A comparison of placement techniques and complications of externalized catheters and implantable port use in children with cancer

A Comparison of Placement Techniques and Complications of Externalized Catheters and Implantable Port Use in Children With Cancer By Joseph Mirro, Jr, Bhaskar N. Rao, Mahesh Kumar, Mary Rafferty, Michael Hancock, Bradford A. Austin, Diane Fairclough, and Them E. Lobe Memphis, Tennessee 9 The complications associated with the placement and use of Hickman catheters (n = 120}, Broviac catheters (n = 146), and implantable ports (n = 93) in children with cancer w e r e analyzed. Percutaneously placed central venous access devices (CVADs) tended to fail less often (P = .86) and to develop infections less often (P = .056) than surgically placed CVADs. The difference in complications with percutaneous versus surgically placed C V A D s requires confirmation in a randomized trial t o assure t h e y are not a result of differences in patient characteristics. W h e n all catheter failures (removal due to infection, obstruction, or dislodgement) w e r e considered, ports had a significantly longer failure-free duration of use than externalized Hickman and Broviac catheters (P ~ .0009). Ports also remained infection-free longer than externalized catheters (P = .0014). The greatest risk of infection occurs in the first 100 days of use, particularly for ports. This study demonstrates that f o r long-term use (greater than 100 days) ports are superior to externalized catheters in children with cancer. 9 1990 by W.B. Saundera Company. INDEX W O R D S : Central venous access devices; Hickman catheters; Broviac catheters; implantable ports.

MPROVEMENTS in supportive care, particularly blood product support and antibiotics, have permitted intensified chemotherapy for oncology patients. This complex supportive care (as well as administration of chemotherapy) often requires access to a large central vein using a central venous access device (CVAD)J Hickman or Broviac (H/B) catheters are the oldest type of CVAD and are used most commonly.2'3 These catheters are tunneled under the skin but have an externalized exit site and require frequent exit site care and flushing. Recently totally implantable

I

From the Departments of Hematology-Oncology, Surgery, Nursing, and Biostatistics, St Jude Children's Research Hospital, and the Departments of Pediatrics and Surgery, University of Tennessee, Memphis, TN. Supported in part by Grants No. CA-21765 and CA-2Ol8Ofrom the National Cancer Institute and by the American LebaneseSyrian Associated Charities (ALSAC). Presented at the 20th Annual Meeting of the American Pediatric Surgical Association, Baltimore, Maryland, May 28-31, 1989. Address reprint requests to Joseph Mirro, Jr, MD, Department of Hematology-Oncology. St. Jude Children's Research Hospital, PO Box 318, 332 N Lauderdale, Memphis, TN 38101. 9 1990 by W.B. Saunders Company. 0022-3468/90/2501-0022503.00/0

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systems (ports) that require less frequent care have been developed. 48 These types of CVADs may have lower complication rates. 6-" In children lower infection rates for ports have been described but generally have not reached statistical significance. 6'911 Documentation of a definite difference in complication rates between catheter types would permit a more rational approach to catheter selection. We therefore expanded our original CVAD study with additional patients and much longer follow-up) 2 Our results in this larger series demonstrate a superiority of ports over Hickman and Broviac catheters, particularly with long-term use.

CVADs can be placed surgically or percutaneously, and in general, the placement technique is based on the surgeon's preference) 3"~5 There are very few studies that address whether one placement technique is better than the other) 3 With the large number of CVADs currently being placed in oncology patients, the best placement technique may be very important. We therefore analyzed whether the placement technique had any effect on the long-term function of CVADs. MATERIALS AND METHODS Patients Three hundred ten children who required long-term central venous access were included in the study. When patients required a second (n = 44) or third catheter (n = 5), each catheter was recorded as a separate event; therefore, analysis was performed on 359 CVADs. This study was approved by the human experimentation committee.

Materials H/B catheters were purchased from Evermed, Inc (Cranston, RI). All Broviae catheters in this study were of the "adult" type, with a 6.6 French external diameter. All implantable ports (PortA-Cath; Pharmacia, Inc, Piscataway, N J) were attached to a single-lumen catheter with an external diameter of 2.8 mm.

