Cardiovascular revascularization medicine : including molecular interventions · 2025
Suture-based vs plug-based vascular access closure in patients undergoing transcatheter transfemoral aortic valve implantation.
СтатьяСравнительное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Paolucci Luca, Buono Andrea, Colucci Michele, Basile Mattia, Galasso Michele, Lenci Ludovica, Marino Angelo Giuseppe, Maffeo Diego, Scarpelli Mario, Focaccio Amelia, Maselli Daniele, Briguori Carlo
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAged, 80 and overFemaleHumansMaleAortic ValveAortic Valve StenosisCardiac CatheterizationCatheterization, PeripheralFemoral ArteryHemorrhageHemostatic TechniquesItalyPuncturesRetrospective StudiesRisk FactorsSuture TechniquesTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeVascular Closure Devices