Femoral artery access site closure with perclose suture mediated device in coronary interventions

Bhat, Keshavamurthy Ganapathy; Janardhanapillai, Ratheesh Kumar; Dabas, Ajay Kumar; Chadha, D.S.; Swamy, Ajay; Chadha, Amitoj Singh

doi:10.1016/j.ihj.2020.12.014

Cited by 6 publications

(5 citation statements)

References 27 publications

(55 reference statements)

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“…No statistically significant differences were observed in terms of bleeding-related VASCs between the VCD group and the MC group in a recent meta-analysis (4.0% vs. 5.2%—RR: 0.77, CI, 0.60–1.00, p = 0.05) [ 18 ]. An interesting speculation is that VCD failure increased the incidence of minor bleeding complications and partially offset the benefits of VCD on hemostasis [ 18 , 58 , 59 , 60 ]. In our retrospective evaluation, we did not observe major vascular complications, with only one case of pseudoaneurysm treated by US-guided percutaneous injection of thrombin.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers

Minici¹,

Serra

Maglia³

et al. 2023

JPM

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Background: Hemostasis of the femoral arterial access site by manual compression or a vascular closure device is critical to the safe completion of any endovascular procedure. Previous investigations evaluated the hemostatic efficacy at the radial access site of some chitosan-based hemostatic pads. This study aims to assess the efficacy and safety of a new chitosan-based hemostatic dressing, namely Axiostat®, in aiding manual compression closure of the femoral arterial access site in patients undergoing endovascular treatments. Furthermore, the outcomes were compared with evidence on manual compression alone and vascular closure devices. Methods: This investigation is a two-center retrospective analysis of 120 consecutive patients who had undergone, from July 2022 to February 2023, manual compression closure of the femoral arterial access site aided by the Axiostat® hemostatic dressing. Endovascular procedures performed with introducer sheaths ranging from 4 Fr to 8 Fr were evaluated. Results: Primary technical success was achieved in 110 (91.7%) patients, with adequate hemostasis obtained in all cases of prolonged manual compression requirements. The mean time-to-hemostasis and time-to-ambulation were 8.9 (±3.9) and 462 (±199) minutes, respectively. Clinical success was achieved in 113 (94.2%) patients, with bleeding-related complications noted in 7 (5.8%) patients. Conclusions: Manual compression aided by the Axiostat® hemostatic dressing is effective and safe in achieving hemostasis of the femoral arterial access site in patients undergoing endovascular treatment with a 4–8 Fr introducer sheath.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers

Minici¹,

Serra

Maglia³

et al. 2023

JPM

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“…One possible explanation is that VCDs indeed promote the efficiency of hemostasis, but the increased number of minor bleeding complications was driven by device failure [ 50 ]. We found evidence to support this explanation from the included studies, namely, that device failure increased the incidence of minor bleeding complications and partially offset the benefits of VCDs [ 35 , 38 , 41 ].…”

Section: Discussionmentioning

confidence: 79%

“…After removing 462 duplicate studies, step by step screening was performed based on inclusion and exclusion criteria. Eventually, 32 studies comprising 12 RCTs [28][29][30][31][32][33][34][35][36][37][38][39], 17 observational studies [40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55], and 3 propensity-score matched studies [56][57][58] were included in this meta-analysis. Figure 1 shows the flowchart of inclusions and exclusions.…”

Section: Search Resultsmentioning

confidence: 99%

“…Of course, VCDs have a certain failure rate, which is approximately 3.1% according to our analysis. Device failure rate has decreased with the development of technology and the operator experience, but it has not yet reached the desired perfection [ 41 ]. Another evidence of the hemostasis efficacy of VCDs is the reduction of TTA, which directly determines patient satisfaction.…”

Section: Discussionmentioning

confidence: 99%

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Vascular Closure Devices versus Manual Compression in Cardiac Interventional Procedures: Systematic Review and Meta-Analysis

