Impact of closure devices on vascular complication and mortality rates in TAVI procedures.
BACKGROUND
Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown.


METHODS
Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7±481.8 (727) days.


RESULTS
There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p=0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p]=0.02), suture rupture (4.7% vs. 1.3%, p=0.04), and pseudoaneurysms (10.2% vs. 1.2%, p<0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3-3.8, p=0.002) and closure devices (OR 0.5; 95% CI 0.3-0.8, p=0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6±1.6% vs. Proglide: 4.9±1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p=0.03).


CONCLUSIONS
Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany. Electronic address: andrea.grasmueck@unimedizin-mainz.de.
Zisis
Z
Dimitriadis
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Werner
W
Scholtz
Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Jochen
J
Börgermann
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Marcus
M
Wiemer
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Cornelia
C
Piper
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Mario
M
Vlachojannis
Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Jan
J
Gummert
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Dieter
D
Horstkotte
Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Stephan
S
Ensminger
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Lothar
L
Faber
Clinic for Cardiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Smita
S
Scholtz
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery; D004867:Equipment Design / Q000401:mortality* / Q000592:standards* / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009026:Mortality / Q000639:trends; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology / Q000401:mortality*; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000401:mortality* / Q000639:trends; D016896:Treatment Outcome; D065506:Vascular Closure Devices / Q000592:standards* / Q000639:trends
Closure devices; Mortality; TAVI; VARC II criteria; Vascular complications