Clemens Steinwender1, Surinder Kaur Khelae2, Christophe Garweg3, Joseph Yat Sun Chan4, Philippe Ritter5, Jens Brock Johansen6, Venkata Sagi7, Laurence M Epstein8, Jonathan P Piccini9, Mario Pascual10, Lluis Mont11, Todd Sheldon12, Vincent Splett12, Kurt Stromberg12, Nicole Wood12, Larry Chinitz13. 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.
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 < 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).
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).
Authors: Zak Loring; Rebecca North; Anne S Hellkamp; Brett D Atwater; Camille G Frazier-Mills; Kevin P Jackson; Sean D Pokorney; Gervasio A Lamas; Jonathan P Piccini Journal: Pacing Clin Electrophysiol Date: 2020-11-05 Impact factor: 1.976
Authors: Moghniuddin Mohammed; Juwairiya Arshi; Brian M Ramza; Alan P Wimmer; Daniel A Steinhaus; Michael J Giocondo; Sanjaya K Gupta; Omair K Yousuf Journal: Indian Pacing Electrophysiol J Date: 2020-03-04