|Year : 2020 | Volume
| Issue : 7 | Page : 1575-1581
Totally implantable venous access devices: The supraclavicular percutaneous approach and early complications
Xu-ming Bai1, Jian Wang2, Yan Zhou3, Xing-wei Sun1, Long Cheng1, Xing-shi Gu1, Qiang Yuan1, Jian Jing1, Jian Zhang1, Li-yan Gu4, Yong Jin1
1 Department of Interventional Radiology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, Jiangsu Provinece, China
2 Department of Interventional Radiology, TaiCang First People's Hospital, Taicang, China
3 Department of Oncology, TaiCang First People's Hospital, Taicang, China
4 Department of Respiration, TaiCang First People's Hospital, Taicang, China
|Date of Submission||05-Dec-2020|
|Date of Decision||13-Jul-2020|
|Date of Acceptance||17-Sep-2020|
|Date of Web Publication||9-Feb-2021|
Department of Interventional Radiology, The Second Affiliated Hospital of Soochow University, Soochow University, Suzhou
Source of Support: None, Conflict of Interest: None
Background: The background of this study was to explore the success rate and early complications concerning the implantation of totally implantable venous access devices (TIVADs) by percutaneous venipuncture and management strategies for early complications.
Materials and Methods: This was a retrospective study of 1923 patients who received TIVAD implantation by percutaneous venipuncture (mostly via the supraclavicular route). The percutaneous access sites were internal jugular vein (810 patients; right/left: 158/652) or proximal right internal jugular vein, brachiocephalic vein, and proximal subclavian vein (1113 patients). Success rates and early complications related to TIVAD placement techniques were summarized, and strategies for managing complications were also analyzed.
Results: In 627 patients, TIVAD implantation was first performed by interventional radiologists using a “blind” approach relying on anatomical landmarks, having a 91.9% success rate. In contrast, there was a 100% success rate among the remaining 1296 patients who received ultrasound-guided implantation, a difference which was statistically significant (P < 0.05). Ultrasound-guided implantation was also successful for the 51 patients for whom the first attempt failed using the blind technique. Further, we found that the incidence of early complications was 5.41% (104/1923) and that the occurrence of immediate complications was significantly higher in the blind technique group compared to the ultrasound-guided group (37 vs. 12; P < 0.05).
Conclusions: It is safe and feasible to implant TIVADs by supraclavicular venipuncture. Ultrasound guidance combined with X-ray monitoring during operation significantly improves the surgery success rate and reduces the risk of early complications. Unclear anatomical landmarks and vascular variation are the main factors affecting success using a blind (nonguided) technique.
Keywords: Complications, percutaneous puncture, totally implantable venous access devices
|How to cite this article:|
Bai Xm, Wang J, Zhou Y, Sun Xw, Cheng L, Gu Xs, Yuan Q, Jing J, Zhang J, Gu Ly, Jin Y. Totally implantable venous access devices: The supraclavicular percutaneous approach and early complications. J Can Res Ther 2020;16:1575-81
|How to cite this URL:|
Bai Xm, Wang J, Zhou Y, Sun Xw, Cheng L, Gu Xs, Yuan Q, Jing J, Zhang J, Gu Ly, Jin Y. Totally implantable venous access devices: The supraclavicular percutaneous approach and early complications. J Can Res Ther [serial online] 2020 [cited 2021 Jun 24];16:1575-81. Available from: https://www.cancerjournal.net/text.asp?2020/16/7/1575/308754
| > Introduction|| |
Totally implantable venous access devices (TIVADs) allow for long-term and/or intermittent implantable venous administration of chemotherapeutic agents, nutrition, blood and blood products, and antibiotics. Since Niederhuber et al. first reported its use in 1982, TIVADs are widely used for infusion of chemotherapy or parenteral nutrition. Minimizing the need for frequent vascular access, it can also improve patient quality of life. TIVAD implantation is performed by either percutaneous puncture or surgical cutdown.,,,, The percutaneous technique has become more popular because it is a simple procedure with a high success rate; however, it is also associated with a higher incidence of early complications.,,, There are two approaches to percutaneous venipuncture, supraclavicular and infraclavicular, and the supraclavicular approach effectively prevents pinch-off syndrome. In this study, we systematically reviewed clinical data of 1923 patients who underwent TIVAD implantation via the supraclavicular approach for vein access and analyzed early complications associated with this procedure.
| > Materials and Methods|| |
Our study cohort of 1923 patients consisted of 1790 patients treated at the Second Affiliated Hospital of Soochow University and 133 patients at the First People's Hospital of Taicang from March 2016 to March 2019. The overall characteristics of the study population are shown in [Table 1]. TIVADs (Bard, USA; B. Braun, France; and Smiths, USA) were implanted in a digital subtraction angiography operating room under noninvasive electrocardiogram (ECG) monitoring.
