Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique

Abstract

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

Vascular complications of ProGlide versus Prostar in transcatheter aortic valve replacement (TAVR) procedures: meta-analysis

“… 8 and Marcusohn et al . 36 demonstrated higher incidences of major vascular complications in the ProGlide group (8.0 versus 3.9 per cent ( P = 0.146) and 4.7 versus 3.8 per cent ( P = 1.000) respectively). However, these results were non-significant, and both studies were single-centre retrospective studies with the smallest and second smallest sample size, which made the results relatively less reliable.…”

“…4 ). According to six studies 7 , 30–32 , 35 , 36 , a total of 316 additional interventions were performed for 918 vascular complications, revealing a similar risk between the ProGlide group and the Prostar group (OR 1.02, 95 per cent c.i. 0.75 to 1.39).…”

“…For ischaemia complications, although the incidence was relatively low, there were more stenoses in the ProGlide group. Previous studies indicated that the interference of both sutures of independently deployed ProGlide may contribute to stenosis 36 , 41 . The manufacturer’s recommended ProGlide deployment is to use two sutures at the 2 and 10 o’clock positions, creating an ‘X’-shaped closure, which might cause suture entanglement and subsequent artery stenosis.…”