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TAVR with Sapien 3 valve yields low mortality, complications at 1 year in high-risk, inoperable patients
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In high-risk and inoperable patients with severe aortic stenosis, transcatheter aortic valve replacement with the balloon-expandable Sapien 3 valve yielded a low rate of complications and mortality at 1 year.
“These results, which likely reflect device iteration and procedural evolution, support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis,” Howard C. Herrmann, MD, from the Hospital of the University of Pennsylvania and a Cardiology Today’s Intervention Editorial Board member, and colleagues wrote in Circulation.
Researchers analyzed 1-year outcomes in the large adjudicated PARTNER 2 registry of high-risk and inoperable patients who underwent TAVR with the Sapien 3 valve (Edwards Lifesciences) via transfemoral (84%) or transapical/transaortic (16%) access. In total, the researchers reported data on 583 high-risk (66%) or inoperable (34%) patients with aortic stenosis who were enrolled at 29 U.S. sites from October 2013 to September 2014. The mean age of the patients was 83 years, 42% were women and the median Society of Thoracic Surgeons score was 8.4%.
Vinod H. Thourani
Eligible patients had severe symptomatic native tri-leaflet degenerative aortic stenosis (mean echocardiographic gradient > 40 mm Hg; jet velocity > 4 m/s; aortic valve area < 0.8 cm2). Patients were considered high risk if they had an STS predicted risk for 30-day mortality greater than 8% or if the local heart team determined a risk for mortality of greater than 15%. Patients were considered inoperable if a cardiologist and two cardiac surgeons determined that the risk for mortality or serious morbidity was greater than 50%.
One-year data
At 1 year, all-cause survival was 85.6% overall — 87.3% in the high-risk group and 82.3% in the inoperable group. Survival free from CV mortality at 1 year was 91.9% overall — 92.6% in the high-risk group and 90.4% in the inoperable group. In the high-risk group that underwent transfemoral access, survival free from all-cause mortality was 87.7% and survival free from CV mortality was 93.3%.
“These are the best reported [survival] numbers thus far in this high-risk group of patients,” Vinod H. Thourani, MD, a cardiothoracic surgeon and researcher at Emory University, told Cardiology Today’s Intervention.
The rate of all-stroke was 1.4% within 30 days and 4.3% from 30 days to 1 year. The rate of major stroke was 0.9% at 30 days and 2.4% from 30 days to 1 year. The rate of disabling stroke was not different among high-risk or inoperable patients or between those who underwent TAVR via transfemoral or transapical/transaortic access. The percentage of patients with NYHA class III/IV HF improved from 90% at baseline to 8% at 1 year. Improvements in 6-minute walk test and Kansas City Cardiomyopathy Questionnaire were also recorded through 1 year in high-risk and inoperable patients.
Overall, 16.8% of patients required a new permanent pacemaker at 1 year. After the researchers excluded patients with pacemakers at baseline, the Kaplan-Meier 1-year estimated rate for a new permanent pacemaker was 20.1%, according to the results.
In other results, 17% of patients were rehospitalized. Three patients required surgical AVR for valve embolization and prosthetic valve endocarditis.
At 1 year, 2.7% of patients had moderate paravalvular leak. When the researchers performed a paired analysis of patients with evaluable echocardiograms at 30 days and 1 year (n = 364), they found no difference over time in paravalvular leak. No cases of severe paravalvular leak occurred. Moderate paravalvular leak was associated with reduced survival, whereas none/trace or mild paravalvular leak had no effect on survival.
Improved features, procedure, experience
According to Thourani, these positive results in high-risk and inoperable patients are due to a combination of improved features available with the Sapien 3 valve. With previous-generation valves, only about 55% of patients were able to receive it via the transfemoral route, he said.
“The Sapien 3 valve offers a smaller sheath size, and this smaller sheath size allows almost 90% of patients to have transfemoral access,” he said. “We have seen that those undergoing transfemoral TAVR have superb outcomes with minimal complications.”
Additionally, the Sapien 3 valve has been updated to address a previously observed issue of paravalvular regurgitation, Thourani said.
“The Sapien 3 valve has a skirt on the ventricular side of the implant, which minimizes paravalvular regurgitation. This study did show the lowest leak rate at 1-year that we have seen thus far in this type of patient,” he said. “That’s the second big distinction of this valve.”
Thourani also cited the availability of four valve sizes vs. the previous three valve sizes as a contributor to the improved success in outcomes with use of this valve.
The researchers also noted that improvements in operator experience and patient selection also may have contributed to the low rates of complications and mortality. – by Jennifer Byrne
For more information:
Vinod H. Thourani, MD, can be reached at vthoura@emory.edu.
Disclosure: The PARTNER trial was funded by Edwards Lifesciences. Thourani is a member of the PARTNER trial steering committee and reports consulting for Abbott Vascular, Edwards Lifesciences, Sorin Medical and St. Jude Medical. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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