardiologist.

Conversion from TAVR to open surgery was required in 0.9% of bicuspid and 0.4% of tricuspid AS patients. Rates of aortic dissection and need for aortic valve reintervention were similarly low in both groups.

The 30-day stroke rate was significantly higher in the bicuspid patients – 2.4% versus 1.6% – but by 1 year there was no significant between-group difference, with stroke rates of 3.4% in the bicuspid and 3.1% in the tricuspid TAVR patients.

“I’d like to point out that more than 75% of strokes occurred in the first 3 days. These are periprocedural strokes, and there was no difference in the time distribution of strokes between the bicuspid and tricuspid groups,” Dr. Makkar said.

These stroke data make a compelling case for the routine use of cerebral protection devices in patients undergoing TAVR, something which now occurs in less than 10% of cases nationally, he continued.

“I would argue that, based on these data, it would be wise for us to use cerebral protection devices, especially when we are doing TAVR in patients with bicuspid AS, because their valves tend to be more heavily calcified than is often the case in tricuspid AS,” Dr. Makkar said.

Discussant Mayra Guerrero, MD, of the Mayo Clinic in Rochester, Minn., took issue with Dr. Makkar’s comment regarding the need for a randomized trial of TAVR in bicuspid AS patients with low surgical risk.

“Do we really need a randomized trial when we see in real-world experience with more than 2,600 patients that the outcomes are fairly similar?” she asked.

Affirmative, Dr. Makkar responded, in light of the fact that the STS/ACC TVT Registry doesn’t include low–surgical risk, typically relatively young bicuspid AS TAVR patients.

“I would say that these data are reassuring and encouraging, but we must not get carried away. I think that would be the important message that I must give,” Dr. Makkar replied. “I think for patients who are high risk and who are intermediate risk, with STS scores of what they were here – 5 and more – I think it’s reasonable to consider them for TAVR based upon CT anatomy. For young patients, as I concluded, I think we must do a randomized clinical trial to definitely establish the safety and efficacy in these patients.”

Dr. Makkar reported receiving research grants from and serving as a consultant to Edwards Lifesciences, which supported the study, as well as Abbott, Medtronic, and Boston Scientific.

[email protected]

SOURCE: Makkar RR. ACC 19, 404-15. Late-breaking clinical trials


 

NEW ORLEANS – Results of the largest-ever analysis of TAVR in patients with bicuspid aortic stenosis indicate that key 30-day and 1-year outcomes are similar to those of propensity-matched TAVR patients with tricuspid disease, Raj R. Makkar, MD, said at the annual meeting of the American College of Cardiology.

“Select bicuspid anatomy is amenable to TAVR with current-generation, balloon-expandable TAVR technology with acceptable clinical outcomes. These data provide an argument for TAVR to be a reasonable alternative for bicuspid AS [aortic stenosis] patients who are at intermediate or high risk for surgical aortic valve replacement, which are the patients that are enrolled in this registry, and provide a sound basis to conduct a randomized clinical trial in young patients with bicuspid AS who are at low risk for surgery,” declared Dr. Makkar, director of interventional cardiology and the cardiac catheterization laboratory at Cedars-Sinai Medical Center in Los Angeles.

The landmark randomized trials of TAVR versus SAVR (surgical aortic valve replacement) that established TAVR as the preferred treatment for patients with severe aortic stenosis who are at high, intermediate, or low surgical risk systematically excluded patients with bicuspid AS, even though bicuspid anatomy is common, particularly in younger patients with AS.

Despite the absence of supportive randomized trial data, TAVR is being done for bicuspid AS. To learn how patients with bicuspid disease have fared, Dr. Makkar and coinvestigators analyzed the real-world Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry of all patients who underwent TAVR with the balloon-expandable Sapien 3 stent in the United States during 2015-2018. They compared outcomes in 2,691 patients with high or intermediate surgical risk who underwent TAVR for bicuspid AS to an equal number of patients who had TAVR for tricuspid disease, with the two groups being propensity-matched across 25 variables.

Key outcomes were reassuringly similar in the two groups. For example, 30-day and 1-year all-cause mortality rates were 2.6% and 10.8% in patients with bicuspid valves and similar, at 2.5% and 12.1%, in those with tricuspid AS. Paravalvular leak rates at 30 days and 1 year were similar in the two groups. The Kansas City Cardiomyopathy Questionnaire scores, reflecting quality of life, improved dramatically – by nearly 30 points – from pre-TAVR baseline in both groups. The proportion of patients who were New York Heart Association functional class III or IV improved from nearly 85% at baseline to about 8% at 30 days and 1 year, again with no significant difference between the bicuspid and tricuspid AS groups. And there were other benefits, too.

“Despite the concerns regarding optimal expansion of these valves in a bicuspid anatomy, what we observed here was a significant and similar reduction in mean gradients and increase in valve area, both in the bicuspid and tricuspid AS patients. So there was no impact of bicuspid anatomy as seen here in terms of valve hemodynamics,” according to the cardiologist.

Conversion from TAVR to open surgery was required in 0.9% of bicuspid and 0.4% of tricuspid AS patients. Rates of aortic dissection and need for aortic valve reintervention were similarly low in both groups.

The 30-day stroke rate was significantly higher in the bicuspid patients – 2.4% versus 1.6% – but by 1 year there was no significant between-group difference, with stroke rates of 3.4% in the bicuspid and 3.1% in the tricuspid TAVR patients.

“I’d like to point out that more than 75% of strokes occurred in the first 3 days. These are periprocedural strokes, and there was no difference in the time distribution of strokes between the bicuspid and tricuspid groups,” Dr. Makkar said.

These stroke data make a compelling case for the routine use of cerebral protection devices in patients undergoing TAVR, something which now occurs in less than 10% of cases nationally, he continued.

“I would argue that, based on these data, it would be wise for us to use cerebral protection devices, especially when we are doing TAVR in patients with bicuspid AS, because their valves tend to be more heavily calcified than is often the case in tricuspid AS,” Dr. Makkar said.

Discussant Mayra Guerrero, MD, of the Mayo Clinic in Rochester, Minn., took issue with Dr. Makkar’s comment regarding the need for a randomized trial of TAVR in bicuspid AS patients with low surgical risk.

“Do we really need a randomized trial when we see in real-world experience with more than 2,600 patients that the outcomes are fairly similar?” she asked.

Affirmative, Dr. Makkar responded, in light of the fact that the STS/ACC TVT Registry doesn’t include low–surgical risk, typically relatively young bicuspid AS TAVR patients.

“I would say that these data are reassuring and encouraging, but we must not get carried away. I think that would be the important message that I must give,” Dr. Makkar replied. “I think for patients who are high risk and who are intermediate risk, with STS scores of what they were here – 5 and more – I think it’s reasonable to consider them for TAVR based upon CT anatomy. For young patients, as I concluded, I think we must do a randomized clinical trial to definitely establish the safety and efficacy in these patients.”

Dr. Makkar reported receiving research grants from and serving as a consultant to Edwards Lifesciences, which supported the study, as well as Abbott, Medtronic, and Boston Scientific.

[email protected]

SOURCE: Makkar RR. ACC 19, 404-15. Late-breaking clinical trials


 

NEW ORLEANS – Results of the largest-ever analysis of TAVR in patients with bicuspid aortic stenosis indicate that key 30-day and 1-year outcomes are similar to those of propensity-matched TAVR patients with tricuspid disease, Raj R. Makkar, MD, said at the annual meeting of the American College of Cardiology.

“Select bicuspid anatomy is amenable to TAVR with current-generation, balloon-expandable TAVR technology with acceptable clinical outcomes. These data provide an argument for TAVR to be a reasonable alternative for bicuspid AS [aortic stenosis] patients who are at intermediate or high risk for surgical aortic valve replacement, which are the patients that are enrolled in this registry, and provide a sound basis to conduct a randomized clinical trial in young patients with bicuspid AS who are at low risk for surgery,” declared Dr. Makkar, director of interventional cardiology and the cardiac catheterization laboratory at Cedars-Sinai Medical Center in Los Angeles.

The landmark randomized trials of TAVR versus SAVR (surgical aortic valve replacement) that established TAVR as the preferred treatment for patients with severe aortic stenosis who are at high, intermediate, or low surgical risk systematically excluded patients with bicuspid AS, even though bicuspid anatomy is common, particularly in younger patients with AS.

Despite the absence of supportive randomized trial data, TAVR is being done for bicuspid AS. To learn how patients with bicuspid disease have fared, Dr. Makkar and coinvestigators analyzed the real-world Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry of all patients who underwent TAVR with the balloon-expandable Sapien 3 stent in the United States during 2015-2018. They compared outcomes in 2,691 patients with high or intermediate surgical risk who underwent TAVR for bicuspid AS to an equal number of patients who had TAVR for tricuspid disease, with the two groups being propensity-matched across 25 variables.

Key outcomes were reassuringly similar in the two groups. For example, 30-day and 1-year all-cause mortality rates were 2.6% and 10.8% in patients with bicuspid valves and similar, at 2.5% and 12.1%, in those with tricuspid AS. Paravalvular leak rates at 30 days and 1 year were similar in the two groups. The Kansas City Cardiomyopathy Questionnaire scores, reflecting quality of life, improved dramatically – by nearly 30 points – from pre-TAVR baseline in both groups. The proportion of patients who were New York Heart Association functional class III or IV improved from nearly 85% at baseline to about 8% at 30 days and 1 year, again with no significant difference between the bicuspid and tricuspid AS groups. And there were other benefits, too.

“Despite the concerns regarding optimal expansion of these valves in a bicuspid anatomy, what we observed here was a significant and similar reduction in mean gradients and increase in valve area, both in the bicuspid and tricuspid AS patients. So there was no impact of bicuspid anatomy as seen here in terms of valve hemodynamics,” according to the cardiologist.

Conversion from TAVR to open surgery was required in 0.9% of bicuspid and 0.4% of tricuspid AS patients. Rates of aortic dissection and need for aortic valve reintervention were similarly low in both groups.

The 30-day stroke rate was significantly higher in the bicuspid patients – 2.4% versus 1.6% – but by 1 year there was no significant between-group difference, with stroke rates of 3.4% in the bicuspid and 3.1% in the tricuspid TAVR patients.

“I’d like to point out that more than 75% of strokes occurred in the first 3 days. These are periprocedural strokes, and there was no difference in the time distribution of strokes between the bicuspid and tricuspid groups,” Dr. Makkar said.

These stroke data make a compelling case for the routine use of cerebral protection devices in patients undergoing TAVR, something which now occurs in less than 10% of cases nationally, he continued.

“I would argue that, based on these data, it would be wise for us to use cerebral protection devices, especially when we are doing TAVR in patients with bicuspid AS, because their valves tend to be more heavily calcified than is often the case in tricuspid AS,” Dr. Makkar said.

Discussant Mayra Guerrero, MD, of the Mayo Clinic in Rochester, Minn., took issue with Dr. Makkar’s comment regarding the need for a randomized trial of TAVR in bicuspid AS patients with low surgical risk.

“Do we really need a randomized trial when we see in real-world experience with more than 2,600 patients that the outcomes are fairly similar?” she asked.

Affirmative, Dr. Makkar responded, in light of the fact that the STS/ACC TVT Registry doesn’t include low–surgical risk, typically relatively young bicuspid AS TAVR patients.

