Evaluation of the efficacy of totally implantable venous access port in breast cancer patients undergoing chemotherapy

Abstract

Objective

The use of Totally Implantable Venous Access Port (TIVAP) has gained importance in chemotherapy for cancer patients due to its ability to reduce complications compared to conventional central venous catheters. Chemotherapy for breast cancer often requires long-term venous access, and the choice of device can impact both treatment efficacy and patient quality of life. This study randomly divided 355 breast cancer chemotherapy patients, who were treated from January 2022 to January 2023, into the TIVAP group (n = 177) and the control group (n = 178) to evaluate the application effect of TIVAP.

Methods

The patients in the TIVAP group used totally implantable venous access ports, while those in the control group used central venous catheters. We compared the clinical efficacy, ability of daily life, complications, and patient satisfaction between the two groups. Statistical analysis was performed using t-tests for continuous data and χ2 tests for categorical data.

Results

Our results showed that the total clinical efficacy was 96.61% in the TIVAP group and 90.45% in the control group, and the data of the two groups were significantly different (P < 0.05). Before the intervention, the daily living ability scores of the two groups were analyzed, and the difference between the two groups was not significant (P > 0.05). After the intervention, the daily living ability scores of the patients in the TIVAP group (77.41 ± 7.02) were significantly higher than those of the control group (66.75 ± 6.42) (P < 0.05).In terms of complication rate, the TIVAP group was 5.08%, which was significantly lower than that of the control group (12.36%), and the difference between the two groups was significant (P < 0.05).

Conclusion

Therefore, the application of TIVAP in breast cancer chemotherapy patients can effectively reduce the toxic and side effects of chemotherapy, ensure that the patients use the drugs according to the chemotherapy cycle, and then improve the clinical outcome.

Supplementary Information

The online version contains supplementary material available at 10.1007/s12672-025-02020-5.

Introduction

Breast cancer is one of the most common female malignant tumors and the leading cause of cancer-related deaths in women [1]. According to statistics, there were about 2.3 million new cases of breast cancer in 2020, accounting for 24.5% of the incidence of all cancers in women [2]. For the first time, the incidence rate of breast cancer has surpassed that of lung cancer to take the first place, and it is a significant risk to life and health. The incidence of breast cancer in Chinese women is on the rise, and the mortality rate has also increased significantly, causing a heavy burden on countless patients and families [3]. The formation process of breast cancer is complicated and is the result of many factors. At present, the process of breast cancer development cannot be fully explained [4]. According to the survey, age, family history, obesity, use of contraceptive pills, menopause, smoking, alcohol consumption, lifestyle, and genetic factors are all significantly associated with the development of breast cancer [5, 6]. Although the incidence of breast cancer is increasing year by year, its prognosis is relatively good. According to the latest research statistics, the 5-year survival rate of breast cancer is 90.9%, and the mortality rate has gradually decreased, accounting for only 6.9% of the total number of cancer deaths. Hence, the number of surviving breast cancer patients has soared.

With the continuous development of medicine, the treatment of breast cancer is becoming more and more mature. For patients with early breast cancer, most patients have the opportunity to achieve clinical cure through systematic and standardized treatment means. With the advancement of medical technology, chemotherapy has now become the primary treatment for breast cancer and plays a vital role in the comprehensive treatment of breast cancer [7]. Chemotherapy can further remove the remaining cancer cells in the body, and for larger tumors, chemotherapy can also achieve the purpose of downgrading surgery. Many breast cancer patients require repeated high-dose intravenous chemotherapy over a long period [8]. The traditional intravenous puncture method of drug delivery is prone to complications such as drug extravasation. In order to alleviate the pain of patients and promote the treatment process, totally implantable venous access port (TIVAP) technology has been gradually applied to clinical practice in recent years [9]. TIVAP is an intravenous infusion device that can be implanted under the skin and left in the body for an extended period of time. It mainly consists of an injection seat for puncture and an intravenous catheter system. The tip of the catheter is directed to the superior vena cava, which can provide safe and reliable reserved venous access for patients with long-term infusion therapy and chemotherapy. TIVAP can be implanted under the skin and left in the body for an extended period of time without any significant limitation of limb movement [10]. After reasonable nursing operation TIVAP can be used for a long time, and its retention time can exceed the average survival period of tumor patients, TIVAP has better data than Peripherally Inserted Central Catheter in terms of placement and incidence of complications [11], but complications are inevitable [12]. Therefore, 355 breast cancer chemotherapy patients treated in our hospital were selected as research subjects in this study and randomly divided into two groups for the control study, aiming to evaluate the application effect of TIVAP in breast cancer chemotherapy patients.

