Author + information
- Received February 26, 2019
- Revision received May 6, 2019
- Accepted May 14, 2019
- Published online September 16, 2019.
- Oliver Husser, MDa,∗∗ (, )
- Costanza Pellegrini, MDb,∗,
- Won-Keun Kim, MDc,
- Andreas Holzamer, MDd,
- Thomas Pilgrim, MDe,
- Stefan Toggweiler, MDf,
- Ulrich Schäfer, MDg,
- Johannes Blumenstein, MDa,
- Florian Deuschl, MDg,
- Tobias Rheude, MDb,
- Michael Joner, MDb,h,
- Michael Hilker, MDd,
- Christian Hengstenberg, MDi and
- Helge Möllmann, MDa
- aKlinik für Innere Medizin I, Kardiologie, St. Johannes-Hospital Dortmund, Dortmund, Germany
- bKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany
- cDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- dKlinik für Herz-, Thorax-, und herznahe Gefäßchirurgie, University of Regensburg Medical Center, Regensburg, Germany
- eDepartment of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland
- fDepartment of Cardiology, Kantonsspital, Luzern, Switzerland
- gDepartment of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany
- hGerman Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany
- iKlinische Abteilung für Kardiologie, Universitätsklinik für Innere Medizin II, Medizinische Universität Wien, Vienna, Austria
- ↵∗Address for correspondence:
Dr. Oliver Husser, Department of Cardiology, St.-Johannes-Hospital Dortmund, Johannesstraße 9-13, 44137 Dortmund, Germany.
Objectives This study sought to evaluate the impact of the ACURATE neo (NEO) (Boston Scientific, Marlborough, Massachusetts) versus SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) on permanent pacemaker implantation (PPI) in patients with pre-existing right bundle branch block (RBBB) after transcatheter aortic valve replacement.
Background Pre-existing RBBB is the strongest patient-related predictor for PPI after transcatheter aortic valve replacement. No comparison of newer-generation transcatheter heart valves with regard to PPI in these patients exists.
Methods This multicenter registry includes 4,305 patients; 296 (6.9%) had pre-existent RBBB and no pacemaker at baseline and formed the study population. The primary endpoint was new PPI at 30 days. The association of NEO versus S3 with PPI was assessed using binary logistic regression analyses and inverse probability treatment weighting in a propensity-matched population.
Results The 30-day PPI rate was 39.2%. The S3 and NEO were used in 66.9% and 33.1%, respectively. The NEO was associated with lower rates of PPI compared with the S3 (29.6% vs. 43.9%; p = 0.025; odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.32 to 0.89; p = 0.018), after multivariable adjustment (OR: 0.48; 95% CI: 0.26 to 0.86; p = 0.014), and in the inverse probability treatment weighting analysis (OR: 0.37; 95% CI: 0.25 to 0.55; p < 0.001). There was no difference in device failure (8.2% vs. 6.6%; p = 0.792) or in-hospital course. In the propensity-matched population, PPI rate was also lower in the NEO versus S3 (23.1% vs. 44.6%; p = 0.016; OR: 0.37; 95% CI: 0.17 to 0.78; p = 0.010), with no difference in device failure (9.2% vs. 6.2%; p = 0.742).
Conclusions In patients with RBBB, risk of PPI was significantly lower with the NEO compared with the S3, suggesting the possibility of a patient tailored transcatheter heart valve therapy.
- ACURATE neo
- permanent pacemaker implantations
- right bundle branch block
- SAPIEN 3
- transcatheter aortic valve replacement
↵∗ Drs. Husser and Pellegrini contributed equally to this work.
Dr. Husser has received proctor fees and minor speaker honoraria from Boston Scientific. Dr. Pellegrini has received minor travel grant support from Edwards Lifesciences, Boston Scientific, and Symetis. Dr. Kim has received proctor fees from Boston Scientific, St. Jude Medical/Abbott; and has received speaker fees from Boston Scientific, St. Jude Medical/Abbott, Edwards Lifesciences, and Pfizer. Dr. Holzamer has received proctor fees from Boston Scientific; has served as a consultant for Boston Scientific, Medtronic, New Valve Technology, and Symetis; received major research grant support from Boston Scientific and Symetis; and has received travel honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Pilgrim has received institutional research grant support from Boston Scientific, Edwards Lifesciences, and Biotronik; has received speaker fees from Boston Scientific and Biotronik; and has received proctor fees for Boston Scientific. Dr. Toggweiler has served as a proctor and consultant for Boston Scientific and New Valve Technology; has received unrestricted research grant support from Boston Scientific; and has received personal fees from Boston Scientific. Dr. Schäfer is a consultant, proctor, and is on the Speakers Bureau for Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Gore, Jena Valve Technology, and New Valve Technology; and has received research support from Abbott Vascular, Boston Scientific, Jena Valve Technology, Edwards Lifesciences and New Valve Technology. Dr. Blumenstein has received proctor fees from Boston Scientific. Dr. Deuschl has received travel support from Boston Scientific, Symetis, Edwards Lifesciences, Abbott, and Neovasc; has received proctor fees from Edwards Lifesciences and Neovasc; and has served as a proctor for Edwards Lifesciences. Dr. Joner has served as a consultant for Biotronik and Orbus Neich. Dr. Hilker has received proctor fees from Boston Scientific. Dr. Hengstenberg has received speaker honoraria and proctor fees from Boston Scientific and Edwards Lifesciences. Dr. Möllmann has received speaker honoraria and proctor fees from Abbott, Biotronik, St. Jude Medical, Boston Scientific, and Edwards Lifesciences. Dr. Rheude has reported that he has no relationships relevant to the contents of this paper to disclose.
- Received February 26, 2019.
- Revision received May 6, 2019.
- Accepted May 14, 2019.
- 2019 American College of Cardiology Foundation
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