Cost-Effectiveness of Open vs. Endoscopic Repair of Zenker's Diverticulum.

OBJECTIVE: To evaluate the cost-effectiveness of open versus endoscopic surgical repair of Zenker's diverticulum. METHODS: In this study, an economic decision tree was utilized to compare the cost-effectiveness of open surgery compared to endoscopic surgery. The primary outcome in this analysis was the incremental cost-effectiveness ratio (ICER) that was calculated based on the economic decision tree. The probability of post-operative esophageal perforation complications, revision rates, and effectiveness of each procedure along with associated costs were extracted to construct the decision tree. Univariate sensitivity analysis was then utilized to determine how changes in esophageal perforation rate affect the cost-effectiveness of each surgical approach. RESULTS: The ICER of open surgery for Zenker's diverticulum was $67 877, above most acceptable willingness to pay (WTP) thresholds. Additionally, if the probability of esophageal perforation with endoscopic surgery is above 5%, then open surgery becomes a more cost-effective option. Probabilistic sensitivity analysis using Monte Carlo simulations also showed that at the WTP thresholds of $30 000 and $50 000, endoscopic surgery is the most cost-effective method with 83.9% and 67.6% certainty, respectively. CONCLUSION: Open surgery and endoscopic surgery are 2 treatment strategies for Zenker's diverticulum that each have their own advantages and disadvantages that can complicate the decision-making process. With no previous cost-effectiveness analysis of open versus endoscopic surgery for Zenker's diverticulum, our results support the endoscopic approach at most common WTP thresholds. Particularly with the current focus on rising healthcare costs, our results can serve as an important adjunct to medical decision-making for patients undergoing treatment for Zenker's diverticulum.

Assessment and treatment of hypopharyngeal and cervical esophagus injury: Literature review.

Wounds and perforations of the upper gastrointestinal tract are serious and life-threatening. The hypopharynx and cervical esophagus, by their respective anatomical positions, are exposed to traumatic wounds, most often during diagnostic tests, but management such wounds remains a subject of discussion. The present article analyzes the current state of knowledge on epidemiology, etiologies, risk factors, diagnostic management, prognostic factors and available treatments.

Valuing innovative endoscopic techniques: endoscopic suturing to prevent stent migration for benign esophageal disease.

BACKGROUND AND AIMS: Reimbursement often presents a significant barrier to widespread adoption of innovative endoscopic devices. We aimed to determine the value (defined as cost savings to a payer) of endoscopic suturing devices in preventing the migration of esophageal stents placed for benign esophageal diseases. METHODS: A decision-analytic model was constructed from a payer perspective evaluating fully covered metal stent placement for benign esophageal diseases (fistula, leak, perforation, or stricture) in a hospital outpatient setting. The model compared 2 strategies: endoscopic suturing to anchor the stent or no suture. Health care outcomes and costs were derived from published systematic reviews and national databases (U.S. Food and Drug Administration Manufacturer and User Facility Device Experience [MAUDE] for safety data; 2018 Medicare Physician Fee Schedule and Provider Utilization and Payment Data databases for reimbursement data). RESULTS: From a payer perspective, reimbursement for care increased by US$1487.98 without endoscopic suturing per patient, compared with US$621.06 with endoscopic suturing, to cover the risk of stent migration in addition to usual professional and facility reimbursement for stent placement. Thus, an average cost saving of US$866.92 per patient was achieved with endoscopic suturing to reduce stent migration risks. Cost savings associated with suturing ranged from US$147.48 to US$1586.36 per patient, based on the indication for the procedure in sensitivity analysis. Cost savings increased with higher rates of technical success in suture placement. CONCLUSIONS: Creating a defined reimbursement pathway for endoscopic suture fixation of a stent for the treatment of benign esophageal diseases appears to be justified from a payer perspective.

Intraluminal mesh erosion after prosthetic hiatoplasty: incidence, management, and outcomes.

The purpose of the present study was to analyze the incidence, presentation, and treatment of mesh erosion into the esophagus or stomach after mesh hiatoplasty for primary or recurrent hiatal hernia. The study is a single-institution, retrospective cohort study. From November 2005 to December 2016, 122 patients consecutively underwent mesh hiatoplasty in our department, 91 during a primary surgery and 31 for a surgical revision. Follow-up was complete for 74%. Six patients of this series were evaluated for mesh erosion. In all cases, the mesh employed was a dual-type circular one. The mean time from surgery to erosion diagnosis was 42 months (median time 46 months, interquartile range 64 months). Three patients were asymptomatic, 1 had dysphagia, 1 had reflux recurrence, and 1 presented with mediastinal perforation. The absolute erosion rate was 4.9%. For patients under surveillance, the erosion rate was 6.6%, or 1 case every 48 patient-years of follow-up. The erosion rate after primary surgery was 3% or 1/86 patient-years of follow-up, and after surgery for recurrent hernia recurrence was 16% or 1/29 patient-years of follow-up. The mesh was left in place in 2 asymptomatic cases and endoscopically removed in 2 cases. Two patients submitted to surgical removal of the mesh, and only one needed a limited gastroesophageal junction resection for a conversion to a Roux-en-Y gastric bypass. The patient with esophageal perforation submitted to mesh removal, drainage, and an anterior partial fundoplication. There was no mortality. Mesh erosion after hiatoplasty presents with a high rate, especially when hiatoplasty is performed during revisional antireflux surgery. Most patients can be managed conservatively, and endoscopic removal should be considered a first-line therapy.

To Pull or to Scope: A Prospective Safety and Cost-effectiveness of Percutaneous Endoscopic Gastrostomy Tube Replacement Methods.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) tubes are routinely used as an effective method for providing enteral nutrition. The need for their exchange is common. GOALS: We aimed to examine the comparative safety and cost-effectiveness of PEG percutaneous counter-traction "pulling" approach or by endoscopically guided retrieval. STUDY: A prospective 215 consecutive patients undergoing PEG tube insertion were included. Fifty patients in total were excluded. The patients were examined for demographics, indications for PEG replacement, as well as procedure-related complications and procedural costs. RESULTS: Group A included 70 patients (42%) with PEG tubes replaced endoscopically, whereas group B included 95 patients (58%) with PEG tubes replaced percutaneously. Baselines characteristics were similar between the 2 groups (P=NS). Group A and group B had similar immediate complication rates including 4 patients in group B (4.2%), and 2 patients in group A (2.8%) (P=0.24). Complications included a conservatively managed esophageal perforation, and self-limited mild bleeding groups A and group B, respectively. The mean procedure cost was significantly higher in the endoscopic PEG replacement group compared with the percutaneous PEG replacement group ($650 vs. $350, respectively). CONCLUSION: Percutaneous PEG replacement appears as safe as endoscopic PEG replacement, however, percutaneous tube exchange is less costly.

Antireflux Surgery in the USA: Influence of Surgical Volume on Perioperative Outcomes and Costs-Time for Centralization?

BACKGROUND: Few studies have analyzed the relationship between surgical volume and outcomes after antireflux procedures. The aim of this study was to determine the effect of surgical volume on postoperative results and costs for patients undergoing surgery for gastroesophageal reflux disease. METHODS: We analyzed the National Inpatient Sample (period 2000-2013). Adult patients (≥18 years old) with gastroesophageal reflux disease who underwent fundoplication were included. Hospital surgical volume was determined using the 30th and 60th percentile cut points using weighted discharges and categorized as low (<10 operations/year), intermediate (10-25 operations/year), or high (>25 operations/year). We performed multivariable logistic regression models to assess the effect of surgical volume on patient outcomes. RESULTS: The studied cohort comprised 75,544 patients who had antireflux surgery. When operations performed at low-volume hospitals, postoperative bleeding, cardiac failure, renal failure, respiratory failure, and inpatient mortality were more common. In intermediate-volume hospitals, patients were more likely to have postoperative infection, esophageal perforation, bleeding, cardiac failure, renal failure, and respiratory failure. The length of hospital stay was longer at low- and intermediate-volume hospitals (1.08 and 0.55 days longer, respectively). There was an increase in charges of 5120 dollars per patient at low-volume centers, and 4010 dollars per patient at intermediate-volume centers. CONCLUSIONS: When antireflux surgery is performed at high-volume hospitals, morbidity is lower, length of hospital stay is shorter, and costs for the healthcare system are decreased.

