Results from the Portico 1 study were presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics conference in San Diego showing that transcatheter aortic valve replacement (TAVR) with the new transcatheter heart valve (THV) in patients at increased surgical risk is associated with low 1-year mortality and stroke rates. In the study, favorable hemodynamic results at 1 year were observed with low transvalvular pressure gradient and incidence of significant Paravalvular leakage (PVL). The results were also published online in the Journal of American College of Cardiology.
The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for the treatment of severe, symptomatic aortic stenosis in patients with high surgical risk. In this study, Søndergaard et al. aimed to report 1-year outcomes of transcatheter aortic valve replacement (TAVR) with the new THV system.
The PORTICO-1 investigators conducted an international, multicentre, real-world post-approval study evaluating 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 was all-cause mortality at 1 year; secondary endpoints included clinical outcomes and echocardiographic measurements. Time to event variables were analyzed using the Kaplan–Meier method and Cox proportional hazard model.
A total of 941 enrollees (82.4 ± 5.9 years, 65.7% female, STS score: 5.8%) underwent an implant at 61 sites in 7 countries in Europe, Australia, and Canada. Significant improvements in valve area and transvalvular pressure gradient remained stable through 1 year. 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. The 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 naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity and quality of life improved significantly from baseline to 1 year.
“Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence. These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery.”- Dr. Lars Sondergaard, M.D.
This study reported high safety, hemodynamic performance, and clinical improvement provided by the THV system at 1 year. Further, 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 reported.
“Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence,” remarked Dr. Lars Sondergaard, M.D., DMSc, Rigshospitalet, Copenhagen, Denmark and principal investigator of the study. “These one-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery.”
These data provide an insight into the new THV and will help clinicians understand the performance profile of the device, which appears similar to other current TAVR technologies. Recently, Abbott received regulatory approval in Europe for a sheathless introduction of the Portico valve, which makes it easier for doctors to use the valve in patients with severe disease and complex anatomies. The small, sheathless profile may lower the risk of serious adverse events and vascular complications such as internal damage to the arteries. However, additional prospective randomized head-to-head comparative studies with contemporary-generation TAVR valves are required to clearly demarcate optimal valve choice in individual patients.
To view the interview with Dr. C. Michael Gibson, click here.
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