“I would say that these data are reassuring and encouraging, but we must not get carried away. I think that would be the important message that I must give,” Dr. Makkar replied. “I think for patients who are high risk and who are intermediate risk, with STS scores of what they were here – 5 and more – I think it’s reasonable to consider them for TAVR based upon CT anatomy. For young patients, as I concluded, I think we must do a randomized clinical trial to definitely establish the safety and efficacy in these patients.”

Dr. Makkar reported receiving research grants from and serving as a consultant to Edwards Lifesciences, which supported the study, as well as Abbott, Medtronic, and Boston Scientific.

[email protected]

SOURCE: Makkar RR. ACC 19, 404-15. Late-breaking clinical trials


 

SNOWMASS, COLO. – A patient who presents with symptomatic low-flow, low-gradient severe aortic stenosis, hypertension, and preserved left ventricular ejection fraction (LVEF) is often referred straightaway for consideration of aortic valve replacement. Not so fast – these patients actually constitute a special case for whom two essential questions must be answered before proceeding to that stage, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

The first question is, What happens to the patient’s symptoms upon control of the hypertension?

“Almost all of these patients with low-flow severe aortic stenosis with preserved ejection fraction are going to be hypertensive. Treat the hypertension first. If they become asymptomatic, you don’t need to intervene. The aortic stenosis wasn’t causing their symptoms. You can afford to continue to watch them,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

An aortic valve area of less than 1.0 cm² is a prerequisite for surgical or transcatheter aortic valve replacement. So the second key question is this, Does the patient have truly severe aortic stenosis (AS), or is it instead a case of pseudo-AS in which the small aortic valve area noted on echocardiography is caused by low flow secondary to a small left ventricle with a low stroke volume?

“If you increase the flow and remeasure the aortic valve area, you’ll find that a lot of these patients don’t have a really small aortic valve area of less than 1.0 cm². You might find the aortic valve area pops up to 1.4-1.6 cm2,” he explained.

These patients with symptomatic low-flow, low-gradient severe AS with preserved LVEF are quite common.

“I don’t know why, but we’re seeing more and more of these patients. I think 10 years ago we just kind of ignored them. We thought we’d made a mistake in our calculations. But in fact if you’re very meticulous about your calculations, 30%-40% of your aortic stenosis patients fit into this category,” the cardiologist said.

Moreover, if these patients undergo aortic valve replacement when their symptoms stemmed from poorly controlled hypertension and/or pseudo-AS, they are not going to benefit from this major intervention, he added.

This issue was addressed, albeit briefly and obliquely, in the American Heart Association/ACC guidelines for management of patients with valvular heart disease, for which Dr. Nishimura served as first author and cochair of the writing committee (Circulation. 2014 Jun 10;129[23]:e521-643) as well as for the 2017 focused update of the guidelines.

The guidelines give a IIa recommendation to aortic valve replacement as “reasonable” in “symptomatic patients with low-flow/low-gradient severe AS (stage D3) with an LVEF 50% or greater, a calcified aortic valve with significantly reduced leaflet motion, and a valve area 1.0 cm² or less only if clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms and data recorded when the patient is normotensive.”

Dr. Nishimura chose the 50th annual meeting of the storied ACC Snowmass conference to elaborate upon that brief guidance. He explained that these patients with low-flow, low-gradient symptomatic “severe” AS with preserved LVEF and hypertension have two resistors in a series.

“You have a resistor at the aortic valve area but probably a greater resistor in the systemic circulation. They have high resistance at the arterial level and diastolic dysfunction due to ventricular-vascular coupling,” the cardiologist continued.

Checking for pseudo-AS in these patients is a matter of boosting their low transvalvular flow. This can be accomplished by increasing their cardiac output via monitored exercise or by pharmacologic afterload reduction.

“We’re exercising these patients in the cath lab, but you could also do it in the echocardiographic laboratory. With exercise, if cardiac output increases and the aortic valve area increases without significant change in the aortic valve mean gradient, the patient probably doesn’t have truly severe AS,” according to Dr. Nishimura.

One reason referral centers are seeing a lot more of these patients during the last decade is an influential study by Canadian investigators entitled “Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival.” Those investigators warned “this condition may often be misdiagnosed, which leads to a neglect and/or underestimation of symptoms and an inappropriate delay of aortic valve replacement surgery” (Circulation. 2007 Jun 5;115(22):2856-64).

This report led to a great deal of interest in performing aortic valve replacement in such patients during a period when transcatheter replacement was really taking off.

When an audience member asked how commonly such patients have undergone inappropriate aortic valve replacement, Michael J. Mack, MD, took the question.

“I don’t think it’s a huge number,” said Dr. Mack, medical director of cardiovascular surgery at the Baylor Health Care System in Plano, Tex. “This is the patient group we wring our hands about most. We know they don’t do as well with aortic valve replacement as patients with high-gradient AS with a low or normal ejection fraction. We’re loathe to treat them. I think most centers are.”
 

[email protected]

SNOWMASS, COLO. – A patient who presents with symptomatic low-flow, low-gradient severe aortic stenosis, hypertension, and preserved left ventricular ejection fraction (LVEF) is often referred straightaway for consideration of aortic valve replacement. Not so fast – these patients actually constitute a special case for whom two essential questions must be answered before proceeding to that stage, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

The first question is, What happens to the patient’s symptoms upon control of the hypertension?

“Almost all of these patients with low-flow severe aortic stenosis with preserved ejection fraction are going to be hypertensive. Treat the hypertension first. If they become asymptomatic, you don’t need to intervene. The aortic stenosis wasn’t causing their symptoms. You can afford to continue to watch them,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

An aortic valve area of less than 1.0 cm² is a prerequisite for surgical or transcatheter aortic valve replacement. So the second key question is this, Does the patient have truly severe aortic stenosis (AS), or is it instead a case of pseudo-AS in which the small aortic valve area noted on echocardiography is caused by low flow secondary to a small left ventricle with a low stroke volume?

