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Surgery versus non‐surgical treatment for femoral pseudoaneurysms

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effects of different treatments for femoral pseudoaneurysms resulting from endovascular procedures. The main focus of the review will be to compare surgery with ultrasound‐guided compression and/or percutaneous thrombin injection.

Background

A pseudoaneurysm (false aneurysm) is a swelling in an artery which does not contain all layers of the normal arterial wall. The swelling consists of adventitial tissue (the outermost layer) lined with layered thrombus (clot). Femoral pseudoaneurysms occur as a result of previous endovascular procedures (e.g. diagnostic arteriogram, angioplasty, cardiac catheterization), vascular trauma, or following open vascular surgery (e.g. aortobifemoral bypass, femoro‐popliteal bypass). Pseudoaneurysms following previous vascular surgery are often associated with vascular graft infection and require debridement (removal) of infected tissue and often complete or partial graft removal. This review will only consider pseudoaneurysms following endovascular procedures.

Pseudoaneurysms result from poor haemostasis (failure to control blood flow) at the time of the initial treatment, i.e. inadequate compression of the puncture site after withdrawing the catheter/sheath or failure to use a closure device. Frequently these patients are anticoagulated (receiving anti‐clotting therapy) or have a coagulopathy (clotting disorder) and this may compound the problem. Pseudoaneurysms are reported to occur in one per cent of diagnostic arteriograms and up to eight per cent of therapeutic endovascular interventions (Eternad‐Rezai 2003). Symptoms include pain, swelling and bruising in the groin area. Duplex ultrasound is the diagnostic test of choice and demonstrates a high velocity jet on colour flow imaging through a defect in the arterial wall. A proportion of small pseudoaneurysms may spontaneously clot over time and active observation is therefore an option. For those pseudoaneurysms that need treatment, surgery has traditionally been considered as the 'gold standard'. This may require simple suture of the defect after evacuation of the haematoma (blood‐filled swelling) or a patch angioplasty (surgical repair using a patch).

Ultrasound‐guided compression is now increasingly used as a therapeutic tool to avoid the need for surgery. Compression with the ultrasound probe at the site of communication between the false aneurysm and the native artery abolishes flow through the arterial wall allowing thrombosis of the aneurysm sac to occur. Patients will require effective analgesia and/or sedation in order to tolerate the procedure, which involves compression for 10 minutes at a time repeated for up to 60 minutes. Success rates of 63 to 88% have been reported (Morgan 2003).

A number of studies have reported successful thrombosis of femoral pseudoaneurysms using Duplex ultrasound‐guided percutaneous bovine thrombin injection (Edgerton 2002; Friedman 2002; Kruger 2003; Lonn 2002; Sackett 2000). This can be performed as an outpatient procedure. Thrombin in a concentration of 1000 U/ml is injected slowly into the pseudoaneurysm, with thrombosis frequently occurring within five seconds (Eternad‐Rezai 2003). The reported dose needed is between 20 U and 6000 U (Eternad‐Rezai 2003; Olsen 2002). A primary success rate of 95 to 98% has been reported (Maleux 2003; Mohler 2001). Thrombin injection can be associated with immediate complications such as thrombosis of the native artery, and rarely venous thrombosis. Delayed reperfusion of the aneurysm may occur in six per cent of cases (Olsen 2002). A potential problem with the use of bovine thrombin may be contamination with prions (protein‐related infectious agents, thought to be responsible for transmission of some degenerative diseases). One study has overcome this risk by using autologous thrombin prepared from patients' blood for treatment of pseudoaneurysms (Quarmby 2002).

A recent study described the use of para‐aneurysmal saline in the treatment of femoral pseudoaneurysms, i.e. injection of saline around the communication between the false aneurysm and the native artery, abolishing blood flow (Gehling 2003). Endovascular treatment methods such as coil embolization (using a coil to encourage formation of a blood clot, thus filling the aneurysm) or stent‐grafts (a prosthetic tube lying within the artery) have also been used to treat femoral pseudoaneurysms (Morgan 2003).

This review aims to explore the evidence for the efficacy of these treatment modalities in the treatment of femoral pseudoaneurysms.

