TY - JOUR
T1 - Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation
AU - Barbash, Israel M.
AU - Wasserstrum, Yishay
AU - Erlebach, Magdalena
AU - Guetta, Victor
AU - Ziegelmüller, Johannes
AU - Segev, Amit
AU - Fefer, Paul
AU - Maor, Elad
AU - Lange, Rüdiger
AU - Ruge, Hendrik
N1 - Publisher Copyright:
© 2023 Wiley Periodicals LLC.
PY - 2024/1/1
Y1 - 2024/1/1
N2 - Background: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. Aim: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. Methods: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. Results: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. Conclusions: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.
AB - Background: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. Aim: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. Methods: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. Results: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. Conclusions: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.
KW - transcatheter aortic valve replacement
KW - vascular closure device
KW - vascular complication
UR - http://www.scopus.com/inward/record.url?scp=85178888800&partnerID=8YFLogxK
U2 - 10.1002/ccd.30921
DO - 10.1002/ccd.30921
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C2 - 38059295
AN - SCOPUS:85178888800
SN - 1522-1946
VL - 103
SP - 160
EP - 168
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 1
ER -