incision was closed with Steri-Strips (3M, St Paul) and the surgical site covered ..... Begala JE, Maher K, Cherry JD: Risk of infection associ- ated with the use of ...
Improved Methods for Venous Access: The Port-A-Cath, A Totally Implanted Catheter System By Stephen Strum, Jonathan McDermed, Alexander Korn, and Corrine Joseph We prospectively evaluated the performance and rate of long-term complications with the Port-A-Cath (PAC), a totally implanted vascular access system. Two catheter styles were evaluated, a small-bore (SB) catheter (0.51-mm diameter) and a large-bore (LB) catheter (1.02-mm diameter), in conjunction with the use of a strict catheter care protocol. The PAC performed well, and with both SB and LB systems, no significant extravasation, skin necrosis, hematoma, septum damage or leakage, or subcutaneous portal infections occurred after 7,240 days of implantation and 1,435 days of use. Complications with the PAC system consisted of catheter occlusion (seven patients, 21.5%) and one instance of possible catheter infection (3.1%). Occlusions were limited to patients im-
VASCULAR
ACCESS PROBLEMS fre-
quently develop in cancer patients receiving chemotherapy. In a recent analysis of patient perceptions of their therapy, cancer patients rated the pain associated with the search for suitable veins to be one of the most distressing physiologic side effects of chemotherapy.' Venous irritation from anticancer drugs and the need for repeated venipuncture for a period of months to years results in gradual sclerosis, thrombosis, and the destruction of available surface veins. In patients with poor peripheral veins, many oncologists recommend the placement of a central venous catheter for venous access to circumvent the high risk of extravasation from administration of vesicant chemotherapy. A relatively new method of venous access is being explored through the use of totally implanted vascular access ports. These systems reFrom the Departments of Medicine and Clinical Pharmacy, University of Southern California, the Norris CancerHospital and Research Institute, Los Angeles; and the Division of Medical Oncology and Hematology, Brotman Medical Center, Culver City, Calif. Submitted March 25, 1985; accepted Oct 18, 1985. Address reprint requests to Stephen B. Strum, MD, 9808 Venice Blvd, #503, Culver City, CA 90230. C 1986 by American Society of Clinical Oncology. 0732-183X/86/0404-0001/$3.00/0
596
planted with the SB catheter (seven of 16, 43.8%), and five of the seven (71.4%) occurred in patients receiving continuous infusion chemotherapy and/or total parenteral nutrition. Patency of the PAC system was maintained using a regular flushing schedule once every 30 days, a significant advantage compared with the daily maintenance schedule required with externally placed venous catheters. The results of this study suggest that the PAC system can provide a safe and reliable method for venous access in patients requiring intermittent or prolonged intravenous therapy. J Clin Oncol 4:596-603. © 1986 by American Society of Clinical Oncology.
tain all of the advantages of external venous catheters with respect to central venous access for drug administration, total parenteral nutrition (TPN), or repeated phlebotomy. The subcutaneous location of the injection site is esthetically desired by some patients and allows uninhibited patient activity when the catheter is not in use. Maintenance requirements for implanted access ports are minimal, and because of the lack of externally exposed parts and decreased catheter manipulation, the risk of catheter-related sepsis is thought to be low. 2' 3 One such system is the Port-A-Cath (PAC) (Pharmacia Nu-Tech, Piscataway, NJ). It differs from other access ports in that a variety of Silastic catheters can be connected to the stainless steel injection portal to provide access for intravenous (IV), intraarterial, or intraperitoneal drug administration. Preliminary reports of clinical experience with the venous PAC have been published from major teaching institutions.3,4 However, little information is available regarding the long-term performance and complication rate with the PAC used in the community setting. The purpose of this study was to present follow-up data on 32 patients who were implanted with the PAC venous access system and were treated in a community setting.
