Rassi, Andrew N.

Abstract Background and Aims The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy vs medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. Methods The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR, and randomized 2:1 to TTVR (n = 267) or control (n = 133). In a post hoc analysis, patients were stratified into severe TR (n = 172) and massive/torrential TR (n = 220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan–Meier estimates for all-cause mortality and heart failure (HF) hospitalization assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. Results One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe {1.64 [95% confidence interval (CI): 1.11, 2.43]} and massive/torrential [2.20 (1.55, 3.14)]. At 18 months, TTVR patients had similar mortality to controls [rate difference: severe 0.2% (−11.6, 11.9), massive/torrential −5.8% (−17.6, 6.0)], whereas HF hospitalization rates favoured TTVR in the massive/torrential cohort [vs control, severe 9.8% (−3.0, 22.7), massive/torrential -15.2% (−28.9, −1.5)]. Conclusions Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

BACKGROUND: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. METHODS: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm 2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm 2 area) using propensity matching to minimize confounding variables. RESULTS: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P <0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P =0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P <0.001) of patients with severe MS was observed. CONCLUSIONS: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

Introduction: The relationship between aortic stenosis (AS) severity, AS-related symptoms, and clinical outcomes is poorly understood. Research Question: Does a history of AS-related symptoms at the time of diagnosis affect clinical outcomes including death and AS-related hospitalization? Methods: Using a combination of natural language processing algorithms and administrative codes, we ascertained physician-assessed AS, AS severity, and AS-related symptoms (chest pain, acute coronary syndrome, syncope, presyncope, orthopnea, dyspnea, PND, and worsening heart failure) in the year prior or up to 60 days after an initial AS diagnosis among 602,821 adults with echocardiograms in a large, integrated health system from 2010-2019. We examined multivariable associations between AS severity and recent AS-related symptoms for the outcomes of death and AS-related hospitalizations using Cox models. Results: Among 40,333 patients identified with incident AS, the majority had recent AS-related symptoms (mild: 80%, mild-moderate: 77%, moderate: 77%, moderate-severe: 85%, and severe AS: 87%). Patients with recent symptoms were older (mean [SD] age 78 [10] vs 75 [11] years; p<0.01), more likely female (51% vs 47%; p<0.01), and had a higher comorbidity burden. In unadjusted analyses, symptom status was a strong discriminator of risk over a median (IQR) of 2.2 (0.8-4.3) years of follow-up ( Figure ). After multivariable adjustment, AS-related symptoms remained strongly associated with death and AS-related hospitalization across the spectrum of AS severity, with moderate symptomatic patients having risk similar to severe asymptomatic patients. Conclusions: The majority of patients diagnosed with AS have recent and/or active AS-related symptoms, which is associated with a significantly increased risk of adverse outcomes. Incorporating symptom status across the individual grades of AS may improve risk stratification beyond AS severity alone.