“If you increase the flow and remeasure the aortic valve area, you’ll find that a lot of these patients don’t have a really small aortic valve area of less than 1.0 cm². You might find the aortic valve area pops up to 1.4-1.6 cm2,” he explained.

These patients with symptomatic low-flow, low-gradient severe AS with preserved LVEF are quite common.

“I don’t know why, but we’re seeing more and more of these patients. I think 10 years ago we just kind of ignored them. We thought we’d made a mistake in our calculations. But in fact if you’re very meticulous about your calculations, 30%-40% of your aortic stenosis patients fit into this category,” the cardiologist said.

Moreover, if these patients undergo aortic valve replacement when their symptoms stemmed from poorly controlled hypertension and/or pseudo-AS, they are not going to benefit from this major intervention, he added.

This issue was addressed, albeit briefly and obliquely, in the American Heart Association/ACC guidelines for management of patients with valvular heart disease, for which Dr. Nishimura served as first author and cochair of the writing committee (Circulation. 2014 Jun 10;129[23]:e521-643) as well as for the 2017 focused update of the guidelines.

The guidelines give a IIa recommendation to aortic valve replacement as “reasonable” in “symptomatic patients with low-flow/low-gradient severe AS (stage D3) with an LVEF 50% or greater, a calcified aortic valve with significantly reduced leaflet motion, and a valve area 1.0 cm² or less only if clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms and data recorded when the patient is normotensive.”

Dr. Nishimura chose the 50th annual meeting of the storied ACC Snowmass conference to elaborate upon that brief guidance. He explained that these patients with low-flow, low-gradient symptomatic “severe” AS with preserved LVEF and hypertension have two resistors in a series.

“You have a resistor at the aortic valve area but probably a greater resistor in the systemic circulation. They have high resistance at the arterial level and diastolic dysfunction due to ventricular-vascular coupling,” the cardiologist continued.

Checking for pseudo-AS in these patients is a matter of boosting their low transvalvular flow. This can be accomplished by increasing their cardiac output via monitored exercise or by pharmacologic afterload reduction.

“We’re exercising these patients in the cath lab, but you could also do it in the echocardiographic laboratory. With exercise, if cardiac output increases and the aortic valve area increases without significant change in the aortic valve mean gradient, the patient probably doesn’t have truly severe AS,” according to Dr. Nishimura.

One reason referral centers are seeing a lot more of these patients during the last decade is an influential study by Canadian investigators entitled “Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival.” Those investigators warned “this condition may often be misdiagnosed, which leads to a neglect and/or underestimation of symptoms and an inappropriate delay of aortic valve replacement surgery” (Circulation. 2007 Jun 5;115(22):2856-64).

This report led to a great deal of interest in performing aortic valve replacement in such patients during a period when transcatheter replacement was really taking off.

When an audience member asked how commonly such patients have undergone inappropriate aortic valve replacement, Michael J. Mack, MD, took the question.

“I don’t think it’s a huge number,” said Dr. Mack, medical director of cardiovascular surgery at the Baylor Health Care System in Plano, Tex. “This is the patient group we wring our hands about most. We know they don’t do as well with aortic valve replacement as patients with high-gradient AS with a low or normal ejection fraction. We’re loathe to treat them. I think most centers are.”
 

[email protected]

SNOWMASS, COLO. – A patient who presents with symptomatic low-flow, low-gradient severe aortic stenosis, hypertension, and preserved left ventricular ejection fraction (LVEF) is often referred straightaway for consideration of aortic valve replacement. Not so fast – these patients actually constitute a special case for whom two essential questions must be answered before proceeding to that stage, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.

Bruce Jancin/MDedge News

The first question is, What happens to the patient’s symptoms upon control of the hypertension?

“Almost all of these patients with low-flow severe aortic stenosis with preserved ejection fraction are going to be hypertensive. Treat the hypertension first. If they become asymptomatic, you don’t need to intervene. The aortic stenosis wasn’t causing their symptoms. You can afford to continue to watch them,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

An aortic valve area of less than 1.0 cm² is a prerequisite for surgical or transcatheter aortic valve replacement. So the second key question is this, Does the patient have truly severe aortic stenosis (AS), or is it instead a case of pseudo-AS in which the small aortic valve area noted on echocardiography is caused by low flow secondary to a small left ventricle with a low stroke volume?

“If you increase the flow and remeasure the aortic valve area, you’ll find that a lot of these patients don’t have a really small aortic valve area of less than 1.0 cm². You might find the aortic valve area pops up to 1.4-1.6 cm2,” he explained.

These patients with symptomatic low-flow, low-gradient severe AS with preserved LVEF are quite common.

“I don’t know why, but we’re seeing more and more of these patients. I think 10 years ago we just kind of ignored them. We thought we’d made a mistake in our calculations. But in fact if you’re very meticulous about your calculations, 30%-40% of your aortic stenosis patients fit into this category,” the cardiologist said.

Moreover, if these patients undergo aortic valve replacement when their symptoms stemmed from poorly controlled hypertension and/or pseudo-AS, they are not going to benefit from this major intervention, he added.

This issue was addressed, albeit briefly and obliquely, in the American Heart Association/ACC guidelines for management of patients with valvular heart disease, for which Dr. Nishimura served as first author and cochair of the writing committee (Circulation. 2014 Jun 10;129[23]:e521-643) as well as for the 2017 focused update of the guidelines.

The guidelines give a IIa recommendation to aortic valve replacement as “reasonable” in “symptomatic patients with low-flow/low-gradient severe AS (stage D3) with an LVEF 50% or greater, a calcified aortic valve with significantly reduced leaflet motion, and a valve area 1.0 cm² or less only if clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms and data recorded when the patient is normotensive.”