Clasificación evolutiva y algoritmo de tratamiento quirúrgico de la mediastinitis aguda por perforación esofágica / Evolutionary classification and surgical treatment algorithm for acute mediastinitis through esophageal perforation

Introducción: la mediastinitis aguda constituye una complicación grave de la perforación esofágica. No existen clasificaciones ni pautas generales para su tratamiento. Objetivo: desarrollar una clasificación evolutiva, y un algoritmo de tratamiento quirúrgico. Métodos: se efectuó una investigación en el Hospital Provincial Saturnino Lora, de Santiago de Cuba, desde 1990 hasta el 2014. Se utilizó la prueba chi cuadrado de homogeneidad para la validación de los resultados, así como el porcentaje como medida de resumen y el calcula de las tasas de incidencia y de mortalidad. El estudio incluyó dos diseños metodológicos: el primero, de desarrollo tecnológico, para la elaboración de la clasificación y el algoritmo de tratamiento, y un cuasiexperimento, para la aplicación del algoritmo. Resultados: se identificó que en los estados más severos de la mediastinitis aguda, la mortalidad es más elevada. La carga de mortalidad para el primer grupo de pacientes fue del 77,7 por ciento y descendió al 22,3 por ciento en el grupo tratado con el algoritmo (decremento del riesgo del 64,8 por ciento). Conclusiones: la clasificación evolutiva pauta la implementación del algoritmo de tratamiento quirúrgico de la enfermedad. La aplicación del algoritmo de tratamiento quirúrgico de la mediastinitis aguda por perforación esofágica permite disminuir la carga de morbilidad. En consecuencia, disminuye de forma relevante el riesgo de morir por esta enfermedad(AU)

Introduction: acute mediastinitis is a serious complication of esophageal perforation. There are no classifications or general guidelines for its treatment. Objective: to develop an evolutionary classification and a surgical treatment algorithm. Methods: aresearch was carried out at Saturnino Lora Provincial Hospital in Santiago de Cuba, from 1990 to 2014. The chi-square homogeneity test was used for the validation of the results, as well as the percentage as a summary measure and the calculation of incidence rates and mortality. The study included two methodological designs: the first, technological development, for the elaboration of the classification and the treatment algorithm, and a quasi-experiment for the application of the algorithm. Results: in the more severe states of acute mediastinitis, mortality was identified as higher. The mortality load for the first group of patients was 77.7 percent and decreased to 22.3 percent in the group treated with the algorithm (risk reduction of 64.8 percent). Conclusions: the evolutionary classification guides the implementation of the surgical treatment algorithm of the disease. The application of the surgical treatment algorithm of acute mediastinitis through esophageal perforation allows reducing the burden of morbidity. Consequently, the risk of dying from this disease decreases significantly(AU)

Epidemiology, diagnosis, and management of esophageal perforations: systematic review.

We performed a systematic review of epidemiological, diagnostic, and therapeutic outcomes of esophageal perforations. A systematic review was performed in PubMed database using the key-phrase 'esophageal perforation'. All studies regarding acute esophageal perforations were reviewed and parameters of epidemiology, diagnosis, and management published in the literature from 2005 up to 2015 were included in the study. Studies of postoperative esophageal leaks were excluded. Two researchers performed individually the research, while quality assessment was performed according to GRADE classification. Main outcomes and exposure were overall mortality, perforation-to-admission interval, anatomical position, cause, prevalent symptom at admission, diagnostic tests used, type of initial management (conservative or surgery), healing rate, and fistula complication. There were 1319 articles retrieved, of which 52 studies including 2,830 cases finally met inclusion criteria. Mean duration of study period was 15.2 years. Mean patient age was 58.4 years. Out of 52 studies included, there were 43 studies of very low or low quality included. The overall mortality rate according to extracted data was 13.3% (n = 214, 1,644 patients, 39 studies). Admission before 24 hours was reported in 58.1% of patients (n = 514). Position was thoracic in 72.6% of patients (n = 813, 1,120 patients, 20 studies). Mean cause of perforation was iatrogenic in 46.5% of patients (n = 899, 1,933 patients, 40 studies). Initial management was conservative in 51.3% of cases (n = 904, 1,762 patients, 41 studies) CT confirmed diagnosis in 38.7% of overall cases in which it was used as imaging diagnostic procedure (n = 266), X-ray in 36.6% (n = 231), and endoscopy in 37.4% (n = 343). Sepsis on admission was observed in 23.3% of cases (209 out of 898 patients, 16 studies). The present systematic review highlighted the significant proportion of cases diagnosed with delay over 24 hours, mortality rates ranging over 10% and no consensus regarding optimal therapeutic approach and optimal diagnostic management. As esophageal perforation represents a high-risk clinical condition without consensus regarding optimal management, there should be large multicenter prospective studies or Randomized Controlled Trial (RCT)s performed in order to advance diagnostic and therapeutic approach of such challenging pathology.

