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Totally implantable venous access devices: evaluation of complications and a prospective comparative study of two different port systems
The Netherlands Journal of Medicine 2000;57:215–223
Original article
Totally implantable venous access devices: evaluation of complications and a prospective comparative study of two different port systems A. Hartkamp*, A.J.H. van Boxtel, B.A. Zonnenberg, P.O. Witteveen Department of Internal Medicine, University Medical Centre ( UMC) Utrecht, F02.126 Heidelberglaan 100, 3584 CX Utrecht, The Netherlands Received 7 April 2000; received in revised form 28 August 2000; accepted 13 September 2000
Abstract Background: Totally implantable venous access devices (TIVADs) are valuable instruments in case prolonged intravenous therapy is required, but implantation and use of these devices are associated with complications. The purpose of this study was to evaluate perioperative and long-term complications associated with TIVADs. In addition, we compared two different types of TIVADs with respect to implantation, care protocol and patients’ comfort. Methods: In a retrospective study perioperative and long-term complications in a general oncology population were analysed. In a prospective randomized study comparison of two types of TIVADs was carried out. Results: Perioperative complications occurred in 27 (21.4%) of 126 implanted TIVADs: catheter malposition (16.7%) in 21 patients, pneumothorax (0.8%) in one and haemorrhage (4.0%) in five. Long-term complications appeared in 31 (25.2%) out of 123 TIVADs: thrombosis in 9 (7.3%), especially associated with malposition of the tip of the catheter; infection in 10 (8.1%); extravasation in 2 (1.6%); migration of the cathetertip in 6 (4.8%); pain at reservoir in 3 (2.4%) and inaccessibility of the port in 1 (0.8%). No significant differences were found with respect to implantation, care accessibility and patients’ comfort between the two TIVADs. Conclusions: The use of TIVADs is associated with some risk of serious perioperative and long-term complications. In case of thrombotic complications these systems can be saved with appropriate treatment. Correct positioning of the catheter tip is essential to prevent thrombotic complications. In case of TIVAD-related infectious complications, the possibility of saving the TIVAD depends on the causative microorganism and type of infection. Furthermore, to increase patients’ satisfaction with TIVADs they should be well informed about the surgical procedure and possible disadvantages of these devices. 2000 Elsevier Science B.V. All rights reserved. Keywords: Venous access; Cytotoxic therapy; Complications; Nursing care; Patients’ comfort
Introduction A broad array of vascular access devices is *Corresponding author. Tel.: 1 31-30-2507-7457; fax: 1 3130-252-3741.
available nowadays, ranging from peripheral catheters to totally implantable catheters that enters the most central vein, e.g. the vena cava superior, in the body. The type of vascular access device used in drug-infusion therapy has implications for both the number of skilled nursing interventions required and
0300-2977 / 00 / $ – see front matter 2000 Elsevier Science B.V. All rights reserved. PII: S0300-2977( 00 )00083-8
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the risk of its complications. Peripheral venous access can have a serious impact on patients undergoing prolonged intravenous therapy. Repeated venous puncture is a painful and often anxious experience for most patients during the course of therapy. The use of totally implantable venous access devices (TIVADs) may minimize these negative experiences. With the introduction of TIVADs, the quality of life of patients receiving intensive intravenous therapy has improved [1,2]. Problems like the accidentally subcutaneous administration of cytotoxic drugs and phlebitis seem to be solved. Although the use of this device appears to be safe and reliable [3,4], there are complications associated with implantation and use of the TIVAD, like pneumothorax during implantation, infectious and thrombotic complications [5–11]. In this paper we describe the results of a retrospective analysis (part one) and a randomized study to compare two types of TIVADs (part two) which was carried out at the University Medical Centre (UMC) Utrecht. In part one of the study we analysed our experiences with TIVAD-related complications in a
general oncology population. Part two of the study focused on comparison of two different types of TIVADs (MRI / Hickman portE, Bard and Port a CathE, Deltec) with respect to implantation, care protocol and comfort for the patient.
Patients and methods For the retrospective part of the study, the medical charts of 118 patients that received a TIVAD in a period of 3 years (January 1992–January 1995) were studied with regard to complications related to TIVAD implantation and in the course of TIVAD use. A total of 126 TIVADs (Port a CathE, Deltec) were implanted in 118 patients at the oncology department of the UMC Utrecht. Patients’ characteristics and indications for TIVAD implantation and removal are given in Table 1. Three patients were lost to follow-up. Therefore, 115 evaluable patients were analysed, in whom a total of 123 TIVADs were implanted. Eight patients received a TIVAD twice.
