Venodisección versus técnica de Seldinger para la colocación de los dispositivos de acceso venoso totalmente implantables
Resumen
Antecedentes
Los puertos de acceso venoso totalmente implantables (PAVTI) proporcionan a los pacientes un acceso venoso seguro y permanente, por ejemplo, para la administración de la quimioterapia en los pacientes de oncología. Hay varios métodos para la colocación de un PAVTI y no está claro el método óptimo basado en las pruebas.
Objetivos
Comparar la eficacia y la seguridad de tres técnicas utilizadas con frecuencia para implantar un PAVTI: la técnica de venodisección, la técnica de Seldinger y la técnica de Seldinger modificada. Esta revisión incluye estudios que utilizaron la ecografía Doppler o bidimensional en tiempo real para localizar la vena en la técnica de Seldinger.
Métodos de búsqueda
El coordinador de búsqueda de ensayos del Grupo Cochrane Vascular (Cochrane Vascular Group) buscó en el registro especializado del Grupo Cochrane Vascular (última búsqueda agosto 2015) y en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL) (2015, número 7), así como en registros de ensayos clínicos.
Criterios de selección
Se incluyeron los ensayos clínicos controlados aleatorios o cuasialeatorios que asignaron al azar a los pacientes que requerían un PAVTI a venodisección, Seldinger o técnica de Seldinger modificada. Dos autores de la revisión evaluaron de forma independiente la elegibilidad de los estudios para la inclusión, y un tercer autor de la revisión verificó los estudios excluidos.
Obtención y análisis de los datos
Dos autores de la revisión extrajeron los datos de forma independiente. Se evaluó el riesgo de sesgo de todos los estudios. La heterogeneidad se evaluó mediante los métodos estadísticos Ji2 y de la varianza (estadística I2). Los resultados dicotómicos, resumidos como odds ratio (OR) con intervalo de confianza (IC) del 95%, fueron: éxito de la implantación primaria, complicaciones (en particular la infección), neumotórax y complicaciones del catéter. Se realizaron análisis separados para evaluar las dos venas de acceso, la vena subclavia y la yugular interna (YI), en la técnica de Seldinger versus la técnica de venodisección. Se utilizaron análisis de intención de tratar y por tratamiento y los datos se agruparon mediante el modelo de efectos fijos.
Resultados principales
En la revisión se incluyeron nueve estudios con 1253 participantes. Cinco estudios compararon la técnica de Seldinger (acceso en la vena subclavia) con la técnica de venodisección (acceso en la vena cefálica). Dos estudios compararon Seldinger (vena YI) versus venodisección (vena cefálica). Un estudio comparó la técnica modificada de Seldinger (vena cefálica) con la venodisección (vena cefálica), y un estudio comparó la técnica de Seldinger (vena subclavia) versus Seldinger (vena YI).
Técnica de Seldinger (acceso en la vena subclavia o YI) versus venodisección (vena cefálica): En el análisis se incluyeron siete estudios con 1006 participantes. El análisis por intención de tratar (OR 0,40; IC del 95%: 0,25 a 0,65) y el análisis por tratamiento (OR 0,59; IC del 95%: 0,36 a 0,98) mostraron que la técnica de Seldinger para la implantación de un PAVTI tuvo una tasa mayor de éxito en comparación con la técnica de venodisección. No se encontraron diferencias entre las tasas de complicaciones generales perioperatorias y posoperatorias: análisis por intención de tratar (OR 1,16; IC del 95%: 0,76 a 1,75) y análisis por tratamiento (OR 0,93; IC del 95%: 0,62 a 1,40). En el grupo de Seldinger, la mayoría de los ensayos informó el uso de la vena subclavia para el acceso venoso y sólo un número limitado de ensayos utilizó la vena YI para el acceso. Cuando se analizaron las tasas de complicaciones individuales de infección, neumotórax y las complicaciones del catéter, la técnica de Seldinger (acceso en la vena subclavia) se asoció con una tasa mayor de complicaciones del catéter en comparación con la técnica de venodisección: análisis por intención de tratar (OR 6,77; IC del 95%: 2,31 a 19,79) y análisis por tratamiento (OR 6,62; IC del 95%: 2,24 a 19,58). No hubo diferencias en la incidencia de infecciones, neumotórax y otras complicaciones entre los grupos.
Técnica modificada de Seldinger (vena cefálica) versus venodisección (vena cefálica): Se identificó un ensayo con 164 participantes. El análisis por intención de tratar no mostró diferencias en la tasa de éxito de la implantación primaria entre la técnica de Seldinger modificada (69/82, 84%) y la técnica de venodisección (66/82, 80%), P = 0,686. No se observaron diferencias en las tasas de complicaciones perioperatorias o posoperatorias.
Seldinger (acceso en la vena subclavia) versus Seldinger (acceso en la vena YI): Se identificó un ensayo con 83 participantes. La tasa de éxito primario fue del 84% (37/44) para Seldinger (vena subclavia) versus del 74% (29/39) para Seldinger (vena YI). Hubo una mayor tasa de complicaciones generales en el grupo subclavio (48%) en comparación con el grupo yugular (23%), P = 0,02. Sin embargo, cuando las complicaciones específicas se compararon individualmente no se encontraron diferencias entre los grupos.
La calidad general de los ensayos incluidos en esta revisión fue moderada. Los métodos utilizados para la asignación al azar no fueron adecuados en cuatro de los nueve estudios incluidos, pero el análisis de sensibilidad que excluyó estos ensayos no modificó el resultado. La naturaleza de las intervenciones, de la venodisección o de las técnicas de Seldinger hizo que no fuera factible cegar al participante o al personal, por lo que se consideró que hubo bajo riesgo de sesgo. La mayoría de los participantes de los ensayos incluidos fueron pacientes de oncología de centros terciarios y los resultados fueron aplicables al escenario clínico habitual. En todos los resultados, cuando se comparó la venodisección y la técnica de Seldinger fue evidente una imprecisión importante por los intervalos de confianza amplios en los ensayos incluidos. Por lo tanto, la calidad general de las pruebas se disminuyó de alta a moderada. Debido al número limitado de estudios incluidos no fue posible evaluar el sesgo de publicación.
Conclusiones de los autores
Pruebas de calidad moderada indicaron que la técnica de Seldinger tiene una mayor tasa de éxito de la implantación primaria en comparación con la técnica de venodisección. La mayoría de los ensayos que aplicaron la técnica de Seldinger utilizaron la vena subclavia para el acceso venoso y sólo unos pocos ensayos informaron el uso de la vena yugular interna para el acceso venoso. Pruebas de calidad moderada no mostraron diferencias en la tasa de complicaciones generales entre las técnicas de Seldinger y de venodisección. Sin embargo, cuando la técnica de Seldinger con acceso en la vena subclavia se comparó con el grupo de venodisección se informó una mayor incidencia de complicaciones del catéter. Las tasas de neumotórax e infección no difirieron entre el grupo de Seldinger y de venodisección. Sólo se identificó un ensayo en cada una de las comparaciones de la técnica de Seldinger modificada (vena cefálica) versus venodisección (vena cefálica) y Seldinger (acceso en la vena subclavia) versus Seldinger (acceso en la vena YI), por lo que no es posible establecer una conclusión definitiva a partir de estas comparaciones y se recomienda la realización de estudios de investigación adicionales.