Procedures were performed under local anesthesia (1% lidocaine) by four experienced interventional radiologists, with significant training and experience in central venous catheterization. The supraclavicular method was used to puncture the internal jugular, proximal internal jugular, brachiocephalic, or proximal subclavian vein. Implantation consisted of initial catheter insertion, second incision, catheter guidance, and port fixation, described in the following steps.
Step 1: The catheter was inserted via percutaneous venipuncture (blind puncture or ultrasound-guided puncture). For blind puncture, the patient was put in a supine position with the head slightly turned to the opposite side of the puncture site. For punctures from the right side, the needle was inserted 1 cm lateral to the posterior edge of the sternocleidomastoid muscle and superior to the clavicle. It was then slowly advanced with negative pressure to within 1 cm of the right inferior edge of the ipsilateral sternoclavicular joint at a 10° angle to the coronal plane. For punctures from the left side, the needle was inserted 1 cm lateral to the posterior edge of the sternocleidomastoid muscle and 2 cm superior to the clavicle. The needle was slowly advanced with negative pressure to the ipsilateral sternoclavicular joint approximately 10°–15° to the coronal plane. A puncture was considered successful if dark red venous blood could be drawn.
For ultrasound-guided puncture, real-time ultrasound guidance was used during percutaneous puncture of the medial and inferior segments of the internal jugular vein, the brachiocephalic vein, or the proximal subclavian vein. The patient lies in the supine position with the head turned contralateral; the operator held the high-frequency ultrasound probe in the left hand and the needle in the right hand. To obtain a cross axis of the distal internal jugular vein or the brachiocephalic vein, or a long axis of the proximal subclavian vein, the operator positioned the probe transversely above the clavicle, usually in the inner third, with an inclination of 20°–30° to the neck and clavicle. An in-plane approach was used to achieve a long-axis view of the needle, and an 18-gauge, 7-cm needle was advanced through the skin under ultrasound guidance into the vein [Figure 1]a and [Figure 1]b. After successful puncture, the guidewire was inserted into the superior vena cava, as confirmed by X-ray fluoroscopy. A 0.5-cm incision to the superficial fascia was made at the guidewire entry site, which was the first incision [incision A in [Figure 1]c]. The peel-away sheath was introduced through the guidewire at incision A, and the guidewire was withdrawn. The catheter was then inserted into the superior vena cava through the peel-away sheath [Figure 1]d. The remaining steps were identically performed for both puncture approaches after successful catheterization.
|Figure 1: (a) Totally implantable venous access devices, percutaneous puncture, complications (b) Real-time ultrasound guided percutaneous puncture of the proximal segment of the internal jugular vein (c) Incision A was made at the puncture site after the guidewire was inserted (d) The catheter was inserted via the peel-away sheath after it was introduced through incision A (e) Incision B (black arrow) was made on the skin above the ipsilateral infraclavicular pectoralis major muscle, and the port pocket was created at incision B (f) The catheter is subcutaneously guided from incision A to incision B with a tunnel needle (g) The catheter tip was located at the junction of the superior vena cava and the right atrium as confirmed by X-ray (h) The catheter connected to the port after its unnecessary part was cut (i) The port was positioned in the pocket, and incisions A and B were sutured (j) Chest X-ray showed that the catheter extends with a natural curve with no folding back, and the catheter tip was in the right position|
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Step 2: A 2.5-cm transverse incision to the superficial fascia was made at the skin of the anterior chest wall under the ipsilateral infraclavicular puncture site and above the pectoralis major muscle. This incision is the second incision [incision B, [Figure 1]e]. The subcutaneous muscular fascia was then bluntly separated at incision B to make a port pocket.
Step 3: The catheter was subcutaneously guided from incision A to incision B using a tunnel needle [Figure 1]f. Under X-ray fluoroscopy, the tip of the catheter was placed at the junction of the superior vena cava and right atrium [Figure 1]g. The catheter was connected to the port after the unneeded length was cut [Figure 1]h, and the port was put in the port pocket, so blood could be drawn from the device without obstruction [Figure 1]i.
