Comparison of ProGlide vs. Prostar in patients undergoing transcatheter aortic valve implantation.

BACKGROUND

Expanding indications to transcatheter aortic valve implantation (TAVI) warrant meticolous vascular management and minimization of access site complications. Two leading vascular closure devices (VCD) are currently used for TAVI, ProGlide vs. Prostar, but their comparative effectiveness and safety are debated. We aimed at comparing acute and 1-month outcomes of patients undergoing TAVI using as VCD either ProGlide (Perclose) or Prostar (XL).

METHODS

The prospective RISPEVA database was queried for baseline, procedural, and outcome details of patients undergoing TAVI and in whom either ProGlide or Prostar had been used as VCD. Outcomes of interest were death, vascular complication, and bleeding, distinguishing specific subtypes. Outcomes were adjudicated according to current Valve Academic Research Consortium definitions.

RESULTS

A total of 1987 subjects were included, 913 (46.0%) receiving ProGlide, and 1074 receiving Prostar (54.0%). Several baseline and procedural differences were evident, including surgical risk, concomitant coronary artery disease, sheath size, use of predilation, and chosen TAVI device (all P<0.05). Periprocedurally, despite similar rates of device success (P=0.262), Prostar was associated with a lower risk of vascular stenosis (P=0.005), but a higher rate of device malfunction (P=0.028). Unadjusted analysis for 1-month outcomes suggested higher rates of major adverse events, any bleeding, major bleeding, and renal failure in patients receiving Prostar (all P<0.05). However, propensity score-adjusted analysis did not confirm any significant differences, suggesting that confounding factors mostly drove unadjusted differences.

CONCLUSIONS

Use of ProGlide and Prostar as VCD of choice for TAVI appears similarly safe and effective, despite some potential benefits associated with ProGlide. Further randomized trials are warranted to confirm or disprove these findings.