Utility of Endoscopy in Hospitalized Patients with Gastrointestinal Hemorrhage and Pulmonary Hypertension.

BACKGROUND: Gastrointestinal hemorrhage (GIH) has been reported as one of the most common GI complications in patients with pulmonary hypertension (PH). There is paucity of data on the national burden of GIH in patients with PH. We aimed to assess the prevalence, trends and outcomes of endoscopic interventions in patients with PH who were admitted with GIH. METHOD: We queried National Inpatient Sample (NIS) database from 2005 to 2014 and identified the patients hospitalized with primary or secondary discharge diagnosis of PH (ICD 9 CM Code: 416.0, 416.8, and 416.9). Using Clinical Classification Software Coding system (153) patients with concurrent diagnosis of GIH were then identified. We studied the prevalence and trends of GIH in PH, factors associated with GIH, use of endoscopy, factors associated with utilization of endoscopic interventions, endoscopy outcomes including mortality, and overall healthcare burden. RESULTS: Out of 7,586,973 PH hospitalizations 3.2% (N = 246,358) had concurrent GIH, with a rising prevalence of GIH in PH patients during the last decade. Clinical predictors for GIH in PH included older age, congestive heart failure, anticoagulation therapy and concurrent alcohol abuse. Mean length of stay (LOS) in PH patients hospitalized with GIH was significantly higher than without GIH (8.6 vs. 6.4 days, p < 0.01) along with a significant increase in hospitalization cost ($20,189 vs. $14,807, p < 0.01). Similarly, odds of in-hospital mortality increase by ~ 1.5 times in PH patients with GIH than those without it (adjusted odds ratio [aOR: 1.45, 95%CI: 1.43-1.47]). Endoscopic interventions were performed in 48.6% of patients with PH and GIH during their hospitalization. Older patients were more likely to undergo endoscopy, as well as the patients who received blood transfusion, and those with hypovolemic shock. Patients with acute respiratory failure and acute renal failure were less likely to get endoscopy. Mean LOS in patients undergoing endoscopic intervention was significantly higher than those who did not receive any intervention (8.7 vs. 8.4 days, p < 0.01), without a substantial increase in hospitalization cost ($20,344 vs. $20,041, p < 0.01). Also, there was a significant decrease in in-hospital mortality in patients undergoing endoscopic interventions. CONCLUSION: Concurrent GIH in patients with PH increases length of stay; healthcare costs and increases in-hospital mortality. Use of endoscopic interventions in these patients is associated with reduced length of stay, in-hospital mortality without significantly increasing the overall health care burden and should be considered in hospitalized patients with PH who are admitted with GIH. Future studies comparing GIH patients with and without PH should be done to assess if PH is a risk factor for worse outcomes. CLINICAL TRIAL REGISTRATION NUMBER: No IRB required due to use of national de-identified data.

Over-The-Scope Clip system as a first-line therapy for high-risk bleeding peptic ulcers: a retrospective study.

BACKGROUND: Effective hemostasis is essential to prevent rebleeding. We evaluated the efficacy and feasibility of the Over-The-Scope Clip (OTSC) system compared to combined therapy (through-the-scope clips with epinephrine injection) as a first-line endoscopic treatment for high-risk bleeding peptic ulcers. METHODS: We retrospectively analyzed data of 95 patients from a single, tertiary center and underwent either OTSC (n = 46) or combined therapy (n = 49). The primary outcome of the present study was the efficacy of the OTSC system as a first-line therapy in patients with high-risk bleeding peptic ulcers compared to combined therapy with TTS clips and epinephrine injection. The secondary outcomes included the rebleeding rate, perforation rate, mean procedure time, reintervention rate, mean procedure cost and days of hospitalization in the two study groups within 30 days of the index procedure. RESULTS: All patients achieved hemostasis within the procedure; two patients in the OTSC group and four patients in the combined therapy group developed rebleeding (p = 0.444). No patients experienced gastrointestinal perforation. OTSC had a shorter median procedure time than combined therapy (11 min versus 20 min; p < 0.001). The procedure cost was superior for OTSC compared to combined therapy ($102,000 versus $101,000; p < 0.001). We found no significant difference in the rebleeding prevention rate (95.6% versus 91.8%, p = 0.678), hospitalization days (3 days versus 4 days; p = 0.215), and hospitalization costs ($108,000 versus $240,000, p = 0.215) of the OTSC group compared to the combined therapy group. CONCLUSION: OTSC treatment is an effective and feasible first-line therapy for high-risk bleeding peptic ulcers. OTSC confers comparable costs and patient outcomes as combined treatments, with a shorter procedure time.

