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24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience.

ABSTRACT: Advantages of vascular closure device over manual compression include patient comfort, early mobilisation and discharge, avoidance of interruption of anticoagulation, avoidance of local compression and its sequelae and less time constraint on staff. No published Indian data exist regarding Perclose Proglide suture mediated vascular closure device (SMC).To study the 24h and 30 day outcome of Perclose Proglide SMC retrospectively.Retrospective observational study conducted in the Department of Cardiology, Government Medical College, Calicut, Kerala from June 2013 to June 2015.All consecutive patients with Perclose Proglide SMC deployment done by a single operator for achieving access site haemostasis where 24h and 30 day post-procedure data were available were included. Major and minor complications, procedure success, device failure were predefined.323 patients were analysed. Procedure success rate was 99.7% (322/323). Transient oozing occurred in 44 patients (13.6%), minor and major complications occurred in 2% and 1.5% of patients respectively. Major complication included one case of retroperitoneal bleed, one access site infection, one pseudo aneurysm formation and two access site arterial stenosis. There was no death or complication requiring limb amputation. "Preclose" technique was used successfully in six patients. Primary device failure occurred in 12 cases which were tackled successfully with second Proglide in all except one.Perclose Proglide SMC is a safe and effective method to achieve haemostasis up to 22F with less complication rate.

SUBMITTER: Vinayakumar D

PROVIDER: S-EPMC5319010 | biostudies-literature | 2017 Jan - Feb

REPOSITORIES: biostudies-literature

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24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience.

Vinayakumar Desabandhu D Kayakkal Shajudeen S Rajasekharan Sandeep S Thottian Julian Johny JJ Sankaran Prasanth P Bastian Cicy C

Indian heart journal 20160628 1

<h4>Introduction</h4>Advantages of vascular closure device over manual compression include patient comfort, early mobilisation and discharge, avoidance of interruption of anticoagulation, avoidance of local compression and its sequelae and less time constraint on staff. No published Indian data exist regarding Perclose Proglide suture mediated vascular closure device (SMC).<h4>Aim</h4>To study the 24h and 30 day outcome of Perclose Proglide SMC retrospectively.<h4>Study design</h4>Retrospective ...[more]

PMID: 28228304

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Project description:The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs.VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD.VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.

Project description:Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99]; P=0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58-0.98]; P=0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow-up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72-1.10]; P=0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P=0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short-term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov; Unique identifier: NCT02713932.

Project description:BackgroundThe location and severity of vascular calcification may influence closure device success in transfemoral transcatheter aortic valve implantation. The aim of this study was to analyze effects of vascular access-site calcification on vascular and bleeding outcomes post-transcatheter aortic valve implantation.MethodsThe Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE) trial assigned 516 patients to access site closure using a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The principal finding of the overall study was that access-site or access-related complications were more common after the plug-based strategy compared to percutaneous closure with a suture-based strategy. In this predefined subgroup analysis, the overall cohort was split into patients with and without anterior calcification at the access site and divided by degree of calcification severity using the classification system developed in the MANTA vs. suture-based vascular closure after transcatHeter aortic valve replacement (MASH) trial. Differences in bleeding and vascular complications were compared. The primary endpoint consisted of access-site- or access-related major and minor vascular complications.ResultsThere were more access-site-related major and minor vascular complications for patients with anterior wall vascular calcification and MASH severe calcification. No significant interaction with choice of closure technique in terms of access-site-related major and minor vascular complications was observed (odds ratio 1.70, 95% CI 0.77-3.78, p = 0.19 for the primary endpoint in plug- vs. suture-based strategy in patients with anterior calcification, odds ratio 1.78, 95% CI 0.56-5.65, p = 0.33 for primary endpoint in plug- vs. suture-based strategy with MASH severe calcification, pint = 0.97 for anterior calcification, pint = 0.95 for MASH severe calcification).ConclusionsThe total number of vascular complications was found to be greater in the presence of anterior and MASH severe calcification. Overall, the presence of anterior or severe calcification does not significantly modify the efficacy of the suture-based strategy compared to the plug-based strategy.

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24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience.

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24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience.

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