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1 All authors: Department of General Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670 Japan.
Received February 22, 2002;
accepted after revision April 23, 2002.
Address correspondence to M. Miyazaki.
Abstract
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MATERIALS AND METHODS. Thirty-nine patients, 15 men and 24 women, underwent initial embolization; 12 of the 39 underwent a repeated embolization. The therapeutic effects of the initial and repeated embolization were classified as a complete response if the patient's platelet count rose to more than 10 x 104/µL without medication 1 year after the initial or repeated embolization, as a partial response if the platlet count reached 5-10 x 104/µL under the same circumstances, or as no response.
RESULTS. Twenty patients (51%) responded to the initial embolization (complete response in 11 and partial response in nine). No significant differences were found between those patients who responded to the treatment (responders) and those who did not respond to the treatment (nonresponders) in age, sex, lowest platelet counts, and steroid response before embolization. Peak platelet response was significantly higher in the responders (p = 0.029). One of the 11 complete responders and five of the nine partial responders relapsed after a median follow-up period of 34 months (range, 15-23 months) and underwent repeated embolization, resulting in complete response in one patient, partial response in the remaining four patients, and no response in one patient. However, in the six nonresponders (to the initial embolism), repeated embolization elicited a partial response in only one patient. The remission rate of 51% was maintained by means of repeated embolization for a median follow-up period of 76 months after the initial embolization.
CONCLUSION. Partial splenic embolization combined with repeated embolization may be an effective alternative to splenectomy in the treatment of chronic idiopathic thrombocytopenic purpura.
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Between 1988 and 2000, 49 patients with chronic idiopathic thrombocytopenic purpura underwent PSE in our institution (no patients with this disease underwent splenectomy alone). After receiving approval from our ethics committee and informed consent from the patients, we retrospectively reviewed these cases, excluding 10 patients from our study for various reasons: Five patients underwent splenectomy after PSE. (Details of the cases of these five patients have been previously described [3].) In one of the 49 patients, complications arising because of coexisting systemic lupus erythematosus were addressed by prescribing a daily dose of prednisolone (5 mg). (This patient maintained a platelet count of more than 10 x 104/µL for 140 months after undergoing PSE.) Four other patients were lost to follow-up after 12 months. Thus, 39 patients, 15 men and 24 women, composed our study population. Sixteen of these patients had been included in a previous study [3]. The median age of our patients was 44 years (range, 17-81 years) (Table 1). Six of the patients who had no response to the initial PSE and six who initially had responded but then relapsed underwent a repeated PSE.
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Among the 39 study subjects, the lowest platelet counts before PSE ranged from 0.3 to 3.5 x 104/µL (median count, 1.5 x 104/µL). All patients had taken various medications before undergoing embolization, including prednisolone and other immunosupressive drugs. Thirteen patients whose platlet counts had been maintained by steroid treatment underwent PSE to allow discontinuation of the steroids. The other 26 patients had not responded to steroid treatment.
All patients were discharged approximately 1 week after PSE and were followed up at our outpatient clinic. The median follow-up period was 97 months (range, 13-156 months). Platelet counts were measured on days 1, 3, and 7 after PSE and subsequently every month during the follow-up period. Peak platelet response was defined as the maximal platelet count measured during the follow-up period.
The therapeutic effect of PSE was evaluated on the basis of the patients' platelet count without medication 1 year after PSE. Complete response was defined as a platelet count of more than 10 x 104/µL, and partial response was defined as a platelet count between 5 and 10 x 104/µL. All other cases were deemed as showing no response.
Partial Splenic Embolization
The PSE procedure used in these patients has been previously described
[3]: a 5-French catheter (JA-NO
3; Hanako Medical, Tokyo, Japan) was advanced through the femoral artery to
the mid splenic artery, and a 0.035-inch (0.089-cm) guidewire (RF-GS35153;
Terumo, Tokyo, Japan) was inserted coaxially. Subsequent catheterization into
the intrasplenic arterial branches was performed using an exchange method with
a 5-French catheter (RF-XL95008; Terumo) as far distally as possible to
prevent unnecessary embolization of the pancreas and the stomach. Embolization
of intrasplenic arterial branches was carried out by injection of 2 x 2
mm fragments of Gelfoam (UpJohn, Kalamazoo, MI) and an antibiotic solution
containing 0.2 g of ampicillin. Splenic embolization was monitored
angiographically during the procedure, and embolization was stopped after
approximately 70% of the splenic parenchyma had been ablated. Typically, one 2
x 6 cm sheet of Gelfoam was required for embolization. After
embolization, the patients received IV antibiotics (2 g of ampicillin per day)
for 3-5 days. The repeated PSE procedure was performed in the same way to
embolize the remaining arterial branches of the spleen.
Volumetric Analysis of the Spleen
All patients underwent CT of the abdomen 4-8 weeks after PSE, and
volumetric analyses were performed. The percentage of splenic infarction was
calculated using a public domain image processing and analysis software (NIH
image software; National Institutes of Health, Bethesda, MD) as infarcted
volume / total splenic volume x 100.
Statistical Analysis
The Mann-Whitney U test was used to analyze unpaired samples.
Fisher's exact test was used to assess the significance between proportions. A
p value of less than 0.05 was considered statistically
significant.
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We found no significant differences in age, sex, lowest platelet counts, or steroid response before PSE between patients with a complete or partial response (responders) and those with no response (nonresponders). Peak platelet response was significantly higher among responders (median, 36 x 104/µL; range, 10-81 x 104/µL) than among nonresponders (median, 25 x 104/µL; range, 11-45 x 104/µL) (p = 0.029). The volume percentage of splenic infarction after the initial PSE was not significantly different between the responders (median, 80%; range, 60-90%) and nonresponders (median, 70%; range 40-89%) (p = 0.135) (Table 1).
