2.1

Devices’ description

The Prostar XL Percutaneous Vascular Surgical system is a 10 F apparatus designed to deliver polyester sutures to close femoral artery puncture sites following catheterization procedures. The Prostar XL device has two sutures and four needles and consists of a sheath, which contains two pairs of sutured needles, a needle guide which controls the placement of needles around the puncture site and a rotating barrel that receives deployed needles. The barrel of the device contains a marker lumen that offers a pathway for back-bleeding from the femoral artery and ensures proper device positioning. The barrel rotates independently from the central core and is designed to prepare the subcutaneous track. Barrel rotation is achieved by depressing the interlocks exiting from the hub. The Prostar XL device tracks over a standard 0.038-in. guidewire. The Perclose Knot Pusher constitutes part of the system, and advances the tied suture knot to the arteriotomy.

The Proglide Suture-Mediated Closure System is a 6 F device designed to close femoral artery puncture sites following diagnostic or interventional catheterization procedures by delivering a single monofilament polypropylene suture. The Proglide device consists of a plunger, handle, guide, and sheath. It tracks over a standard 0.038-in. guidewire. Blood flow through the sheath is restricted by a hemostasis valve with or without the guide wire being in place. The guide houses the needles and the foot, and precisely controls the placement of these needles around the puncture site. The handle is used to stabilize the device during use. The plunger advances the needles and retrieves the suture. The guide also contains a marker lumen that allows a pathway for back-bleeding from the femoral artery to ensure proper device positioning. Knot pusher accessory (Perclose Suture Trimmer) is enclosed, and accomplishes the positioning of the tied suture knot to the top of the arteriotomy and the trimming of the trailing limbs of the suture.

Both the Prostar XL and ProGlide systems are used in standard fashion to close access sites after endovascular procedures performed through sheaths up to 10 Fr and 8 Fr, respectively. Percutaneous closure in presence of larger sheaths, such as those used during EVAR or TAVR requires the “preclose technique” .

2.2

The preclose technique

The preclose technique using Prostar XL closure system device consists of standard percutaneous femoral access and closure device deployment over the wire until adequate blood flow is achieved through the dedicated marker lumen. The four needles are then unfolded and sutures removed from the hub and left untied over the operating filed. At this time, Prostar XL is removed leaving a guide-wire in place for appropriate sheath exchange to perform the procedure. Once the stent-graft or the valve is successfully positioned, having the guidewire still in place, the sutures are tied with a sliding knot, and the knot pusher is used to provide approximation of the knot to the vessel wall and satisfactory hemostasis. This technique utilizing Prostar XL allows closing femoral access sites up to 24 F.

The preclose technique has also been described using two ProGlide systems. After having obtained standard common femoral artery percutaneous access, the first ProGlide is advanced and rotated 30° medially before needle deployment and suture retrieval. The second device is then forwarded over standard wire and rotated 30° laterally before deployment. A standard sheath is then exchanged and EVAR or TVR implemented. After the completion of the procedure, preformed knots are advanced with the pusher and tightened to the arteriotomy ensuring adequate hemostasis. However, the reduction of sheath size down to 14Fr in some new generation valves, makes it possible to perform percutaneous closure after TAVR with one ProGlide.

2.3

Information sources and search

This systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for meta-analyses of intervention trials PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials were searched using the key words “vascular closure”, “arterial closure”, “arteriotomy closure”, “Prostar” and “ProGlide” in February 2016. The following search strategy used in the PubMed database: ((((randomized controlled trial[pt] OR controlled clinical trial[pt] OR randomized [tiab] OR hemostasis [tiab] OR hemostasis [tiab] OR prostar [tiab] OR [proglide] OR clinical trials as topic [mesh:noexp] OR randomly [tiab] OR trial [ti]) NOT (animals [mh] NOT humans [mh])))) AND (((vascular closure devices[Title/Abstract]) OR vascular closure device[Title/Abstract]) OR closure devices[Title/Abstract]). References to previous meta-analyses and reviews were further manually searched.

2.4

Eligibility criteria

Published prospective randomized controlled trials (RCTs) and cohort non-random designed trials comparing those two VCDs in patients undergoing TAVR or EVAR via the femoral artery were included with language restrictions (only in English). RCTs evaluating compression devices, such as hemostasis pads, sandbag, FemoStop, D-Stat Dry or C-Clamp or only one VCD were excluded. Case–Control studies, case series and trials without the outcomes of interest or enough information for data extraction were excluded.

2.5

Data collection

Two reviewers reviewed (C.A. and C.M.) and extracted the data independently. Any disagreements between these two reviewers were resolved by a third reviewer (M. K). To assess the methodological quality of the included trials, we used the criteria for quality assessment recommended by the Cochrane Collaboration Handbook. The following items from each eligible study were included: the first author, year of publication, types of VCDs, sample size, number of combined adverse vascular events, haematomas and kidney injury regardless of the size of each study arm, country, funding source, the duration of follow-up and methodological aspects of each trial.

2.6

Outcome measures

General information about the included trials is shown in Table 1 . The outcomes assessed in this systematic review include the rates of all vascular complications, hemorrhage and end stage acute kidney injury (AKI). Definitions of are shown in Table 2 . Updated standardized endpoint definitions of VARC-2 were used in most studies. Repetitive records of complications were screened and excluded.

Table 2

Definitions of all outcomes.

Study	All vascular complications	Bleeding complications	End stage Acute Kidney Injury
Barbash et al. (CONTROL Study)	According to VARC-2	According to VARC-2	According to VARC-2
Barbanti et al.	According to VARC-2	According to VARC-2	According to VARC-2
Nelson et al. (PEVAR trial)	Groin haematoma, retroperitoneal haematoma, arteriovenous fistula, pseudoaneurysm, arterial dissection, limb ischaemia or distal embolization, local infection, deep vein thrombosis and femoral artery thrombosis.	hemorrhage (access site bleeding requiring blood transfusion or surgical or percutaneous intervention)	temporary or permanent dialysis
Jochheim D et al.	According to VARC-2	Life-threatening or disabling bleeding according to VARC-2 (BARC type 3b,3c,5)
Seeger J et al.	According to VARC-2	According to VARC-2	According to VARC-2

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