The CCSG Prospective Study of Venous Access Devices: An Analysis of Insertions and Causes for Removal By Eugene S. Wiener, Patricia McGuire, Donna L. Betcher, Anneliese
Charles J.H. Stolar, R. Hampton
L. Sitarz, Jonathan D. Buckley, and G. Denman Hammond
Rich,
Vincent
C. Albo, Arthur
R. Ablin,
Mark D. Krailo, Connie Versteeg,
Pittsburgh, Pennsylvania; Denver, Colorado; New York, New York; Minneapolis, Minnesota; San Francisco, California; Rochester, Minnesota; Los Angeles, California l This is an interval analysis of the 2-year prospective multicenter Childrens Cancer Study Group study of 1,141 chronic venous access devices in 1,019 children with cancer. Device type was external catheter (EC) 72%, totally implantable (TID) 28%, and did not differ for diagnosis or age except more double-lumen devices in bone marrow transplant protocols (77%) and more TlDs in children less than 1 year old (17.7%). Insertion characteristics evaluated in 1,078 (95%) were: operating room placement 99%; general anesthesia 98%; cutdown 67%; percutaneous 33%; atrial position 50%, caval position 50%; and perioperative antibiotics 48%. Vein entry was the external jugular 33%. internal jugular 22%. subclavian 35%. cephalic 7%. and saphenous 3%. Insertion was difficult or very difficult in only 10% and operative complications occurred in only 0.7%. Degree of difficulty bore no relationship to device type or patient age. The reasons for removal in 736 devices (67%) were due to complications in 39%. of which infections were the most frequent. There was some variance between centers ranging from 8.5% to 31% for infection; 2.8% to 24% for dislodgment; and 0% to 13% for occlusion. ECs had a higher risk of dislodgment; elective removals were more frequent in TIDs; there was no difference in infection as a cause for removal between ECs and TIDs. Dislodgment was associated with the shortest distance of the cuff to the skin exit (mean, 4 cm): 5 2 cm, 49%; >2 cm, 28% (P = .009) and occurred most frequently in the younger patient (18.9%. 0 to 1 years; 0.5%, > 8 years). Copyright (~17992 by W.B. Saunders Company
INDEX WORDS: Central venous catheters; devices; implantable ports.
venous access
C (VADs) have gained widespread ENTRALLY
PLACED
venous access devices use and acceptance in the management of children with cancer and leukemia in whom frequent and/or prolonged access is required for chemotherapeutic agents, pain relief, intravenous fluids, antibiotics, blood products, total parenteral nutrition, and blood sampling. Patients and parents frequently request these devices when they see the ease with which other children are managed. Despite this widespread use there is little information concerning choice of device, methods of insertion, management, and complications. The Childrens Cancer Study Group (CCSG) conducted a prospective study (CCG S-31) of VADs to gain this information. This report is limited to the analysis of the insertion characteristics and causes for removal generated from this study. Other data will be reported separately. JournatofPedtatric Surgery, Vol.27, No 2 (February), 1992: pp 155-164
MATERIALS
AND METHODS
Eligibility requirements were: age 21 years or less, a diagnosis of cancer, insertion in a CCSG institution, and no long-term central venous device in the previous 6 months. CCSG investigators were encouraged to register all inserted devices. Each patient and newly placed device was registered at the time of insertion at the CCSG statistical office and assigned a study number, which was also used for any subsequent device placed in that patient during the study period. The CCG S-31 study was opened for patient entry on August 20, 1986, closed to new patient entry, except children 0 to 1 year of age, on May 31, 1988, and to all patients on December 15, 1988. The protocol was approved by the National Cancer Institute Clinical Trials Evaluation Branch and by each participating hospital’s Institutional Review Board. Informed consent was obtained before study entry and for each device insertion. Registration data came from the CCSG registration system used for all CCSG studies. Three data collection forms were specifically designed for this study and included the information tabulated in Table 1. If more than one device was placed in the same patient, each was entered and evaluated as a separate event. Only registration, insertion, and removal data were addressed in this report. VADs were designated as follows: external catheters (ECs), totally implantable devices (TIDs), double-lumen (DL), singlelumen (SL), small-lumen ([SmL] 2.7F to 4.4F), standard lumen ([StL] 6F to 7F), and large lumen ([LgL] 9F to 12F). The study committee established guidelines for device insertion, care, and usage, and for complication management. In addition each institution established its own device guidelines that were forwarded for committee review.