Table 1 Patients’ characteristics and indications of TIVAD implantation and removal Total number of patients Evaluable no. of patients Gender: % male Mean age in years (range) Number of implanted TIVADs
118 115 24.6 54 (16–74) 126
Indication for implantation TIVAD (%) Chemotherapy TPN / fluid i.v. Drugs a Sampling of blood Total catheter days Mean catheter days per patient (range)b
87 7 6 1 23 673 192.5 (2–1091)
(n 5 109) (n 5 9) (n 5 8) (n 5 1)
Indications of explantation TIVAD (%) Completion of therapy Complications c Total number removed TIVADs In situ on January 1st, 1995 No. patients died with TIVAD in situ
6.5 13.0 19.5 23.6 56.9
(n 5 8) (n 5 16) (n 5 24) (n 5 29) (n 5 70)
a
(n 5 126)a
In 1993, one patient had a TIVAD implanted for morphine intraveneously as well as infusion of fluids. Cut-off point evaluation: January 1st, 1995. c Combination of complications leading to removal of five TIVADs: one catheter-related sepsis (CRS) in a patient with a total hipprothesis in situ; two pocket infections in combination with CRS with S. aureus in patients with progressive malignant disease under chemotherapy; venous thrombosis with vena cava superior syndrome and persistent pain at the TIVAD reservoir in a patient with progressive malignant disease; one patient with CRS and thrombosis and progressive malignant disease under chemotherapy. b
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According to the local protocol TIVADs were implanted under local anaesthesia and antibiotic prophylaxis was given. Immediately after implantation, a chest X-ray was made to determine the position of the tip of the TIVAD catheter and to exclude pneumothorax. TIVAD-related complications were categorized as perioperative complications (malposition of the tip of the catheter, pneumothorax, haemorrhage associated with TIVAD implantation or removal) and long-term complications (infection, thrombosis, extravasation, migration of the tip of the catheter, pain at TIVAD reservoir and inaccessibility of the port). For the prospective part of the study, we compared two types of TIVADs (MRI / Hickman portE, Bard and Port a CathE, Deltec). The port of the MRI / Hickman port, Bard, is made of plastic and is not visible on a chest X-ray, in contrast with the metal (titanium) port of the Port a Cath, Deltec. Both TIVADs have an open ended silicon catheter connected to the port. We evaluated differences in implantation, use in daily practice and clinical benefit to the patients of both types of TIVADs. No specific instrument to assess the difference between the two port systems regarding the implantation procedure, comfort for the patient and handling by professionals could be found. Therefore the researchers developed the patient questionnaire (PQ). Next to patient variables like gender and weight, the PQ focuses on the following aspects. The first part of the PQ evaluates the implantation procedure and is completed by the surgeon who implanted the TIVAD. The next part takes the opinion of nurses working with the TIVAD into consideration. The last part focuses on the view of the patient. Two experts in the field of access devices were asked to give comment on the construct validity of the PQ. In Table 2 some examples of the questions of the PQ are given. Immediately after implantation of the TIVAD the surgeons filled out their part of the questionnaire. The nursing staff answered questions concerning the care protocol every time a blood sample was taken and when the Huber needle was changed. Patients filled out three evaluation forms (2, 4 and 6 weeks after implantation of the TIVAD). Implantation and care protocol were evaluated for a period of 6 weeks. Variables of the PQ between the two groups were compared using
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two-tailed t test. The data were analyzed using the 7.5E software package. Patients requiring longterm i.v. therapy for treatment of his or her disease, e.g. cytotoxic therapy continuously in case of neoplastic disease or antibiotic or anti-viral therapy for serious infections, could be included in the study. After informed consent was obtained forty consecutive patients who met the inclusion criteria where randomized by the study coordinator by drawing 1 out of 40 blank envelopes with the brand of device that should be implanted. The study coordinator contacted the operation room to tell the surgeon which device should be implanted. No one but the surgeon was informed about the choice of TIVAD that was made. Twenty patients received a MRI / Hickman port and twenty patients a Port a Cath. Nineteen (47.5%) patients were male. The mean age was 50 years (range 32–74 years). Indications for implantation of the TIVAD were cytotoxic therapy for malignant diseases in 26 (65%) of 40 patients (carcinoma of the mamma, ovarium, head / neck and carcinoid). In 14 (35%) of the patients the TIVAD was implanted for prolonged intravenous therapy for infectious complications in patients with AIDS.
SPSS
Results In part 1 of the study a total of 126 TIVADs were implanted in 118 patients with advanced cancer. A total of 123 TIVADs in 115 patients were evaluable for long-term complications. Patients’ characteristics and indications for implantation and removal of the TIVAD are given in Table 1. A total of 16 TIVADs (13.0%) was removed because of long-term complications. The total number of catheter days in function at the time of evaluation was 23.673 days with a mean of 192.5 days (range 2 –1091 days) (Table 1). Perioperative complications Perioperative complications occurred in 27 (21.4%) of 126 TIVAD implantations (Table 3). Malposition of the tip of the catheter immediately after insertion was a relative frequent occurrence (16.7%). No efforts were made to relocate a malpositioned tip of the catheter. Twelve (57.1%) out of 21 malpositioned tips were localised in the right
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Table 2 Examples of the patient questionnaire Implantation procedure
Taking blood immediately after implantation was Very easy Easy Difficult Very difficult Not possible Were there any influencing factors during implantation? Yes, please explain No
Professionals using the TIVAD
Taking blood from the TIVAD is Possible without problems Only possible when the patient takes a specific position Only possible with syringes and not with the vacuum system Only occasionally possible Not possible at all Flushing the TIVAD with heparin 600 IE in saline is performed every time the TIVAD is disconnected Yes No
Patients’ perspective
How do you experience the comfort of the TIVAD (do you feel the TIVAD) while standing? Never Sometimes Regularly Often (Almost) all the time Is the location of the TIVAD well chosen? Yes, I can’t think of a better location in my circumstances Yes, but another location could be convenient too No, with some activities the location of the TIVAD is not well chosen No, the TIVAD gives problems with all activities
atrium immediately after implantation (Tables 3 and 4). Iatrogenic pneumothorax was observed once (0.8%) which necessitated pleuradrainage. Haemorrhage related with TIVAD implantation or removal was observed in four, respectively one patient (4.0%). In one of these four patients, haematothorax was very severe. Despite several thoracotomies a focus of bleeding could not be identified. The patient was admitted to an I.C.U. for mechanical ventilation because of respiratory insufficiency. This patient died 16 days later, probably as a result of this complication. Whether concomitant rapid progression of the malignancy contributed to this serious adverse event is not clear. In another patient, a mediastinal haemorrhage was seen after removal of a TIVAD; two transfusions of blood were given, no subsequent
complications were observed. Haemorrhagic complications delayed the start of cytotoxic treatment in three patients. One of these systems had to be replaced for persistent inaccessibility of the TIVAD reservoir. Long-term complications of TIVAD use In 115 patients 123 TIVADs were implanted which remained in situ for a total of 23 673 days. During this period a total of 31 (25.2%) long term complications related to the TIVAD occurred (Table 3). In 19 (16.5%) of 115 patients these complications concerned TIVAD related infections, thrombosis and extravasation, indicating 0.89 complication episodes per 1000 catheter days (Table 3).
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Table 3 Complications associated with implantation and use of TIVADs Total no. of complications
Percentage of catheters (%)
Perioperative complications Malposition catheter Pneumothorax Haemorrhage Around TIVAD pocket Mediastinal After explantation
21 1 5 3 1 1
16.7 0.8 4.0 2.4 0.8 0.8
Long-term complications Infectious complications a Exit-site infection Pocket infection Catheter related sepsis Thrombotic complications Catheter thrombosis Venous thrombosis Combination Extravasation Migration catheter-tip Pain at TIVAD reservoir Inaccessibility port
10 3 5 6 9 2 5 2 2 6 3 1
8.1 2.4 4.1 4.9 7.3 1.6 4.1 1.6 1.6 4.8 2.4 0.8
a
1.3 0.42
0.38
0.08
Combination of catheter related sepsis and pocket infection was diagnosed in four patients.
Table 4 Thrombosis associated with catheter malposition Catheter malposition a
No. catheters
Thrombosis
After implantation RA Distal VCS Anonyma V. jugularis V. mammaria
21 12 5 2 1 1
5 0 4 1 0 0
6 2 3 1
2 1 0 1
99
2
After migration RA V. jugularis V. brachiocephalica Correct catheter position a
Complications / 1000 cath. days
RA, right atrium; VCS, vena cava superior.
Ten catheter-related infectious complications were seen in nine patients (8.1%), indicating 0.42 infectious complications per 1000 catheter days. Catheter related sepsis (CRS) was diagnosed in six patients, four of them in combination with pocket infection. One isolated pocket-infection was documented in one patient and three exit-site infections occurred in two patients. In 80% of TIVAD-related infections the
causative microorganisms were Staphylococcal species: Staphylococcus aureus (50%), S. epidermidis (20%) and S. hominis (10%). In the remaining two (20%) TIVAD-related infections, both exit site infections, the causative microorganism remained obscure. Two TIVADs with exit-site infections remained in situ after successful antibiotic treatment and local care. The remaining TIVADs were removed. Five TIVADs were removed because of a combination of complications of the TIVAD or rapidly progressive malignant disease (Table 1). Three TIVADs were removed without prior antibiotic treatment. Only two TIVADs were removed as a consequence of progressive infection despite appropriate antibiotic treatment. Nine thrombotic complications in nine patients were associated with the use of TIVADs (7.3%), indicating 0.38 thrombotic complications per 1000 catheter days (Table 3). The diagnosis of thrombosis was made clinically and confirmed by ultrasound and / or catheter-contrast studies. In two patients thrombosis of the catheter occurred and was successfully treated by low dose streptokinase infusion into the lumen of the catheter. Venous thrombosis was
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observed in five patients, a combination of catheter and venous thrombosis in two patients. Six out of seven patients were treated with oral coumarin derivates and heparin intravenously. One TIVAD was removed without previous therapy. Two TIVADs were removed despite therapy; in one patient concomitant catheter-related sepsis attributed to the decision of removal; in the second TIVAD the reasons for removal was unknown. No complications of anticoagulant therapy were observed. Restoration of catheter function and amelioration of symptoms of venous thrombosis were seen in the remaining four patients. So, six (66.7%) out of nine TIVADs remained in situ and functioned normally after appropriate therapy despite associated thrombotic complications. Extravasation of cytotoxic drugs complicated TIVAD use in two patients (1.6%) (Table 3). In one patient a lesion caused this complication by a suture in the TIVAD catheter. In the second patient, extravasation was caused by needle dislodgement. The infunded cytotoxic drugs were cyclophosphamide / methotrexate / 5-fluorouracil, and epirubicin / cyclophosphamide, respectively, given as bolus i.v. injections for treatment of metastatic breast cancer. Both TIVADs were removed. After removal both patients received another TIVAD without further complications. Migration of the tip of the TIVAD catheter after initial correct position in the proximal part of the superior cava vein was seen in six patients (4.8%) (Table 3). Rupture with embolization of the TIVAD catheter was not documented. Three patients complained of pain in the area of the TIVAD pocket (2.4%). The pain resolved after removal of the TIVAD in these patients. Persistent inaccessibility of the port was present in one patient (0.8%), in whom implantation of the TIVAD had been complicated by subcutaneous haemorrhage around the port. The system was removed for this reason. Thrombosis associated with catheter malposition Thrombotic events associated with catheter malposition are given in Table 4. Immediately after implantation of the TIVAD, malposition of the tip of the catheter was observed in 21 (16.7%) of 126 TIVADs. In none of these cases efforts were made to
relocate a malpositioned tip of the TIVAD catheter. Thrombotic complications occurred in 5 (23.8%) out of 21 malpositioned catheters. A very high risk on thrombotic complications was documented when the catheter-tip was located in the distal part of the vena cava superior: four (80.0%) out of five patients developed thrombosis. In one patient, the tip of the TIVAD catheter was positioned in the vena anonyma and thrombosis developed subsequently. No thrombotic complications were observed with the tip of the catheter located in the right atrium. Migration of the tip of the TIVAD catheter after initial correct position in the superior cava vein was seen in 6 (4.9%) of 123 evaluable TIVADs. In two patients, this migration was accompanied with venous thrombosis. Therefore, 7 thrombotic complications associated with 27 malpositions of the tip of the catheter were observed (25.9%), either catheter and / or venous thrombosis. On the contrary, only 2 (2.0%) thrombotic complications occurred in 99 patients with the tip of the TIVAD catheter correctly located proximal in the superior cava vein. Prospective study In part two of the study 40 consecutive patients were randomized to receive two different types of TIVADs. Due to the academic setting, 21 different surgeons and trainees were involved in the implantation of 40 TIVADs. From the surgeons point of view, implantation of both TIVADs was judged as (very) easy. Implantation of three Port a Cath systems was difficult. These difficulties included problems in making a subcutaneous pocket (n 5 2), difficulties concerning advancing the guide wire and in one case the TIVAD was not complete after opening the sterile package. The nursing staff experienced several problems in relation to TIVAD use. In five patients (12.5%) the access port was not palpable on physical examination, which made the accessibility of the TIVAD difficult. Sampling of blood from the TIVAD was difficult in three TIVADs (7.5%), either directly or several weeks after implantation. A significant correlation was found between the possibility to get access to the TIVAD and palpation of the reservoir and therefore the site of the TIVAD (P 5 0.004). No statistical significant correlations were found between the different TIVAD models with respect to
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the variables implantation, care accessibility, sampling of blood and comfort of the patients. From the patients’ point of view, some additional remarks were made. First, half of the patients mentioned that the implantation was more painful than expected. Second, seven (17.5%) out of 40 patients were not satisfied with the pocket-site of the TIVAD. In fact, none of the patients were formally asked about the pocket-site of the TIVAD on the chest prior to implantation.
