Citations

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: Aging increases the risk of resistant hypertension which is associated with an increased risk of mortality and cardiovascular events. Here, we examined the characteristics, blood pressure (BP) trajectories, and treatment patterns of older patients with apparent treatment resistant hypertension (aTRH). Hypothesis: We hypothesized aTRH would be undertreated, especially in octogenarians. Methods: We conducted a retrospective study of all patients with two available ambulatory BP measurements separated by at least 3 months in a community-based teaching hospital. aTRH was defined as BP above goal despite the use of ≥3 antihypertensive medication classes or controlled BP on ≥4 antihypertensive medication classes. Results: Of the 71,470 patients with available data, 7308 (10.2%) met criteria for aTRH with a mean follow-up length of 18.9 months. Compared to patients with normal BP, patients with aTRH were older with a mean age of 74 years versus 65 years (p<0.001). Patients with aTRH were more likely to be males (58.3%) compared to the normal BP groups (40.6%, p<0.001) (Figure 1). Compared to patients with normal BP, patients with aTRH were more likely to be obese and have a higher prevalence of smoking history, diabetes, coronary artery disease, heart failure, peripheral arterial disease, atrial fibrillation, and chronic kidney disease (Figure 1). Amongst those with aTRH, 1566 (5.3%) were aged 18-65, 3763 (13.2%) were aged 66-79, and 2623 (19.7%) were ≥80 years old. At follow-up, among those with aTRH at baseline, 5773 (72.6%) remained with aTRH, 896 (11.3%) improved to non-aTRH, 1270 (16.0%) improved to controlled BP, and 13 (0.2%) improved to normal BP (Figure 2). Most patients irrespective of age had no change in the number of medications at follow-up; only 15.5% of octogenarians with aTRH had an increase in antihypertensives (Figure 3). Between baseline and follow up, octogenarians as a whole had a systolic BP drop of -2.34 (p<0.001), and diastolic BP drop of -0.56 (p=0.061), whereas octogenarians with aTRH had a systolic BP drop of -3.7 (p<0.001) and diastolic BP drop of -0.55 (p=0.050). Conclusion: In an ambulatory population of patients at a community hospital, the prevalence of aTRH was high among patients ≥80 years and associated with established cardiovascular risk factors. Most patients with aTRH do not have a change in BP status over time. Anti-hypertensive medication escalation is infrequent among patients with aTRH irrespective of age.