Vascular closure devices for femoral arterial puncture site haemostasis.

Published on Mar 7, 2016in Cochrane Database of Systematic Reviews7.89
· DOI :10.1002/14651858.CD009541.PUB2
Lindsay Robertson22
Estimated H-index: 22
(Freeman Hospital),
Alina Andras11
Estimated H-index: 11
(Keele University)
+ 1 AuthorsRalph Jackson13
Estimated H-index: 13
(Freeman Hospital)
Sources
Abstract
Background Vascular closure devices (VCDs) are widely used to achieve haemostasis after procedures requiring percutaneous common femoral artery (CFA) puncture. There is no consensus regarding the benefits of VCDs, including potential reduction in procedure time, length of hospital stay or time to patient ambulation. No robust evidence exists that VCDs reduce the incidence of puncture site complications compared with haemostasis achieved through extrinsic (manual or mechanical) compression. Objectives To determine the efficacy and safety of VCDs versus traditional methods of extrinsic compression in achieving haemostasis after retrograde and antegrade percutaneous arterial puncture of the CFA. Search methods The Cochrane Vascular Trials Search Co-ordinator searched the Specialised Register (April 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 3). Clinical trials databases were searched for details of ongoing or unpublished studies. References of articles retrieved by electronic searches were searched for additional citations. Selection criteria We included randomised and quasi-randomised controlled trials in which people undergoing a diagnostic or interventional procedure via percutaneous CFA puncture were randomised to one type of VCD versus extrinsic compression or another type of VCD. Data collection and analysis Two authors independently extracted data and assessed the methodological quality of trials. We resolved disagreements by discussion with the third author. We performed meta-analyses when heterogeneity (I2) was < 90%. The primary efficacy outcomes were time to haemostasis and time to mobilisation (mean difference (MD) and 95% confidence interval (CI)). The primary safety outcome was a major adverse event (mortality and vascular injury requiring repair) (odds ratio (OR) and 95% CI). Secondary outcomes included adverse events. Main results We included 52 studies (19,192 participants) in the review. We found studies comparing VCDs with extrinsic compression (sheath size ≤ 9 Fr), different VCDs with each other after endovascular (EVAR) and percutaneous EVAR procedures and VCDs with surgical closure after open exposure of the artery (sheath size ≥ 10 Fr). For primary outcomes, we assigned the quality of evidence according to GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria as low because of serious imprecision and for secondary outcomes as moderate for precision, consistency and directness. For time to haemostasis, studies comparing collagen-based VCDs and extrinsic compression were too heterogenous to be combined. However, both metal clip-based (MD -14.81 minutes, 95% CI -16.98 to -12.63 minutes; five studies; 1665 participants) and suture-based VCDs (MD -14.58 minutes, 95% CI -16.85 to -12.32 minutes; seven studies; 1664 participants) were associated with reduced time to haemostasis when compared with extrinsic compression. For time to mobilisation, studies comparing collagen-, metal clip- and suture-based devices with extrinsic compression were too heterogeneous to be combined. No deaths were reported in the studies comparing collagen-based, metal clip-based or suture-based VCDs with extrinsic compression. For vascular injury requiring repair, meta-analyses demonstrated that neither collagen (OR 2.81, 95% CI 0.47 to 16.79; six studies; 5731 participants) nor metal clip-based VCDs (OR 0.49, 95% CI 0.03 to 7.95; three studies; 783 participants) were more effective than extrinsic compression. No cases of vascular injury required repair in the study testing suture-based VCD with extrinsic compression. Investigators reported no differences in the incidence of infection between collagen-based (OR 2.14, 95% CI 0.88 to 5.22; nine studies; 7616 participants) or suture-based VCDs (OR 1.66, 95% CI 0.22 to 12.71; three studies; 750 participants) and extrinsic compression. No cases of infection were observed in studies testing suture-based VCD versus extrinsic compression. The incidence of groin haematoma was lower with collagen-based VCDs than with extrinsic compression (OR 0.46, 95% CI 0.40 to 0.54; 25 studies; 10,247 participants), but no difference was evident when metal clip-based (OR 0.79, 95% CI 