Cochrane Database of Systematic Reviews

Venous cutdown versus the for placement of totally implantable ports (Protocol)

Hsu CCT, Kwan GNC, van Driel ML, Rophael JA

Hsu CCT, Kwan GNC, van Driel ML, Rophael JA. versus the Seldinger technique for placement of totally implantable venous access ports. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD008942. DOI: 10.1002/14651858.CD008942. www.cochranelibrary.com

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER...... 1 ABSTRACT ...... 1 BACKGROUND ...... 1 OBJECTIVES ...... 3 METHODS ...... 3 REFERENCES ...... 5 CONTRIBUTIONSOFAUTHORS ...... 6 DECLARATIONSOFINTEREST ...... 6 SOURCESOFSUPPORT ...... 6

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) i Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports

Charlie C-T Hsu1, Gigi NC Kwan2, Mieke L van Driel3, John A Rophael4

1The Alfred Hospital, Prahran, Australia. 2Box Hill Hospital, Box Hill, Australia. 3Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia. 4Department of Surgery - St Vincent’s Hospital, University of Melbourne, Fitzroy, Australia

Contact address: Charlie C-T Hsu, The Alfred Hospital, Commercial Road, Prahran, Victoria, 3181, Australia. [email protected].

Editorial group: Cochrane Vascular Group. Publication status and date: New, published in Issue 1, 2011.

Citation: Hsu CCT, Kwan GNC, van Driel ML, Rophael JA. Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD008942. DOI: 10.1002/14651858.CD008942.

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

This is the protocol for a review and there is no abstract. The objectives are as follows:

The review aims to compare the success rate and safety of three commonly used techniques for implanting totally implantable venous access ports (TIVAPs); the venous cutdown technique, the Seldinger technique and the newly described modified Seldinger technique. The review will include studies that use doppler or real time two-dimensional ultrasonography for locating the in the Seldinger technique.

BACKGROUND requiring external dressing, and they are associated with reduced access-related anxiety, pain and discomfort (Bow 1999). TIVAPs Totally implantable venous access ports (TIVAPs) are devices po- are maintained through regular flushing with heparinised sitioned beneath the skin with a reservoir covered with sili- as well as following administration of chemotherapeutic agents to cone rubber. The port is attached to a that enters a cen- maintain patency of the catheter lumen. tral vein. The port is accessed by needle puncture through the pa- tient’s skin and into the port reservoir. TIVAPs have become an important tool for patients undergoing chemotherapeutic inter- Description of the intervention ventions for malignancies. TIVAPS are commonly placed in pa- tients commencing chemotherapy to provide central venous ac- The main approaches to placement of a TIVAP are the venous cess and to reduced the risk of , and extravasa- cutdown technique, the Seldinger technique and the modified tion of chemotherapeutic agents (Ng 2007). Other applications of Seldinger technique. The cephalic vein is most commonly used in TIVAPs include administration of medications, parenteral nutri- the venous cutdown technique, followed by the external jugular tion, transfusion of blood products and periodic blood sampling. vein and less commonly the internal jugular vein and basilic vein. TIVAPs are positioned subcutaneously thus providing several ad- The Seldinger technique involves percutaneous puncture with the vantages over externalised indwelling catheter systems, such as not right internal jugular vein being the ideal site for venous access fol-

