One-Year Outcomes with a Self-Expanding, Repositionable Transcatheter Heart Valve in Severe Aortic Stenosis Patients: PORTICO-I.
- 2018
Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007
BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk. CONCLUSION: Transcatheter aortic valve replacement with the new THV in patients at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant PVL. Copyright (c) 2018. Published by Elsevier Inc. METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated. OBJECTIVES: To report 1-year outcomes of transcatheter aortic valve replacement (TAVR) with new THV system. RESULTS: A total of 941 patients (82.4 +/- 5.9 years, 65.7% female, STS score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates and myocardial infarction are 12.1%, 6.6%, 2.2% and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66mmHg and 1.75cm2 respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naive patients at 30 days and 1 year, respectively. Functional class, exercise capacity and quality of life improved significantly from baseline to 1 year.