Clipping Over the Scope for Recurrent Peptic Ulcer Bleeding is Cost-Effective as Compared to Standard Therapy: An Initial Assessment.

Clipping over the scope (C-OTS) is a novel closure technique used for the treatment of nonvariceal gastrointestinal bleeding, especially for high-risk lesions. C-OTS devices cost more than clipping through the scope and thermal devices. The high upfront cost of C-OTS may pose a barrier to its use and the cost-effectiveness of C-OTS for peptic ulcer disease bleeding is unknown. Cost-effectiveness studies of C-OTS for peptic ulcer bleeding as both first-line and second-line therapy can provide the current estimate of the conditions in which the use of C-OTS is cost-effective and give insights of the determinants to the cost-effectiveness of C-OTS.

Over-the-scope clips are cost-effective in recurrent peptic ulcer bleeding.

Background: A recent prospective randomised controlled trial ('STING') showed superiority of over-the-scope clips compared to standard treatment in recurrent peptic ulcer bleeding. Cost-effectiveness studies on haemostasis with over-the-scope clips have not been reported so far. Objective: The aim of this study was to investigate whether the higher efficacy of the over-the-scope clips treatment outweighs the higher costs of the device compared to standard clips. Methods: For the analysis, the study population of the STING trial was used. Costs for the hospital stay in total as well as treatment-related costs were obtained. The average cost-effectiveness ratio, representing the mean costs per designated outcome, and the incremental cost-effectiveness ratio, expressing the additional costs of a new treatment strategy per difference in outcome were calculated. The designated outcome was defined as successful haemostasis without rebleeding within seven days, which was the primary endpoint of the STING trial. Average cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated for total costs of the hospital stay as well as the haemostasis treatment alone. The cost-effectiveness analysis is taken from the perspective of the care provider.Results: Total costs and treatment-related costs per patient were 13,007.07 € in the standard group vs 12,808.56 € in the over-the-scope clip group (p = 0.812) and 2084.98 € vs 1984.71 € respectively (p = 0.663). The difference was not statistically significant. Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05 € vs 15,104.43 € and 4917.41 € vs 2340.46 € for the haemostasis treatment. The additional costs per successful haemostasis with over-the-scope clip treatment (incremental cost-effectiveness ratio) is -468.18 € for the whole treatment and -236.49€ for the haemostasis treatment. Conclusions: Over-the-scope clip treatment is cost-effective in recurrent peptic ulcer bleeding.

Use of Doppler Probe in Nonvariceal Upper-Gastrointestinal Bleeding Is Less Costly and More Effective Than Standard of Care.

BACKGROUND & AIMS: Upper gastrointestinal bleeding is a common emergency and rebleeding is associated with an increased risk of death. Proper assessment of high-risk lesions and appropriate endoscopic hemostasis are required for the best outcomes. The endoscopic Doppler probe examination (DPE) allows for a more complete assessment of the stigmata of hemorrhage, providing better evaluation of the need for endoscopic hemostasis and determination of its completeness. We aimed to evaluate whether use of the DPE provides an additional advantage in cost and effectiveness compared with traditional endoscopic visual assessment (TEA) of high-risk stigmata in patients with nonvariceal upper gastrointestinal bleeding. METHODS: We drew a decision tree representing the choice between DPE and TEA approaches for patients undergoing an index endoscopy for active nonvariceal upper gastrointestinal bleeding. Clinical probabilities were retrieved from randomized controlled trial data. Costs were expressed in 2017 US dollars. A third-party payer perspective was adopted. We performed deterministic and probabilistic sensitivity analyses. The adopted time horizon was 30 days after the index endoscopy. RESULTS: We found that DPE is a dominant strategy over the TEA, in that DPE is more efficacious (92.6% of patients avoiding rebleeding vs 78.6% for TEA) and less expensive ($8502 vs $9104 for TEA). The economic dominance of DPE over TEA was robust to sensitivity analyses across all assumptions of the model when varied among ranges spanning 30% of their respective baseline values. CONCLUSIONS: In a cost-effectiveness analysis, we found DPE to be an economically dominant strategy to TEA (the traditional approach) in the management of high-risk lesions in patients with nonvariceal upper gastrointestinal bleeding. DPE was less costly and more effective.