Dr. Nishimura chose the 50th annual meeting of the storied ACC Snowmass conference to elaborate upon that brief guidance. He explained that these patients with low-flow, low-gradient symptomatic “severe” AS with preserved LVEF and hypertension have two resistors in a series.

“You have a resistor at the aortic valve area but probably a greater resistor in the systemic circulation. They have high resistance at the arterial level and diastolic dysfunction due to ventricular-vascular coupling,” the cardiologist continued.

Checking for pseudo-AS in these patients is a matter of boosting their low transvalvular flow. This can be accomplished by increasing their cardiac output via monitored exercise or by pharmacologic afterload reduction.

“We’re exercising these patients in the cath lab, but you could also do it in the echocardiographic laboratory. With exercise, if cardiac output increases and the aortic valve area increases without significant change in the aortic valve mean gradient, the patient probably doesn’t have truly severe AS,” according to Dr. Nishimura.

One reason referral centers are seeing a lot more of these patients during the last decade is an influential study by Canadian investigators entitled “Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival.” Those investigators warned “this condition may often be misdiagnosed, which leads to a neglect and/or underestimation of symptoms and an inappropriate delay of aortic valve replacement surgery” (Circulation. 2007 Jun 5;115(22):2856-64).

This report led to a great deal of interest in performing aortic valve replacement in such patients during a period when transcatheter replacement was really taking off.

When an audience member asked how commonly such patients have undergone inappropriate aortic valve replacement, Michael J. Mack, MD, took the question.

“I don’t think it’s a huge number,” said Dr. Mack, medical director of cardiovascular surgery at the Baylor Health Care System in Plano, Tex. “This is the patient group we wring our hands about most. We know they don’t do as well with aortic valve replacement as patients with high-gradient AS with a low or normal ejection fraction. We’re loathe to treat them. I think most centers are.”
 

[email protected]

NEW ORLEANS – Patients with severely symptomatic aortic stenosis at low surgical risk had significantly better key outcomes with transcatheter aortic valve replacement than with surgical valve replacement through 1 year of follow-up in the landmark PARTNER 3 and Evolut Low Risk randomized trials presented at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

As the two study presenters stepped down from the stage after sharing their results, the packed audience in the meeting’s main arena rose to shower them with a prolonged standing ovation.

“This is a historic moment, and all of us here should recognize it as such,” thundered discussant Eugene Braunwald, MD, professor of medicine at Harvard Medical School, Boston. “We’re going to remember it. We’re going to tell our grandchildren and great grandchildren that we were there at the time these incredible advances in the care of patients with aortic stenosis were presented.”

This was in fact the day that transcatheter aortic valve replacement (TAVR), a relatively young, rapidly evolving nonsurgical technique, finally overtook surgical aortic valve replacement (SAVR), a mature operation first successfully performed back in 1962. Previous large, randomized trials had established that TAVR was superior to SAVR in extreme-risk patients and noninferior to surgery in high- and intermediate-risk patients, yet with the advantage of much quicker recovery. The only remaining question was how TAVR would stack up in low-risk patients, who comprise 80% of those who currently undergo SAVR for aortic stenosis.

“Two separate groups using two separate valves have come to very similar conclusions. This doesn’t double the acceptability, it quadruples it,” Dr. Braunwald said.

PARTNER 3

Martin B. Leon, MD, presented the findings of the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial, in which 1,000 low-risk patients at 71 centers were randomized to TAVR with transfemoral placement of the balloon-expandable Edwards Lifesciences Sapien 3 bioprosthetic valve or to SAVR. The mean age of the patients was 73 years, with a mean Society of Thoracic Surgeons risk score of 1.9%. Operators had to have more than 1 year of experience using the Sapien 3 valve in order to participate in the trial.

Bruce Jancin/MDedge News

At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with SAVR, for a highly significant 46% relative risk reduction. All three components of the primary endpoint occurred significantly less often in the TAVR group. And the rate of the key endpoint of death or disabling stroke was 1.0% with TAVR, compared with 2.9% with SAVR, reported Dr. Leon, coprincipal investigator in PARTNER 3 and professor of medicine at Columbia University, New York.

TAVR also outperformed SAVR on all six prespecified major secondary endpoints. These included new-onset atrial fibrillation within 30 days, at 5.0% with TAVR and 39.5% with SAVR; length of index hospitalization at 3 versus 7 days; all stroke at 30 days at 0.6% versus 2.4%; and death or a significant deterioration in quality of life at 30 days as measured by the Kansas City Cardiomyopathy Questionnaire at 3.9% versus 30.6%. There was significantly less life-threatening or major bleeding within 30 days in the TAVR group, by a margin of 3.6% versus 24.5%, and similarly low rates of new pacemaker implantation at 6.5% versus 4.0%. There was, however, a higher 30-day incidence of new left bundle branch block with TAVR, by a margin of 22% versus 8%, which may eventually translate into need for a pacemaker.

“Based upon these findings, TAVR, through 1 year, should be considered the preferred therapy in low-surgical-risk aortic stenosis patients. The PARTNER randomized trials over the past 12 years clearly indicate that the relative value of TAVR, compared with surgery, is independent of surgical risk profiles,” Dr. Leon declared.

Evolut Low Risk

Michael J. Reardon, MD, coprincipal investigator for the Evolut Low Risk study and professor of cardiovascular surgery at Houston Methodist Hospital, reported on 1,468 patients randomized to TAVR with a Medtronic self-expanding, supra-annular bioprosthetic valve or to SAVR. Of them, 22% of patients got the most recent version of the valve, known as the Evolut PRO, 74% got the Evolut R, and the remainder received the first-generation CoreValve.

