Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).

OBJECTIVES: PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation. BACKGROUND DATA: The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear. METHODS: PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint. RESULTS: Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups. CONCLUSION: A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts. TRIAL REGISTRATION: German Clinical Trials Register DRKS 00004900.

Use of a hydrophilic coating wire reduces significantly the rate of central vein punctures and the incidence of pneumothorax in totally implantable access port (TIAP) surgery.

BACKGROUND: Insertion of a Totally Implantable Access Port (TIAP) can be performed either via Central Vein Puncture (CVP) or Brachiocephalic Vein Cut-down (venous section-VS). The primary success rate of TIAP implantation using VS rarely ever achieves 100%. The objective of this study was to describe a modified VS approach using a hydrophilic coated wire (TVS). METHODS: From 01.01.2015 to 31.12.2015, all patients receiving TIAP implantations were screened. During this time, all patients in whom the primary VS procedure was found to be unsuccessful were analysed. RESULTS: In 2015, 1152 patients had TIAP implantations performed by 24 different surgeons. Of these, 277 patients needed a second line rescue strategy either by CVP (n = 69) or TVS (n = 208). There were no statistically significant differences regarding demographics or indication for TIAP implantation between CVP and TVS. The operation time and the qualification of the operating surgeon between CVP and TVS did not differ significantly. After the introduction of the guidewire with a hydrophilic coated wire, the need for CVP decreased significantly from 12.7% to 8.8% (p < 0.0001). In patients receiving CVP as a second line rescue strategy, the incidence of pneumothorax (n = 3 patients (4.3%)) was significantly higher compared to patients with TVS as a second line rescue strategy (n = 1 patient (0.48%), p = 0.02). CONCLUSION: The use of a hydrophilic coated wire significantly decreased the number of CVP and the incidence of pneumothorax. TVS is a safe and successful second-line rescue strategy.

Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial.

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

Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444).

OBJECTIVE: Comparison of two different insertion techniques for implantation of totally implantable access ports (TIAP). BACKGROUND: TIAP are introduced through different open and closed cannulation strategies and by various medical experts. The aim of this expertise-based randomized trial was to compare venous cutdown approach with puncture of subclavian vein. METHODS: One hundred and ten patients scheduled for primary implantation of a TIAP were randomly assigned to either open insertion technique performed by surgeons or puncture of the subclavian vein under fluoroscopic guidance by radiologists at an outpatient single university center. The primary endpoint was the primary success rate of the cannulation strategy. A logistic regression model was used for analysis adjusting for age, Karnofsky index, body mass index and surgeons', and the radiologists' experience. RESULTS: Percutaneus cannulation was not superior to surgical venous cutdown in the intention-to-treat analysis (odds ratio, 0.37; 95% CI, 0.07; 2.15) and the as-treated analysis (odds ratio, 0.16; 95% CI, 0; 1.28). The procedure was shorter with surgery (median, 21 minutes; 95% CI, 14; 30) than with radiology (median, 45 minutes; 95% CI, 43; 50) (P < 0.001), and the dose of radiation was lower with surgery (median, 37 cGy/cm(2); 95% CI, 26; 49) than with radiology (200 cGy/cm(2); 95% CI, 200; 300) (P < 0.001). CONCLUSION: Central venous cannulation for insertion of TIAPs can be performed safely and effectively with both approaches. The open direct surgical access requires further strategies for successful placement of a TIAP, and percutaneous Seldinger technique requires more time and a higher dose of radiation and is associated with risk of pneumothorax.

Reasons for explantation of totally implantable access ports: a multivariate analysis of 385 consecutive patients.

BACKGROUND: The objective of this study was to analyze factors leading to explantation of totally implanted access ports (TIAPs) and to assess its occurrence and clinical relevance. METHODS: Of 438 patient consecutive patients with a port explantation, 385 were eligible for this retrospective cohort study. Reasons for explantation as well as demographic, clinical, and surgical characteristics were analyzed by univariate and multivariate models. RESULTS: The diagnoses leading to TIAP implantation were hematological malignancies in 142 patients (36.8%), breast cancer in 103 patients (26.8%), gastrointestinal cancer in 76 patients (19.8%), nonmalignant diseases in 46 patients (11.9%), and other malignant diseases in 18 patients (4.7%). The reasons for TIAP explantation were infection in 178 patients (46.2%), end of treatment in 129 patients (33.5%), thrombosis in 44 patients (11.4%), TIAP dysfunction in 22 patients (5.7%), and other reasons in 12 patients (3.2%). At the time of TIAP explantation, 115 patients (29.9%) were receiving chemotherapy, and 49 patients (12.7%) were considered immunocompromised. In case of TIAP explantation due to infection, the median length of TIAP in situ time was 303.3 days, whereas the cumulative 10-day and 30-day explantation rates were 2.8% and 10.6%, respectively. By multivariate models, TIAP explantation due to infection is statistically significantly decreased in patients with breast cancer (P < .01) but significantly increased in patients with recurrent TIAP implantation and with ongoing chemotherapy (P < .01). CONCLUSIONS: TIAP explantations are caused primarily by late-term complications, mainly infections. The subsequent interruption of ongoing treatment makes further efforts necessary to reduce such complications.