Rehospitalization, Treatment, and Resource Use After Inpatient Admission for Achalasia in the USA.

INTRODUCTION: Readmission for achalasia treatment is associated with significant morbidity and cost. Factors predictive of readmission would be useful in identifying patients at risk. METHODS: We performed a retrospective study using the Nationwide Readmission Database for the year 2016 and 2017. We collected data on hospital readmissions of 17,848 adults who were hospitalized for achalasia and discharged. The 30-day readmission rate as well as the primary cause, mortality rate, in-hospital adverse events, and total hospitalization charges were examined. A cox multivariate regression model was used to identify independent risk factors for 30-day readmission, including the surgical or endoscopic treatment used during the index admission. RESULTS: From 2016 to 2017, the 30-day readmission rate for index admission with achalasia was 15.2%. Of these 15.2%, 34% were readmitted with persistent symptoms of achalasia or treatment-related complications. Older age, higher comorbidity index, possessing private insurance, and those with either pneumatic balloon dilation or no endoscopic/surgical treatment showed higher odds of readmission on multivariate analysis. Those treated with laparoscopic Heller myotomy (LHM) or peroral endoscopic myotomy (POEM) showed lower odds of readmission. There was no difference in rates of readmission between those undergoing POEM or LHM, but mortality rate for readmission was significantly higher for the LHM group. The in-hospital mortality rate and length of stay were significantly higher for readmissions (p < 0.01) than the index admissions. CONCLUSION: Three in 20 patients admitted with achalasia are likely to be readmitted within 30 days of their initial hospitalization, a number which can be higher in untreated patients and in those with multiple comorbidities. Rehospitalizations bear a higher mortality rate than the initial admission and present a burden to the healthcare system.

Comparing cost and outcomes between peroral endoscopic myotomy and laparoscopic heller myotomy.

BACKGROUND: Peroral endoscopic myotomy (POEM) has previously been shown to be equally if not more expensive than laparoscopic Heller myotomy (LHM). We compare perioperative outcomes and charges between POEM and LHM at a single institution. METHODS: Outcomes and charge data of 33 patients who underwent LHM and 126 patients who underwent POEM were analyzed. Patients who did not present electively were excluded. RESULTS: There were no demographic differences between groups. Patients who underwent POEM had a significantly shorter mean operative time and median length of stay (both p < 0.001). Patients who underwent POEM stopped narcotics earlier and had faster return to activities of daily living (both p < 0.05). When adjusted for inflation, POEM incurred less in hospital charges than LHM (35.5 ± 12.8 vs 30.7 ± 10.3 in thousands of US dollars, p = 0.006). CONCLUSIONS: Patients who underwent POEM compared to LHM had significantly better perioperative outcomes. Our results suggest POEM may be the more cost-effective option.

Valuing innovative endoscopic techniques: per-oral endoscopic myotomy for the management of achalasia.

BACKGROUND AND AIMS: Unclear reimbursement for new and innovative endoscopic procedures can limit adoption in clinical practice despite effectiveness in clinical trials. The aim of this study was to determine maximum cost-effective reimbursement for per-oral endoscopic myotomy (POEM) in treating achalasia. METHODS: We constructed a decision-analytic model assessing POEM versus laparoscopic Heller myotomy with Dor fundoplication (LHM) in managing achalasia from a payer perspective over a 1-year time horizon. Reimbursement data were derived from 2017 Medicare data. Responder rates were based on clinically meaningful improvement in validated Eckardt scores. Validated health utility values were assigned to terminal health states based on data previously derived with a standard gamble technique. Contemporary willingness-to-pay (WTP) levels per quality-adjusted life year (QALY) were used to estimate maximum reimbursement for POEM using threshold analysis. RESULTS: Effectiveness of POEM and LHM was similar at 1 year of follow-up (0.91 QALY). Maximum cost-effective reimbursement for POEM was $8033.37 to $8223.14, including all professional and facility fees. This compares favorably with contemporary total reimbursement of 10 to 15 total relative value units for advanced endoscopic procedures. Rates of postprocedural GERD did not affect the preference for POEM compared with LHM, assuming at least 10% cost savings with POEM compared with LHM in cost-minimization analysis, or at least 44% cost savings in cost-effectiveness analysis (WTP = $100,000/QALY). LHM was only preferred over POEM if both procedures were reimbursed similarly, and these findings were primarily driven by lower rates of postprocedural GERD. The rate of conversion to open laparotomy due to perforation or bleeding was infrequent in published clinical practice experience, thus did not significantly affect reimbursement. DISCUSSION: POEM is an example of an innovative and potentially disruptive endoscopic technique offering greater cost-effective value and similar outcomes to the established surgical standard at contemporary reimbursement levels.

