Khera, Sahil

Importance Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited. Objective To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. Design, Setting, and Population Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026. Exposure Device-enabled TTVR. Main Outcomes and Measures Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes. Results Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality ( P = .47), heart failure hospitalization ( P > .99), and functional outcomes ( P = .55) when patients were stratified by baseline CIED status. Conclusions and Relevance Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.

Background— A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited. Methods and Results— We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend <0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P <0.001), stroke (1.4% versus 2.7%; P <0.001), bleeding complications (10.6% versus 24.6%; P <0.001), and acute kidney injury (16.2% versus 19.3%; P <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR. Conclusions— TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients.