Novel emboli protection system during cardiac surgery: a multi-center, randomized, clinical trial.

Bolotin, Gil; Huber, Christoph; Shani, Liran; Mohr, Friedrich Wilhelm; Carrel, Thierry; Borger, Michael Andrew; Falk, Volkmar; Taggart, David; Nir, Rony-Reuven; Englberger, Lars; Seeburger, Joerg; Caliskan, Etem; Starck, Christoph Thomas (2014). Novel emboli protection system during cardiac surgery: a multi-center, randomized, clinical trial. The Annals of Thoracic Surgery, 98(5), pp. 1627-1634. Elsevier 10.1016/j.athoracsur.2014.06.061

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BACKGROUND

Stroke is a major cause of morbidity and mortality during open-heart surgery. Up to 60% of intraoperative cerebral events are emboli induced. This randomized, controlled, multicenter trial is the first human study evaluating the safety and efficacy of a novel aortic cannula producing simultaneous forward flow and backward suction for extracting solid and gaseous emboli from the ascending aorta and aortic arch upon their intraoperative release.

METHODS

Sixty-six patients (25 females; 68±10 years) undergoing elective aortic valve replacement surgery, with or without coronary artery bypass graft surgery, were randomized to the use of the CardioGard (CardioGard Medical, Or-Yehuda, Israel) Emboli Protection cannula ("treatment") or a standard ("control") aortic cannula. The primary endpoint was the volume of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI), performed preoperatively and postoperatively. Device safety was investigated by comparisons of complications rate, namely neurologic events, stroke, renal insufficiency and death.

RESULTS

Of 66 patients (34 in the treatment group), 51 completed the presurgery and postsurgery MRI (27 in the treatment group). The volume of new brain lesion for the treatment group was (mean±standard error of the mean) 44.00±64.00 versus 126.56±28.74 mm3 in the control group (p=0.004). Of the treatment group, 41% demonstrated new postoperative lesions versus 66% in the control group (p=0.03). The complication rate was comparable in both groups.

CONCLUSIONS

The CardioGard cannula is safe and efficient in use during open-heart surgery. Efficacy was demonstrated by the removal of a substantial amount of emboli, a significant reduction in the volume of new brain lesions, and the percentage of patients experiencing new brain lesions.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery

UniBE Contributor:

Huber, Christoph; Carrel, Thierry and Englberger, Lars

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1552-6259

Publisher:

Elsevier

Language:

English

Submitter:

Sara Baumberger

Date Deposited:

20 Feb 2015 11:29

Last Modified:

27 Oct 2015 11:27

Publisher DOI:

10.1016/j.athoracsur.2014.06.061

PubMed ID:

25258158

BORIS DOI:

10.7892/boris.63502

URI:

https://boris.unibe.ch/id/eprint/63502

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