Christos Maniotis1, Constantinos Andreou2, Ioannis Karalis2, Giasemi Koutouzi3, Maria Agelaki1, Michael Koutouzis4. 1. 2nd Cardiology Department, Hellenic Red Cross Hospital of Athens, Athens, Greece. 2. Interventional Cardiology Department, University Hospital of Leiden, Leiden, The Netherlands. 3. Interventional Radiology Department, Sahlgrenska University Hospital, Gothenburg, Sweden. 4. 2nd Cardiology Department, Hellenic Red Cross Hospital of Athens, Athens, Greece. Electronic address: koutouzismike@yahoo.gr.
Abstract
BACKGROUND: Endovascular aortic aneurysm repair (EVAR) and transfemoral transcatheter aortic valve replacement (TAVR) are widely spreading minimally invasive procedures performed mainly through the femoral artery. Prostar XL and ProGlide vascular closure devices are used in clinical practice for the hemostasis in these procedures and they have been shown to be safe and effective. PURPOSE: The aim of our systematic review is to compare the safety of these two devices for percutaneous closure of large arteriotomies in patients undergoing TAVR and EVAR. METHODS: We searched PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials for all randomized and observational published studies that compared Prostar XL vs. ProGlide. Relative risk was calculated by random-effects model. Review Manager 5.1 was used for statistical analysis. RESULTS: A total number of 2909 patients were included in our analysis. The rate of overall vascular complications did not differ between Prostar XL and ProGlide {RR 1.35 (0.80-2.29), p=0.27}. In contrary, the risk ratio of all bleeding complications with Prostar XL compared to ProGlide was 1.82 (1.47-2.24, p<0.001) and for major and life-threatening bleeding complications was 2.48 (1.65-3.73, p<0001, suggesting a lower bleeding risk with ProGlide). No statistical difference was found between groups for end-stage acute kidney injury (AKI), with a risk ratio of 2.14 (0.81-5.66), p=0.05. Finally, there were no differences in in-hospital and 30-days mortality rate between the two groups (1.41, 0.56-3.54, p=0.46 and 1.43, 0.55-3.73, p=0.47, respectively). CONCLUSIONS: Prostar XL is associated with greater risk of any bleeding as well as life threatening bleeding compared to the ProGlide device. However, no significant differences were observed in the rate of overall vascular complications, end stage AKI and in-hospital and 30-days mortality.
BACKGROUND:Endovascular aortic aneurysm repair (EVAR) and transfemoral transcatheter aortic valve replacement (TAVR) are widely spreading minimally invasive procedures performed mainly through the femoral artery. Prostar XL and ProGlide vascular closure devices are used in clinical practice for the hemostasis in these procedures and they have been shown to be safe and effective. PURPOSE: The aim of our systematic review is to compare the safety of these two devices for percutaneous closure of large arteriotomies in patients undergoing TAVR and EVAR. METHODS: We searched PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials for all randomized and observational published studies that compared Prostar XL vs. ProGlide. Relative risk was calculated by random-effects model. Review Manager 5.1 was used for statistical analysis. RESULTS: A total number of 2909 patients were included in our analysis. The rate of overall vascular complications did not differ between Prostar XL and ProGlide {RR 1.35 (0.80-2.29), p=0.27}. In contrary, the risk ratio of all bleeding complications with Prostar XL compared to ProGlide was 1.82 (1.47-2.24, p<0.001) and for major and life-threatening bleeding complications was 2.48 (1.65-3.73, p<0001, suggesting a lower bleeding risk with ProGlide). No statistical difference was found between groups for end-stage acute kidney injury (AKI), with a risk ratio of 2.14 (0.81-5.66), p=0.05. Finally, there were no differences in in-hospital and 30-days mortality rate between the two groups (1.41, 0.56-3.54, p=0.46 and 1.43, 0.55-3.73, p=0.47, respectively). CONCLUSIONS:Prostar XL is associated with greater risk of any bleeding as well as life threatening bleeding compared to the ProGlide device. However, no significant differences were observed in the rate of overall vascular complications, end stage AKI and in-hospital and 30-days mortality.
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