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Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii, Kawaramachi-Hirokoji, Kamigyo, Kyoto 602-8566, Japan.
Received March 8, 2004;
accepted after revision August 10, 2004.
Address correspondence to T. Yamagami
(yamagami{at}koto.kpu-m.ac.jp).
Abstract
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MATERIALS AND METHODS. A port-catheter system with the catheter tip fixed to the gastroduodenal artery by embolic agents was percutaneously implanted in 156 patients (102 men, 54 women; mean age, 63.2 years) with unresectable liver cancer. In 98 patients the original method was used, and in 58 patients the modified method was used. Existence of persistent blood flow beyond the indwelling catheter tip as shown on arteriography via the port performed immediately and 2-10 days after port-catheter placement was compared between these two groups.
RESULTS. In all cases, percutaneous port-catheter placement was successfully performed. In one (1.0%) of 98 procedures involving the original method, the gastroduodenal artery was detected on arteriography just after implantation, compared with 23 (39.7%) of 58 procedures using the modified method. However, arteriography performed 2-10 days (mean, 5.02 days) after implantation detected the gastroduodenal artery in only one case.
CONCLUSION. This retrospective study indicates that closure of the end hole appears to occur spontaneously shortly after implantation. Thus, such closure is not always necessary to avoid persistent hepatofugal blood flow in the gastroduodenal artery.
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With the most common fixed catheter tip method [7, 18] (referred to here as the original method), a side hole is made in the indwelling catheter and is located at the common hepatic artery ostium. A microcoil inserted via a microcatheter advanced inside the indwelling catheter beyond the side hole is used to close the end hole of the catheter. The tip of the indwelling catheter is fixed to the gastroduodenal artery with microcoils via the microcatheter. This microcatheter is introduced into the gastroduodenal artery through the side hole of the indwelling catheter.
Because of the difficulty and complexity of this original method, Irie [16] modified the procedure whereby the indwelling catheter tip is fixed to the gastroduodenal artery with microcoils through a microcatheter coaxially advanced from a catheter that is inserted beside the indwelling catheter. For further simplification, he did not close the inside lumen of the catheter tip.
After learning of his report, we aggressively adopted this easy method in implanting port-catheter systems for hepatic arterial infusion chemotherapy at our institution. However, a possible limitation of this modified method is that that some of the infused anticancer drugs could pass over the side hole and through the unclosed end hole of the indwelling catheter to organs supplied with blood from the gastroduodenal or right gastroepiploic artery. Reactive gastric or duodenal mucosal lesions from chemical irritants caused by infusion of the chemotherapeutic agents could be the result [20-23].
The aim of our study was to evaluate whether a contrast agent injected via the port flows only out from the side hole of the implanted catheter or flows as well through the catheter tip to the gastroduodenal artery. Comparisons were made between the original and modified fixed catheter tip methods.
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Approval was obtained from the institutional ethics committee before the start of this study. 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 implantation, arteries were embolized for two purposes
with microcoils (Diamond Coil, Boston Scientific; Trufill, Cordis; or Tornade
Coil, Cook) as has been described previously
[7,
20]. One purpose was to
prevent infusion of anticancer drugs into extrahepatic adjacent organs during
hepatic arterial infusion chemotherapy and the other was to allow perfusion of
the entire tumor-bearing region from one catheter.
For the first purpose, in all patients, all angiographically revealed branches that supply 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. Examples of such arteries are the right gastric and the dorsal pancreatic arteries.
With regard to the second purpose, in patients with more than two hepatic arteries these arteries were converted into one hepatic artery. To accomplish this, all hepatic arteries were embolized except the hepatic artery from which the gastroduodenal artery diverged.
Implantation of Port-Catheter System
Percutaneous placement of long-term indwelling catheters was performed for
frequent hepatic arterial infusion chemotherapy. The indwelling catheter was
inserted from a branch of the left subclavian artery (n = 146) or the
right femoral artery (n = 10) with the patient under local
anesthesia. In the first 98 cases, the indwelling catheter was implanted with
the original catheter tip fixation method
[7,
18]
(Fig. 1A); in the most recent
58 cases (since April 2002), implantation was by the modified method as
described by Irie [16]
(Fig. 1B). Details of the order
of implementation of each procedure are shown as follows and key points for
each procedure are summarized in Table
2.