PICOs
Resumen en términos sencillos
Venodisección versus técnica de Seldinger para la colocación de los dispositivos de acceso venoso totalmente implantables
Antecedentes
Los puertos de acceso venoso totalmente implantables (PAVTI) proporcionan a los pacientes un acceso seguro y permanente a una vena. Se utilizan a menudo en pacientes que necesitan la administración continua de fármacos inyectables, como los que reciben quimioterapia. Los PAVTI también se utilizan cuando se necesita administrar de forma regular fármacos intravenosos, transfusión de productos sanguíneos o nutrición por vía parenteral, o si se requiere la toma periódica regular de muestras sanguíneas. Hay dos métodos para la inserción o la implantación de un PAVTI: la técnica de venodisección quirúrgica es un procedimiento quirúrgico abierto donde se abre y se accede a la vena cefálica y la técnica de Seldinger que utiliza un acceso percutáneo (a través de la piel sin tener que preparar quirúrgicamente la vena) de la vena subclavia o la yugular interna (YI). Se revisaron las pruebas disponibles de los ensayos controlados aleatorios para evaluar la efectividad y la seguridad de diferentes técnicas de inserción de un PAVTI, mediante la comparación de las tasas de éxito y las complicaciones.
Características de los estudios y resultados clave
Se incluyeron nueve estudios con un total de 1253 participantes en la revisión (actualizada hasta agosto 2015). Cinco estudios compararon la técnica de Seldinger (vena subclavia) con la técnica de venodisección (vena cefálica). Dos estudios compararon la técnica de Seldinger (vena YI) versus la venodisección (vena cefálica). Un estudio comparó la técnica modificada de Seldinger (vena cefálica) con la venodisección (vena cefálica) y un estudio comparó la técnica de Seldinger (vena subclavia) con la técnica de Seldinger (vena YI). La técnica de Seldinger tuvo una tasa mayor de éxito que la técnica de venodisección. Para la técnica de Seldinger, la mayoría de los ensayos utilizó la vena subclavia para el acceso venoso y sólo dos ensayos informaron el uso de la vena YI. En los ensayos que utilizaron la técnica de Seldinger con acceso subclavio, más participantes presentaron complicaciones del catéter con respecto a los que habían estado expuestos a la técnica de venodisección. Sin embargo, no hubo diferencias en las tasas de complicaciones generales entre las técnicas de Seldinger y venodisección. Las comparaciones entre la técnica modificada de Seldinger (con el uso de la vena cefálica) y la técnica de venodisección (también con el uso de la vena cefálica) y entre las técnicas de Seldinger (acceso en la vena subclavia) y Seldinger (acceso en la vena YI) estuvieron limitadas por los tamaños de la muestra pequeños, por lo que no es posible establecer una conclusión definitiva a partir de estas comparaciones y se recomienda la realización de estudios adicionales.
Calidad de la evidencia
La calidad general de los ensayos incluidos era moderada. Los métodos utilizados para la asignación al azar no fueron adecuados en cuatro de los nueve estudios incluidos, pero un análisis que excluyó estos ensayos no modificó el resultado. La naturaleza de las intervenciones, de la venodisección o de las técnicas de Seldinger hizo que no fuera factible cegar al participante o al personal, por lo que se consideró que hubo bajo riesgo de sesgo. La gran mayoría de los participantes de los ensayos incluidos fueron pacientes con cáncer de centros terciarios, y los resultados fueron aplicables al escenario clínico habitual. En todos los resultados, cuando se comparó la venodisección y la técnica de Seldinger fue evidente una imprecisión importante por los intervalos de confianza amplios en los ensayos incluidos. Por lo tanto, la calidad general de las pruebas se disminuyó de alta a moderada. Debido al número limitado de estudios incluidos no fue posible evaluar el sesgo de publicación.
Authors' conclusions
Summary of findings
| Venous cutdown versus Seldinger technique for placement of implantable venous access ports | ||||||
| Patient or population: patients requiring an elective TIVAP insertion for treatment of benign or malignant disease | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with venous cutdown technique | Risk with Seldinger technique | |||||
| Success of primary implantation | Study population | OR 0.40 | 1006 | ⊕⊕⊕⊝ | ||
| 113 per 1000 | 48 per 1000 | |||||
| Moderate | ||||||
| 118 per 1000 | 51 per 1000 | |||||
| Overall perioperative and postoperative complications | Study population | OR 1.16 | 1006 | ⊕⊕⊕⊝ | ||
| 92 per 1000 | 105 per 1000 | |||||
| Moderate | ||||||
| 59 per 1000 | 68 per 1000 | |||||
| Pneumothorax | Study population | OR 1.97 | 1006 | ⊕⊕⊕⊝ | ||
| 2 per 1000 | 5 per 1000 | |||||
| Infections | Study population | OR 0.63 | 906 | ⊕⊕⊕⊝ | ||
| 29 per 1000 | 18 per 1000 | |||||
| Moderate | ||||||
| 21 per 1000 | 13 per 1000 | |||||
| Catheter/port‐related complications | Study population | OR 1.00 | 1006 | ⊕⊕⊕⊝ | ||
| 62 per 1000 | 62 per 1000 | |||||
| Moderate | ||||||
| 20 per 1000 | 20 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Wide confidence interval ‐ imprecision ‐ downgraded by one level. | ||||||
Background
Totally implantable venous access ports (TIVAPs) are subcutaneous reservoir ports with a catheter that reside in the superior vena cava or central veins. TIVAPs are commonly placed in patients prior to commencement of chemotherapy to provide central venous access and to reduce the risk of thrombosis, infection, and extravasation of chemotherapeutic agents (Ng 2007). Other applications of TIVAPs include administration of medications, parenteral nutrition, transfusion of blood products, and periodic blood sampling. The reservoir port is accessed by needle puncture through the patient's skin. TIVAP is positioned beneath the skin, thus providing several advantages over externalised indwelling catheter systems including reduced access‐related anxiety, pain, and discomfort (Bow 1999).
Description of the intervention
The main approaches to placement of a TIVAP are the venous cutdown, the Seldinger, and a recently described modified Seldinger technique. The venous cutdown technique uses the cephalic vein and requires skin incision and surgical dissection of the cephalic vein. Venotomy is then performed to allow catheter insertion. The modified Seldinger technique is similar to the venous cutdown technique with the addition of a guidewire and peel‐away vein dilator sheath featured to further assist in catheter insertion and placement.