Cost varies with procedure type in pediatric GI foreign bodies.

BACKGROUND/PURPOSE: In pediatric cases of ingested foreign bodies, gastrointestinal foreign bodies (GIFB) have distinct factors contributing to longer and more costly hospitalizations. METHODS: Patients admitted with ingested foreign bodies were identified in the Kids' Inpatient Database (1997-2009). RESULTS: Overall, 7480 cases were identified. Patients were most commonly <5years of age (44%), male (54%), and Caucasian (57%). A total of 2506 procedures were performed, GI surgical procedures (57%) most frequently, followed by GI endoscopy (24%), esophagoscopy (11%), and bronchoscopy - in cases of inhaled objects (9%). On multivariate analysis, length of stay increased when cases were associated with intestinal obstruction (OR=1.7), esophageal perforation (OR=40.0), intestinal perforation (OR=4.4), exploratory laparotomy (OR=1.9), and gastric (OR=2.9), small bowel (OR=1.5), or colon surgery (OR=2.5), all p<0.02. Higher total charges (TC) were associated with intestinal obstruction (OR=2.0), endoscopy of esophagus (OR=1.8), stomach (OR=2.1), or colon (OR=3.3), and exploratory laparotomy (OR=3.6) or surgery of stomach (OR=5.6), small bowel (OR=6.4), or colon (OR=3.4), all p<0.001. CONCLUSIONS: Surgical or endoscopic procedures are performed in approximately one third of GIFB cases. Associated psychiatric disorder or self-inflicted injury is seen in more than 20% of GIFB patients. Resource utilization is determined heavily by associated diagnoses and treatment procedures.

Brief Report: Risk of Gastrointestinal Perforation Among Rheumatoid Arthritis Patients Receiving Tofacitinib, Tocilizumab, or Other Biologic Treatments.

OBJECTIVE: To evaluate gastrointestinal (GI) perforation in rheumatoid arthritis (RA) patients receiving tofacitinib, tocilizumab, or other biologic agents. METHODS: Using health plan data from 2006 through 2014, RA patients without prior GI perforation were identified. Those in whom treatment with tofacitinib or a biologic agent was being initiated were followed up for incident GI perforation with hospitalization. Crude incidence rates were calculated by exposure. Adjusted Cox proportional hazards models were used to evaluate the association between GI perforation and exposures. Hazard ratios (HRs) with 95% confidence intervals (95% CIs) were calculated. RESULTS: A cohort of 167,113 RA patients was analyzed. Among them, 4,755 began treatment with tofacitinib, 11,705 with tocilizumab, 115,047 with a tumor necrosis factor inhibitor (TNFi), 31,214 with abatacept, and 4,392 with rituximab. Compared to TNFi recipients, abatacept recipients were older, tofacitinib and rituximab recipients were younger, and tocilizumab recipients were similar in age. Patients beginning treatment with a non-TNFi agent were more likely to have previously received biologic agents than patients beginning treatment with a TNFi. The incidence of GI perforation per 1,000 patient-years was 0.86 (tofacitinib), 1.55 (tocilizumab), 1.07 (abatacept), 0.73 (rituximab), and 0.83 (TNFi). Most perforations occurred in the lower GI tract: the incidence of lower GI tract perforation per 1,000 patient-years was 0.86 (tofacitinib), 1.26 (tocilizumab), 0.76 (abatacept), 0.48 (rituximab), and 0.46 (TNFi). Lower GI tract perforation risk was significantly elevated with tocilizumab treatment, and numerically elevated with tofacitinib treatment, versus treatment with TNFi. Adjusted HRs were 2.51 (95% CI 1.31-4.80) for tocilizumab and 1.94 (95% CI 0.49-7.65) for tofacitinib. Older age (HR 1.16 per 5 years [95% CI 1.10-1.22]), diverticulitis/other GI conditions (HR 3.25 [95% CI 1.62-6.50]), and prednisone use at >7.5 mg/day (HR 2.29 [95% CI 1.39-3.78]) were associated with lower GI tract perforation. The incidence of upper GI tract perforation was similar among all drug exposures. CONCLUSION: The risk of lower GI tract perforation associated with tocilizumab treatment, and possibly tofacitinib treatment, is elevated compared to that associated with TNF blockade.