Statistical
Analysis
The significance levels for cross-tabulated data were calculated using the x’ test of the independence of traits across populations. When expected cell frequencies were less than 10, exact methods were used to calculate the significance level. When multiple
From the Children’s Hospital of Pittsburgh. Pittsbqh, PA; Children’s Hospital of Denver, Denver, CO; Babies Hospital, New York, NY; Minneapolis Children S Hospital, Minneapolis, MN; Universitv of California, San Francisco, CA; Mayo Clinic. Rochester. MN; Llniversity of Southern California School of Medicine, Los Angeles, CA. Supported in part by the Division of Cancer Treatment, National Cancer institute, National Institutes of Health, Department of Health and Human Services. Contributing Childrens Cancer Study Group investigators, institutions, and grant numbers are given in the Appendix. Presented at the 22nd Annual Meeting of the American Pediatric SurgicalAssociation, Lake Buena Vista, Florida, Mav 15-18, 1991. Address reprint requests to The Childrens Cancer Study Group, 440 E Huntingdon Dr, Suite 300, PO B0.x 60012, Arcadia, CA 910666012. Copyright Q 1992 by W B. Saunders Companv 0022-346819212702-0004$03.00!0 155
WIENER ET AL
156
Table 1. Data Capture Forms CCG S-31
to 7 devices. Six institutions entered 702 devices, 66% of the total study. Registration data are complete for all entered devices. At the time of this analysis, surgical check sheets have been completed for 1,078 devices (94%) and removal forms have been completed for 736 of the 766 (96%) removed devices. A comparison of the age distribution of patients registered on CCG S-31 to that of the tota CCSG patients registered during the same time period is shown in Table 2. Despite the attempt to increase the accrual of children aged 0 to 1 year, the number of children with registered VADs in that age group (17.7%) was less than that of other ages. A comparison of the diagnoses in the study children and in the overall CCSG is shown in Table 3. The most common oncologic diagnosis was leukemia (43%). Patients with bone tumors and neuroblastomas had the highest ratio of insertions (35%), whereas patients with Wilms’ tumors had the lowest insertion ratio (15%).
Surgical check sheet (completed by surgeon with operative note) Date of insertion Device type Method of insertion Indication for insertion Anesthetic used Difficulty of insertion according to grade shown below* Vein entry Tip position Tunnel length Cuff position Perioperative antibiotics Complication form (completed by nurse for each complication) Infection type, site, bacteriology, and treatment Catheter occlusion or vein thrombosis and treatment Catheter dislodgment Unable to withdraw blood Use and removal form (completed by nurse and/or data manager) Date of removal Cause for removal Device usage Device care Specify complications during the “life” of the device *Insertion
Device Type
difficulty: grading system. I. No difficulty: Catheter in-
serted in proper position at first attempt. Minor repositioning required to achieve final tip position. Insertion time
1 hour. IV. Very difficult: Initial access
site not
successful. One or more additional sites required. Insertion time > 1 hour. V. Complicated: Any or several of the following occur: never able to achieve central position, excessive
bleeding,
pneumothorax,
or
other significant operative or anesthetic complications.
adjustments for several factors were required, the multinomial logistic model was used.’ For all calculations, a P value of < 0.05 was considered significant. The number of catheter days contributed by each device was calculated as the number of days from insertion to removal or last patient contact, if the device was in place at the time of last contact.
Insertion information is available for 1,078 devices (Table 4). SL ECs were 44% of the total, SmL ll.l%, StL 20.8%, and LgL 12%. DL devices were 24.3% and TIDs were 26.9% of the total. Device type was not specified in 4.9%. Thus, ECs were chosen for 735 (72%) insertions and TIDs for 290 (28%). SmL ECs were used most commonly in children 3 years or less (79/120; 66%). DLs were used most frequently in children with leukemia, non-Hodgkin’s lymphoma, and neuroblastoma, who were potential bone marrow transplantation candidates (201/262; 77%). TIDs were used with the least frequency in children ages r3 years (65/343; 19%) and most frequently in children > 15 years (591124; 48%). No other patient demographic or diagnosis had any significant relationship to choice of device.
RESULTS
There were 1,141 devices inserted in 1,019 children from 25 CCSG institutions. Seventeen institutions entered at least 15 devices each; 8 contributed from 1
Insertion Characteristics
VAD insertion was performed in the operating room in 99% of cases, under general anesthesia in
Table 2. Age Distribution Age W
CCG S-31 Patients
EC
TID
All CCSGPatients*
S-31/Alit
1
113
82%
18%*
639
18%
2 to 3
274
80%
20%
a73
31%
4 to 7
268
77%
23%
1,059
25%
8tolO
122
68%
32%
506
24%
227
63%
37%
787
29%
137
52%
48%
427
32%
1,141
72%
28%
4,291
27%
oto
11
to 15
>I5 Total
Abbreviations: EC, external catheter; TID, totally implantable device. *All registered cancer patients in CCSG hospitals during study period. tPercent study patients compared with total CCSG in each age group. SP = ,013 patients I 1 year old compared with patients > 1 year old.
157
CCSG VENOUS ACCESS STUDY
Table 3. Common Oncologic Diagnoses Diagnostic Groups
CCSG Patients With VADt
Total CCSG Patients*
Leukemias
CCG S-31 Patients
Mean Age lyrl
6.9
1,850
27%
491 (43%)
Lymphomas
466
26%
121 (11%)
9.8
Brain tumors
481
24%
117 (10%)
7.1
Neuroblastoma
288
34%
99 (9%)
3.5
Sarcomas
394
22%
86 (8%)
7.3
Bone tumors
213
35%
74 (7%)
13.5
Nephroblastoma
444
15%
67 (6%)
3.3
Total
1,055
4,136
*All CCSG patients whether or not on study. tPercent of all CCSG patients entered onto CCG S-31 with VADs.
98%, by cut down in 66.7%, and percutaneously in 33.3% of cases. There was a trend toward more frequent percutaneous procedures as the patients became older (I 1 year, 24%; > 15 years, 40%). Only 7% of all percutaneous insertions were performed in children aged I 1 year. The most common veins of entry were: subclavian 34.8%, external jugular 33.4%, and internal jugular 22.4%. The cephalic and saphenous veins were used infrequently (7% and 3%, respectively). The right side was used in 70%. The tip of the catheter was positioned equally in the right atrium or in the superior vena cava. Perioperative antibiotics were used for 47.5% of the insertions. For ECs the average tunnel length was 11.2 cm and the average distance from the skin exit to the Dacron cuff was 4.1 cm. The insertion procedure was not difficult in 822 (76.9%) and only mildly difficult in 140 (13%). There was no significant difference in the difficulty of insertion according to device type, cutdown or percutaneous technique, and/or age of the patient. There were 8 (0.7%) complications associated with device insertions, of which 6 had cutdowns, 4 had DL ECs, and 1 was in a child I 3. Four were noncentral catheter tip positions, only one of which led to early VAD replacement. The other 4 were complications of the procedure: bleeding in 3, none of whom had thromboTable 4. Device Longevity NO.
Type of VAD
External catheter
735 (72%)
DD
DDiVAD
369,422
502.61 493.28
Single lumen Small
120
59,193
Standard
224
128,729
574.68
Large
129
57,716
447.41
Double lumen Totally implantable
262
123,784
472.46
290 (28%)
189,495
635.43 579.34
Other
53
30,705
Not available
63
5,919
1,141
595,541
Total Abbreviations:
521.95
VAD, venous access device; DD, device days; DD/
VAD, mean no. of days per device.
cytopenia, and postanesthetic aspiration in 1. None of the VAD placements led to patient deaths (Table 5). Causes for Device Removal
At the time of this analysis, 595,541 device days have accrued and 766 (67%) devices have been removed. TIDs accounted for 189,495 days or 653 days per device and ECs have accrued 369,422 days or 502 days per device (Table 4). Data on causes for removal are evaluable for 736 removed devices (Table 6). The most common causes for removal were not related to device complications: elective at end of therapy in 295 (40.1%) and death (noncatheter-related) with device in place in 157 (21.3%). For this report both of these categories combined were designated “elective.” Infection accounted for 47% of the 284 removals caused by device complications. In only two patients was death related to the presence of the device; both children died of catheter-related sepsis. A comparison of device types showed significantly more TID elective removals (73% 1’ 58%) and EC dislodgments (13% v 4%) in the entire cohort. These differences were not noted in the subset with leukemia. There were significantly more dislodgment removals for SmL ECs (22%) and StL ECs (16.8%) than the other ECs (8.6%). LgL and DL catheters had similar rates of elective removals (67% and 72%, respectively). Both had low rates of complications leading to removal when compared with all devices or with TIDs. More patients died with DLs in place (32%) than with the other VAD types. There was no difference in the percentage of ECs and TIDs removed due to infection. Dislodgment was more frequent when the cuff was closest to the skin exit site: 2 2 cm, 49%; > 2 cm, 28% (P = .009). This was confirmed in the subset with leukemia (P = .03). Dislodgment occurred most frequently in the younger age patient (0 to 1 years, 18.9%; 2 to 3 years, 12%; 4 to 7 years, 0.75%; and > 8 years, 0.5%). Tunnel length and cuff position had no
158
WIENER ET AL
Table 5. Difficulty of Insertion According to Device Type and Patient Age Age Iv) Device
ECst
TIDS
Grade*
2-3
Charles J.H. Stolar, R. Hampton
L. Sitarz, Jonathan D. Buckley, and G. Denman Hammond
Rich,
Vincent
C. Albo, Arthur
R. Ablin,
Mark D. Krailo, Connie Versteeg,
Pittsburgh, Pennsylvania; Denver, Colorado; New York, New York; Minneapolis, Minnesota; San Francisco, California; Rochester, Minnesota; Los Angeles, California l This is an interval analysis of the 2-year prospective multicenter Childrens Cancer Study Group study of 1,141 chronic venous access devices in 1,019 children with cancer. Device type was external catheter (EC) 72%, totally implantable (TID) 28%, and did not differ for diagnosis or age except more double-lumen devices in bone marrow transplant protocols (77%) and more TlDs in children less than 1 year old (17.7%). Insertion characteristics evaluated in 1,078 (95%) were: operating room placement 99%; general anesthesia 98%; cutdown 67%; percutaneous 33%; atrial position 50%, caval position 50%; and perioperative antibiotics 48%. Vein entry was the external jugular 33%. internal jugular 22%. subclavian 35%. cephalic 7%. and saphenous 3%. Insertion was difficult or very difficult in only 10% and operative complications occurred in only 0.7%. Degree of difficulty bore no relationship to device type or patient age. The reasons for removal in 736 devices (67%) were due to complications in 39%. of which infections were the most frequent. There was some variance between centers ranging from 8.5% to 31% for infection; 2.8% to 24% for dislodgment; and 0% to 13% for occlusion. ECs had a higher risk of dislodgment; elective removals were more frequent in TIDs; there was no difference in infection as a cause for removal between ECs and TIDs. Dislodgment was associated with the shortest distance of the cuff to the skin exit (mean, 4 cm): 5 2 cm, 49%; >2 cm, 28% (P = .009) and occurred most frequently in the younger patient (18.9%. 0 to 1 years; 0.5%, > 8 years). Copyright (~17992 by W.B. Saunders Company
INDEX WORDS: Central venous catheters; devices; implantable ports.
venous access
C (VADs) have gained widespread ENTRALLY
PLACED
venous access devices use and acceptance in the management of children with cancer and leukemia in whom frequent and/or prolonged access is required for chemotherapeutic agents, pain relief, intravenous fluids, antibiotics, blood products, total parenteral nutrition, and blood sampling. Patients and parents frequently request these devices when they see the ease with which other children are managed. Despite this widespread use there is little information concerning choice of device, methods of insertion, management, and complications. The Childrens Cancer Study Group (CCSG) conducted a prospective study (CCG S-31) of VADs to gain this information. This report is limited to the analysis of the insertion characteristics and causes for removal generated from this study. Other data will be reported separately. JournatofPedtatric Surgery, Vol.27, No 2 (February), 1992: pp 155-164
MATERIALS
AND METHODS
Eligibility requirements were: age 21 years or less, a diagnosis of cancer, insertion in a CCSG institution, and no long-term central venous device in the previous 6 months. CCSG investigators were encouraged to register all inserted devices. Each patient and newly placed device was registered at the time of insertion at the CCSG statistical office and assigned a study number, which was also used for any subsequent device placed in that patient during the study period. The CCG S-31 study was opened for patient entry on August 20, 1986, closed to new patient entry, except children 0 to 1 year of age, on May 31, 1988, and to all patients on December 15, 1988. The protocol was approved by the National Cancer Institute Clinical Trials Evaluation Branch and by each participating hospital’s Institutional Review Board. Informed consent was obtained before study entry and for each device insertion. Registration data came from the CCSG registration system used for all CCSG studies. Three data collection forms were specifically designed for this study and included the information tabulated in Table 1. If more than one device was placed in the same patient, each was entered and evaluated as a separate event. Only registration, insertion, and removal data were addressed in this report. VADs were designated as follows: external catheters (ECs), totally implantable devices (TIDs), double-lumen (DL), singlelumen (SL), small-lumen ([SmL] 2.7F to 4.4F), standard lumen ([StL] 6F to 7F), and large lumen ([LgL] 9F to 12F). The study committee established guidelines for device insertion, care, and usage, and for complication management. In addition each institution established its own device guidelines that were forwarded for committee review.
Statistical
Analysis
The significance levels for cross-tabulated data were calculated using the x’ test of the independence of traits across populations. When expected cell frequencies were less than 10, exact methods were used to calculate the significance level. When multiple
From the Children’s Hospital of Pittsburgh. Pittsbqh, PA; Children’s Hospital of Denver, Denver, CO; Babies Hospital, New York, NY; Minneapolis Children S Hospital, Minneapolis, MN; Universitv of California, San Francisco, CA; Mayo Clinic. Rochester. MN; Llniversity of Southern California School of Medicine, Los Angeles, CA. Supported in part by the Division of Cancer Treatment, National Cancer institute, National Institutes of Health, Department of Health and Human Services. Contributing Childrens Cancer Study Group investigators, institutions, and grant numbers are given in the Appendix. Presented at the 22nd Annual Meeting of the American Pediatric SurgicalAssociation, Lake Buena Vista, Florida, Mav 15-18, 1991. Address reprint requests to The Childrens Cancer Study Group, 440 E Huntingdon Dr, Suite 300, PO B0.x 60012, Arcadia, CA 910666012. Copyright Q 1992 by W B. Saunders Companv 0022-346819212702-0004$03.00!0 155
WIENER ET AL
156
Table 1. Data Capture Forms CCG S-31
to 7 devices. Six institutions entered 702 devices, 66% of the total study. Registration data are complete for all entered devices. At the time of this analysis, surgical check sheets have been completed for 1,078 devices (94%) and removal forms have been completed for 736 of the 766 (96%) removed devices. A comparison of the age distribution of patients registered on CCG S-31 to that of the tota CCSG patients registered during the same time period is shown in Table 2. Despite the attempt to increase the accrual of children aged 0 to 1 year, the number of children with registered VADs in that age group (17.7%) was less than that of other ages. A comparison of the diagnoses in the study children and in the overall CCSG is shown in Table 3. The most common oncologic diagnosis was leukemia (43%). Patients with bone tumors and neuroblastomas had the highest ratio of insertions (35%), whereas patients with Wilms’ tumors had the lowest insertion ratio (15%).