Journal of Clinical Oncology, Vol 4, No 4 (April), 1986: pp 596-603
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PAC-AN IMPROVED METHOD FOR VENOUS ACCESS Table 1. Patient Demographics Type of Catheter Characteristic
SB
LB
Total number of patients Sex (M:F) Age (yr) Mean Median Range Primary malignancy Female breast Pulmonary Gastrointestinal Head and neck Sarcoma Genitourinary Lymphoma Pattern of use Short-term (chemotherapy) Long-term (primarily TPN)
16 3:13
16 6:10
63.8 68 41-68
66.1 67 52-81
5 4 3 2 1 1 0
2 3 5 1 2 2 1
9 7
6 10
MATERIALS AND METHODS This was an uncontrolled clinical evaluation of the performance and rate of complications encountered with the use of the PAC venous access port. Two catheter styles were evaluated in the course of the study: a small-bore (SB) catheter (0.51-mm diameter) and a large-bore (LB) catheter (1.02-mm diameter). Between January and May 1983, all patients enrolled received the SB system implant. All patients subsequently enrolled received the LB system implant, which had become available for use after May 1983.
Patients The population studied consisted of 32 cancer patients who were candidates for central venous catheter placement for purposes of chemotherapy and/or TPN. Patient demographic data is outlined in Table 1. Sixteen patients received the SB system implant, and 16 patients received the LB system. The PAC was implanted for TPN and chemotherapy administration in 24 of 32 patients, continuous, low-dose chemotherapy in two patients and short-term intermittent chemotherapy in six patients. Eleven patients received TPN for less than 30 days, whereas 13 others received TPN for more than 30 days.
Patients were provided with written information describing the PAC implant system as well as a description of available external central venous catheters. The potential advantages and disadvantages of these access devices were thoroughly discussed. Patients were informed of the purpose of the research study and the investigational status of the PAC system. Thirtytwo of 35 eligible patients agreed to be enrolled into the study. The protocol was approved by both the human research and human rights committees, which constitute the institutional review board at Brotman Medical Center. Written informed consent was obtained in all patients.
Materials The PAC was purchased from Pharmacia Nu-Tech (Piscataway, NJ). It consisted of two components: (1) a stainless steel injection portal that housed a high-density, self-sealing silicone septum and (2) interchangeable Silastic catheters that were connected to the portal with a locking ring (Fig 1). The two catheter styles studied were constructed of identical inert materials and differed only in their bore diameters.
Surgical Procedure Under local anesthesia, the catheter was introduced into the superior vena cava via either the internal jugular, cephalic, or subclavian venous route with the aid of a guide wire. The proximal end of the catheter was tunneled beneath the skin into a subcutaneous pocket created in the right or left infraclavicular space and was connected to the portal with the locking ring (Fig 2). The system was filled with heparinized saline and the portal implanted and secured into position to underlying muscle fascia using nonabsorbable 2.0 Ethibond sutures (Ethicon, Summerville, NJ) on an OS-4 needle at the four suture loop sites. The incision was closed with Steri-Strips (3M, St Paul) and the surgical site covered with a sterile transparent dressing. Catheter tip location was determined by chest radiograph before administration of drugs, IV fluids, or TPN solutions through the PAC.
Injection of the Subcutaneous Portal Per prescribed protocol, flushing or drug administration could only be performed after receiving the in-servicing required by the manufacturer and by those personnel formally trained in the care and maintenance of the PAC. Handwashing with a bactericidal soap or scrub was required, and the use of sterile gloves and aseptic technique during the procedure was mandatory. In the majority of patients, the portal could be easily palpated below the overlying skin, and the portal septum could be located
Fig 1.
cC&OWW· Catheter
(A) Schematic diagram
of the PAC system showing its component parts: (1) stainless steel portal housing with a highdensity, self-sealing silicone septum; (2) a catheter lock that mates the standard portal with various catheter styles; and (3) a Silastic catheter that is cut to the desired length at the time of surgical implantation. (B) Cross-sectional diagram depicting the direct method of PAC access using a syringe and straight Huber needle.
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598
tion. When used for overnight to long-term periods of time, the bent Huber needle was inserted into the portal and firmly affixed to the overlying skin as will be described.
