Long-Awaited Data Published in JAMA Confirms Minimally Invasive Procedure for Degenerative Mitral Regurgitation Is Successful in Nearly 90% of Patients

Long-awaited outcomes data of transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation (MR) revealed the procedure to be safe and effective in nearly 90% of patients.

The findings, which are from a registry-based study conducted by physician-scientists at the Smidt Heart Institute at Cedars-Sinai, were recently published in the Journal of the American Medical Association (JAMA). This represents the largest outcomes study to date for patients treated outside of a clinical trial with TEER.

“Treatment was successful in nearly 9 out of every 10 patients in whom TEER was used,” said Raj Makkar, MD, Cedars-Sinai’s vice president of Cardiovascular Innovation and Intervention; the Stephen R. Corday, MD, Chair in Interventional Cardiology; and the study’s senior author.

Using data from the Transcatheter Valve Therapy (TVT) Registry—a jointly maintained database from the Society of Thoracic Surgeons and the American College of Cardiology—investigators analyzed a cohort of 19,088 consecutive patients who underwent TEER for moderate to severe isolated degenerative mitral valve regurgitation between January 2014 and June 2022.

“These strong safety and efficacy outcomes were validated, despite the advanced age and significant comorbidities of these patients,” Makkar said. 

The study’s primary endpoint was mitral regurgitation success, defined by investigators as moderate or better residual mitral regurgitation without narrowing of the mitral valve. Additional endpoints included death while hospitalized, as well as within 30 days and within one year of the procedure.

Key findings include:

• Patients’ average age was 82.
• 49% of patients were women.
• Mitral regurgitation success was shown in 88.9% of patients. 
• At 30 days, the incidence of death was 2.7%, stroke was 1.2% and mitral valve reintervention was 0.97%.
• The lowest mortality rate was observed in patients who had both mild or less residual mitral regurgitation.

“For patients at elevated risk for surgery, TEER with the MitraClip device is a meaningful treatment option,” said Makkar, who is also the associate director of the Smidt Heart Institute. “The procedure is getting many patients back to a more energetic life and back to activities some haven’t been able to do for years.”

To treat mitral valve regurgitation, experts from the Smidt Heart Institute at Cedars-Sinai rely on either the minimally invasive TEER procedure, minimally invasive robotic surgery or minimally invasive surgery. All patients treated at Cedars-Sinai meet with an interventional cardiologist as well as a cardiac surgeon before making their treatment decision.

“Surgery is successful in nearly 100% of patients having degenerative mitral repair today in the U.S., restoring normal life expectancy in most patients,” said Joanna Chikwe, MD, chair of the Department of Cardiac Surgery at Cedars-Sinai; the Irina and George Schaeffer Distinguished Chair in Cardiac Surgery in honor of Alfredo Trento, MD; and a study author. “A discussion with the heart team is essential for patients deciding between surgery or interventional approaches, and we need randomized trials to inform these important decisions.”

Chikwe is principal investigator of the PRIMARY clinical trial—a multicenter, international trial that compares the surgical approach for valve repair with the TEER procedure. The trial, funded by the National Institutes of Health, is expected to complete enrollment in January 2026.

“This landmark study epitomizes the way Smidt Heart Institute physicians and surgeons work together to advance knowledge, guiding us in doing what’s best for any given patient—this is, after all, why we come to work every day,” said Eduardo Marbán, MD, PhD, the Mark Siegel Family Foundation Distinguished Chair and executive director of the Smidt Heart Institute.

Cedars-Sinai has performed more transcatheter aortic valve replacements and mitral valve repairs than any other center in the U.S., with outcomes that place Cedars-Sinai among the top-performing programs nationally. The Smidt Heart Institute team has also performed more than 1,500 robotic mitral valve repairs, with a near 100% success rate.

The Smidt Heart Institute was named #1 in California and #3 in the nation for Cardiology & Heart Surgery, according to U.S. News & World Report’s “Best Hospitals 2022-2023” rankings.

For more information, please email heartinstitute@cshs.org.

DOI: 10.1001/jama.2023.7089

JAMA abstract: https://jamanetwork.com/journals/jama/article-abstract/2805140