Materials and methods

General information about patients

The 355 female breast cancer chemotherapy patients received in Zhangzhou Affiliated Hospital Fujian Medical University from January 2022 to January 2023 were randomly assigned to the TIVAP group (n = 177) and control group (n = 178). In the control group, age ranged from 24 to 60 years, with a mean age of (35.36 ± 4.42) years; disease duration ranged from 3 to 16 months, with a mean duration of (7.58 ± 2.88) months. In the TIVAP group, the age ranged from 25 to 59 years old, with a mean age of (35.54 ± 4.12) years; the disease duration ranged from 3 to 16 months, with a mean duration of (7.67 ± 2.94) months. The difference between the general information data of the two groups of patients was not significant (P > 0.05). This study complied with the principles of medical ethics. All patients agreed to this study and signed the relevant documents.

Inclusion and exclusion criteria

Inclusion criteria: (1) Patients met the clinical diagnostic criteria of breast cancer. (2) No underlying disease. (3) The medication was administered at the same time, and all of them followed the doctor's instructions. (4) Patients and their family members gave informed consent.

Exclusion criteria: (1) Patients with distant metastases and other complications. (2) Patients who are unconscious and unable to cooperate. (3) Patients who are older than 65 years old. (4) Patients suspected of having skin infections.

Method

Control group (Central venous catheter)

Keep the patient's arm and vein at 90°. Sterilize the puncture point. The cannula and skin are kept at 15–30°. Head tilted in the opposite direction. The brachial vein or elbow vein puncture point is selected, and the sheath is inserted along the guidewire, with the catheter tail located in the mid-lower part of the upper large vein. After insertion, the nurse verifies the accuracy of the position based on the X-ray film. The catheter is sealed with positive pressure after 3 mL pulses of 100 U/mL sodium heparin solution once/week.

TIVAP group

Patients are kept in a flat position with their heads facing away from the implant site. The area to be punctured is disinfected, and local anesthesia is administered. Ultrasound-guided clavicular vein puncture is performed to the superior vena cava. The tail of the catheter at the junction of the right atrium and the superior great vein was confirmed by X-ray, the subcutaneous tissue was separated from the right subclavian fossa, and the flap was separated. The cut catheter was connected to the base of the TIVAP, and the catheter was drawn through a tunnel needle to adjust the position of the catheter and the base of the TIVAP. The catheter placement was viewed through an X-ray. The cut muscle layer at the collarbone is sutured, tissue glue is applied to the puncture and covered with gauze. The tube was sealed with 30 mL of 100 U/mL heparin sodium solution after pulse once a month.

Observation indicators

The clinical efficacy of the two groups

The clinical efficacy of the two groups was evaluated and categorized into three grades: obvious effect, effective, and ineffective. "Obvious effect" was defined as complete control of clinical symptoms with rare complications. "Effective" was defined as partial control of clinical symptoms with a low complication rate. "Ineffective" was defined as a lack of improvement in clinical symptoms or the occurrence of significant complications. The overall effective rate was calculated as the sum of the rates for "obvious effect" and "effective." The table of relevant evaluation criteria can be found in the Supplementary Materials.

The daily living ability of the two groups

The activities of daily living (ADL) score is used for evaluation. There are 10 items: eating, toileting, mobility, bathing, and clothing. Each item is scored 0, 5, 10, and 15 points, totaling 100 points. A score of > 60 indicates that the patient can complete basic daily life. 41–60 points indicate the need for assistance, 20–40 points indicate more assistance, < 20 points indicate complete need for help, and higher scores indicate higher ability to live.

The occurrence of complications between the two groups

These complications included puncture difficulties, venous thrombosis, no blood in the retraction, and infection.

Satisfaction of patients

A homemade satisfaction questionnaire was used to record the satisfaction of patients in both groups, which were categorized as comparatively satisfied (80–100 points), generally satisfied (60–79 points), and dissatisfied (< 60 points). Total satisfaction = (comparative satisfaction + general satisfaction)/total number of cases × 100%. The specific content of the patient satisfaction questionnaire can be found in the Supplementary Materials.

Statistical methods

The collected data were analyzed by SPSS 27.0. The measurement data were expressed as (mean ± SD) by t-test, the count data were expressed as (%) by χ² test, and the difference was statistically significant as P < 0.05.