Discussion Totally implantable venous access devices (TIVADs) have become a widespread instrument for long-term intravenous therapy. Implantable Ports are seen as a safe, reliable method of venous access associated with a low rate of complications, and need a minimum of care compared with external central venous catheters [3–14]. Moreover, there is a high degree of patient acceptance of the TIVAD [1–6]. The advantages of the use of TIVADs seem to outweigh the disadvantages. Nevertheless, TIVADrelated complications can be very serious [5], as was demonstrated in our evaluation. One patient with advanced colorectal cancer died 16 days after TIVAD implantation due to severe haematothorax. In our study, a strikingly high incidence of thrombotic complications (25.9%) was observed in TIVADs with malpositioned tips of the catheter, especially when located in the distal part of the vena cava superior, a correlation also reported by Puel et al. [10]. As a consequence, correction of this malposition should be performed in order to prevent removal of the TIVAD for thrombotic complications [15]. The overall incidence of TIVAD associated thrombosis was 7.3% in our study, indicating 0.38 thrombotic complications per 1000 catheter days, and is comparable with results in the literature which vary from 0 to 16% [3,6,7,9,10,13,16]. In most cases, catheter thrombosis can be successfully treated by low dose streptokinase or urokinase into the catheter lumen [15,17], as was observed in two of our patients. In occluded catheters not responding to this regimen, a 12-h infusion of 40 000 units of urokinase per hour can restore catheter function in the majority
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of patients without bleeding complications [17]. Although removal of the TIVAD is recommended if, despite appropriate treatment with heparinisation and oral coumarin derivates, the venous thrombosis persists, the superior vena cava becomes involved or if there is a severe pain syndrome [6], this could not be confirmed by our investigation. Vena cava superior syndrome developed in two of our patients, but ameliorated in both with appropriate treatment and with stenting of the superior vena cava in one of these patients. The latter TIVAD remained in function without subsequent complications. Bern et al. [18] found a reduction of thrombotic complications associated with TIVADs with the use of low dose warfarin. However, more randomized prospective studies are needed before this regimen can become a standard procedure for TIVAD implantation. Ten episodes of TIVAD-associated infectious complications (8.1%) were documented, indicating 0.42 infectious complications per 1000 catheter days. In the literature, TIVAD-associated infection rates range from 0.6 to 27% [3–8,12,13,16,19–22], but comparison with data from the literature is difficult since the definition of TIVAD-associated infection is not always clear. The occurrence of TIVAD-associated infectious complications is not necessarily followed by removal of the TIVAD [21,22]. Generally, catheter related bacteriaemia and exit-site infections can be treated with antibiotic regimen and local care for the latter, but success of treatment depends on the causative microorganism as well. In TIVAD-associated pocket-infections with severe cellulitis successful antibiotic treatment is very difficult and most TIVADs will be removed for this reason. In summary, the decision of removal of the system must be based upon type and severity of infection, the causative microorganism, success of treatment and degree of difficulty in obtaining alternative venous access [9]. In our study, eight out of ten TIVADs with infectious complications were removed. Only two systems were removed because of progressive infection despite appropriate antibiotic treatment. The remaining six systems were removed because of a combination of complications with or without previous antibiotic treatment for unknown reasons. The extravasation rate of 1.6% found in our study is comparable with data from the literature which range from 0.9 to 6.5% [3,4,6,13,16]. In our patients,
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local complications of extravasated fluids were only mild. In the prospective part of the study, no statistically significant differences were observed between the two types of TIVADs with respect to perioperative complications, care protocol, use in daily care and patients’ satisfaction. TIVAD-related complications might be influenced by many factors, such as the experience of the surgeon and the site of the TIVAD reservoir; location of the TIVAD in the breast or at the site of a bra can complicate accessibility of the device. Furthermore, for the daily maintenance of the TIVAD, many different care protocols are used. In our hospital, the Huberpoint needle in the TIVAD is changed every 2 weeks, when continuous i.v. administration of medication is needed. In many other centres the needle is changed every week or even more frequently. Of course, these differences could influence the patients’ comfort and the incidence of long-term complications associated with TIVAD use. A protocol should include how to maintain blood flow and good access to the TIVAD and prevent infectious complications. Long et al. [23] studied two care protocols, comparing the use of sterile gloves versus non-sterile gloves, and found no difference in infection rates. Finally, the patient should be well informed about advantages and disadvantages of a TIVAD, like the chance that the TIVAD cannot be used for sampling of blood. The responsible nurse must discuss the site of implantation with the patient and a mark must be made at the most suitable place. These factors might contribute to increasing the patients’ acceptance of TIVADs.
Conclusion Totally implantable venous access devices are valuable instruments for long-term intravenous therapy. These systems are well accepted by patients, physicians and nursing staff and are associated with a low risk of perioperative and long-term complications. To prevent at least part of the thrombotic complications, correct positioning of the tip of the catheter in the proximal part of the superior cava vein is essential. Malpositioned catheter tips, especially located in the distal part of the superior cava vein, should be relocated to prevent subsequent
thrombosis. The rate of TIVAD-associated infectious complications was low and were not an obligate reason for TIVAD removal. Early recognition, antibiotic and / or local treatment of catheter related sepsis and exit-site infections could save the TIVAD. To increase patients’ acceptance and satisfaction with implantation and use of TIVADs, sufficient information prior to implantation should be given. Only well-educated and experienced medical and nursing staff should be responsible for the implantation and care of the TIVAD. Furthermore, research on care protocols should be carried out to define the frequency of inserting the Huber needle and to identify other specific risk factors associated with TIVADs.