A
Entry Inaubcuta• oal pocketfor portW
Dressing an Indwelling Huber Needle The length of the bent Huber needle to be used was individually determined for each patient by the thickness of the skin and subcutaneous tissue overlying the portal. In most cases, the 25.4 mm-bent needle was of sufficient length to penetrate fully the septum and overlying skin and result in close proximity of the needle junction to the skin surface. The overlying skin in some obese patients was thick enough to require the use of the 38.1 mm-bent needle. In all cases, that portion of the needle projecting above the skin surface was minimized by the use of the appropriate needle length and, if required, reinforcement with one or more sterile gauze pads. To provide an added barrier against infection, the needle entry site was coated with a thin layer of antibiotic ointment, and the skin overlying the portal was protected with a sterile transparent dressing. The dressing was firmly placed over the Huber needle and its junction with the connection tubing and reinforced with hypoallergenic adhesive tape. This was done to prevent inadvertent needle dislodgement, or migration from the portal by so-called plastic crawl, which could result in septum damage or drug extravasation.
Catheter Maintenance
Fig 2. (A) For central venous access, the PAC portal was surgically implanted into a subcutaneous pocket created in the right or left infraclavicular space. The catheter was introduced into the superior vena cava with the aid of a guide wire via the external jugular or cephalic vein. The catheter was cut to the proper length, tunneled subcutaneously to the pocket, and connected to the portal with the locking ring. (B) The portal was secured in position to underlying fascia with four 2.0 Ethibond sutures on an OS-4 needle at the four suture loop sites.
by triangulation. However, in some obese patients, the portal was more difficult to locate. In such cases, India ink was used to tattoo the skin overlying the portal, thereby outlining the portal perimeter. Huber needles were specified for injection of the PAC to minimize potential septum damage, or coring. The feel of the needle passing through the dense portal septum was sufficiently characteristic to preclude inadvertent injection of drug into the subcutaneous tissue overlying the PAC. Special care was taken during the injection procedure to maintain fluid flow into the PAC, and constant positive pressure was applied on the syringe plunger when withdrawing the needle from the portal to prevent possible aspiration of blood into the system. For simple heparin flushing or bolus injections of chemotherapy, a direct approach was used in accessing the PAC, using a syringe and straight Huber needle. For patients receiving TPN or intermittent or long-term chemotherapy infusions, a Huber needle bent 90 degrees was used in conjunction with a short length of connection tubing to facilitate drug or TPN administra-
Catheter patency was maintained in accordance with study protocol through a routine flushing schedule and strict adherence to prescribed catheter care procedure. 5 If the system was not used for drug or TPN administration within 24 to 48 hours after placement, the PAC was flushed with 5 mL heparinized saline using an empiric concentration of 200 U/mL. The PAC was flushed with 5 mL normal saline before each use to verify the patency of the system and to clear residual heparin to avoid potential drug-drug interactions. If used for intermittent chemotherapy, the PAC was flushed with heparinized saline after each use and once every 30 days if treatment was administered less frequently. If used for TPN or long-term chemotherapy, the PAC was flushed once each week at the time the indwelling Huber needle, connection tubing, and sterile dressing were changed.
Patterns of Use Catheter applications were not uniformly distributed within the two subgroups; the majority of patients in the LB group had their PAC placed for purposes of TPN, which related to the higher proportion of patients having gastrointestinal obstruction resulting from abdominal and/or pelvic carcinomatosis. However, all patients received treatment with either intermittent or continuous infusion chemotherapy. To assess the performance and complication rate with the PAC under the various conditions described, two broad criteria were used to define patterns of use. Patients who received their therapy as an intermittent injection or infusion were classified into the short-term category. In these patients, the PAC was not in use for 1- to 4-week periods, with the frequency of use dependent on the type of chemotherapy regimen used. In all cases, the system was flushed with heparinized saline at 30-day intervals or after each use, whichever occurred first. Patients who were receiving TPN or continuous infusions of chemothera-
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PAC--AN IMPROVED METHOD FOR VENOUS ACCESS py were classified into the long-term category. In these patients, the PAC was in use for extended periods, in some, for the entire time the system was implanted. Monitoring parameters were defined to assess the integrity and relative occurrence of complications with the PAC. Implantation time was defined as the number of days the system was in place, from the date of implantation to the date complication(s) or death occurred. This parameter was used as a global assessment of PAC integrity. Time used was defined as the total number of days the system was actually in use and was used to evaluate catheter integrity and differentiate occurrence of complications with relation to patterns of use. Number of punctures was defined as the total number of times the portal septum and overlying skin was penetrated with a Huber needle. This was used to assess septum integrity and cutaneous reactions and to differentiate the occurrence of complications with relation to patterns of use. All patients who had PAC system implanted continued to be monitored on study, even after having completed the prescribed course of chemotherapy.