An Assessment of the Optimal Time for Removal of Esophageal Stents Used in the Treatment of an Esophageal Anastomotic Leak or Perforation.

BACKGROUND: Esophageal stent for the treatment of a perforation or anastomotic leak has been shown to be effective and safe. However, the optimal timing for stent removal is in question. This purpose of this investigation was to identify a time for stent removal in patients treated for an acute perforation or anastomotic leak that resulted in sealing of the leak while minimizing the incidence of stent-related complications. METHODS: Patients undergoing esophageal stent placement for the treatment of an acute perforation or intrathoracic anastomotic leak were identified from a single institution's prospectively collected database. Patient outcomes were recorded and analyzed. Complications were segregated by stent dwell time. RESULTS: During the study period, 162 patients underwent esophageal stent placement for an acute perforation (n = 117) or anastomotic leak (n = 45). Patients whose stent was removed in less than 28 days after placement for an acute perforation realized a stent complication rate that was independently reduced by 39% (odds ratio, 0.61; 95% confidence interval, 0.54 to 0.78; p < 0.01), whereas patients whose stent was removed in less than 14 days after placement for an acute perforation realized a stent complication rate that was independently reduced by 56% (odds ratio, 0.44; 95% confidence interval, 0.38 to 0.69; p < 0.001). CONCLUSIONS: Endoluminal esophageal stent placement is a safe and effective treatment for patients with an acute esophageal perforation or intrathoracic anastomotic leak after esophagectomy. Removal of stents at 2 weeks for anastomotic leak or 4 weeks for perforation has the potential to significantly decrease the incidence of complications associated with stent use.

Full-thickness esophageal perforation after fluoroscopic balloon dilation: incidence and management in 820 adult patients.

OBJECTIVE: The purpose of this study is to investigate the incidence, management, and outcomes of esophageal perforation after fluoroscopic balloon dilation in 820 adult patients with esophageal diseases. MATERIALS AND METHODS: Between December 1990 and April 2014, a total of 820 adult patients (age range, 21-93 years) underwent 1869 fluoroscopic balloon dilation sessions (mean, 2.3 sessions/patient; range, 1-29 sessions/patient) for esophageal diseases. We retrospectively reviewed the prospectively collected medical records and images of these patients and collected the data of patients who developed esophageal perforations after fluoroscopic balloon dilation. RESULTS: During this period, 12 patients (six men and six women; mean age, 51 years; age range, 28-69 years) developed perforations. The perforation rate was 1.5% per patient and 0.6% per dilation. Among the first eight patients, four who were treated with surgery had perforations 2 cm or larger, and the other four who underwent fasting, parenteral alimentation, and treatment with antibiotics had perforations smaller than 2 cm. The last four patients underwent stent placement immediately after the diagnosis, regardless of the perforation's size. The median hospital stay was 11.5 days. CONCLUSION: Fluoroscopic balloon dilation of esophageal diseases is a safe procedure with a low perforation rate. A perforation size greater than 2 cm is considered large and requires aggressive treatment. Although the number of patients with esophageal perforation we treated is relatively small and further clinical trials are needed, temporary stent placement seems to be an initial choice in the management of esophageal perforations after fluoroscopic balloon dilation.

A propensity-matched comparison of cost and outcomes after esophageal stent placement or primary surgical repair for iatrogenic esophageal perforation.

OBJECTIVES: Esophageal stent placement has been shown to be a safe and effective treatment for acute esophageal perforation in selected patients. However, a comparison between surgical repair and stent placement has not been reported. This investigation compares the outcomes and costs of the 2 treatment modalities. METHODS: The Premiere database for a single health system's hospitals was used to identify patients undergoing treatment for an acute intrathoracic esophageal perforation over a 4-year period. Patient cohorts for stent placement or surgical repair were formed using propensity matching. The 2 cohorts were compared for length of stay, morbidity, mortality, and costs. RESULTS: Between 2009 and 2012, 60 patients undergoing esophageal stent placement or surgical repair were propensity matched. Mean patient age and Charlson comorbidity scores did not differ significantly (P = .4 and P = .4, respectively). Significant differences in morbidity (4% vs 43%; P = .02), mean length of stay (6 vs 11 days; P = .0007), time to oral intake (3 vs 8 days; P = .0004), and cost ($91,000 vs $142,000; P < .0001) were identified in the esophageal stent cohort when compared with patients receiving surgical repair. Operative mortality did not differ significantly. CONCLUSIONS: Esophageal stent placement for the treatment of an acute esophageal perforation seems to be as effective as surgical repair when compared between propensity-matched patients. However, stent placement resulted in a shorter length of stay, lower rates of morbidity, and lower costs when compared with traditional surgical repair.

