The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.
Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement
Open accessAbstract
BACKGROUND: Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke. METHODS: We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR. RESULTS: A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site. CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.).
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Cites
Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Leon, M. B., Smith, C. R., Mack, M., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1008232 · Cited by 7,205
Self-citationTranscatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
Smith, C. R., Leon, M. B., Mack, M. J., Miller, D. C., Moses, J. W., Svensson, L. G., Tuzcu, E. M., Webb, J. G., Fontana, G. P., Makkar, R. R., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1103510 · Cited by 6,345
Self-citationTranscatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients
Leon, M. B., Smith, C. R., Mack, M. J., Makkar, R. R., Svensson, L. G., Kodali, S. K., Thourani, V. H., Tuzcu, E. M., Miller, D. C., Herrmann, H. C., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1514616 · Cited by 5,053
Self-citationTranscatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients
Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., Pibarot, P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1814052 · Cited by 4,847
Self-citationTranscatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients
Popma, J. J., Deeb, G. M., Yakubov, S. J., Mumtaz, M., Gada, H., O’Hair, D., Bajwa, T., Heiser, J. C., Merhi, W., Kleiman, N. S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816885 · Cited by 3,674
Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis
Adams, D. H., Popma, J. J., Reardon, M. J., Yakubov, S. J., Coselli, J. S., Deeb, G. M., Gleason, T. G., Buchbinder, M., Hermiller, J., Kleiman, N. S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1400590 · Cited by 2,902
Popma, J. J., Adams, D. H., Reardon, M. J., Yakubov, S. J., Kleiman, N. S., Heimansohn, D., Hermiller, J., Hughes, G. C., Harrison, J. K., Coselli, J., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.02.556 · Cited by 1,040
Thourani, V. H., Kodali, S., Makkar, R. R., Herrmann, H. C., Williams, M., Babaliaros, V., Smalling, R., Lim, S., Malaisrie, S. C., Kapadia, S., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)30073-3 · Cited by 1,028
Self-citationTranscatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis
Thyregod, H. G. H., Steinbrüchel, D. A., Ihlemann, N., Nissen, H., Kjeldsen, B. J., Petursson, P., Chang, Y., Franzen, O. W., Engstrøm, T., Clemmensen, P., et al. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.03.014 · Cited by 933
Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement
Kapadia, S. R., Kodali, S., Makkar, R., Mehran, R., Lazar, R. M., Zivadinov, R., Dwyer, M. G., Jilaihawi, H., Virmani, R., Anwaruddin, S., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2016.10.023 · Cited by 509
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Cited by
Martin, S. S., Aday, A. W., Almarzooq, Z. I., Anderson, C. A. M., Arora, P., Avery, C. L., Baker-Smith, C. M., Barone Gibbs, B., Beaton, A. Z., Boehme, A. K., et al. (2024) · Circulation · doi:10.1161/cir.0000000000001209 · Cited by 2,800
Metadata
- Authors
- Kapadia, S. R., Makkar, R., Leon, M., Abdel-Wahab, M., Waggoner, T., Massberg, S., Rottbauer, W., Horr, S., Sondergaard, L., Karha, J., Gooley, R., Satler, L., Stoler, R. C., Messé, S. R., Baron, S. J., Seeger, J., Kodali, S., Krishnaswamy, A., Thourani, V. H., Harrington, K., Pocock, S., Modolo, R., Allocco, D. J., Meredith, I. T., & Linke, A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-10-06
- Volume
- 387
- Issue
- 14
- Pages
- 1253-1263
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4296143892
- Cited by
- 325
- References
- 30
- FWCI
- 38.29
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Kapadia, S. R., Makkar, R., Leon, M., Abdel-Wahab, M., Waggoner, T., Massberg, S., Rottbauer, W., Horr, S., Sondergaard, L., Karha, J., Gooley, R., Satler, L., Stoler, R. C., Messé, S. R., Baron, S. J., Seeger, J., Kodali, S., Krishnaswamy, A., Thourani, V. H., . . . Linke, A. (2022). Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2204961
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