First clinical research on the frequency and composition of embolic debris captured during TAVI published

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Claret Medical has announced the publication of an original manuscript by Nicolas Van Mieghem et al—“Histopathology of embolic debris captured during transcatheter aortic valve implantation [TAVI]”. The research was published ahead of print in Circulation on 7 May. The research is the result of collaboration between Erasmus Medical Center, Rotterdam, the Netherlands, and the pathology team of Renu Virmani of the Cardiovascular Pathology Institute, Gaithersburg, USA.

According to a company release, this is the first time any research has reported the frequency and composition of debris captured in a series of patients who underwent TAVI combined with the use of the Claret Montage Dual Filter System. The results showed, from the 40 patient series, that there was visible debris in 75% of patients. Histological analysis of the captured debris was performed at Erasmus Medical Center as well as independently confirmed at the Cardiovascular Pathology Institute. The debris consisted of thrombotic, calcific and connective tissue.  Overall, thrombotic material was found in 52% of patients and tissue fragments compatible with aortic valve or aortic wall origin in 52% of patients. The captured material varied in size from 0.15mm to 4.0mm.

Differential analysis provided further insight into the origin of captured aortic debris, according to the results.  The samples captured were compared with histological samples of surgically removed valve leaflets. Virmani noted: “valve tissue consistent with aortic leaflets were captured in the filters in 27% of the patients with captured debris and either aortic valve or thrombotic material was captured in 75% of all patients undergoing TAVI. Therefore, it is important that we provide protection to patients undergoing TAVI.”

Speaking about the findings, Van Mieghem said, “During almost every TAVI procedure, significant debris is dislodged. The filter-based Montage 2 is the only way of capturing and getting this debris out of the body. One may wonder, how long until embolic protection is used in every TAVI procedure?”

The Montage 2 Dual Filter System is CE marked, but is not available for sale in the USA.

The Montage 2, according to the company, is the only approved device to protect the carotid arteries by capturing embolic debris during TAVI.

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