RESULTS Performance The PAC venous access system was implanted for a total of 7,240 days, in use for a total of 1,435 days, and was subjected to a total of 525 needle punctures. Septum integrity was excellent; there was no evidence of septum damage or leakage, and no necrosis of the overlying skin was noted. No inadvertent extravasation of heparin, contrast dye, or vesicant chemotherapy occurred, and no significant movement of the portal from the original site of implantation was observed. Resistance to fluid flow was minimal with the venous PAC, and infusion rates of up to 300 mL/hr were achievable with a number of commercially available infusion devices. Clinical data for the 32 patients who received implants with each of the two venous configurations are outlined in Table 2 and separated according to principal pattern of use. Because of the open-label design of the study, patient-related variables such as diagnosis, age, extent of disease, or chemotherapy treatment could not be controlled and thus affected measured parameters for system performance. In addition, the LB configuration was not available before May 1983, resulting in a relatively shorter median implantation time for LB patients as opposed to SB patients. There were more patients in the SB group with favorable diagnoses, and this resulted in more long-term survivors in the SB group than in the LB group. It is apparent that the majority of longterm survivors were receiving short-term chemo-
599
therapy, resulting in a significantly longer median implantation time (552 days) in the short-term subset as compared with the other three patient groups. Despite the shorter median implantation time in LB patients, median times of use were comparable in both groups. This could be explained by a greater proportion of the LB patients with long-term patterns of use. Only seven of 16 SB patients (43.8%) received TPN or continuous chemotherapy, in contrast to ten of 16 LB patients (62.5%) receiving similar therapies (P = .07). The median implantation time, and the time of actual use were both longer in LB patients than in SB patients in this long-term subgroup. This could be related to the somewhat higher incidence of early death and the significantly higher incidence of complications in SB patients in contrast to LB patients. Complications Mild local erythema and swelling of the skin overlying the portal was frequently noted postoperatively, but resolved in all cases within 72 hours of implantation. Mild to moderate surgical discomfort was also noted and lasted from 2 to 7 days, but in no instance interfered with the use of the device. Septum damage or leakage was not observed during the course of this study; however, local complications included irritation of the skin overlying the PAC in two patients receiving TPN via an indwelling Huber needle. Both patients recovered following local measures and Huber needle replacement. Dislodgement of an indwelling needle occurred in one patient and resulted in extravasation into the subcutaneous portal pocket. This patient was receiving IV fluids and recovered uneventfully. Resistance to fluid flow was observed in 11 patients implanted with the venous PAC system after multiple uses. In four cases, a repeat flushing procedure was uneventful and implied that incomplete needle insertion was the cause of flow resistance. In seven patients (21.5%), resistance to flow was persistent, and the administration of radiographic contrast dye through the PAC confirmed catheter occlusion as the cause of flow resistance in all cases. Five patients underwent catheter declotting with urokinase (Abbott Laboratories, North Chicago, Ill) via a procedure previously described, 6 with patent flow reestablished in two cases. Four patients under-
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600
STRUM ET AL
went surgery, with thrombectomy and replacement of the clotted catheter. One patient was moribund at the time of venous catheter occlusion and was not considered to be a surgical candidate. Examination of the explanted catheter in all cases revealed the presence of organized thrombi occluding the catheter tip at the distal end. All seven occlusions were noted to occur in patients who received the SB venous catheter implant (seven of 16, 43.8%), which occurred a median of 64 days post-implantation and after a median of 34 days of use. Five of seven occlusions (71.4%) occurred in patients receiving TPN or continuous chemotherapy for a median of 54 days of use (Table 3). In contrast, no occlusions occurred in patients who received the LB catheter implant (zero of 16, 0%, P < .01). This
occurred after a median implantation time of 112 days despite the significantly greater frequency of TPN use in the LB subgroup. Severe neutropenia following chemotherapy for small-cell lung carcinoma developed in one patient with an LB catheter. Clinical sepsis developed, with peripheral blood cultures positive on two occasions for Klebsiellapneumoniaeand Candidaalbicans. Despite treatment with broadspectrum antibiotics and antifungal therapy, the patient died on the tenth postoperative day. Antemortem studies of the explanted catheter failed to reveal fungal elements, and catheter tip cultures were negative. DISCUSSION The results of this study indicate that the implanted PAC system is able to provide reliable
Patient Data With the Venous PAC System
Table 2.
