Dataset Information

Meta-analysis of primary open versus closed cannulation strategy for totally implantable venous access port implantation.

ABSTRACT:

Background

There is still no reference standard for the implantation of totally implantable venous access ports (TIVAPs). A recently published multicentre randomised controlled trial (RCT) revealed a significantly greater risk of pneumothorax after closed cannulation than after an open strategy. The aim of this meta-analysis was to provide an update of the available evidence for the safety and effectiveness of primary open versus closed cannulation strategy.

Methods

RCTs comparing outcomes of open cut-down of the cephalic vein and closed cannulation of the subclavian vein were sought systematically in MEDLINE, Web of Science and CENTRAL. The primary outcome was the occurrence of pneumothorax. A beta-binominal model was applied to combine the respective outcomes, and results are presented as odds ratios (OR) with 95% confidence interval (CI).

Results

Six RCTs with a total of 1831 patients were included in final analysis. Meta-analysis showed statistically significant superiority of the open cut-down technique regarding pneumothorax (OR 0.308, 95% CI 0.122 to 0.776), but a statistically significant higher failure of the primary technique for the open cut-down technique than for closed cannulation (OR 2.364, 95% CI 1.051 to 5.315). There were no significant differences between the two procedures regarding other morbidity endpoints.

Conclusion

This meta-analysis shows a general superiority of open cut-down of the cephalic vein over closed cannulation of the subclavian vein regarding the occurrence of pneumothorax. Open cut-down should be the first-line approach for TIVAP implantation. Closed cannulation should be performed with ultrasound as second-line procedure if the open technique fails.

Systematic review registration

PROSPERO CRD42013005180.

SUBMITTER: Klaiber U

PROVIDER: S-EPMC8106576 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Totally implantable venous access port (TIVAP) implantation is one of the most often performed operations in general surgery (over 100,000/year in Germany). The two main approaches for TIVAP placement are insertion into the cephalic vein through an open cut-down technique (OCD) or closed cannulation technique of the subclavian vein (CC) with Seldinger technique. Both procedures are performed with high success rates and very low complication frequencies. Because of the low incidence of complications, no single interventional trial is able to report a valid comparison of peri- and postoperative complication frequencies between both techniques. Therefore, the aim of this systematic review is to summarize evidence for peri- and postoperative complication rates in patients undergoing OCD or CC.A systematic literature search will be conducted in The Cochrane Library, MEDLINE, and Embase to identify randomized controlled trials (RCTs), observational clinical studies (OCS), or case series (CS) reporting peri- and/or postoperative complications of at least one implantation technique. A priori defined data will be extracted from included studies, and methodological quality will be assessed. Event rates with their 95% confidence intervals will be derived taking into account the follow-up time per study by patient-months where appropriate. Pooled estimates of event rates with corresponding 95% confidence intervals will be calculated on the base of the Freeman-Tukey double arcsine transformation within a random effect model framework.The findings of this systematic review with proportional meta-analysis will help to identify the procedure with the best benefit/risk ratio for TIVAP implantation. This may have influence on daily practice, and data may be implemented in treatment guidelines. Considering the impact of TIVAP implantation on patients' well being together with its socioeconomic relevance, patients will benefit from evidence-based treatment and health-care costs may also be reduced.PROSPERO CRD42013005180.

Project description:The insertion of central venous access devices, such as totally implantable venous access ports (TIVAPs), is routine in patients who need a safe and permanent venous access. The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies. Currently, two different strategies are being routinely used: surgical cut-down of the cephalic vein (vena section) and direct puncture of the subclavian vein. The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax.The PORTAS-3 trial is designed as a multicentre, randomised controlled trial to compare two implantation strategies. A total of 1,154 patients will be randomised after giving written informed consent. Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side. The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies. The experimental intervention is as follows: open strategy, defined as surgical cut-down of the cephalic vein, supported by a rescue technique if necessary, and in the case of failure, direct puncture of the subclavian vein. The control intervention is as follows: direct puncture of the subclavian vein using the Seldinger technique guided by sonography, fluoroscopy or landmark technique. The trial duration is approximately 36 months, with a recruitment period of 18 months and a follow-up period of 30 days.The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax. Since TIVAP implantation is one of the most common procedures in general surgery, the results will be of interest for a large community of surgeons as well as oncologists and general practitioners. The pragmatic trial design ensures that the results will be generalizable to a wide range of patients.The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register (DRKS00004900) . The World Health Organization's Universal Trial Number is U1111-1142-4420.