Suture-based vs plug-based vascular access closure in patients undergoing transcatheter transfemoral aortic valve implantation.

BACKGROUND AND AIMS: Suture-based vascular closure devices (S-VCD) plus the liberal use of an additional small plug-based VCD have been demonstrated to be superior to "pure" plug-based VCD (P-VCD) in patients treated with transcatheter aortic valve implantation (TAVI). Preliminary data suggests that the systematic use of the arteriotomy-site ballooning plus concomitant manual compression following P-VCD (MANTA, Teleflex) delivery may optimize the device apposition and should be adopted to improve the final hemostatic efficacy.

METHODS

Consecutive patients undergoing transfemoral TAVI at two Italian centers were included. Patients treated with S-VCD and balloon assisted P-VCD were matched for major variables. The primary outcome was the occurrence of any in-hospital vascular complication. All outcomes were defined according to the Valve Academic Research Consortium (VARC)-3 statement.

RESULTS

Overall, 799 patients were included (S-VCD: 451; balloon-assisted P-VCD: 348). Patients in the S-VCD group received 2 ProGlides (Abbott Vascular Inc.) plus the liberal use of an additional small plug-based VCD. Patients in the P-VCD group received the systematic use of the arteriotomy-site ballooning plus concomitant manual compression. After matching, 123 pairs of subjects were selected. The primary outcome occurred in 11.4 % of patients in the S-VCD group and 6.5 % in the balloon assisted P-VCD group (OR 0.56, 95 % CI (0.22-1.40); p = 0.217). Major VARC-3 vascular complications were more frequent in the S-VCD cohort (OR 0.12, 95 % CI (0.01-0.96); p = 0.048). No differences were found for the composite of major vascular complications and in-hospital death (OR 0.59, 95 % CI (0.19-1.88); p = 0.377). Any VARC-3 access related bleedings were slightly more frequent in the S-VCD group (OR 0.27, 95 % CI (0.07-0.99); p = 0.048), while no differences were evident for major bleedings (OR 0.28, 95 % CI (0.06-1.40); p = 0.122).

CONCLUSIONS

The balloon-assisted P-VCD showed similar vascular outcomes compared to traditional S-VCD in patients undergoing transfemoral TAVI.