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Original Research |
1 All authors: Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-chyo, Kawaramachi-Hirokoji, Kamigyo, Kyoto 602-8566, Japan.
Received January 23, 2008;
accepted after revision May 14, 2008.
Address correspondence to T. Yamagami
(yamagami{at}koto.kpu-m.ac.jp).
Abstract
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MATERIALS AND METHODS. We retrospectively studied 166 consecutive patients with unresectable advanced liver cancer for whom a port-catheter system was percutaneously implanted with its tip fixed at the gastroduodenal artery with microcoils. In 107 patients, NBCA was also used for catheter tip fixation. We compared this group with a control cohort of 59 patients who did not receive NBCA. Outcomes, including rate of success in implantation, details of embolic agents for fixation, and occurrence of complications related to catheter placement that would prohibit continuation of chemotherapy if not corrected, were compared.
RESULTS. In all, port-catheter placement was successful. However, 38 complications occurred in 32 patients. Catheter dislocation occurred in nine. Hepatic artery obstruction or severe stenosis was seen in 10. Recanalization of a once-embolized gastroduodenal artery was found in two patients. The rate of dislocation did not differ significantly between patients in whom NBCA was and those in whom it was not used. However, hepatic artery obstruction appeared at a significantly higher rate, and recanalization of a gastroduodenal artery at a significantly lower rate, in patients in whom the catheter tip was fixed with NBCA.
CONCLUSION. The use of NBCA correlated with a higher rate of hepatic artery obstruction. The use of NBCA should not always be required in port-catheter implantation with the fixed-catheter-tip method.
Keywords: arteries • catheterization • catheters • chemotherapeutic infusion • interventional radiology • liver • neoplasm • technology • therapeutic blockade
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Among various methods to achieve such implantation using interventional techniques [7–22], implantation with the fixed-catheter-tip method [7, 8, 16–22] is advantageous from the standpoint of preventing catheter dislocation and hepatic artery obstruction [8, 17–22]. Usually, microcoils are used to fix the catheter tip to the gastroduodenal artery. In some reports, the additional use of N-butyl cyanoacrylate (Histoacryl, Braun) (NBCA) is recommended [7, 17, 18], whereas in other articles NBCA is not or not always used [15, 16, 20].
In this study, we retrospectively evaluated the necessity of the additional use of NBCA for fixation of the port-catheter tip to the gastroduodenal artery in port-catheter placement with the fixed-catheter-tip method.
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All procedures were performed after the patient provided written informed consent. The consent form included permission to use records, images, and data for research purposes.
Preparation Before Implantation of the Port-Catheter System
Before port-catheter placement, in each patient, all angiographically
visualized branches that supplied blood to extrahepatic adjacent organs (i.e.,
stomach, duodenum, and pancreas) and that arose from any segment in the
hepatic artery beyond the projected side-hole opening in the common hepatic
artery were embolized with microcoils. An example of such an artery is the
right gastric artery. In patients with more than two hepatic arteries, all
hepatic arteries were embolized except the hepatic artery from which the
gastroduodenal artery diverged to convert multiple hepatic arteries into one
so that the entire tumor-bearing region in the liver could be perfused from
one catheter.
Implantation of Port-Catheter System
Percutaneous placement of long-term indwelling catheters was performed for
repeated hepatic arterial infusion chemotherapy (Figs.
1A,
1B and
2A,
2B,
2C,
2D). First, the indwelling
catheter was inserted from a branch of the left subclavian artery (n
= 150) or the right femoral artery (n = 16) with the patient under
local anesthesia. The tip of the indwelling catheter was inserted into the
gastroduodenal artery. A side hole was created in the catheter to be opened at
the common hepatic artery to administer infusion chemotherapy. Next, a second
5-French catheter was inserted via the femoral artery. This catheter was
inserted exclusively for fixation of the indwelling catheter tip. Its tip was
positioned at the celiac or common hepatic artery. The gastroduodenal artery
was embolized with microcoils (Diamond Coil, Boston Scientific; Trufill,
Cordis; or Tornade or Micronester Coil, Cook) through a microcatheter inserted
coaxially from the second 5-French catheter into the gastroduodenal artery
outside the indwelling catheter. The number of microcoils used was within the
number considered to be accep table (mean number, 3.9 microcoils; maximum,
12).
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Finally, the proximal end of the indwelling catheter was connected to a port (Septum port, Sumitomo Bakelite; or Celsite port, Toray Medical) implanted subcutaneously. More complete details on port-catheter placement with the fixed-cathetertip technique can be found elsewhere [17, 21].
