Author + information
- Received March 8, 2018
- Revision received April 11, 2018
- Accepted April 17, 2018
- Published online September 3, 2018.
- Won-Keun Kim, MDa,b,c,∗∗ (, )
- Helge Möllmann, MD, PhDd,∗,
- Christoph Liebetrau, MD, PhDa,c,
- Matthias Renker, MDa,
- Andreas Rolf, MD, PhDa,c,
- Philippe Simona,
- Arnaud Van Linden, MDe,
- Mani Arsalan, MDe,
- Mirko Doss, MD, PhDb,
- Christian W. Hamm, MD, PhDa,c and
- Thomas Walther, MD, PhDe
- aDepartment of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany
- bDepartment of Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany
- cDepartment of Cardiology, Justus-Liebig University of Giessen, Giessen, Germany
- dDepartment of Cardiology, St. Johannes Hospital, Dortmund, Germany
- eDepartment of Cardiac Surgery, Johann-Wolfgang-Goethe University, Frankfurt, Germany
- ↵∗Address for correspondence:
Dr. Won-Keun Kim, Kerckhoff Heart Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
Objectives The aim of this study was to perform a comprehensive analysis of factors that affect procedural outcomes of transcatheter aortic valve replacement using the ACURATE neo prosthesis (Symetis/Boston, Ecublens, Switzerland).
Background Predictors of procedural outcomes using the ACURATE neo prosthesis are poorly understood.
Methods A total of 500 patients underwent transfemoral aortic valve replacement with the ACURATE neo prosthesis. Device landing zone calcification was stratified as severe, moderate, or mild. Anatomic and procedural predictors of second-degree or greater paravalvular leakage and permanent pacemaker implantation were assessed.
Results Post-procedural second-degree or greater paravalvular leakage was more frequent with increasing device landing zone calcification (mild 0.8% vs. moderate 5.0% vs. severe 13.0%; p < 0.001), whereas permanent pacemaker implantation was independent of device landing zone calcification. More severe periannular calcification (odds ratio [OR]: 1.007; 95% confidence interval [CI]: 1.003 to 1.010; p < 0.001), less oversizing (OR: 0.867; 95% CI: 0.773 to 0.971; p = 0.014), the presence of annular plaque protrusions (OR: 2.756; 95% CI: 1.138 to 6.670; p = 0.025), and aortic movement of the delivery system after full deployment (OR: 5.593; 95% CI: 1.299 to 24.076; p = 0.02), and sinotubular junction height (OR: 1.156; 95% CI: 1.007 to 1.328; p = 0.04) independently predicted second-degree or greater paravalvular leakage. Predictors of permanent pacemaker implantation were pre-existing right bundle branch block (OR: 3.122; 95% CI: 1.261 to 7.731; p = 0.01) and more oversizing (OR: 1.111; 95% CI: 1.009 to 1.222; p = 0.03).
Conclusions Successful transcatheter aortic valve replacement using the ACURATE neo device predominantly depends on careful patient selection with appropriate oversizing and taking into account the individual anatomy and calcium distribution of the aortic root.
↵∗ Drs. Kim and Möllmann contributed equally to this work.
Dr. Kim is a proctor for Symetis and St. Jude Medical; and has received lecture honoraria from Symetis, St. Jude Medical, and Edwards Lifesciences. Dr. Möllmann has received proctoring fees and/or speaking honoraria from Abbott, Biotronic, Edwards Lifesciences, St. Jude Medical, and Symetis. Dr. Liebetrau has received lecture honoraria from Abbott, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Daiichi-Sankyo, and Pfizer/Bristol-Myers Squibb; and meeting expenses from Bayer and Daiichi-Sankyo. Dr. Renker has received lecture honoraria from St. Jude Medical; and meeting expenses from Daiichi-Sankyo. Dr. Rolf has received lecture honoraria from AstraZeneca, Boehringer, Pfizer, Merck Sharpe & Dohme, and Bristol-Myers Squibb. Dr. Doss is a proctor for St. Jude Medical. Dr. Hamm is a member of the advisory board for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 8, 2018.
- Revision received April 11, 2018.
- Accepted April 17, 2018.
- 2018 American College of Cardiology Foundation