H Shennib1, S J Korkola, N Bousette, A Giaid. 1. Center for Innovative Cardiovascular Therapy, Roosevelt and Beth Israel Hospital, New York, New York, USA. mchs@musica.mcgill.ca
Abstract
BACKGROUND: The purpose of this study was to have a preliminary assessment of the safety and efficacy of an automated vascular suturing device. METHODS: The device (Heartflo, Perclose/Abbott Labs, Redwood City, CA), which delivers 10 interrupted 7-0 polypropylene sutures between side-to-side arteriotomies, was evaluated in animals (8 Yorkshire pigs). RESULTS: Tissue edge capture and quality of anastomosis were highly rated. Time of anastomoses averaged 22 minutes. This time was prolonged primarily due to suture management, tying of interrupted sutures, and learning curve effects. Six of the anastomoses were hemostatic and two required an additional stitch each. Angiography and histology of the anastomosis confirmed patency and quality of the anastomosis. CONCLUSIONS: Our preliminary results indicate that the Heartflo automated anastomotic device is safe and effective. Preclinical and clinical studies to validate its acute and long-term effectiveness will commence shortly.
BACKGROUND: The purpose of this study was to have a preliminary assessment of the safety and efficacy of an automated vascular suturing device. METHODS: The device (Heartflo, Perclose/Abbott Labs, Redwood City, CA), which delivers 10 interrupted 7-0 polypropylene sutures between side-to-side arteriotomies, was evaluated in animals (8 Yorkshire pigs). RESULTS: Tissue edge capture and quality of anastomosis were highly rated. Time of anastomoses averaged 22 minutes. This time was prolonged primarily due to suture management, tying of interrupted sutures, and learning curve effects. Six of the anastomoses were hemostatic and two required an additional stitch each. Angiography and histology of the anastomosis confirmed patency and quality of the anastomosis. CONCLUSIONS: Our preliminary results indicate that the Heartflo automated anastomotic device is safe and effective. Preclinical and clinical studies to validate its acute and long-term effectiveness will commence shortly.