LB System
SB System
Time (days) Patient Implant Used No. Short term
1 2 3 5 9
729 209 63 699 623
10 11 13 14
552 256 286 643 4,060 552
Total Median Long term
Total Median
4
79
6 7
31 633
8 12 15 16
135 69 35 72 1,054 72
36 17 13 40 13 (30) 31 27 35 27 239 27 56 (13) 23 34 (62) 34 69 35 54 (18) 305 35
No. of PAC ComInjec- plication tions 36 16 3 39 41 19 8 14 26 202 19 18 3 61 9 5 11 9 116 9
no no no no yes no no yes no no
yes no no yes no yes yes no yes no
Status alive dead dead alive alive dead dead dead olive
dead dead alive dead dead dead dead
Patient No. 18 23 25 27 28 32
17 19 20 21 22 24 26 29 30 31
Time (days) Used Implant
No. of PAC ComInjec- plications tion
83 324 159 149 124 45
9 94 21 7 29 10
5 19 8 7 20 10
884 136
170 15.5
69 9
8 263 225 10 138 38 271 111 112 66 1,242 111.5
8 260 120 8 46 38 45 111 21 64 721 45.5
1 36 22 3 9 5 25 15 12 10 138 11
Status
no no no no no no
dead dead dead dead alive alive
no no no no* no no no no no no
dead dead dead dead dead dead alive dead alive alive
NOTE: Patients 1 to 16 received SB catheter implants; patients 17 to 32 received LB catheter implants. Abbreviations: Pt, patient; implant time, days PAC implanted through Feb 1, 1985, until complication noted, or patient death; time used, days PAC actually used; no. of PAC injections, number of skin/septum punctures; ( ), days replaced catheter used. *Septic death, 10 days postimplantation.
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601
PAC-AN IMPROVED METHOD FOR VENOUS ACCESS Table 3.
Thrombotic Complications in Patients With SB Systems No. of
Patient No. 9 11 4 7 8 12 16
Primary Use CT CT TPN, TPN, TPN, TPN, TPN,
CT CT CT CT CT
Term
Implant
Used
PAC Injections
short short long long long long long
123 256 63 34 112 64 54
14 27 56 34 26 64 54
13 8 18 12 9 5 8
706 64
275 34
73 9
Time (days)
Total Median
Treatment replaced* not replacedt replaced* replaced* urokinaset urokinaset replaced
NOTE: Catheter thrombosis was the major complication limiting clinical use of the PAC, and all occurred in patients who received SB system implants. Five of seven thrombotic complications occurred in patients receiving TPN and/or continuous chemotherapy. Surgical correction consisted of thrombectomy and surgical replacement of catheter. Abbreviations: implant time, number of days PAC implanted until occlusion occurred; time used, number of days PAC actually used until occlusion occurred; no. of PAC injections, number of skin/septum punctures until occlusion occurred; CT, chemotherapy. *Urokinase failure. tPatient moribund and surgery not indicated. tUrokinase success (5,000 IU instilled into PAC for one or two attempts). §Urokinase use not attempted.
