Implementation of a Modified WHO Pediatric Procedural Sedation Safety Checklist and Its Impact on Risk Reduction.

BACKGROUND AND OBJECTIVES: Major adverse events (AEs) related to pediatric deep sedation occur at a low frequency but can be of high acuity. The high volume of deep sedations performed by 3 departments at our institution provided an opportunity to reduce variability and increase safety through implementation of a procedural sedation safety checklist. We hypothesized that implementation of a checklist would improve compliance of critical safety elements (CSEs) (primary outcome variable) and reduce the sedation-related AE rate (secondary outcome variable). METHODS: This process improvement project was divided into 5 phases: a retrospective analysis to assess variability in capture of CSE within 3 departments that perform deep sedation and the association between noncapture of CSE and AE occurrence (phase 1), design of the checklist and trial in simulation (phase 2), provider education (phase 3), implementation and interim analysis of checklist completion (phase 4), and final analysis of completion and impact on outcome (phase 5). RESULTS: We demonstrated interdepartmental variability in compliance with CSE completion prechecklist implementation, and we identified elements associated with AEs. Completion of provider education was 100% in all 3 departments. Final analysis showed a checklist completion rate of 75%, and its use significantly improved capture of several critical safety elements. Its use did not significantly reduce AEs (P = .105). CONCLUSIONS: This study demonstrates that the implementation of a sedation checklist improved process adherence and capture of critical safety elements; however, it failed to show a significant reduction in sedation-related AEs.

Barrett's esophagus at a tertiary care center: association of age on incidence and prevalence of dysplasia and adenocarcinoma.

OBJECTIVES: Barrett's esophagus (BE) is traditionally thought of as a disease of middle-aged Caucasian men. Little is known about BE in younger patients. We sought to assess the effect of age on features of BE including the prevalence and incidence of dysplasia and carcinoma. METHODS: All patients enrolled into the Cleveland Clinic BE registry from 1979 to 2002 were studied. Age, ethnicity, number of endoscopies, hiatal hernia size, length of Barrett's segment, prevalence and incidence of dysplasia, and cancer were compared between patients > or = 50 yr old and < 50 yr old. RESULTS: There were 837 patients in the registry (638 > or = 50 yr, 199 < 50 yr). Hiatal hernia size was larger in patients > or = 50 yr than in those < 50 yr (median 4.0 cm, interquartile range 2.0-5.0 cm vs 3.0, 2.0-4.0 cm; p < 0.01). Otherwise, there were no significant differences among other features in the patient population. There were 225 patients with dysplasia or cancer (195 > or = 50 yr and 30 < 50 yr; p < 0.01). Of this group, 176 were prevalent cases (159 > or = 50 yr and 17 < 50 yr) and 49 were incident cases (36 > or = 50 yr and 13 < 50 yr). The odds of those > or = 50 yr being a prevalent case of high-grade dysplasia or cancer was five times the odds of those < 50 yr (p < 0.01). The incidence of dysplasia or cancer was similar in both age groups. CONCLUSIONS: Our study supports emerging data that approximately 25% of BE patients are less than 50 yr of age. While older patients had a higher prevalence of dysplasia or adenocarcinoma, the incidence of dysplasia and adenocarcinoma is similar in both age groups. Future screening strategies for BE should recognize these important findings.

The long-term efficacy of pneumatic dilatation and Heller myotomy for the treatment of achalasia.

BACKGROUND & AIMS: Studies comparing long-term success after pneumatic dilatation (PD) and laparoscopic Heller myotomy (HM) are lacking. This study compares long-term outcome of PD (single dilatation and graded approach) and laparoscopic HM and identifies risk factors for treatment failure. METHODS: A cross-sectional follow-up evaluation of an achalasia cohort treated between 1994 and 2002 was followed-up for a mean of 3.1 years. There was a total of 106 patients treated by graded PD (1-3 dilatations with progressively larger balloons) and 73 patients treated by HM (20 had failed graded PD and crossed over to HM). A symptom assessment (structured telephone interview or clinic visit) was performed and patients were given freedom from alternative therapies to determine treatment outcome. Endoscopy, manometry, and timed barium esophagram were performed to determine the cause of treatment failure. RESULTS: The success of single PD was defined as freedom from additional PDs: 62% at 6 months and 28% at 6 years (risk factors for failure: younger age, male sex, wider esophagus, and poor emptying on posttreatment timed barium esophagram). Freedom from subsequent PDs increased with each dilatation (graded PD). The success of graded PD and HM, defined as dysphagia/regurgitation less than 3 times/wk or freedom from alternative treatment, was similar: 90% vs 89% at 6 months and 44% vs 57% at 6 years (no risk factors for failure were identified). Causes of symptom recurrence were incompletely treated achalasia (96% after PD vs 64% after HM) and gastroesophageal reflux disease (4% after PD vs 36% after HM). CONCLUSIONS: No treatment cures achalasia. Short- and long-term success is similar for graded PD and laparoscopic HM. Therapeutic success decreases steadily over time. Achalasia patients need careful long-term follow-up evaluation.

