Newswise — An international study of more than 400 adults concludes that people who undergo mitral valve surgery (between the left atrium and the left ventricle of the heart) and also have less than severe leakage of the tricuspid valve (a section of the heart that directs blood from the right atrium to the ventricle) may benefit from having both valves repaired at the same time. Study results showed that simultaneous repair reduced the chance of severe leakage in the tricuspid.
The results of the clinical trial were presented Nov. 13 at the American Heart Association’s annual Scientific Sessions meeting. The full study was published simultaneously in the New England Journal of Medicine.
Heart valves regulate blood flow between the four chambers. Leaflets are thin, but sturdy flaps of tissue that protect the valves from blood leaking back into them. Regurgitation is the term for a valve that leaks. Regurgitation is a condition that causes shortness of breath and fatigue. Leaky mitral valves, the most common type heart valve abnormality are often replaced or repaired by surgery. In the U.S., more than 50,000 operations are performed to fix mitral valve regurgitation annually. To treat the tricuspid valvule, a ring is placed around it to prevent further leakage and fluid accumulation. This is an independent risk factor that can lead to increased death risk.
“Surgeons agree that severe leakage of tricuspids should be treated. Lead investigator James Gammie. , is the surgical leader and codirector of the Heart and Vascular Institute of Johns Hopkins University School of Medicine. “However, there has been considerable uncertainty as to whether the tricuspid valve needs repair at the time of mitral valve surgery when the leakage is only moderate or less.”
To study the potential effectiveness and safety of less than moderate tricuspid valve repair during mitral valve surgery, researchers conducted an international, multicenter, randomized controlled trial at 39 locations across the U.S., Canada and Germany between 2016 and 2018. A total of 401 adults were included in the study; 203 had only the mitral valve operation, while 198 had mitral valve surgery plus tricuspid valve repair. The participants were primarily white men (91% white; 75% male) and on average were 67 years old. Researchers evaluated the rates of death, repeat operations for tricuspid regurgitation, and progression of tricuspid leakage. After a two year follow-up, researchers discovered that people who had their mitral and tricuspid valve problems repaired simultaneously had better outcomes. This included fewer cases of severe or moderate leakage, and greater treatment success.
The study’s key findings:
Only 3.4% of people who had both valves repaired progressed to moderate or severe tricuspid regurgitation after two years, compared with 25% of those who had the mitral valve surgery alone.
Less than 1% (0.6%) of patients who had both valves fixed progressed to severe tricuspid regurgitation after two years, compared with 5.6% of those in the mitral valve-only surgery group.
The treatment failure rate, defined as death and/or reoperation for tricuspid valve surgery, was higher (10.2%) among the group that did not have their tricuspid valve fixed at the same time as mitral valve surgery, compared with those who did (3.9%).
The death rate for participants undergoing modern mitral valve surgery was less than 1%, and two years later the survival was over 96%. While repairing the tricuspid valve during mitral valve surgery limited leakage and potential damage to the heart, researchers also found disadvantages:
The addition of tricuspid valve repair prolonged the length of surgery time and time spent on a heart-lung machine by 34 minutes.
Permanent pacemakers were needed in 14% of patients in the tricuspid valve repair group compared with 2.5% of patients who had the mitral-only surgery. Researchers found that this had no negative effect on patients.
Patients had a longer median hospital stay by two days.
“We clearly need to better understand the risk factors for needing a permanent pacemaker implanted after tricuspid valve repair and how to best mitigate the risk with technique modifications or different postoperative management strategies,” says Gammie. “But for the first time, we have high-level evidence to help us understand what to do in the operating room when it comes to tricuspid valve repair in those with less than severe regurgitation.”
Gammie says the trial is designed to continue to follow patients up to five years after surgery to see if there is further progression of tricuspid valve leakage. Other researchers were involved in this study are Michael Chu of Western University, London Health Sciences Centre, Vokmar Falk of Charite Universitatsmedizin Berlin, Samantha Raymond, Ellen Moquete, Karen O’Sullivan, Mary Marks, Emilia Bagiella and Annetine gelijns of Icahn School of Medicine, Mary Marks, Mary Marks, Annetine Gelijns of Baylor Scott & White Health, Pierre Voisine of Institut Universitaire de Cardiologie et de Pneumologie de Pneumologie de Pneumologie de Montréal; Friedhelm Beyersdorf of University Heart Center Freiburg, Arnar Geirsson of Yale School of Medicine, Judy Hung of Massachusetts General Hospital, and Patrick O’Gara of Brigham and Women’s Hospital and Patrick O’Gara of Brigham and Women’s Hospital and Patrick O’s Hospital and Women’s Hospital and Women’s Hospital and Women’s Hospital and Patrick O’s Hospital and Women’s Hospital and Women’s Hospital and
Funding for this trial was supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute and a grant from the German Centre for Cardiovascular Research.
Authors do not have conflicts of interest.
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