Safety Of Vascular Closure Devices Research Articles

Vascular closure devices in living-donor nephrectomy: a much-needed systematic review and meta-analysis focusing on safety.

To assess the safety of vascular closure devices in living-donor nephrectomy (LDN), as staplers and non-transfixion techniques (polymer locking and metal clips) are the methods employed to secure the renal vessels during laparoscopic and robotic LDN, but the use of clips has come into question since the United States Food and Drug Administration and manufacturers issued a contraindication. A systematic review and meta-analysis were conducted to assess the safety of vascular closure devices (International Prospective Register of Systematic Reviews [PROSPERO] registration: CRD42022364349). The PubMed, Scopus, the Excerpta Medica dataBASE (EMBASE), and the Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) databases were searched in September 2022. For comparative and non-comparative studies, incidence estimates and odds ratios (ORs), respectively, for the main variables regarding safety of vascular closure devices were pooled by using random effects meta-analyses. Quality assessment of the included comparative studies was conducted using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Of the 863 articles obtained, data were retrieved from 44 studies, which included 42 902 patients. In non-comparative studies, the pooled estimate rates for device failure, severe haemorrhage rate, conversion to open surgery, and mortality were similar for both clips and staplers. Regarding the meta-analyses for comparative studies (three studies), there were no significant differences between the two groups for the severe haemorrhage rate (OR 0.57, 95% confidence interval [CI] 0.18-1.75; P = 0.33), conversion to open surgery (OR 0.35, 95% CI 0.08-1.54; P = 0.16), or death rate (OR 3.64, 95% CI 0.47-28.45; P = 0.22). Based on weak evidence, device failure was lower in the polymer clip group (OR 0.41, 95% CI 0.23-0.75; P = 0.00). This study has confirmed that there is no evidence for the superiority of any vascular closure device in terms of safety in LDN. Standardised recommendations for vascular control in this context should be carefully designed and prospectively evaluated.

Abstract 12685: Feasibility and Safety of Vascular Closure Devices After Undergoing Leadless Pacemaker Implantation

Introduction: Transcatheter pacing systems have recently emerged as a safe and effective alternative in treating patients who require right ventricular pacing therapy. Traditionally, the right femoral venous was the preferred insertion site for the 23 French Micra introducer catheter due to the manufactured design of the delivery system. Vascular closure of the venous access has been performed with figure 8 closure technique and manual pressure . There is no data supporting the use of closure devices in this specific procedure. The purpose of this study was to assess the feasibility and safety of vascular closure devices after undergoing implantation of the leadless pacemaker device. Methods: One hundred and eighty ( 180 ) consecutive patients who had undergone implantation of a Micra transcatheter pacing were evaluated. One hundred and sixty eight ( 168 ) patients had traditional vascular closure after implantation and twelve ( 12 ) received the Perclose vascular closure device for the femoral venous access . A t-test analysis was used to compare patient demographics total procedure times and complications rates Results: None of the 180 patients suffered complications during the procedure. The mean procedure time using the traditional figure eight technique was 21.24 min versus 30.67 min (P = 0.01) by the closure device . The mean number of recaptures required for the patients undergoing the traditional venous closure was 0.48 vs. 0.67 (P = 0.70) by the closure device Conclusions: The Perclose device appears safe and feasible alternative for the vascular closure after implantation of the Micra transcatheter leadless pacemaker system. This approach tends to have longer procedure times

Single-center experience with vascular closure devices in real-world endovascular peripheral interventions.

The aim of the current study was to evaluate the efficacy and safety of vascular closure devices (VCDs) in non-cardiac endovascular interventions. Retrospective analysis of consecutive patients submitted to endovascular interventions, with deployment of 2327 vascular closure devices. Demographic, clinical/periprocedural, post-operative, complication and reintervention data were reviewed. A total of 2107 patients (1409 [66.9%] men) were included. Perclose ProGlide® (Abbott Vascular) was employed 1683 times (72.3%), Angio-Seal™ (St. Jude Medical Inc.) 463 (19.9%) and 181 (7.8%) Exoseal® (Cordis). Patients were 70.4±11 years old. Of all vascular approaches, 1794 were retrograde (77.1%) and 533 antegrade (22.9%), with sheath size ranging from 5 to 8 French. Overall success rate was 95.2% and did not significantly vary according to the device. Overall failure rate was 4.8%, with high puncture site, morbid obesity, previous total anticoagulation and severe calcification being related to worse efficiency results. Major complications occurred in 15 patients (0.6%). All patients were evaluated before discharge from the hospital, and were scheduled to return for ambulatory follow-up visits at 30 days postoperatively. Control duplex ultrasonography was performed on a regular basis, or within this period in case of clinical complain/signs. Vascular closure devices proved to be safe and effective in this study. Additional prospective randomized studies are recommended.

