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Mehilli, Julinda; Jochheim, David; Abdel-Wahab, Mohamed; Rizas, Konstantinos D.; Theiss, Hans; Spenkuch, Nina; Zadrozny, Magda; Baquet, Moritz; El-Mawardy, Mohamed; Sato, Takao; Lange, Philipp; Kuppatt, Christian; Greif, Martin; Hausleiter, Jörg; Bauer, Axel; Schwarz, Florian; Pichlmaier, Maximilian; Hagl, Christian; Richardt, Gert; Massberg, Steffen (2016): One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. In: Eurointervention, Vol. 12, No. 10: pp. 1298-1304
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Aims: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. Methods and results: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001;VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively). Conclusions: In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02289339