Endoscopy Is Relatively Safe in Patients with Acute Ischemic Stroke and Gastrointestinal Hemorrhage.

BACKGROUND: Gastrointestinal hemorrhage (GIH) is reported to occur in 1-8% of patients admitted with acute ischemic stroke (AIS). AIS is considered to be a relative contraindication to GIE. AIMS: Evaluate the outcomes of gastrointestinal endoscopy (GIE) in patients hospitalized with AIS and GIH. METHODS: Patients hospitalized with AIS and GIH were included from the National Inpatient Sample 2005-2014. Primary outcome measure was in-hospital mortality in patients with AIS and GIH who underwent gastrointestinal endoscopy. Secondary outcomes were (1) resource utilization as measured by length of stay (LOS) and total hospitalization costs and (2) to identify independent predictors of undergoing GIE in patients with AIS and GIH. Confounders were adjusted for by using multivariable regression analysis. RESULTS: A total of 75,756 hospitalizations were included in the analysis. Using a multivariate analysis, the in-hospital mortality was significantly lower in patients who underwent GIE as compared to those who did not [aOR: 0.4, P < 0.001]. Patients who underwent GIE also had significantly shorter adjusted mean LOS [adjusted mean difference in LOS: 0.587 days, P < 0.001]. Patients with AIS and GIH who did not undergo GIE had significantly higher adjusted total hospitalization costs. [Mean adjusted difference in total hospitalization costs was $5801 (P < 0.001).] Independent predictors of undergoing GIE in this population were male gender, age > 65 years, Asian or Pacific race, hypovolemic shock, need for blood transfusion and admission to urban non-teaching hospital. CONCLUSIONS: Gastrointestinal endoscopy can be safely performed in a substantial number of patients with AIS and GIH.

Transparent cap-assisted endoscopic sclerotherapy in esophageal varices: a randomized-controlled trial.

BACKGROUND AND AIM: Endoscopic treatment is widely accepted as the first-line therapy selection for esophageal variceal bleeding. Nevertheless, endoscopic injection sclerotherapy requires experienced endoscopists and is associated with a high risk of bleeding. Our study evaluates the feasibility and efficacy of transparent cap-assisted endoscopic sclerotherapy in the management of esophageal varices. PATIENTS AND METHODS: A randomized-controlled trial was conducted in a tertiary referral center from April 2015 to May 2016. Patients who received endoscopic sclerotherapy were randomized in a blinded manner into two groups: the transparent cap-assisted group (n=59) and the control group (n=61). RESULTS: The average injection sites were reduced in the transparent cap-assisted group compared with the control group (1.2±0.4 vs. 1.4±0.05, P=0.000), whereas no difference was observed in the dosage of lauromacrogol (16.97±4.91 vs. 16.85±4.57, P=0.662) and the hemorrhage that occurred during injection made no difference (50.8 vs. 61.0%, P=0.276); yet, salvage hemostasis methods were used in only nine patients in the transparent cap-assisted group compared with 17 patients in the control group (25.0 vs. 38.7%, P=0.0936). The cost of each procedure in the cap-assisted group was ¥2578 (1878-4202), whereas it was ¥3691 for the control group (2506-5791) (P=0.023). Moreover, in both groups, no esophageal constriction was observed during the 6-month follow-up period, whereas the rebleeding rate between two groups showed no statistical significance in 6 months (89.8 vs. 93.4%, P=0.563). CONCLUSION: Transparent cap-assisted sclerotherapy provided a clear field of vision and helped to fix the targeted veins, thus significantly reducing the use of the salvage hemostasis method during sclerotherapy injection hemorrhage. It is also associated with reduced injection sites and endoscopic therapy cost.

Using Hemospray Improves the Cost-effectiveness Ratio in the Management of Upper Gastrointestinal Nonvariceal Bleeding.