Catheter Placement Surgical placement of externalized catheters and ports was performed by cutdown on the cephalic vein. Percutaneous placement was performed by a single experienced physician using the Seldinger technique."~5 All placements (surgical and percutaneous) were performed in the operating room under general anesthesia, and catheter position was verified using fluoroscopy. Chest radiographs were obtained 6 hours after percutaneous placements to evaluate potential complications.

Journal of Pediatric Surgery, Vo125, No 1 (January),1990: pp 120-124

CENTRAL VENOUS ACCESS DEVICES

Catheter Care and Use

121 T a b l e 1. Clinical and H e m a t o l o g i c C h a r a c t e r i s t i c s ( M e d i a n ) of Patients at Catheter Placement

Catheter care was standardized and uniform throughout this study and has recently been described in detail) 2 H / B catheters were flushed with 10 cc of heparinized (10 U / m L ) saline every 12 hours. Ports were flushed with 5 cc of heparinized (100 U / m L ) saline at least every 2 weeks. All catheters were used as required to administer chemotherapy, blood products, and hyperalimentation. Chemotherapy was typically administered once weekly. It was not feasible to document the precise frequency of catheter entry over the study period; However, because of twice-daily flushing, H / B catheters were entered more often.

Infections

Catheter Type Characteristic

Age (yr) Leukocyte count (x 109/L) Platelet count (• 10S/L) Diagnosis Leukemia Lymphoma CNS tumors Solid tumors

Hickman (n = 120)

Broviac (n = 146)

Port (n = 93)

Total (n = 359)

12.2 4.6 185"

2.7* 4.2 272

12.0 3.3* 271

7.5 3.8 245

69 13 2 36

90 3 19 34

72 4 1 16

231 20 22 86

~Statistically different, P < .05.

All catheter infections were treated with appropriate antimicrobial therapy) 6 Catheters were removed only when the organism could not be cleared from cultures. Definitions of infections generally followed those of Press et al, ~7 with the modifications we previously described.~2 Infections were considered to be definitely catheter related if there was clear evidence of CVAD contamination. Such infections were catagorized as follows: (1) catheter exit site or port infections, (2) tunnel infections, or (3) definite catheter-related septicemia. An episode of definite catheter-related infection included documented evidence of catheter contamination: (1) fever and bacteremia that resolved after catheter removal, (2) organisms isolated only in blood obtained from the catheter, ~8or (3) the same organism isolated from the blood and the removed catheter tip. Septicemia that was not definitely catheter-related was recorded and analyzed as sepsis of unknown source because such episodes may reflect CVAD colonization or contamination. Episodes of septicemia with a clinically apparent source such as a perirectal abscess or pneumonia were excluded from analyses of infections.

Obstruction CVADs that could not be used to infuse fluids were considered obstructed) 9 Only catheters that still could not be used to infuse fluids after at least two doses of urokinase (5,000 U/cc; dose: Broviac 1.0 co, Hickman 1.6 ce, port 2.0 cc) were removed and included as obstruction failures in analyses.

Catheter Failure Removal of a CVAD for infection, obstruction, or dislodgement was considered a failure. Removal due to completion of therapy or death was considered a censored event in the time-to-failure analyses. Only two patients were lost to follow-up and they were censored at the time of their last follow-up.

Statistical Analysis Patient characteristics were compared among the three groups (Kruskal-Wallis test) and pair-wise (Kruskal-Wallis multiple comparisons). Categorical variables were compared using the chi-square test of independence. Comparisons of failure-free, infection-free, and obstruction-free duration of CVAD use were based on KaplanMeier estimates and the log-rank test. RESULTS