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Original article
Totally implantable venous access devices: evaluation of complications and a prospective comparative study of two different port systems A. Hartkamp*, A.J.H. van Boxtel, B.A. Zonnenberg, P.O. Witteveen Department of Internal Medicine, University Medical Centre ( UMC) Utrecht, F02.126 Heidelberglaan 100, 3584 CX Utrecht, The Netherlands Received 7 April 2000; received in revised form 28 August 2000; accepted 13 September 2000
Abstract Background: Totally implantable venous access devices (TIVADs) are valuable instruments in case prolonged intravenous therapy is required, but implantation and use of these devices are associated with complications. The purpose of this study was to evaluate perioperative and long-term complications associated with TIVADs. In addition, we compared two different types of TIVADs with respect to implantation, care protocol and patients’ comfort. Methods: In a retrospective study perioperative and long-term complications in a general oncology population were analysed. In a prospective randomized study comparison of two types of TIVADs was carried out. Results: Perioperative complications occurred in 27 (21.4%) of 126 implanted TIVADs: catheter malposition (16.7%) in 21 patients, pneumothorax (0.8%) in one and haemorrhage (4.0%) in five. Long-term complications appeared in 31 (25.2%) out of 123 TIVADs: thrombosis in 9 (7.3%), especially associated with malposition of the tip of the catheter; infection in 10 (8.1%); extravasation in 2 (1.6%); migration of the cathetertip in 6 (4.8%); pain at reservoir in 3 (2.4%) and inaccessibility of the port in 1 (0.8%). No significant differences were found with respect to implantation, care accessibility and patients’ comfort between the two TIVADs. Conclusions: The use of TIVADs is associated with some risk of serious perioperative and long-term complications. In case of thrombotic complications these systems can be saved with appropriate treatment. Correct positioning of the catheter tip is essential to prevent thrombotic complications. In case of TIVAD-related infectious complications, the possibility of saving the TIVAD depends on the causative microorganism and type of infection. Furthermore, to increase patients’ satisfaction with TIVADs they should be well informed about the surgical procedure and possible disadvantages of these devices. 2000 Elsevier Science B.V. All rights reserved. Keywords: Venous access; Cytotoxic therapy; Complications; Nursing care; Patients’ comfort
Introduction A broad array of vascular access devices is *Corresponding author. Tel.: 1 31-30-2507-7457; fax: 1 3130-252-3741.
available nowadays, ranging from peripheral catheters to totally implantable catheters that enters the most central vein, e.g. the vena cava superior, in the body. The type of vascular access device used in drug-infusion therapy has implications for both the number of skilled nursing interventions required and
0300-2977 / 00 / $ – see front matter 2000 Elsevier Science B.V. All rights reserved. PII: S0300-2977( 00 )00083-8
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the risk of its complications. Peripheral venous access can have a serious impact on patients undergoing prolonged intravenous therapy. Repeated venous puncture is a painful and often anxious experience for most patients during the course of therapy. The use of totally implantable venous access devices (TIVADs) may minimize these negative experiences. With the introduction of TIVADs, the quality of life of patients receiving intensive intravenous therapy has improved [1,2]. Problems like the accidentally subcutaneous administration of cytotoxic drugs and phlebitis seem to be solved. Although the use of this device appears to be safe and reliable [3,4], there are complications associated with implantation and use of the TIVAD, like pneumothorax during implantation, infectious and thrombotic complications [5–11]. In this paper we describe the results of a retrospective analysis (part one) and a randomized study to compare two types of TIVADs (part two) which was carried out at the University Medical Centre (UMC) Utrecht. In part one of the study we analysed our experiences with TIVAD-related complications in a
general oncology population. Part two of the study focused on comparison of two different types of TIVADs (MRI / Hickman portE, Bard and Port a CathE, Deltec) with respect to implantation, care protocol and comfort for the patient.
Patients and methods For the retrospective part of the study, the medical charts of 118 patients that received a TIVAD in a period of 3 years (January 1992–January 1995) were studied with regard to complications related to TIVAD implantation and in the course of TIVAD use. A total of 126 TIVADs (Port a CathE, Deltec) were implanted in 118 patients at the oncology department of the UMC Utrecht. Patients’ characteristics and indications for TIVAD implantation and removal are given in Table 1. Three patients were lost to follow-up. Therefore, 115 evaluable patients were analysed, in whom a total of 123 TIVADs were implanted. Eight patients received a TIVAD twice.