GOALS: We compared the cost-effectiveness of traditional recommended endoscopic hemostatic therapies and Hemospray alone or in combination when treating nonvariceal upper gastrointestinal bleeding (NVUGIB). BACKGROUND: Hemospray (TC-325) is a novel endoscopic hemostatic powder, achieving hemostasis through adherence to actively bleeding biological surfaces. STUDY: A decision tree of patients with NVUGIB assessed 4 possible treatment strategies: traditional therapy alone (T), Hemospray alone (H), traditional therapy completed by Hemospray if needed (T+H), or Hemospray completed by traditional therapy if needed (H+T). Using published probabilities, effectiveness was the likelihood of avoiding rebleeding over 30 days. Costs in 2014 US$ were based on the US National Inpatient Sample. A third-party payer perspective was adopted. Sensitivity and subgroup analyses were performed. RESULTS: For all patients, T+H was more efficacious (97% avoiding rebleeding) and less expensive (average cost per patient of US$9150) than all other approaches. The second most cost-effective approach was H+T (5.57% less effective and US$635 more per patient). Sensitivity analyses showed T+H followed by a strategy of H+T remained more cost-effective than H or T alone when varying all probability assumptions across plausible ranges. Subgroup analysis showed that the inclusion of H (especially alone) was least adapted for ulcers and was more cost-effective when treating lesions at low risk of delayed rebleeding. CONCLUSIONS: Hemospray improves the effectiveness of traditional hemostasis, being less costly in most NVUGIB patient populations. A Hemospray first approach is most cost-effective for nonulcer bleeding lesions at low risk of delayed hemorrhage.

Second-look endoscopy for bleeding peptic ulcer disease: a decision-effectiveness and cost-effectiveness analysis.

BACKGROUND: Second-look endoscopy after initial therapeutic endoscopy for bleeding peptic ulcer disease may decrease the risk of rebleeding; however, it is not recommended routinely. Understanding conditions under which second-look endoscopy is beneficial might be useful for clinical decision making. METHODS: Using a decision model, literature-based probabilities, and Medicare reimbursement costs, we compared routine second-look endoscopy with no second-look endoscopy. We measured rebleeding, need for surgery, hospital mortality, and costs, and calculated the cost to avoid each outcome, expressed as the number needed to treat, along with the cost per outcome prevented. RESULTS: In the base case, routine second-look endoscopy reduced rebleeding from 16% to 10% (needed to treat=16) but had no effect on other outcomes. The cost to prevent 1 case of rebleeding was nearly $13,000. Threshold analysis revealed a rebleeding threshold of 31% to neutralize the cost difference between routine second-look endoscopy and no routine second-look endoscopy. If routine second-look endoscopy was 100% effective in preventing rebleeding, then the rebleeding threshold for cost neutrality would be 17.5%. When rebleeding risks after the index endoscopy and second-look endoscopy were simultaneously considered, the cost per bleed prevented ranged from a cost savings of $165 when the respective risks were 25% and 5%, to a cost of nearly $33,000 when the risks were 20% and 15%. CONCLUSIONS: The results suggest that routine second-look endoscopy is not indicated after therapeutic endoscopy for bleeding peptic ulcer disease. However, if rebleeding risk is 31% or greater, then routine second-look endoscopy reduces this risk at no additional cost.

Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding.

Peptic ulcer bleeding (PUB) is a serious and sometimes fatal condition. The outcome of PUB strongly depends on the risk of rebleeding. A recent multinational placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT00251979) showed that high-dose intravenous (IV) esomeprazole, when administered after successful endoscopic haemostasis in patients with PUB, is effective in preventing rebleeding. From a policy perspective it is important to assess the cost efficacy of this benefit so as to enable clinicians and payers to make an informed decision regarding the management of PUB. Using a decision-tree model, we compared the cost efficacy of high-dose IV esomeprazole versus an approach of no-IV proton pump inhibitor for prevention of rebleeding in patients with PUB. The model adopted a 30-day time horizon and the perspective of third-party payers in the USA and Europe. The main efficacy variable was the number of averted rebleedings. Healthcare resource utilization costs (physician fees, hospitalizations, surgeries, pharmacotherapies) relevant for the management of PUB were also determined. Data for unit costs (prices) were primarily taken from official governmental sources, and data for other model assumptions were retrieved from the original clinical trial and the literature. After successful endoscopic haemostasis, patients received either high-dose IV esomeprazole (80 mg infusion over 30 min, then 8 mg/hour for 71.5 hours) or no-IV esomeprazole treatment, with both groups receiving oral esomeprazole 40 mg once daily from days 4 to 30. Rebleed rates at 30 days were 7.7% and 13.6%, respectively, for the high-dose IV esomeprazole and no-IV esomeprazole treatment groups (equating to a number needed to treat of 17 in order to prevent one additional patient from rebleeding). In the US setting, the average cost per patient for the high-dose IV esomeprazole strategy was $US14 290 compared with $US14 239 for the no-IV esomeprazole strategy (year 2007 values). For the European setting, Sweden and Spain were used as examples. In the Swedish setting the corresponding respective figures were Swedish kronor (SEK)67 862 ($US9220 at average 2006 interbank exchange rates) and SEK67 807 ($US9212) [year 2006 values]. Incremental cost-effectiveness ratios were $US866 and SEK938 ($US127), respectively, per averted rebleed when using IV esomeprazole. For the Spanish setting, the high-dose IV esomeprazole strategy was dominant (more effective and less costly than the no-IV esomeprazole strategy) [year 2008 values]. All results appeared robust to univariate/threshold sensitivity analysis, with high-dose IV esomeprazole becoming dominant with small variations in assumptions in the US and Swedish settings, while remaining a dominant approach in the Spanish scenario across a broad range of values. Sensitivity variables with prespecified ranges included lengths of stay and per diem assumptions, rebleeding rates and, in some cases, professional fees. In patients with PUB, high-dose IV esomeprazole after successful endoscopic haemostasis appears to improve outcomes at a modest increase in costs relative to a no-IV esomeprazole strategy from the US and Swedish third-party payer perspective. Whereas, in the Spanish setting, the high-dose IV esomeprazole strategy appeared dominant, being more effective and less costly.