3:36 PMAbstract No. 211 - Efficacy and safety of vascular closure devices (VCD) after intra-arterial thrombolytic therapy in critical limb ischemia (CLI)

3:36 PMAbstract No. 211 - Efficacy and safety of vascular closure devices (VCD) after intra-arterial thrombolytic therapy in critical limb ischemia (CLI)

Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis.

The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs) and haematomas by calculating the risk ratios and 95% confidence intervals. Forty RCTs including 16868 patients were included. Traditional meta-analysis demonstrated that there was no significant difference in the rate of CAVEs between all the VCDs and manual compression (MC). Subgroup analysis showed that FemoSeal and VCDs reported after the year 2005 reduced CAVEs. Moreover, the use of VCDs reduced the risk of haematomas compared with MC. Network meta-analysis showed that AngioSeal, which might be the best VCD among all the included VCDs, was associated with reduced rates of both CAVE and haematomas compared with MC. In conclusion, the use of VCDs is associated with a decreased risk of haematomas, and FemoSeal and AngioSeal appears to be better than MC for reducing the rate of CAVEs.

Use of vascular closure device is safe and effective in electrophysiological procedures.

Little is known about the usefulness and safety of vascular closure devices (VCDs) in electrophysiological procedures. We present a retrospective analysis of our experience assessing the utility and outcomes of collagen vascular closure device (Angioseal) in patients that required periprocedural anticoagulation and multiple vascular access sites. An retrospective chart review of patients who have undergone the deployment of VCD following electrophysiological procedures. In 26 patients (16 males, age 57 ± 15years, weight 96 ± 21kg), a total of 76 VCD were deployed. Seventy-three VCDs in femoral veins (right or left) and three in femoral artery. The mean number of VCD per patient was 3 (range, 2-4). VCD was successfully deployed in 75 out of 76 access sites. One patient was noted to have ecchymosis in both groins during follow-up visit. No other complications were noted. We provide evidence that a collagen plug-based VCD designed for arterial closure can be safely and effectively used to close multiple venous accesses even in the same vein. This can be accomplished with a venotomy size up to 2Fr larger than the size of the closure device.

Comparative Safety of Vascular Closure Devices

Letters18 March 2014Comparative Safety of Vascular Closure DevicesRahman Shah, MD and M. Rehan Khan, MDRahman Shah, MDFrom University of Tennessee, Memphis, Tennessee; and Virginia Commonwealth University, Richmond, Virginia.Search for more papers by this author and M. Rehan Khan, MDFrom University of Tennessee, Memphis, Tennessee; and Virginia Commonwealth University, Richmond, Virginia.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L14-5006 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:In their recent article Gurm and colleagues (1) repeatedly used the term “benefit of vascular closure devices [VCDs]” for several subgroups, which is misleading. Observational studies cannot provide evidence of cause and effect; they can only suggest some relationship between exposure and outcome (2).Moreover, they concluded that VCD use was associated with decreased vascular complication rates, which contradicts findings of multiple randomized trials (3, 4). Although most of these trials may have been underpowered, several meta-analyses have shown that VCD use did not decrease vascular complication rates (3, 4). Furthermore, VCD use reportedly increased the risk ...