The Seldinger technique involves percutaneous puncture of either the internal jugular vein or the subclavian vein. The right internal jugular vein is most commonly used because its leads directly to the superior vena cava, thus minimising catheter contact with the vessel wall. This unique anatomy may explain the lower risk of catheter malposition, thrombosis, and pneumothorax/haemothorax. Although traditionally the Seldinger technique is based on anatomical landmarks, ultrasonography‐guided venous access has become universal in obtaining vascular access. A meta‐analysis by Hind et al found that real‐time ultrasound for internal jugular vein procedures in adults resulted in fewer failed catheter placements, fewer complications with catheter placement, and a lower failure rate on first attempt (Hind 2003).
Potential complications of TIVAP placement techniques include stenosis, kinking, or dislodgement of the catheter, subcutaneous haematoma, and wound infection (Di Carlo 2001). The Seldinger technique, in particular the subclavian vein puncture, may be associated with complications such as pneumothorax, haemothorax, and injuries to the great vessels (Di Carlo 2010).
Over the past two decades, there has been a shift in practice towards the Seldinger technique over the venous cutdown technique due to the availability of operators, perceived cost‐effectiveness of the procedure, and probable shorter procedure time than the venous cutdown technique, which requires access to an operating theatre. This review investigated the success rates and complications of TIVAP placement comparing the three techniques.
Why it is important to do this review
Over the years placement of TIVAPs has increasingly been used as a method of delivering chemotherapeutic regimes and for other uses such as administration of medications, parenteral nutrition, transfusion of blood products, and periodic blood sampling. It is therefore important to identify the placement technique associated with the highest primary success rate and the lowest risk of complications, as well as the technique associated with the greatest patient satisfaction.
Objectives
To compare the efficacy and safety of three commonly used techniques for implanting totally implantable venous access ports (TIVAPs): the venous cutdown technique, the Seldinger technique, and the modified Seldinger technique. The review includes studies that use Doppler or real‐time two‐dimensional ultrasonography for locating the vein in the Seldinger technique.
Methods
Criteria for considering studies for this review
Types of studies
Randomised or quasi‐randomised controlled clinical trials comparing the venous cutdown technique with the Seldinger technique and the modified Seldinger technique for implantation of TIVAPs. This review encompassed all potential venous access locations, involving both superficial and deep arm veins: cephalic vein, basilic vein, axillary vein, subclavian vein, and internal and external jugular veins. We included trials of the Seldinger technique with the use of ultrasound guidance. A distinction was made between real‐time brightness mode ultrasound with/without colour Doppler function and Doppler ultrasound which only provides auditory feedback.
Types of participants
People requiring an elective TIVAP insertion for treatment of benign or malignant disease. Indications for insertion of a TIVAP include safe administration of chemotherapy, parenteral nutrition, application of medications, transfusion of blood products, and recurrent periodic blood sampling.
Exclusion criteria: lack of compliance, impaired mental state, acquired or congenital coagulopathy, and perceived difficulties with venous access.
Types of interventions
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Seldinger group: a percutaneous technique with use of either the subclavian vein or internal jugular vein.
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Venous cutdown group: a surgical technique which uses the cephalic vein.
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Modified Seldinger group: a hybrid surgical technique which also uses the cephalic vein.
Types of outcome measures
Primary outcomes
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The correct placement of a functional TIVAP (success of primary implantation). The position of the catheter tip was checked by fluoroscopy and the functionality assessed by aspiration of blood as well as injection of heparinised saline solution during the procedure. Initial procedural failure could include the following: vein not found, vein too small, venous occlusion, inability to advance catheter, failure of venepuncture.
Secondary outcomes
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Overall perioperative and postoperative complications: pneumothorax, infection, catheter/port‐related complications, and others
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Pneumothorax/haemothorax
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Infections: localised infection: insertion site infection, reservoir infection, subcutaneous tunnel infection; or systemic infection such as sepsis, septic deep vein thrombosis, endocarditis, or septic emboli.
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Catheter/port related‐complications: thrombosis, fibrin sleeve, stenosis, kinking, extravasation, or migration of the catheter or dislodgement of the reservoir port.
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Other complications: mortality, haematoma, seroma, nerve palsy, thoracic duct injury.
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Patient outcomes
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Duration of the procedure
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Postoperative pain
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Patient satisfaction
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Search methods for identification of studies
There was no restriction on language.
Electronic searches
The Cochrane Vascular Trials Search Co‐ordinator (TSC) searched the Cochrane Vascular Specialised Register (August 2015). In addition, the TSC searched the Cochrane Register of Studies (CRS) (www.metaxis.com/CRSWeb/Index.asp) (Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 7)). See Appendix 1 for details of the search strategy used to search the CRS. The Specialised Register is maintained by the TSC and is constructed from weekly electronic searches of MEDLINE, EMBASE, CINAHL, AMED, and through handsearching relevant journals. The full list of the databases, journals, and conference proceedings which have been searched, as well as the search strategies used, are described in the Specialised Register section of the Cochrane Vascular module in the Cochrane Library (www.cochranelibrary.com).
The TSC searched the following trial databases (August 2015) using the term 'Seldinger' for details of ongoing and unpublished studies:
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World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch/);
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ClinicalTrials.gov (clinicaltrials.gov/);
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Current Controlled Trials (www.controlled‐trials.com/).
Searching other resources
We searched citations within identified studies and contacted authors of the identified studies to inquire about potential unpublished studies.
Data collection and analysis
All randomised or quasi‐randomised trials that compared the success rate of the venous cutdown technique with the Seldinger or modified Seldinger techniques were eligible. Once the studies were selected, two review authors (CC‐TH and GNCK) independently extracted data from the studies.
Selection of studies
Two review authors (CC‐TH and GNCK) independently assessed the identified studies for inclusion in the review using the criteria stated above. The two review authors resolved disagreements by discussion or by consulting a third review author (MLvD). The third review authors (MLvD) also checked the excluded studies.
Data extraction and management
Two review authors (CC‐TH and GNCK) independently extracted data from the included studies using a standard data extraction form created for the review. The two review authors resolved disagreements by discussion or by consulting a third review author (MLvD).
Assessment of risk of bias in included studies
Three review authors (CC‐TH, GNCK, and MLvD) assessed the risk of bias for each study as described in the Cochrane Handbook for Systematic Reviews of Interventions 5.1 (Higgins 2011). We assessed the risk of bias for each of the following domains:
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randomisation;
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allocation concealment;
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blinding (of participants, personnel, and outcome assessors);
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completeness of data;
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selective outcome reporting;
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other sources of bias.
The review authors evaluated each criterion as 'low risk of bias', 'high risk of bias', or if these criteria were not discussed in the publication, as 'unclear'.
