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Embolic debris captured in most patients undergoing TAVR
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A cerebral embolic protection system captured embolic debris in nearly all patients undergoing transcatheter aortic valve replacement, regardless of valve type, according to recent data published in JACC: Cardiovascular Interventions.
The researchers conducted a pooled analysis of 246 patients from the prospective SENTINEL and SENTINEL-H trials. Of these patients, 16% received an Evolut R valve (Medtronic), 15% received a Lotus valve (Boston Scientific), 59% received a Sapien 3 valve (Edwards Lifesciences) and 10% received a Sapien XT valve (Edwards Lifesciences).
Results showed that embolic debris was captured in 99% of all patients. When comparing debris across valves, patients who received an Evolut R valve had significantly greater amounts of particles related to the vascular bed and implantation region than patients who received a Sapien 3 valve. Additionally, foreign material particles were more common in patients who received a Lotus valve vs. a Sapien 3 valve.
More than half of all patients (53%) had at least one particle that was 1 mm or larger, according to the data. Patients who received an Evolut R valve, as compared with a Sapien XT or Sapien 3 valve, more frequently had particles of 500 m or greater (P = .019 and .008, respectively) and 1,000 m or greater (P = .035 and .003, respectively). Patients who received a Lotus, as compared with a Sapien 3 valve, also more frequently had particles of 1,000 m or greater (P = .003).
Moreover, particle count, total particle area and maximum of largest dimension were significantly greater in patients who received Lotus and Evolut R valves, as compared with Sapien 3 and Sapien XT valves.
The overall study population was elderly (median age, 82 years) and had a high prevalence of comorbidities, including peripheral artery disease, atrial fibrillation and prior stroke. The researchers found no differences in median total particle count, median total area and largest particle per patient medians across the demographic and procedural characteristics investigated in any of the size ranges examined.
This study demonstrates that “capture of embolic debris is universal across valve types,” thereby supporting the potential benefit of using cerebral embolic protection in all TAVR procedures, the researchers wrote. – by Melissa Foster
Disclosures: The SENTINEL and SENTINEL-H trials were funded by Claret Medical. Please see the full study for a list of the authors’ relevant financial disclosures.
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