Bruce Jancin/MDedge News

The primary endpoint – death or disabling stroke – was slightly different from that in PARTNER 3. At 1 year, the rate was 2.9% in the TAVR arm and 4.6% with SAVR, a statistically significant difference, while at 2 years the rate was 5.3% with TAVR and 6.7% with SAVR, a difference that was not significant. Impressively, the rate of the composite of death, disabling stroke, or heart failure hospitalizations through 1 year was 5.6% with TAVR versus 10.2% with SAVR.

“We’ve shown that, with TAVR, you’re more likely to be alive, without a stroke, and outside the hospital. This is exactly what my patients tell me they want when we sit down for shared decision-making and talk about their expectations,” Dr. Reardon said.

Noting the striking similarity of across-the-board outcomes in the two trials, Dr. Reardon concluded, “I think what we’re seeing here is a class effect of TAVR, and we have to recognize it as such.”

Dr. Leon agreed, with a caveat. “I think the class effect for these two versions of TAVR systems is very real. I wouldn’t presume to think that every TAVR device will perform the same way, so I think we need a lot more data on the newer devices that are being introduced.”

The reaction

During the question-and-answer session, the two investigators were asked about stroke rates, which were significantly lower in the TAVR patients even though in the early randomized trials in high-risk patients the stroke rates were twice as high with TAVR than SAVR. The explanation probably lies in a mix of device refinements over time, better techniques, standardized procedures, and careful patient selection, they said.

“If you look at stroke in the TAVR arm in both these trials, we’re almost approaching the background stroke rate in a group of 74-year-olds sitting around in a room,” Dr. Reardon observed.

Both trials will continue to assess participants both clinically and by echocardiography through 10 years, in part to assess TAVR valve durability, but also to evaluate the durability of surgical valves, which isn’t nearly as well established as most people think, according to the investigators.

“There is a myth of surgical bioprosthetic valve immortality. It’s based upon relatively few numbers of patients, largely sponsor-based studies, with numbers at risk at 15-20 years that are extremely low,” Dr. Leon asserted. “The majority of surgical valves being used today and touted as being durable are backed by only 2-4 years of data.”

In contrast, he added, “We have 5-year TAVR data which is absolutely definitive of no early structural valve deterioration.”

Discussant Mayra E. Guerrero, MD, of the Mayo Clinic in Rochester, Minn., expressed concern that “this paradigm shift to ‘TAVR for all’ ” could break the bank for many institutions because the cost of TAVR valves is far greater than for SAVR valves. But she was heartened by the fresh PARTNER 3 and Evolut Low Risk data showing TAVR patients had fewer ICU days, shorter hospital stays, fewer strokes, more frequent discharge home, and a lower rehospitalization rate.

Dr. Reardon was reassuring on this score.

“I am 100% convinced that when we do the financials for these two trials, TAVR is going to be a cost saver and a huge winner,” the surgeon said.

He reported serving as a consultant to Medtronic and receiving research grants from Medtronic and Boston Scientific. Dr. Leon reported receiving research grants from Edwards Lifesciences and St. Jude Medical and acting as a consultant to several medical device companies.

The two trials have been published online by the New England Journal of Medicine.

[email protected]

SOURCES: Leon MB et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1814052; Reardon MJ et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1816885.

NEW ORLEANS – Patients with severely symptomatic aortic stenosis at low surgical risk had significantly better key outcomes with transcatheter aortic valve replacement than with surgical valve replacement through 1 year of follow-up in the landmark PARTNER 3 and Evolut Low Risk randomized trials presented at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

As the two study presenters stepped down from the stage after sharing their results, the packed audience in the meeting’s main arena rose to shower them with a prolonged standing ovation.

“This is a historic moment, and all of us here should recognize it as such,” thundered discussant Eugene Braunwald, MD, professor of medicine at Harvard Medical School, Boston. “We’re going to remember it. We’re going to tell our grandchildren and great grandchildren that we were there at the time these incredible advances in the care of patients with aortic stenosis were presented.”

This was in fact the day that transcatheter aortic valve replacement (TAVR), a relatively young, rapidly evolving nonsurgical technique, finally overtook surgical aortic valve replacement (SAVR), a mature operation first successfully performed back in 1962. Previous large, randomized trials had established that TAVR was superior to SAVR in extreme-risk patients and noninferior to surgery in high- and intermediate-risk patients, yet with the advantage of much quicker recovery. The only remaining question was how TAVR would stack up in low-risk patients, who comprise 80% of those who currently undergo SAVR for aortic stenosis.

“Two separate groups using two separate valves have come to very similar conclusions. This doesn’t double the acceptability, it quadruples it,” Dr. Braunwald said.

PARTNER 3

Martin B. Leon, MD, presented the findings of the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial, in which 1,000 low-risk patients at 71 centers were randomized to TAVR with transfemoral placement of the balloon-expandable Edwards Lifesciences Sapien 3 bioprosthetic valve or to SAVR. The mean age of the patients was 73 years, with a mean Society of Thoracic Surgeons risk score of 1.9%. Operators had to have more than 1 year of experience using the Sapien 3 valve in order to participate in the trial.

Bruce Jancin/MDedge News

At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with SAVR, for a highly significant 46% relative risk reduction. All three components of the primary endpoint occurred significantly less often in the TAVR group. And the rate of the key endpoint of death or disabling stroke was 1.0% with TAVR, compared with 2.9% with SAVR, reported Dr. Leon, coprincipal investigator in PARTNER 3 and professor of medicine at Columbia University, New York.

TAVR also outperformed SAVR on all six prespecified major secondary endpoints. These included new-onset atrial fibrillation within 30 days, at 5.0% with TAVR and 39.5% with SAVR; length of index hospitalization at 3 versus 7 days; all stroke at 30 days at 0.6% versus 2.4%; and death or a significant deterioration in quality of life at 30 days as measured by the Kansas City Cardiomyopathy Questionnaire at 3.9% versus 30.6%. There was significantly less life-threatening or major bleeding within 30 days in the TAVR group, by a margin of 3.6% versus 24.5%, and similarly low rates of new pacemaker implantation at 6.5% versus 4.0%. There was, however, a higher 30-day incidence of new left bundle branch block with TAVR, by a margin of 22% versus 8%, which may eventually translate into need for a pacemaker.