Whose patient is it? The path to multidisciplinary management of achalasia.

In the past decade, the introduction of high-resolution manometry and the classification of achalasia into subtypes has made possible to accurately diagnose the disease and predict the response to treatment for its different subtypes. However, even to date, in an era of exponential medical progress and increased insight in disease mechanisms, treatment of patients with achalasia is still rather simplistic and mostly confined to mechanical disruption of the lower esophageal sphincter by different means. In addition, there is partial consensus on what is the best form of available treatments for patients with achalasia. Herein, we provide a comprehensive outlook to a general approach to the patient with suspected achalasia by: 1) defining the modern evaluation process; 2) describing the diagnostic value of high-resolution manometry and the Chicago Classification in predicting treatment outcomes and 3) discussing the available treatment options, considering the patient conditions, alternatives available to both the surgeon and the gastroenterologist, and the burden to the health care system. It is our hope that such discussion will contribute to value-based management of achalasia through promoting a leaner clinical flow of patients at all points of care.

Incidence and costs of achalasia in The Netherlands.

BACKGROUND: Recent reports show increasing incidence of achalasia in some populations. The aim of this study was to estimate incidence, prevalence, and healthcare costs of achalasia in a large cohort in The Netherlands. METHODS: Data were obtained from the largest Dutch healthcare insurance company (±4.4 million insured). Adult achalasia patients were identified between 2006 and 2014 when having an achalasia diagnosis code registered. A total of 907 achalasia patients were identified and included in our database, along with 9068 control patients (non-achalasia patients), matched by age and gender. KEY RESULTS: The mean incidence over the 9-year period was 2.2 per 100 000 persons and the mean prevalence was 15.3 per 100 000 persons. Mean age of achalasia patients was 54 (range 18-98) years. Male to female ratio was 1:1. Socio-economic status distribution was similar in achalasia patients and controls. Prior to the diagnosis, 74% of achalasia patients received proton pump inhibitors and 26% received anti-emetic medication. The first year after diagnosis median total direct medical costs of achalasia patients were €2283 (IQR 969-3044) per year. Patients above the 90th percentile of €4717 were significantly older than other patients below the 90th percentile (mean age 63 vs 57); P = .005. CONCLUSION & INFERENCES: In this large study that used a database comprising about 25% of all inhabitants of The Netherlands, it is confirmed that achalasia affects individuals of both genders and all ages. The costs associated with diagnosis and treatment of new cases of achalasia increase with increasing age.

Achalasia Treatment, Outcomes, Utilization, and Costs: A Population-Based Study from the United States.

BACKGROUND: Randomized trials show that pneumatic dilation (PD) ≥30 mm and laparoscopic myotomy (LM) provide equivalent symptom relief and disease-related quality of life for patients with achalasia. However, questions remain about the safety, burden, and costs of treatment options. STUDY DESIGN: We performed a retrospective cohort study of achalasia patients initially treated with PD or LM (2009 to 2014) using the Truven Health MarketScan Research Databases. All patients had 1 year of follow-up after initial treatment. We compared safety, health care use, and total and out-of-pocket costs using generalized linear models. RESULTS: Among 1,061 patients, 82% were treated with LM. The LM patients were younger (median age 49 vs 52 years; p < 0.01), but were similar in terms of sex (p = 0.80) and prevalence of comorbid conditions (p = 0.11). There were no significant differences in the 1-year cumulative risk of esophageal perforation (LM 0.8% vs PD 1.6%; p = 0.32) or 30-day mortality (LM 0.3% vs PD 0.5%; p = 0.71). Laparoscopic myotomy was associated with an 82% lower rate of reintervention (p < 0.01), a 29% lower rate of subsequent diagnostic testing (p < 0.01), and a 53% lower rate of readmission (p < 0.01). Total and out-of-pocket costs were not significantly different (p > 0.05). CONCLUSIONS: In the US, LM appears to be the preferred treatment for achalasia. Both LM and PD appear to be safe interventions. Along a short time horizon, the costs of LM and PD were not different. Mirroring findings from randomized trials, LM is associated with fewer reinterventions, less diagnostic testing, and fewer hospitalizations.

Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy.

BACKGROUND/AIM: Several uncontrolled studies comparing peroral endoscopic myotomy (POEM) and Heller myotomy have demonstrated equivalent short-term efficacy and safety. However, no data exists rergarding the cost of POEM and how it compares to that of robotic Heller myotomy (RHM). The primary aim of this study was to compare the inpatient charges incurred in patients who underwent POEM or RHM for the treatment of achalasia. PATIENTS AND METHODS: A retrospective single center review was conducted among 52 consecutive POEM patients (2012-2014) and 52 consecutive RHM patients (2009-2014). All RHM procedures included a Toupet fundoplication and were performed via a transabdominal approach. All POEM procedures were performed by a gastroenterologist in the endoscopy unit. Clinical response was defined by improvement of symptoms and decrease in Eckardt stage to ≤I. All procedural and facility charges were obtained from review of the hospital finance records. RESULTS: There was no difference between POEM and RHM with regards to age, gender, symptom duration, achalasia subtype, manometry findings, or Eckardt symptom stage. There was no significant difference in the rate of adverse events (19.2% vs 9.6%, P = 0.26) or the length of stay (1.9 vs. 2.3, P = 0.18) between both groups. Clinical response rate of patients in the POEM groups was similar to that in the RHM group (94.3% vs. 88.5%, P = 0.48). POEM incurred significantly less total charges compared to LHM ($14481 vs. $17782, P = 0.02). CONCLUSIONS: POEM when performed in an endoscopy unit was similar in efficacy and safety to RHM. However, POEM was associated with significant cost savings ($3301/procedure).

Achalasia-an unnecessary long way to diagnosis.

Although achalasia presents with typical symptoms such as dysphagia, regurgitation, weight loss, and atypical chest pain, the time until first diagnosis often takes years and is frustrating for patients and nevertheless associated with high costs for the healthcare system. A total of 563 patients were interviewed with confirmed diagnosis of achalasia regarding their symptoms leading to diagnosis along with past clinical examinations and treatments. Included were patients who had undergone their medical investigations in Germany. Overall, 527 study subjects were included (male 46%, female 54%, mean age at time of interview 51 ± 14.8 years). Dysphagia was present in 86.7%, regurgitation in 82.9%, atypical chest pain in 79%, and weight loss in 58% of patients before diagnosis. On average, it took 25 months (Interquartile Range (IQR) 9-65) until confirmation of correct diagnosis of achalasia. Though, diagnosis was confirmed significantly quicker (35 months IQR 9-89 vs. 20 months IQR 8-53; p < 0.01) in the past 15 years. The majority (72.1%) was transferred to three or more specialists. Almost each patient underwent at least one esophagogastroduodenoscopy (94.2%) and one radiological assessment (89.3%). However, esophageal manometry was performed in 70.4% of patients only. The severity of symptoms was independent with regard to duration until first diagnosis (Eckardt score 7.14 ± 2.64 within 12 months vs. 7.29 ± 2.61 longer than 12 months; P = 0.544). Fifty-five percent of the patients primarily underwent endoscopic dilatation and 37% a surgical myotomy. Endoscopic dilatation was realized significantly faster compared to esophageal myotomy (1 month IQR 0-4 vs. 3 months IQR 1-11; p < 0.001). Although diagnosis of achalasia was significantly faster in the past 15 years, it still takes almost 2 years until the correct diagnosis of achalasia is confirmed. Alarming is the fact that although esophageal manometry is known as the gold standard to differentiate primary motility disorders, only three out of four patients had undergone this diagnostic pathway during their diagnostic work-up. Better education of medical professionals and broader utilization of highly sensitive diagnostic tools, such as high-resolution manometry, are strictly necessary in order to correctly diagnose affected patients and to offer therapy faster.

POEM is a cost-effective procedure: cost-utility analysis of endoscopic and surgical treatment options in the management of achalasia.

