The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry
Open accessAbstract
AIMS: Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. METHODS AND RESULTS: Baseline/implant data are available for 1021 subjects. Subjects in the study were at high risk of stroke (average CHADS2 score: 2.8 ± 1.3, CHA2DS2-VASc: 4.5 ± 1.6) and moderate-to-high risk of bleeding (average HAS-BLED score: 2.3 ± 1.2). Almost half of the subjects (45.4%) had a history of TIA, ischaemic stroke, or haemorrhagic stroke; 62% of patients were deemed unsuitable for novel oral anticoagulant by their physician. The device was successfully deployed in 98.5% of patients with no flow or minimal residual flow achieved in 99.3% of implanted patients. Twenty-eight subjects experienced 31 serious adverse events (SAEs) within 1 day of the procedure. The overall 30-day mortality rate was 0.7%. The most common SAE occurring within 30 days of the procedure was major bleeding requiring transfusion. Incidence of SAEs within 30 days was significantly lower for subjects deemed to be ineligible for oral anticoagulation therapy (OAT) compared with those eligible for OAT (6.5 vs. 10.2%, P = 0.042). CONCLUSION: Left atrial appendage closure with the WATCHMAN device has a high success rate in complete LAAC with low peri-procedural risk, even in a population with a higher risk of stroke and bleeding, and multiple co-morbidities. Improvement in implantation techniques has led to a reduction of peri-procedural complications previously limiting the net clinical benefit of the procedure.
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Cites
Mehran, R., Rao, S. V., Bhatt, D. L., Gibson, C. M., Caixeta, A., Eikelboom, J., Kaul, S., Wiviott, S. D., Menon, V., Nikolsky, E., et al. (2011) · Circulation · doi:10.1161/circulationaha.110.009449 · Cited by 4,476
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2014 ESC/EACTS Guidelines on myocardial revascularization
Kolh, P., Windecker, S., Alfonso, F., Collet, J.-P., Cremer, J., Falk, V., Filippatos, G., Hamm, C., Head, S. J., Jüni, P., et al. (2014) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezu366 · Cited by 4,199
2012 focused update of the ESC Guidelines for the management of atrial fibrillation
Authors/Task Force Members, Camm, A. J., Lip, G. Y. H., De Caterina, R., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., Kirchhof, P., ESC Committee for Practice Guidelines (CPG), et al. (2012) · EP Europace · doi:10.1093/europace/eus305 · Cited by 3,822
2012 focused update of the ESC Guidelines for the management of atrial fibrillation
Authors/Task Force Members, Camm, A. J., Lip, G. Y. H., De Caterina, R., Savelieva, I., Atar, D., Hohnloser, S. H., Hindricks, G., Kirchhof, P., ESC Committee for Practice Guidelines (CPG), et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs253 · Cited by 2,899
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Self-citationHolmes, D. R., Kar, S., Price, M. J., Whisenant, B., Sievert, H., Doshi, S. K., Huber, K., & Reddy, V. Y. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.04.029 · Cited by 1,845
Self-citationAppendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation
Blackshear, J. L., & Odell, J. A. (1996) · The Annals of Thoracic Surgery · doi:10.1016/0003-4975(95)00887-x · Cited by 1,686
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Cited by
Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström-Lundqvist, C., Boriani, G., Castella, M., Dan, G.-A., Dilaveris, P. E., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehaa612 · Cited by 9,971
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418
Van Gelder, I. C., Rienstra, M., Bunting, K. V., Casado-Arroyo, R., Caso, V., Crijns, H. J. G. M., De Potter, T. J. R., Dwight, J., Guasti, L., Hanke, T., et al. (2024) · European Heart Journal · doi:10.1093/eurheartj/ehae176 · Cited by 3,024
January, C. T., Wann, L. S., Calkins, H., Chen, L. Y., Cigarroa, J. E., Cleveland, J. C., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., Furie, K. L., et al. (2019) · Circulation · doi:10.1161/cir.0000000000000665 · Cited by 2,744
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403
Metadata
- Authors
- Boersma, L. V. A., Schmidt, B., Betts, T. R., Sievert, H., Tamburino, C., Teiger, E., Pokushalov, E., Kische, S., Schmitz, T., Stein, K. M., & Bergmann, M. W.
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2016-01-27
- Volume
- 37
- Issue
- 31
- Pages
- 2465-2474
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W2278350753
- Cited by
- 522
- References
- 20
- FWCI
- 54.78
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Boersma, L. V. A., Schmidt, B., Betts, T. R., Sievert, H., Tamburino, C., Teiger, E., Pokushalov, E., Kische, S., Schmitz, T., Stein, K. M., & Bergmann, M. W. (2016). Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. European Heart Journal. https://doi.org/10.1093/eurheartj/ehv730
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