Expandable Heart Valves Could Mean Fewer Surgeries

19 Mars, 2019, 09:22 | Auteur: Yves Courtet
  • Edwards Medtronic heart valve systems prove worth in low-risk patients-studies

At a glance, the second option - a transcatheter aortic valve replacement (TAVR) - would seem to be a no-brainer.

Research from a group of cardiac surgeons has found that patients with a low surgery risk can still benefit from a minimally invasive procedure known as transcatheter aortic valve replacement or TAVR, in the place of the traditional option of open-heart surgery.

Both late-breaking trials - featuring the lowest-risk TAVR patients studied to date, both with an average surgical mortality risk score of 1.9% - were released early due to an embargo break before presentation here at the American College of Cardiology's annual meeting and publication in the New England Journal of Medicine. The patients were randomized 1:1 for surgical or catheter-based valve replacement with a SAPIEN-3 valve manufactured by Edwards LifeSciences.

Northwestern Medicine's Bluhm Cardiovascular Institute is one of the top 10 national programs for cardiology and heart surgery, according to U.S. News and World Report, and ranked the top cardiovascular program in Chicago, Illinois and the surrounding states for more than 10 consecutive years. Without an operation, most aortic stenosis suffers die within two years.

The Transcatheter Aortic Valve Replacement Market Analysis Also Covers the Upstream Raw Materials, Downstream Client Survey, Equipment, Industry Development Trend, Proposals and Marketing Channels. Patients at low surgical risk comprise the majority of people who are candidates for surgery to have their aortic valve replaced. There were also more men than women enrolled (67.5 percent vs. 32.5 percent, respectively).

Both study teams will continue to follow their patients.

Separately, in a prespecified interim analysis of the Evolut Low Risk Trial, the rate of combined deaths and disabling strokes at 24 months was 5.3% for TAVR with Medtronic's line of self-expanding bioprostheses and 6.7% with surgery.

In the study to which Penn and Lankenau contributed, 8.5 percent of people whose valves were replaced via catheter died, had a stroke, or went back to the hospital within one year, compared with 15.1 percent of patients who had the valve replaced with open-heart surgery.

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Scott M. Goldman, a co-author of the first study and director of the structural heart program at Lankenau, said he was not surprised that TAVR patients fared so well.

Patients in the Partner-3 study had a mean age of 73 and were experiencing symptoms of advanced aortic stenosis, including shortness of breath, chest pain, fainting or palpitations. In 2012, Hoag began offering TAVR, an innovative percutaneous procedure that offered hope to individuals at high risk for surgery. "Today's findings suggest that TAVR may be superior to surgery, even for patients with low operative risk".

"Hoag not only is helping guide research for these procedures, but we are able to provide it directly to our community".

Jefferies analyst Raj Denhoy said he expects the TAVR market to grow in both size and competition, with Boston Scientific's Lotus system poised for potential US approval this year.

Expandable heart valves that can be placed in the heart through a minimally invasive procedure appear to be as safe or safer than those implanted through surgery, according to two news studies.

"These results are a game changer for the treatment of aortic stenosis". Dr. Herrmann was not involved in either study.

Across 71 centers in the United States, the researchers recruited 1,000 patients who have severe aortic stenosis, a condition in which the heart valve narrows and prevents normal blood flow. Hoag's cardiac surgery program has received a 3-star rating - which is the top 5% in the country - the highest rating awarded by The Society of Thoracic Surgeons - one of the most sophisticated and highly regarded organizations that measures quality and compares cardiothoracic surgery programs across the USA and Canada.

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