Cost-effectiveness analysis of high-dose omeprazole infusion before endoscopy for patients with upper-GI bleeding.

BACKGROUND: The use of intravenous (i.v.) proton pump inhibitors (PPI) before an endoscopy in upper-GI bleeding (UGIB) was shown to reduce the need of endoscopic therapy and shorten hospital stay. OBJECTIVE: To investigate whether preemptive use of a PPI in UGIB is a cost-effective strategy. DESIGN: A decision analysis model that represents treatment pathways for patients with UGIB was constructed and structuralized by 30-day outcomes. Direct costs of medical treatment, diagnostic and therapeutic endoscopy, endoscopic re-treatment, surgery, and hospitalization were analyzed. SETTING: Prince of Wales Hospital, Hong Kong. PATIENTS: A total of 631 patients were recruited. Sixty patients (19.1%) in the PPI group and 90 patients (28.4%) in the placebo group required endoscopic hemostasis at index endoscopy. MAIN OUTCOME MEASUREMENTS: The primary measurements were cost-effectiveness ratios and incremental cost-effectiveness ratios (ICER) to avert endoscopic therapy between PPI and placebo treatment. Sensitivity analyses were conducted by varying the cost of endoscopy, hospitalization, the incidence rate of endoscopic therapy, and the proportion of bleeding peptic ulcers. RESULTS: The overall direct cost per patient was U.S. dollars (USD) $2813 for PPI treatment and USD $2948 for the placebo. A PPI reduced endoscopic therapy by 7.4% and resulted in a lower cost-effectiveness ratio per endoscopic therapy averted (USD $3561) than the placebo (USD $4117). The ICER value was USD -$1843, which indicated that preemptive PPI treatment is more effective and less costly for UGIB. When the proportions of patients with peptic ulcer bleeding were greater than 8.3%, the preemptive PPI treatment remained cost saving. CONCLUSIONS: Preemptive use of IV PPI before an endoscopy is a cost-effective strategy in the management of UGIB.

Estimates of costs of hospital stay for variceal and nonvariceal upper gastrointestinal bleeding in the United States.

OBJECTIVES: Variceal (VUGIB) and nonvariceal (NVUGIB) upper gastrointestinal bleeding are prevalent causes of hospitalization. Cost estimates are needed to determine the impact of their contemporary treatments (endoscopic hemostasis and high-dose proton pump inhibition). We determined the costs of upper gastrointestinal bleeding with or without complications (rebleeding). METHODS: Charges and length of stay (LOS) were obtained from the United States Nation-wide Inpatient Sample. We defined NVUGIB using Diagnosis Related Groups, and VUGIB using International Classification of Diseases, Ninth Revision, Clinical Modification codes. RESULTS: Hospitalization costs with and without complications were $5632 and $3402 for NVUGIB, and $23,207 and $6612 for VUGIB, respectively; similarly, mean LOS were 4.4 and 2.7 days, and 15.2 and 3.8 days. CONCLUSION: We present hospitalization costs and LOS for VUGIB and NVUGIB with and without complications. The reliability of our estimates rests with the size and the national representativeness of the databases used, and should prove helpful for cost analyses for UGIB requiring updated national estimates.