“Based upon these findings, TAVR, through 1 year, should be considered the preferred therapy in low-surgical-risk aortic stenosis patients. The PARTNER randomized trials over the past 12 years clearly indicate that the relative value of TAVR, compared with surgery, is independent of surgical risk profiles,” Dr. Leon declared.

Evolut Low Risk

Michael J. Reardon, MD, coprincipal investigator for the Evolut Low Risk study and professor of cardiovascular surgery at Houston Methodist Hospital, reported on 1,468 patients randomized to TAVR with a Medtronic self-expanding, supra-annular bioprosthetic valve or to SAVR. Of them, 22% of patients got the most recent version of the valve, known as the Evolut PRO, 74% got the Evolut R, and the remainder received the first-generation CoreValve.

Bruce Jancin/MDedge News

The primary endpoint – death or disabling stroke – was slightly different from that in PARTNER 3. At 1 year, the rate was 2.9% in the TAVR arm and 4.6% with SAVR, a statistically significant difference, while at 2 years the rate was 5.3% with TAVR and 6.7% with SAVR, a difference that was not significant. Impressively, the rate of the composite of death, disabling stroke, or heart failure hospitalizations through 1 year was 5.6% with TAVR versus 10.2% with SAVR.

“We’ve shown that, with TAVR, you’re more likely to be alive, without a stroke, and outside the hospital. This is exactly what my patients tell me they want when we sit down for shared decision-making and talk about their expectations,” Dr. Reardon said.

Noting the striking similarity of across-the-board outcomes in the two trials, Dr. Reardon concluded, “I think what we’re seeing here is a class effect of TAVR, and we have to recognize it as such.”

Dr. Leon agreed, with a caveat. “I think the class effect for these two versions of TAVR systems is very real. I wouldn’t presume to think that every TAVR device will perform the same way, so I think we need a lot more data on the newer devices that are being introduced.”

The reaction

During the question-and-answer session, the two investigators were asked about stroke rates, which were significantly lower in the TAVR patients even though in the early randomized trials in high-risk patients the stroke rates were twice as high with TAVR than SAVR. The explanation probably lies in a mix of device refinements over time, better techniques, standardized procedures, and careful patient selection, they said.

“If you look at stroke in the TAVR arm in both these trials, we’re almost approaching the background stroke rate in a group of 74-year-olds sitting around in a room,” Dr. Reardon observed.

Both trials will continue to assess participants both clinically and by echocardiography through 10 years, in part to assess TAVR valve durability, but also to evaluate the durability of surgical valves, which isn’t nearly as well established as most people think, according to the investigators.

“There is a myth of surgical bioprosthetic valve immortality. It’s based upon relatively few numbers of patients, largely sponsor-based studies, with numbers at risk at 15-20 years that are extremely low,” Dr. Leon asserted. “The majority of surgical valves being used today and touted as being durable are backed by only 2-4 years of data.”

In contrast, he added, “We have 5-year TAVR data which is absolutely definitive of no early structural valve deterioration.”

Discussant Mayra E. Guerrero, MD, of the Mayo Clinic in Rochester, Minn., expressed concern that “this paradigm shift to ‘TAVR for all’ ” could break the bank for many institutions because the cost of TAVR valves is far greater than for SAVR valves. But she was heartened by the fresh PARTNER 3 and Evolut Low Risk data showing TAVR patients had fewer ICU days, shorter hospital stays, fewer strokes, more frequent discharge home, and a lower rehospitalization rate.

Dr. Reardon was reassuring on this score.

“I am 100% convinced that when we do the financials for these two trials, TAVR is going to be a cost saver and a huge winner,” the surgeon said.

He reported serving as a consultant to Medtronic and receiving research grants from Medtronic and Boston Scientific. Dr. Leon reported receiving research grants from Edwards Lifesciences and St. Jude Medical and acting as a consultant to several medical device companies.

The two trials have been published online by the New England Journal of Medicine.

[email protected]

SOURCES: Leon MB et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1814052; Reardon MJ et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1816885.

NEW ORLEANS – Patients with severely symptomatic aortic stenosis at low surgical risk had significantly better key outcomes with transcatheter aortic valve replacement than with surgical valve replacement through 1 year of follow-up in the landmark PARTNER 3 and Evolut Low Risk randomized trials presented at the annual meeting of the American College of Cardiology.

Bruce Jancin/MDedge News

As the two study presenters stepped down from the stage after sharing their results, the packed audience in the meeting’s main arena rose to shower them with a prolonged standing ovation.

“This is a historic moment, and all of us here should recognize it as such,” thundered discussant Eugene Braunwald, MD, professor of medicine at Harvard Medical School, Boston. “We’re going to remember it. We’re going to tell our grandchildren and great grandchildren that we were there at the time these incredible advances in the care of patients with aortic stenosis were presented.”

This was in fact the day that transcatheter aortic valve replacement (TAVR), a relatively young, rapidly evolving nonsurgical technique, finally overtook surgical aortic valve replacement (SAVR), a mature operation first successfully performed back in 1962. Previous large, randomized trials had established that TAVR was superior to SAVR in extreme-risk patients and noninferior to surgery in high- and intermediate-risk patients, yet with the advantage of much quicker recovery. The only remaining question was how TAVR would stack up in low-risk patients, who comprise 80% of those who currently undergo SAVR for aortic stenosis.