Measures of treatment effect
When dealing with dichotomous outcome measures, we calculated a pooled estimate of the treatment effect for each outcome across trials using the odds ratio (OR) (the odds of an outcome among treatment‐allocated participants to the corresponding odds among participants in the control group) and the 95% confidence interval (CI). For continuous outcomes, we recorded either mean change from baseline for each group or mean post‐intervention values and standard deviation (SD) for each group. Then, where appropriate, we calculated a pooled estimate of treatment effect by calculating the mean difference and SD.
Unit of analysis issues
We did not include cross‐over trials in the review because only a single treatment is designated to each group. We did not include cluster‐randomised trials, where the unit of randomisation is not the same as the unit of analysis.
Dealing with missing data
In order to allow an intention‐to‐treat analysis, we sought data on the number of participants with each outcome event by allocated treatment group irrespective of compliance and whether or not the participant was later thought to be ineligible or otherwise excluded from the treatment or follow‐up. We analysed the overall data using both intention‐to‐treat and on‐treatment analysis. We scrutinised difference in both analyses for both confidence interval and statistical significance.
Assessment of heterogeneity
We assessed heterogeneity using a two‐stage approach. Firstly, we assessed face value heterogeneity (for example population, setting, risk of complications). Secondly, we assessed statistical heterogeneity in the meta‐analysis using the I2 statistic (Higgins 2011). A guide to interpretation is described in the Cochrane Handbook as (Higgins 2011):
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0% to 40% might not be important;
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30% to 60% may represent moderate heterogeneity;
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50% to 90% may represent substantial heterogeneity;
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75% to 100% represents considerable heterogeneity.
The observed importance of the I2 statistic depends on factors including: (i) magnitude and direction of effects, and (ii) strength of evidence for heterogeneity determined by the P value from the Chi2 test or a confidence interval for the I2 statistic (Higgins 2011).
We explored and discussed reasons for heterogeneity in the Discussion section of this review.
Assessment of reporting biases
We were unable to investigate publication bias as an insufficient number of studies were available for a funnel plot (at least 10 required), as recommended by the Cochrane Handbook 5.1 (Higgins 2011; Sterne 2001). If we suspected reporting bias, we contacted trial authors. We assessed outcome reporting bias by comparing the methods section of a published trial to the results section where the original protocol was not available.
Data synthesis
We used a fixed‐effect model in our analysis. However, if moderate (or more) heterogeneity (I2 greater than 30%) was detected, we reassessed the significance of the treatment effect by using a random‐effects model in the form a sensitivity analysis.
Subgroup analysis and investigation of heterogeneity
Where data were available, we planned to perform the following separate analyses for the potential percutaneous puncture sites.
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Potential percutaneous puncture site
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subclavian vein
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internal jugular vein
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cephalic vein
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basilic vein
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external jugular vein
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axillary vein
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Where data were available, we planned to perform the following subgroup analyses.
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Reasons for implanting TIVAP
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malignancy: administration of chemotherapy
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other: parenteral nutrition, application of pharmaceutical drugs, transfusion of blood products, and recurrent periodic blood sampling
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Experience of the operator (surgeon or interventional radiologist): years, additional certifications
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Anatomical landmark technique versus the use of either Doppler or real‐time two‐dimensional ultrasonography in the Seldinger technique
Sensitivity analysis
If possible, we planned to perform a sensitivity analysis to assess the impact of trials with high risk of bias on the overall outcome of the pooling of data.
Summary of findings
We presented the main findings of the review results concerning the quality of evidence, the magnitude of effect of the interventions examined, and the sum of available data for the main outcomes of this review (success rate of implantation, overall perioperative and postoperative complications, pneumothorax, infections, catheter/port‐related complications) for the comparison venous cutdown versus Seldinger technique for placement of implantable venous access ports in a 'Summary of findings' table, according to the GRADE principles as described by Higgins 2011 and Atkins 2004. We used the GRADEprofiler (GRADEpro) software to assist in the preparation of the 'Summary of findings' table (www.guidelinedevelopment.org).
Results
Description of studies
Results of the search
See Figure 1.
Study flow diagram.
Included studies
We included nine trials with a total of 1253 participants in the review. All nine trials were conducted in the 2000s (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2009; Knebel 2011; Nocito 2009; Riapisarda 2006; Ribeiro 2012). Seven trials compared the Seldinger with the venous cutdown technique (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006), one trial compared the modified Seldinger technique with the venous cutdown technique (Knebel 2009), and one trial compared the Seldinger techniques subclavian vein versus internal jugular vein (Ribeiro 2012).
Four trials included only participants aged 18 years or older (Biffi 2009; Knebel 2009; Knebel 2011; Nocito 2009). Four trials did not specify the inclusion criteria for age (Boldó 2003; Chen 2007; D'Angelo 2002; Riapisarda 2006); in two of these trials the youngest participants were 17 and 19 years old, respectively (Boldó 2003; D'Angelo 2002). The remaining two trials did not specify age range (Chen 2007; Riapisarda 2006). Lastly, the trial by Ribeiro 2012 included paediatric and young people aged between 5 and 293 months (24 years) old.
Nearly all participants in the included trials were oncology patients, with the majority of oncology patients requiring TIVAP placement for chemotherapy. In eight trials all participants were oncology patients with known malignancy (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2009; Knebel 2011; Riapisarda 2006; Ribeiro 2012).
In the trial by Nocito 2009 the major indication for TIVAP was administration of chemotherapy, and so we assumed that this trial also included oncology patients. In three other trials TIVAP placement was specified as to facilitate administration of chemotherapy (Biffi 2009; D'Angelo 2002; Riapisarda 2006).
Imaging was used consistently across all included studies to confirm final catheter position using either intraoperative fluoroscopy or postprocedural chest radiograph or both. Six trials utilised intraprocedural fluoroscopy in both Seldinger and venous cutdown groups (Boldó 2003; D'Angelo 2002; Knebel 2009; Knebel 2011; Nocito 2009; Riapisarda 2006). Two studies used only postprocedural radiograph to document final catheter position (Biffi 2009; Ribeiro 2012). In one study fluoroscopy was used to guide intraoperative venous cutdown technique, whilst the Seldinger group used electrocardiogram to confirm catheter tip position (Chen 2007). However, postprocedural chest radiographic was performed in both groups to confirm the final catheter position. Only one trial described ultrasound guidance (Biffi 2009). In this trial the Seldinger group venus access was obtained via either subclavian puncture guided by two‐dimensional ultrasound or landmark technique for internal jugular vein puncture.
Seven trials compared the Seldinger technique and the venous cutdown technique (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). Four trials used the subclavian vein as the access port for the Seldinger technique (D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006), and one trial used the right internal jugular vein (Chen 2007). In two trials both subclavian and jugular veins were used as the access vein for the Seldinger technique (Biffi 2009; Boldó 2003). One trial compared the Seldinger techniques subclavian vein versus internal jugular vein (Ribeiro 2012). The trial by Boldó 2003 did not specify the numbers of participants in whom access was obtained through either the subclavian or the jugular vein.
