Abstract
OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system.
METHODS: Adult swines (n = 15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days.
RESULTS: All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12 ± 3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5 ± 4 mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence.
CONCLUSIONS: Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patients.
Maisano, Francesco