BACKGROUND: Achalasia is a rare motility disorder of the esophagus. Treatment is palliative with the goal of symptom remission and slowing the progression of the disease. Treatment options include per oral endoscopic myotomy (POEM), laparoscopic Heller myotomy (LM) and endoscopic treatments such as pneumatic dilation (PD) and botulinum toxin type A injections (BI). We evaluate the economics and cost-effectiveness of treating achalasia. METHODS: We performed cost analysis for POEM, LM, PD and BI at our institution from 2011 to 2015. Cost of LM was set to 1, and other procedures are presented as percentage change. Cost-effectiveness was calculated based on cost, number of interventions required for optimal results for dilations and injections and efficacy reported in the current literature. Incremental cost-effectiveness ratio was calculated by a cost-utility analysis using quality-adjusted life year gained, defined as a symptom-free year in a patient with achalasia. RESULTS: Average number of interventions required was 2.3 dilations or two injections for efficacies of 80 and 61 %, respectively. POEM cost 1.058 times the cost of LM, and PD and BI cost 0.559 and 0.448 times the cost of LM. Annual cost per cure over a period of 4 years for POEM, and LM were consistently equivalent, trending the same as PD although this has a lower initial cost. The cost per cure of BI remains stable over 3 years and then doubles. CONCLUSION: The cost-effectiveness of POEM and LM is equivalent. Myotomy, either surgical or endoscopic, is more cost-effective than BI due to high failure rates of the economical intervention. When treatment is being considered BI should be utilized in patients with less than 2-year life expectancy. Pneumatic dilations are cost-effective and are an acceptable approach to treatment of achalasia, although myotomy has a lower relapse rate and is cost-effective compared to PD after 2 years.

Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study.

BACKGROUND: This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome. The frequency and degree of dysphagia, the effects on quality of life (QoL), and health economy were also examined. METHODS: Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [laparoscopic myotomy (LM) n = 25] or repetitive pneumatic dilatation [pneumatic dilatation (PD) n = 28]. The median observation period was 81.5 months (range 12-131). RESULTS: At the minimal follow-up of 5 years, ten patients (36%) in the dilatation group and two patients (8%) in the myotomy group, including two patients lost to follow-up (one in each arm), were classified as failures (p = 0.016). The cumulative incidence of treatment failures was analyzed by survival statistics. Taking the entire follow-up period into account, a significant difference was observed in favor of the LM strategy (p = 0.02). Although both treatments resulted in significant improvements in dysphagia scores, LM was significantly favored over PD after 1 and 3 years, but not after 5 years. Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years, but the difference was not fully statistically significant at 5 years. Direct medical costs during the entire follow-up period were in median $13,421 for LM as compared to $5,558 for PD (p = 0.001). CONCLUSIONS: This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia, albeit that this surgical strategy is burdened by high initial direct medical costs. www.ClinicalTrials.gov NCT 02086669.

Outcomes of esophagectomy for esophageal achalasia in the United States.

BACKGROUND: While the outcomes after Heller myotomy have been extensively reported, little is known about patients with esophageal achalasia who are treated with esophagectomy. METHODS: This was a retrospective analysis using the Nationwide Inpatient Sample over an 11-year period (2000-2010). Patients admitted with a primary diagnosis of achalasia who underwent esophagectomy (group 1) were compared to patients with esophageal cancer who underwent esophagectomy (group 2) during the same time period. Primary outcome was in-hospital mortality. Secondary outcomes included length of stay, postoperative complications, and total hospital charges. A propensity-matched analysis was conducted comparing the same outcomes between group 1 and well-matched controls in group 2. RESULTS: Nine hundred sixty-three patients with achalasia and 18,003 patients with esophageal cancer underwent esophagectomy. The propensity matched analysis showed a trend toward a higher mortality in group 2 (7.8 vs. 2.9 %, p = 0.08). Postoperative length of stay and complications were similar in both groups. Total hospital charges were higher for the achalasia group ($115,087 vs. $99, 654.2, p = 0.006). CONCLUSION: This is the largest study to date examining outcomes after esophagectomy in patients with achalasia. Based on our findings, esophagectomy can be considered a safe option, and surgeons should not be hindered by a perceived notion of prohibitive operative risk in this patient population.

How does the robot affect outcomes? A retrospective review of open, laparoscopic, and robotic Heller myotomy for achalasia.

BACKGROUND: Robotic techniques are routinely used in urological and gynecological procedures; however, their role in general surgical procedures is limited. A robotic technique has been successfully adopted for a minimally invasive Heller myotomy procedure for achalasia. This study aims to compare perioperative outcomes following open, laparoscopic, and robotic Heller myotomy. METHODS: This study is a multicenter, retrospective analysis utilizing a large administrative database. The University Health System Consortium (UHC) is an alliance between academic medical centers and affiliate hospitals. The UHC database was accessed using International Classification of Diseases, Ninth Revision, Clinical Modification codes and analyzed. RESULTS: 2,683 patients with achalasia underwent Heller myotomy between October 2007 and June 2011. Myotomy was performed by open surgery (OM) in 418 patients, by laparoscopic approach (LM) in 2,116, and by robotic approach (RM) in 149. Comparison between LM and RM groups demonstrated no significant difference in mortality (0.14 vs. 0.0%; P = 1), morbidity (5.19 vs. 4.02%; P = 0.7), intensive care unit (ICU) admission (6.62 vs. 3.36%; P = 0.12), length of stay (LOS) (2.70 ± 3.87 days vs. 2.42 ± 2.69 days; P = 0.34), or 30-day readmission (1.41 vs. 2.84%; P = 0.27). However, hospital costs were significantly lower for the LM group (US $7,441 ± 7,897 vs. US $9,415 ± 5,515; P = 0.0028). Comparison between OM and RM demonstrated significant lower morbidity (9.08 vs. 4.02%; P = 0.02), ICU admission rate (14.01 vs. 3.36%, P = 0.0002), and LOS (4.42 ± 5.25 days vs. 2.42 ± 2.69 days; P = 0.0001). CONCLUSIONS: The perioperative outcomes are superior in LM and RM groups when compared with OM. The outcomes for the LM and RM group are comparable, with the robotic group having slightly improved results, although with increased costs. We conclude that robotic surgery is equivalent in safety and efficacy to laparoscopic Heller myotomy, and feel that the increased cost should come down as surgeons and manufacturers work together on cost reduction strategies.

Impact of minimally invasive surgery in the spectrum of current achalasia treatment options.

Minimally invasive Heller myotomy has evolved the "gold standard" procedure for achalasia in the spectrum of current treatment options. The laparoscopic technique has proved superior to the thoracoscopic approach due to improved visualization of the esophagogastric junction. Operative controversies most recently include the length of the myotomy, especially of its fun-dic part, with respect to the balance between postoperative persistent dysphagia and development of gastroesophageal reflux, as well as the type of the added antireflux procedure. Peri-operative mortality should approach 0%, and favorable long-term results can be achieved in > 90%.

Health economic evaluation of therapeutic strategies in patients with idiopathic achalasia: results of a randomized trial comparing pneumatic dilatation with laparoscopic cardiomyotomy.

BACKGROUND: We have prospectively collected information concerning the costs incurred during the management of patients allocated to either forceful dilatation or to an immediate laparoscopic operation because of newly diagnosed achalasia. METHODS: Fifty-one patients with newly diagnosed achalasia were randomized to either pneumatic dilatation to a diameter of 30-40 mm or to a laparoscopic myotomy to which was added a posterior partial fundoplication. Follow-ups were scheduled at 1, 3, 6, and 12 months after inclusion. At each follow-up visit a study nurse interviewed the patients regarding symptoms and their quality of life (QoL) and a health economic questionnaire was completed. In the latter questionnaire, patients were asked to report the presence and character of contacts with the healthcare system since the last visit. RESULTS: In the dilatation group six patients (23%), including the patient who was operated on because of perforation, were classified as failures during the first 12 months of follow-up compared to one (4%) in the myotomy group (p = 0.047). Five of those classified as failures in the dilatation group subsequently had a surgical myotomy and the sixth patient was treated with repeated dilatations. The patient classified as failure in the myotomy group was treated with endoscopic dilatation. The initial treatment cost and the total costs were significantly higher for laparoscopic myotomy compared to a pneumatic dilatation-based strategy (p = 0.0002 and p = 0.0019, respectively). When the total costs were subdivided into the different resources used, we found that the single largest cost item for pneumatic dilatation was that for hospital stay and that for laparoscopic myotomy was the actual operative treatment (operating room time). The cost-effectiveness analysis, relating to the actual treatment failures, revealed that the cost to avoid one treatment failure (incremental cost-effectiveness ratio) amounted to 9239 euros. CONCLUSION: The current prospective, controlled clinical trial shows that despite a higher level of clinical efficacy of laparoscopic myotomy to prevent treatment failure in newly diagnosed achalasia, the cost effectiveness of pneumatic dilatation is superior, at least when a reasonable time horizon is applied.

The cost of laparoscopic myotomy versus pneumatic dilatation for esophageal achalasia.

