Edwards Lifesciences, Medtronic tout TAVR data
Two-year quality-of-life data from Partner II for Edwards’ Sapien XT: The 2,000-patient Partner II study of the 2nd-generation Sapien XT valve made by Edwards showed improved health after a month but similar quality-of-life outcomes after 2 years, compared with surgical valve replacement, in intermediate-risk patients.
The study assessed quality of life at baseline, 1, 12 and 24 months using the Kansas City Cardiomyopathy Questionnaire, SF-36 and EQ-5D.
The 2-year change in KCCQ Overall Summary Score was 19.2 points for the Sapien XT cohort, compared with 18.3 points for the surgical arm. Similarly, the 2-year change in the SF-36 Physical Component Summary Score was 3.0 points with TAVR versus 2.7 points with SAVR. (By comparison, at 1 month, TAVR was associated with significantly better QoL than SAVR, but this difference was restricted to patients who were treated via transfemoral access and was not seen in patients that were treated via transapical or transaortic access). There were no significant differences between TAVR and SAVR in any QoL measures at 1 year or 2 years.
“This study shows that among intermediate-risk patients with severe AS, quality of life improved significantly and to a similar extent with TAVR and SAVR through 2 years. However, transfemoral (but not transthoracic) TAVR was associated with a substantial and clinically important early health status benefit compared with SAVR,” lead investigator Dr. David Cohen, of Kansas City’s Saint Luke’s Mid America Heart Institute, said in prepared remarks. “We believe that these early differences in quality of life may be important to many patients who are suitable candidates for both procedures. Longer-term follow up is needed to assess the durability of quality of life improvement with TAVR versus SAVR in this intermediate risk population.”
Five-year hemodynamic data from Partner I for Edwards’ Sapien: A 5-year follow-up sub-study from the Partner I trial showed excellent durability without significant structural valve deterioration at five years for the 1st-generation Sapien valve made by Edwards. Researchers performed and analyzed echocardiograms at 7 days, 30 days, 6 months and annually for 5 years after that.
The modeled trend of mean AV gradient decreased in the first few months post-implant then increased non-significantly over follow-up (12.1 vs. 9.2 at 3 months vs. 10.3 mmHg at 5 years. Among the 2,230 patients with multiple post-op AV gradients, a large interval change between subsequent echoes was uncommon, with just 10 patients (0.45%) having an interval increase of ³20 mmHg.
“TAVR is a safe and effective treatment for severe aortic stenosis,” lead investigator Dr. Pamela Douglas, of the Duke University School of Medicine, said in prepared remarks. “However, the long-term durability of transcatheter heart valves and the potential implications for patient outcomes are not completely understood. Therefore, determining the midterm hemodynamic profiles is critical to patient and device selection.”
“The 5-year data from the largest, core-lab based study of TAVR to date showed stable AV mean gradients over the mid-term, with no suggestion of late structural deterioration,” Douglas said. “Similarly, severely abnormal hemodynamics in individual patients which might be suggestive of valve thrombosis or stenosis were rare. Together, the results suggest that the low 5-year survival observed in this cohort is not due to adverse hemodynamics.”
“We are very pleased with the scientifically rigorous 5-year outcomes data presented at TCT,” added Edwards vice president Larry Wood. “While this research is meaningful and important information for both clinicians and patients, we see this as the starting point for further evaluations, and our intention is to use the Partner and Partner II trial data to generate additional longer-term evidence on durability for the Sapien family of heart valves.”
One-year pivotal, real-world data for Medtronic’s CoreValve Evolut R: Medtronic touted results from a trio of studies covering its CoreValve Evolut R TAVR, including 1-year pivotal data and real-world results from 2 registry trials.
Evolut R U.S. IDE Study: One-year data from the 241-patient Evolut R’s pivotal investigational device exemption study in extreme- and high-risk patients showed a 91.4% survival rate a 5.1% rate of disabling stroke. Initial use of the larger Evolut R 34mm valve resulted in no deaths, stroke or vascular complications and 2 pacemaker implants (13.3%) at 30 days, the company said. Mean aortic gradients were 9.0 ± 4.8 mm Hg; there were no patients with severe paravalvular leak and low rates of moderate PVL (3.7%). There were no incidents of embolization or migration, valve dysfunction requiring repeat procedure, endocarditis or valve thrombosis; the pacemaker rate was 18.3% at 1 year.
In the 34mm group at 30 days, mean aortic valve area was 2.8 ± 0.9 cm2, mean gradient of 5.4 ± 2.3 mm Hg, and 1 patient with moderate PVL. No severe PVL was observed at 30 days.
“The remarkable 1-year results from the Evolut R IDE study, as well as the first outcomes with the 34mm valve size, further strengthens the positive body of evidence that supports the Evolut R system’s clinical performance in a wide range of patient anatomies,” Dr. Jeffrey Popma, of Boston’s Beth Israel Deaconess Medical Center, said in prepared remarks. “It is reassuring to see that patients continued to experience positive clinical outcomes with the Evolut R system at 1-year follow-up.”
“One-year data from the Evolut R U.S. IDE study reinforce the positive results from the Evolut R CE Study, demonstrating the unique ability of the Evolut R system design to assist with valve placement accuracy and improve clinical outcomes,” Robb added. “It’s especially encouraging to see the excellent initial outcomes from the Evolut R 34 mm subset, which has the potential to expand the TAVR market by enabling more patients with larger sized native valves to receive this first-of-its-kind treatment option.”
Evolut R Forward: Real-world data from this 300-patient study in Europe, Australia, the Middle East, Africa, Latin America and Canada showed a 98% survival rate and an all-stroke rate of 3% at 30 days. Mean aortic valve gradientwas 42.5 ± 17.7mm Hg at baseline and 8.7 ±6.9mm Hg at discharge; the rate of major vascular complications was 2.7% and there were no reports of valve thrombosis.
“We’re encouraged by the initial 30-day outcomes of the Forward study, which further showcase the advantages of the recapturable and repositionable capabilities of the Evolut R system,” co-principal investigator Dr. Eberhard Grube, of Bonn’s University Hospital, said in prepared remarks. “As patient follow-up continues at 1, 2 and 3 years post-implant, we look forward to seeing how the features of the Evolut R System can address everyday clinical needs in various severe aortic stenosis patient scenarios worldwide.”
STS/ACC TVT Registry Data: New data from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry, tracking more than 9,600 patients, showed a survival rate of 96.3% and an all-stroke rate of 3.1% at 30 days, with successful valve implantation in 99% of cases. Mean gradient was 43.7 ± 15.4mm Hg at baseline and 8.6 ± 5.5mm Hg at discharge; the rate of major vascular complication was 1.5%. Post-procedure hospital stays were a median of 4 days and 75.7% of patients returned home following discharge instead of being referred to a rehab center.
“As commercial adoption of the Evolut R system increases, it’s important that we work in collaboration with heart teams to offer this advanced, next-generation device that helps provide clinical improvements in ‘real-world’ patient populations,” Robb said. “The latest Forward and TVT Registry results presented today further builds upon the growing body of global evidence supporting our self-expanding TAVR systems as safe and effective treatment options.”