JACC. Cardiovascular interventions最新文献

Background: Conservative treatments for tricuspid regurgitation (TR) frequently yield suboptimal outcomes. Transcatheter interventions provide a new therapeutic avenue, with ongoing assessments of safety and effectiveness.

Objectives: The TriStar (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System) study investigated 1-year outcomes of the K-Clip transcatheter tricuspid annuloplasty system in treating patients with severe functional TR.

Methods: Patients with TR grade ≥4, resistant to medical management, were enrolled and selected by core laboratory evaluation. Oversight by a data and safety monitoring board and event adjudication by a clinical events committee occurred. Assessments at 30 days, 6 months, and 1 year included echocardiographic data, clinical symptoms, quality of life, study endpoints, and major adverse events.

Results: A total of 96 patients (mean age 72.6 years, 59.4% women) were included, with a 97.9% implantation success rate. One-year outcomes showed 5.2% all-cause mortality, a 19.8% composite major adverse event rate, and no device-related reinterventions. TR decreased by ≥1 grade in 94.2%, and by ≥2 grades in 87.2% of patients. Kaplan-Meier estimates demonstrated 94.7% ± 2.3% survival and 90.4% ± 3.0% freedom from heart failure rehospitalization. NYHA functional class significantly improved (P < 0.001), with 97.7% reaching functional class I or II. The 6-minute walk distance improved by 42.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score increased by 7.0 points (P < 0.001).

Conclusions: The K-Clip transcatheter tricuspid annuloplasty system showed high procedural success, a favorable safety profile, sustained TR reduction, and marked improvements in clinical outcomes and quality of life at 1 year. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar]; NCT05173233).

Background: Transcatheter tricuspid valve edge-to-edge repair (T-TEER) has been reported to be associated with right ventricular reverse remodeling (RVRR). Data on the temporal evolution of this phenomenon are scarce.

Objectives: The aim of this study was to evaluate RVRR over the course of 2-year follow-up after T-TEER using sequential 3-dimensional echocardiograms (3DE).

Methods: The study included T-TEER patients with available 3DE at baseline and discharge. Further follow-ups were scheduled at 1 month, 6 months, as well as 1 and 2 years. The 3DE evaluation included right ventricular volumes (right ventricular end-diastolic volume [RVEDV^3D]; right ventricular end-systolic volume [RVESV^3D]), right ventricular ejection fraction (RVEF^3D), and RV longitudinal strain of the free wall and the septum.

Results: The study included 231 patients (median age 82 [IQR: 79-86] years, 48% women). We observed a biphasic pattern of RVRR following T-TEER consisting of early RV volume unloading (phase 1, reduced RVEDV^3D) and later structural remodeling (phase 2, reduced RVESV^3D). Whereas RVEDV^3D was significantly reduced early after the procedure (-9.7% from baseline to discharge; P < 0.001), RVESV^3D remained unchanged at 1-month follow-up. Reduction in RVESV^3D was observed at 6-month follow-up for the first time (-5.4% from baseline to 6-month follow-up; P < 0.001). Reduction in both RVEDV^3D and RVESV^3D peaked at 1-year follow-up and remained stable until 2 years after T-TEER. RV function declined early after T-TEER and gradually increased over the course of follow-up (RVEF^3D at baseline 42.2% ± 8.9%, discharge 31.1% ± 9.4%, 2-year follow-up 41.6% ± 8.9%). The 3D RV longitudinal strain of the septum and 3D RV longitudinal strain of the free wall developed analogously.

Conclusions: RVRR following T-TEER occurs in 2 stages and involves early RV unloading (reduction in RVEDV^3D) and later structural RVRR (reduction in RVESV^3D) with an improvement in RVEF.

Despite the challenges associated with periprocedural imaging, transcatheter tricuspid valve interventions have shown important impact on outcomes. A comprehensive understanding of the anatomy of the right heart and surrounding structures is crucial. One way to optimize these interventions is by identifying the optimal fluoroscopic viewing angles along the S-curve of the tricuspid valve. Integration of chamber views using multimodality imaging (multislice computed tomography, fluoroscopy, and echocardiography) may increase operator confidence and reduce procedural duration, radiation exposure, contrast volume, and complication rates.

Background: Procedural success following tricuspid transcatheter edge-to-edge repair (TEER) has been defined variably over time; however, the consequences of achieving a tricuspid regurgitation (TR) grade of 0/1+ are still unclear.

Objectives: This study aimed to assess the predictors and prognostic impact of achieving TR 0/1+ after TEER and its role in clinical events.

Methods: This multicenter registry included patients undergoing tricuspid TEER in 15 Spanish centers from June 2020 and May 2023. Patients were categorized into the following groups based on the TR grade after procedure: optimal (0/1+), acceptable (2+), and not acceptable (≥3+). The primary endpoint was the 1-year composite of all-cause death, heart failure hospitalization, and tricuspid reintervention. Secondary endpoints included each component of the primary endpoint assessed separately, NYHA functional class, and TR grade at follow-up.

Results: Among 280 enrolled patients, 120 (42.9%) had residual TR 0/1+, 111 (39.6%) had residual TR 2+, and 49 (17.5%) had residual TR ≥3+. Patients with TR 0/1+ experienced lower rates of the primary endpoint (13% vs 20% vs 31%; log-rank P = 0.036). Residual TR ≥3+ was an independent predictor of primary endpoint (HR: 2.277; P = 0.044). Higher rates of NYHA functional class I or II and sustained TR reduction were seen in the TR 0/1+ group (P < 0.001 for both). A small coaptation gap and absence of septal leaflet tethering were independent predictors of achieving TR 0/1+.

Conclusions: An optimal procedural result after TEER might be associated with improved outcomes. TR coaptation gap and leaflet restriction may aid in assessing suitability for TEER.