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 1 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. lowed by the subclavian or external jugular vein. The right internal anaesthetic. The use of real time ultrasound guidance is a necessity jugular vein runs a straight course to the superior vena cava thus with internal jugular vein puncture. Successful needle entry into minimizing catheter contact with the vessel wall and is of some dis- the vein can be verified by easy flow of blood into the syringe. A tance away from the lung apices. For these reasons internal jugular flexible guidewire is advanced through the hub of the venipunc- vein puncture is associated with a lower risk of catheter malposi- ture needle and passed into the SVC. The needle is withdrawn tion, thrombosis and (presence of air in the pleu- and removed when the guidewire is securely in the SVC. Vein ral cavity) and/or haemothorax (presence of blood in the pleural dilators and a peel-away sheath are used to insert the catheter.A cavity). The anatomy of the external jugular vein is such that both catheter is threaded through the vein dilator sheath into the SVC sides of the vein open into the subclavian at close to right angles, under fluoroscopic guidance so that the correct tip positioning is which can potentially complicate catheter placement and provoke achieved. The vein dilator sheath is constructed so that it tears subclavian vein stenosis and thrombosis. More recently, Knebel et away as it is pulled out of the vein. In contrast to the cephalic vein al described the use of a modified Seldinger technique that employs cutdown technique, two small skin incisions are required. One is attributes of both venous cutdown and the Seldinger technique in- at the guidewire exit site and the second is for implantation of volving the cephalic vein (Knebel 2009). Potential complications the port reservoir in a port pocket created 8 cm from the catheter of these techniques include stenosis, kinking or dislodgement of exist site. The catheter is passed through a subcutaneous tunnel the catheter, subcutaneous haematoma, nerve palsy, thoracic duct to connect to the reservoir port. Finally, the functionality of the injury and wound infection (Di Carlo 2001). The Seldinger tech- TIVAP system is checked by flushing the lumen with heparinised nique in particular reference to subclavian vein puncture is associ- saline solution and an upright chest radiograph is taken to check ated with complications such as pneumothorax, haemothorax and for pneumothorax (Nocito 2009). potential injuries to the great vessels (Di Carlo 2010). Over the Traditionally the Seldinger technique described percutaneous past two decades, there has been a shift in practice towards the puncture using anatomical landmarks. Increasingly ultrasound is Seldinger technique over the venous cutdown technique because used to guide percutaneous . Real time ultrasonog- surgical expertise is not required (Di Carlo 2010). Another factor raphy generates a two dimensional image to locate the that may contribute to the change in practice is that the Seldinger and Doppler ultrasonography generates an audible sound from technique is more cost effective with a shorter turnaround times flowing venous blood. A meta-analysis by Hind et al found that than traditional cutdown technique which requires access to op- real time ultrasound for internal jugular vein procedures in adults erating theatre. resulted in fewer failed catheter placements, fewer complications with catheter placement and a lower failure rate on first attempt (Hind 2003). On the other hand, the use of Doppler ultrasound Venous cutdown technique guidance was less successful and more time consuming than us- An incision is made under local anaesthesia along the deltopectoral ing the anatomical landmark method (Hind 2003). The benefit groove; the cephalic vein is located then dissected out circumfer- of real time ultrasonography in guiding percutaneous puncture of entially. Two separate sutures are placed around the cephalic vein, the subclavian vein, cephalic vein, basilic vein or the axillary vein one proximal and one distal. The suture placed distally around is uncertain as current evidence is sparse. the cephalic vein is securely tied down. The cephalic vein is then partially transected in a transverse fashion along its midportion. A catheter is passed proximally into the lumen of the partially Modified Seldinger technique transected cephalic vein and advanced centrally into the superior vena cava (SVC). The catheter is manipulated under fluoroscopic The modified Seldinger technique involves surgical dissection of guidance until it reaches the desired position above the atrial-caval the cephalic vein with the use of the guidewire and peel away junction. To prevent catheter migration, the suture placed prox- vein dilator sheath featured in the Seldinger technique. The ini- imally around the catheter and the proximal end of the cephalic tial approach involves the cephalic vein cutdown technique, thus vein are tied down in a non-constricting fashion. The catheter is avoiding risks associated with blind percutaneous puncture. After then connected to the implanted port and positioned and secured the cephalic vein is dissected and ligated with an absorbable su- in a port pocket created along the inferior aspect of the infraclav- ture, a guidewire is introduced into the vein and advanced into icular incision. Finally, the functionality of the TIVAP is verified the distal SVC under fluoroscopic guidance. Next, a vein dila- by aspirating blood and by flushing the lumen with heparinised tor and sheath are passed over the guidewire; the guidewire and saline solution (Seiler 2006). dilator are then removed and the catheter introduced through the peel-away sheath. After insertion, the peel-away sheath is removed. Correct positioning of the catheter is checked under fluoroscopy Seldinger technique and the catheter is connected to the TIVAP port. Using the same The Seldinger technique involves percutaneous puncture of the method described above, the reservoir port is placed in a subcu- central most commonly the internal jugular vein under local taneous pocket prepared in the pectoral fascia. The functionality

