One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study.
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Kerkouri Fawzi, Clementy Nicolas, Defaye Pascal, Ait Said Mina, Andorin Antoine, Anselme Frédéric, Aoudjeghout Warda, Badoz Marc, Behar Nathalie, Benhenda Nazih, Ben Kilani Mouna, Bodin Alexandre, Bordachar Pierre, Bouzeman Abdeslam, Citerne Olivier, Deharo Jean-Claude, Dommerc Carine, Echivard Mathieu, Extramiana Fabrice, Fauchier Laurent, Garcia Rodrigue, Gitenay Edouard, Guenancia Charles, Guy-Moyat Benoît, Jacon Peggy, Jesel Laurence, Juin Christophe, Khoueiry Ziad, Kubala Maciej, Leclercq Christophe, Mansourati Vincent, Marquié Christelle, Mechulan Alexis, Mondoly Pierre, Narayanan Kumar, Ollitrault Pierre, Pasquié Jean-Luc, Peret Angelique, Poty Hervé, Sebag Frederic, Villejoubert Olivier, Waintraub Xavier, Waldmann Victor, Boveda Serge, Mansourati Jacques, Marijon Eloi, AV-CESAR Investigators
Аннотация
METHODS: The AV-CESAR study (French Cohort Evaluating the Effectiveness of Atrioventricular Synchrony by the micRa AV) is a nationwide retrospective cohort, including the first 1000 patients implanted with a Medtronic Micra AV leadless pacemaker in France (2020-2024). Mean follow-up was 13.4±10.6 months. Primary end points were early (in-hospital) and late (postdischarge) device-related major complications; pacemaker syndrome and need for implantation of a new pacing system were centrally adjudicated.
RESULTS: Among 1003 patients, device implantation was successful in 1000 (99.7%). Mean age was 72.0±15 years; 62.8% were men, 44.0% had ≥2 comorbidities, and 62.4% were unsuitable for transvenous pacemakers. The primary indication was permanent complete atrioventricular block with preserved sinus rhythm (78.0%). Early major complications occurred in 2.4%, including pericardial effusion (0.8%; 3 requiring surgery), access-site complications (0.8%), and thromboembolism (0.3%). Late major complications included pacemaker syndrome (2.5%), pacing-induced cardiomyopathy (1.2%), high thresholds (>4 V/0.24ms, 0.3%), and premature battery depletion (0.2%). No device infections or dislodgements were observed. Overall, 2.5% of patients required implantation of a new pacing system (pacing-induced cardiomyopathy n=11; pacemaker syndrome n=7; high threshold n=3; battery/software failure n=3; tricuspid regurgitation n=1) and 12.7% were permanently reprogrammed to ventricular paced/sensed, inhibited (VVI) mode. In pacing-dependent patients with ambulatory Holter monitoring (>3.4 million paced cycles), mean atrioventricular synchrony was 67.6±17.3% and correlated with device-reported AM-VP (74.8±17.1%; R2=0.92; P<0.001). Atrioventricular synchrony declined at heart rates >90 beats per minute (5.6% of monitored time). All-cause mortality was 13.8%, with 0.2% directly device-related; 41.7% of deaths were cardiovascular.
CONCLUSIONS: The Micra AV system is primarily used as an alternative when dual-chamber conventional pacemakers are not feasible. It demonstrated acceptable safety and clinical performance in a high-risk population. The marked reduction in atrioventricular synchrony at higher heart rates may suggest limited clinical benefit in patients with higher exertional heart rates.
REGISTRATION: URL: https://clinicaltrials.gov/study/NCT05953558; Unique identifier: NCT05953558.