Results

Results of clinical efficacy

Table 1 and Fig. 1 show results of clinical efficacy between TIVAP and central venous catheter. Among the patients treated with TIVAP, there were 95 cases (53.67%) of significant effect, 76 cases (42.94%) of efficacy, and 6 cases (3.39%) of ineffectiveness. At the same time, there were 80 cases (44.94%) of significant effect, 81 cases (45.51%) of efficacy, and 17 cases (9.55%) of ineffectiveness in patients with central venous catheters. These results suggest that TIVAP has better clinical efficacy than central venous catheters (P = 0.018).

Table 1.

Comparison of clinical efficacy

Group	Obvious effect	Effective	Ineffective	Total effective rate
TIVAP (n = 177)	95 (53.67%)	76 (42.94%)	6 (3.39%)	171 (96.61%)
Control (n = 178)	80 (44.94%)	81 (45.51%)	17 (9.55%)	161 (90.45%)
χ2				5.559
P				0.018

Fig. 1.

Results of clinical efficacy between TIVAP group (A) and control group (B)

Results of ADL scores

Table 2 and Fig. 2 demonstrate the results of ADL scores before and after the intervention in the two groups of patients. The ADL scores of patients in the two groups before intervention were (5.26 ± 5.42) and (4.96 ± 5.28) respectively, with no statistical difference. After the intervention, the ADL scores of patients with TIVAP and central venous catheter were (77.41 ± 7.02) and (66.75 ± 6.42), respectively (P < 0.05). These results reveal that patients with TIVAP have stronger self-care abilities in daily life and can complete it independently.

Table 2.

Comparison of ADL score between TIVAP group and control group

Group	Before intervention	After intervention
TIVAP (n = 177)	45.26 ± 5.42	77.41 ± 7.02
Control (n = 178)	44.96 ± 5.28	66.75 ± 6.42
t	0.527	14.920
P	0.599	< 0.001

Fig. 2.

Results of ADL scores before (A) and after intervention (B). Significant differences between groups are indicated: **** for P < 0.0001, and ns for not significant (P > 0.05)

Results of complications for patients

Table 3 and Fig. 3 present the results of complications occurring in the two groups of breast cancer chemotherapy patients. There were 7 cases of difficult puncture, 5 cases of venous thrombosis, 6 cases of no blood back, and 4 cases of infection in patients with central venous catheters. At the same time, there were 3 cases of puncture difficulties, 2 cases of venous thrombosis, 2 cases of no blood back, and 2 cases of infection in the patients using TIVAP. These results imply that applying TIVAP contributes to reducing the incidence of complications (P = 0.015).

Table 3.

Comparison of complications in both groups

Indicators	TIVAP (n = 177)	Control (n = 178)	χ2	P
Puncture difficulties	3 (1.69%)	7 (3.93%)
Venous thrombosis	2 (1.13%)	5 (2.81%)
No blood back	2 (1.13%)	6 (3.37%)
Infection	2 (1.13%)	4 (2.25%)
Total incidence	9 (5.08%)	22 (12.36%)	5.893	0.015

Fig. 3.

Results of complications in both groups

Results of satisfaction for patients

Table 4 and Fig. 4 depict the satisfaction results of patients with chemotherapy for breast cancer in the two groups. In the TIVAP group, 74 patients (41.81%) were relatively satisfied, 95 (53.67%) were generally satisfied, and 8 (4.52%) were dissatisfied. In the control group, 67 patients (37.64%) were relatively satisfied, 86 (48.32%) were generally satisfied, and 25 (14.04%) were dissatisfied. It is clear that the overall satisfaction of patients with TIVAP (95.48%) was significantly higher than those with central venous catheters (85.96%). These results suggest that patients' satisfaction using TIVAP is higher than those using central venous catheters (P = 0.002).

Table 4.

Comparison of satisfaction for patients

Indicators	TIVAP (n = 177)	Control (n = 178)	χ2	P
Comparative satisfaction	74 (41.81%)	67 (37.64%)
General satisfaction	95 (53.67%)	86 (48.32%)
Dissatisfaction	8 (4.52%)	25 (14.04%)
Overall satisfaction	169 (95.48%)	153 (85.96%)	9.550	0.002

Fig. 4.