Median follow-up for the 359 CVADs (120 Hickmans, 146 Broviacs, and 93 ports) was 419 days. Characteristics of patients are summarized by catheter type in Table 1. Children with Broviac catheters were

younger than children with either Hickman catheters or ports. Leukocyte counts at the time of placement were lower in children with ports, and platelet counts were lower in children with Hickman catheters. Complications occurred in 2 of the 70 percutaneous placements (2.9%). One patient developed a pneumothorax and in the other case the subclavian vein could not be entered and surgical placement was performed. There were 3 complications in the 289 surgical placements (1%). In one case the catheter slipped out of the vessel immediately postoperatively; in two cases the cephalic or subclavian vein could not be identified and surgical implantation on the opposite side was performed. There was a trend for percutaneously placed catheters to have a longer time to failure (P = .086) (Fig 1A) and a lower infection rate (P = .056) (Fig 1B). These differences did not achieve statistical significance and analysis of these groups demonstrated differences in patient characteristics. In all subsequent analysis percutaneously and surgically placed catheters were grouped together. Multiple comparison procedures indicate that H / B catheters did not differ in failure-free duration of use (data not shown). Therefore, H/B catheters were grouped in further analysis. The overall duration of failure-free use (Fig 2) was longer in patients with ports (P = .0009) when compared with patients with externalized devices (H/B catheters). Dislodgement was a frequent problem and the cause of catheter failure in 30 children. In patients with H/B catheters, the children experiencing dislodgement were significantly younger (P = .04) than those without this complication. Three ports had to be removed because of catheter migration into an unacceptable position. There was no significant difference in obstructionfree duration of catheter use for the three catheter types (P = 0.56). Eighty-seven percent of obstructions were cleared by urokinase. Almost half (47%) of the catheters that became obstructed subsequently developed a second obstruction. Obstruction resulted in the

122

MIRRO ET AL

100

100 80

80

o~ =,

60

60

l__

~ 40

~_ 40 20

A

...... - -

Percutaneous Surgical

n=7O n=289

I

I

I

200

400

600

20 I

800 Days

Percutaneous Surgical

. . . . . . . . .

P=.086

I

I

I

1000

1200

1400

R

- -

I

I

I

400

600

I

800 Days

I

I

I

1000

1200

1400

(B) Time t o first infection in percutaneously and

catheter-related infections and 5 instances of sepsis of unknown source (Table 3). Only 4 of the 10 definite catheter-related infections required removal of the port (1 for sepsis and 3 for port infections). H / B catheters had a significantly higher incidence of sepsis of an unknown source than did ports (41/266 v 5/93; P = .01). Thus, it seems clear that H / B catheter contamination is responsible for some of these episodes of sepsis of an unknown source. DISCUSSION

Despite intensive surveillance in this study of 359 central venous catheters, we found a very low incidence of septicemia and other catheter-related infections compared with previous trials, s'9,llJS'2~ As in previous studies, infections were the most frequent and challenging complication. 12'17'18'22'23 Gram-positive organisms accounted for the largest number of isolates from blood or exit site infections. Despite the frequency of infections (n = 118) in this series only 30 catheter failures were due to infection. Obstruction was also common but rarely caused catheter failure because of the excellent therapeutic results with urokinase. 24'25Urokinase was successful in clearing the obstruction 87% of the time, however, catheters that became obstructed were at a high risk of obstructing a second time (47%). Additional flushing 100

100

o) 80

=~ 80

o) LL

t

60 =o ~_ 40

~ 60

o

20

P=.056

200

Fig 1. (A) Time to catheter failure for percutaneously and surgically placed catheters. surgically placed catheters.

failure of only 15 CVADs: 4 Hickman, 4 Broviac, and 7 ports. Infection was the most frequent and difficult complication to manage. Only 4 of the 93 ports required removal while 26 of 266 H / B catheters were removed for infection. When all documented infections are considered, a significant difference ( P = .0014) emerges between ports and externalized ( H / B ) catheters (Fig 3). A total of 103 infections were identified in the 266 H / B catheters: 62 were definitely catheter related (exit site, 43; septicemia, 16; tunnel tract, 3) and 41 were episodes of sepsis of unknown source (Table 2). Staphylococcus epidermidis was isolated in 22% of these infections. Four patients developed Mycobacterium exit site infection and 23 patients had fungal exit site infections. The response to antimicrobial therapy appeared to depend on the organism and site of infection. Of the 62 episodes of definite catheter-related infections, 23 (37%) resulted in catheter removal after unsuccessful antimicrobial therapy. Only 2 of the 11 gram-positive exit site infections required catheter removal, whereas all 4 Mycobacterium and the 1 Nocardia exit site infection resulted in catheter removal. In the 16 episodes of definite H / B catheter septicemia, 8 catheters were removed. Among the 93 ports, there were only 10 definite

n=7O n=289

~ 40 ........... - -

Port Hickman

I 200

P=.00O9

+ Broviac

I 400

t 600

I 800 Days

I 1000

N 20 I 1200

I 1400

Fig2. Time to c a t h e t e r failure for any complication in patients w i t h ports or externalized H/B catheters. All 3 1 0 patients (359 catheters) a r e included in this analysis.