Esophageal perforation management using a multidisciplinary minimally invasive treatment algorithm.

BACKGROUND: The surgical management of esophageal perforation (EP) often results in mortality and significant morbidity. Recent less invasive approaches to EP management include endoscopic luminal stenting and minimally invasive surgical therapies. We wished to establish therapeutic efficacy of minimally invasive therapies in a consecutive series of patients. STUDY DESIGN: An IRB-approved retrospective review of all acute EPs between 2007 and 2013 at a single institution was performed. Patient demographic, clinical outcomes data, and hospital charges were collected. RESULTS: We reviewed 76 consecutive patients with acute EP presenting to our tertiary care center. Median age was 64 ± 16 years (range 25 to 87 years), with 50 men and 26 women. Ninety percent of EPs were in the distal esophagus, with 67% of iatrogenic perforations occurring within 4 cm of the gastroesophageal junction. All patients were treated within 24 hours of initial presentation with a removable covered esophageal stent. Leak occlusion was confirmed within 48 hours of esophageal stent placement in 68 patients. Median lengths of ICU and hospital stay were 3 and 10 days, respectively (range 1 to 86 days). One-third of the patients were noted to have prolonged intubation (>7 days) and pneumonia that required a tracheostomy. One in-hospital (1.3%) mortality occurred within 30 days. Median total hospital charges for EP were $85,945. CONCLUSIONS: Endoscopically placed removable esophageal stents with minimally invasive repair of the perforation and feeding access is an effective treatment method for patients with EP. This multidisciplinary method enabled us to care for severely ill patients while minimizing morbidity and mortality and avoiding open esophageal surgery.

Diagnostic endoscopic ultrasonography: assessment of safety and prevention of complications.

Endoscopic ultrasonography (EUS) has gained wide acceptance as an important, minimally invasive diagnostic tool in gastroenterology, pulmonology, visceral surgery and oncology. This review focuses on data regarding risks and complications of non-interventional diagnostic EUS and EUS-guided fine-needle biopsy (EUS-FNB). Measures to improve the safety of EUS und EUS-FNB will be discussed. Due to the specific mechanical properties of echoendoscopes in EUS, there is a low but noteworthy risk of perforation. To minimize this risk, endoscopists should be familiar with the specific features of their equipment and their patients' specific anatomical situations (e.g., tumor stenosis, diverticula). Most diagnostic EUS complications occur during EUS-FNB. Pain, acute pancreatitis, infection and bleeding are the primary adverse effects, occurring in 1% to 2% of patients. Only a few cases of needle tract seeding and peritoneal dissemination have been reported. The mortality associated with EUS and EUS-FNB is 0.02%. The risks associated with EUS-FNB are affected by endoscopist experience and target lesion. EUS-FNB of cystic lesions is associated with an increased risk of infection and hemorrhage. Peri-interventional antibiotics are recommended to prevent cyst infection. Adequate education and training, as well consideration of contraindications, are essential to minimize the risks of EUS and EUS-FNB. Restricting EUS-FNB only to patients in whom the cytopathological results may be expected to change the course of management is the best way of reducing the number of complications.

Evaluation of the incidence of esophageal complications associated with balloon dilation and their management in patients with malignant esophageal strictures.