All nine trials reported complications, including pneumothorax, infection, and catheter complications. The study by Boldó 2003 did not specify infection as an outcome measure is therefore not included in the meta‐analysis.
Additional outcome measures mentioned in the trials included periprocedural satisfaction and pain/comfort (Chen 2007; D'Angelo 2002), mean operation time (Chen 2007; D'Angelo 2002; Riapisarda 2006), experience of operator (Nocito 2009), and cost (D'Angelo 2002).
Excluded studies
We excluded two trials because they were not randomised controlled trials (D'Angelo 1997; Munro 1999). We excluded one trial because it was withdrawn prior to enrolment (NCT01584193).
Risk of bias in included studies
Four of the nine included studies had an acceptable risk of bias (Biffi 2009; Knebel 2009; Knebel 2011; Nocito 2009). The remaining five studies either poorly reported the methods that were used or used inadequate methods (see Figure 2; Figure 3).
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Allocation
The generation of random numbers was adequate in most trials (Biffi 2009; Chen 2007; D'Angelo 2002; Knebel 2009; Knebel 2011), unclear in two studies (Nocito 2009; Riapisarda 2006), and inadequate in two trials (Boldó 2003; Ribeiro 2012). Boldó 2003 described the method as "randomized" but did not mention the method used, and the authors acknowledged this weakness in their discussion. In the Ribeiro 2012 trial the surgeons tossed a coin to decide who was allocated to which group.
Allocation concealment was adequately described and performed in Knebel 2009 and Nocito 2009, but unclear (inadequately described) in Biffi 2009, Chen 2007, D'Angelo 2002, Knebel 2011 and Riapisarda 2006. Two studies used high‐risk methods (Boldó 2003; Ribeiro 2012), such as envelopes, in Boldó 2003, or by tossing a coin at the moment of surgery (Ribeiro 2012).
Blinding
Only one trial described the method for blinding of outcome assessors, which we assessed as at low risk of performance bias (Knebel 2011). The study by Boldó 2003 was not blinded (high risk of bias), and in the study by Nocito 2009 a study nurse was tasked with outcome assessment, but blinding was not described. In the other studies blinding of outcome assessors was not mentioned, and they were therefore judged to be at unclear risk of bias (Biffi 2009; Chen 2007; D'Angelo 2002; Knebel 2009; Riapisarda 2006; Ribeiro 2012).
All of the included studies made no specific mention of blinding of either personnel or participants, and we assessed this as low risk of bias. Given that the implementation of the procedure requires technical knowledge by the personnel to undertake the randomised tasks, blinding of personnel carrying out the procedure was not feasible. Blinding of participants, however, is practically feasible, but as this was not specifically mentioned in the included studies, it is unlikely it was undertaken.
Incomplete outcome data
Dropouts were accounted for in all except for four studies (Boldó 2003; Chen 2007; Riapisarda 2006; Ribeiro 2012).
Selective reporting
All included trials reported the outcomes prespecified in their methods section except the study by Riapisarda 2006, and it was not clearly described in the trial by Ribeiro 2012.
Other potential sources of bias
Only two studies mention that they have received funding from an external source (Biffi 2009; Knebel 2009), and one reports that they have not received any external funding (Nocito 2009). The remaining studies do not mention external funding at all.
Three studies declared that the authors do not have a conflict of interest (Knebel 2009; Knebel 2011; Nocito 2009); the other studies do not address conflict of interest.
In D'Angelo 2002 and Riapisarda 2006 patients were excluded post randomisation without explanation, therefore we assessed these studies as at high risk of bias in this category.
Effects of interventions
Comparison 1: Seldinger versus venous cutdown
Success of primary implantation
Data presented in the analysis tables and forest plots represent the numbers of primary implantation failures in each group (Analysis 1.1; Analysis 1.2; Analysis 1.3; Analysis 1.4; Analysis 1.5; Analysis 1.6). This means that the number of events in the table for a 100% success rate of primary implantation would be 0. An effect estimate on the left side of the equipose (effect estimate of 1) therefore indicates an effect in favour of the Seldinger group, whereas an effect estimate on the right side indicates an effect in favour of the venous cutdown group. Hence, odds ratios less than 1 favour the Seldinger group, and odds ratios greater than 1 favour the venous cutdown group.
Intention‐to‐treat analysis (ITT)
ITT analysis of the Seldinger technique versus the venous cutdown technique included seven trials (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006), with a total of 1006 participants. The analysis showed that the Seldinger technique had a greater primary success rate than the venous cutdown technique for TIVAP implantation (odds ratio (OR) 0.40; 95% confidence interval (CI) 0.25 to 0.65; moderate quality evidence; Analysis 1.1).
We performed a separate analysis to assess the different access veins used in the Seldinger technique with the venous cutdown technique. In four trials the subclavian vein was the only venous access point used in the Seldinger group (D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). In two trials both subclavian and internal jugular veins were used (Biffi 2009; Boldó 2003). The trial by Boldó 2003 did not specify the numbers of participants in the Seldinger group with access through either the subclavian or the internal jugular vein and thus could not be included in the analysis.
Analysis of five trials included 672 participants in whom the subclavian vein was used as access point in the Seldinger group (Biffi 2009; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). The ITT analysis showed Seldinger to be the more successful implantation technique of TIVAP (OR 0.23; 95% CI 0.13 to 0.41; Analysis 1.2).
Two trials with 367 participants reported internal jugular vein access in the Seldinger technique (Biffi 2009; Chen 2007). When compared to the venous cutdown group, there was no difference in success rate (OR 0.62; 95% CI 0.3 to 1.28; Analysis 1.3).
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
On‐treatment analysis
The on‐treatment analysis of Seldinger versus venous cutdown technique included 972 participants and showed differences between the Seldinger technique and the venous cutdown technique for implantation of TIVAP (OR 0.59; 95% CI 0.36 to 0.98; Analysis 1.4). Sensitivity analysis using a random‐effects model, as the I2 statistic was larger than 30% (76%), showed that although the estimate of effect remained in favour of the Seldinger technique, the confidence intervals widened and crossed the line of equipoise.
The on‐treatment analysis of the subclavian vein access Seldinger group versus the venous cutdown group included 640 participants and showed subclavian vein access Seldinger technique to be more successful than the venous cutdown technique for implantation of TIVAP (OR 0.27; 95% CI 0.15 to 0.49; Analysis 1.5).
Two trials with 332 participants used the internal jugular vein as the access vein for the Seldinger technique, and analysis showed no difference in comparison with the venous cutdown technique (OR 0.48; 95% CI 0.22 to 1.03; Analysis 1.6) (Biffi 2009; Chen 2007).