Pang

Gao

Zhang

et al. 2022

Cardiovascular Therapeutics

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Backgrounds. Manual compression (MC) and vascular closure device (VCD) are two methods of vascular access site hemostasis after cardiac interventional procedures. However, there is still controversial over the use of them and a lack of comprehensive and systematic meta-analysis on this issue. Methods. Original articles comparing VCD and MC in cardiac interventional procedures were searched in PubMed, EMbase, Cochrane Library, and Web of Science through April 2022. Efficacy, safety, patient satisfaction, and other parameters were assessed between two groups. Heterogeneity among studies was evaluated by I2 index and the Cochran Q test, respectively. Publication bias was assessed using the funnel plot and Egger’s test. Results. A total of 32 studies were included after screening with inclusion and exclusion criteria (33481 patients). This meta-analysis found that VCD resulted in shorter time to hemostasis, ambulation, and discharge ( p < 0.00001 ). In terms of vascular complication risks, VCD group might be associated with a lower risk of major complications ( p = 0.0001 ), but the analysis limited to randomized controlled trials did not support this result ( p = 0.68 ). There was no significant difference in total complication rates ( p = 0.08 ) and bleeding-related complication rates ( p = 0.05 ) between the two groups. Patient satisfaction was higher in VCD group ( p = 0.002 ). Meta-regression analysis revealed no specific covariate as an influencing factor for above results ( p > 0.05 ). Conclusions. Compared with MC, the use of VCDs significantly shortens the time of hemostasis and allows earlier ambulation and discharge, meanwhile without increase in vascular complications. In addition, use of VCDs achieves higher patient satisfaction and leads cost savings for patients and institutions.

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“…The study was conducted in a prospective manner and the final sample of the study was determined as 80 patients. Power analysis was performed by evaluating the data of the reference literature on the subject, it was calculated that a total of 80 patients should be included, with a 95% confidence interval and a 20% margin of error [6]. The study started in December 2021 and finished in December 2022.…”

Section: Methodsmentioning

confidence: 99%

Learning Curve of Perclose ProGlide Utilization During Percutaneous Coronary Intervention

Varis¹,

Gurbuz²

2023

Cureus

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Objective: This study aimed to investigate the learning curve (LC) of Perclose ProGlide (Chicago, IL: Abbott Laboratories) utilization for percutaneous coronary intervention (PCI) for the first time.Methods: The study was conducted in a prospective manner and the final sample of the study was determined as 80 patients. Patients' characteristics, diameter of common femoral artery (CFA), distance from skin to CFA, degree of calcification (<50% or ≥50%), procedure-related parameters, complications, and success of procedures were recorded. Patients were equally divided into four groups and groups were compared according to patient demographic properties, procedure-related parameters, complications, and success.Results: The mean age and mean BMI of the study population were 55.5 years and 27.5 kg/m 2 , respectively. The mean procedure time was 144.8 minutes (min) in group 1, 138.9 min in group 2, 122.2 min in group 3, and 101.1 min in group 4, and the difference was statistically shorter in favor of group 3 and group 4 (p=0.023). Moreover, mean fluoroscopy time significantly decreased after 20 cases (p=0.030). Hospitalization period was significantly shortened following 40 procedures (p=0.031). Complications were detected in five patients in group 1, four patients in group 2, and one patient in group 4 (p=0.044). Success was significantly higher in group 3 and group 4 in comparison to group 1 and group 2 (p=0.040).Conclusion: This study showed that procedure time and hospitalization time significantly decreased after 40 cases and fluoroscopy time significantly decreased after 20 cases. Moreover, after 40 procedures, the success of Perclose ProGlide utilization during PCI significantly increased and complications of the procedure significantly decreased.

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Femoral artery access site closure with perclose suture mediated device in coronary interventions

Cited by 6 publications

References 27 publications

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers

Vascular Closure Devices versus Manual Compression in Cardiac Interventional Procedures: Systematic Review and Meta-Analysis

Learning Curve of Perclose ProGlide Utilization During Percutaneous Coronary Intervention

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