Percutaneous Therapy for Tricuspid Regurgitation
A New Frontier for Interventional Cardiology
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Functional tricuspid regurgitation (TR) is common, whether in association with mitral or aortic valve disease or presenting as an isolated valvular disease. Several studies have shown that TR is associated with poor patient outcomes, although a cause-and-effect relationship of TR to mortality has not been proven. Similarly, the impact of surgical treatment of TR on outcomes needs well-controlled randomized trials that are under planning.1 The current professional society guidelines for TR treatment are based on expert opinions with a level of evidence C for all indications.2
Transcatheter therapies for valvular heart disease are often based on established surgical techniques. When surgical therapy has well-studied benefits, including a reduction in mortality (eg, aortic valve replacement for aortic stenosis), percutaneous therapies can be compared to surgery with survival as an end point. Similarly, the safety of surgical therapies (eg, surgical aortic valve replacement) can serve as a benchmark for the safety of percutaneous treatment. However, in establishing percutaneous treatments for TR, several challenges are found: (1) the severity of TR and right ventricle dysfunction are often difficult to determine, (2) the impact of TR on mortality or heart failure outcomes is not as clearly defined, and (3) surgical treatments are multiple without robust data for indications and outcomes. It is important to note that the US Food and Drug Administration is interested in providing expedited access for devices that fill an unmet clinical need by demonstrating appropriate intermediate and surrogate end points.3 Therefore, the aforementioned challenges also present opportunities to better define how trials for percutaneous treatments of TR can be conducted as we move forward (Table).
In this issue of Circulation, Nickenig and colleagues5 describe their multicenter experience …