Step 4: The port was then fixed by suturing the first and second incisions along the subcutaneous fascial layer and the holes located on the base of the port. X-ray imaging of the port was performed to assess placement and monitor for complications. Criteria for successful placement was the ability to aspirate blood freely as well as the ability to freely flush with heparin saline solution and that the catheter tip was located at the junction of the superior vena cava and right atrium [Figure 1]j.
Criteria for complication assessment
Immediate complications occurred either during the procedure or 24 h postoperative, while early complications happened within 30 days after operation. The main diagnostic criteria for complications were as follows: (1) radiological confirmation of pneumothorax; (2) clinical diagnosis of arterial puncture; (3) confirmation of arrhythmia using ECG; (4) radiological confirmation of catheter/guidewire misplacement (i.e., catheter or guidewire not located in the superior vena cava); (5) confirmation of thrombosis by ultrasound or venography examination; and (6) clinical testing to identify local or bloodstream infections (i.e., infection of the wound, port, or subcutaneous catheter tunnel). The diagnostic criteria for bloodstream infection, defined as a body temperature >38°C and elevated peripheral blood leukocyte and/or neutrophil counts, were as follows: (1) exclusion of other sources of infection; (2) cultures of peripheral blood and blood drawn using the port device both test positive for the same microorganisms, or a blood culture from the port device tests positive; or (3) port or catheter cultures tested positive after device removal.
The R package was used for statistical analysis. The Chi-square test and Fisher's exact test were used for statistical comparisons. P < 0.05 was considered statistically significant.
| > Results|| |
Percutaneous access sites
The anatomic sites for venous access are shown in [Table 2].
Surgery success rate
The total success rate of implantation was 100%. The percutaneous blind technique was used on 627 patients and was successful for 576 patients (91.9%). Of the 51 patients in which a second attempt was required, the ultrasound-guided technique was successfully used (final total success rate: 100%). Of the remaining 1296 patients, the ultrasound-guided approach was used as the primary technique with a success rate of 100%. This approach had a significantly higher success rate compared to that of the blind technique (P < 0.05).
The overall early complication rate was 5.41% (104 patients), of which 100 patients (5.2%) had immediate complications during surgery and 4 patients (0.21%) had other complications, namely three cases of device-related infection and a case of catheter-related thrombosis.
We found that the ultrasound-guided approach had a significantly lower incidence of immediate intraoperative complications compared to the blind approach (12 cases vs. 88 cases, respectively, P < 0.05). The occurrence of guidewire/catheter misplacement and arrhythmia was lower in the blind puncture group compared to the ultrasound-guided group (three cases vs. five cases and four cases vs. seven cases, respectively); however, the differences were not statistically significant (both P > 0.05). We found a significantly increased number of cases of pneumothorax (12 cases), arterial puncture (18 cases), and failure at first attempt (51 cases) in the blind puncture group compared to no affected cases in the ultrasound-guided group [all P < 0.05; [Table 3]].
Management of complications
To manage guidewire/catheter misplacement, real-time X-ray was used to correct the position of a misplaced guidewire/catheter, which occurred in eight patients [Figure 2]. In cases of arrhythmia, X-ray fluoroscopy showed that the catheter was in the right ventricle. The arrhythmia disappeared after withdrawing the catheter. Of those cases of pneumothorax, high-flow oxygen therapy and close monitoring were administered to five patients with <15% lung compression, followed by switching to the ultrasound-guided method. In addition, ultrasound combined with X-ray-guided percutaneous insertion of the central venous catheter into the pleural cavity was performed in two patients with over 30% lung compression for simultaneous aspiration of air and TIVAD implantation. The remaining five affected patients underwent closed chest drainage for treatment. For all cases of arterial puncture, the puncture needle was withdrawn, and local compression was applied to the puncture site for 5 to 10 min. Insertion was then successful by changing the puncture site and switching to the ultrasound-guided approach.
|Figure 2: (a) X-ray shows misplaced catheter (b) Angiography confirms that the catheter has entered into the azygos vein (c) The guidewire was introduced through the catheter (d) The catheter is threaded into the superior vena cava via the guidewire (e) The totally implantable venous access device was planned to be implanted through the left internal jugular vein. But obstruction was felt during guidewire insertion. X-ray shows that the guidewire entered the ipsilateral subclavian vein (f) Guided by X-ray, the guidewire was re-positioned into the superior vena cava|
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We had four cases of device-related infection. For the two cases with a local infection, antibiotics were administered and debridement was performed with a topical incision. The infection was brought under control in one patient, whereas the other patient had the TIVAD removed because of an uncontrolled infection. Another patient had a bloodstream infection caused by Staphylococcus epidermidis. Vancomycin was administered to this patient for 10 days to fight infection but was ineffective. The device was then removed, and the infection cleared. One patient with catheter-related thrombosis was treated with low-molecular-weight heparin for 7 days followed by warfarin to reduce blood clots. The patient died from primary disease after 6 months with the device in place.
| > Discussion|| |
The success rate of TIVAD implantation through percutaneous venipuncture has increased significantly to approximately 92% (89%–100%) since it was first reported in 1992.,,, In our study, we achieved a total success rate of 100%. It is our position that the key to a successful insertion lies in the percutaneous puncture itself, which has two approaches, blind and ultrasound-guided. We report a first-attempt success rate of 91.9% using the blind technique. We also found that implantation failure was closely related to clinical experience of the interventional radiologist and unclear anatomical landmarks of the target veins caused by obesity, short neck and scars, as well as the small diameter, variation, and even stenosis of target veins. Therefore, we believe that the blind approach to TIVAD implantation can only be adopted if the interventional radiologist is very experienced in central venous catheterization and the patient has clear surface landmarks. We also report a success rate of 100% for the ultrasound-guided group. The 51 patients for whom the first attempt was unsuccessful using the blind technique also had a successful placement after switching to the ultrasound technique, proving its superior efficacy in improving the success rate of TIVAD insertion. Our findings support the broader view that an ultrasound-guided percutaneous approach to TIVAD implantation is and will be the norm in the future.
Complications related to TIVAD placement can be divided into two types: early complications, which occur either during operation or within 30 days postoperative, and late complications, which happen after 30 days following surgery. Early complications are mainly related to the surgical procedure itself, whereas late complications are primarily a result of the patient's primary disease as well as the long-term use and maintenance of the port device. Therefore, we recommend that efforts should be made to prevent and treat early complications, in particular immediate complications that occur during operation or 24 h postoperative, so as to improve the safety profile of this procedure.
Pneumothorax is a common complication of TIVAD implantation with the percutaneous approach. Following a review of the clinical literature, and based on our experience, we attribute it to a number of factors., First, it is related to the access site for venous puncture. The supraclavicular approach to venipuncture has a lower incidence of pneumothorax compared to that found using the infraclavicular approach. In addition, the infraclavicular approach to the internal jugular vein has a lower incidence of pneumothorax compared to catheterization via the subclavian vein. Second, the risk of pneumothorax is associated with insertion technique. In our study, there were 12 cases of pneumothorax, all of which occurred using the blind technique, compared to no cases in the ultrasound-guided group. This finding suggests that real-time ultrasound-guided venous puncture can significantly reduce the incidence of pneumothorax, which is consistent with that found in other studies.,,, Although pneumothorax mainly occurs during the operation, it is warranted to monitor for delayed occurrence. For instance, three patients in our study experienced pneumothorax 4 h postoperative. As 90% of the cases of delayed pneumothorax can be diagnosed by X-ray within 6 h postoperative, close postoperative observation and monitoring are needed for the timely diagnosis of this complication. Based on clinical symptoms and degree of lung compression, the main treatments for pneumothorax are oxygen inhalation, simple catheter aspiration, and closed chest drainage. We found that TIVAD implantation was successful in those nine patients with intraoperative pneumothorax in our cohort. Based on our experience, we believe that close monitoring and high-flow oxygen therapy should be administered to patients with mild pneumothorax and that a central venous catheter be inserted into the thoracic cavity to release trapped air for patients with severe pneumothorax. In addition, we recommend that TIVAD implantation should be completed using the ultrasound-guided approach.
Arterial puncture is also a common complication of percutaneous venipuncture, with an incidence rate of between 0.5% and 8%., In our study, we report that the 18 cases of arterial puncture all occurred with the blind technique. In addition to technical factors, thin venous wall and low venous pressure increase the likelihood to accidentally puncture the anterior and posterior venous walls into the adjacent artery, which can be observed by ultrasound imaging. Thus, we recommend slowly puncturing the anterior wall of the vein under negative pressure with a syringe to avoid penetrating the posterior wall of the vein. If an accidental arterial puncture occurs, withdraw the needle slowly by applying mild negative pressure. Adopting this approach makes it possible to return to the vein again and avoid another puncture. Based on our experience, we found that compression of the puncture site for approximately 5–10 min was effective to treat arterial puncture, followed by switching to the ultrasound-guided approach to implant the TIVAD using a new access site. In our study, we identified arterial puncture using ultrasound imaging and observed that a small hematoma quickly formed in the arterial puncture area, which compressed the adjacent vein, and resulted in temporary stenosis or occlusion of the target vein. Arterial puncture can also cause hemothorax, large hematoma, pseudoaneurysm, and arteriovenous fistula., Although we did not encounter these complications in our study, awareness of these complications is warranted.