OBJECTIVE: The objective of this study was to investigate the incidence of esophageal complications associated with balloon dilation and their management in patients with malignant esophageal strictures. MATERIALS AND METHODS: Fluoroscopically guided esophageal balloon dilation was performed in 89 patients with malignant esophageal strictures during a period of 15 years. Inclusion criteria were patients with unresected esophageal or gastric carcinoma showing short-segment stricture (≤4 cm) at the esophagogastric junction; patients who had previously received chemotherapy, radiation therapy, or both to manage malignant strictures; or patients who were scheduled for chemotherapy or radiation therapy to manage malignant strictures. Of these patients, 72 had esophageal cancer and 17 had stomach cancer. Esophageal rupture was categorized as intramural, transmural, or transmural with mediastinal leakage. RESULTS: A total of 120 procedures were performed, with each patient undergoing one to four procedures. Esophageal rupture occurred in 13 patients (15%): eight with intramural rupture, four with transmural rupture, and one with transmural rupture with mediastinal leakage. Improvements in dysphagia score were observed in 76 of 89 patients (85%) after balloon dilation. All esophageal ruptures were detected immediately after the procedure. Intramural and transmural ruptures were treated conservatively, whereas transmural rupture with mediastinal leakage was treated by temporary stent placement. CONCLUSION: The overall prevalence of esophageal rupture was 15%. All intramural and transmural ruptures were successfully managed conservatively, whereas transmural rupture with mediastinal leakage was treated by temporary stent placement. We found no relationship between rupture incidence and balloon diameter.

Fluoroscopically guided balloon dilation of benign esophageal strictures: incidence of esophageal rupture and its management in 589 patients.

OBJECTIVE: The purpose of this article is to investigate the incidence and management of esophageal rupture caused by balloon dilation in patients with benign esophageal strictures. MATERIALS AND METHODS: Fluoroscopically guided esophageal balloon dilation was performed on 589 patients with benign esophageal strictures during an 18-year period. The strictures had a range of causes: postoperative anastomotic stricture, corrosive stricture, postradiation stricture, esophageal achalasia, esophageal reflux, congenital stricture, esophageal web, esophageal ulcer, medication fibrosis, chronic inflammation, and posttraumatic stricture (in descending order of frequency). Esophageal rupture was assigned to one of three categories: type 1 was intramural, type 2 was transmural with a contained leak, and type 3 was transmural with an uncontained mediastinal leakage. RESULTS: A total of 1421 procedures were performed in 589 patients, with each patient undergoing 1-29 procedures. The technical success rate was 99.8%, and the clinical success rate was 91.7%. Patients with corrosive stricture underwent the highest number of procedures (mean, 4.38 procedures). The incidence of esophageal rupture was 14.7%. All esophageal ruptures were detected immediately after the procedure. Most ruptures (98.6%) were types 1 and 2 and were successfully managed conservatively. Only 1.4% of the ruptures were type 3 and required active management. One of the type 3 ruptures was successfully treated with a retrievable covered stent. Two patients with type 3 ruptures (0.96% of ruptures) underwent surgery and were successfully treated. The rupture rate was not statistically related to the diameter of balloon used. CONCLUSION: The incidence of esophageal rupture after fluoroscopically guided esophageal balloon dilation was 14.7%. Almost all ruptures were type 1 or 2 and were successfully managed conservatively. Only 1.4% of the ruptures were type 3 and required active management. There was no procedure-related mortality in any patient. Therefore, in spite of the high incidence of ruptures, fluoroscopically guided balloon dilation is a safe procedure, particularly if a rupture is identified early and managed appropriately.

Validation of ICD-9-CM codes to identify gastrointestinal perforation events in administrative claims data among hospitalized rheumatoid arthritis patients.

PURPOSE: To validate, using physician review of abstracted medical chart data as a gold standard, a claims-based algorithm developed to identify gastrointestinal (GI) perforation cases among rheumatoid arthritis (RA) patients. METHODS: Patients with established RA, aged 18 years or older with hospital admissions between January 2004 and September 2009, were selected from a large US-hospital-based database. An algorithm with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for GI perforation and combinations of GI-related diagnosis codes and Current Procedural Terminology (CPT-4) procedure codes for relevant GI surgeries was used to identify potential GI perforation cases. Two senior experienced specialist physicians independently reviewed abstracted chart data and classified cases as confirmed or unconfirmed GI perforations. Positive predictive values (PPVs) to identify confirmed GI perforation were calculated and stratified by upper versus lower GI tract. RESULTS: Overall, 86 of 92 GI perforation cases were confirmed, yielding an overall PPV of 94% (95%confidence interval [CI] = 86%-98%). PPV was 100% (95%CI = 100%-100%) for upper GI perforation (esophagus, stomach) and 91% (95%CI = 90%-97%) for lower GI perforation (small intestine, PPV = 100%; large intestine, PPV = 94%; unspecified lower GI, PPV = 89%). CONCLUSIONS: This algorithm, consisting of a combination of ICD-9-CM diagnosis and CPT-4 codes, could be used in future safety studies to evaluate GI perforation risk factors in RA patients.