The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry
Abstract
Background—: Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results—: We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions—: Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00395447.
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Cites
Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure
Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., Domanski, M., Troutman, C., Anderson, J., Johnson, G., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa043399 · Cited by 6,552
Self-citationBristow, M. R., Saxon, L. A., Boehmer, J., Krueger, S., Kass, D. A., De Marco, T., Carson, P., DiCarlo, L., DeMets, D., White, B. G., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa032423 · Cited by 5,812
Wilkoff, B. L., Auricchio, A., Brugada, J., Cowie, M., Ellenbogen, K. A., Gillis, A. M., Hayes, D. L., Howlett, J. G., Kautzner, J., Love, C. J., et al. (2008) · Heart Rhythm · doi:10.1016/j.hrthm.2008.04.013 · Cited by 364
Cited by
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
Kusumoto, F. M., Schoenfeld, M. H., Wilkoff, B. L., Berul, C. I., Birgersdotter-Green, U. M., Carrillo, R., Cha, Y.-M., Clancy, J., Deharo, J.-C., Ellenbogen, K. A., et al. (2017) · Heart Rhythm · doi:10.1016/j.hrthm.2017.09.001 · Cited by 1,199
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
Kirkfeldt, 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
Daubert, J.-C., Saxon, L., Adamson, P. B., Auricchio, A., Berger, R. D., Beshai, J. F., Breithard, O., Brignole, M., Cleland, J., DeLurgio, D. B., et al. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2012.07.025 · Cited by 467
Metadata
- Authors
- Poole, J. E., Gleva, M. J., Mela, T., Chung, M. K., Uslan, D. Z., Borge, R., Gottipaty, V., Shinn, T., Dan, D., Feldman, L. A., Seide, H., Winston, S. A., Gallagher, J. J., Langberg, J. J., Mitchell, K., Holcomb, R., & for the REPLACE Registry Investigators
- Venue
- Circulation
- Published
- 2010-10-19
- Volume
- 122
- Issue
- 16
- Pages
- 1553-1561
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2089979282
- Cited by
- 790
- References
- 3
- FWCI
- 24.73
- Type
- journal article
- Language
- en
- Open access
- closed
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- Poole, J. E., Gleva, M. J., Mela, T., Chung, M. K., Uslan, D. Z., Borge, R., Gottipaty, V., Shinn, T., Dan, D., Feldman, L. A., Seide, H., Winston, S. A., Gallagher, J. J., Langberg, J. J., Mitchell, K., Holcomb, R., & for the REPLACE Registry Investigators. (2010). Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry. Circulation. https://doi.org/10.1161/circulationaha.110.976076
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