Meta-analysis: Transapical TAVR associated with higher mortality

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller

BARCELONA – The transfemoral approach to aortic valve replacement is associated with lower risk of death, stroke, and bleeding, compared with the more invasive transapical approach, according to a meta-analysis of more than a dozen studies.

After adjustment for baseline characteristics, Italian researchers found that, compared with patients who underwent transapical transcatheter aortic valve replacement (TAVR), the transfemoral group was nearly 20% less likely to die within 30 days and during the first year after the procedure. The transfemoral group also was significantly less likely to have periprocedural bleeding or stroke.

Although the findings should be viewed as hypothesis generating, they suggest that “transapical access should be reserved as a last option in TAVR patients. This choice may guarantee less mortality, less stroke, and less bleeding in this frail and elderly population,” Dr. Federico Conrotto said at the annual congress of the European Society of Cardiology.

Although the transfemoral approach for aortic valve replacement is completely percutaneous, the transapical approach is more invasive and involves the direct puncture of the left ventricle. Also, the transapical approach is mostly reserved for patients in whom femoral vessels are unapproachable. These patients also turn out to be sicker, hence making it difficult to compare the two approaches, and there are no randomized trials comparing the two, said Dr. Conrotto of Città della Salute e della Scienza Hospital in Turin, Italy.

In the absence of randomized trials, Dr. Conrotto and his colleagues selected 13 studies that reported the adjustments for clinical baseline characteristics and reported the baseline, periprocedural, and midterm (median, 365 days) outcomes for patients who underwent transfemoral and transapical TAVR.

Their primary endpoint was all-cause mortality at 1-year follow-up. The secondary endpoint was 30-day mortality and in-hospital complications, including bleeding and stroke.

In total, the studies included 10,468 patients who underwent TAVR between 2005 and 2012. The patients’ median age was 82 years and half were men: one-fourth had diabetes, 18% had renal dysfunction, 61% had coronary artery disease, and the average ejection fraction was 50%. Almost 70% of the TAVR procedures were performed transfemorally.

Results showed that patients who underwent the transfemoral approach were 15% less likely to die at 365 days following TAVR and 20% less likely to die at 30 days, compared with those who underwent the transapical approach, Dr. Conrotto said. Both differences were statistically significant.

Those who underwent the transfemoral approach were almost 30% less likely to have periprocedural bleeding and 10% less likely to have a periprocedural stroke. Again, both differences were statistically significant, he noted.

“Not only does the transfemoral approach lead to longer life, but it’s safer,” said Dr. Conrotto.

But Dr. Michael A. Borger, director of the cardiovascular institute at Columbia University Medical Center, New York, had his reservations about drawing any practice-changing conclusion from the study. In many centers, the transfemoral approach is the preferred method, so naturally only sicker patients undergo transapical TAVR, “and those patients are going to have worse outcomes. So no matter how much they try with statistics, they will not be able to account for that selection bias. And really, the only way to know is with a randomized trial, but there’s no desire within the cardiology community for a randomized trial,” he said, citing the current widespread preference for the transfemoral approach.

Dr. Conrotto and Dr. Borger had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemmiller