CRD summary

This review found that larger-bore femoral access sheaths (20F or greater) introduced for percutaneous endovascular aortic aneurysm repair after the pre-application of suture-mediated vascular closure devices were implicated in primary failure and requirements for conversion to a femoral cutdown. The authors' conclusions should be interpreted with caution due to methodological weaknesses and unclear reliability.

Authors' objectives

To determine whether success rates for percutaneous endovascular aortic aneurysm repair were higher for smaller sheaths (18F or less) outer diameter than for larger sheaths (20F or greater).

Searching

MEDLINE and Scopus were searched from 1999 to August 2010 for studies in English; search terms were reported. The "related articles" function of the search engine was used and the references of retrieved relevant articles were searched to identify additional studies.

Study selection

Eligible studies provided data on success rates related to sheath size in patients undergoing percutaneous endovascular aortic aneurysm repair surgery. Articles that reported on thoracic aortic pathology other than aneurysm disease (trauma or dissection) or reported success rates for all sheath sizes or for a mean sheath size were excluded from the review. The primary outcome was defined as closure of a common femoral artery arteriotomy without the need for any adjunctive surgical or endovascular procedure within 30 days.

Sheath sizes in included studies ranged from 12F to 26F. The 8F/10F Perclose Prostar XL was the most frequently used suture-mediated vascular closure device followed by the 6F ProGlide the 6F Perclose AT and 6F Closer S. Follow-up across the trials, where stated, ranged from one month to 66 months. Additional haemastatic measures taken after removal of the vascular closure device where reported, included the application of manual compression, pressure or external pressure, sandbags for four hours with suture-mediated vascular closure devices, and the use of felt pledget patch attached to Prostar XL needles. Either single or multiple suture-mediated vascular closure devices were utilised in the trials.

Two reviewers independently performed the study selection; any discrepancies were were resolved by consensus.

Assessment of study quality

Methodological quality was evaluated using the Newcastle-Ottawa nine-point scale nine, for quality of selection, comparability, exposure and outcome of study participants.

The authors did not state how many reviewers assessed study quality.

Data extraction

Two reviewers extracted data on an intention-to-treat basis to calculate proportions and odds ratios (OR) and 95% confidence intervals (CI) for the estimates. Any discrepancies between the reviewers were resolved by consensus.

Methods of synthesis

Pooled proportions and odds ratios, and 95% confidence intervals for the summary estimates were calculated using a Mantel-Haenszel fixed-effects model. Statistical heterogeneity was assessed using the Cochran Q-statistic. The authors performed sensitivity analyses by removing one study at a time and comparing single and multiple suture-mediated vascular closure devices. The potential for publication bias was investigated using adjusted rank correlations, the Begg and Egger tests and visual appraisal of the symmetry of funnel plots.

Results of the review

Seventeen studies (1,693 patients with 2,447 femoral access sites) were included in the review; one randomised controlled trial, eight prospective studies and eight retrospective studies. The Newcastle-Ottawa scores ranged from five points (one study) to the maximum nine points (two studies). Although one RCT was included in the review, only the treatment arm using percutaneous component was evaluated in the review.

In 10 out of 2,447 femoral access sites (4.1%), percutaneous endovascular aortic aneurysm repair was abandoned primarily due to access problems, and infections and stenosis each occurred in less than 1% of patients.

There was a significantly higher likelihood of a successful operation without conversion to femoral cutdown using sheaths smaller than 18F compared to the use of 20F or greater large-bore sheaths (OR 1.78, 95% CI 1.24 to 2.54). Meta-analyses of the prospective studies showed a marginally significant OR of 1.6 (95% CI 0.99 to 2.44) and the pooled OR of the retrospective studies was 2.24 (95% CI 1.25 to 4.02). A sensitivity analysis found that the benefits of using 18F or smaller sheaths were more pronounced when multiple rather than single suture-mediated vascular closure devices were used (OR 2.16, 95% CI 1.28 to 3.64).

There was no statistically significant heterogeneity observed across the studies for the results. There was no evidence of publication bias found using visual appraisal of the funnel plots or on the Begg and Egger tests.

Authors' conclusions

The use of larger-bore femoral access sheaths (20F or greater) introduced for percutaneous endovascular aortic aneurysm repair after the pre-application of suture-mediated vascular closure devices were implicated in primary failure and the need for conversion to a femoral cutdown. Planned use of multiple suture-mediated vascular closure devices may have been more beneficial when 18F or smaller sheaths were required.

CRD commentary

The review addressed a clear question and criteria for the inclusion of studies were stipulated and reproducible. Some appropriate databases were searched for studies, but the restriction of the review to studies in English meant there was some risk of language bias. In addition, there were no attempts to identify unpublished studies. The authors evaluated the likelihood of publication bias using validated measures and no evidence of publication bias was identified. Steps were reported to minimise errors and bias for study selection and data extraction but were not reported for the assessment of methodological quality.

Very little information was provided about patients in the studies. Included studies were uncontrolled retrospective and prospective studies, including one randomised controlled trial, in which only one treatment arm was evaluated. The results of uncontrolled studies were vulnerable to several potential biases, which meant the pooling the results in a meta-analysis may not have been appropriate. The authors acknowledged some of the limitations of the review including the potential for selection bias. In general, the lack of information on the patients and some methodological flaws meant the results should be interpreted with a substantial degree of caution and the authors' conclusions may not have been reliable.

Implications of the review for practice and research

Practice: The authors stated that the use of large-bore introducers carry technical risks that appeared to increase with the sheath size. For 18F or smaller sheaths, multiple suture-mediated vascular closure devices could reduce conversion to cutdown rates even further.

Research: The authors stated that large randomised controlled trials were required to consolidate the results of the meta-analysis.

Funding

None stated.

Bibliographic details

Georgiadis GS, Antoniou GA, Papaioakim M, Georgakarakos E, Trellopoulos G, Papanas N, Lazarides MK. A meta-analysis of outcome after percutaneous endovascular aortic aneurysm repair using different size sheaths or endograft delivery systems. Journal of Endovascular Therapy 2011; 18(4): 445-459. [PubMed: 21861729]

Original Paper URL

http://jevtonline.org/doi/abs/10.1583/11-342.1

Indexing Status

Subject indexing assigned by NLM

MeSH

Aortic Aneurysm /surgery; Blood Vessel Prosthesis Implantation /adverse effects /instrumentation; Catheters; Endovascular Procedures /adverse effects /instrumentation; Equipment Design; Femoral Artery; Hemorrhage /etiology /prevention & control; Hemostatic Techniques; Humans; Odds Ratio; Punctures; Risk Assessment; Risk Factors; Suture Techniques /adverse effects /instrumentation; Treatment Outcome

AccessionNumber

12011005847

Database entry date

18/05/2012

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.