Author + information
- Received October 24, 2019
- Revision received October 31, 2019
- Accepted October 31, 2019
- Published online January 20, 2020.
- Clemens Steinwender, MDa,b,∗ (, )
- Surinder Kaur Khelae, MDc,
- Christophe Garweg, MDd,
- Joseph Yat Sun Chan, MDe,
- Philippe Ritter, MDf,
- Jens Brock Johansen, MD, PhDg,
- Venkata Sagi, MDh,
- Laurence M. Epstein, MDi,
- Jonathan P. Piccini, MD, MHSj,
- Mario Pascual, MDk,
- Lluis Mont, MDl,
- Todd Sheldon, MSm,
- Vincent Splett, MSm,
- Kurt Stromberg, MSm,
- Nicole Wood, BSm and
- Larry Chinitz, MDn
- aDepartment of Cardiology, Kepler University Hospital, Linz, Austria
- bDepartment of Cardiology, Paracelsus Medical University Salzburg, Salzburg, Austria
- cDepartment of Electrophysiology, Institut Jantung Negara, Kuala Lumpur, Malaysia
- dDepartment of Cardiovascular Sciences, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium
- eDepartment of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong
- fDepartment of Electrophysiology and Cardiac Stimulation, Hôpital Haut- Lévêque – CHU de Bordeaux, Pessac, France
- gDepartment of Cardiology, Odense University Hospital, Odense, Denmark
- hBaptist Heart Specialists, Baptist Medical Center Jacksonville, Florida
- iDepartment of Electrophysiology, North Shore University Hospital, Manhasset, New York
- jDivision of Cardiology, Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina
- kMiami Cardiac & Vascular Institute, Baptist Hospital, Miami, Florida
- lInstitut Clinic Cardiovascular (ICCV), Hospital Clínic, Universitat de Barcelona, Catalonia, Barcelona, Spain
- mMedtronic, Inc., Mounds View, Minnesota
- nLeon H. Charney Division of Cardiology, NYU Langone Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Clemens Steinwender, Department of Cardiology, Kepler University Hospital, Johannes Kepler University Linz, Medical Faculty, Krankenhausstrasse 9, 4021 Linz, Austria.
Objectives This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing.
Background Despite many advantages, leadless pacemakers are currently only capable of single-chamber ventricular pacing.
Methods The prospective MARVEL 2 (Micra Atrial tRacking using a Ventricular accELerometer 2) study assessed the performance of an automated, enhanced accelerometer-based algorithm downloaded to the Micra leadless pacemaker for up to 5 h in patients with AV block. 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 of >100 beats/min.
Results Overall, 75 patients from 12 centers were enrolled; an accelerometer-based algorithm was downloaded to their leadless pacemakers. Among the 40 patients with sinus rhythm and complete AV block included in the primary efficacy objective analysis, the proportion 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 percentage of 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 oversensing-induced tachycardia reported during VDD pacing in all 75 patients.
Conclusions Accelerometer-based atrial sensing with an automated, enhanced algorithm significantly improved AV synchrony in patients with sinus rhythm and AV block who were implanted with a leadless ventricular pacemaker. (Micra Atrial Tracking Using a Ventricular Accelerometer 2 [MARVEL 2]; NCT03752151).
The MARVEL 2 study was funded by Medtronic, Inc. Dr. Steinwender has been a member of the Advisory Board for Biotronik and Medtronic; and has been a member of the Speakers Bureau for Abbott, Biotronik, Boston Scientific, and Medtronic. Dr. Khelae has been a member of the Speakers Bureau for Bayer/Schering Pharma, Boston Scientific, Medtronic, and Pfizer. Dr. Garweg has been a consultant for Medtronic. Dr. Chan has received honoraria from Medtronic. Dr. Ritter has received fees for services from Medtronic. Dr. Johansen has been a speaker for Medtronic and Merit Medical; and has received honoraria as a member of the Scientific Board for Medtronic and Biotronik. Dr. Epstein has received honoraria for speaking and consulting for Medtronic, St. Jude Medical, and Spectranetics Corporation. Dr. Piccini has received grants for clinical research from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and has been a consultant for Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, Sanofi, and Phillips. Dr. Mont has received honoraria as a lecturer and consultant from Abbott, Boston Scientific, and Medtronic; and has received financial support for fellowship/research projects from Abbott, Biotronik, Boston Scientific, and Medtronic. Mr. Sheldon, Mr. Splett, Mr. Stromberg, and Ms. Wood are also employees of Medtronic. Mr. Sheldon holds stock in Medtronic. Mr. Splett holds stock in Medtronic. Mr. Stromberg holds stock in Medtronic. Ms. Wood holds stock in Medtronic. Dr. Chinitz has received fees services from Abbott, Biosense Webster, Pfizer, Biotronik, and Medtronic; and had received fellowship support from Biotronik, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received October 24, 2019.
- Revision received October 31, 2019.
- Accepted October 31, 2019.
- 2020 The Authors