Of the 11 patients with a complete response, seven patients maintained a platelet count of more than 10 x 104/µL, and three had a platelet count of more than 7 x 104/µL without medication after a median follow-up period of 58 months (range, 21-156 months) (Fig. 1). The one other complete responder relapsed 32 months after the initial PSE and underwent a repeated PSE. This patient maintained a platelet count of more than 20 x 104/µL at the last follow-up, 78 months after the repeated PSE.
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Four of the nine patients with a partial response maintained a platelet count of more than 5 x 104/µL without relapse after a median follow-up period of 73 months (range, 14-142 months). The other five partial responders relapsed after a median period of 34 months (range, 15-123 months) after the initial PSE and underwent a repeated PSE, which brought about a partial response in four (80%) of the five patients and no response in one (20%) (Table 1). The four patients maintained a platelet count of more than 5 x 104/µL at the last follow-up, a median follow-up period of 66 months (range, 60-72 months) after the repeated PSE.
Six of the 19 patients with no response also underwent a repeated PSE after a median period of 8 months (range, 3-22 months) after the initial PSE. The repeated PSE brought about a partial response in only one (17%) of the six patients and no response in five (83%) (Table 1 and Fig. 2A,2B).
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Therefore, 20 (51%) of the 39 patients maintained a platelet count of more than 5 x 104/µL without medication after a median follow-up period of 76 months (range, 14-147 months) after the initial PSE.
All patients had a fever for several days after PSE. Of the 39 patients, 35 (90%) had pain in the left upper quadrant of the abdomen, 27 (69%) had nausea, six (15%) had a perisplenic fluid collection, and five (13%) had a left-sided pleural effusion. Splenic rupture or abscess was not observed in any patient.
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Fabris et al. [9] reported that although 88% of patients had an immediate response to splenectomy, 25% of the responders relapsed after a median follow-up period of 7.6 years. These researchers also reported that the probability curve of continued remission showed a constant relapse rate during the first 36 months; further stages of relapse were observed beginning 70 months after surgery. We found that six of the 20 responders relapsed at 15-123 months after the initial PSE and that the disease recurred within 38 months in five of these six patients. The relapse rate after PSE seems to be very similar to the relapse rate after splenectomy.
A functioning accessory spleen has been described as playing an important role in relapses after an initial splenectomy for chronic idiopathic thrombocytopenic purpura [10]. Researchers have recommended investigation of the possible presence of a functioning accessory spleen be undertaken in all patients who fail to respond to splenectomy [10, 11]. These reports strongly suggest that complete removal of functioning splenic tissue is essential in treating chronic idiopathic thrombocytopenic purpura. However, in our study, complete infarction of the spleen was avoided to reduce the prevalence of complications after PSE. Furthermore, platelet response after PSE was not affected by the percentage of splenic infarction. A recent study found that laparoscopic accessory splenectomy was not effective in patients with chronic idiopathic thrombocytopenic purpura in whom the disease persists or recurs after the initial splenectomy [12]. This finding suggests that the responsiveness of each patient may be a more important factor in determining outcome than complete reduction of functioning splenic volume, which is in agreement with the observations in a previous report [3]. In that study, five patients underwent splenectomy after PSE; in four of them, the effect of surgery was similar to that of embolization.
In our study, a repeated PSE was effective in patients who responded to the initial PSE but later relapsed, but it was not effective in patients who had no response to the initial PSE. A repeated PSE could not elicit a complete response in patients who had no more than partial response to the initial PSE. As a consequence, most patients who responded to the initial PSE and later relapsed were aided by a repeated PSE, which resulted in long-term remission. These results also confirm the importance of the responsiveness of each patient.
Katkhouda et al. [13] reported that a patient's platelet count at discharge is a significant predictor of response after laparoscopic splenectomy for chronic idiopathic thrombocytopenic purpura. We found that peak platelet response was significantly higher among the responders than among the nonresponders. However, early platelet response was not found to be a sufficient predictor of long-term results, because there was substantial overlap among individuals.
Some research has shown that a patient's age is a predictor of response after splenectomy [9, 13,14,15] and that the remission rate after splenectomy is significantly lower in steroid nonresponders than in patients who relapsed after initially responding to steroid treatment [5]. However, we found that patient age and response to steroid treatment were not associated with response after PSE.
Winde et al. [16] have reported that isolated splenic thrombocytolysis and hyperplasia of megakaryocytopoiesis and of splenic follicles correlated with a better postoperative outcome and could serve as possible prognostic factors for the postoperative course in patients with chronic idiopathic thrombocytopenic purpura. Uchida et al. [17] reported that the therapeutic outcome of PSE can be more accurately predicted using a normalized spleen—liver uptake ratio of 111In-labeled platelets in patients with chronic idiopathic thrombocytopenic purpura than with a conventional splenic—hepatic uptake ratio on delayed images. Further investigations may be necessary to select candidates for PSE or splenectomy for whom long-term remission is expected.
Although the remission rate 1 year after PSE among the patients we studied was only 51% and the relapse rate reached 30% thereafter, the remission rate was maintained by means of a repeated PSE for a median follow-up period of 76 months. It may be concluded that a repeated PSE is an effective alternative to splenectomy in the treatment of chronic idiopathic thrombocytopenic purpura.
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