People who received a minimally invasive procedure to replace their heart’s aortic valve experienced similar health outcomes years after treatment as those who underwent open-heart surgery, according to new research led by Cedars-Sinai investigators.
Raj Makkar, MD, an interventional cardiologist in the Department of Cardiology at the Smidt Heart Institute and senior author of the study, said, “These results show that seven years after treatment, health outcomes for patients were similar whether they underwent a minimally invasive procedure or open-heart surgery.” Makkar is also the inaugural director of the Karsh Division of Interventional Cardiology at Cedars-Sinai.
Aortic valve disease impacts around 2% of people in the United States, with risk increasing as people age. The condition is expected to become more common over time.
The findings come from the international PARTNER 3 trial, which included 1,000 patients at 71 healthcare locations. All participants had severe aortic valve stenosis—a narrowing and stiffening of the heart’s aortic valve that can lead to heart failure or stroke. Participants were randomly assigned to receive either open-heart surgery or transcatheter aortic valve replacement (TAVR), using a commercially available bioprosthetic SAPIEN 3 valve.
TAVR involves threading a catheter through an artery to reach and replace the diseased heart valve. Previous studies have shown similar outcomes between TAVR and surgery five years after treatment among patients with varying surgical risks.
This latest study focused on patients considered low risk for surgical complications. Seven years after treatment, composite rates of death, stroke, or rehospitalization related to treatment were 34.6% for TAVR (496 people) and 37.2% for surgery (454 people). This difference was not statistically significant. Rates of failure for the bioprosthetic valve were also close: 6.9% for TAVR and 7.3% for surgery. Both groups reported similar quality of life outcomes.
“These rich data exemplify the vital information clinicians need to guide patient treatment,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and Mark Siegel Family Foundation Distinguished Chair. “We are proud to offer leading-edge clinical care while also advancing the field of cardiology with groundbreaking research.”
Cedars-Sinai Medical Center is recognized globally for its expertise in both surgical and transcatheter treatments for heart valve disease. Makkar leads a team performing nearly 800 TAVRs each year.
Researchers plan to release additional data on patient outcomes and valve durability at ten years post-treatment.
The study’s other authors include Martin B. Leon, MD; Michael J. Mack, MD; Philippe Pibarot, DVM, PhD; Rebecca T. Hahn, MD; Vinod H. Thourani, MD; S.H. Kodali, MD; Philippe Genereux, MD; Samir R. Kapadia, MD; David J. Cohen, MD, MSc; Stuart J. Pocock, PhD; Yiran Zhang, MS; Molly Szerlip, MD; Julien Ternacle, MD, PhD; S. Chris Malaisrie, MD; Howard C. Herrmann, MD; Wilson Y. Szeto, MD; Mark J. Russo, MD; Vasilis Babaliaros, MD; Tamim Nazif, MD; John G. Webb, MD.
Funding was provided by Edwards Lifesciences. Makkar receives research grants and travel support from Edwards Lifesciences.
Cedars-Sinai Health Sciences University continues its work in medical research and education across various disciplines.
Cedars-Sinai Medical Center is located in Los Angeles and was founded in 1902.
Its current president is Thomas M. Priselac.
The hospital includes pediatric services and serves as a training hospital.
In 2022,
the center admitted over 50,
000 patients for treatment
(https://www.cedars-sinai.org/about.html).