Results of satisfaction between the TIVAP group (A) and the control group (B)

Discussion

Breast cancer is a class of common malignant tumors mostly occurring in women, accounting for 23% of all malignant tumors suffered by women [13]. In recent years, the rapid increase in the number of new breast cancer cases has made breast cancer the most common malignant tumor among Chinese women, posing a serious threat to women's health [14]. The treatment principles for breast cancer usually emphasize multidisciplinary and comprehensive treatment. The main therapeutic modalities include surgery, chemotherapy, radiation therapy, endocrine therapy, molecular targeted therapy, and psychotherapy. Due to the pathological characteristics of breast cancer tumor cells, a large number of breast cancer patients need to be treated with chemotherapy [15]. In clinical practice, appropriate chemotherapeutic agents and regimens are often chosen based on the pathological type of breast cancer tumor cells, immunohistochemical results, and the patient's condition [16]. Chemotherapeutic agents can kill breast cancer cells and shrink the size of the tumor, which is conducive to the downgrading and downstaging of the cancer [17]. Chemotherapy allows patients to have the opportunity of surgical treatment, which significantly improves the therapeutic effect and the patient's prognosis [18]. It also increases breast and axillary preservation rates, reduces postoperative complications, and improves the life quality of patients after surgery [19]. With the introduction of various chemotherapeutic agents, chemotherapy's clinical effects have become increasingly obvious in controlling disease progression, improving clinical symptoms, reducing the risk of recurrence and metastasis, and lowering the mortality rate [20]. Recent studies have provided deeper insights into breast cancer treatment and prognosis. For instance, research on malignant phyllode tumors of the breast indicates that adjuvant chemotherapy may not significantly enhance long-term survival outcomes [21]. Additionally, the expression of CLEC10A has been identified as a potential prognostic biomarker in breast cancer, with lower levels correlating with poorer clinical outcomes [22]. These findings underscore the importance of personalized treatment strategies and the potential for novel therapeutic targets in improving patient prognosis.

TIVAP is an infusion device that can be implanted subcutaneously into the infusion port and can be left in the body for a long time. It is also an effective infusion route for long-term infusion of drugs, nutrient solutions, blood transfusion, blood collection, and other patient treatments. TIVAP consists of a reservoir and a central venous catheter connected to the reservoir. Since it is completely embedded under the skin, the patient's movement is not restricted. At the same time, TIVAP overcomes the shortcomings of traditional peripheral venous infusion, which requires repeated venous puncture, reduces the pain caused by the operation, further improves the life quality of patients, and has been widely used in the treatment of cancer patients with chemotherapy. Peripheral central venous catheter infusion is also commonly used in chemotherapy, but it may cause many complications. TIVAP, as a new type of infusion device, may have andmore advantages. In recent years, in the treatment of leukemia, breast cancer, and lymphoma, the use of TIVAP can solve many difficult problems, such as the difficulty of infusion. TIVAP provides both clinical and psychological benefits, especially for oncology patients. Its concealed design minimizes the visible stigma of illness, promoting psychological well-being and improving quality of life during prolonged treatments like chemotherapy [23]. However, TIVAP use is associated with complications such as thrombosis, catheter-related bloodstream infections, and mechanical issues. Thrombosis risk is heightened in cancer patients due to hypercoagulability and the presence of central venous devices [24]. Infections, often linked to procedural or maintenance lapses, underscore the need for strict adherence to aseptic protocols [25]. Despite these challenges, TIVAP remains cost-effective over long-term treatments, as it reduces device replacements and improves treatment adherence [11]. Specialized training for healthcare providers is essential to optimize device use, minimize complications, and enhance patient outcomes. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a significant complication in breast cancer patients, particularly those undergoing chemotherapy or central venous catheter placement. The pathogenesis of thrombosis in breast cancer is multifactorial. Tumor cells release tissue factors and pro-inflammatory cytokines, promoting hypercoagulability and systemic inflammation [26]. Chronic inflammation damages vascular endothelium, facilitating thrombus formation. Furthermore, chemotherapy exacerbates endothelial injury and disrupts hemostasis, while central venous catheters induce local vascular trauma, further increasing VTE risk [27]. Patient factors, such as obesity, immobility, and advanced age, amplify these risks. Understanding these mechanisms underscores the need for targeted thromboprophylaxis. Regular monitoring of biomarkers like D-dimer and tailored anticoagulation strategies are critical to mitigate thrombotic risks [28]. Future research into the molecular basis of cancer-associated thrombosis could improve prevention and treatment strategies, optimizing patient outcomes in breast cancer care.