Comparative Safety of Vascular Closure Devices and Manual Closure Among Patients Having Percutaneous Coronary Intervention

The role of vascular closure devices (VCDs) in patients having percutaneous coronary intervention (PCI) is controversial, and recommendations for use vary. To examine the use of and outcomes associated with VCDs in real-world practice. Observational cohort study. 32 hospitals in Michigan that participate in a large multicenter quality improvement collaborative. Consecutive patients having emergent and nonemergent PCI from 2007 to 2009. Vascular complications and the need for transfusion. Of the 85 048 PCIs performed during the study that met the inclusion criteria, 28 528 (37%) procedures used VCDs. In propensity score-matched analysis, VCDs were associated with reductions in vascular complications (odds ratio [OR], 0.78 [95% CI, 0.67 to 0.90]; P = 0.001) and postprocedure transfusions (OR, 0.85 [CI, 0.74 to 0.96]; P = 0.011). These findings were consistent across many prespecified subgroups except for patients with a body mass index (BMI) less than 25 kg/m2 and those treated with platelet glycoprotein (GP) IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated. When the specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR, 0.69 [CI, 0.58 to 0.83]; P < 0.001) or pseudoaneurysms (OR, 0.54 [CI, 0.38 to 0.76]; P < 0.001) but an increase in the odds of retroperitoneal bleeding (OR, 1.57 [CI, 1.12 to 2.20]; P = 0.009). Unmeasured confounding cannot be excluded despite the study having measured and balanced many confounders. Vascular closure devices were associated with a significant reduction in vascular complications and need for transfusion in this large cohort of patients having transfemoral PCI. This benefit was lost in patients receiving GP IIb/IIIa inhibitors and those with normal or lean BMI and was counterbalanced by a small increase in the more serious risk for retroperitoneal bleeding.

Feasibility and Safety of Vascular Closure Devices in an Antegrade Approach to Either the Common Femoral Artery or the Superficial Femoral Artery

The purpose of the present study was to analyze complications following antegrade puncture of the common femoral artery (CFA) and the superficial femoral artery (SFA) using vascular closure systems (VCS). A single-center, retrospective study was performed after obtaining approval from the institutional review board and informed consent from all patients. At our center, the CFA or SFA are used for arterial access. All patients were evaluated clinically on the same day. If there was any suspicion of an access site problem, Duplex ultrasound was performed. Access location was the CFA in 50 patients and the SFA in 130 patients. The sheath size ranged from 4F to 10F. Two patients had to be excluded because of lack of follow-up. Successful hemostasis was achieved in 162 of 178 cases (91 %). The following complications were observed in 16 patients (8.9 %): 4 pseudoaneurysms (2.2 %), 11 hematomas (6.2 %), and 1 vascular occlusion (0.5 %). The two pseudoaneurysms healed spontaneously, in one case an ultrasound-guided thrombin injection was performed, and one aneurysm was compressed manually. No further medical therapy was needed for the hematomas. The one vascular occlusion was treated immediately with angioplasty using a contralateral approach. No significant difference was noted between the CFA and the SFA group with respect to complications (p = 1.000). The use of closure devices for an antegrade approach up to 10F is feasible and safe. No differences in low complication rates were observed between CFA and SFA.

Vascular Closure Devices

In the endovascular procedure setting, vascular closure devices (VCD) have emerged as an alternative to mechanical compression in order to achieve vascular hemostasis after puncture of the femoral artery. VCD are categorized based primarily on the principle mechanism of hemostasis, which includes biodegradable plug, suture, staples, or ultrasound. While VCD offer advantages over mechanical compression (shorter time to hemostasis and patient ambulation, high rate of patient satisfaction, and greater cost-effectiveness) complications related to the site of femoral access are still present. Efficacy and safety of VCD have been evaluated in a number of clinical trials, but to date there is still a lack of randomized clinical trials with sample sizes large enough to reveal superiority or non-inferiority of VCD compared with mechanical compression. Mechanical compression and VCD are effective and well tolerated in the setting of diagnostic procedures and procedures that do not use anticoagulation. For both methods, success rates are lower, and complication rates higher, in the setting of interventional procedures and when anticoagulation medications are used. Regardless of the device type, deployment failure is the major drawback of VCD. However, overall, meta-analysis data demonstrated that complications and success rates are not significantly different between mechanical compression and VCD. Current data suggest that the correct answer on whether or not to use VCD still remains in the operator domain where integration of clinical data and familiarity with a particular closure device plays a key role in achieving successful hemostasis and avoiding access site complication.