This is the first study to assess prospectively the resource utilization of preventing rebleeding from esophageal varices treated by variceal decompression using either a TIPS or DSRS. We feel this study provides a unique view of the cost of caring for patients over a 5 year period with well compensated cirrhosis who bled from varices. In addition, QOL data was obtained prospectively on all patients. Because this data was obtained prospectively no assumptions were needed as to incidence of rebleeding, etc. and thus the results are a more accurate reflection of the costs associated with these procedures and subsequent follow-up care than are the numbers obtained from the use of modeling.
Although the initial direct cost of DSRS was greater than for TIPS, in the first year hospital costs and out-patient costs associated with TIPS were significantly greater than for DSRS patients reflecting the need for monitoring and re-intervention to maintain TIPS patency (6
). This need for monitoring and re-intervention did not disappear over time as the out-patient costs for TIPS increased over the 5 year period of observation ().
One way to reduce the need for re-intervention is the use of coated stents. When using coated stents 13% of patients required re-intervention during the first 300 days of a trial (14
). We estimated the differences in costs and outcomes for the TIPS cohort when coated stents were theoretically used for all TIPS procedures. As can be seen in the greatest reduction in overall costs for the TIPS cohort was seen with a 15% restenosis rate but the differences were small. Part of the reason that overall cost reduction were not greater is the additional cost to all patients of the coated as compared to the bare stents. Hence, the cost of TIPS using coated stents over a period of 5 years is still likely to be greater than the cost of a DSRS.
Costs of management of variceal bleeding have been determined or estimated in a number of studies. In one study the one year direct costs of managing patients who bled from varices with endoscopic therapy were $13,197 for sclerotherapy and $9,696 for variceal band ligation (25
). In two reports using modeling the estimated annual direct costs for preventing rebleeding using variceal band ligation or TIPS were $16,600 to $23,459 and $26,275 to $30,900 respectively (13
). In the current study the median annual direct costs for survivors at 5 years were for TIPS = $16,363 and for DSRS = $13,492. Part of the difference between this and the above reports reflects the failure in the latter to consider that the cost of treating these patients is greatest in the first year and then steadily declines over time as can be seen in and . In addition, by preventing rebleeding in ~90% of patients with portal decompression the need for hospitalization due to variceal rebleeding was reduced to a greater degree that previously appreciated and this would result in a cost savings over a 5 year period. Lastly, the current study only included patients with well compensated liver disease whereas in the modeling reports there was no restriction on the type of patients enrolled and patients with more advanced disease are likely to incur higher costs.
Although the direct costs were less for DSRS patients than for those receiving a TIPS, the effectiveness in terms of QALYs favored those receiving a TIPS. This occurred because HRQL data in QALYs was always greater for the TIPS group due to the survival advantage in terms of months that was seen at an early stage in the study. Over the total span of the study there was no survival advantage (6
) but this early difference affected all of the calculations. An ICER of < $50,000/QALY would be considered a cost effective strategy, whereas an ICER of $50,000–$100,000/QALY would be considered moderately cost effective. Therefore, TIPS was more expensive than DSRS at each time point and its benefits were not sufficient to make it moderately cost effective compared to DSRS until 5 years post procedure. Based on acceptability curves the probability that TIPS at years 1 and 3 of follow-up could be cost effective is low. The acceptability curves also suggest that even at year 5 TIPS has a probability of 0.5 to 0.65 of being moderately cost effective and thus may be marginally more cost effective than DSRS ().
Patients with alcoholic liver disease have been shown to have a worse prognosis following DSRS than non-alcoholic patients have (26
) and the current study stratified patients to control for this variable. No difference between TIPS and DSRS was found in these two populations as far as survival, rebleeding rates (6
) or cost () are concerned. However, the cost of DSRS in the alcoholic population was significantly greater than in the non-alcoholic patients. The reasons for this are unclear but resumption of drinking is known to increase the likelihood of liver dysfunction and this would add to cost of management (27
There are several limitations to this study. When this study was begun the only tool available to assess QOL was the SF-36. Subsequently a Liver Disease Questionnaire (CLDQ) has been developed to assess QOL in patients with liver disease. The SF-36 has been compared to the CLDQ in a number of studies. Reasonably good correlations between the SF-36/SF-6D and CLDQ for most domains were found and similar changes in both tools with disease progression have been reported (28
). We, therefore, feel the SF-36 is a suitable tool for calculating cost-effectiveness of the two procedures. This analysis applies only to the USA as we used Medicare costs but it does give relative costs that can be used world-wide. Lastly, indirect costs were not measured so only the costs associated with management were determined.
This study has shown that both TIPS and DSRS are effective therapies in the prevention of rebleeding from varices, being 10.5% and 5.5% respectively with excellent survival (6
). In the current report these initial observations are extended and show that TIPS is somewhat more expensive than DSRS. However, the cost effectiveness of the two approaches is similar and with the use of coated stents TIPS approaches being more cost-effective. Given the efficacy, safety, and cost effectiveness of TIPS and the increasing lack of surgeons who can perform portasystemic shunts well, TIPS should be considered the procedure of choice to treat recurrent variceal bleeding refractory to medical therapy in patients with well compensated cirrhosis.