Jonathan P Piccini1, Kurt Stromberg2, Kevin P Jackson1, Robert C Kowal2, Gabor Z Duray3, Mikhael F El-Chami4, George H Crossley5, John D Hummel6, Calambur Narasimhan7, Razali Omar8, Philippe Ritter9, Paul R Roberts10, Kyoko Soejima11, Dwight Reynolds12, Shu Zhang13, Clemens Steinwender14,15, Larry Chinitz16. 1. Electrophysiology Section, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. 2. Medtronic plc, Mounds View, MN, USA. 3. Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. 4. Emory University Hospital, Atlanta, GA, USA. 5. Vanderbilt University Medical Center, Nashville, TN, USA. 6. Ohio State University, Columbus, OH, USA. 7. CARE Hospitals and CARE Foundation, Hyderabad, India. 8. Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia. 9. Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France. 10. University Hospital Southampton, Southampton, UK. 11. Department of Cardiology, Kyorin University Hospital, Tokyo, Japan. 12. Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, OK, USA. 13. Fuwai Hospital, Beijing, China. 14. Kepler University Hospital, Linz, Austria. 15. Paracelsus Medical University Salzburg, Salzburg, Austria. 16. New York University, New York, NY, USA.
Abstract
AIMS: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial. METHODS AND RESULTS: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59). CONCLUSION: Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Patient selection is a key component of securing optimal patient outcomes with leadless pacing. We sought to describe and compare patient characteristics and outcomes of Micra patients with and without a primary pacing indication associated with atrial fibrillation (AF) in the Micra IDE trial. METHODS AND RESULTS: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AFpatients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillationpatients programmed to VVI received significantly more ventricular pacing compared to non-AFpatients (median 67.8% vs. 12.6%; P < 0.001). The overall occurrence of the composite outcome at 24 months was 1.8% with no difference between the AF and non-AF groups (hazard ratio 1.36, 95% confidence interval 0.45-4.2; P = 0.59). CONCLUSION: Nearly one-third of patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF. Published on behalf of the European Society of Cardiology. All rights reserved.
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: Vincenzo Russo; Antonello D'Andrea; Stefano De Vivo; Anna Rago; Gianluca Manzo; Antonio Bocchetti; Andrea Antonio Papa; Valerio Giordano; Ernesto Ammendola; Berardo Sarubbi; Paolo Golino; Antonio D'Onofrio; Gerardo Nigro Journal: Front Cardiovasc Med Date: 2022-01-14
Authors: Jonathan P Piccini; Ryan Cunnane; Jan Steffel; Mikhael F El-Chami; Dwight Reynolds; Paul R Roberts; Kyoko Soejima; Clemens Steinwender; Christophe Garweg; Larry Chinitz; Christopher R Ellis; Kurt Stromberg; Dedra H Fagan; Lluis Mont Journal: Europace Date: 2022-07-21 Impact factor: 5.486