A polyurethane-covered catheter with a tapered tip (Anthron P-U catheter, Toray Medical) was used as the indwelling catheter. The outer diameter of the 50-cm proximal shaft was 5-French and that of the 20-cm distal shaft was 2.7-French; the inner diameter of the proximal shaft was 0.035 inches and that of the distal shaft was 0.018 inches. A side hole was created by clipping the distal shaft with small scissors at a point 3–10 cm from the end of the indwelling catheter. The distance between the side hole and the distal end of the indwelling catheter was decided on the basis of a celiac arteriogram.
To prevent thrombosis of the port-catheter system, the catheter was flushed with saline and heparin after every administration of chemotherapeutic drugs.
Follow-Up
All patients were examined with digital subtraction angiography after
contrast material was infused via the port to confirm patency of the hepatic
artery. This angiographic study was done just after and within 10 days of
implantation, and every 1–4 months thereafter while maintenance of the
port-catheter system was required for chemotherapy. Such intervals depended on
the clinical circumstances of the patient.
Hepatic Arterial Infusion Chemotherapy
The chemotherapeutic drugs used for the principal cancers for which
chemotherapy was administered were as follows: 5-fluorouracil (1,000
mg/m2 weekly in a 5-hour infusion) for patients with liver
metastasis from colorectal cancer; 5-fluorouracil (330 mg/m2
weekly), mitomycin C (2.7 mg/m2 biweekly), and epirubicin (30
mg/m2 every 4 weeks) for patients with liver metastasis from breast
and gastric cancers; and 5-fluorouracil (1,000 mg/m2 weekly in a
5-hour infusion) and cisplatin (10 mg weekly in a bolus infusion) for patients
with hepatocellular carcinoma.
Parameters Investigated
We investigated the rate of success of port-catheter placement, details of
embolic agents used to fix the indwelling catheter tip to the gastroduodenal
artery, distance between the side hole and the distal end of the indwelling
catheter, and occurrence of complications or difficulties closely related to
indwelling catheter placement that would prohibit continuation of chemotherapy
if not corrected, and management thereafter.
For statistical analysis, quantitative variables were compared using the Student's t test. Qualitative variables were compared using the chi-square test or Fisher's exact probability test. Differences were considered significant when the p value was less than 0.05.
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Overall, the mean distance to the side hole from the end hole of the indwelling catheter was 6.0 ± 0.9 cm (range, 3–10 cm). The mean number of microcoils used to fix the catheter tip in the gastroduodenal artery was 3.9 ± 1.7 (SD) microcoils (range, 1–12 microcoils). In addition, the NBCA–Lipiodol mixture was used to fix the catheter tip in 107 procedures. The mean time required for catheter implantation was 88.2 ± 31.8 minutes (range, 36–200 minutes). Differences in sex, age, the artery from which the port-catheter system was inserted, distance of the side hole from the end hole, number of coils used to fix the catheter tip, and time required for catheter implantation between patients in whom the NBCA–Lipiodol mixture was and was not used are summarized in Table 1. The difference was not statistically significant for any of these parameters.
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Regarding difficulties that would prohibit continuation of chemotherapy if not corrected (Table 2), catheter dislocation occurred in nine of 166 (5.4%) procedures (Fig. 1A, 1B). Hepatic artery obstruction or severe stenosis was seen in 10 of 166 (6.0%) procedures (occurring 35–1,058 days after implantation; mean, 321.8 ± 110.7 days) (Fig. 2A, 2B, 2C, 2D). Recanalization of a once-embolized gastroduodenal artery was found in two patients (1.2%) (occurring 7 and 78 days after implantation, respectively). The NBCA–Lipiodol mixture was not used in either of these two patients. No statistically significant difference was found in the rate of dislocation between NBCA-use and nonuse groups (4/107 vs 5/59; p = 0.2826, Fisher's exact probability test). However, significant differences were seen in the frequency of hepatic artery obstruction or stenosis and the frequency of recanal ization of a once-embolized gastroduodenal artery between the NBCA-use and nonuse groups (10/107 vs 0/59, p = 0.0148, Fisher's exact probability test; and 0/107 vs 2/59, p = 0.0434, respectively, Fisher's exact probability test).
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Other such complications were gastrointestinal mucosal lesions caused by distribution of anticancer drugs due to insufficient embolization of a branch of the pancreaticoduodenal arcade in one patient, large subcutaneous hematoma around the port in two, necrosis of the skin covering the subcutaneous port in one, infection from the port-catheter system in two, thrombotic obstruction of the catheter lumen or the inside of the port in four, pseudoocclusion of the hepatic artery due to a fibrin sheath covering the catheter in one, and kinking of the catheter in the subcutaneous space in six patients (Table 2). These findings include patients who did and those who did not receive the NBCA–Lipiodol mixture.
