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PORTICO-I Study: Outcomes of Self-Expanding, Repositionable Transcatheter Heart Valve
Study Questions:
What are the 1-year outcomes of transcatheter aortic valve replacement (TAVR) with the new self-expanding, repositionable transcatheter heart valve (THV) system?
Methods:
The PORTICO-I investigators conducted an international, real-world post-approval, nonrandomized multicenter study to evaluate 941 patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access. Follow-up was at 30 days, 1 year, and will be annually through 5 years. The primary endpoint was all-cause mortality at 1 year; secondary endpoints included clinical outcomes and echocardiographic measurements, both adjudicated.
Results:
A total of 941 patients (82.4 ± 5.9 years, 65.7% female, Society of Thoracic Surgeons [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 were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, 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-naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year. Time to event variables were analyzed using Kaplan–Meier method and Cox proportional hazard model.
Conclusions:
The authors concluded that TAVR with the new THV in patients at increased surgical risk is associated with low 1-year mortality and stroke rates.
Perspective:
This study reports high safety, hemodynamic performance, and clinical improvement provided by the THV system at 1 year. Furthermore, a low mortality and disabling stroke rate given the higher-risk patients enrolled, low and stable transvalvular pressure gradients, and low rate of more than mild significant paravalvular leakage through 1 year was noted. These data provide insight on the new THV and will help clinicians understand the performance profile of the device, which appears similar to other current TAVR technologies. Additional prospective randomized head-to-head comparative studies with contemporary-generation TAVR valves are indicated to delineate optimal valve choice in individual patients.
Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Aortic Valve Stenosis, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Myocardial Infarction, Pacemaker, Artificial, Quality of Life, Stroke, Transcatheter Aortic Valve Replacement
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