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Short-Term Outcomes of Tricuspid Edge-to-Edge Repair
Quick Takes
- This post-approval study reports low rates of major adverse events and mortality through 30 days, significant tricuspid regurgitation reduction, and significant clinical improvements in KCCQ score and NYHA class following the T-TEER procedure.
- Of note, the current study is a single-arm registry with no comparison treatment group and results are limited to acute 30-day outcomes.
- Additional prospective studies are indicated to assess longer-term anatomical and clinical outcomes compared with standard of care to help guide selection of patients for the T-TEER procedure.
Study Questions:
What are the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip system in a contemporary, real-world setting?
Methods:
The investigators conducted the bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) post-approval study (PAS), a prospective, single-arm, open-label, multicenter, post-market registry that was designed to confirm the safety and performance of T-TEER with the transcatheter tricuspid valve repair system in a contemporary real-world setting. A total of 511 consecutive subjects were enrolled at 26 sites in Europe, where eligibility for T-TEER was determined through site-specific standard of care procedures in addition to evaluating the patient according to the protocol-specified inclusion and exclusion criteria. The primary endpoint was acute procedural success defined as successful implantation of the device with resulting tricuspid regurgitation (TR) reduction of at least one grade at discharge. An exact binomial test was used to evaluate the primary endpoint.
Results:
Enrolled subjects were elderly (79 ± 7 years) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR and 80% of subjects were in New York Heart Association (NYHA) class III or IV. Successful device implantation occurred in 99% of subjects and TR was reduced to ≤ moderate at 30 days in 77%. Associated significant improvements in NYHA class (20-79% class I/II, p < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 23 points improvement, p < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤ moderate at discharge (odds ratio [OR], 0.679; 95% confidence interval [CI], 0.537-0.858; p = 0.0012; OR, 0.722; 95% CI, 0.564-0.924; p = 0.0097). Fourteen (2.5%) subjects experienced a major adverse event at 30 days.
Conclusions:
The authors report that T-TEER was found to be safe and effective in treating significant TR in a diverse, real-world population.
Perspective:
This post-approval study reports low rates of major adverse events and mortality through 30 days, significant TR reduction, and significant clinical improvements in KCCQ score and NYHA class following the T-TEER procedure. Furthermore, this study highlights the acute success in achieving TR reduction and the associated clinical benefit with the transcatheter tricuspid valve repair system in a nonselected cohort. Of note, the current study is a single-arm registry with no comparison treatment group and results are limited to acute 30-day outcomes. Additional prospective studies are indicated to assess longer-term anatomical and clinical outcomes compared with standard of care to help guide selection of patients for the T-TEER procedure.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Cardiac Surgical Procedures, Cardiomyopathies, Comorbidity, Geriatrics, Heart Failure, Heart Valve Diseases, Patient Discharge, Secondary Prevention, Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency
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