Barrett's esophagus in women: demographic features and progression to high-grade dysplasia and cancer.

BACKGROUND & AIMS: Barrett's esophagus is traditionally considered a disease of older white men. The aims of this study were to compare the demographic features of Barrett's esophagus in men and women and to determine the prevalence and incidence of high-grade dysplasia and cancer in these patients. METHODS: All patients enrolled in the Cleveland Clinic Barrett's Esophagus Registry from 1979-2002 were studied. Age, ethnicity, number of endoscopies, hiatal hernia size, length of Barrett's segment, and prevalence and incidence of high-grade dysplasia and cancer were compared between men and women. RESULTS: There were 839 patients in the registry (628 men and 211 women). Barrett's segment length was greater in men than in women (mean, 5.06 +/- 4.2 vs 4.05 +/- 3.27 cm, respectively; P = .003). There were no significant differences for other parameters. There were 114 prevalence cases of high-grade dysplasia or cancer (96 men, 18 women). Women were less likely to have prevalent high-grade dysplasia or cancer than men (odds ratio, 0.52; 95% confidence interval, 0.31-0.88; P = .015). There were 13 incidence cases of high-grade dysplasia or cancer (11 men, 2 women) during a mean follow-up of 4.72 years, which was similar in both genders with an incidence rate of 1 in 179 patient-years of follow-up for women and 1 in 91 patient-years of follow-up in men. CONCLUSIONS: Twenty-five percent of patients in our registry are women. The length of Barrett's esophagus is greater in men than in women, but other features are similar. The prevalence of high-grade dysplasia/cancer in women is approximately half that of men. Incidence rates for high-grade dysplasia/cancer are similar in men and women, although the number of cases is small.

Complexities of managing achalasia at a tertiary referral center: use of pneumatic dilatation, Heller myotomy, and botulinum toxin injection.

PURPOSE: The purpose of this study is to describe the results and complexity of treatment for achalasia patients presenting to a single esophagologist at a tertiary referral center and to make treatment recommendations based on this experience. METHODS: Retrospective chart review of achalasia patients treated between 1994 and 2002. Symptoms, manometric and timed barium esophagram results, and treatments/outcome at CCF determined. RESULTS: 232 patients (51% male, mean age = 53) were evaluated. Untreated patients (n = 184): Pneumatic dilatation (PD) used in 111 patients. Symptoms and barium emptying improved in 86% and 54%, respectively. Nineteen (17%) patients required subsequent Heller myotomy (HM). Perforation rate: 3/111 (2.7%) patients. 16% required proton-pump inhibitor (PPI) for GERD. HM was used in 72 patients (81% laparoscopic). Symptoms and barium emptying improved in 89% and 44%, respectively. PPI required in 53%. Botulinum toxin (Botox) was used in 39 older patients (mean age = 71); symptom improvement lasted for a mean 6.2 months, with frequent need for repeated injection (mean: 1.7, range: 1-7). About 43% required additional treatment with a different modality. Esophagectomy was done in three patients. Patients with prior surgery (n = 48): PD (n = 10) achieved symptom and barium emptying improvement in 67% and 11%, comparable to redo HM (n = 21) with 57% symptom improvement and 38% improved emptying. Esophagectomy required in eight patients. CONCLUSIONS: Successful management of achalasia can be complex and may require more than one treatment modality. PD and HM are presently the best treatments for untreated achalasia with similar efficacy but greater PPI use after surgery. Both are less successful after prior HM.