The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study
Open accessAbstract
BACKGROUND: Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months. OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months. METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates. RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years. CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
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Cites
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ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities
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Cited by
Chinitz, L., Ritter, P., Khelae, S. K., Iacopino, S., Garweg, C., Grazia-Bongiorni, M., Neuzil, P., Johansen, J. B., Mont, L., Gonzalez, E., et al. (2018) · Heart Rhythm · doi:10.1016/j.hrthm.2018.05.004 · Cited by 170
Self-citationLyu, H., John, M., Burkland, D., Greet, B., Post, A., Babakhani, A., & Razavi, M. (2020) · Scientific Reports · doi:10.1038/s41598-020-59017-z · Cited by 51
Lyu, H., John, M., Burkland, D., Greet, B., Xi, Y., Sampaio, L. C., Taylor, D. A., Babakhani, A., & Razavi, M. (2018) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.13738 · Cited by 5
Metadata
- Authors
- Duray, G. Z., Ritter, P., El-Chami, M., Narasimhan, C., Omar, R., Tolosana, J. M., Zhang, S., Soejima, K., Steinwender, C., Rapallini, L., Cicic, A., Fagan, D. H., Liu, S., & Reynolds, D.
- Venue
- Heart Rhythm
- Publisher
- Elsevier BV
- Published
- 2017-05
- Volume
- 14
- Issue
- 5
- Pages
- 702-709
- ISSN
- 1547-5271 (ISSN-L)
- OpenAlex
- W2587560734
- Cited by
- 302
- References
- 3
- FWCI
- 22.83
- Type
- journal article
- Language
- en
- Open access
- hybrid
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
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- Duray, G. Z., Ritter, P., El-Chami, M., Narasimhan, C., Omar, R., Tolosana, J. M., Zhang, S., Soejima, K., Steinwender, C., Rapallini, L., Cicic, A., Fagan, D. H., Liu, S., & Reynolds, D. (2017). Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study. Heart Rhythm. https://doi.org/10.1016/j.hrthm.2017.01.035
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