Long-term outcomes of transcatheter tricuspid valve repair in prohibitive risk patients: futility or benefit?

Abstract

Abstract Background Transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR) is an emerging treatment option in inoperable patients. However, patient selection is challenging, and mostly predetermined by comorbidities and non-specific surgical risk scores. Current guidelines (1) distinguish between high-risk (HR) and prohibitive risk (PR) patients, in order to avoid clinical and procedural futility. Therefore, the aim of this study was to understand if PR patients can benefit from TTVR long-term. Methods Forty-one consecutive patients with severe TR were assessed by the heart team, considered inoperable, and underwent edge-to-edge TTVR at our institution between November 2020 and January 2022. They were divided into a PR (n=23) and an HR group (n=18), in accordance with the latest guidelines (1). Subgroup allocation took into account STS (Society of Thoracic Surgeons) risk score, and several comorbidities (Figure 1A). Mean age was 82.2±5.9 (PR) vs 81.1±3.5 years (HR), with mean STS-Score 14.3±6.7% vs 6.2±1.6% (Figure 1B). Results The primary efficacy endpoint of at least one-grade TR reduction by 30 days was recorded in 92.7% of all patients, with no device related complications. By 12 months, 6 patients died, 5 PR and 1 HR, and MACE rate was 18.1%. Secondary endpoints addressed symptoms, quality of life and multiorgan function, which improved in both groups (Figure 2). More precisely, at inclusion, all patients in the PR group were in NYHA class III and IV, while after 12 months only 27.7%. In comparison, there were no more HR patients in NYHA stage III and IV, after one year. Similarly, self-reported quality of life increased, as assessed by the "Kansas City Cardiomyopathy Questionnaire" (KCCQ) score, which 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 also improved by 79.2±82 (p<0.001) vs 113.6±72.8 (p<0.001) meters. Renal and liver function were also impacted by TR reduction, 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)]. Conclusions TTVR is feasible in very sick symptomatic 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 specific percutaneous treatment.Figure 1Figure 2