Therefore, in order to ensure the successful treatment of chemotherapy for breast cancer patients, the prevention of complications is crucial, which can improve the ability of daily life for patients and reduce the occurrence of complications. The results of this study showed that in terms of total effective rate, the TIVAP group was 96.61%, significantly higher than the 90.45% of the control group (P < 0.05), indicating that the use of TIVAP was more effective. At the same time, our results suggest that after the intervention, the ADL score of the TIVAP group was significantly higher than that of the control group (P < 0.05). In terms of the complication rate, it was 5.08% in the TIVAP group, which was significantly lower than that of the control group, which was 12.36% (P < 0.05). Not surprisingly, patients with TIVAP are more satisfied (P < 0.05). Therefore, compared with central venous catheterization, TIVAP can reduce the risk of infusion, prevent infection, improve daily life, and reduce the occurrence of complications.

Meanwhile, selectingselecting TIVAP catheter materials may also affect factors such as biocompatibility, thrombogenicity, and infection rate. Recent studies have shown that compared to non mixed silver ports, mixed silver ports can reduce the infection rate associated with venous access ports [29]. Here before, novel Y–Z magnetic TIVAP can improve the success rate of one-time needle insertion and shorten surgical time [30]. These findings underscore the need for continued innovation and evaluation of TIVAP materials and designs to optimize patient outcomes and reduce procedural risks. Future research should further investigate the long-term clinical effects of these innovations in diverse patient populations.

This study focuses on the differences between the use of TIVAP and central venous catheters in chemotherapy for breast cancer patients in terms of treatment outcomes, the occurrence of catheter complications, the ability to perform daily living activities, and patient satisfaction with the route of treatment, providing a reference for choosing the ideal intravenous infusion tool for breast cancer patients undergoing chemotherapy. Of course, there are still shortcomings in this study: (1) This study is a single-center study conducted in a specific region, and the sample size is relatively small, while the findings provide valuable insights into the efficacy of TIVAP in breast cancer chemotherapy, the generalizability of the results may be limited. These limitations could influence the external validity of the study in the context of breast cancer diagnosis and treatment strategies; (2) Although the occurrence of the two types of catheter complications was compared in this study, the occurrence mechanism of complications was not studied in depth; (3) Thrombus in catheterized veins can be divided into asymptomatic thrombus and symptomatic thrombus. All the thrombus in this study were found through ultrasound examination when patients had poor transfusion, so the probability of thrombus in catheterized veins may be higher than the study result. To address the limitations of this study, future research should include multi-center trials with, more extensive, and more diverse populations to improve generalizability. Mechanistic studies on catheter-related complications, such as thrombosis and infections, are essential to develop targeted prevention strategies. Routine ultrasound monitoring should be considered in future studies to detect asymptomatic thrombus and provide more accurate incidence data. Additionally, exploring advanced catheter materials and designs, such as coated or magnetic TIVAP systems, could help reduce complications and enhance clinical outcomes. These efforts will refine the application of TIVAP in cancer care. In addition, in China, the cost of TIVAP is not uniformly covered by national medical insurance and often varies by region. In some areas, partial reimbursement is available, while in others, patients must bear the full cost. This financial aspect may influence the accessibility and widespread adoption of TIVAP in clinical practice, making it an important consideration for evaluating its clinical and economic value.

Conclusion

In conclusion, for breast cancer patients receiving chemotherapy, the application of TIVAP can effectively mitigate the adverse effects associated with chemotherapy, ensure that patients use drugs according to the chemotherapy cycle, and improve clinical outcomes. The application of targeted nursing care in the process of treatment can significantly improve the patients' ability of daily life, reduce the occurrence of complications, and improve the satisfaction of patients. Therefore, TIVAP is more worthy of clinical promotion and use.

Author contributions

Yujuan Guo and Yueqiong Wang contributed to the concept and designed the research study. Yujuan Guo and Xiaoping Wang performed the research. Yaping Huang, Xiong Wu and Zhaorong Xu contributed to the analysis and interpretation of the data. All authors contributed to editorial changes in the manuscript. All authors read and approved the final manuscript.

Funding

This work was supported by the Joint Funds for the innovation of science and Technology, Fujian province, China (2021Y9068).

Data availability 

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval and consent to participate

This study complied with the principles of medical ethics of Zhangzhou Affiliated Hospital Fujian Medical University. Ethical approval for this study was obtained from Zhangzhou Affiliated Hospital Fujian Medical University.

Informed consent

All patients agreed to this study and signed the relevant documents. All participants or, if participants are under 18, from a parent and/or legal guardian.

Competing interests

The authors declare no competing interests.