Endoscopic ligation vs. sclerotherapy in adults with extrahepatic portal venous obstruction: a prospective randomized study.

BACKGROUND: Endoscopic sclerotherapy is a well-established treatment for bleeding esophageal varices, although it has a substantial complication rate. A prospective randomized trial was conducted to determine whether endoscopic variceal ligation is safer and more effective than sclerotherapy in adults with bleeding esophageal varices because of extrahepatic portal venous obstruction. METHODS: Thirty-six patients underwent sclerotherapy and 37 had band ligation. RESULTS: Ligation and sclerotherapy were equally effective for achieving variceal eradication (94.6% vs. 91.7%, respectively; p=0.67). However, ligation achieved eradication with fewer endoscopic sessions (3.7 [1.2] vs. 7.7 [3.3]; p <0.0001) and within a shorter time interval (50.1 [17.7] days vs. 99 [54.8] days; p <0.0001). In the ligation group, recurrent bleeding was less frequent (2.7% vs. 19.4%; p=0.028; however, Bonferroni correction for multiple testing removes this significance) and the rate of major complications was lower (2.7% vs. 22.2%; p=0.014). Total cost per patient was significantly higher in the sclerotherapy vs. the ligation group ($216.6 [71.8] vs. $182.6 [63.4]; p=0.035). During the follow-up period after variceal eradication, no significant differences were found between the sclerotherapy and the ligation groups with respect to recurrent bleeding (3% vs. 2.9%; p=1.0), esophageal variceal recurrence (9.1% vs. 11.4%; p=1.0), and formation of new gastric varices (9.1% vs. 14.3%; p=0.51). CONCLUSIONS: Variceal band ligation is superior to sclerotherapy, because it is less costly and achieves variceal eradication more quickly, with lower relative frequencies of recurrent variceal bleeding and complications.

Detachable endoloop vs. elastic band ligation for bleeding esophageal varices.

BACKGROUND: Variceal bleeding is a serious complication with a mortality rate that ranges from 20% to 50%. Patients who have variceal hemorrhage usually are treated by endoscopic injection sclerotherapy or elastic band ligation to eradicate the varices. Endoloop ligation is a newly developed technique for achieving hemostasis and variceal eradication. This study compared endoloop ligation with elastic band ligation in patients with acute esophageal variceal bleeding. METHODS: Fifty patients with acute esophageal variceal bleeding were recruited: 25 were treated by elastic band ligation and 25 by endoloop ligation. RESULTS: Although the number of patients in whom bleeding recurred during a follow-up period of 6 months was smaller in the endoloop group (12%) vs. the band group (28%), this difference was not statistically significant. Furthermore, no statistically significant difference was found between the two groups with respect to the number of patients in whom variceal eradication was achieved, the number of treatment sessions required for variceal eradication, or the frequency of variceal recurrence. The total cost for variceal obliteration by endoloop ligation was 342 dollars per patient, whereas, the total cost of variceal eradication by elastic band ligation was 356 dollars per patient. The endoloop had certain technical advantages over band application: a better field of vision, tighter application, good results with junctional varices, and a lack of strain exerted by the device on the endoscope. CONCLUSIONS: Endoloop ligation is a promising new technique for management of patients with bleeding esophageal varices.

N-2-butyl-cyanoacrylate for bleeding gastric varices: a United States pilot study and cost analysis.