0.46 to 1.34; four studies; 1523 participants) or suture-based VCDs (OR 0.65, 95% CI 0.41 to 1.02; six studies; 1350 participants) were compared with extrinsic compression. The incidence of pseudoaneurysm was lower with collagen-based devices than with extrinsic compression (OR 0.74, 95% CI 0.55 to 0.99; 21 studies; 9342 participants), but no difference was noted when metal clip-based (OR 0.76, 95% CI 0.20 to 2.89; six studies; 1966 participants) or suture-based VCDs (OR 0.79, 95% CI 0.25 to 2.53; six studies; 1527 participants) were compared with extrinsic compression. For other adverse events, researchers reported no differences between collagen-based, clip-based or suture-based VCDs and extrinsic compression. Limited data were obtained when VCDs were compared with each other. Results of one study showed that metal clip-based VCDs were associated with shorter time to haemostasis (MD -2.24 minutes, 95% CI -2.54 to -1.94 minutes; 469 participants) and shorter time to mobilisation (MD -0.30 hours, 95% CI -0.59 to -0.01 hours; 469 participants) than suture-based devices. Few studies measured (major) adverse events, and those that did found no cases or no differences between VCDs. Percutaneous EVAR procedures revealed no differences in time to haemostasis (MD -3.20 minutes, 95% CI -10.23 to 3.83 minutes; one study; 101 participants), time to mobilisation (MD 1.00 hours, 95% CI -2.20 to 4.20 hours; one study; 101 participants) or major adverse events between PerClose and ProGlide. When compared with sutures after open exposure, VCD was associated with shorter time to haemostasis (MD -11.58 minutes, 95% CI -18.85 to -4.31 minutes; one study; 151 participants) but no difference in time to mobilisation (MD -2.50 hours, 95% CI -7.21 to 2.21 hours; one study; 151 participants) or incidence of major adverse events. Authors' conclusions For time to haemostasis, studies comparing collagen-based VCDs and extrinsic compression were too heterogeneous to be combined. However, both metal clip-based and suture-based VCDs were associated with reduced time to haemostasis when compared with extrinsic compression. For time to mobilisation, studies comparing VCDs with extrinsic compression were too heterogeneous to be combined. No difference was demonstrated in the incidence of vascular injury or mortality when VCDs were compared with extrinsic compression. No difference was demonstrated in the efficacy or safety of VCDs with different mechanisms of action. Further work is necessary to evaluate the efficacy of devices currently in use and to compare these with one other and extrinsic compression with respect to clearly defined outcome measures.
📖 Papers frequently viewed together
7 Authors (Jun Jiang, ..., Yi Miao)
27 Citations
173 Citations
37 Citations
References83
Newest
#1Jun Jiang (Nanjing Medical University)H-Index: 4
#2Junjie Zou (Nanjing Medical University)H-Index: 8
Last. Yi Miao (Nanjing Medical University)H-Index: 5
view all 7 authors...
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) an...
27 CitationsSource
#1Thomas LarzonH-Index: 18
#2Håkan Roos (Sahlgrenska University Hospital)H-Index: 8
Last. Lars NorgrenH-Index: 27
view all 8 authors...
Objectives The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. Methods In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outc...
21 CitationsSource
#2Sandra HeldeH-Index: 4
Last. Adnan KastratiH-Index: 146
view all 30 authors...
Importance The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial. Objective To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access—a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemost...
116 CitationsSource
#1Erion XhepaH-Index: 9
#2Robert A. ByrneH-Index: 79
view all 23 authors...
Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking.The Instrumental Sealing of ARterial puncture site - CLOSURE...
7 CitationsSource
#1Birthe Sindberg (Aarhus University Hospital)H-Index: 2
#2Mia Schou (Aarhus University Hospital)H-Index: 2
Last. Jens Flensted Lassen (Aarhus University Hospital)H-Index: 69
view all 10 authors...
Background:Pain and discomfort in relation to vascular closure are the predominant patient complaints after coronary angiography (CAG). No large-scale randomized studies have evaluated pain and discomfort after CAG with access site closure by manual compression versus a vascular closure device (VCD).Aim:To compare pain and discomfort after femoral artery closure by manual compression versus FemoSeal® VCD.Methods:The study is a sub study to the CLOSE-UP study, a randomized, single centre comparis...
