Abstract 19137: Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcutaneous Aortic Valve Replacement: Experience from the PARTNER Continued Access Registry
Introduction: It is unknown if an evolution of case selection or accruing case experience over time has resulted in a change in the rates of complications and outcomes of patients undergoing Transfemoral (TF) Transcutaneous Aortic Valve Replacement (TAVR).
Hypothesis: We hypothesized that such evolution may have occurred during the course of the PARTNER Continued Access Registry
Methods: TF-TAVR patients enrolled in the PARTNER Continued Access (CA) Registry (n=1063, enrolled from 2009-2012 after completion of the PARTNER randomized trial) were divided into tertiles based upon enrollment date. The characteristics of patients enrolled and rates of adjudicated periprocedural and adverse events were compared over time.
Results: There were no significant differences in sex, prevalence of NYHA III/IV symptoms, prior revascularization, pulmonary hypertension, renal disease or liver disease over time. There was an increase in the mean age of enrolled patients, but a decrease in the prevalence of porcelain aorta, COPD (including O2-dependent COPD), and prior chest wall radiation, and a slight decrease in median STS score over the enrollment period (Table). There was no difference in stroke, need for any aortic-valve-reintervention, major bleeding, and major vascular complications over time. There was, however, a decrease in the 30-day incidence of moderate/severe paravalvular leak (PVL) (from 19.2% to 13.8% to 10.1% in the 3rd enrollment tertile, p=0.004). There was no difference in mortality at 30-days but a significant decrease in all-cause mortality at 6 months, 1 year and 2 years of follow up was observed.
Conclusions: Over the enrollment period in the PARTNER-CA registry, in patients undergoing TF-TAVR, changes in case selection and a decreasing rate of paravalvular leak were observed. Additionally, a decrease in intermediate-longer term mortality was observed over time.
Author Disclosures: N. Beohar: None. A.J. Kirtane: None. E. Blackstone: Other; Modest; PARTNER Trial Executive Committee. R. Waksman: Honoraria; Modest; Boston Scientific, Medtronic, AstraZeneca, Biotronik, Abbott Vascular. D. Holmes: None. S. Minha: None. O. Alli: None. R.M. Suri: Other; Modest; Institutional Research Funding from Edwards Lifesciences, St. Jude Medical and Sorin Medical, National PI: PERCEVAL Trial (Sorin Medical), Steering Committee: PORTICO Trial (St. Jude). L. Svensson: Other; Modest; PARTNER Trial Executive Committee, Equity: CardioSolutions, Equity: ValvXchange, Intellectual Property: Posthorax. K. Xu: None. M.B. Leon: Other; Modest; PARTNER Trial Executive Committee. S. Kodali: Consultant/Advisory Board; Modest; Thubrikar Aortic Valve, Edwards Lifesciences.
- © 2014 by American Heart Association, Inc.