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 2 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. of the TIVAP is checked through drawing blood and injecting Types of participants heparinised saline solution. The additional use of the guidewire Patients who need an elective TIVAP insertion for treatment of and vein dilator sheath allows the introduction of the catheter into benign or malignant disease. Indications for insertion of a TIVAP smaller cephalic veins and aids navigation through potential ob- include safe administration of chemotherapy, , stacles (Knebel 2009). application of medications, transfusion of blood products and pe- riodic blood sampling. Exclusion criteria: lack of compliance, impaired mental state, ac- quired or congenital coagulopathy and perceived difficulties with Why it is important to do this review venous access. Placement of TIVAPs has increased over the years as a method of delivering chemotherapeutic regimes and for other uses such as Types of interventions administration of medications, parenteral nutrition, transfusion Intervention: the venous cutdown technique (group A) of blood products and periodic blood sampling. It is therefore Comparator: Seldinger technique with or without ultrasound important to identify the placement technique associated with the guidance (group B) highest primary success rate and the least number of complications Comparator: modified Seldinger technique (group C) and also the technique associated with greater patient satisfaction.

Types of outcome measures

OBJECTIVES Primary outcomes • The primary outcome is defined as the correct placement of The review aims to compare the success rate and safety of three a functional TIVAP. The position of the catheter tip is checked commonly used techniques for implanting totally implantable ve- by fluoroscopy and the functionality assessed by aspiration of nous access ports (TIVAPs); the venous cutdown technique, the blood as well as injection of heparinised saline solution during Seldinger technique and the newly described modified Seldinger the procedure. technique. The review will include studies that use doppler or real time two-dimensional ultrasonography for locating the vein in the Seldinger technique. Secondary outcomes • The secondary outcome is defined as the correct placement of a functional TIVAP after conversion to an alternative technique; for example, from venous cutdown technique to the METHODS Seldinger technique. • Procedure failure defined as: ◦ absence of functional TIVAP: vein not found, vein too small, venous occlusion, inability to advance catheter, failure of Criteria for considering studies for this review venepuncture. • Perioperative and postoperative complications up to 30 days after intervention: ◦ death, thrombosis, stenosis, kinking or dislodgement Types of studies of the catheter or reservoir port, subcutaneous haematoma, nerve Randomised or quasi-randomised controlled clinical trials com- palsy, thoracic duct injury, pneumothorax, haemothorax; ◦ paring the venous cutdown technique with the Seldinger tech- that are ⋄ nique and the modified Seldinger technique for implantation of localised, such as insertion site infection, TIVAPs. The review will encompass all potential venous access phlebitis, reservoir infection, subcutaneous tunnel infection, ⋄ locations, involving both superficial and deep arm veins: cephalic systemic, such as sepsis, suppurative vein, basilic vein, axillary vein, subclavian vein, internal and ex- thrombophlebitis, endocarditis or metastatic abscess. • ternal jugular veins. Trials of the Seldinger technique with the use Patient outcomes: ◦ of ultrasound guidance will be included in the review. A distinc- duration of the procedure; ◦ tion will be made between real time ultrasound and doppler ul- postoperative pain; ◦ trasound. patient satisfaction.

