The Value of Fundoplication in the Treatment of Type I Achalasia.

BACKGROUND: Type I achalasia comprises 20% of achalasia and has nearly absent esophageal motor activity. Concerns that fundoplication decreases the effectiveness of Heller myotomy in these patients has increased adoption of peroral endoscopic myotomy (POEM). Hence, we compared outcomes after Heller myotomy with Dor fundoplication vs POEM. METHODS: From 2005 to 2020, 150 patients with type I achalasia underwent primary surgical myotomy (117 Heller myotomy, 33 POEM). Patient demographics, prior treatments, timed barium esophagrams, Eckardt scores, and reinterventions were assessed between the 2 groups. Median follow-up was 5 years for Heller myotomy and 2.5 years for POEM. RESULTS: The Heller myotomy group was younger, had fewer comorbidities, and lower body mass index vs POEM. Risk-adjusted models demonstrated clinical success (Eckardt ≤3) in 83% of Heller myotomies and 87% of POEMs at 3 years; longitudinal complete timed barium esophagram emptying and reintervention were also similar. An abnormal pH test result was documented in 10% (6 of 60) after Heller myotomy and in 45% (10 of 22) after POEM (P < .001). CONCLUSIONS: Despite nearly absent esophageal contractility, Heller myotomy with Dor fundoplication and POEM result in similar long-term symptom relief, esophageal emptying, and occurrence of reintervention in patients with type I achalasia. There is decreased esophageal acid exposure with the addition of a fundoplication, without compromised esophageal drainage, allaying fears of a detrimental effect of a fundoplication. Hence, choice of procedure may be personalized based on patient characteristics and esophageal morphology and not solely on manometric subtype.

Development and Characterization of Hygroscopicity-Controlled Sustain Release Formulation of Divalproex Sodium.

Objectives: Divalproex sodium (DS), being a hygroscopic drug, requires low humidity during product manufacturing. This study aims to develop a hygroscopicity controlled sustained release formulation of DS that can be manufactured in relatively high humid conditions in facilities lacking dehumidifiers. Materials and Methods: This study focuses on the role of polyethylene glycol (PEG-8000) and hydroxypropyl methylcellulose (HPMC K100M) as polymers of choice to control hygroscopicity and retard release of DS using solid dispersion technique. In this study, homogeneous solid dispersions containing various ratios of PEG-8000, HPMC K100M, and DS were obtained via melt granulation technique. Fifteen different solid dispersions were prepared based on Box-Behnken experimental design created in MiniTab software. The obtained solid dispersions were separately broken down into granules and their hygroscopic properties were determined via moisture uptake studies. Granular solid dispersions were then compressed into tablets and their sustained release dissolution profiles were studied as per the United States Pharmacopoeia (USP) monograph of DS extended-release tablets. Dissolution profiles of all fifteen formulations were then analyzed in Box-Behnken experimental design under MiniTab software to determine an optimized formulation having low hygroscopic properties as well as required multipoint drug release as per USP monograph. The final optimized formulation was prepared and subjected to moisture uptake study to determine its hygroscopicity, dissolution study to determine drug release kinetics and fourier transform infrared (FTIR) and differential scanning calorimetry (DSC) analysis to determine molecular interactions between drug and polymers. Result: Optimized final formulation yielded granular solid dispersion with 28% less hygroscopicity compared to DS and tablets with an excellent release profile in accordance with USP monograph. FTIR and DSC analysis did not show any significant interaction between DS and components of the solid dispersion. Conclusion: Optimized formulation from this study can be used to manufacture divalproex extended-release tablets inside facilities lacking dehumidifiers.

A comparative study of robotic and laparoscopic approaches to Heller myotomy.

OBJECTIVE: Minimally invasive Heller myotomy for achalasia is commonly performed laparoscopically, but recently done with robotic assistance. We compare outcomes of the 2 approaches. METHODS: From January 2010 to January 2020, 447 patients underwent Heller myotomy with anterior fundoplication (170 with robotic assistance and 277 laparoscopically). End points included short-term and longitudinal esophageal emptying according to timed barium esophagram, symptom relief according to Eckardt score, and time-related reintervention. Normal esophageal morphology, present in 328 patients, was defined as nonsigmoidal with width <5 cm. We performed a propensity score--matched analysis to evaluate outcomes among robotic and laparoscopic groups. RESULTS: Timed barium esophagrams showed complete emptying at 5 minutes in 58% (77/132) of the robotic group and 48% (115/241) of the laparoscopic group in the short term (within 6 months of surgery). In the propensity-matched patients with normal esophageal morphology, the robotic group had a higher longitudinal prevalence of complete emptying of barium at 5 minutes (54% vs 34% at 4 years; P = .05), better intermediate-term Eckardt scores (1.7% vs 10% > 3 at 4 years; P = .0008), and actuarially fewer reinterventions (1.2% vs 11% at 3 years; P = .04). CONCLUSIONS: Both robotically assisted and laparoscopic Heller myotomy had excellent outcomes in patients treated for achalasia. In a matched subgroup of patients with normal esophageal morphology within this heterogeneous disease, the robotic approach might be associated with greater esophageal emptying, palliation of symptoms, and freedom from reintervention in the intermediate term. Long-term analysis would be important to determine if this trend persists.

Minimally Invasive "3-Stitch" Modification of the Dor Fundoplication: Simple and Effective.

BACKGROUND: A 180-degree anterior (Dor) fundoplication is usually paired with an esophagogastric myotomy in the surgical treatment of achalasia. The traditional technique, however, is not easily reversible and the execution is variable. This study examined a simplified ''3-stitch'' Dor fundoplication that addressed these challenges and presented the results. METHODS: A prospectively collected, longitudinal surgical achalasia database was queried for patients undergoing a Heller myotomy with '3-stitch 180-degree fundoplication from 2008 to 2019. Preoperative and postoperative Eckardt score, postoperative DeMeester score (24- or 48-hour pH studies), and endoscopic evidence of esophagitis were collected and analyzed to determine the effectiveness and safety of the fundoplication. