Peroral endoscopic myotomy versus pneumatic dilation in treatment-naive patients with achalasia: 5-year follow-up of a randomised controlled trial.

BACKGROUND: 2-year follow-up data from our randomised controlled trial showed that peroral endoscopic myotomy is associated with a significantly higher efficacy than pneumatic dilation as initial treatment of therapy-naive patients with achalasia. Here we report therapeutic success rates in patients treated with peroral endoscopic myotomy compared with pneumatic dilation at the 5-year follow-up. METHODS: We did a multicentre, randomised controlled trial in six hospitals in the Netherlands, Germany, Italy, Hong Kong, and the USA. Adults aged 18-80 years with newly diagnosed symptomatic achalasia (based on an Eckardt score >3) were eligible for inclusion. Patients were randomly assigned (1:1) to peroral endoscopic myotomy or pneumatic dilation using web-based randomisation with a random block size of 8 and stratification according to site. Randomisation concealment for treatment type was double blind until official study enrolment. Treatment was unmasked because of the different technical approach of each procedure. Patients in the pneumatic dilation group were dilated with a single series of 30-35 mm balloons. The need for subsequent dilations in the pneumatic dilation group, and the need for dilation after initial treatment in the peroral endoscopic myotomy group, was considered treatment failure. The primary outcome was therapeutic success (Eckardt score ≤3 in the absence of severe treatment-related complications and no need for retreatment). Analysis of the primary outcome was by modified intention to treat, including all patients randomly assigned to a group, excluding those patients who did not receive treatment or were lost to follow-up. Safety was assessed in all included patients. This study is registered at the Dutch Trial Registry, NTR3593, and is completed. FINDINGS: Between Sept 21, 2012, and July 20, 2015, 182 patients were assessed for eligibility, 133 of whom were included in the study and randomly assigned to peroral endoscopic myotomy (n=67) or pneumatic dilation (n=66). 5-year follow-up data were available for 62 patients in the peroral endoscopic myotomy group and 63 patients in the pneumatic dilation group. 50 (81%) patients in the peroral endoscopic myotomy group had treatment success at 5 years, compared with 25 (40%) in the pneumatic dilation group, an adjusted absolute difference of 41% (95% CI 25-57; p<0·0001). Reasons for failure were no initial effect of treatment (one patient in the peroral endoscopic myotomy group vs 12 patients in the pneumatic dilation group) and recurrent symptoms causing treatment failure (11 patients in the peroral endoscopic myotomy group [seven patients between 2 and 5 years] vs 25 patients in the pneumatic dilation group [nine patients between 2 and 5 years]); one patient in the pneumatic dilation group had treatment failure due to an adverse event. Proton-pump inhibitor use (mostly daily) was significantly higher after peroral endoscopic myotomy than after pneumatic dilation among patients still in clinical remission (23 [46%] of 50 patients vs three [13%] of 24 patients; p=0·008). 5-year follow-up endoscopy of patients still in clinical remission showed reflux oesophagitis in 14 (33%) of 42 patients in the peroral endoscopic myotomy group (12 [29%] grade A or B, two [5%] grade C or D) and two (13%) of 16 patients in the pneumatic dilation group (two [13%] grade A or B, none grade C or D; p=0·19). No intervention-related serious adverse events occurred between 2 and 5 years after treatment. The following non-intervention-related serious adverse events occurred between 2 and 5 years: a stroke (one [2%]) in the peroral endoscopic myotomy group; and death due to a melanoma (one [2%]) and dementia (one [2%]) in the pneumatic dilation group. INTERPRETATION: Based on this study, peroral endoscopic myotomy should be proposed as an initial treatment option for patients with achalasia. Although our study has shown that peroral endoscopic myotomy has greater long-term efficacy with a low risk of major treatment-related complications, this should not lead to abandonment of pneumatic dilation from clinical practice. Ideally, all treatment options should be discussed with treatment-naive patients with achalasia and a shared decision should be made. FUNDING: Fonds NutsOhra and European Society of Gastrointestinal Endoscopy.

Implementation of the Synergy Tool: A Potential Intervention to Relieve Health Care Worker Burnout.

(1) Background: Healthcare workers experienced rising burnout rates during and after the COVID-19 pandemic. A practice-academic collaboration between health services researchers and the surgical services program of a Canadian tertiary-care urban hospital was used to develop, implement and evaluate a potential burnout intervention, the Synergy tool. (2) Methods: Using participatory action research methods, this project involved four key phases: (I) an environmental scan and a baseline survey assessment, (II), a workshop, (III) Synergy tool implementation and (IV) a staffing plan workshop. A follow-up survey to evaluate the impact of Synergy tool use on healthcare worker burnout will be completed in 2023. (3) Results: A baseline survey assessment indicated high to severe levels of personal and work-related burnout prior to project initiation. During the project phases, there was high staff engagement with Synergy tool use to create patient care needs profiles and staffing recommendations. (4) Conclusions: As in previous research with the Synergy tool, this patient needs assessment approach is an efficient and effective way to engage direct care providers in identifying and scoring acuity and dependency needs for their specific patient populations. The Synergy tool approach to assessing patient needs holds promise as a means to engage direct care providers and to give them greater control over their practice-potentially serving as a buffer against burnout.

Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).

Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial.

Importance: Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking. Objective: To compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia. Design, Setting, and Participants: This randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017. Interventions: Randomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital. Main Outcomes and Measures: The primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis. Results: Of the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM. Conclusions and Relevance: Among treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia. Trial Registration: Netherlands Trial Register number: NTR3593.

Robotic-assisted minimally invasive esophagectomy for treatment of esophageal carcinoma.

Minimally invasive esophagectomy (MIE) is technically challenging. Da Vinci Robotic system could improve surgical dissection with additional degree of freedom from robotic arms. This study aimed to assess the feasibility and safety of performing MIE using Da Vinci Robotic system among patients with esophageal cancers. From 2009 to 2013, consecutive patients with esophageal cancers who received robotic-assisted MIE were recruited. We excluded tumors with suspected invasion to adjacent organs. Preoperative staging included EUS, CT thorax and abdomen and bronchoscopy. We perform mobilization of thoracic esophagus with two-field lymphadenectomy using robotic system, followed by laparoscopic gastric mobilization and hand-sewn cervical esophagogastric anastomosis. A total of 20 patients were recruited (16 male and 4 female) with mean age of 64.2 ± 8.8 years. All patients were successfully treated with robotic-assisted MIE with mean operative time of 499.5 ± 70 min and blood loss of 355.7 ± 329.6 mls. There was no pulmonary complication, while three patients sustained anastomotic leakage and managed conservatively. The mean hospital stay was 13 ± 6 days. Five patients had stage I tumors, five had stage II, and nine had stage III disease. One patient had complete response after neoadjuvant chemoradiotherapy. The number of lymph node dissection was 18.2 ± 13.2, and 2.8 ± 5.7 nodes involved. The follow-up period was 21 ± 9 months, and the overall survival was 75 %. Robotic-assisted MIE is feasible and safe for treatment of esophageal cancers. The surgical dissection can be enhanced by improved ergonomics from robotic arms and sense of depth from 3D images.

Evaluating the Clinical Utility of the Medical Symptom Validity Test (MSVT): A Clinical Series.

Performance validity tests (PVTs) are not widely used beyond medico-legal contexts in the UK. A UK survey suggests clinicians have reservations about their accuracy in clinical settings. This study sought to explore the validity of PVTs in an acute adult neuropsychology setting and to establish a potential "false positive" (FP) base rate. Failures on the Medical Symptom Validity Test (MSVT) in a consecutive clinical series of 405 patients were evaluated systematically and allocated to groups depending on clinical context. All failures were checked against the test's "dementia profile". Of the 405 participants, 329 passed the MSVT (81.2%), while 76 participants (18.8%) failed based on standard criteria. A 5.2% rate of potentially 'unexplained' failures was found. Other reasons for failure were classified as: presumed malingered neurocognitive dysfunction (4.6%), dementia/significant cognitive impairment (3.7%), technical/visual problems (1.8%), and "unexplained failure" with contributory factors (2.4%). These results suggest test specificity between 0.95 and 0.90. Most of the clinically significantly impaired patients matched the dementia profile (86.7%). Our results support the sensitivity, but not the specificity, of the dementia profile. However, approximately 1 in 20 patients failed the MSVT despite an otherwise unremarkable neuropsychological presentation; moreover, mood and pain may affect MSVT performance. Clinical implications for interpreting test scores are discussed.

A community-acquired methicillin-resistant Staphylococcus aureus liver abscess.

Liver abscesses caused by community-acquired methicillin-resistant Staphylococcus aureus are rarely reported. We report such a case in a 25-year-old man who presented with an intermittent fever. He had a history of prolonged antibiotic use for acne and skin abscesses. The liver abscess was successfully treated with percutaneous drainage and a prolonged course of linezolid. To our knowledge, this is the first reported case of a community-acquired methicillin-resistant Staphylococcus aureus liver abscess in Hong Kong, demonstrating the increasing threat posed by this multidrug-resistant organism. This case also suggests that a different epidemiology and route of infection may apply to community-acquired methicillin-resistant Staphylococcus aureus liver abscesses in contrast to the more common pyogenic liver abscesses.

Is four a deadly number for the Chinese?

BACKGROUND: The numbers 4, 14 and 24 are associated with death for Cantonese-speaking Chinese people, as the words for these numbers sound like the words for "death", "must die" and "easy to die", respectively. A previous study in the United States investigating psychological stress engendered by fear of the number 4 found more cardiac deaths in Chinese and Japanese people, compared with white Americans, on the 4th day of the month. OBJECTIVE: To determine whether more cardiac deaths occur in Hong Kong Chinese people on the days of the month with "deathly connotations" (4, 14 and 24). DESIGN: Analysis of mortality data (1995-2000) of the Chinese population of Hong Kong from the Census and Statistics Department of the Hong Kong Government for these three days of the month, compared with the remaining days, according to both the Gregorian and Lunar calendars. RESULTS: There were 17 346 cardiac deaths registered under ICD-9 codes 410-414 in 1995-2000. The mean (+ 1 SD) of the cumulative number of cardiac deaths on each day of the month was 587 (+ 30) for the Gregorian calendar or 573 (+ 24) for the Lunar calendar. The mean number of deaths on the 4th, 14th and 24th day of the month was not significantly different from the mean number of deaths on the remaining days of the month. CONCLUSION: Our study of Hong Kong Chinese people does not support the concept that more cardiac deaths occur in Cantonese people on the 4th, 14th and 24th day of the month.