venous access to cancer patients in whom all peripheral sites have been exhausted. Our clinical experience with the PAC appears similar to those of others who investigated other implanted devices2,3 and to those of Bothe et al4 who also evaluated the PAC system. However, in contrast to previous studies, we have reported data regarding long-term performance and complication rates, including five patients who have had a PAC system implanted for more than 2 years. Ten study patients (five with SB catheters and five with LB catheters) are alive with functional implanted systems after a median implantation time of 623 days (range, 165 to 729 days). A number of approaches have been tried in the past to provide intermittent to long-term vascular access. These include arteriovenous fistulas 7 bovine heterografts,5 and external catheterization of the right atrium via the peripheral or subclavian routes with various types of silicone or Silastic catheters.-4 2 Of these, the Broviac" and Hickman' 2 catheters are perhaps the most commonly used. Although efficient, they possess problems with infection and occlusions that generally limit their use to approximately 100 days.13,14 They also require a tedious maintenance schedule, and because of the externally exposed injection site,
inhibit activities such as swimming and bathing besides being cosmetically unattractive. Patient acceptance of the PAC system has been excellent. The cosmetic appearance of this implanted access system has been favorably received, especially by female patients. Of greater importance, however, is that the PAC system has eliminated the tedious search for suitable peripheral veins. In addition, the 1.02-mm diameter of the LB system currently in use also allows for blood sampling. Pain, anxiety, and apprehension previously experienced by our patients with respect to blood sampling and chemotherapy administration have virtually been eliminated. Complications with the PAC system were limited primarily to patients receiving TPN with the SB catheter configuration. Since May 1983, this system was replaced with the LB catheter, which appears to have eliminated thrombotic complications with the PAC. However, the SB systems appear to perform well for short-term intermittent therapies. Thrombosis developed in only two of nine patients (22.2%) after a mean of 462 days of implantation and a mean of 20 days of use. In two of five cases in which thrombolytic therapy was used, 5,000 to 10,000 U of urokinase instilled into the PAC effectively declotted
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602
the system, thus avoiding the need for surgical intervention. The performance of a similar implanted catheter system was tested in 24 patients by Gyves et al. 2 In this study, catheter occlusion was noted in five of six patients (83.3%) who received a 0.38-mm-diameter catheter implant after a median of 180 days of implantation. However, no thrombotic complications were noted in 18 patients with a 0.63-mm internal diameter catheter implant after 300 days of observation. This is in agreement with our results with the PAC system and suggests that risk for catheter occlusion is related to the bore size of the catheter used. The potential for drug extravasation with vascular access ports has been documented in the recent literature." In this study, five of ten patients who received implants with various implanted catheter systems suffered drug extravasation into the skin overlying the portal during overnight infusions. In three cases, resultant tissue injury was severe enough to warrant surgical removal of the access port. However, in our experience with the PAC system, risks for extravasation with this device appear to be much lower, occurring in one of 32 patients (3.1%). This is similar to results of another study of the PAC device in which three of 74 patients (4. 1%) experienced drug extravasation.4 We attribute our lower rate of drug extravasation with the PAC to strict adherence to our catheter care protocoP and weekly changes of the indwelling Huber needle in patients receiving TPN or continuous chemotherapy. Another important factor relates to the specific design features of the PAC system that differentiate it from other vascular access ports. The silicone septum and portal chamber of the PAC device require significantly deeper needle penetration, thereby providing greater friction between the needle and septum. This feature makes inadvertent dislodgement of an indwelling Huber needle less likely to occur, thus reducing risks for extravasation. Controlled trials are required to determine the relative risks of drug extravasation among other commercially available vascular access ports, in conjunction with rigid adherence to a catheter care protocol. Infectious complications with the PAC in our study were negligible and confirm initial reports of a low incidence of infection with such implanted systems. Strict aseptic technique in all
STRUM ET AL