............... P o r t - Hickman

I 200

P=.O014

* Broviac

I 400

I 600

I 800 Days

I 1000

I 1200

1400

Fig 3. Time to first infection in patients w i t h ports or e x t e r nalized H / B c a t h e t e r s ( 3 5 9 catheters). All microbiologic isolates (see Tables 2 and 3) w e r e considered in this analysis.

CENTRAL VENOUS ACCESS DEVICES

123

Table 2. Microbiologic Isolates From 103 Infections in 266 External Catheters

Table 3. Microbiologic Isolates From 15 Infections in 93 Ports Definite Catheter Related*

Definite Catheter Related

Organisms

Exit Tunnel Sepsis SepticemiaSite Tract Unknown Source Total

Staphy/ococcus species Streptococcus species

6 2

11

Pseudomonas species Escherichia coil Other gram-negative

4

1

3

2

Candida species Mycobacterium species Other fungal None isolated

Total

1

16

2

23 4 1 1

1

43

3

17 6

36 8

6 4 2

11 4 7

3 1 2

27 5 4 1

41

103

or use o f urokinase in such c a t h e t e r s appears warranted because the subsequent obstructions were cleared less often with urokinase. T h i r t y c a t h et er s failed because of dislodgement, which occurred m o r e frequently in young children. As in our previous report, r e m o v a l of c a t h e t e r s for any reason was significantly m o r e f r e q u e n t for H / B c a t h et er s than for ports. ~2 Overall differences favoring ports were also seen in the analysis of t i m e to infection. We, like others, found that the risk of infection was greatest in the first 100 days of use (Fig 3) and declined t h e r e a f t e r . 9,12 Thus, studies with v a r y i n g mean durations of c a t h e t e r use or follow-up m a y not be

Organism

Septicemia

Port

Sepsis Unknown Source

Total

Staphylococcus species Other gram-positive

1

3 1

2 1

6 2

Escherichia coil Other gram-negative

1 1

2 2

3 3

1

1

Candida species Total

3

7

5

15

*No patient had a tunnel tract infection.

c o m p a r a b l e . Also, because patient populations and c a t h e t e r care vary a m o n g institutions and over time, the use o f historic controls or cross-institutional comparisons m a y lead to i n a c c u r a t e conclusions. O u r results suggest t h a t p e r c u t a n e o u s p l a c e m e n t is safe and m a y be ad v an t ag eo u s. H o w e v e r , definite conclusions r e g a r d i n g the best p l a c e m e n t t e c h n i q u e ( p e r c u t a n e o u s v surgical) m u s t aw ai t a large r a n d o m ized trial in which the potential co n f o u n d i n g p a t i e nt differences are controlled. ACKNOWLEDGMENT

We thank M. Colten, D. Shelton, and L. Justin for data collection and excellent patient care and Peggy Vandiveer for typing. We also thank the physicians and nurse practitioners of SJCRH for excellent and dedicated patient care.

REFERENCES

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simplified management of obstructed Hickman and Broviac catheters. J Pediatr Snrg 24:257-262, 1989 20. Krog MP, Ekbom A, Nystrom-Rosander C, et al: Central venous catheters in acute blood malignancies. Cancer 59:1358-1361, 1987 21. Cairo MS, Spooner S, Sowden L, et al: Long-term use of indwelling multipurpose silastic catheters in pediatric cancer patients treated with aggressive chemotherapy. J Clin Oneol 4:784788, 1986 22. Johnson PR, Decker MD, Edwards KM, et al: Frequency of

MIRRO ET AL

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