2.3 Statistical analysis
Summary statistics are presented as numbers and percentages for categorical variables and as the mean ± standard deviation for continuous variables. The Chi-square test or Fisher exact test was used to compare categorical variables, and the independent t test was used for continuous variables. Univariate and multivariate logistic regression analyses were applied to analyze the correlation of the possible risk factors with delayed malfunction of the implanted venous devices. We considered a 2-sided P-value < .05 to be statistically significant. All statistical analyses were performed using the software package SAS 9.4 (SAS Institute, Inc, Cary, NC).
A total of 508 patients were included in this study: 230 patients were included in the subclavian group; 134 in the IJV group; 25 in the EJV group; and 119 in the cephalic vein group. Regarding demographic characteristics (Table 1), the cephalic group had a large portion of the colorectal malignancies compared to that of the IJV and subclavian groups (53.7% vs 34.3%, P < .01; 53.7% vs 35.2%, respectively, P < .01), and the IJV group included more female patients than the cephalic group (70% vs 57%, P = .03). The body mass index (BMI), patient age, and side of the access were similar between the cephalic and other groups. The mean operation time of the entire cohort was 46.9 minutes. The cephalic group had a longer operation time than the subclavian group (51.5 minutes vs 38.1 minutes, P < .01); however, there was no difference in the operation time between the cephalic and IJV groups (51.5 minutes vs 53.7 minutes, P = .59). Comparatively, the operation time was longer in the EJV group than in the cephalic group (69.1 minutes vs 51.5 minutes, P < .01). The length of catheter use and cycles of chemotherapy were comparable between the cephalic and other groups. In addition, the incidence of unscheduled catheter removal caused by late complications was similar between the cephalic and other groups as well. Infection and malfunction of the catheter were found to be late complications causing impairment in cyclic chemotherapy. We found 6 cases (1.2%) of immediate complications after the operation: the 4 cases in the subclavian group were all pneumothorax, and the 2 cases in the cephalic group were pneumothorax and postoperative bleeding. The statistical analysis was difficult for a few complicated cases.
Univariate analysis for the risk factors of late complications was performed according to the venous access routes, BMI, operation time, and age; however, the results were nonsignificant: odds ratios were 0.959 for the noncephalic approach (P = .93), 1.031 for BMI (P = .56), 1.004 for operation time (P = .64), and 0.979 for age (P = .21). In the multivariate logistic regression analysis (Table 2), no factor was demonstrated to increase the incidence of late complications, including infection and catheter malfunction.
This study revealed that the cephalic vein approach can be safely performed and has acceptable surgical, clinical, and functional outcomes compared to conventional percutaneous techniques. Central venous access devices in cancer patients were first introduced in 1982 to reduce complications associated with frequent venous puncture during chemotherapy. There are several approaches for implantable central venous access. While the IJV approach with real-time USG has been widely performed because it has a good success rate without increasing the procedure duration,[8,9] we noticed that the surgical and clinical outcomes of the existing central venous approaches seem to be comparable.[10–12] Despite its safety and feasibility, the conventional IJV approach requires specialized and expensive medical resources, including percutaneous vascular surgical kits, tunneling instruments, vascular USG, and/or fluoroscopic techniques; therefore, this approach might preclude wide clinical applications in small-volume regional hospitals or private clinics. Comparatively, the subclavian vein approach using the Seldinger landmark technique without a USG can be considered alternatively because it is easily performed with no special equipment; however, this approach might cause life-threatening complications such as hemothorax, pneumothorax, mediastinal hematoma, vascular perforation, and myocardial injury. Consequently, we employed the cephalic vein cut-down approach to reduce the risk of immediate complications while achieving cost-effectiveness and patient comfort. Several studies have reported that the cephalic vein approach can avoid possible immediate fatal complications, including pneumothorax and arterial puncture, although this approach might have a low success rate.[15–19]
In our study, the general surgeons performed central venous catheter insertion, and the failure rate of cephalic vein access was found to be 12.5%, which was superior to that of previous reports, ranging from 12% to 20%.[11,17–21] This result is similar to that of IJV and subclavian access.[9,19] Of the 136 patients who received the cephalic vein approach, the diameter of the cephalic vein was recorded in 62 cases. The mean diameters were 3.1 mm in the success group and 2.2 mm in the failure group, which were statistically significant (P < .01); therefore, we carefully suggest that identifying the diameter of the cephalic vein would be helpful in successful procedure attempts. Two cases of immediate complications were found in the cephalic vein group (1.7%), and late complications occurred in 7 cephalic vein cases (5.9%). These results were similar to those of cephalic vein access in previous studies.[16–23] Additionally, the complication rate of cephalic vein access in this study was lower than that of IJV access and subclavian access in other studies.[9,18,19] Accordingly, we suggest that the cephalic vein cut-down approach can be safely performed with a comparable success rate and without increasing acute and late catheter-related complications compared to those of conventional percutaneous approaches. In addition, previous studies have shown that age, underlying cancer type, prior anticoagulant therapy, catheter tip position, and surgeon are independent prognostic factors for catheter complications.[9,24–26] However, in our study, patient BMI, age, and operation time did not increase the risk of long-term catheter dysfunction in univariate and multivariate logistic regression analyses; therefore, it seems reasonable that a central venous port can be considered in elderly or obese patients.
Since our procedures were performed by several surgeons, there might have been interoperator variations as well as other confounding biases associated with the retrospective study design. Moreover, there might have been a reporting bias in analyzing the cephalic vein diameter between success and failure groups because the small size of the cephalic vein tended to be emphasized when the procedure failed. Nevertheless, our study was performed with a sufficiently large sample size, and the surgical records were documented by the specialized medical recorder immediately after the surgery. All surgeries were performed according to identical protocols. We suggest that these features might enhance the level of evidence of our study.
The present study demonstrates that cut-down central venous catheter insertion through the cephalic vein can be performed safely by nonvascular surgeons with no differences in surgical and clinical outcomes compared to those of conventional percutaneous approaches. Moreover, this approach requires no specialized equipment, including percutaneous vascular kits, tunneling instruments, and intraoperative USG. Therefore, the cephalic vein cut-down technique might incur less medical expenses than conventional approaches and would be helpful for both patients and surgeons.
Conceptualization: Jinbeom Cho, Kang Woong Jun, Byung Joo Song, Kiyoung Sung.
Data curation: Jiyoung Rhu.
Writing – original draft: Jiyoung Rhu.
Writing – review and editing: Jinbeom Cho.
Jinbeom Cho orcid: 0000-0002-6329-016X.
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Keywords:Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.
cephalic vein; feasibility; implantable central venous access; safety