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Cerebral protection during MitraClip implantation safe, effective
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Use of a filter-based cerebral protection system during MitraClip implantation was safe and effective, and captured embolic debris that was potentially conducive to cerebrovascular events, according to results of a small study performed at two centers.
Fourteen patients at high risk for surgery underwent MitraClip implantation with cerebral protection with a dual-filter system (Sentinel, Claret Medical) between July 2014 and March 2015 at two centers in Germany. All patients had severe mitral regurgitation, impaired left ventricular ejection fraction (mean, 37%) and reduced NYHA functional class (III/IV). Eight patients also had a history of atrial fibrillation and one had a history of stroke. The mean age of the cohort was 75 years and the mean logistic EuroSCORE was 21%.
After MitraClip implantation, the filters (28 filters total; two per patient) were removed and analyzed for the presence of thrombus, valve and atrial wall tissue, vascular structures with or without atherosclerotic changes, myocardial fragments, calcification and foreign material.
All procedures demonstrated success for MitraClip implantation and cerebral protection system placement and removal. No or trace residual mitral regurgitation was observed in six patients, five had mild mitral regurgitation and three were discharged with moderate mitral regurgitation. Seven patients received one MitraClip and the remainder received two.
On microscopic analysis, the researchers identified debris from the filters of all 14 patients. A total of 515 sections (242 from proximal filters, 273 from distal filters) were detected. Acute thrombus and small fragments of foreign material were the most common tissue types, and were found in 12 patients (85.7%) each, according to the results. Four patients (28.6%) had organizing thrombus, and two patients were free of any thrombus. Nine patients (64.3%) had fibroelastic tissue with proteoglycan deposition that was suspected to be valve tissue and/or superficial atrial wall tissue. The researchers observed no evidence of calcified tissue fragments in any of the filters.
In other results, no patient experienced stroke/transient ischemic attack or died during the procedure or during a median follow-up of 8.4 months.
“Further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy,” the researchers wrote. – by Jennifer Byrne
Disclosure: One researcher reports receiving lecture honoraria from Claret Medical. See the full study for a list of all other researchers’ relevant financial disclosures.
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