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 3 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Search methods for identification of studies 2. allocation concealment; 3. blinding (of participants, personnel and outcome assessors); 4. completeness of data; Electronic searches 5. selective outcome reporting; The Cochrane Peripheral Vascular Diseases (PVD) Group will 6. other sources of bias. search their Specialised Register and the Cochrane Central Regis- The authors will evaluate each criterion as ’Yes’ (low risk of bias) ter of Controlled Trials (CENTRAL) (The Cochrane Library). The or ’No’ (high risk of bias). If these criteria are not discussed, the Specialised Register is maintained by the Trials Search Co-ordina- authors will judge the risk of bias as ’Unclear’. tor and is constructed from weekly electronic searches of MED- LINE, EMBASE, CINAHL and AMED, and through hand- Measures of treatment effect searching relevant journals. The full list of the databases, journals and conference proceedings which have been searched, as well as When dealing with dichotomous outcome measures, we aim to the search strategies used, are described in the Specialised Register calculate a pooled estimate of the treatment effect for each outcome section of the Cochrane PVD Group module in The Cochrane Li- across trials using the odds ratio (OR) (the odds of an outcome brary. among treatment-allocated participants to the corresponding odds among participants in the control group) and the 95% confidence interval (CI). For continuous outcomes, we plan to record either Searching other resources mean change from baseline for each group or mean post-inter- We will search citations within identified studies and contact au- vention values and standard deviation (SD) for each group. Then, thors of the identified studies about unpublished studies. We will where appropriate, we will calculate a pooled estimate of treatment contact manufacturers of the devices for unpublished and pub- effect by calculating the mean difference and SD. lished studies. There will be no restriction on language.

Unit of analysis issues Data collection and analysis Cross-over trials will not be included in the review because there is only a single treatment designated to each group. In case of cluster- All randomised or quasi-randomised trials that compare the suc- randomised trials, where the unit of randomisation is not the same cess rate of the venous cutdown technique with the Seldinger or as the unit of analysis, appropriate adjustment for clustering will modified Seldinger techniques will be identified. Once the stud- be performed. ies are selected, two authors (CC-TH and GNCK) will indepen- dently extract data from the studies. Dealing with missing data Selection of studies In order to allow an intention-to-treat analysis, we will seek data on Two authors (CC-TH and GNCK) will independently assess any the number of participants with each outcome event by allocated studies identified for inclusion in the review using the criteria treatment group irrespective of compliance and whether or not the stated above. Disagreements between the two authors will be re- participant was later thought to be ineligible or otherwise excluded solved by discussion or by consulting a third author (MLvD). from the treatment or follow up. The review authors will request any missing data from the original investigators, if appropriate.

Data extraction and management Two authors (CC-TH and GNCK) will independently extract Assessment of heterogeneity data from the included studies using a standard data extraction Heterogeneity will be assessed using a two-staged approach. Firstly, form created for the review. face value heterogeneity will be assessed (for example population, setting, risk of complications). Secondly, we plan to assess statistical heterogeneity in the meta-analysis using the I2 statistic (Higgins Assessment of risk of bias in included studies 2009). Reasons for heterogeneity will also be explored. A guide to The authors (CC-TH, GNCK and MLvD) will assess the risk interpretation is described in the Cochrane Handbook (Higgins of bias for each study as described in the Cochrane Handbook 2009) as: for Systematic Reviews of Interventions 5.0.1 (Higgins 2008). • 0% to 40% might not be important; The authors will assess the risk of bias for each of the following • 30% to 60% may represent moderate heterogeneity; domains: • 50% to 90% may represent substantial heterogeneity; 1. randomisation; • 75% to 100% represents considerable heterogeneity.

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 4 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The observed importance of the I2 statistic depends on factors Subgroup analysis and investigation of heterogeneity including: (i) magnitude and direction of effects, and (ii) strength • Reasons for implanting TIVAP of evidence for heterogeneity determined by the P value from the ◦ malignancy: administration of chemotherapy; 2 2 Chi test or a confidence interval for the I statistic (Higgins 2009). ◦ other: parenteral nutrition, application of pharmaceutical drugs, transfusion of blood products, and recurrent blood sampling. • Insertion site: Assessment of reporting biases ◦ subclavian vein; We will investigate publication bias using funnel plots if we are able ◦ cephalic vein; to include a sufficient number of studies (at least 10), as recom- ◦ basilic vein; mended by the Cochrane Handbook 5.0.1 (Higgins 2008; Sterne ◦ internal jugular vein; 2001). If we detect asymmetry, we will explore causes other than ◦ external jugular vein; publication bias. Asymmetrical funnel plots can indicate outcome ◦ axillary vein. reporting bias (ORB) or heterogeneity. If ORB is suspected, trial- • Experience of the operator (surgeon or interventional ists will be contacted. Outcome reporting bias can be assessed by radiologist): years, additional certifications. comparing the methods section of a published trial to the results • Anatomical landmark technique versus the use of either section where the original protocol is not available. doppler or real time two-dimensional ultrasonography in the Seldinger technique.