Table 1 Patients’ characteristics and indications of TIVAD implantation and removal Total number of patients Evaluable no. of patients Gender: % male Mean age in years (range) Number of implanted TIVADs
118 115 24.6 54 (16–74) 126
Indication for implantation TIVAD (%) Chemotherapy TPN / fluid i.v. Drugs a Sampling of blood Total catheter days Mean catheter days per patient (range)b
87 7 6 1 23 673 192.5 (2–1091)
(n 5 109) (n 5 9) (n 5 8) (n 5 1)
Indications of explantation TIVAD (%) Completion of therapy Complications c Total number removed TIVADs In situ on January 1st, 1995 No. patients died with TIVAD in situ
6.5 13.0 19.5 23.6 56.9
(n 5 8) (n 5 16) (n 5 24) (n 5 29) (n 5 70)
a
(n 5 126)a
In 1993, one patient had a TIVAD implanted for morphine intraveneously as well as infusion of fluids. Cut-off point evaluation: January 1st, 1995. c Combination of complications leading to removal of five TIVADs: one catheter-related sepsis (CRS) in a patient with a total hipprothesis in situ; two pocket infections in combination with CRS with S. aureus in patients with progressive malignant disease under chemotherapy; venous thrombosis with vena cava superior syndrome and persistent pain at the TIVAD reservoir in a patient with progressive malignant disease; one patient with CRS and thrombosis and progressive malignant disease under chemotherapy. b
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According to the local protocol TIVADs were implanted under local anaesthesia and antibiotic prophylaxis was given. Immediately after implantation, a chest X-ray was made to determine the position of the tip of the TIVAD catheter and to exclude pneumothorax. TIVAD-related complications were categorized as perioperative complications (malposition of the tip of the catheter, pneumothorax, haemorrhage associated with TIVAD implantation or removal) and long-term complications (infection, thrombosis, extravasation, migration of the tip of the catheter, pain at TIVAD reservoir and inaccessibility of the port). For the prospective part of the study, we compared two types of TIVADs (MRI / Hickman portE, Bard and Port a CathE, Deltec). The port of the MRI / Hickman port, Bard, is made of plastic and is not visible on a chest X-ray, in contrast with the metal (titanium) port of the Port a Cath, Deltec. Both TIVADs have an open ended silicon catheter connected to the port. We evaluated differences in implantation, use in daily practice and clinical benefit to the patients of both types of TIVADs. No specific instrument to assess the difference between the two port systems regarding the implantation procedure, comfort for the patient and handling by professionals could be found. Therefore the researchers developed the patient questionnaire (PQ). Next to patient variables like gender and weight, the PQ focuses on the following aspects. The first part of the PQ evaluates the implantation procedure and is completed by the surgeon who implanted the TIVAD. The next part takes the opinion of nurses working with the TIVAD into consideration. The last part focuses on the view of the patient. Two experts in the field of access devices were asked to give comment on the construct validity of the PQ. In Table 2 some examples of the questions of the PQ are given. Immediately after implantation of the TIVAD the surgeons filled out their part of the questionnaire. The nursing staff answered questions concerning the care protocol every time a blood sample was taken and when the Huber needle was changed. Patients filled out three evaluation forms (2, 4 and 6 weeks after implantation of the TIVAD). Implantation and care protocol were evaluated for a period of 6 weeks. Variables of the PQ between the two groups were compared using
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two-tailed t test. The data were analyzed using the 7.5E software package. Patients requiring longterm i.v. therapy for treatment of his or her disease, e.g. cytotoxic therapy continuously in case of neoplastic disease or antibiotic or anti-viral therapy for serious infections, could be included in the study. After informed consent was obtained forty consecutive patients who met the inclusion criteria where randomized by the study coordinator by drawing 1 out of 40 blank envelopes with the brand of device that should be implanted. The study coordinator contacted the operation room to tell the surgeon which device should be implanted. No one but the surgeon was informed about the choice of TIVAD that was made. Twenty patients received a MRI / Hickman port and twenty patients a Port a Cath. Nineteen (47.5%) patients were male. The mean age was 50 years (range 32–74 years). Indications for implantation of the TIVAD were cytotoxic therapy for malignant diseases in 26 (65%) of 40 patients (carcinoma of the mamma, ovarium, head / neck and carcinoid). In 14 (35%) of the patients the TIVAD was implanted for prolonged intravenous therapy for infectious complications in patients with AIDS.
SPSS
Results In part 1 of the study a total of 126 TIVADs were implanted in 118 patients with advanced cancer. A total of 123 TIVADs in 115 patients were evaluable for long-term complications. Patients’ characteristics and indications for implantation and removal of the TIVAD are given in Table 1. A total of 16 TIVADs (13.0%) was removed because of long-term complications. The total number of catheter days in function at the time of evaluation was 23.673 days with a mean of 192.5 days (range 2 –1091 days) (Table 1). Perioperative complications Perioperative complications occurred in 27 (21.4%) of 126 TIVAD implantations (Table 3). Malposition of the tip of the catheter immediately after insertion was a relative frequent occurrence (16.7%). No efforts were made to relocate a malpositioned tip of the catheter. Twelve (57.1%) out of 21 malpositioned tips were localised in the right
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Table 2 Examples of the patient questionnaire Implantation procedure
Taking blood immediately after implantation was Very easy Easy Difficult Very difficult Not possible Were there any influencing factors during implantation? Yes, please explain No
Professionals using the TIVAD
Taking blood from the TIVAD is Possible without problems Only possible when the patient takes a specific position Only possible with syringes and not with the vacuum system Only occasionally possible Not possible at all Flushing the TIVAD with heparin 600 IE in saline is performed every time the TIVAD is disconnected Yes No
Patients’ perspective
How do you experience the comfort of the TIVAD (do you feel the TIVAD) while standing? Never Sometimes Regularly Often (Almost) all the time Is the location of the TIVAD well chosen? Yes, I can’t think of a better location in my circumstances Yes, but another location could be convenient too No, with some activities the location of the TIVAD is not well chosen No, the TIVAD gives problems with all activities
atrium immediately after implantation (Tables 3 and 4). Iatrogenic pneumothorax was observed once (0.8%) which necessitated pleuradrainage. Haemorrhage related with TIVAD implantation or removal was observed in four, respectively one patient (4.0%). In one of these four patients, haematothorax was very severe. Despite several thoracotomies a focus of bleeding could not be identified. The patient was admitted to an I.C.U. for mechanical ventilation because of respiratory insufficiency. This patient died 16 days later, probably as a result of this complication. Whether concomitant rapid progression of the malignancy contributed to this serious adverse event is not clear. In another patient, a mediastinal haemorrhage was seen after removal of a TIVAD; two transfusions of blood were given, no subsequent
complications were observed. Haemorrhagic complications delayed the start of cytotoxic treatment in three patients. One of these systems had to be replaced for persistent inaccessibility of the TIVAD reservoir. Long-term complications of TIVAD use In 115 patients 123 TIVADs were implanted which remained in situ for a total of 23 673 days. During this period a total of 31 (25.2%) long term complications related to the TIVAD occurred (Table 3). In 19 (16.5%) of 115 patients these complications concerned TIVAD related infections, thrombosis and extravasation, indicating 0.89 complication episodes per 1000 catheter days (Table 3).