BACKGROUND: The two main treatment options for esophageal achalasia are laparoscopic distal esophageal myotomy (LM) and pneumatic dilatation (PD). Our objective was to compare the costs of these management strategies. METHODS: We constructed a decision analytic model consisting of two treatment strategies for patients diagnosed with achalasia. Probabilities of events were systematically derived from a literature review, supplemented by expert opinion when necessary. Costs were estimated from the perspective of a third-party payer and society, including both direct and indirect costs. Future costs were discounted at a rate of 5.5% over a time horizon of 5 and 10 years. Uncertainty in the probability estimates was incorporated using probabilistic sensitivity analyses. We tested uncertainty in the model by modifying key assumptions and repeating the analysis. RESULTS: From the societal perspective, the expected cost per patient was $10,789 (LM) compared with $5,315 (PD) five years following diagnosis, and $11,804 (LM) compared with $7,717 (PD) after 10 years. The 95% confidence interval of the incremental cost per patient treated with LM was ($5,280, $5,668) after five years, and ($3,863, $4,311) after 10 years. The incremental cost of LM was similar from the third-party payer perspective and in the secondary model analyzed. CONCLUSIONS: Initial LM is a more costly management strategy under all clinically plausible scenarios tested in this model. Further research is needed to determine patients' preferences for the two treatment modalities, and society's willingness to bear the incremental cost of LM for those who choose it.

Patient perception of a clinical pathway for laparoscopic foregut surgery.

Clinical pathways have been implemented for a number of surgical procedures, yet few data are available that explore the patients' perception of these changes in clinical practice. A clinical pathway was developed for laparoscopic fundoplication, Heller myotomy, and paraesophageal hernia repair. Data collected from a cohort of patients undergoing surgery with the pathway over a 12-month period was compared with a group of patients operated on in the 12 months prior to pathway implementation. A questionnaire examining patient-based outcomes and perceptions was completed 6 weeks after surgery. From November 2001 through November 2003, 49 patients underwent primary laparoscopic foregut surgery, 27 before and 22 after pathway implementation. There were no differences in age, gender, procedure, or ASA Class. Parenteral opioid use diminished significantly without compromising the patients' perceived pain control. The number of patients undergoing postoperative investigations diminished, as did length of stay. Of the 20 post-pathway patients completing satisfaction questionnaires, 95% were satisfied or very satisfied with their care during admission. Pathway implementation resulted in a significant reduction in direct postoperative hospital costs. A clinical pathway for laparoscopic foregut surgery was successfully implemented in a single-payer system, resulting in decreased utilization of hospital resources while maintaining high patient satisfaction.

Heller myotomy vs Heller myotomy plus Dor fundoplication: cost-utility analysis of a randomized trial.

BACKGROUND: The addition of a Dor antireflux procedure reduces the risk of pathologic gastroesophageal reflux (GER) by ninefold following laparoscopic Heller myotomy for achalasia. It is not clear, however, how these benefits compare with the increased cost of the fundoplication. The objective of this study was to estimate the cost-effectiveness of Heller myotomy plus Dor fundoplication compared with Heller alone in patients with achalasia. METHODS: We conducted a cost-utility analysis using the Markov simulation model to examine the two treatment alternatives. The model estimated the total expected costs of each strategy over a 10-year time horizon. Data for the model were derived from our randomized clinical trial. The strategies were compared using the method of incremental cost-effectiveness analysis. RESULTS: The incidence of pathologic GER was 47.6% (10 of 21 patients) in the Heller group and 9.1% (2 of 22 patients) in the Heller plus Dor group using an intention-to-treat analysis (p = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GERD (relative risk 0.11; 95% confidence interval 0.02-0.59; p = 0.01). The cost of surgery was significantly higher for Heller plus Dor than for Heller alone (mean difference $942; p = 0.04), secondary to a longer operating room time (mean difference 40 min; p = 0.01). At a time horizon of 10 years, when proton pump inhibitor (PPI) therapy costs are considered, the cost-utility analysis demonstrates that Heller plus Dor surgery is associated with a total cost of $6,861 per patient and a quality-adjusted life expectancy of 9.9 years, whereas Heller-alone surgery is associated with a cost of $9,541 per patient and a quality-adjusted life expectancy of 9.5 years. CONCLUSIONS: In achalasia patients, Heller myotomy plus Dor fundoplication is preferred to Heller alone because it is both more effective in preventing postoperative GERD and more cost-effective at a time horizon of 10 years.