10 CitationsSource
#1Niels Ramsing HolmH-Index: 30
#2Birthe SindbergH-Index: 2
Last. Jens Flensted LassenH-Index: 69
view all 14 authors...
AIMS: To compare in a randomised trial the safety and efficacy of the FemoSeal vascular closure device (VCD) versus manual compression (MC) after femoral access coronary angiography (CAG). METHODS AND RESULTS: In 13 months, 1,014 patients were included and 1,001 patients entered analysis. Median [interquartile range] closure time was 8.0 [6-10] minutes after MC versus 1.0 [1-1] minute (p<0.0001) for the FemoSeal VCD. Bed rest for one hour after the closure procedure was recommended in both group...
41 CitationsSource
#1Peter R. Nelson (USF: University of South Florida)H-Index: 20
#2Zvonimir Kracjer (St Lukes Episcopal Hospital)H-Index: 1
Last. J. Michael Bacharach (North Central College)H-Index: 18
view all 8 authors...
Objective The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8F or 10F suture-mediated closure system (the PEVAR trial, NCT01070069 ). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. Methods Between 2010 and 2012, 20 U.S. institutions partici...
161 CitationsSource
#1Gregor LeibundgutH-Index: 1
#2Jürgen Pache (LMU: Ludwig Maximilian University of Munich)H-Index: 1
Last. Franz-Josef NeumannH-Index: 1
view all 9 authors...
Introduction In ISAR-REACT-4 (abciximab and heparin vs. bivalirudin for non-ST-elevation myocardial infarction [NSTEMI]), bivalirudin reduced the risk of bleeding after percutaneous coronary intervention (PCI) compared with unfractionated heparin plus abciximab (UFH + abciximab). Vascular closure devices (VCDs) may also prevent bleeding complications, and thus attenuate the benefit of bivalirudin. This analysis examined whether there exists an interaction on bleeding between VCDs and bivalirudin...
6 CitationsSource
#1Ching-Pei Chen (CTU: Chienkuo Technology University)H-Index: 3
#2Huang-Kai HuangH-Index: 1
Last. Cheng-Liang LeeH-Index: 1
view all 6 authors...
Background: The Cardiva Boomerang^(TM) is a device used to perform femoral vascular closure. It facilitates passive hemostasis at the arteriotomy site, leaving no residual foreign body.Methods: We performed a controlled, randomized study of 60 patients undergoing percutaneous coronary intervention. Patients were randomized into two groups (30 per group) to undergo vascular closure with the Boomerang^(TM) or the Perclose^(TM) suture-based device after the intravenous administration of protamine s...
2 Citations
#1Jpt HigginsH-Index: 1
#2S. R. GreenH-Index: 1
Last. Julian P T HigginsH-Index: 135
view all 3 authors...
5,090 Citations
Cited By43
Newest
#1Yann Gouëffic (French Institute of Health and Medical Research)H-Index: 23
#2Jean Picquet (University of Angers)H-Index: 6
Last. Marie GuillouH-Index: 1
view all 11 authors...
PURPOSES The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. MATERIALS AND METHODS STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the...
Source
#1Suman S. Rao (State University of New York Upstate Medical University)
#2Pradyumna AgasthiH-Index: 5
Cardiac catheterization is required for many procedures such as angiography, angioplasty, valve replacement, valvuloplasty, ablation, or congenital heart repair. This process is required to assess and manage many patients presenting with myocardial infarction, heart disease, valvular disease, or congenital heart disease. Needless to say, catheterization is a heavily performed procedure in the field of interventional cardiology. A common site of entry for catheterization is the femoral artery. Af...
#1Chang Hun Kim (PNU: Pusan National University)
#2Min Ho Ju (PNU: Pusan National University)H-Index: 5
Last. Hyung Gon Je (PNU: Pusan National University)H-Index: 7
view all 5 authors...