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Table 3 Complications associated with implantation and use of TIVADs Total no. of complications
Percentage of catheters (%)
Perioperative complications Malposition catheter Pneumothorax Haemorrhage Around TIVAD pocket Mediastinal After explantation
21 1 5 3 1 1
16.7 0.8 4.0 2.4 0.8 0.8
Long-term complications Infectious complications a Exit-site infection Pocket infection Catheter related sepsis Thrombotic complications Catheter thrombosis Venous thrombosis Combination Extravasation Migration catheter-tip Pain at TIVAD reservoir Inaccessibility port
10 3 5 6 9 2 5 2 2 6 3 1
8.1 2.4 4.1 4.9 7.3 1.6 4.1 1.6 1.6 4.8 2.4 0.8
a
1.3 0.42
0.38
0.08
Combination of catheter related sepsis and pocket infection was diagnosed in four patients.
Table 4 Thrombosis associated with catheter malposition Catheter malposition a
No. catheters
Thrombosis
After implantation RA Distal VCS Anonyma V. jugularis V. mammaria
21 12 5 2 1 1
5 0 4 1 0 0
6 2 3 1
2 1 0 1
99
2
After migration RA V. jugularis V. brachiocephalica Correct catheter position a
Complications / 1000 cath. days
RA, right atrium; VCS, vena cava superior.
Ten catheter-related infectious complications were seen in nine patients (8.1%), indicating 0.42 infectious complications per 1000 catheter days. Catheter related sepsis (CRS) was diagnosed in six patients, four of them in combination with pocket infection. One isolated pocket-infection was documented in one patient and three exit-site infections occurred in two patients. In 80% of TIVAD-related infections the
causative microorganisms were Staphylococcal species: Staphylococcus aureus (50%), S. epidermidis (20%) and S. hominis (10%). In the remaining two (20%) TIVAD-related infections, both exit site infections, the causative microorganism remained obscure. Two TIVADs with exit-site infections remained in situ after successful antibiotic treatment and local care. The remaining TIVADs were removed. Five TIVADs were removed because of a combination of complications of the TIVAD or rapidly progressive malignant disease (Table 1). Three TIVADs were removed without prior antibiotic treatment. Only two TIVADs were removed as a consequence of progressive infection despite appropriate antibiotic treatment. Nine thrombotic complications in nine patients were associated with the use of TIVADs (7.3%), indicating 0.38 thrombotic complications per 1000 catheter days (Table 3). The diagnosis of thrombosis was made clinically and confirmed by ultrasound and / or catheter-contrast studies. In two patients thrombosis of the catheter occurred and was successfully treated by low dose streptokinase infusion into the lumen of the catheter. Venous thrombosis was
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observed in five patients, a combination of catheter and venous thrombosis in two patients. Six out of seven patients were treated with oral coumarin derivates and heparin intravenously. One TIVAD was removed without previous therapy. Two TIVADs were removed despite therapy; in one patient concomitant catheter-related sepsis attributed to the decision of removal; in the second TIVAD the reasons for removal was unknown. No complications of anticoagulant therapy were observed. Restoration of catheter function and amelioration of symptoms of venous thrombosis were seen in the remaining four patients. So, six (66.7%) out of nine TIVADs remained in situ and functioned normally after appropriate therapy despite associated thrombotic complications. Extravasation of cytotoxic drugs complicated TIVAD use in two patients (1.6%) (Table 3). In one patient a lesion caused this complication by a suture in the TIVAD catheter. In the second patient, extravasation was caused by needle dislodgement. The infunded cytotoxic drugs were cyclophosphamide / methotrexate / 5-fluorouracil, and epirubicin / cyclophosphamide, respectively, given as bolus i.v. injections for treatment of metastatic breast cancer. Both TIVADs were removed. After removal both patients received another TIVAD without further complications. Migration of the tip of the TIVAD catheter after initial correct position in the proximal part of the superior cava vein was seen in six patients (4.8%) (Table 3). Rupture with embolization of the TIVAD catheter was not documented. Three patients complained of pain in the area of the TIVAD pocket (2.4%). The pain resolved after removal of the TIVAD in these patients. Persistent inaccessibility of the port was present in one patient (0.8%), in whom implantation of the TIVAD had been complicated by subcutaneous haemorrhage around the port. The system was removed for this reason. Thrombosis associated with catheter malposition Thrombotic events associated with catheter malposition are given in Table 4. Immediately after implantation of the TIVAD, malposition of the tip of the catheter was observed in 21 (16.7%) of 126 TIVADs. In none of these cases efforts were made to
relocate a malpositioned tip of the TIVAD catheter. Thrombotic complications occurred in 5 (23.8%) out of 21 malpositioned catheters. A very high risk on thrombotic complications was documented when the catheter-tip was located in the distal part of the vena cava superior: four (80.0%) out of five patients developed thrombosis. In one patient, the tip of the TIVAD catheter was positioned in the vena anonyma and thrombosis developed subsequently. No thrombotic complications were observed with the tip of the catheter located in the right atrium. Migration of the tip of the TIVAD catheter after initial correct position in the superior cava vein was seen in 6 (4.9%) of 123 evaluable TIVADs. In two patients, this migration was accompanied with venous thrombosis. Therefore, 7 thrombotic complications associated with 27 malpositions of the tip of the catheter were observed (25.9%), either catheter and / or venous thrombosis. On the contrary, only 2 (2.0%) thrombotic complications occurred in 99 patients with the tip of the TIVAD catheter correctly located proximal in the superior cava vein. Prospective study In part two of the study 40 consecutive patients were randomized to receive two different types of TIVADs. Due to the academic setting, 21 different surgeons and trainees were involved in the implantation of 40 TIVADs. From the surgeons point of view, implantation of both TIVADs was judged as (very) easy. Implantation of three Port a Cath systems was difficult. These difficulties included problems in making a subcutaneous pocket (n 5 2), difficulties concerning advancing the guide wire and in one case the TIVAD was not complete after opening the sterile package. The nursing staff experienced several problems in relation to TIVAD use. In five patients (12.5%) the access port was not palpable on physical examination, which made the accessibility of the TIVAD difficult. Sampling of blood from the TIVAD was difficult in three TIVADs (7.5%), either directly or several weeks after implantation. A significant correlation was found between the possibility to get access to the TIVAD and palpation of the reservoir and therefore the site of the TIVAD (P 5 0.004). No statistical significant correlations were found between the different TIVAD models with respect to
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the variables implantation, care accessibility, sampling of blood and comfort of the patients. From the patients’ point of view, some additional remarks were made. First, half of the patients mentioned that the implantation was more painful than expected. Second, seven (17.5%) out of 40 patients were not satisfied with the pocket-site of the TIVAD. In fact, none of the patients were formally asked about the pocket-site of the TIVAD on the chest prior to implantation.