Surgical check sheet (completed by surgeon with operative note) Date of insertion Device type Method of insertion Indication for insertion Anesthetic used Difficulty of insertion according to grade shown below* Vein entry Tip position Tunnel length Cuff position Perioperative antibiotics Complication form (completed by nurse for each complication) Infection type, site, bacteriology, and treatment Catheter occlusion or vein thrombosis and treatment Catheter dislodgment Unable to withdraw blood Use and removal form (completed by nurse and/or data manager) Date of removal Cause for removal Device usage Device care Specify complications during the “life” of the device *Insertion
Device Type
difficulty: grading system. I. No difficulty: Catheter in-
serted in proper position at first attempt. Minor repositioning required to achieve final tip position. Insertion time
1 hour. IV. Very difficult: Initial access
site not
successful. One or more additional sites required. Insertion time > 1 hour. V. Complicated: Any or several of the following occur: never able to achieve central position, excessive
bleeding,
pneumothorax,
or
other significant operative or anesthetic complications.
adjustments for several factors were required, the multinomial logistic model was used.’ For all calculations, a P value of < 0.05 was considered significant. The number of catheter days contributed by each device was calculated as the number of days from insertion to removal or last patient contact, if the device was in place at the time of last contact.
Insertion information is available for 1,078 devices (Table 4). SL ECs were 44% of the total, SmL ll.l%, StL 20.8%, and LgL 12%. DL devices were 24.3% and TIDs were 26.9% of the total. Device type was not specified in 4.9%. Thus, ECs were chosen for 735 (72%) insertions and TIDs for 290 (28%). SmL ECs were used most commonly in children 3 years or less (79/120; 66%). DLs were used most frequently in children with leukemia, non-Hodgkin’s lymphoma, and neuroblastoma, who were potential bone marrow transplantation candidates (201/262; 77%). TIDs were used with the least frequency in children ages r3 years (65/343; 19%) and most frequently in children > 15 years (591124; 48%). No other patient demographic or diagnosis had any significant relationship to choice of device.
RESULTS
There were 1,141 devices inserted in 1,019 children from 25 CCSG institutions. Seventeen institutions entered at least 15 devices each; 8 contributed from 1
Insertion Characteristics
VAD insertion was performed in the operating room in 99% of cases, under general anesthesia in
Table 2. Age Distribution Age W
CCG S-31 Patients
EC
TID
All CCSGPatients*
S-31/Alit
1
113
82%
18%*
639
18%
2 to 3
274
80%
20%
a73
31%
4 to 7
268
77%
23%
1,059
25%
8tolO
122
68%
32%
506
24%
227
63%
37%
787
29%
137
52%
48%
427
32%
1,141
72%
28%
4,291
27%
oto
11
to 15
>I5 Total
Abbreviations: EC, external catheter; TID, totally implantable device. *All registered cancer patients in CCSG hospitals during study period. tPercent study patients compared with total CCSG in each age group. SP = ,013 patients I 1 year old compared with patients > 1 year old.
157
CCSG VENOUS ACCESS STUDY
Table 3. Common Oncologic Diagnoses Diagnostic Groups
CCSG Patients With VADt
Total CCSG Patients*
Leukemias
CCG S-31 Patients
Mean Age lyrl
6.9
1,850
27%
491 (43%)
Lymphomas
466
26%
121 (11%)
9.8
Brain tumors
481
24%
117 (10%)
7.1
Neuroblastoma
288
34%
99 (9%)
3.5
Sarcomas
394
22%
86 (8%)
7.3
Bone tumors
213
35%
74 (7%)
13.5
Nephroblastoma
444
15%
67 (6%)
3.3
Total
1,055
4,136
*All CCSG patients whether or not on study. tPercent of all CCSG patients entered onto CCG S-31 with VADs.
