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Novel device enables surgical mitral valve repair without stopping heart
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In a first-in-human study, a novel preformed expanded polytetrafluoroethylene cordal implantation device conferred positive outcomes in patients undergoing surgical mitral valve repair.
Unlike with conventional mitral valve repair, the device enables the surgery to be performed while the heart is still beating.
Researchers reported results from the first 11 patients (mean age, 65 years) with posterior leaflet prolapse and severe mitral regurgitation to undergo mitral valve repair with the minimally invasive device (Harpoon TSD-5, Harpoon Medical) in Circulation.
According to the study background, the device is inserted into the heart and guided to the prolapsed leaflet’s ventricular surface by transesophageal echocardiography. The surgeon then anchors several expanded polytetrafluoroethylene cords into the leaflet and adjusts the length to restore mitral valve leaflet coaptation, then secures the cords to the epicardium.
The outcomes of interest were reduction in mitral regurgitation and effect on left ventricular and left anterior reverse remodeling at 1 month.
The procedural success rate was 100%, James S. Gammie, MD, from the division of cardiac surgery at University of Maryland School of Medicine, and colleagues wrote.
At 1 month, the mean grade of mitral regurgitation was mild, and the patients experienced significant drops in LV end-diastolic volume (mean at baseline, 139 mL; mean at 1 month, 107 mL; P = .03) and left atrial volume (mean at baseline, 118 mL; mean at 1 month, 85 mL; P = .04), according to the researchers.
Of the four patients followed to 6 months, reduction in mitral regurgitation was sustained in three, Gammie and colleagues wrote. One patient needed reoperation for recurrent mitral regurgitation.
“We believe that compared to conventional mitral valve surgery, beating-heart mitral valve repair will be associated with a shorter hospital length of stay, substantially less resource utilization, and faster return to preoperative functional status,” Gammie and colleagues wrote. “This initial experience will require follow-up to assure durability and effectiveness in larger numbers of patients.” – by Erik Swain
Disclosure: The study was funded by Harpoon Medical. Gammie and three other researchers report ownership of stock or stock options in Harpoon Medical. Another researcher reports being a co-inventor of the technology, which has been licensed from the University of Maryland by Harpoon Medical.
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