ABSTRACT
BACKGROUND: Trans-carotid Transcatheter Aortic Valve Replacement (TC-TAVR) has emerged as an alternative TAVR access. However, scarce data on long-term outcomes following TC-TAVR exist. This study aimed to evaluate 5-year clinical outcomes post-TC-TAVR. METHODS: One hundred ten consecutive patients who underwent TC-TAVR and completed the 5-year after the procedure were included. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. The primary endpoint was the incidence of a composite of all-cause mortality, stroke, and repeat hospitalization. Echocardiography results, New York Heart Association (NYHA) class, and quality of life (QOL) assessed with the EuroQol visual analogue scale (EQ-VAS) were examined over the 5-year follow-up. RESULTS: The median age was 77 (72-82.2) years, 42.3% were women, and the median STS risk score was 5.02% (3.4-7.5%). The incidence of the composite endpoint was 54.5%. Death from any cause occurred in 45.6% of cases (11.9 per 100 patients-years), stroke in 8.2% (1.9 per 100 patient-years), disabling stroke in 2.7% (0.7 per 100 patient-years), and rehospitalization in 27.2%. The improvements in valve hemodynamics, NYHA class, and EQ-VAS following the procedure persisted at the 5-year follow-up (p<.001). Bioprosthetic valve failure occurred in 0.9%. CONCLUSIONS: About half of the moderate-to-high-risk patients undergoing TC-TAVR survived with no major cardiovascular events at 5-year follow-up. The yearly incidence of strokes was low, and early improvements in valve hemodynamics, functional status and QOL persisted at 5 years. These results suggest the long-term safety and efficacy of TC-TAVR, and would support this approach as an alternative to surgery in non-transfemoral candidates.
ABSTRACT
BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria. METHODS: We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected. RESULTS: PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality. CONCLUSIONS: About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.
