By Jeffrey Zimmet, MD, PhD
Synopsis: In this randomized, multicenter trial involving more than 7,600 patients undergoing transcatheter aortic valve replacement, routine use of a cerebral embolic protection device did not reduce the incidence of early post-procedure stroke.
Source: Kharbanda RK, Kennedy J, Jamal Z, et al; BHF PROTECT-TAVI Investigators. Routine cerebral embolic protection during transcatheter aortic-valve implantation. N Engl J Med. 2025; Mar 30. doi: 10.1056/NEJMoa2415120. [Online ahead of print].
Stroke as an early complication of transcatheter aortic valve replacement (TAVR) has been reported to occur in approximately 2% to 3% of patients in clinical trials. Patients who experience stroke as a procedural complication have significantly increased rates of both intermediate-term mortality and long-term disability. The Sentinel cerebral embolic protection (CEP) device typically is deployed from the right radial artery and works by positioning two filters across the innominate and left carotid arteries. This device has been approved for use in Europe and the United States based on trial data demonstrating its ability to capture embolic material during TAVR and to reduce the frequency of new imaging-defined brain lesions after the procedure. However, prior trials have not shown a reduction in clinical stroke. The 2022 PROTECTED TAVR trial showed no effect of the device on overall stroke rate but did report a CEP-related reduction in the less common category of disabling stroke, suggesting that their results may not rule out a benefit of CEP during TAVR.
The British Heart Foundation conducted the current trial (BHF PROTECT-TAVI) at 33 sites in the United Kingdom. All patients presenting for TAVR who were judged by the local site to be suitable for the Sentinel device were considered for enrollment. The primary outcome was stroke within 72 hours of the procedure or prior to hospital discharge. For the purposes of the trial, stroke as an endpoint required a new neurologic deficit that persisted for at least 24 hours. Over the four-year course of the trial, 7,635 patients were randomly assigned 1:1 to receive TAVR either with or without a CEP device. Among patients assigned to the CEP group, both filters of the device were successfully deployed in 81.2% of subjects, while 87.5% had at least one filter deployed.
At 72 hours post-procedure, 81 (2.1%) patients in the CEP group and 82 (2.2%) patients in the standard care group had experienced stroke. Severe stroke occurred in 18 (0.5%) and 19 (0.5%) patients in the two groups, respectively. Most strokes were seen within the first 24 hours. All-cause death also was not different between the two groups, either at 72 hours or within eight weeks of the procedure. Access site complications occurred in 8.1% of patients in the CEP group and in 7.7% of the standard therapy patients, which was not significantly different. Complications involving the site of secondary arterial access for the TAVR procedure were low but were more frequent in the CEP group (0.8% vs. 0.4%; difference, 0.4 percentage points; 95% confidence interval, 0.1 to 0.8. The study concluded that routine use of cerebral embolic protection in TAVR procedures did not reduce the risk of early stroke.
Commentary
Sometimes even very good ideas with a solid theoretical grounding turn out not to have clinical benefit in routine situations. Much of the initial commentary about the negative results with embolic protection devices has focused on the concept that this need to learn clinical truth is precisely why we do randomized controlled trials. CEP is a concept that should work, and this particular device previously has demonstrated the ability to capture debris that otherwise would go to the brain. The 2022 PROTECTED TAVR trial certainly threw cold water on the CEP concept, but that trial enrolled fewer than half as many study subjects as this one (3,000 vs. 7,635) and had insufficient statistical power, but it kept some hope alive by reporting an advantage in reducing the incidence of disabling stroke, which was not replicated in the larger BHF PROTECT TAVI trial.
Some have noted that CEP device success was lower in this trial compared to PROTECTED TAVR. The authors reported that their definition of device success was more specific than in the earlier trial, requiring both filters to be fully deployed for the duration of the procedure. In addition, enrollment criteria regarding aortic arch and great vessel anatomy were less restrictive in this trial, such that a larger proportion of all TAVR patients were enrolled. The device success reported here represents a more real-world TAVR population and informs decisions regarding the routine use of CEP in TAVR. Fortunately, placement of the Sentinel device did not result in a significant increase in total complications, despite the necessity for an additional arterial access site compared with standard care. However, CEP adds both time and substantial cost to these procedures. TAVR operators may continue to use CEP in selected situations with elevated embolic risk, but continued routine use will be more difficult to justify in the face of these results.
Jeffrey Zimmet, MD, PhD, is Associate Professor of Medicine, University of California, San Francisco; Director, Cardiac Catheterization Laboratory, San Francisco VA Medical Center.
In this randomized, multicenter trial involving more than 7,600 patients undergoing transcatheter aortic valve replacement, routine use of a cerebral embolic protection device did not reduce the incidence of early post-procedure stroke.
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