News | Heart Valve Technology | November 07, 2016

Early Quality of Life Improvements Sustained for Intermediate-Risk Patients Treated with Edwards Transcatheter Valves

Quality-of-life study performed alongside PARTNER II trial shows improvements in health status over surgery for transfemoral TAVR; transthoracic TAVR shows equal mortality and quality of life benefits

Edwards, Sapien 3, Sapien XT, quality of life study, PARTNER II Trial, TAVR, intermediate-risk patients, TCT 2016

November 7, 2016 — Edwards Lifesciences Corp. recently announced new data demonstrating dramatic and sustained improvements in quality of life for severe aortic stenosis (AS) patients at intermediate surgical risk treated with Edwards transcatheter heart valves. Study results were presented at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C.

The new data, involving more than 3,000 patients enrolled in The PARTNER II Trial, showed dramatic improvements in cardiovascular health status as well as overall physical and mental well-being after transcatheter aortic valve replacement (TAVR) with the Edwards Sapien XT and Sapien 3 valves. The health benefits with TAVR were early and sustained.

“Because AS patients are generally elderly and often have multiple comorbid conditions, many of them care more about maintaining or improving their quality of life rather than simply achieving a longer life,” said David J. Cohen, M.D., professor of medicine at the University of Missouri-Kansas City and director of cardiovascular research at Saint Luke’s Mid America Heart Institute, who presented the late-breaking data from the PARTNER II randomized trial at TCT. “Taken together with previous data demonstrating very low mortality and disabling stroke rates with transfemoral TAVR among patients at intermediate surgical risk, these findings demonstrate that, for such patients, ­­­TAVR provides both early and late benefits that are important from the patient’s perspective.” 

In the quality-of-life study performed alongside the PARTNER II Trial comparing TAVR with surgical aortic valve replacement, patients treated via transfemoral TAVR with the Sapien XT valve saw substantially greater health status improvements at one month than patients treated with surgery. Overall, 71.1 percent of patients treated with transfemoral TAVR experienced health status improvements at one month compared with just 44.7 percent of patients treated surgically. Moreover, when mortality and the extent of quality of life improvement were evaluated together, transfemoral TAVR with the Sapien XT valve was superior to surgery at the one- and two-year follow-up, as well. In the transthoracic cohorts, mortality and quality of life benefits were similar to surgery.

Building off the foundational work of the PARTNER II randomized trial, a separate analysis of intermediate-risk patients treated with the Sapien 3 valve in the PARTNER II Trial demonstrated even greater health status improvements than the Sapien XT valve at one month with persistent benefits compared with surgery at one year. These data were presented by Suzanne J. Baron, M.D., M.Sc., assistant professor of medicine at the University of Missouri-Kansas City and a clinical scholar at Saint Luke’s Mid America Heart Institute.

The Sapien XT and Sapien 3 are the only transcatheter aortic valves approved for the treatment of intermediate-risk patients in the United States.

Cohen is a consultant to Edwards Lifesciences.

For more information: www.crf.org/tct

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init