Author + information
- Received September 12, 2018
- Revision received November 8, 2018
- Accepted November 26, 2018
- Published online March 4, 2019.
- Matteo Pagnesi, MDa,
- Won-Keun Kim, MDb,
- Lenard Conradi, MDc,
- Marco Barbanti, MDd,
- Giulio G. Stefanini, MD, PhDe,
- Tobias Zeus, MDf,
- Thomas Pilgrim, MDg,
- Joachim Schofer, MD, PhDh,
- David Zweiker, MDi,
- Luca Testa, MDj,
- Maurizio Taramasso, MDk,
- David Hildick-Smith, MDl,
- Alexandre Abizaid, MD, PhDm,
- Alexander Wolf, MDn,
- Nicolas M. Van Mieghem, MD, PhDo,
- Alexander Sedaghat, MDp,
- Jochen Wöhrle, MDq,
- Saib Khogali, MDr,
- Jan A.S. Van der Heyden, MD, PhDs,
- John G. Webb, MDt,
- Rodrigo Estévez-Loureiro, MD, PhDu,
- Darren Mylotte, MDv,
- Philip MacCarthy, MDw,
- Salvatore Brugaletta, MD, PhDx,
- Christian W. Hamm, MDb,
- Oliver D. Bhadra, MDc,
- Ulrich Schäfer, MDy,
- Giuliano Costa, MDd,
- Corrado Tamburino, MD, PhDd,
- Francesco Cannata, MDe,
- Bernhard Reimers, MDe,
- Verena Veulemans, MDf,
- Masahiko Asami, MDg,
- Stephan Windecker, MDg,
- Amnon Eitan, MDh,
- Albrecht Schmidt, MDi,
- Giovanni Bianchi, MDj,
- Francesco Bedogni, MDj,
- Matteo Saccocci, MDk,
- Francesco Maisano, MDk,
- Osama Alsanjari, MDl,
- Dimytri Siqueira, MDm,
- Christoph J. Jensen, MDn,
- Christoph K. Naber, MDn,
- Francesca Ziviello, MDo,
- Jan-Malte Sinning, MDp,
- Julia Seeger, MDq,
- Wolfgang Rottbauer, MDq,
- Jorn Brouwer, MDs,
- Abdullah Alenezi, MDt,
- David A. Wood, MDt,
- Vasileios Tzalamouras, MDw,
- Ander Regueiro, MDx,
- Antonio Colombo, MDa and
- Azeem Latib, MDa,z,∗ ()
- aInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- bDepartment of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- cDepartment of Cardiovascular Surgery, University Heart Center, Hamburg, Germany
- dDepartment of Cardiology, C.A.S.T. Policlinic G. Rodolico Hospital, University of Catania, Catania, Italy
- eCardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy
- fDivision of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany
- gDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- hDepartment for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany
- iDivision of Cardiology, Medical University of Graz, Graz, Austria
- jDepartment of Cardiology, IRCCS Policlinico San Donato, Milan, Italy
- kHeart Valve Clinic, University Hospital of Zürich, Zürich, Switzerland
- lDepartment of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom
- mInstituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
- nContilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany
- oDepartment of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- pDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany
- qDepartment of Internal Medicine II, University of Ulm, Ulm, Germany
- rHeart and Lung Centre, New Cross Hospital, Wolverhampton, United Kingdom
- sDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
- tCentre for Heart Valve Innovation, St. Paul’s and Vancouver General Hospital, Vancouver, British Columbia, Canada
- uDepartment of Cardiology, Hospital of León, León, Spain
- vDepartment of Cardiology, Galway University Hospitals, Galway, Ireland
- wDepartment of Cardiology, King’s College Hospital, London, United Kingdom
- xClinic Cardiovascular Institute, University Hospital Clinic, IDIBAPS, Barcelona, Spain
- yDepartment of Cardiology, University Heart Center, Hamburg, Germany
- zDepartment of Cardiology, Montefiore Medical Center, Bronx, New York
- ↵∗Address for correspondence:
Dr. Azeem Latib, Department of Cardiology, Montefiore Medical Center, 111 East 210th Street, Bronx, New York 10467.
Objectives The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices.
Background The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR.
Methods The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)–2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles.
Results A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.
Conclusions In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.
Dr. Kim is a proctor for Symetis/Boston Scientific and Abbott Vascular; and has received speaking fees from Edwards Lifesciences. Dr. Conradi and Prof. Schäfer are proctors for Symetis/Boston Scientific and Medtronic, and have received lecture fees and travel support from both companies. Dr. Barbanti has served as a consultant for Edwards Lifesciences. Dr. Stefanini has received a research grant (to the institution) from Boston Scientific; and has received speaking and consulting fees from B. Braun, Biosensors, and Boston Scientific. Dr. Zeus is a proctor for Medtronic; and has received speaker fees and financial scientific support from Medtronic and Edwards Lifesciences. Dr. Pilgrim has received research grants (to the institution) from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaking fees from Boston Scientific and Biotronik. Dr. Taramasso is a consultant for Boston Scientific, Abbott Vascular, 4Tech and CoreMedic; and has received speaking fees from Edwards Lifesciences. Dr. Hildick-Smith is an advisor and a proctor for Boston Scientific, Symetis, and Medtronic. Dr. Wolf is a proctor for Medtronic and Boston Scientific. Dr. Van Mieghem has received research grant support from Boston Scientific, Abbott Vascular, Medtronic, Claret, and Essential Medical. Dr. Sedaghat has received travel grants and support from Medtronic. Dr. Khogali is a proctor for Medtronic and Boston Scientific. Prof. Webb is a consultant for Abbott Vascular and Edwards Lifesciences. Dr. Mylotte is a proctor for Medtronic and Microport. Dr. MacCarthy is a proctor for Edwards Lifesciences. Dr. Hamm has served on advisory boards for Medtronic. Prof. Tamburino has received speaking honoraria from Medtronic. Dr. Veulemans has received lecture fees and travel support from Medtronic and Edwards Lifesciences. Prof. Windecker has received grants from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Bedogni is a proctor for Medtronic and Boston Scientific. Dr. Maisano has served as a consultant for Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Valtech; and has received royalties from Edwards Lifesciences. Dr. Siqueira is proctor for Medtronic, Symetis, and Edwards Lifesciences. Dr. Naber has received lecture fees from Boston Scientific, Medtronic, and Abbott Vascular; and has served on advisory boards for Boston Scientific and Abbott Vascular. Prof. Sinning is a proctor for Medtronic and Boston Scientific; and has received speaking honoraria and research grants from Medtronic, Edwards Lifesciences, and Boston Scientific. Prof. Wood has received grant support from Boston Scientific; and is a consultant for Medtronic. Dr. Latib has served on the advisory boards of Medtronic and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 12, 2018.
- Revision received November 8, 2018.
- Accepted November 26, 2018.
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