Sensitivity analysis excluding three studies at high risk of bias did not lead to a any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Overall perioperative and postoperative complications
Intention‐to‐treat analysis (ITT)
ITT analysis of the Seldinger technique versus the venous cutdown technique included seven trials with a total of 1006 participants (Biffi 2009; Boldó 2003; Chen 2007; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). The analysis showed no difference in overall complication rate between the Seldinger technique and the venous cutdown technique (OR 1.16; 95% CI 0.76 to 1.75; moderate quality evidence; Analysis 2.1). Sensitivity analysis using a random‐effects model, as the I2 statistic was larger than 30% (60%), also showed no difference in overall complication rate between the Seldinger technique and the venous cutdown technique.
Further analyses were performed comparing different access veins used in the Seldinger technique versus the venous cutdown technique. In four trials, the subclavian vein was the only venous access point used in the Seldinger group (D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). In two trials both subclavian and internal jugular veins were used (Biffi 2009; Boldó 2003). The trial by Boldó 2003 did not specify the numbers of participants in the Seldinger group with access through either the subclavian or the internal jugular vein and thus could not be included in the analysis.
Five trials with 672 participants reported outcomes for the Seldinger technique using the subclavian vein access versus the venous cutdown technique (Biffi 2009; D'Angelo 2002; Knebel 2011; Nocito 2009; Riapisarda 2006). The ITT analysis showed no difference in overall complication rate between the two groups (OR 1.28; 95% CI 0.78 to 2.1; Analysis 2.2).
In two trials with 367 participants the internal jugular vein was used as the access vein for the Seldinger technique (Biffi 2009; Chen 2007). In these two trials there was no difference in perioperative and postoperative complications between the Seldinger technique and the venous cutdown technique (OR 0.72; 95% CI 0.4 to 1.31; Analysis 2.3).
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
On‐treatment analysis
The on‐treatment analysis of the Seldinger versus the venous cutdown technique included 938 participants. We observed no difference in overall complication rate between the Seldinger technique and the venous cutdown technique (OR 0.93; 95% CI 0.62 to 1.40; Analysis 2.4). Sensitivity analysis using a random‐effects model, as the I2 statistic was larger than 30% (45%), also showed no difference in overall complication rate between the Seldinger technique and the venous cutdown technique.
The on‐treatment analysis of the Seldinger group with subclavian vein access versus the venous cutdown group included 618 participants and showed no difference between subclavian vein Seldinger technique and venous cutdown technique (OR 1.06; 95% CI 0.66 to 1.72; Analysis 2.5).
Two trials with 332 participants used the internal jugular vein as the access vein for the Seldinger technique, and analysis showed no difference in comparison with the venous cutdown technique (OR 0.67; 95% CI 0.37 to 1.23; Analysis 2.6) (Biffi 2009; Chen 2007).
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Specific perioperative and postoperative complications
We performed ITT and on‐treatment analyses to assess the effects of Seldinger and venous cutdown techniques with regards to specific complications such as pneumothorax, infection, and catheter complications. This analysis followed the format of the overall perioperative and postoperative complications above.
Pneumothorax/haemothorax
The ITT analysis showed no difference in pneumothorax between the Seldinger and venous cutdown techniques (OR 1.97; 95% CI 0.53 to 7.34; moderate quality evidence; Analysis 3.1). Separate analysis of the Seldinger technique using subclavian vein and internal jugular vein access versus the venous cutdown technique also showed no difference between the two techniques: OR 4.49; 95% CI 0.75 to 26.82 (Analysis 3.2) and OR 0.33; 95% CI 0.01 to 8.13 (Analysis 3.3), respectively.
The on‐treatment analysis showed no difference in pneumothorax between the Seldinger and venous cutdown techniques (OR 2.06; 95% CI 0.56 to 7.57; Analysis 3.4). Separate analysis of the Seldinger technique using subclavian vein and internal jugular vein access versus the venous cutdown technique also showed no difference between the two comparator groups: OR 4.96; 95% CI 0.83 to 29.56 (Analysis 3.5) and OR 0.31; 95% CI 0.01 to 7.65 (Analysis 3.6), respectively.
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Infections
The ITT analysis showed no difference in infection rate between the Seldinger and venous cutdown techniques (OR 0.63; 95% CI 0.25 to 1.56; moderate quality evidence; Analysis 4.1). Separate analysis of the Seldinger technique using subclavian vein and internal jugular vein access versus the venous cutdown technique also showed no difference between the two techniques: OR 0.85; 95% CI 0.28 to 2.58 (Analysis 4.2) and OR 0.27; 95% CI 0.06 to 1.34 (Analysis 4.3), respectively.
The on‐treatment analysis showed no difference in infection rate between the Seldinger and venous cutdown techniques (OR 0.61; 95% CI 0.24 to 1.51; Analysis 4.4). Separate analysis of the Seldinger technique using subclavian vein and internal jugular vein access versus the venous cutdown technique also showed no difference between the two comparator groups: OR 0.79; 95% CI 0.26 to 2.40 (Analysis 4.5) and OR 0.27; 95% CI 0.05 to 1.30 (Analysis 4.6), respectively.
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Catheter/port‐related complications
The ITT analysis showed no difference in catheter‐related complication rate between the Seldinger and venous cutdown techniques (OR 1; 95% CI 0.61 to 1.64; moderate quality evidence; Analysis 5.1). Sensitivity analysis using a random‐effects model, as the I2 statistic was larger than 30% (33%), also showed no difference in catheter‐related complication rate between the Seldinger technique and the venous cutdown technique.
Separate analysis of the Seldinger technique using subclavian vein versus the venous cutdown technique showed a greater rate of catheter complications in the subclavian Seldinger group (OR 6.77; 95% CI 2.31 to 19.79; Analysis 5.2). Analysis of the internal jugular vein Seldinger group versus the venous cutdown group showed no difference in catheter‐related complication rate (OR 0.81; 95% CI 0.43 to 1.52; Analysis 5.3).
The on‐treatment analysis showed no difference in catheter‐related complication rate between the Seldinger and venous cutdown techniques (OR 0.93; 95% CI 0.57 to 1.53; Analysis 5.4). Sensitivity analysis using a random‐effects model, as the I2 statistic was larger than 30% (42%), also showed no difference in catheter‐related complication rate between the Seldinger technique and the venous cutdown technique.
Separate analysis of the Seldinger technique using subclavian vein versus the venous cutdown technique showed a greater rate of catheter complications in the subclavian Seldinger group (OR 6.62; 95% CI 2.24 to 19.58; Analysis 5.5). Analysis of the internal jugular vein Seldinger group versus the venous cutdown group showed no difference in catheter‐related complication rate (OR 0.75; 95% CI 0.4 to 1.43; Analysis 5.6).
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Other complications
The ITT analysis showed no difference in the rate of other complications between the Seldinger and venous cutdown techniques (OR 0.59; 95% CI 0.18 to 1.96; Analysis 6.1). Analysis of the Seldinger technique using the subclavian vein versus the venous cutdown technique also showed no difference between the two techniques (OR 0.59; 95% CI 0.18 to 1.96; Analysis 6.2). No other complications were reported in the Seldinger group using the internal jugular vein for venous access and the venous cutdown group.