98%, by cut down in 66.7%, and percutaneously in 33.3% of cases. There was a trend toward more frequent percutaneous procedures as the patients became older (I 1 year, 24%; > 15 years, 40%). Only 7% of all percutaneous insertions were performed in children aged I 1 year. The most common veins of entry were: subclavian 34.8%, external jugular 33.4%, and internal jugular 22.4%. The cephalic and saphenous veins were used infrequently (7% and 3%, respectively). The right side was used in 70%. The tip of the catheter was positioned equally in the right atrium or in the superior vena cava. Perioperative antibiotics were used for 47.5% of the insertions. For ECs the average tunnel length was 11.2 cm and the average distance from the skin exit to the Dacron cuff was 4.1 cm. The insertion procedure was not difficult in 822 (76.9%) and only mildly difficult in 140 (13%). There was no significant difference in the difficulty of insertion according to device type, cutdown or percutaneous technique, and/or age of the patient. There were 8 (0.7%) complications associated with device insertions, of which 6 had cutdowns, 4 had DL ECs, and 1 was in a child I 3. Four were noncentral catheter tip positions, only one of which led to early VAD replacement. The other 4 were complications of the procedure: bleeding in 3, none of whom had thromboTable 4. Device Longevity NO.
Type of VAD
External catheter
735 (72%)
DD
DDiVAD
369,422
502.61 493.28
Single lumen Small
120
59,193
Standard
224
128,729
574.68
Large
129
57,716
447.41
Double lumen Totally implantable
262
123,784
472.46
290 (28%)
189,495
635.43 579.34
Other
53
30,705
Not available
63
5,919
1,141
595,541
Total Abbreviations:
521.95
VAD, venous access device; DD, device days; DD/
VAD, mean no. of days per device.
cytopenia, and postanesthetic aspiration in 1. None of the VAD placements led to patient deaths (Table 5). Causes for Device Removal
At the time of this analysis, 595,541 device days have accrued and 766 (67%) devices have been removed. TIDs accounted for 189,495 days or 653 days per device and ECs have accrued 369,422 days or 502 days per device (Table 4). Data on causes for removal are evaluable for 736 removed devices (Table 6). The most common causes for removal were not related to device complications: elective at end of therapy in 295 (40.1%) and death (noncatheter-related) with device in place in 157 (21.3%). For this report both of these categories combined were designated “elective.” Infection accounted for 47% of the 284 removals caused by device complications. In only two patients was death related to the presence of the device; both children died of catheter-related sepsis. A comparison of device types showed significantly more TID elective removals (73% 1’ 58%) and EC dislodgments (13% v 4%) in the entire cohort. These differences were not noted in the subset with leukemia. There were significantly more dislodgment removals for SmL ECs (22%) and StL ECs (16.8%) than the other ECs (8.6%). LgL and DL catheters had similar rates of elective removals (67% and 72%, respectively). Both had low rates of complications leading to removal when compared with all devices or with TIDs. More patients died with DLs in place (32%) than with the other VAD types. There was no difference in the percentage of ECs and TIDs removed due to infection. Dislodgment was more frequent when the cuff was closest to the skin exit site: 2 2 cm, 49%; > 2 cm, 28% (P = .009). This was confirmed in the subset with leukemia (P = .03). Dislodgment occurred most frequently in the younger age patient (0 to 1 years, 18.9%; 2 to 3 years, 12%; 4 to 7 years, 0.75%; and > 8 years, 0.5%). Tunnel length and cuff position had no
158
WIENER ET AL
Table 5. Difficulty of Insertion According to Device Type and Patient Age Age Iv) Device
ECst
TIDS
Grade*
2-3