Botulinum toxin injection versus laparoscopic myotomy for the treatment of esophageal achalasia: economic analysis of a randomized trial.

BACKGROUND: The treatment of esophageal achalasia is still controversial: current therapies are palliative and aim to relieve dysphagia by disrupting or relaxing the lower esophageal sphincter muscle fibers with botulinum toxin. The aim of this study was to compare the clinical and economic results of two such treatments: laparoscopic myotomy and botulinum toxin injection. METHODS: A total of 37 patients with esophageal achalasia were randomly assigned to receive laparoscopic myotomy (20) or two Botox injections 1 month apart (17). All patients were treated at the same hospital and were part of a larger multicenter study. Symptom score, lower esophageal sphincter pressure, and esophageal diameter at barium swallow were compared. The economic analysis was performed considering only the direct costs (cost per treatment and cost effectiveness, i.e., cost per patient healed). RESULTS: Mortality and morbidity were nil in both groups. The actuarial probability of being asymptomatic at 2 years was 90% for surgery and 34% for Botox (p < 0.05). The initial cost was lower for Botox (1,245 Euros) than for surgery (3,555 Euros), but when cost effectiveness at 2 years was considered, this difference nearly disappeared: Botox 3,364 Euros, surgery 3,950 Euros. CONCLUSION: Botox is still the least costly treatment, but the minimal difference in the longer term does not justify its use, given that surgery is a risk-free, definitive treatment.

Cost-assessment of alternative management strategies for achalasia.

Achalasia is a primary oesophageal motor disorder characterised by the abnormal relaxation of the lower oesophageal sphincter (LES) and absent oesophageal peristalsis. It is a rare disease, with an estimated incidence of approximately 1/100,000 and a prevalence close to 10/100,000 [1]. Its exact aetiology remains unknown. Autoimmune, infectious, degenerative and hereditary processes have all been proposed as factors that lead to a chronic inflammatory response in the myenteric plexus, thus resulting in selective loss of inhibitory neurons [2] and failure of the LES to relax and aperistalsis in the body of the oesophagus. The most common symptoms of achalasia are dysphagia for solids and liquids, regurgitation, chest pain, weight loss and heartburn in > 90 approximately 75, 40 - 50, approximately 60, approximately 40%, respectively [3,4]. The diagnosis is based on symptoms, barium swallow and manometry. A barium oesophagram typically shows a dilated oesophagus that tapers into a 'bird-beak' at the gastro-oesophageal junction with lack of normal peristalsis on fluoroscopic evaluation. The characteristic manometric features of achalasia are abnormal LES relaxation and aperistalsis; additionally, the LES pressure is frequently high, but can also be normal. Current practice of medicine is faced with rising healthcare costs and limited budgets [5]. We are therefore confronted with an increasing demand to justify the value of our therapeutic interventions, not only from the risk/benefit standpoint but also from the cost perspective [6,7].

Pneumatic dilation versus intrasphincteric botulinum toxin injection in the treatment of achalasia cardia in India: an economic analysis.

BACKGROUND: Pneumatic dilation (PD) is an established therapeutic option for achalasia cardia. Recently, intrasphincteric botulinum toxin (BT) has been used to treat achalasia cardia in view of its simplicity and safety. However, it is likely to be a costly treatment as repeated injections are often needed due to its short-lasting effect. No economic analysis of PD and BT strategies has been done in India. METHODS: A decision tree was constructed using decision analysis software (DATA 4.0; TreeAge Software, Williamstown, MA, USA). Probability estimates for BT injection and PD (and, in case of failure, surgery) were obtained from published literature, preferably from India. Direct "out-of-pocket" costs (in Indian rupees; currently US$ 1 = 49 rupees approximately) for baseline analysis were obtained from our hospital and from some private hospitals. Sensitivity analysis was done using a wide range of probability and cost estimates. RESULTS: Intrasphincteric BT injection strategy was more costly at 18,520 rupees per patient than PD strategy (4,568 rupees), yielding an incremental cost of 13,952 rupees per patient successfully treated. Sensitivity analysis supported the conclusions of the baseline analysis. CONCLUSION: Primary intrasphincteric BT injection strategy was costlier than primary PD strategy in the treatment of achalasia cardia in India, and therefore cannot be justified despite its efficacy, relative ease of administration and safety.