Objectives. The purpose of this study was to compare the efficacy and safety of the Evolut PRO to the Evolut R valve in a real-world setting. Background. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. Methods. We retrospectively studied 134 patients who underwent TAVR with the Evolut PRO or Evolut R valve over one year at a tertiary center. Endpoints, defined by the Valve Academic Research Consortium-2 criteria, included device success, paravalvular leak (PVL), and a composite safety endpoint including mortality, stroke, major vascular complications, life-threatening bleeding, acute kidney injury, coronary artery obstruction, and repeat procedure for valve-related dysfunction. Results. 60 Evolut PRO and 56 Evolut R patients met the study criteria. Both groups had similar device success rates (90 vs. 89%, p=0.44). Incidence of moderate PVL was similar on discharge (5 vs. 11%, p=0.68) and at 30 days (11 vs. 13%, p=0.79), with nil incidence of severe PVL. There were no mortalities, and the VARC-2 safety endpoint at 30 days was comparable. Conclusion. Despite the additional pericardial skirt and larger sheath size of Evolut PRO, outcomes were comparable between the two Evolut systems, supporting adoption of the newest generation valve in the management of severe aortic stenosis as well as continued use of the Evolut R in patients with smaller vasculature warranting a lower profile device.
Objective: To examine if older age (>70 years) should be a relative contraindication for heart transplantation, we evaluated the characteristics and outcomes of patients with age ≥70 years listed for heart transplantation; and whether post-transplantation survival was inferior to younger counterparts. Design: Retrospective cohort analysis.Setting: The scientific registry of transplant recipients (SRTR).Participants: Adults (≥18 years) listed for heart transplantation in the SRTR between 2000 and 2018.Interventions: Heart transplantation. Measurements: Characteristics and outcomes were compared for adults ≥70 years and <70 years. We evaluated waitlist mortality and post-transplant 1-year and 5-year survivals. Results: The study included 57,285 patients (age range 18-79 years) listed for heart transplantation; 1203 (2.1%) age ≥70 years. Of these, 37,135 patients underwent heart transplantation; 806 (2.2%) were age ≥70 years. Yearly listing of those age ≥70 years has consistently increased from 2.5% (n = 30) in 2000 to 11% (n = 132) in 2017 (p < 0.01). As compared with the age <70 years group, those ≥70 years had a similar risk of death while waiting (sub-hazard ratio[SHR] 0.86, 95% confidence interval [HR] 0.68-1.08; p = 0.19) but were more likely to be transplanted (SHR 1.36, 95% CI 1.26-1.48; p < 0.01). Among the older patients, the overall post-transplant 1-and 5-year mortality rate was 10.4% and 19.2%, respectively. Older recipients had lower unadjusted survival compared with younger recipients (log-rank p = 0.03). However, after adjustment for relevant covariates, there was no significant difference in 5-year mortality between both groups (HR 1.06, 95% CI 0.91-1.254; p = 0.43).Conclusions: Post-transplant survival up to 5 years among patients of age ≥70 years was similar to that of younger recipients. Older patients who received heart transplantation appear to have lower risk features but receive hearts from higher risk donors. Chronologic age alone should not constitute a
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.