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Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study

Steinwender C 1 , Khelae SK 2 , Garweg C 3 , Chan JYS 4 , Ritter P 5 , Johansen JB 6 Show all authors , Sagi V 7 , Epstein LM 8 , Piccini JP 9 , Pascual M 10 , Mont L 11 , Sheldon T 12 , Splett V 12 , Stromberg K 12 , Wood N 12 , Chinitz L 13

Affiliations 

  • 1 Department of Cardiology, Kepler University Hospital, Linz, Austria; Department of Cardiology, Paracelsus Medical University Salzburg, Salzburg, Austria. Electronic address: clemens.steinwender@kepleruniklinikum.at
  • 2 Department of Electrophysiology, Institut Jantung Negara, Kuala Lumpur, Malaysia
  • 3 Department of Cardiovascular Sciences, Department of Cardiology, University Hospitals Leuven, Leuven, Belgium
  • 4 Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong
  • 5 Department of Electrophysiology and Cardiac Stimulation, Hôpital Haut- Lévêque - CHU de Bordeaux, Pessac, France
  • 6 Department of Cardiology, Odense University Hospital, Odense, Denmark
  • 7 Baptist Heart Specialists, Baptist Medical Center Jacksonville, Florida, USA
  • 8 Department of Electrophysiology, North Shore University Hospital, Manhasset, New York, USA
  • 9 Division of Cardiology, Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA
  • 10 Miami Cardiac & Vascular Institute, Baptist Hospital, Miami, Florida
  • 11 Institut Clinic Cardiovascular (ICCV), Hospital Clínic, Universitat de Barcelona, Catalonia, Barcelona, Spain
  • 12 Medtronic, Inc., Mounds View, Minnesota, USA
  • 13 Leon H. Charney Division of Cardiology, NYU Langone Medical Center, New York, New York, USA
JACC Clin Electrophysiol, 2020 01;6(1):94-106.
PMID: 31709982 DOI: 10.1016/j.jacep.2019.10.017

Abstract

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 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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