A study by researchers at the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Center has shown that a less invasive cardiac procedure for a common condition is just as effective as conventional open-heart surgery. The conclusions are published in the Journal of the American Medical Association (JAMA) today (Tuesday May 17).
The study compared transcatheter aortic valve implantation (TAVI) to conventional surgery in the treatment of severe symptomatic aortic stenosis. In this condition, there is narrowing of the valve through which blood flows as it leaves the heart, and treatment often requires surgery. An estimated 1.5% of UK adults over 55 and 3.5% of those over 75 suffer from the disease.
The study is the first publicly funded study of its kind, receiving over £3 million from the NIHR’s Health Technology Assessment (HTA) program and involving all centers in the UK performing the TAVI.
The first TAVI in the UK was performed in Leicester in 2007 by a multidisciplinary team from Glenfield Hospital Leicester, led by Professor Jan Kovac. In a TAVI procedure, a new valve is threaded through a small tube inserted into an artery in the groin, arm, or chest. It offers an alternative to open heart surgery and is widely used throughout the UK.
Previous studies have shown TAVI to be a safe and effective treatment for people who are ineligible for conventional surgery or who are at high operative risk. However, this study included patients at low risk and suitable for either procedure. The study found that one year after treatment, all-cause death rates and other important clinical outcomes such as strokes were similar between the TAVI group and the surgery group.
The study included 913 participants who were randomized to undergo either the TAVI procedure or conventional surgery. The average age of the participants was 81 years old. Those who underwent TAVI were more likely to have vascular complications and need a pacemaker, while those who underwent surgery were more likely to have severe bleeding. There was greater improvement in symptoms, functional ability and quality of life at 6 weeks in patients who received TAVI and the quality of life benefit was still present at one year.
Professor William Toff, Professor of Cardiology in the Department of Cardiovascular Sciences at the University of Leicester, led the UK TAVI study. He said: “It’s great news for patients that TAVI is just as safe and effective as surgery, even in low operative risk patients. This procedure is far less invasive than conventional approaches. People who would otherwise need open-heart surgery can have this procedure, and since it has a faster recovery time, it means a shorter hospital stay for patients.
“These are extremely encouraging results after one year. However, we will continue to follow the participants for at least 5 years to ensure that no late differences in the groups emerge and to assess the durability of the TAVI valves. We hope to publish the 5-year results by the end of next year.In the meantime, patient-specific treatment recommendations should continue to be made by a multidisciplinary cardiac team.
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