Background The use of ProGlide as a percutaneous vascular closure device in cardiac surgery remains inconclusive. This study investigated the clinical outcomes of using Pro-Glide in the percutaneous cannulation of femoral vessels in adult cardiac surgery. Methods From September 2017 to July 2018, 131 consecutive patients underwent femoral vessel cannulation during cardiac surgery. The ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA) with percutaneous cannulation was used in 118 patients (me...
Source
#2K. MeisenbacherH-Index: 5
Last. Dittmar Böckler (University Hospital Heidelberg)H-Index: 53
view all 6 authors...
Die Angaben zu Komplikationsraten nach perkutanen Interventionen in der Behandlung der peripheren arteriellen Verschlusskrankheit (pAVK) variieren in der Literatur, zwischen 2,4 und 18,1 % sind beschrieben. Hierunter werden sowohl Zugangs- bzw. punktionsbedingte Komplikationen als auch systemische Komplikationen, wie z. B. kardiovaskulare Ereignisse erfasst. Aufgrund des hohen Stellenwerts interventioneller Techniken in der pAVK-Versorgung, zunehmend auch im ambulanten Sektor, sowie vor dem Hint...
Source
#1Shunbo Wei (Zhengzhou University)H-Index: 4
#2Yanhua Xu (Zhengzhou University)
Last. Alan Dardik (Yale University)H-Index: 55
view all 11 authors...
Abstract Introduction : Incomplete hemostasis after vascular cannulation can cause a hematoma or pseudoaneurysm. We hypothesized that a hydrogel-coated needle would effectively and rapidly stop bleeding after vascular cannulation. Method : A hydrogel composed of sodium alginate, hyaluronic acid, and calcium carbonate was coated onto the surface of suture needles. Needles were observed using scanning electronic microscopy (SEM) and immunofluorescence. Cannulation was performed in both mouse and r...
2 CitationsSource
OBJECTIVE Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA). METHODS This was a retrospective review o...
1 CitationsSource
#2Rigoberto Ramirez (University of Kansas Hospital)
Last. Sanjaya Gupta (UMKC: University of Missouri–Kansas City)H-Index: 10
view all 8 authors...
PURPOSE This registry compared the safety and efficacy of vascular closure device Perclose (PC) with figure-of-eight stitch (Fo8) and manual compression (MC) following catheter ablation of atrial fibrillation/flutter. METHODS VAscular Closure for Cardiac Ablation Registry (VACCAR) is a prospective, observational registry that assessed the time to hemostasis (TTH), time to ambulation (TTA), length of stay (LOS), complications, patient-reported outcomes, and pain medication use. RESULTS A total of...
1 CitationsSource
#1A. Rodway (Brighton and Sussex University Hospitals NHS Trust)H-Index: 1
Last. Christian Heiss (University of Surrey)H-Index: 62
view all 12 authors...
Summary: Background: Peripheral artery disease presents an increasing healthcare burden worldwide. Day-case angioplasty in a secondary care setting can be a safe and effective means of meeting the ...
Source
#1Sean A. Kennedy (UHN: University Health Network)H-Index: 2
#2Dheeraj K. Rajan (UHN: University Health Network)H-Index: 33
Last. Sebastian Mafeld (UHN: University Health Network)H-Index: 4
view all 6 authors...
Abstract Background Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating at the common femoral artery (CFA). However, off-label use in antegrade and/or superficial femoral artery (SFA) access has become more common in the treatment of peripheral arterial disease. Despite this, there is a paucity of comparative literature assessing individual VCD safety profiles and relative complica...
7 CitationsSource
#1Rejane Reich (UFRGS: Universidade Federal do Rio Grande do Sul)H-Index: 6
#2Lucas Helal (UFRGS: Universidade Federal do Rio Grande do Sul)H-Index: 5
Last. Eneida Rejane Rabelo-Silva (UFRGS: Universidade Federal do Rio Grande do Sul)H-Index: 11
view all 4 authors...
Background Access site hemostasis after percutaneous procedures done in the catheterization laboratory still needs to be better studied in relation to such aspects as the different results achieved with different hemostasis strategies, the impact of different introducer sheath sizes, and arterial versus venous access. The objective of this review is to synthesize the available scientific evidence regarding different techniques for hemostasis of femoral access sites after percutaneous diagnostic ...
Source