Author + information
- Received August 21, 2018
- Revision received September 13, 2018
- Accepted September 14, 2018
- Published online December 3, 2018.
- Lars Søndergaard, MDa,∗ (, )@uni_copenhagen@Rigshospitalet,
- Josep Rodés-Cabau, MDb,
- Axel Hans-Peter Linke, MDc,
- Stephan Fichtlscherer, MDd,
- Ulrich Schäfer, MDe,
- Karl-Heinz Kuck, MDf,
- Joerg Kempfert, MDg,
- Dabit Arzamendi, MDh,
- Francesco Bedogni, MDi,
- Federico M. Asch, MDj,
- Stephen Worthley, MDk and
- Francesco Maisano, MDl
- aDepartment of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
- bQuebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
- cTechnical University Dresden, Heart Center Dresden, Dresden, Germany
- dKlinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt, Germany
- eUKE Hamburg (Universitatsklinik Eppendorf), Hamburg, Germany
- fAsklepios Klinik St. Georg, Lohmuehlenstrasse, Hamburg, Germany
- gDeutsches Herzzentrum Berlin, Berlin, Germany
- hHospital de la Santa Creu I Sant Pau, Sant Antoni Maria Claret, Barcelona, Spain
- iIRCCS Policlinico San Donato, Piazza E. Malan, San Donato Milanese, Italy
- jCardiovascular Core Laboratories, MedStar Health Research Institute at Washington Hospital Center, Washington, DC
- kRoyal Adelaide Hospital, Adelaide, South Australia, Australia
- lClinic for Heart and Vascular Surgery, University Hospital Zurich, Zurich, Switzerland
- ↵∗Address for correspondence:
Dr. Lars Søndergaard, Department of Cardiology, Rigshospitalet, Rigshospitalet–University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Background The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.
Objectives The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.
Methods This ongoing, international, multicenter study evaluated 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 is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.
Results A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. 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. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, 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.
Conclusions Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)
This study was funded by Abbott. Dr. Søndergaard has received consultant fees and an institutional research grant from Abbott (formerly St. Jude Medical). Dr. Rodés-Cabau has received institutional research grants from Abbott. Dr. Linke has received speaker honoraria as a consultant for and grant support from Abbott. Drs. Fichtlscherer, Schäfer, and Maisano have served as proctors for and have received travel/speaker’s honoraria and grant support from Abbott Vascular. Dr. Kuck has received research grants and is a consultant for Abbott; and has served as a consultant for Medtronic, Boston Scientific, Biosense Webster, and Edwards. Drs. Kempfert and Arzamendi have served as proctors for Abbott. Dr. Bedogni has served as a proctor and consultant for Abbott. Dr. Asch, as Director of MedStar Health, has received institutional contracts from Abbott, Edwards, Medtronic, Boston Scientific, JenaValve, Livanova, and Biotronik. Dr. Worthley has received research grants from Abbott and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 21, 2018.
- Revision received September 13, 2018.
- Accepted September 14, 2018.
- 2018 American College of Cardiology Foundation
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