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Order of Implantation Using Original Procedure
Figure 2 shows a
port-catheter system implanted using the original catheter tip fixation
method. Implantation took place in the following order. Step 1: A 5-French
catheter was inserted from a branch of the left subclavian artery or the right
femoral artery and advanced to the common hepatic artery via the celiac
artery. Step 2: A microcatheter (Renegade-18, Boston Scientific) was inserted
coaxially, after which a 0.016-inch microguidewire (GT wire, Terumo) was
advanced far into the right gastroepiploic or pancreaticoduodenal artery. Step
3: Using the catheter exchange method, an indwelling catheter with a side hole
was inserted with the tip into the gastroduodenal artery approximately 5-10 cm
from the bifurcation. The side hole was placed into the common hepatic artery
at a site just proximal to the bifurcation where the gastroduodenal artery
diverged. Step 4: The distal lumen of the indwelling catheter was occluded
with a 1.2-cm microcoil (Hilal Embolization Microcoils, Cook) through a
coaxial microcatheter (Renegade-18) advanced inside the indwelling catheter
beyond the side hole. Step 5: The gastroduodenal artery was embolized with
microcoils (Diamond Coil, Trufill, or Tornade Coil) through a microcatheter
inserted through the side hole of the indwelling catheter coaxially into the
gastroduodenal artery outside of the indwelling catheter. If necessary,
0.5-1.25 mL of n-butyl cyanoacrylate (NBCA) mixed with Lipiodol
(iodized oil, Guerbet) was added for sufficient embolization and to fix the
catheter tip more completely. The ratio of NBCA to Lipiodol was 1:1-2. Step 6:
The proximal end of the indwelling catheter was connected to a port (Septum
port, Sumitomo Bakelite; or Celsite Port, Toray Medical) implanted
subcutaneously.
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In most patients (n = 76), a polyurethane-covered catheter with a tapered tip (outer diameter of the 50-cm proximal shaft was 5-French and that of the 20-cm distal shaft was 2.7-French; inner diameter of the proximal shaft was 0.035 inches and that of the distal shaft was 0.018 inches) (Anthron P-U catheter, Toray Medical) was used as the indwelling catheter, and a side hole was created by clipping with small scissors the folded indwelling catheter at the region where the diameter began to taper. The distance between the side hole and the distal end of the indwelling catheter was decided on the basis of celiac arteriography, and the redundant distal part of the catheter tip was cut off with small scissors. In 22 cases, a 5-French Gently catheter (Solution) in which the side hole was made during manufacture was implanted.
Order of Implantation Using Modified Procedure
In the modified procedure, steps 1-3 (Figs.
3A,
3B,
3C) were the same as described
for the original method with one exception. In the modification, the side hole
was created in the 2.7-French diameter, 20-cm-long distal shaft at a point
5-10 cm from the end of the indwelling catheter, whereas in the original
method the side hole was created at the point where narrowing of the lumen
began. Thus, the process of cutting the redundant tip, as in the original
method, was not necessary. Step 4: A second 5-French catheter was inserted via
the femoral artery and its tip was positioned at the celiac axis. Step 5: The
gastroduodenal artery or the right gastroepiploic artery was embolized with
microcoils (Diamond Coil, Trufill, or Tornade Coil) through a microcatheter
inserted coaxially from the second 5-French catheter into the gastroduodenal
artery outside of the indwelling catheter beyond the tip of the indwelling
catheter. One or two microcoils (Diamond Coil, Trufill, or Tornade Coil) were
positioned at the gastroduodenal artery beyond the tip of the indwelling
catheter (Fig. 3D). Step 6: The
microcatheter was repositioned in the gastroduodenal artery, and this artery
outside of the tip of the indwelling catheter was embolized with microcoils or
a mixture of NBCA and Lipiodol (Fig.
3E). Step 7: The proximal end of the indwelling catheter was
connected to a port (Septum port, Sumitomo Bakelite; or Celsite Port, Toray
Medical). implanted subcutaneously.
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Follow-Up
All patients were examined with digital subtraction angiography after
contrast material was infused via the port to confirm the patency of the
hepatic artery. This angiographic study was done just after (Figs.
2,
3E,
4A) and within 2-10 days (mean,
5.02 ± 2.31 [SD] days) after (Fig.
4B) implantation and every 1-4 months thereafter while maintenance
of the port-catheter system was required for hepatic arterial infusion
chemotherapy therapy. Such intervals depended on the clinical circumstances of
each patient, which varied.
