McCabe, James M

BACKGROUND: The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.

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.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.