Capture Devices Hold Promise for Decreasing TAVR-Related Stroke

During a session on aortic valve therapies, two experts addressed the incidence and multifactorial origin of stroke after transcatheter aortic valve replacement (TAVR), as well as current and future management considerations. Both speakers stressed the importance of prevention.

mon.kapadia.headDuring his presentation, Samir Kapadia, MD, of Cleveland Clinic, Ohio, revisited 30-day stroke data from all PARTNER trials, demonstrating a decline in stroke incidence for both transapical and transfemoral approaches. He cited a meta-analysis published this year in the Journal of the American College of Cardiology demonstrating a 4.9% incidence of stroke in feasibility trials. When major registries for stroke occurring in-hospital or at 30 days were analyzed, similar rates were seen for transapical (2.8%) and transfemoral (2.9%) approaches, as well as for comparison of the Edwards Sapien (3.1%) and Medtronic CoreValve (2.5%) devices.

Additionally, data from a head-to-head comparison of TAVR and surgical aortic valve replacement (SAVR) in the PARTNER trial, demonstrated no statistically significant difference between the two treatment arms, Kapadia said. However, recent data, including 1-year results of the CoreValve U.S. Pivotal Trial and a cohort study published this year in Circulation, demonstrate a slightly higher rate of stroke after SAVR vs. TAVR. Given these discrepancies, the current belief that the risk for stroke is lower with SAVR than TAVR is questionable, he said, and cited timing of stroke as an additional “conundrum.”

He noted that stroke prevention using embolic protection devices as well as carotid pressure and careful manipulation of catheters, is important and suggested that a better understanding of stroke prevention will help move TAVR to lower-risk patient populations. He and colleagues are currently conducting the SENTINEL trial, which is comparing the Sentinel Cerebral Protection System (Claret Medical) for embolic debris capture and removal during TAVR with standard care. The randomized trial will include 15 sites and enroll 360 patients. Primary endpoints include reduction in total new lesion volume by diffusion-weighted MRI and rate of MACCE.

Management considerations

In the second presentation, Nicolas M. Van Mieghem, MD, at Erasmus Medical Center in Rotterdam, the Netherlands, discussed present and future considerations in the management of stroke after TAVR.

Though relatively rare, the occurrence of clinically apparent stroke following TAVR is devastating, Van Mieghem said. Data published last year in Circulation by his group demonstrate the presence of visible debris liberated from the TAVR procedure and captured in >70% of patients who received a filter-based embolic protection device. In this case, he suggests mechanical retrieval as the best treatment option.

Management options for acute stroke include mechanical thrombectomy and stent retriever technology. In strokes occurring more than 48 hours post-procedure, Van Mieghem suggests thrombus “is the culprit.” Various factors should be considered, including preexisting AF and incidence of new-onset AF; accurate and timely diagnosis is critical, he added.

Silent brain ischemia remains an enigma, but is a relevant issue, Van Mieghem said, adding that the “truth of the matter is that brain ischemia with TAVR is the rule, rather than the exception.” Furthermore, numerous papers in the literature suggest a relationship between embolic lesions and neurocognitive deficit.

When asked whether he believes identifiable risk factors exist to determine which patients should receive embolic protection during TAVR, Van Mieghem said if it were economically feasible, the devices should be used in all patients.

 

Disclosures:

 

  • Kapadia reports off-label use of newer aortic valves and mitral devices.
  • Van Mieghem reports receiving grant/research support and consulting fees/honoraria from Abbott Vascular, Boston Scientific, Claret Inc., Edwards Lifesciences, Medtronic and Terumo Medical Corporation.

 

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