Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement
Samir KapadiaRaj MakkarMartin B. LeonMohamed Abdel‐WahabThomas WaggonerSteffen MaßbergWolfgang RottbauerSamuel HorrLars SøndergaardJuhana KarhaRobert GooleyLowell F. SatlerRobert StolerSteven R. MesséSuzanne J. BaronJulia SeegerSusheel KodaliAmar KrishnaswamyVinod H. ThouraniKatherine HarringtonStuart PocockRodrigo ModoloDominic J. AlloccoIan T. MeredithAxel Linke
Key result
Cerebral embolic protection during TAVR fails to reduce periprocedural stroke compared to control.
- difference -0.6 percentage points
- 95% CI -1.7 to 0.5
- P=0.30
- n=3,000
Why the study?
Does cerebral embolic protection reduce stroke in patients with aortic stenosis undergoing transfemoral TAVR?
Key Points
- To determine whether cerebral embolic protection reduces the incidence of periprocedural stroke in patients undergoing transfemoral transcatheter aortic-valve replacement for aortic stenosis.
- Multicenter randomized trial (PROTECTED TAVR, NCT04149535) conducted across North America, Europe, and Australia, randomizing 3000 patients 1:1 to transfemoral TAVR with cerebral embolic protection (CEP; N=1501) or without CEP (control; N=1499).
- Patients underwent formal neurological assessments at baseline and post-procedure; the primary endpoint was stroke within 72 hours after TAVR or prior to hospital discharge evaluated in the intention-to-treat population.
- Stroke within 72 hours or before discharge occurred in 2.3% of patients in the CEP group compared with 2.9% in the control group (difference, -0.6 percentage points; 95% CI, -1.7 to 0.5; P=0.30).
- Disabling stroke occurred in 0.5% of the CEP group versus 1.3% of the control group, while the CEP device was successfully deployed in 94.4% of attempted procedures.
- Secondary outcomes showed similar incidence between the CEP and control groups for death (0.5% vs. 0.3%), the composite of stroke, transient ischemic attack, or delirium (3.1% vs. 3.7%), and acute kidney injury (0.5% vs. 0.5%).
Study Design
Type
RCT (n=3,000)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does cerebral embolic protection reduce stroke in patients with aortic stenosis undergoing transfemoral TAVR?
P
Population
3,000 patients with aortic stenosis undergoing transfemoral TAVR across North America, Europe, and Australia, assessed for periprocedural stroke.
I
Intervention
Transfemoral TAVR with cerebral embolic protection (CEP)
C
Comparator
Transfemoral TAVR without cerebral embolic protection
O
Outcome
Stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat populationhard clinical
Main Result
Effect estimate: difference -0.6 percentage points (95% CI -1.7 to 0.5)
Absolute Event Rate: 2.3% vs 2.9%
Absolute Risk Reduction: 0.6%
p-value: p=0.30
Limitations
- The 95% confidence interval around the primary outcome may not rule out a benefit of CEP during TAVR.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
AJACC Journal Scan
“Thus, although Emboliner represents a technically successful evolution in EPD design, its clinical advantage over existing devices – and over no protection at all – remains unproven.”
“These registry data are consistent with existing evidence from smaller trials and other registry data from the U.S. and other countries that generally demonstrate a reduction in clinical stroke, with the reduction in disabling stroke being the most significant.”
“Regional differences in patient characteristics and procedural practices may influence the effectiveness of cerebral embolic protection in reducing TAVR-related stroke. However, these results are only hypothesis-generating, and further studies are required to explore whether benefit from cerebral embolic protection in TAVR may be greater in specific subgroups.”
Implication
The use of cerebral embolic protection during transfemoral TAVR did not significantly reduce the incidence of periprocedural stroke.
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.).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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Cite This Study
Kapadia et al. (2022) conducted an RCT in Aortic stenosis (n=3,000). Cerebral embolic protection (CEP) vs. Without CEP (control group) was evaluated on Stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population (difference -0.6 percentage points, 95% CI -1.7 to 0.5, p=0.30). Cerebral embolic protection during transfemoral TAVR did not significantly reduce periprocedural stroke compared to control (2.3% vs. 2.9%; difference -0.6%; 95% CI -1.7 to 0.5; P=0.30).