Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide.

Background: Despite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI with two different principles, pre-suture with ProGlide and collagen plug closure with Manta.

Results: Seventy-six patients treated with ProGlide and 75 with Manta were analysed. The endpoints were 1: access site vascular complications and 2: non-planned vascular or endovascular surgery at the puncture site. Complications occurred in 2 (2.7%) ProGlide and in 8 (10.7%) Manta cases,  = 0.047. During the learning phase there were no significant differences. In the established phase there was one event (2%) in the ProGlide group, compared to 6 endpoints (12.0%),  = 0.047, in the Manta group.Unplanned surgery or intervention was seen in two (2.7%) ProGlide and in 7 (9.3%) Manta patients, p = ns. There were no significant differences during the learning phase. In established use, endpoints occurred more frequently in patients treated with the Manta device (12%), than in patients treated with the ProGlide (2%),  = 0.047.

Conclusion: The ProGlide presuture closure device was associated with significantly lower rates of vascular complications and lower rates of surgery and interventions compared to the collagen plug Manta system.

Trial Registration: The data were collected from Internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål.