Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study

Francesco Maisano, Stephen Worthley, Josep Rodés-Cabau, Axel Hans-Peter Linke, Stephan Fichtlscherer, Ulrich Schäfer, Raj R. Makkar, Gregory Fontana, Federico M. Asch, Lars Søndergaard
2018 EuroIntervention  
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
more » ... 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 cm 2 vs. 1.79±0.48 cm 2 ) 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.
doi:10.4244/eij-d-18-00343 pmid:30111522 fatcat:6aaelomxmjee3i3qibmhp5snhe