OBJECTIVES: N-butyl-2-cyanoacrylate has been reported to be effective for bleeding varices but is not available in the United States. We report the initial US experience with cyanoacrylate in this prospective trial and evaluate its safety, efficacy, and relative costs. METHODS: Patients with active or recent gastric variceal bleeding were eligible. Cyanoacrylate therapy was performed until variceal occlusion was achieved. Rebleeding was assessed at 72 h (acute phase), 6 wk (subacute phase), and 1 yr (chronic phase). Survival was assessed at 3 months and 1 yr. Cost analysis was performed comparing the first 17 patients to historical control patients not treated with cyanoacrylate. RESULTS: A total of 44 patients were enrolled, 37 with cirrhosis and seven with noncirrhotic portal hypertension (NCPH). In cirrhotic patients, rebleeding was seen in two of 37 (5%) at 72 h, one of 30 (3%) at 6 wk, and five of 28 (18%) at 1 yr. Survival without shunt at 3 months was 30 of 34 (88%) and at 1 yr was 24 of 31 (77%). In NCPH patients, rebleeding was seen in two of seven (29%) at 72 h. These patients received definitive therapy for NCPH after diagnosis. Mortality and costs were substantially higher in the non-cyanoacrylate group. The odds of death were greater by 7-fold in the non-cyanoacrylate group than within the cyanoacrylate group (95% CI = 1.18-41.36, p = 0.0318). At 3 months, there was a 3.18-fold difference (95% CI = 1.05-9.64, p = 0.0411) in accrued costs; at 1 yr, the difference was 2.55-fold (95% CI = 0.96-6.94, p = 0.0585). The cost-effective ratio was estimated as 108,237 US dollars/death averted, reflecting marked cost reduction with improved survival in the cyanoacrylate-treated group. This is believed to result largely from avoidance of shunt interventions. CONCLUSIONS: Cyanoacrylate treatment of gastric varices is safe, clinically effective, and cost effective.

From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.

BACKGROUND: A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol. OBJECTIVE: To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes. DESIGN: A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group). METHODS: An incremental cost-effectiveness analysis and comparison of outcomes was performed using chi-squared tests and Kaplan-Meier survival analysis. A survey was carried out using a questionnaire in the five hospitals on local guidelines for management of ulcer bleeding, and its results were analysed qualitatively. The measure of effectiveness is the number of prevented rebleedings. Further variables were length of hospital stay and length of intensive care unit (ICU) stay. RESULTS: The cost for the prevention of one additional rebleeding by repeated fibrin glue treatment amounts to 14,316 +/- 4981 euros (incremental cost-effectiveness ratio). There were no significant differences in length of stays in ICU or in hospital. The physicians did not change their management plans for patients with upper-gastrointestinal bleeding. In a survey, it was seen that other factors, such as local guidelines, attitudes towards new treatment options, and ease of handling of drugs, are more important than a result of a single study for a behavioural change of the doctors. CONCLUSIONS: The study was not designed prospectively to address a pharmacoeconomic question. As relevant variables (e.g. length of ICU stay) could not be reliably ascertained retrospectively, this may lead to biased estimates of the incremental cost-effectiveness ratio.

Cost-effectiveness analysis of high-dose omeprazole infusion as adjuvant therapy to endoscopic treatment of bleeding peptic ulcer.

BACKGROUND: Intravenous administration of proton pump inhibitors after endoscopic treatment of bleeding peptic ulcers has been shown to decrease the rate of recurrent bleeding and the need for subsequent surgery. Yet there is a relative lack of formal assessment of this practice. The aim of this study was to examine the cost-effectiveness of this therapy by using standard pharmacoeconomic methods. METHODS: The present study was performed in conjunction with a randomized controlled clinical trial that included 232 patients who received either omeprazole (80 mg intravenous bolus followed by infusion at 8 mg/hour for 72 hours) or placebo after hemostasis was achieved endoscopically. A cost-effectiveness analysis was performed to evaluate the different outcomes of the trial. All related direct medical costs were identified from patient records. Cost-effectiveness ratios were calculated. RESULTS: Analysis by the Kolmogorov-Smirnov test showed that the direct medical cost in the omeprazole group was lower than that for the placebo group. Cost-effectiveness ratios for omeprazole and placebo groups were, respectively, HK$ 28,764 (US$ 3688) and HK$ 36,992 (US$ 4743) in averting one episode of recurrent bleeding in one patient after initial hemostasis was achieved endoscopically. CONCLUSIONS: Intravenous administration of high-dose omeprazole appears to be a cost-effective therapy in reducing the recurrence of bleeding and need for surgery in patients with active bleeding ulcer after initial hemostasis is obtained endoscopically.

Cost analysis for the prevention of variceal rebleeding: a comparison between transjugular intrahepatic portosystemic shunt and endoscopic sclerotherapy in a selected group of Italian cirrhotic patients.

