Circulation. Arrhythmia and electrophysiology, 2026, ⟨10.1161/CIRCEP.126.014850⟩
BACKGROUND: Evidence supporting the Micra AV leadless pacing system has largely derived from highly experienced centers, potentially limiting generalizability to routine clinical practice. METHODS: The AV-CESAR study 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 male, 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 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%; R 2 =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://www.clinicaltrials.gov ; Unique identifier: NCT05953558.
Fawzi Kerkouri, Nicolas Clementy, Pascal Defaye, Mina Ait Said, Antoine Andorin, et al.. One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study. Circulation. Arrhythmia and electrophysiology, 2026, ⟨10.1161/CIRCEP.126.014850⟩ (lien externe). ⟨hal-05629364⟩ (lien externe)
Citations
APA
Kerkouri, F., Clementy, N., Defaye, P., Ait Said, M., Andorin, A., Anselme, F., Aoudjeghout, W., Badoz, M., Behar, N., Benhenda, N., Ben Kilani, M., Bodin, A., Bordachar, P., Bouzeman, A., Citerne, O., Deharo, J.-C., Dommerc, C., Echivard, M., Extramiana, F., … Hugues, N. (2026). One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study. In Circulation. Arrhythmia and electrophysiology. https://dx.doi.org/10.1161/CIRCEP.126.014850
MLA
Kerkouri, Fawzi, et al. “One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study.” Circulation. Arrhythmia and Electrophysiology, May 2026, https://dx.doi.org/10.1161/CIRCEP.126.014850.
Chicago
Kerkouri, Fawzi, Nicolas Clementy, Pascal Defaye, et al. 2026. “One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study.” In Circulation. Arrhythmia and Electrophysiology. https://dx.doi.org/10.1161/CIRCEP.126.014850.
Harvard
Kerkouri, F. et al. (2026) “One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study,” Circulation. Arrhythmia and electrophysiology. Available at: https://dx.doi.org/10.1161/CIRCEP.126.014850.
ISO 690
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, PERRET, Angelique, POTY, Hervé, SEBAG, Frederic, VILLEJOUBERT, Olivier, WAINTRAUB, Xavier, WALDMANN, Victor, BOVEDA, Serge, MANSOURATI, Jacques, MARIJON, Eloi, HOURDAIN, Jérôme, MAILLE, Baptiste, PREVOT, Sébastien, BOUHARAOUA, Ahmed, BARS, Clément, SEITZ, Julien, CHAMP RIGOT, Laure, MILLIEZ, Paul-Ursmar, PELLISSIER, Arnaud, LEBON, Alain, GOMES, Sophie, BERTAUX, Géraldine, LAURENT, Gabriel, SAGNARD, Audrey, FICHOT, Marie, FAVOULET, Baptiste, SERZIAN, Guillaume, PUJADAS, Pénélope, MAURY, Philippe, DOMAIN, Guillaume, COMBES, Nicolas, COMBES, Stéphane, CARDIN, Christèle, ALBENQUE, Jean-Paul, TOUBOUL, Olivier, CASSAGNEAU, Romain, PLOUX, Sylvain, SACHER, Frédéric, DERVAL, Nicolas, STRIK, Marc, CRANSAC, Frederic, PASQUIÉ, Jean Luc, GARNIER, Mathieu, MARTINS, Raphael, PAVIN, Dominique, PIERRE, Bertrand, BISSON, Arnaud, ZAKINE, Cyril, LOOSE, Christophe, OTMANI, Akli, CARABELLI, Adrien, VENIER, Sandrine, PROBST, Vincent, BAPTISTE GOURRAUD, Jean, ARNAUD, Marine, MINOIS, Damien, LE PAGE, Sophie, PIERRE CHABERT, Jean, LESAFFRE, François, ESPINOSA, Madeline, LUCONI, Nicolas, SADOUL, Nicolas, BLANGY, Hugues, DE CHILLOU, Christian, POTELLE, Charlotte, NINNI, Sandro, KLUG, Didier, MIZON-GÉRARD, Frédérique, VAKSMANN, Arthur, VANNESSON, Claire, HUS, Thibault, ESCHALIER, Romain, JEAN, Frederic, MASSOULLIÉ, Grégoire, LAGRANGE, Philippe, SULTAN, Pierre, NADJI, Georges, SCHATZ, Alexandre, DURAND, Cyril, DURAND DUBIEF, Alexis, BRAHIC, Hugo, SIMÉON, Edouard, MIGNOT, Nicolas, JORROT, Pierre, VARLET, Émilie, BAUDINAUD, Pierre, PHILIBERT, Séverine, PINON, Pauline, CHALBIA, Tej, BADENCO, Nicolas, GANDJBAKHCH, Estelle, DUTHOIT, Guillaume, LAREDO, Mikael, MESSALI, Anne, LEENHARDT, Antoine, ALGALARRONDO, Vincent, GODIN, Benedicte, SAVOURÉ, Arnaud, CHAUMONT, Corentin, BERTRAND, Cathy, HALIMI, Franck, HERMIDA, Jean-Sylvain, HERMIDA, Alexis, OTMANI, Akli, DEGAND, Bruno, LE GAL, François, HORVILLEUR, Jerôme, FIORINA, Laurent, LACOTTE, Jerôme, SALERNO, Fiorella, YOUNSI, Salem, MANENTI, Vladimir, ALONSO, Christine, LAZARUS, Arnaud, MOUBARAK, Ghassan, THOMAS, Olivier, SHARIFZADEHGAN, Ardalan, PERROT, David, ZHAO, Alexandre, LELLOUCHE, Nicolas, ELBAZ, Nathalie, ROUFFIAC-NOEL, Ségolène and HUGUES, Nicolas, 2026. One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study [en ligne]. May 2026. Disponible à l'adresse : https://dx.doi.org/10.1161/CIRCEP.126.014850