“Two separate groups using two separate valves have come to very similar conclusions. This doesn’t double the acceptability, it quadruples it,” Dr. Braunwald said.

PARTNER 3

Martin B. Leon, MD, presented the findings of the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial, in which 1,000 low-risk patients at 71 centers were randomized to TAVR with transfemoral placement of the balloon-expandable Edwards Lifesciences Sapien 3 bioprosthetic valve or to SAVR. The mean age of the patients was 73 years, with a mean Society of Thoracic Surgeons risk score of 1.9%. Operators had to have more than 1 year of experience using the Sapien 3 valve in order to participate in the trial.

Bruce Jancin/MDedge News

At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with SAVR, for a highly significant 46% relative risk reduction. All three components of the primary endpoint occurred significantly less often in the TAVR group. And the rate of the key endpoint of death or disabling stroke was 1.0% with TAVR, compared with 2.9% with SAVR, reported Dr. Leon, coprincipal investigator in PARTNER 3 and professor of medicine at Columbia University, New York.

TAVR also outperformed SAVR on all six prespecified major secondary endpoints. These included new-onset atrial fibrillation within 30 days, at 5.0% with TAVR and 39.5% with SAVR; length of index hospitalization at 3 versus 7 days; all stroke at 30 days at 0.6% versus 2.4%; and death or a significant deterioration in quality of life at 30 days as measured by the Kansas City Cardiomyopathy Questionnaire at 3.9% versus 30.6%. There was significantly less life-threatening or major bleeding within 30 days in the TAVR group, by a margin of 3.6% versus 24.5%, and similarly low rates of new pacemaker implantation at 6.5% versus 4.0%. There was, however, a higher 30-day incidence of new left bundle branch block with TAVR, by a margin of 22% versus 8%, which may eventually translate into need for a pacemaker.

“Based upon these findings, TAVR, through 1 year, should be considered the preferred therapy in low-surgical-risk aortic stenosis patients. The PARTNER randomized trials over the past 12 years clearly indicate that the relative value of TAVR, compared with surgery, is independent of surgical risk profiles,” Dr. Leon declared.

Evolut Low Risk

Michael J. Reardon, MD, coprincipal investigator for the Evolut Low Risk study and professor of cardiovascular surgery at Houston Methodist Hospital, reported on 1,468 patients randomized to TAVR with a Medtronic self-expanding, supra-annular bioprosthetic valve or to SAVR. Of them, 22% of patients got the most recent version of the valve, known as the Evolut PRO, 74% got the Evolut R, and the remainder received the first-generation CoreValve.

Bruce Jancin/MDedge News

The primary endpoint – death or disabling stroke – was slightly different from that in PARTNER 3. At 1 year, the rate was 2.9% in the TAVR arm and 4.6% with SAVR, a statistically significant difference, while at 2 years the rate was 5.3% with TAVR and 6.7% with SAVR, a difference that was not significant. Impressively, the rate of the composite of death, disabling stroke, or heart failure hospitalizations through 1 year was 5.6% with TAVR versus 10.2% with SAVR.

“We’ve shown that, with TAVR, you’re more likely to be alive, without a stroke, and outside the hospital. This is exactly what my patients tell me they want when we sit down for shared decision-making and talk about their expectations,” Dr. Reardon said.

Noting the striking similarity of across-the-board outcomes in the two trials, Dr. Reardon concluded, “I think what we’re seeing here is a class effect of TAVR, and we have to recognize it as such.”

Dr. Leon agreed, with a caveat. “I think the class effect for these two versions of TAVR systems is very real. I wouldn’t presume to think that every TAVR device will perform the same way, so I think we need a lot more data on the newer devices that are being introduced.”

The reaction

During the question-and-answer session, the two investigators were asked about stroke rates, which were significantly lower in the TAVR patients even though in the early randomized trials in high-risk patients the stroke rates were twice as high with TAVR than SAVR. The explanation probably lies in a mix of device refinements over time, better techniques, standardized procedures, and careful patient selection, they said.

“If you look at stroke in the TAVR arm in both these trials, we’re almost approaching the background stroke rate in a group of 74-year-olds sitting around in a room,” Dr. Reardon observed.

Both trials will continue to assess participants both clinically and by echocardiography through 10 years, in part to assess TAVR valve durability, but also to evaluate the durability of surgical valves, which isn’t nearly as well established as most people think, according to the investigators.

“There is a myth of surgical bioprosthetic valve immortality. It’s based upon relatively few numbers of patients, largely sponsor-based studies, with numbers at risk at 15-20 years that are extremely low,” Dr. Leon asserted. “The majority of surgical valves being used today and touted as being durable are backed by only 2-4 years of data.”

In contrast, he added, “We have 5-year TAVR data which is absolutely definitive of no early structural valve deterioration.”

Discussant Mayra E. Guerrero, MD, of the Mayo Clinic in Rochester, Minn., expressed concern that “this paradigm shift to ‘TAVR for all’ ” could break the bank for many institutions because the cost of TAVR valves is far greater than for SAVR valves. But she was heartened by the fresh PARTNER 3 and Evolut Low Risk data showing TAVR patients had fewer ICU days, shorter hospital stays, fewer strokes, more frequent discharge home, and a lower rehospitalization rate.

Dr. Reardon was reassuring on this score.

“I am 100% convinced that when we do the financials for these two trials, TAVR is going to be a cost saver and a huge winner,” the surgeon said.

He reported serving as a consultant to Medtronic and receiving research grants from Medtronic and Boston Scientific. Dr. Leon reported receiving research grants from Edwards Lifesciences and St. Jude Medical and acting as a consultant to several medical device companies.

The two trials have been published online by the New England Journal of Medicine.

[email protected]

SOURCES: Leon MB et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1814052; Reardon MJ et al. N Engl J Med. 2019 Mar 16. doi: 10.1056/NEJMoa1816885.