Key result
Vascular access closure using the ProGlide parallel suture technique resulted in similar rates of VARC-2 major complications compared to the Prostar device (4.7% vs 3.8%, P=1).
Why the study?
Reliable femoral artery closure devices are essential for trans-femoral TAVI success, and device choice may influence vascular complications and bleeding rates.
Does the ProGlide parallel suture technique compared to the Prostar closure device reduce vascular complications in patients undergoing trans-femoral TAVI?
Cohort (n=191)
Does the ProGlide parallel suture technique compared to the Prostar closure device reduce vascular complications in patients undergoing trans-femoral TAVI?
Absolute Event Rate: 4.7% vs 3.8%
p-value: p=1
The parallel suture technique using two ProGlide sutures provides comparable rates of vascular complications to the Prostar closure device in patients undergoing trans-femoral TAVI.
Similar vascular complication rates observed; leaves open optimal device selection pending randomized data.
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.
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Marcusohn et al. (2022) conducted a cohort in Trans-femoral Transcatheter Aortic Valve Implantation (TAVI) (n=191). ProGlide parallel suture vs. Prostar closure device was evaluated on Valve Academic Research Consortium (VARC)-2 major complications (p=1). Vascular access closure using the ProGlide parallel suture technique resulted in similar rates of VARC-2 major complications compared to the Prostar device (4.7% vs 3.8%, P=1).
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