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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 catheter tip, existence of
persistent blood flow beyond the tip of the indwelling catheter as shown on
arteriography, and occurrence of complications closely correlated with
indwelling catheter placement for hepatic arterial infusion chemotherapy.
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 number of coils used to fix the catheter tip in the gastroduodenal artery was 4.6 ± 2.1 (range, 0-12). With the original method that value was 4.6 ± 2.1 (range, 0-10), whereas it was 4.5 ± 2.0 (range, 0-12) with the modified method. In addition, NBCA-Lipiodol was used to fix the catheter tip in 93 procedures using the original method and in 50 using the modified method. No statistically significant difference was seen either in the number of coils or in the frequency of additional use of NBCA-Lipiodol between the original and modified methods (p = 0.86, Student's t test and p = 0.06, Fisher's exact probability test, respectively).
In one (1.0%) of 98 procedures using the original catheter tip fixation method, the gastroduodenal artery and the right gastroepiploic artery beyond the end of the indwelling catheter were detected on arteriography via the port just after implantation, whereas these arteries were detected in 23 (39.7%) of 58 procedures with the modified method (Fig. 4A and Table 3). The difference between the two methods was statistically significant (p < 0.0001, chi-square test). However, when such arteriography was performed 2-10 days after implantation, the gastroduodenal or right gastroepiploic artery was not detected (Fig. 4B) in any of the 156 patients with one exception. In that one patient, in whom the original method was used, hepatofugal blood flow in the gastroduodenal artery was revealed on arteriography via the port performed 5 days after port-catheter implantation. However, this was not due to the opening of the end hole but to the recanalization of the once-embolized gastroduodenal artery. Later, successful reembolization was accomplished in this patient.
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The mean distance of the side hole from the end hole of the indwelling catheter in patients in whom the modified method was used was 6.10 ± 1.10 cm (range, 4-10 cm). In those patients in whom blood flow continued beyond the catheter end in the gastroduodenal or the right gastroepiploic artery, the distance was 6.12 ± 0.93 cm versus 6.09 ± 1.23 cm in patients without such blood flow (p = 0.94, Student's t test).
Regarding difficulties that would prohibit continuation of hepatic arterial infusion chemotherapy if not corrected (Table 3), catheter dislocation occurred in six procedures (3.8%) (original method, n = 4; modified method, n = 2). Hepatic arterial obstruction or severe stenosis was seen in nine (5.8%) of 156 procedures (within 10 days after implantation, n = 3; thereafter, n = 6). Of the nine patients, seven were with the original method and two with the modified method. No statistically significant difference was seen in the frequency of hepatic arterial obstruction or stenosis between the original and modified catheter tip fixation methods (7/98 vs 2/58; p = 0.28, Fisher's exact probability test). Other such complications were gastrointestinal mucosal lesions caused by distribution of anticancer drugs due to insufficient embolization of the arterial branch supplying blood to organs adjacent to the liver in seven patients, a large subcutaneous hematoma in one, necrosis of the skin covering the subcutaneous port in one, infection from the port-catheter system in one, and kinking of the catheter in the subcutaneous space in two. Brain infarction, which was strongly suspected to be related to catheter placement, occurred in three patients in whom the catheter was inserted via the left subclavian artery.
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Theoretically, catheter tip fixation to the gastroduodenal artery is useful to avoid dislocation of the indwelling catheter. Some studies [8, 18] recommended additional use of an NBCA-Lipiodol mixture with the microcoils for an even stronger fixation.
Hepatic arterial occlusion or severe stenosis often interferes with effective hepatic arterial infusion chemotherapy. According to Seki et al. [15], patency of the 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 arterial occlusion is thrombotic occlusion resulting from mechanical stimulation of the vascular endothelium of the common or proper hepatic artery caused by movement of the unfixed catheter tip [15]. Hence, methods to fix the distal tip of the indwelling catheter using the gastroduodenal artery have decreased the rate of hepatic arterial occlusion.