Data synthesis Sensitivity analysis We plan to use a fixed-effect model in our analysis. If we detect If possible, we plan to perform a sensitivity analysis to assess the moderate heterogeneity (I2 > 30%), we plan to reassess the signif- impact of trials with high risk of bias on the overall outcome of icance of the treatment effect by using a random-effects model. the pooling of data.

REFERENCES

Additional references Higgins 2009 Higgins JPT, Green S, editors. Cochrane Handbook Bow 1999 for Systematic Reviews of Interventions Version 5.0.2 Bow EJ, Kilpatrick MG, Clinch JJ. Totally implantable [updated September 2009]. Available from www.cochrane- venous access ports systems for patients receiving handbook.org. The Cochrane Collaboration, 2009. chemotherapy for solid tissue malignancies: A randomized Hind 2003 controlled clinical trial examining the safety, efficacy, costs, Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, and impact on quality of life. Journal of Clinical Oncology Beverley C, et al. Ultrasonic locating devices for central 1999;17(4):1267. venous cannulation: meta-analysis. BMJ 2003;327(7411): Di Carlo 2001 361. Di Carlo I, Cordio S, La Greca G, Privitera G, Russello D, Knebel 2009 Puleo S, et al. Totally implantable venous access devices Knebel P, Fischer L, Huesing J, Hennes R, Büchler implanted surgically: a retrospective study on early and late MW, Seiler CM. Randomized clinical trial of a modified complications. Archives of Surgery 2001;136(9):1050–3. Seldinger technique for open central venous cannulation for implantable access devices. The British Journal of Surgery Di Carlo 2010 2009;96(2):159–65. Di Carlo I, Pulvirenti E, Mannino M, Toro A. Increased use Ng 2007 of percutaneous technique for totally implantable venous Ng F, Mastoroudes H, Paul E, Davies N, Tibballs J, access devices. Is it real progress? A 27-year comprehensive Hochhauser D, et al. A comparison of Hickman line- and review on early complications. Annals of Surgical Oncology Port-a-Cath-associated complications in patients with solid 2010;17(6):1649–56. tumours undergoing chemotherapy. Clinical Oncology Higgins 2008 (Royal College of Radiologist (Great Britain)) 2007;19(7): Higgins JPT, Green S, editors. Cochrane Handbook 551–6. for Systematic Reviews of Interventions Version 5.0.1 Nocito 2009 [updated September 2008]. Available from www.cochrane- Nocito A, Wildi S, Rufibach K, Clavien PA, Weber M. handbook.org. The Cochrane Collaboration, 2008. Randomized clinical trial comparing venous cutdown with

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 5 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. the Seldinger technique for placement of implantable venous access ports. The British Journal of Surgery 2009;96 (10):1129–34. Seiler 2006 Seiler CM, Frohlich BE, Dorsam UJ, Kienle P, Buchler MW, Knaebel HP.Surgical technique for totally implantable access ports (TIAP) needs improvement: a multivariate analysis of 400 patients. Journal of Surgical Oncology 2006;1 (93):24–9. Sterne 2001 Sterne JA, Egger M. Funnel plots for detecting bias in meta- analysis: guidelines on choice of axis. Journal of Clinical Epidemiology 2001;54(10):1046–55. ∗ Indicates the major publication for the study

CONTRIBUTIONSOFAUTHORS The protocol was written by Charlie Chia-Tsong Hsu (CC-TH), Gigi Nga Chi Kwan (GNCK) and John A Rophael (JAR). Mieke L van Driel (MLvD) commented on the protocol and provided support in assessing the methodological quality of the protocol.

DECLARATIONSOFINTEREST None known

SOURCES OF SUPPORT

Internal sources • No sources of support supplied

External sources • Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports (Protocol) 6 Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.