The aim of the present study was to compare the cumulative cost of the first 18-month period in a selected group of Italian cirrhotic patients treated with transjugular intrahepatic portosystemic shunt (TIPS) versus endoscopic sclerotherapy (ES) to prevent variceal rebleeding. Thirty-eight patients enrolled in a controlled trial were considered (18 TIPS and 20 sclerotherapy). The number of days spent in the hospital for the initial treatment and during the follow-up period were defined as the costs of hospitalization. ES sessions, TIPS procedures, angioplasty or addition of a second stent to maintain the shunt patency, were defined as the costs of therapeutic procedures. The two groups were comparable for age, sex, and Child-Pugh score. During the observation period 4 patients died in the TIPS group, and 2 died and 1 was transplanted in the sclerotherapy group. The rebleeding rate was significantly higher in the sclerotherapy group. Despite this, the number of days spent in the hospital was similar in the two groups. This was because of a higher number of hospital admissions for the treatment of hepatic encephalopathy and shunt insufficiency in the TIPS group. The therapeutic procedures were more expensive for TIPS. Consequently, the cumulative cost was higher for patients treated with TIPS than for those treated with sclerotherapy. The extra cost was because of the initial higher cost of the procedure and the difference was still maintained at the end of the 18-month follow-up. When the cumulative costs were expressed per month free of rebleeding, the disadvantage of TIPS disappeared. In conclusion, a program of prevention of variceal rebleeding with TIPS, despite the longer interval free of rebleeding, is not a cost-saving strategy in comparison with sclerotherapy.

In vitro evaluation of integrity and sterilization of single-use argon beam plasma coagulation probes.

OBJECTIVE: Argon plasma coagulation probes (APC) are currently marketed in the United States as single-use items, and may constitute a significant per-procedure expense. It is unknown whether these probes can be sterilized after endoscopic use and if electrical integrity can be maintained after reprocessing. METHODS: Ten probes (2.3 mm diameter, 220 cm length) manufactured by ERBE Inc., (Marietta, GA) were studied using the ERBE APC 300 at 60 watts. Baseline coagulation depth was measured by coagulating a piece of beefsteak for 60 s. Probes were contaminated with 10(6) Bacillus subtilis spores, cultured, and manually cleaned. Culturing involved introducing 10 cc sterile water through the probes; water was filtered, plated onto blood agar, and incubated for 48 h. After ethylene oxide (ETO), the probes were cultured to determine sterilization. Finally, the per-procedure cost of each probe was assessed. RESULTS: Ten of 10 probes completed 10 testing sessions. One probe split at the proximal end but remained functionally intact. Electrical integrity remained intact for all 10 sessions. All probes grew too numerous to count colonies of B. subtilis after inoculation and no B. subtilis was detected after ETO sterilization. Assuming 10 uses clinically, a total per-procedure equipment cost would approximate $24.00, whereas per-procedure probe cost would equal $42.66 if only five uses were obtained in vivo. CONCLUSIONS: The combination of manual cleaning and ETO sterilization consistently sterilized APC probes. Ninety percent of the probes showed no sign of physical deterioration and 100% maintained their electrical activity after 10 uses. APC probes can potentially be safely and effectively reused up to 10 times, and a significant procedural savings is possible with reuse.

The economic impact of esophageal variceal hemorrhage: cost-effectiveness implications of endoscopic therapy.

Esophageal variceal hemorrhage (EVH) is a serious and expensive sequela of chronic liver disease, leading to increased utilization of resources. Today, endoscopic sclerotherapy (ES) and endoscopic ligation (EL) are the accepted, community standards of endoscopic treatment of patients with EVH. However, there are no published studies comparing the economic costs of treating EVH using these interventions. As part of a prospective, randomized trial comparing ES and EL for the treatment of EVH, we estimated the direct costs of health care utilization and cost-effectiveness for the prevention of variceal rebleeding and patient survival at 1-year follow-up. Treatment groups were similar in incidence of variceal rebleeding (41.9% vs. 42.9%), variceal obliteration (41.9% vs. 40.0%), hospital days, blood transfusions, shunt requirements, and survival (71.0% vs. 60.0%). There were significantly more treatment failures for active bleeding using EL (42% vs. 0%; P =.027) and esophageal stricture formation in the ES-treated patients (19.4% vs. 2.9%; P = 0.03). Median total direct cost outcomes were similar between groups (EL = $9,696 and ES = $13,197; P =.46). EL and ES had similar cost/variceal rebleeding prevented ($28,678 vs. $29,093) and cost/survival ($27,313 vs. $23,804). In the subgroup of active bleeders, ES had a substantially lower cost/survival ($28,523 vs. $51,696). We conclude that resource utilization was similar between treatment groups and that the choice of endoscopic therapy for EVH must still rely on clinical grounds. Further studies comparing costs and resource utilization in this patient population are needed.