Key result
Portico TAVI shows a low ~2.7% 30-day mortality in high-risk severe aortic stenosis.
Why the study?
Procedural and short-term outcomes of TAVI with the Portico bioprosthetic valve in a large multicentre cohort were not well characterized.
Cohort (n=941)
Yes
Portico TAVI shows acceptable early safety in high-risk severe AS; leaves open randomized comparisons to contemporary devices.
AIMS: The aim of this study was to investigate the procedural and short-term outcomes of transcatheter aortic valve implantation (TAVI) with the Portico™ self-expanding, resheathable TAVI system from an ongoing long-term multicentre study. METHODS AND RESULTS: A total of 941 patients (82.4±5.9 years, 65.7% female, STS score 5.8±4.9%) with severe symptomatic aortic stenosis underwent TAVI using the Portico bioprosthesis. Patients were clinically and echocardiographically assessed at implantation, discharge and 30 days post TAVI. An independent CEC and core laboratory adjudicated adverse events (according to VARC-2) and follow-up echocardiograms, respectively. Implantation was successful in 96.0% of patients. Thirty-day all-cause, cardiovascular mortality and disabling stroke rates were 2.7%, 2.4% and 1.6%, respectively. Major vascular complications and life-threatening bleeding occurred in 5.5% and 3.1% of patients, respectively. A new pacemaker was implanted in 18.7% of patients. Aortic valve area (0.70±0.33 cm2 vs. 1.79±0.48 cm2) and transvalvular gradient (49.7±15.3 mmHg vs. 8.6±3.9 mmHg) improved significantly. The 30-day rate of moderate or higher paravalvular leak (PVL) was 3.9%. CONCLUSIONS: The Portico TAVI system allows safe and effective treatment of aortic stenosis in patients at increased surgical risk. At 30 days, mortality was low, and good haemodynamic performance was indicated by low transvalvular gradient and a low rate of moderate or higher PVL.
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Maisano et al. (2018) conducted a cohort in Severe symptomatic aortic stenosis (n=941). Portico transcatheter bioprosthetic aortic valve was evaluated on 30-day all-cause mortality. Transcatheter aortic valve implantation with the Portico system in high-risk patients with severe aortic stenosis demonstrated a 30-day all-cause mortality rate of 2.7% and a disabling stroke rate of 1.6%.
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