Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement

Samir R Kapadia, Raj Makkar, Martin Leon, Mohamed Abdel-Wahab, Thomas Waggoner, Steffen Massberg, Wolfgang Rottbauer, Samuel Horr, Lars Sondergaard, Juhana Karha, Robert Gooley, Lowell Satler, Robert C Stoler, Steven R Messé, Suzanne J Baron, Julia Seeger, Susheel Kodali, Amar Krishnaswamy, Vinod H Thourani, Katherine HarringtonStuart Pocock, Rodrigo Modolo, Dominic J Allocco, Ian T Meredith, Axel Linke, PROTECTED TAVR Investigators


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.).

Original languageEnglish
JournalThe New England journal of medicine
Issue number14
Pages (from-to)1253-1263
Number of pages11
Publication statusPublished - 6 Oct 2022


  • Acute Kidney Injury/etiology
  • Aortic Valve/surgery
  • Aortic Valve Stenosis/surgery
  • Delirium/etiology
  • Embolic Protection Devices
  • Humans
  • Intracranial Embolism/etiology
  • Ischemic Attack, Transient/etiology
  • Prosthesis Implantation/instrumentation
  • Risk Factors
  • Stroke/etiology
  • Transcatheter Aortic Valve Replacement/adverse effects
  • Treatment Outcome


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