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Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control
Open accessAbstract
BACKGROUND: Early results of the Micra Investigational Device Exemption (IDE) study and Micra Post-Approval Registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated. OBJECTIVES: We report updated performance of the Micra transcatheter pacemaker from a worldwide PAR and compare it with the IDE study as well as a transvenous historical control. METHODS: The safety objective of the analysis was system- or procedure-related major complications through 12 months postimplantation. We compared the major complication rate with that of the 726 patients from the IDE and with a reference data set of 2667 patients with transvenous pacemakers by using a Fine-Gray competing risk model. RESULTS: The Micra device was successfully implanted in 1801 of 1817 patients (99.1%). The mean follow-up period was 6.8 ± 6.9 months. Through 12 months, the major complication rate was 2.7% (95% confidence interval [CI] 2.0%-3.7%). The risk of major complications for Micra PAR patients was 63% lower than that for patients with transvenous pacemakers through 12 months postimplantation (hazard ratio 0.37; 95% CI 0.27-0.52; P < .001). The major complication rate trended lower in the PAR than in the IDE study (hazard ratio 0.71; 95% CI 0.44-1.1; P = .160), driven by the lower pericardial effusion rate in the PAR. There were 3 cases of infection associated with the procedure, but none required device removal and there were no battery or telemetry issues. Pacing thresholds were low and stable through 12 months postimplantation. CONCLUSION: Performance of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. Major complications were infrequent and occurred 63% less often compared to transvenous systems. CLINICAL TRIAL REGISTRATION: Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.
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A Leadless Intracardiac Transcatheter Pacing System
Reynolds, D., Duray, G. Z., Omar, R., Soejima, K., Neuzil, P., Zhang, S., Narasimhan, C., Steinwender, C., Brugada, J., Lloyd, M., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1511643 · Cited by 933
Self-citationKirkfeldt, R. E., Johansen, J. B., Nohr, E. A., Jorgensen, O. D., & Nielsen, J. C. (2014) · European Heart Journal · doi:10.1093/eurheartj/eht511 · Cited by 871
Self-citationUdo, E. O., Zuithoff, N. P. A., van Hemel, N. M., de Cock, C. C., Hendriks, T., Doevendans, P. A., & Moons, K. G. M. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2011.12.014 · Cited by 597
Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker
Reddy, V. Y., Exner, D. V., Cantillon, D. J., Doshi, R., Bunch, T. J., Tomassoni, G. F., Friedman, P. A., Estes, N. A. M., Ip, J., Niazi, I., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1507192 · Cited by 539
Roberts, P. R., Clementy, N., Al Samadi, F., Garweg, C., Martinez-Sande, J. L., Iacopino, S., Johansen, J. B., Vinolas Prat, X., Kowal, R. C., Klug, D., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.05.017 · Cited by 332
Self-citationDuray, G. Z., Ritter, P., El-Chami, M., Narasimhan, C., Omar, R., Tolosana, J. M., Zhang, S., Soejima, K., Steinwender, C., Rapallini, L., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.01.035 · Cited by 302
Self-citationVámos, M., Erath, J. W., Benz, A. P., Bári, Z., Duray, G. Z., & Hohnloser, S. H. (2016) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.13140 · Cited by 91
How to Implant a Leadless Pacemaker With a Tine‐Based Fixation
El‐Chami, M. F., Roberts, P. R., Kypta, A., Omdahl, P., Bonner, M. D., Kowal, R. C., & Duray, G. Z. (2016) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.13092 · Cited by 66
Self-citationPyatt, J. R., Somauroo, J. D., Jackson, M., Grayson, A. D., Osula, S., Aggarwal, R. K., Charles, R. G., & Connelly, D. T. (2002) · EP Europace · doi:10.1053/eupc.2002.0233 · Cited by 61
Complete encapsulation of a leadless cardiac pacemaker
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2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Glikson, M., Nielsen, J. C., Kronborg, M. B., Michowitz, Y., Auricchio, A., Barbash, I. M., Barrabés, J. A., Boriani, G., Braunschweig, F., Brignole, M., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab364 · Cited by 2,019
2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy
Glikson, M., Nielsen, J. C., Kronborg, M. B., Michowitz, Y., Auricchio, A., Barbash, I. M., Barrabés, J. A., Boriani, G., Braunschweig, F., Brignole, M., et al. (2022) · EP Europace · doi:10.1093/europace/euab232 · Cited by 914
A Dual-Chamber Leadless Pacemaker
Knops, R. E., Reddy, V. Y., Ip, J. E., Doshi, R., Exner, D. V., Defaye, P., Canby, R., Bongiorni, M. G., Shoda, M., Hindricks, G., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2300080 · Cited by 283
Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker
Steinwender, C., Khelae, S. K., Garweg, C., Chan, J. Y. S., Ritter, P., Johansen, J. B., Sagi, V., Epstein, L. M., Piccini, J. P., Pascual, M., et al. (2020) · JACC: Clinical Electrophysiology · doi:10.1016/j.jacep.2019.10.017 · Cited by 257
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Metadata
- Authors
- El-Chami, M. F., Al-Samadi, F., Clementy, N., Garweg, C., Martinez-Sande, J. L., Piccini, J. P., Iacopino, S., Lloyd, M., Viñolas Prat, X., Jacobsen, M. D., Ritter, P., Johansen, J. B., Tondo, C., Liu, F., Fagan, D. H., Eakley, A. K., & Roberts, P. R.
- Venue
- Heart Rhythm
- Publisher
- Elsevier BV
- Published
- 2018-12
- Volume
- 15
- Issue
- 12
- Pages
- 1800-1807
- ISSN
- 1547-5271 (ISSN-L)
- OpenAlex
- W2885247491
- Cited by
- 355
- References
- 10
- FWCI
- 23.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- El-Chami, M. F., Al-Samadi, F., Clementy, N., Garweg, C., Martinez-Sande, J. L., Piccini, J. P., Iacopino, S., Lloyd, M., Viñolas Prat, X., Jacobsen, M. D., Ritter, P., Johansen, J. B., Tondo, C., Liu, F., Fagan, D. H., Eakley, A. K., & Roberts, P. R. (2018). Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. https://doi.org/10.1016/j.hrthm.2018.08.005
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