The on‐treatment analysis showed no difference in the rate of other complications between the Seldinger and venous cutdown techniques (OR 0.64; 95% CI 0.19 to 2.14; Analysis 6.4). Analysis of the Seldinger technique using the subclavian vein versus the venous cutdown technique also showed no difference between the two techniques (OR 0.64; 95% CI 0.19 to 2.14; Analysis 6.5). No other complications were reported in the Seldinger group using the internal jugular vein for venous access and the venous cutdown group.
Sensitivity analysis excluding three studies at high risk of bias did not lead to any material differences in the result (Boldó 2003; D'Angelo 2002; Riapisarda 2006).
Patient outcomes
Duration of the procedure
Three trials reported the duration of the procedure in minutes (Chen 2007; D'Angelo 2002; Riapisarda 2006). The trial by Chen 2007 reported a mean operation time of 28 minutes for the internal jugular vein access Seldinger technique and 35 minutes for the venous cutdown technique. The trial by Riapisarda 2006 reported a mean operation time of 35 minutes for the subclavian access Seldinger technique and 48 minutes for the venous cutdown technique. The trial by D'Angelo 2002 reported a mean operation time of 40 minutes for the subclavian Seldinger technique and 50 minutes for the venous cutdown technique (P = 0.108). Overall, the Seldinger technique appears to be the shorter procedure, however the three studies did not specify how the procedure was timed.
Postoperative pain
Two trials reported postoperative pain (Chen 2007; D'Angelo 2002).
In the study by Chen 2007 periprocedure satisfaction and comfort scores were defined as follows: 1, comfortable and in no pain; 2, comfortable but with a slight sensation of pain; 3, tolerable pain; and 4, intolerable pain. The result did not specify participant numbers in each category but rather a generalised approximation, with the Seldinger group reporting a comfort and satisfaction score of between 1 and 2 and the venous cutdown group reporting a score of 2 to 3.
In the study by D'Angelo 2002 postoperative pain was defined as mild, moderate, or severe. No difference in postoperative pain was found between the Seldinger and venous cutdown groups. In the Seldinger group (23/25, 95%) complained of mild to moderate pain, and (2/25, 5%) complained of severe pain. The same figures were reported for the venous cutdown group.
Patient satisfaction
None of the trials in this comparison reported patient satisfaction.
Comparison 2: Modified Seldinger versus venous cutdown
We identified only one trial using the modified Seldinger technique (Knebel 2009). ITT analysis of 164 participants showed no difference in primary implantation success rate between the modified Seldinger technique (69/82, 84%) and venous cutdown technique (66/82, 80%), P = 0.686. No difference in infection rate between the modified Seldinger technique (1/82) and venous cutdown technique (3/82) was reported. No cases of pneumothorax were reported. Catheter‐related complications and thrombosis rates were similar in the modified Seldinger technique (2/82) and the venous cutdown technique (3/82).
The remaining prespecified primary and secondary outcomes of this review were not assessed by Knebel 2009.
Comparison 3: Seldinger technique (subclavian vein) versus Seldinger technique (internal jugular vein)
One study in children and adolescents compared the effectiveness and safety of using a Seldinger technique in the subclavian versus the internal jugular vein (Ribeiro 2012). The primary success rate for the initial attempt at implantation was 84% (37/44) for puncture in the subclavian vein and 74% (29/39) for the internal jugular vein. Six participants (7%) were excluded from the study because of procedure failure at both sites. Alternative techniques were used, which included catheter implanted by dissection (four participants), femoral vein by puncture (one participant), and one did not have any implantation. Among the excluded participants, three cases (3.6%) presented with early complications: one case with haemothorax, one with pneumothorax, and one with cervical haematoma. The authors made no mention of complications in participants with successful initial implantation. There was a difference in overall complication rate in the subclavian group (48%) versus the jugular group (23%), P = 0.02. However, when specific complications were compared individually, no differences were found between the groups.
The remaining prespecified primary and secondary outcomes of this review were not assessed by Ribeiro 2012.
Discussion
Summary of main results
The primary success rate for TIVAP placement is higher with the Seldinger technique than with the venous cutdown technique. The majority of included trials reporting on the Seldinger technique used the subclavian vein for access, while the internal jugular vein was used less frequently. Additional analyses showed that the Seldinger group using subclavian vein access was more successful in TIVAP insertion than the venous cutdown technique, while no difference was found between the Seldinger group using the internal jugular vein access and the venous cutdown technique. However, this can be attributed to the small number of participants in the internal jugular vein access group.
There was no difference in overall complication rates between the two techniques. Analysis per access vein used in the Seldinger technique versus the venous cutdown technique showed that the Seldinger technique using the subclavian vein has a greater rate of catheter‐related complications compared to the venous cutdown group. The remaining outcomes, infections, pneumothorax, and other complications, did not show differences between the groups.
We identified only one trial for each of the comparisons modified Seldinger technique (cephalic vein) versus venous cutdown (cephalic vein), and Seldinger (subclavian vein access) versus Seldinger (internal jugular vein access), thus a definitive conclusion cannot be drawn for these comparisons and further research is recommended.
Overall completeness and applicability of evidence
The Cochrane Vascular Group Trials Search Co‐ordinator searched multiple databases to identify trials for this review. The review authors scrutinised all trials. A sufficient number of trials was available to conduct a meaningful comparison between the subclavian vein Seldinger technique and the venous cutdown technique. However, there was paucity of data on the internal jugular vein Seldinger technique, since only three of the identified trials used internal jugular vein access for the Seldinger technique (Biffi 2009; Chen 2007; Ribeiro 2012). Only one trial compared the two different access sites for the Seldinger technique (Ribeiro 2012); this was also the only study including children and adolescents.
Fundamentally, the techniques for implantation of venous access ports are dependent on the choice of vein with venous cutdown technique limited to the cephalic vein and Seldinger technique utilising either subclavian or internal jugular vein. Both trials by Biffi 2009 and Nocito 2009 reported numbers of failed primary insertion via the venous cutdown technique, which were shifted to another group. Pre‐randomisation visualisation of cephalic vein via imaging was not an inclusion criteria and would certainly go against the concept of randomisation as it would introduce bias.