A review of reports describing implantation of port-catheter systems with catheter tip fixation [7, 8, 17-20] shows the advantages of this method in preventing catheter dislocation and hepatic arterial obstruction or severe stenosis. However, the original method developed by Arai et al. [7] is difficult and complex. Especially requiring much skill are advancement and control of the microcatheter via the side hole of the indwelling catheter into the gastroduodenal artery outside the indwelling catheter. To simplify this technique, Irie [16] recommended a modified method described in detail in his article and in our article. In addition, to eliminate the procedure for closing the end hole, Irie suggested another advantage of the modified method. In the modified method, the part of the shaft of the indwelling catheter that is tapered to 2.7 French is positioned in the entire segment from the celiac to the hepatic artery. On the other hand, with the original method, the 5-French part of the shaft is positioned in the celiac and common hepatic artery, because the side hole is created just at the point where the caliber of the indwelling catheter changes from a 5- to a 2.7-French shaft. Thus, the modified method reduces both disturbance of hepatic arterial flow and mechanical stimulation of the vascular endothelium of the hepatic artery. This may result in a further decrease in hepatic arterial obstruction [16]. In fact, in our study the frequency of hepatic arterial obstruction or severe stenosis was lower with the modified method than with the original method (2/58 [3.4%] vs 7/98 [7.1%]), although the difference was not statistically significant.
Reactive gastric or duodenal mucosal lesions resulting from infusion of chemotherapeutic agents into adjacent organs through arteries originating from the common hepatic artery are known potential complications of continuing hepatic arterial infusion chemotherapy [21-23]. The efficacy of selective transcatheter arterial embolization for arteries that supply blood to extrahepatic adjacent organs to avoid reactive gastric or duodenal mucosal lesions resulting from infusion of chemotherapeutic agents into these organs has been described [7, 20, 21, 24-26]. With the catheter tip fixation method, the gastroduodenal artery is embolized at the time of implantation. Hence, such difficulties can be prevented by additional embolization of all arterial branches (e.g., right gastric artery) that arise from the point between the side hole and the right or left hepatic artery other than the gastroduodenal artery and that supply blood to extrahepatic adjacent organs (i.e., stomach, duodenum, and pancreas) [20, 25, 26].
However, the modified method [16] differs from the original method in that the end of the indwelling catheter is not closed with microcoils [7, 18]. Although the gastroduodenal artery beyond the end is embolized with one or two microcoils, this may be insufficient to stop distribution of chemotherapeutic agents over the side hole to the outside of the indwelling catheter from the catheter tip. Thus, even if branches that supply blood to extrahepatic adjacent organs were embolized before indwelling catheter implantation, leaving the catheter tip open offers the possibility of development of gastroduodenal mucosal lesions as a result of inflow of chemotherapeutic agents through the end hole into the gastroduodenal artery or the right gastroepiploic artery, which arises from the gastroduodenal artery.
In our study, indeed, arteriography via the port just after implantation showed persistence of hepatofugal blood flow beyond the catheter tip at a relatively high frequency (i.e., in 23 [39.7%] of 58 cases). This rate was significantly higher than with the original method. However, this flow had disappeared on arteriography via the port performed within 2-10 days after implantation of the indwelling catheter in all cases. Thus, it appears that closure of the end hole, a step that made the procedure more technically demanding, can be dispensed with. Furthermore, the number of coils used in the modified method was almost equal to that in the original method. Also, the difference in the additional use of NBCA and Lipiodol for more sufficient embolization was insignificant between the original and modified methods. Both findings suggest that neither additional cost nor additional effort is required to stop blood flow beyond the tip when the end hole of the indwelling catheter is left open. Spontaneous closure of the catheter tip within 2-10 days after implantation as observed here might be explained by gradual coagulation after port-catheter implantation as described by Irie [16]. The findings in our study that the distance of the side hole from the end of the indwelling catheter does not significantly differ between cases with and those without persistent hepatofugal blood flow in the gastroduodenal artery beyond the catheter tip and that no blood flow is seen on arteriography via the port performed within 10 days after implantation allow us to confirm that coagulation inside the lumen of the catheter tip beyond the side hole can take place irrespective of the distance of the side hole from the tip.
In conclusion, the modified fixed catheter tip method is superior to the original method for technical ease and rate of hepatic arterial obstruction. Use of embolic agents to fix the catheter, such as the number of coils used, is equal between the two methods. A weakness of the modified method compared with the original method is persistent hepatofugal blood flow in the gastroduodenal artery via the end hole. However, this is not very problematic because closure of the end hole appears to occur spontaneously shortly after implantation in most patients. Results of our study indicate that it would be prudent, before initiating hepatic arterial infusion chemotherapy through an implanted port-catheter system, to wait approximately 10 days so that most patients will no longer have persistent hepatofugal blood flow into the gastroduodenal artery beyond the catheter tip.
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