Author + information
- Received October 24, 2019
- Revision received October 31, 2019
- Accepted October 31, 2019
- Published online November 12, 2019.
- Clemens Steinwender, MD1,2,∗ (, )
- Surinder Kaur Khelae, MD3,
- Christophe Garweg, MD4,
- Joseph Yat Sun Chan, MD5,
- Philippe Ritter, MD6,
- Jens Brock Johansen, MD, PhD7,
- Venkata Sagi, MD8,
- Laurence M. Epstein, MD9,
- Jonathan P. Piccini, MD, MHS10,
- Mario Pascual, MD11,
- Lluis Mont, MD12,
- Todd Sheldon, MS13,
- Vincent Splett, MS13,
- Kurt Stromberg, MS13,
- Nicole Wood, BS13 and
- Larry Chinitz, MD14
- 1Department of Cardiology, Kepler University Hospital, Linz, Austria
- 2Paracelsus Medical University Salzburg, Salzburg, Austria
- 3Institut Jantung Negara, Kuala Lumpur, Malaysia
- 4University Hospitals Leuven, Leuven, Belgium
- 5Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong
- 6Hôpital Haut- Lévêque, CHU de Bordeaux, Pessac, France
- 7Odense University Hospital, Odense, Denmark
- 8Baptist Medical Center Jacksonville, Florida, USA
- 9North Shore University Hospital, Manhasset, New York, USA
- 10Duke University Medical Center & Duke Clinical Research Institute, Durham, North Carolina, USA
- 11Baptist Hospital, Miami, Florida, USA
- 12Hospital Clínic. Universitat de Barcelona, Catalonia, Spain
- 13Medtronic, Inc., Mounds View, Minnesota, USA
- 14NYU Langone Medical Center, New York, New York, USA
- ↵∗Address for correspondence: Assoc.-Prof. Clemens Steinwender, MD Department of Cardiology Kepler University Hospital Johannes Kepler University Linz, Medical Faculty Krankenhausstrasse 9 4021 Linz, Austria Telephone:+43 (0)5 7680 83-6220.
Objectives We report performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms to provide atrioventricular (AV) synchronous pacing.
Background Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing.
Methods The prospective Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) 2 study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded for up to 5 hours in patients with AV block implanted with a Micra leadless pacemaker. The primary efficacy objective was to demonstrate the superiority of the algorithm to provide AV synchronous (VDD) pacing versus VVI-50 pacing in patients with sinus rhythm and complete AV block. The primary safety objective was to demonstrate that the algorithm did not result in pauses or heart rates >100 bpm.
Results Overall, 75 patients from 12 centers were enrolled and received a software download of the accelerometer-based algorithm to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the percentage of patients with ≥70% AV synchrony at rest was significantly greater with VDD pacing than with VVI pacing (95% vs. 0%, P<0.001). The mean %AV synchrony increased from 26.8% (median 26.9%) during VVI pacing to 89.2% (median 94.3%) during VDD pacing. There were no pauses or episodes of pacing-induced tachycardia reported during VDD pacing in all 75 patients.
Conclusion Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block implanted with a leadless ventricular pacemaker.
Funding: The MARVEL 2 study was funded by Medtronic, Inc.
Disclosures: CS: Compensation for Services: Biotronik, Medtronic; Speaker’s Bureau: Abbott, Biotronik, Boston Scientific, Medtronic. SKK: Speaker’s Bureau: Bayer/Schering Pharma, Boston Scientific, Medtronic, Pfizer; CG: Compensation for Services: Medtronic; JYSC: receives honorarium from Medtronic. PR: Compensation for services: Medtronic; JBJ: Honoraria, scientific board: Medtronic, Biotronik. VS: Nothing to disclose; LME: Honoraria/Speaking/Consulting Fee - Medtronic, Inc.; St. Jude Medical; Spectranetics Corporation.; JPP: receives grants for clinical research from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips and serves as a consultant to Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, Sanofi, and Philips. MP: LM: receives honoraria as a lecturer and consultant from Abbott, Boston Scientific, and Medtronic and receives financial support for fellowship/research projects from Abbott, Biotronik, Boston Scientific, and Medtronic. TS, VS, KS, and NW: shareholders and employees of Medtronic, Inc. LC: Compensation for Services: Abbott, Biosense Webster, Pfizer, Biotronik, Medtronic; Fellowship Support: Biotronik, Boston Scientific, Medtronic.
- Received October 24, 2019.
- Revision received October 31, 2019.
- Accepted October 31, 2019.
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