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Outcomes of Transcatheter Repair for Tricuspid Regurgitation
Study Questions:
What are the 6-month outcomes for patients with moderate or severe functional tricuspid regurgitation (TR) treated with the Cardioband system (Edwards Lifesciences)?
Methods:
Between October 2016 and July 2017, 30 patients were enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study, a single-arm, multicenter, prospective trial that included patients with symptomatic moderate to severe TR with septal-lateral annular diameter ≥40 mm, in the absence of untreated left-heart disease, and thought by a local heart team to be inoperable because of unacceptable risk for open-heart surgery. The Cardioband system uses transfemoral venous access, and is designed to reduce TR by tricuspid valve annular reduction. Technical success was defined as successful access, deployment, and positioning of the implant; and reduction of the septal-lateral annular diameter at the end of the procedure and at discharge. The primary safety endpoint was the rate of major serious adverse events (a composite of death, myocardial infarction, tamponade, device-related cardiac surgery, and stroke). Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core laboratory assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events.
Results:
Mean patient age was 75 ± 7 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III-IV, and mean LVEF was 57 ± 10% (range 30-71%); the Society of Thoracic Surgeons score was 2.6 ± 1.6. Technical success was 100%. Through 6 months, three patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septal-lateral diameter of 9% (42 mm vs. 38 mm, p < 0.01), proximal isovelocity surface area (PISA) effective regurgitant orifice area (EROA) of 50% (0.8 cm2 vs. 0.4 cm2, p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm, p < 0.01). Clinically, 76% of patients improved by ≥1 NYHA functional class, with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01).
Conclusions:
Six-month outcomes suggest that the Cardioband system performed as intended and appears to be safe in patients with symptomatic moderate to severe functional TR. A significant decrease in septal-lateral annular diameter was accompanied by a reduction in TR severity, and improvement in heart failure symptoms, quality of life, and exercise capacity. The authors concluded that further studies are warranted to validate these initially promising results.
Perspective:
There is increasing recognition of the clinical importance of functional TR, with active efforts aimed at both surgical and transcatheter therapies. This relatively small, short-term study supports the feasibility and short-term effectiveness of one transcatheter therapy that is designed to treat functional TR by reducing the tricuspid annular dimension. It is perhaps surprising that an approximate 10% reduction in septal-lateral tricuspid annular dimension (from 42 mm at baseline to 38 mm at 30 days) was accompanied by an approximate 50% reduction in TR severity (PISA EROA 0.79 cm2 to 0.39 cm2 at 30 days). Although enrollment criteria stipulated that patients were on a stable medical regimen, this report does not include medications at baseline and at follow-up, or whether additional diuretic therapy was administered in between; without those data, there should remain some degree of uncertainty as to how much of the reduction in TR was attributable to the implanted device.
Keywords: Cardiac Surgical Procedures, Cardiac Tamponade, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Myocardial Infarction, Quality of Life, Stroke, Tricuspid Valve, Tricuspid Valve Insufficiency
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