Gil Bolotin1, Christoph Hans Huber2, Liran Shani3, Friedrich Wilhelm Mohr4, Thierry P Carrel2, Michael Andrew Borger4, Volkmar Falk5, David Taggart6, Rony-Reuven Nir3, Lars Englberger2, Joerg Seeburger4, Etem Caliskan5, Christoph Thomas Starck5. 1. Department of Cardiac Surgery, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel. Electronic address: g_bolotin@rambam.health.gov.il. 2. University Clinic for Cardiovascular Surgery Inselspital, Bern, Switzerland. 3. Department of Cardiac Surgery, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel. 4. Heart Center Leipzig, University of Leipzig, Leipzig, Germany. 5. University Hospital Zurich, Zurich, Switzerland. 6. University of Oxford, Oxford, United Kingdom.
Abstract
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) undergoingelective 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.
RCT Entities:
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.
Authors: Michael J Mack; Michael A Acker; Annetine C Gelijns; Jessica R Overbey; Michael K Parides; Jeffrey N Browndyke; Mark A Groh; Alan J Moskowitz; Neal O Jeffries; Gorav Ailawadi; Vinod H Thourani; Ellen G Moquete; Alexander Iribarne; Pierre Voisine; Louis P Perrault; Michael E Bowdish; Michel Bilello; Christos Davatzikos; Ralph F Mangusan; Rachelle A Winkle; Peter K Smith; Robert E Michler; Marissa A Miller; Karen L O'Sullivan; Wendy C Taddei-Peters; Eric A Rose; Richard D Weisel; Karen L Furie; Emilia Bagiella; Claudia Scala Moy; Patrick T O'Gara; Steven R Messé Journal: JAMA Date: 2017-08-08 Impact factor: 56.272
Authors: Vinay Garg; Mark D Peterson; Michael Wa Chu; Maral Ouzounian; Roderick Gg MacArthur; John Bozinovski; Ismail El-Hamamsy; F Victor Chu; Ankit Garg; Judith Hall; Kevin E Thorpe; Natasha Dhingra; Hwee Teoh; Thomas R Marotta; David A Latter; Adrian Quan; Muhammad Mamdani; Peter Juni; C David Mazer; Subodh Verma Journal: BMJ Open Date: 2017-06-10 Impact factor: 2.692
Authors: Wiebe G Knol; Ricardo P J Budde; Edris A F Mahtab; Jos A Bekkers; Ad J J C Bogers Journal: Eur J Cardiothorac Surg Date: 2021-12-01 Impact factor: 4.191