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Transcatheter Edge-to-Edge Repair for Tricuspid Regurgitation
Quick Takes
- This study shows promising safety and durability data with TriClip edge-to-edge repair in a cohort of isolated TR.
- These results present a catheter-based option for a disease process that is largely treated with medical therapy only in current clinical practice.
- A future COAPT-like clinical trial is needed to validate this finding in a larger cohort before this therapy can be adopted in clinical practice.
Study Questions:
What are the 1-year outcomes with the TriClip transcatheter tricuspid valve repair system (TTVR), in the treatment of moderate or greater tricuspid regurgitation (TR)?
Methods:
This single-arm multicenter trial enrolled 85 patients for percutaneous edge-to-edge repair with the TriClip TTVR system. Inclusion criteria were high surgical risk with moderate or greater TR (by transthoracic and transesophageal echocardiography) and no significant other concurrent valvular disease. Exclusion criteria were pulmonary artery systolic pressure >60 mm Hg, estimated by echocardiography, prior tricuspid valve procedure or coaptation gap >10 mm. Pre-device 1-year outcomes were compared to post-device 1-year outcomes.
Results:
Mean age was 77.8 ± 7.9 years with an average EuroSCORE II of 8.7 ± 10.7%. TR etiology was functional (84%), degenerative (12%), and mixed (4%). Thirty-three percent of subjects had a prior mitral intervention and 75% were classified as New York Heart Association (NYHA) functional class III/IV. At 1 year, TR was reduced to moderate or less in 71% of subjects. Patients experienced significant clinical improvements in NYHA functional class I/II (31% to 83%, p < 0.01), 6-minute walk test improved from 272.3 ± 15.6 to 303.2 ± 15.6 meters (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 20 ± 2.61 points (p < 0.01). Significant reverse right ventricular remodeling was observed in terms of size and function. The overall major adverse event rate and all-cause mortality were both 7.1% at 1 year.
Conclusions:
TTVR using the TriClip device is safe and effective in patients with moderate or greater TR. The repair itself was durable at reducing TR at 1 year and was associated with a sustained and marked clinical benefit with low mortality after 1 year in a fragile population that was at high surgical risk.
Perspective:
In a selected group of patients with isolated moderate or greater TR, TriClip promises to be a durable option with improvements in quality of life and functional capacity. Positive structural and functional right ventricular reverse remodeling was also noted over time. Future randomized trials should compare this therapy to conservative medical management and/or open surgical repair in patients with moderate or greater TR.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Echocardiography, Transesophageal, Geriatrics, Heart Failure, Heart Valve Diseases, Quality of Life, Tricuspid Valve, Tricuspid Valve Insufficiency, Ventricular Remodeling
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