Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement | NEJM

Abstract

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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Funding and Disclosures

Supported by Boston Scientific.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on September 17, 2022, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

Author Affiliations

From the Department of Cardiovascular Medicine (S.R.K.), Cleveland Clinic Foundation (A.K.), Cleveland; Smidt Heart Institute, Cedars–Sinai Medical Center, Los Angeles (R. Makkar); Columbia Interventional Cardiovascular Care (M.L.), Columbia University Medical Center (S.K.), New York; Leipzig Heart Center, University of Leipzig, Leipzig (M.A.-W.), Medizinische Klinik und Poliklinik I, Klinikum der Universität München and German Center for Cardiovascular Research (DZHK), Munich Heart Alliance, Munich (S.M.), Universitaetsklinikum Ulm, Ulm (W.R.), Medical Campus Lake Constance, Friedrichshafen (J.S.), and the Clinic for Internal Medicine and Cardiology, Technische Universität Dresden, Herzzentrum, Dresden (A.L.) — all in Germany; Pima Heart and Vascular, Tucson Medical Center Healthcare, Tucson, AZ (T.W.); Centennial Medical Center, Nashville (S.H.); Rigshospitalet, Copenhagen University Hospital, Copenhagen (L. Sondergaard); Heart Hospital of Austin, Austin (J.K.), Baylor Heart and Vascular Hospital, Dallas (R.C.S.), and Baylor Scott and White the Heart Hospital–Plano, Plano (K.H.) — all in Texas; Monash Medical Centre, Clayton, VIC, Australia (R.G.); Washington Hospital Center, Washington, DC (L. Satler); the Department of Neurology, University of Pennsylvania, Philadelphia (S.R.M.); Lahey Hospital and Medical Center, Burlington (S.J.B.), and Boston Scientific, Marlborough (R. Modolo, D.J.A., I.T.M.) — both in Massachusetts; Piedmont Heart Institute, Atlanta (V.H.T.); and the London School of Hygiene and Tropical Medicine, London (S.P.).

Dr. Kapadia can be contacted at [email protected] or at the Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Ave., J2-3, Cleveland, OH 44195.

A full list of the PROTECTED TAVR investigators is provided in the Supplementary Appendix, available at NEJM.org.

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