Objectives

To assess the effects of different treatments for femoral pseudoaneurysms resulting from endovascular procedures. The main focus of the review will be to compare surgery with ultrasound‐guided compression and/or percutaneous thrombin injection.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials comparing two or more different treatments for femoral pseudoaneurysms will be considered for inclusion in this review.

Types of participants

All patients with femoral pseudoaneurysms following endovascular procedures will be considered for inclusion, without any restriction on the size of the pseudoaneurysm. Patients with pseudoaneurysms resulting from previous vascular surgery or following trauma will be excluded.

Types of interventions

Surgical treatment of femoral pseudoaneurysms; ultrasound‐guided compression; percutaneous thrombin injection; other interventions (e.g. para‐aneurysmal saline injection, coil embolization, endovascular stent‐graft).

Types of outcome measures

Primary outcome
Complete thrombosis of the pseudoaneurysm (confirmed by Duplex ultrasound or angiography) in the absence of significant complications.

Secondary outcomes
Objective clinical measures
(1) Pseudoaneurysm recurrence rate;
(2) Rate of re‐intervention for pseudoaneurysm;
(3) Complication rate, specifically native artery thrombosis;
(4) Length of hospital stay;
(5) 30‐day mortality rate.

Subjective measures
(1) Symptoms, such as pain, swelling and bruising; pain scores if available
(2) Quality of life measures, using formal quality of life questionnaires administered either in person or by post.

Search methods for identification of studies

All publications directly, or indirectly, describing randomised controlled trials that compare, or might compare different treatments for femoral pseudoaneurysms will be sought using the search strategy described by the Cochrane Review Group on Peripheral Vascular Diseases. This strategy includes computerised searches of EMBASE (1980 to present) and MEDLINE (1966 to present) and handsearches of relevant medical journals. Additional searches will be made of the Cochrane Central Register of Controlled Trials (CENTRAL), and bibliographies of papers found through these searches will also be scrutinised to identify any further randomised trials. Relevant journals will be handsearched (including British Journal of Radiology, British Journal of Surgery, Clinical Radiology, European Journal of Vascular and Endovascular Surgery, Journal of Vascular Surgery, Radiology). Trialists will be contacted for further information in cases where there is missing data or doubts about whether to include trials in the review.

Data collection and analysis

Selection of trials
Paul Tisi will collate all randomised trials identified from the search strategy for potential inclusion in the review. Additional information, if required, will be sought from relevant authors to enable the quality of the trial to be assessed.

Quality of trials
Potentially eligible trials will be assessed independently by both authors to determine the relevance of each study. Ideally, studies should have sufficient statistical power to detect a difference between treatment groups. Trials will only be accepted if both authors agree on the inclusion criteria. Disagreements will be resolved through discussion. Trials will be scrutinised for allocation concealment, ensuring that a trial participant did not influence the randomisation process. Blinding may not be possible if the one treatment arm is surgical as the incision would be obvious to the observer. Trials will be scrutinised to ascertain whether follow‐up was explicitly reported or implied, in order to avoid attrition bias. Missing follow‐up data will be sought from the original investigators, where possible. If this information is unavailable, the data will be re‐analysed using a reasonable range of values for missing data, to determine if this affects the overall results. Standard check‐lists will be used to ascertain quality of the trials: the Schulz scale and the Jadad scale.

Data extraction
Data from the trials will be extracted independently by Paul Tisi and Michael Callam using a specifically designed data collection form. This will include all data relating to both objective and subjective outcome measures as defined above, in addition to any other relevant data, such as sample size, inclusion and exclusion criteria, follow‐up etc.. The figures will then be cross‐checked for agreement.

Statistical analysis
Finer points of the analysis will be determined by the type and quality of the data extracted. Heterogeneity of the combined results from different studies for each outcome comparison will be assessed using RevMan Analyses (RevMan software version 4.2.3), as well as by clinical judgement. The data extracted from the trials will be critically appraised in a sensitivity analysis, which will involve examining the key decisions and assumptions that might affect the results. Both the original and re‐analysed results will be reported, if appropriate. A funnel plot may be considered to identify any publication bias. Sub‐group analysis will be carried out if appropriate. Results will be expressed as Peto odds ratios (OR) with 95% confidence intervals (CI) for dichotomous variables, although for comparisons with a high frequency of events, outcomes will be given as relative risk (RR) with 95% CI. Results for continuous variables will be expressed as standardised mean differences (SMD).