During TIVAD implantation via percutaneous venipuncture, the guidewire entering the superior vena cava is needed to guarantee that the catheter tip is positioned at the junction of the superior vena cava and right atrium. Failure to insert the guidewire or catheter into the superior vena cava is called guidewire/catheter malposition or misplacement. The catheter was misplaced to the ipsilateral subclavian vein, azygos vein, or contralateral brachiocephalic vein in eight patients from our study. We found that venous tortuosity and difficulty in real-time monitoring of the superior vena cava were the reasons for erroneous catheter placement. In some clinical centers, chest X-ray is performed after TIVAD implantation, so if catheter misplacement occurred, sutures are reopened to reposition the catheter. In the current study, TIVAD implantation was performed in the catheter room and catheter malposition was immediately identified and corrected. This approach not only avoided the necessity of a second procedure to locate and adjust the misplaced catheter but also reduced the economic burden on patients. Therefore, intraoperative X-ray monitoring plays an important role in detecting and correcting guidewire/catheter misplacement.
Arrhythmia that occurs during TIVAD implantation is mainly the result of irritating the endocardium by the guidewire or catheter. We found during guidewire insertion that 11 patients in our study cohort experienced arrhythmia, with premature ventricular beats in 10 cases and 1 case of paroxysmal supraventricular tachycardia. X-ray confirmed that the guidewire entered the right ventricle in all instances. We noted that the main clinical symptom was palpitation and that arrhythmia disappeared after timely withdrawal of the guidewire from the right ventricle. Fortunately, no refractory arrhythmia occurred in our study, which may be related to the fact that our patients have no prior history of serious arrhythmia, electrolyte imbalance, and uremia before operation. Experience shows that arrhythmia during TIVAD implantation can be prevented by measuring the length from the puncture site to the right atrium on the body surface and inserting the guidewire to the desired depth. In addition, overadvancing the guidewire or catheter beyond the right atrial-superior vena cava junction may also occur because of anatomic variations and minor differences in measurement. ECG monitoring and effective communication with patients under local anesthesia during operation may also help. If patients experience discomfort from palpitation, the guidewire needs to be immediately withdrawn from the right atrium to the superior vena cava.
TIVAD-related infections can be divided into two categories, namely local infection and bloodstream infection. They are usually a late complication related to progression of the patient's primary disease or instances of hematological malignancy, granulocytopenia, cachexia, or low immunity. Early infection is rare and largely dependent on the skill of the operator or a failure to work aseptically during surgery. Priority should be given to treat bloodstream infections that may be life-threatening. We experienced one case of TIVAD-related bloodstream infection. Chemotherapy drugs were administered via the TIVAD 48 h after implantation, after which a Grade 4 myelosuppression occurred, resulting in a catheter-related bloodstream infection from S. epidermidis. Initial efforts to treat the infection were ineffective; however, the bloodstream infection cleared following removal of the TIVAD 11 days later. There is still no consensus whether an infection is related to early TIVAD use. Narducci et al. proposed that TIVAD use within 7 days postoperative can cause complications including infection and recommend its use 8 days after operation. In contrast, Ozdemir et al. found that it is safe to use the port device within 4 h following surgery, and in our study, the TIVAD was used 24 h after implantation, with only a single case of early infection. Our findings demonstrate the safety of TIVAD use 24 h after placement, which are also consistent with those of Karanlik et al.
TIVAD-related thrombosis usually occurs at a later stage, with early occurrence uncommon. It is frequently caused by inaccurate position of the catheter tip.,,, In our study, one patient experienced deep vein thrombosis. For this patient, the 8F catheter was finally placed after a lengthy effort to insert it via the peel-away sheath. Thrombosis occurred 6 days later, although it was relieved following anticoagulation therapy. The cause of the thrombosis was attributed to venous wall injury. In our experience, this complication can be prevented by fully evaluating the vein diameter before operation, proper choice of catheter, and gentle insertion during operation.
Other early complications associated with TIVADs, such as nerve plexus injury, chylothorax, hemoptysis, hemothorax, and air embolism, did not occur in our study.
| > Conclusions|| |
We demonstrate that percutaneous venipuncture for TIVAD implantation is safe and effective and that ultrasound guidance and X-ray monitoring can improve the success rate and reduce early complications, particularly in cases with unclear anatomical landmarks and vascular variation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]