Tricuspid regurgitation (TR) is a condition associated with high morbidity and mortality. Currently, surgery is the recommended treatment; however, it carries a high complication rate due to the anatomical complexity and comorbidities of affected patients.
Transcatheter edge-to-edge repair (TEER) has emerged as a promising alternative. Previous studies have shown it is a safe and effective strategy for improving symptoms and quality of life, and reducing TR severity during follow-up.
The TRI-SPA registry included 280 patients with severe or worse TR who were receiving optimal medical therapy and underwent TEER. Of these, 120 patients (49.9%) achieved an optimal outcome (0/1+, OO), 111 (39.6%) achieved an acceptable outcome (2+, AO), and 49 (17.5%) had an unacceptable outcome (≥3+, UO).
The primary endpoint (PEP) was a composite of all-cause mortality, first hospitalization for heart failure, and reintervention (whether percutaneous or surgical) at one year of follow-up.
The devices used included TriClip (75.7%), Pascal ACE (18.7%), MitraClip (8.6%), and Pascal P10 (2.5%).
Patient Characteristics and Clinical Outcomes
The groups were similar in baseline characteristics. The mean age was 71 years and 70% of patients were women. The TRI-SCORE was 4.5%, EuroSCORE was 3.8%, and comorbidities included diabetes (18%), hypertension (68%), atrial fibrillation (91%), implantable cardiac devices (10%), renal impairment (40%, average eGFR: 56 mL/min), edema or ascites (70%), chronic obstructive pulmonary disease (15%), and prior myocardial revascularization surgery (8%). The average NT-proBNP was 1,470 pg/mL. Patients with UO had higher bilirubin levels.
Read also: ACCESS-TAVI: Comparing Post TAVR Vascular Closure Devices.
The etiology of TR was predominantly secondary (57%), followed by atrial (21%), primary (13%), and pacemaker lead-related (7%).
The average ejection fraction was 57%, and 26% of patients had moderate or worse mitral regurgitation. The right ventricular ejection fraction was 40%, the tricuspid annular plane systolic excursion (TAPSE) was 38 mm, the inferior vena cava diameter was 19 mm, and the average effective regurgitant orifice area was 0.7 mm². Patients with UO had more severe TR (massive or torrential in 70% of cases), larger coaptation gaps (7 mm), greater vena contracta diameters (12 mm), and septal leaflet restriction in 54% of cases.
Procedural Outcomes
The average procedure time was 137 minutes, with two clips used in most cases (52%), followed by one clip (36.5%) and three clips in the remaining cases. The average final gradient was 1.5 mmHg. Complications included vascular complications (2%), severe bleeding (1.4%), and clip detachment (1.8%). The average hospital stay was 3 days.
Patients with ≥3+ TR required longer procedure times and more clips (including three clips); they experienced higher rates of clip detachment and had longer hospital stays.
Clinical Outcomes at 1 Year
The PEP was significantly lower in patients with OO compared to AO and UO (13% vs. 20% vs. 31%; log-rank P = 0.036). Mortality was higher in the UO group compared to the AO and OO groups (14% vs. 6% vs. 2%; P = 0.005). The need for reintervention was also higher in the UO and AO groups compared to the OO group, although there were no differences in their rehospitalization rates.
Additionally, functional class I-II was more prevalent among patients with residual TR from OO and AO. Residual mild or moderate TR at one year was less common in the OO and AO groups.
Predictors of AO included a coaptation gap of 5.2 mm and the absence of leaflet restriction.
Conclusion
An optimal outcome following edge-to-edge repair is associated with better clinical evolution. Reducing the coaptation gap and minimizing leaflet restriction may be key to sustaining treatment benefits.
Original Title: Impact of Optimal Procedural Result After Transcatheter Edge-to-Edge Tricuspid Valve Repair. Results From TRI-SPA Registry.
Reference: Julio Echarte-Morales, et al. JACC Cardiovasc Interv. 2024. Article in Press.
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