(CCSP071) LONG-TERM OUTCOMES OF TRANSCATHETER TRICUSPID VALVE REPAIR IN PROHIBITIVE RISK PATIENTS: FUTILITY OR BENEFIT?

Background: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) is an emerging treatment option in inoperable patients with high-grade tricuspid regurgitation (TR). However, patient selection is mostly predetermined by comorbidities and non-specific surgical risk scores. Current guidelines distinguish between high-risk and prohibitive-risk patients, in order to avoid clinical futility. Therefore, the aim of this study was to understand if even prohibitive risk patients can benefit long-term from T-TEER.

METHODS AND RESULTS: Forty-one consecutive patients with severe TR were considered by the heart team inoperable, and underwent T-TEER at our institution between November 2020 and January 2022. According to the latest American guidelines on valvular heart disease, 23 patients were at prohibitive (PR) and 18 at high risk (HR) (Fig. 1A). Mean age in PR patients was 82.2±5.9 years vs 81.1±3.5 in HR patients, with mean STS-Score 14.3±6.7% vs 6.2±1.6% (Fig. 1B).

The primary efficacy endpoint of at least one-grade TR reduction was 92.7% in all patients, with no device related complications. By 12 months, 6 patients died, 5 PR and 1 HR, while MACE rate was 18.1%. Secondary endpoints addressed symptoms, quality of life and multiorgan function, which improved in both groups (Fig. 2). At inclusion, all patients in the PR group were in NYHA class III and IV, after 12 months only 27.7%. In comparison, there were no more HR patients in NYHA stage III and IV. Similarly, self-reported quality of life increased, as Kansas City Cardiomyopathy Questionnaire Score increased by 23±18.2 (p < 0.001) in PR and 27.5±16.1 (p < 0.001) points in HR patients, respectively. Walk distance in the 6-minute test improved by 79.282 (p < 0.001) vs 113.672.8 (p < 0.001) meters. Renal and liver function also improved, with statistical significance in the PR group [GFR- Glomerular Filtration Rate improvement from 46.7±13.9ml/min/1,73m2 to 51.9±18.1 (p=0.045) vs 62.1±17.1 to 62.1±18.5 (p=0.990); AST- Aspartate Aminotransferase from 33.7±15.4U/L to 27.3±12.3 (p=0.001) vs 33.2±26.1 to 26.2±6.8 (p=0.188)]. Furthermore, TR reduction led to long-term reverse cardiac remodeling, as right ventricular systolic function increased [TAPSE from 14.2±3.1mm to 17.7±2.2 (p < 0.001) vs 16.4±3.5 to 20.7±5.4 (p < 0.001)], and right atrial size decreased [indexed volume from 93.5±39.1 ml/m2 to 66.3±42.6 (p=0.005) vs 86.3±57.8 to 63.3±59.5 (p=0.032)].

Conclusion: T-TEER is feasible in very sick symptomatic TR patients and is associated with improved quality of life, functional capacity, multiorgan function and reverse cardiac remodeling. Patient selection based on risk assessment with surgical risk scores may deprive many symptomatic inoperable patients of this effective percutaneous treatment.