Transcatheter aortic valve replacement (TAVR) using the new self-expanding, repositionable transcatheter heart valve (THV) system was associated with low one-year mortality and stroke rates in patients at increased surgical risk, based on findings from the PORTICO-I trial presented Sept. 25 at TCT 2018 and published in the Journal of the American College of Cardiology.

The ongoing study led by Lars Søndergaard, MD, et al., involved 941 patients at 61 sites in Europe, Asia and Canada with severe, symptomatic aortic stenosis. Patients were implanted with the THV via transfemoral access and follow-up at 30 days, one year and annually through five years. The primary endpoint was all-cause mortality at one year, with secondary endpoints involving clinical outcomes and echocardiographic measurements.

Results at one year showed Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates and myocardial infarction of 12.1 percent, 6.6 percent, 2.2 percent and 2.5 percent, 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 percent of patients with no severe leakage, while new pacemaker rates were 18.7 percent and 21.3 percent for pacemaker naïve patients at 30 days and one year, respectively.unctional class, exercise capacity and quality of life significantly improved from baseline to one year.

"Overall, the study outcomes confirm the high safety, hemodynamic performance and clinical improvement provided by the THV system at one year," said Søndergaard and colleagues. They add that the "results provide important information on the new THV and are expected to help clinicians understand the performance profile of the device which is similar to other current TAVR technologies."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Aortic Valve Stenosis, Heart Valves, Transcatheter Aortic Valve Replacement

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