Discussion Totally implantable venous access devices (TIVADs) have become a widespread instrument for long-term intravenous therapy. Implantable Ports are seen as a safe, reliable method of venous access associated with a low rate of complications, and need a minimum of care compared with external central venous catheters [3–14]. Moreover, there is a high degree of patient acceptance of the TIVAD [1–6]. The advantages of the use of TIVADs seem to outweigh the disadvantages. Nevertheless, TIVADrelated complications can be very serious [5], as was demonstrated in our evaluation. One patient with advanced colorectal cancer died 16 days after TIVAD implantation due to severe haematothorax. In our study, a strikingly high incidence of thrombotic complications (25.9%) was observed in TIVADs with malpositioned tips of the catheter, especially when located in the distal part of the vena cava superior, a correlation also reported by Puel et al. [10]. As a consequence, correction of this malposition should be performed in order to prevent removal of the TIVAD for thrombotic complications [15]. The overall incidence of TIVAD associated thrombosis was 7.3% in our study, indicating 0.38 thrombotic complications per 1000 catheter days, and is comparable with results in the literature which vary from 0 to 16% [3,6,7,9,10,13,16]. In most cases, catheter thrombosis can be successfully treated by low dose streptokinase or urokinase into the catheter lumen [15,17], as was observed in two of our patients. In occluded catheters not responding to this regimen, a 12-h infusion of 40 000 units of urokinase per hour can restore catheter function in the majority
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of patients without bleeding complications [17]. Although removal of the TIVAD is recommended if, despite appropriate treatment with heparinisation and oral coumarin derivates, the venous thrombosis persists, the superior vena cava becomes involved or if there is a severe pain syndrome [6], this could not be confirmed by our investigation. Vena cava superior syndrome developed in two of our patients, but ameliorated in both with appropriate treatment and with stenting of the superior vena cava in one of these patients. The latter TIVAD remained in function without subsequent complications. Bern et al. [18] found a reduction of thrombotic complications associated with TIVADs with the use of low dose warfarin. However, more randomized prospective studies are needed before this regimen can become a standard procedure for TIVAD implantation. Ten episodes of TIVAD-associated infectious complications (8.1%) were documented, indicating 0.42 infectious complications per 1000 catheter days. In the literature, TIVAD-associated infection rates range from 0.6 to 27% [3–8,12,13,16,19–22], but comparison with data from the literature is difficult since the definition of TIVAD-associated infection is not always clear. The occurrence of TIVAD-associated infectious complications is not necessarily followed by removal of the TIVAD [21,22]. Generally, catheter related bacteriaemia and exit-site infections can be treated with antibiotic regimen and local care for the latter, but success of treatment depends on the causative microorganism as well. In TIVAD-associated pocket-infections with severe cellulitis successful antibiotic treatment is very difficult and most TIVADs will be removed for this reason. In summary, the decision of removal of the system must be based upon type and severity of infection, the causative microorganism, success of treatment and degree of difficulty in obtaining alternative venous access [9]. In our study, eight out of ten TIVADs with infectious complications were removed. Only two systems were removed because of progressive infection despite appropriate antibiotic treatment. The remaining six systems were removed because of a combination of complications with or without previous antibiotic treatment for unknown reasons. The extravasation rate of 1.6% found in our study is comparable with data from the literature which range from 0.9 to 6.5% [3,4,6,13,16]. In our patients,
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local complications of extravasated fluids were only mild. In the prospective part of the study, no statistically significant differences were observed between the two types of TIVADs with respect to perioperative complications, care protocol, use in daily care and patients’ satisfaction. TIVAD-related complications might be influenced by many factors, such as the experience of the surgeon and the site of the TIVAD reservoir; location of the TIVAD in the breast or at the site of a bra can complicate accessibility of the device. Furthermore, for the daily maintenance of the TIVAD, many different care protocols are used. In our hospital, the Huberpoint needle in the TIVAD is changed every 2 weeks, when continuous i.v. administration of medication is needed. In many other centres the needle is changed every week or even more frequently. Of course, these differences could influence the patients’ comfort and the incidence of long-term complications associated with TIVAD use. A protocol should include how to maintain blood flow and good access to the TIVAD and prevent infectious complications. Long et al. [23] studied two care protocols, comparing the use of sterile gloves versus non-sterile gloves, and found no difference in infection rates. Finally, the patient should be well informed about advantages and disadvantages of a TIVAD, like the chance that the TIVAD cannot be used for sampling of blood. The responsible nurse must discuss the site of implantation with the patient and a mark must be made at the most suitable place. These factors might contribute to increasing the patients’ acceptance of TIVADs.
Conclusion Totally implantable venous access devices are valuable instruments for long-term intravenous therapy. These systems are well accepted by patients, physicians and nursing staff and are associated with a low risk of perioperative and long-term complications. To prevent at least part of the thrombotic complications, correct positioning of the tip of the catheter in the proximal part of the superior cava vein is essential. Malpositioned catheter tips, especially located in the distal part of the superior cava vein, should be relocated to prevent subsequent
thrombosis. The rate of TIVAD-associated infectious complications was low and were not an obligate reason for TIVAD removal. Early recognition, antibiotic and / or local treatment of catheter related sepsis and exit-site infections could save the TIVAD. To increase patients’ acceptance and satisfaction with implantation and use of TIVADs, sufficient information prior to implantation should be given. Only well-educated and experienced medical and nursing staff should be responsible for the implantation and care of the TIVAD. Furthermore, research on care protocols should be carried out to define the frequency of inserting the Huber needle and to identify other specific risk factors associated with TIVADs.
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