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Region Hovedstaden - en del af Københavns Universitetshospital
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Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

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  • 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
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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.

OriginalsprogEngelsk
TidsskriftEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Vol/bind14
Udgave nummer8
Sider (fra-til)886-893
Antal sider8
ISSN1774-024X
DOI
StatusUdgivet - 20 okt. 2018

ID: 56523930