Quality of the evidence
The overall quality of the trials included in this review was moderate, although the methods used for randomisation (a key to avoiding selection bias) were inadequate in four of the nine included studies (Boldó 2003; D'Angelo 2002; Riapisarda 2006; Ribeiro 2012). However, sensitivity analysis excluding these trials did not alter the outcome of the analyses. We reported a fixed‐effect model for all the outcomes, and in the presence of statistical heterogeneity (I2 greater than 30%) used a random‐effects model to assess the robustness of the outcome estimates. However, all effect estimates remained unchanged. The nature of the interventions, either venous cutdown or Seldinger techniques, meant that it was not feasible to blind the participant or personnel, therefore we judged this to be at low risk of bias. The great majority of participants in the included trials were oncology patients at tertiary centres, and the outcomes were applicable to the usual clinical setting. The venous access for Seldinger technique can utilise either subclavian or internal jugular veins, whereas the venous cutdown technique consistently uses the cephalic vein, as it is superficial and surgically more accessible. Only one trial described ultrasound guidance (Biffi 2009). In this trial the venous access in the Seldinger group was obtained via either subclavian vein puncture guided by two‐dimensional ultrasound or landmark technique for the internal jugular vein puncture. No serious inconsistencies were evident. For all outcomes, when comparing venous cutdown and Seldinger technique, serious imprecision was evident from wide confidence intervals in the included trials. Due to the limited number of included studies, we were unable assess publication bias. Two trials received research grants and funding (Biffi 2009; Knebel 2009), but we determined that these were at low risk of bias. We therefore judged the overall quality of the evidence to be moderate.
Potential biases in the review process
We followed Cochrane guidance to assess the results of the searches and select the included studies (Higgins 2011). Each step was carried out independently by two review authors and discussed with a third review author who does not professionally perform the interventions investigated in this review and thus does not have professional interest in either of the procedures investigated in this review. This was intended to reduce the risk of selection bias in the review process. Contacting authors did not result in the identification of additional studies, therefore we believe it is unlikely that we have missed eligible studies.
In the secondary outcome we categorise complications into periprocedural complication, mechanical failure of catheter/port, and infection without a specifying a time frame. It is an assumption that periprocedural complications (pneumothorax, haemothorax, haematoma, seroma, nerve palsy, thoracic duct injury) occur early, whereas mechanical failure (fibrin sleeve, stenosis, kinking, extravasation, or migration of the catheter or dislodgement of the reservoir port) are likely long term. Infection of the port/catheter can occur as an early or late complication.
Agreements and disagreements with other studies or reviews
We have identified no other reviews comparing the Seldinger and venous cutdown techniques.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Success of primary implantation, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 1 Success of primary implantation, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 1 Success of primary implantation, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 1 Success of primary implantation, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 1 Success of primary implantation, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 1 Success of primary implantation, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 2 Overall perioperative and postoperative complications, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 2 Overall perioperative and postoperative complications, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 2 Overall perioperative and postoperative complications, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 2 Overall perioperative and postoperative complications, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 2 Overall perioperative and postoperative complications, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 2 Overall perioperative and postoperative complications, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 3 Pneumothorax, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 3 Pneumothorax, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 3 Pneumothorax, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 3 Pneumothorax, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 3 Pneumothorax, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 3 Pneumothorax, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 4 Infections, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 4 Infections, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 4 Infections, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 4 Infections, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 4 Infections, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 4 Infections, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 5 Catheter/port‐related complications, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 5 Catheter/port‐related complications, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 5 Catheter/port‐related complications, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 5 Catheter/port‐related complications, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 5 Catheter/port‐related complications, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 5 Catheter/port‐related complications, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 6 Other complications, Outcome 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT.
Comparison 6 Other complications, Outcome 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT.
Comparison 6 Other complications, Outcome 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT.
Comparison 6 Other complications, Outcome 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 6 Other complications, Outcome 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
Comparison 6 Other complications, Outcome 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis.
| Venous cutdown versus Seldinger technique for placement of implantable venous access ports | ||||||
| Patient or population: patients requiring an elective TIVAP insertion for treatment of benign or malignant disease | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with venous cutdown technique | Risk with Seldinger technique | |||||
| Success of primary implantation | Study population | OR 0.40 | 1006 | ⊕⊕⊕⊝ | ||
| 113 per 1000 | 48 per 1000 | |||||
| Moderate | ||||||
| 118 per 1000 | 51 per 1000 | |||||
| Overall perioperative and postoperative complications | Study population | OR 1.16 | 1006 | ⊕⊕⊕⊝ | ||
| 92 per 1000 | 105 per 1000 | |||||
| Moderate | ||||||
| 59 per 1000 | 68 per 1000 | |||||
| Pneumothorax | Study population | OR 1.97 | 1006 | ⊕⊕⊕⊝ | ||
| 2 per 1000 | 5 per 1000 | |||||
| Infections | Study population | OR 0.63 | 906 | ⊕⊕⊕⊝ | ||
| 29 per 1000 | 18 per 1000 | |||||
| Moderate | ||||||
| 21 per 1000 | 13 per 1000 | |||||
| Catheter/port‐related complications | Study population | OR 1.00 | 1006 | ⊕⊕⊕⊝ | ||
| 62 per 1000 | 62 per 1000 | |||||
| Moderate | ||||||
| 20 per 1000 | 20 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Wide confidence interval ‐ imprecision ‐ downgraded by one level. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 7 | 1006 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.40 [0.25, 0.65] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.23 [0.13, 0.41] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.62 [0.30, 1.28] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 7 | 972 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.36, 0.98] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 5 | 640 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.27 [0.15, 0.49] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.48 [0.22, 1.03] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 7 | 1006 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.16 [0.76, 1.75] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.28 [0.78, 2.10] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.72 [0.40, 1.31] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 7 | 938 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.62, 1.40] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 5 | 618 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.06 [0.66, 1.72] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.67 [0.37, 1.23] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 7 | 1006 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.97 [0.53, 7.34] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 4.49 [0.75, 26.82] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.01, 8.13] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 7 | 938 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.06 [0.56, 7.57] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 6 | 718 | Odds Ratio (M‐H, Fixed, 95% CI) | 4.96 [0.83, 29.56] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.31 [0.01, 7.65] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 6 | 906 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.63 [0.25, 1.56] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.85 [0.28, 2.58] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.27 [0.06, 1.34] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 6 | 838 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.24, 1.51] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 5 | 618 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.79 [0.26, 2.40] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.27 [0.05, 1.30] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 7 | 1006 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.61, 1.64] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.77 [2.31, 19.79] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.43, 1.52] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 7 | 938 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.93 [0.57, 1.53] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 5 | 618 | Odds Ratio (M‐H, Fixed, 95% CI) | 6.62 [2.24, 19.58] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.75 [0.40, 1.43] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein) ITT Show forest plot | 7 | 1006 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.18, 1.96] |
| 2 Seldinger (subclavian vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 5 | 672 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.18, 1.96] |
| 3 Seldinger (IJ vein) versus venous cutdown (cephalic vein) ITT Show forest plot | 2 | 367 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
| 4 Seldinger (subclavian & IJ) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 7 | 938 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.19, 2.14] |
| 5 Seldinger (subclavian vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 5 | 618 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.19, 2.14] |
| 6 Seldinger (IJ vein) versus venous cutdown (cephalic vein). On‐treatment analysis Show forest plot | 2 | 332 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