In summary, 38 complications related to indwelling catheter placement that would prohibit continuation of chemotherapy if not corrected occurred in 32 patients (19.3%). However, after various trials to correct complications, chemotherapy could be continued in most of these patients (23/32, 71.9%).
Table 3 shows the characteristics of the 10 patients who experienced hepatic artery obstruction or severe stenosis and the management strategies used to continue hepatic arterial infusion chemotherapy. No statistically significant differences were seen in the rate of occurrence of hepatic artery obstruction or severe stenosis among the diagnosed diseases (hepatocellular carcinoma [n = 6]; liver metastasis from colon [n = 3] or gastric [n = 1] cancer). This would indicate no relationship between these complications and the anticancer drugs administered. The mean volume of the NBCA–Lipiodol mixture used in these 10 patients was 0.67 ± 0.16 mL, which did not differ significantly from that in patients for whom NBCA was used but who did not experience hepatic artery obstruction (mean, 0.65 ± 0.13 mL; p = 0.5906, Student's t test).
In one patient, the migration of NBCA to the hepatic artery was confirmed on arteriography during the port-catheter implantation procedure, and percutaneous transluminal angioplasty of the narrowed segment was performed to recanalize the artery during the procedure. However, 76 days later, the artery was again narrowed and percutaneous transluminal angioplasty successfully recanalized the hepatic artery, with the result that chemotherapy could be continued. In the other patients with hepatic artery obstruction or severe stenosis, such migration of NBCA was not observed on arteriographic studies during the port-catheter implantation procedure.
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Theoretically, it is evident that catheter tip fixation to the gastroduodenal artery is useful to avoid dislocation of the indwelling catheter. Hepatic artery occlusion or severe stenosis often interferes with effective infusion chemotherapy. According to Seki et al. [15], the number of patients with a patent hepatic artery was significantly higher when port-catheter systems were implanted with than without catheter tip fixation. This leads us to speculate that a principal cause of hepatic artery occlusion is thrombotic occlusion due to mechanical stimulation of the vascular endothelium of the common or proper hepatic artery caused by movement of the unfixed catheter tip [15]. Hence, development of methods to fix the distal tip of the indwelling catheter using the gastroduodenal artery has decreased the rate of hepatic artery occlusion.
Some studies [7, 8, 17, 18] have recommended using an NBCA–Lipiodol mixture in addition to microcoils for an even stronger fixation to prevent dislocation [8, 18] and recanalization [22] of the gastroduodenal artery. On the other hand, most research involving percutaneous port-catheter implantation using the fixed-catheter-tip method has focused on catheter fixation with microcoils alone [15, 16, 20].
The results of our study show that with the additional use of an NBCA–Lipiodol mixture, the rate of dislocation was similar to that without the NBCA–Lipiodol mixture, but that the rate of hepatic artery obstruction or severe stenosis was significantly higher with the use of the NBCA–Lipiodol mixture. The reason for this high rate is unknown, but a possible explanation is migration of or embolization by a portion of the NBCA–Lipiodol mixture during or after implantation. This explanation might be valid, especially in patients in whom the hepatic artery obstruction or severe stenosis occurred relatively soon after implantation. At least in one patient, the role of NBCA in hepatic artery obstruction was strongly suspected in that the NBCA had moved to the hepatic artery at the time of port-catheter implantation, although the artery was subsequently recanalized by immediate performance of percutaneous transluminal angioplasty of the narrowed segment. On the other hand, with arterial obstruction occurring at a long interval after implantation, many other explanations are possible, such as denaturation of the vascular endothelium due to long-term infusion of chemotherapeutic agents via the port-catheter system into the hepatic artery. However, from the point of view of recanalization of the gastroduodenal artery, implantation with NBCA is advantageous. Although the number of cases was few, in both patients in whom recanalization of the gastroduodenal artery occurred, NBCA was not used in catheter tip fixation to the gastroduodenal artery.
Although ours was a nonrandomized, retrospective, and observational study, the number of subjects for such an evaluation is relatively large, and only consecutively treated patients were evaluated. Hence, results of this study might be valuable and reliable and might exemplify the potential advantage or disadvantage of using an NBCA–Lipiodol mixture for this purpose. From our results, it can be considered that use of NBCA would not be essential to fix the catheter tip to the gastroduodenal artery in port-catheter implantation with the fixed-catheter-tip method. Only when complete embolization of the gastroduodenal artery is not possible with microcoils alone would the addition of NBCA be necessary. Some previous reports have recommended as an alternative to NBCA in such situations the aggressive usage of microcoils that provide immediate cross-sectional vessel occlusion when nested in a densely packed mass of coils such as Micronester coils [21, 23]. In any event, in situations in which NBCA must be used, meticulous care must be taken to reduce the possibility that it will migrate to the hepatic artery and result in the occurrence of hepatic artery obstruction.
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