aspects of care of the PAC as well as uniform surgical technique by a single surgeon (A.K.) may account for our favorable infection rate. However, patient selection in our study population would also appear important since other factors such as underlying disease status and immune suppression are known to affect the potential for infection developing in a cancer patient. In earlier studies in which Hickman catheters were used in granulocytopenic patients, the risks of infection and sepsis developing were obviously much higher.' 6 Since only one patient in our study population became severely neutropenic during chemotherapy, this bias may have favorably influenced the incidence of infection in our study. Further studies of implanted catheter systems involving a larger patient sample with varying clinical circumstances are required to determine the true incidence of infectious complications with totally implanted catheter systems. The availability of the LB catheter configuration allows the PAC system to be used for blood sampling, as well as the administration of blood or blood products, an advantage that was not present with the earlier SB catheter configuration. However, we did not use the LB catheter extensively for phlebotomy purposes except in patients who had no other peripheral sites. It should be noted that strict adherence to protocol was required for optimal use of the LB catheter for phlebotomy purposes. If excessive suction was applied, the thin-walled design of the catheter was noted to collapse and result in the inability to withdraw blood from the PAC, even though the lumen remained patent for drug administration or TPN. This phenomenon, referred to as a partial occlusion, has also been observed to occur in patients with Hickman catheters.14 We conclude that the PAC system is a safe and reliable method of venous access for intermittent or extended periods of time and appears to be a reasonable alternative to external catheter placement in patients receiving cancer chemotherapy or TPN. Complications consisted primarily of a high rate of system occlusion, which appeared to be related to the use of the SB catheter system. For patients receiving chemotherapy or TPN, the complication rate with the LB catheter configuration presently available would appear much lower. Comparative trials involving a large sample size are required to determine relative per-
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PAC-AN IMPROVED METHOD FOR VENOUS ACCESS
formance, complication rates, and patient preferences between totally implanted access ports and external venous catheters. REFERENCES 1. Coates A, Abraham S, Kaye SB, et al: On the receiving end-Patient perception of the side effects of cancer chemotherapy. Eur J Cancer Clin Oncol 19:203-208, 1983 2. Gyves J, Ensminger W, Niderhuber J, et al: Totally implanted system for intravenous chemotherapy in patients with cancer. Am J Med 73:841-845, 1982 3. Ecoff L, Barone RM, Simons RM: Implantable infusion port (Port-A-Cath). Journal of the National Intravenous Therapy Association 2:406-408, 1983 4. Bothe A, Piccione W, Ambrosino JJ, et al: Implantable central venous access system. Am J Surg 147:565-569, 1984 5. McDermed JE, Tracy JT, Strum SB: Port-A-Cath policies and procedures. A manual for physicians, pharmacists, and nurses. Piscataway, NJ, Pharmacia Laboratories, 1985 6. Lawson M, Bottino JC, Hurtubise MR, et al: The use of urokinase to restore patency of occluded central venous catheters. Am J Intra Ther Clin Nutr 9:29-32, 1982 7. Wade JC, Newman KA, Schimpff SC, et al: Two methods for improved venous access in acute leukemia patients. JAMA 246:140-144, 1981
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8. Lempert N, MacDowell RT, Karmody A, et al: Vascular access for cancer chemotherapy. Cancer 43:1934-1936, 1979 9. Bottino J, McCreadie KB, Groschel DH, et al: Long-term intravenous therapy with peripherally inserted silicone elastomer central venous catheters in patients with malignant diseases. Cancer 43:1937-1943, 1979 10. Laird JJ: Permanent subcutaneous vascular access: The chemo shunt. Can J Surg 25:690-692, 1982 11. Broviac JW, Cole JJ, Scribner BH: A silicone rubber atrial catheter for prolonged parenteral alimentation. Surg Gynecol Obstet 136:602-606, 1973 12. Hickman RO, Buckner CD, Clift RA, et al: A modified right atrial catheter for access to the venous system in marrow transplant recipients. Surg Gynecol Obstet 148:871-875, 1979 13. Thomas JH, MacArtur RI, Pierce GE, et al: HickmanBroviac catheters-indications and results. Am J Surg 140: 791-796, 1980 14. Begala JE, Maher K, Cherry JD: Risk of infection associated with the use of Broviac and Hickman catheters. Am J Infect Control 10:17-23, 1982 15. Reed WP, Newman KA, Applefeld MM, et al: Drug extravasation as a complication of venous access ports. Ann Intern Med 102:788-789, 1985 16. Reed WP, Newman KA, De Jongh C, et al: Prolonged venous access for chemotherapy by means of the Hickman catheter. Cancer 52:185-192, 1983
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