BACKGROUND: The MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: This is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD. RESULTS: VARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p = 0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p = 0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p = 0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p = 0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p < 0.0001). CONCLUSIONS: In patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis.
BACKGROUND: The MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: This is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD. RESULTS: VARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p = 0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p = 0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p = 0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p = 0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p < 0.0001). CONCLUSIONS: In patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis.
Authors: Herbert G Kroon; Pim A L Tonino; Mikko Savontaus; Giovanni Amoroso; Mika Laine; Evald H Christiansen; Stefan Toggweiler; Jur Ten Berg; Janarthanan Sathananthan; Joost Daemen; Peter P de Jaegere; Guus B R G Brueren; Markus Malmberg; Ton Slagboom; Noriaki Moriyama; Christian J Terkelsen; Federico Moccetti; Livia Gheorghe; John Webb; David Wood; Nicolas M Van Mieghem Journal: Catheter Cardiovasc Interv Date: 2020-12-21 Impact factor: 2.692
Authors: Maarten P van Wiechen; Herbert Kroon; Thijmen W Hokken; Joris F Ooms; Marjo J de Ronde-Tillmans; Joost Daemen; Peter P de Jaegere; Nicolas M Van Mieghem Journal: Catheter Cardiovasc Interv Date: 2021-02-03 Impact factor: 2.585
Authors: Pavel Hoffmann; Ahmed Al-Ani; Thomas von Lueder; Jenny Hoffmann; Peter Majak; Ove Hagen; Helga Loose; Nils Einar Kløw; Anders Opdahl Journal: CVIR Endovasc Date: 2018-09-21
Authors: Sergio Berti; Francesco Bedogni; Arturo Giordano; Anna S Petronio; Alessandro Iadanza; Antonio L Bartorelli; Bernard Reimers; Carmen Spaccarotella; Carlo Trani; Tiziana Attisano; Angela Marella Cenname; Gennaro Sardella; Roberto Bonmassari; Massimo Medda; Fabrizio Tomai; Giuseppe Tarantini; Eliano P Navarese Journal: J Am Heart Assoc Date: 2020-10-24 Impact factor: 5.501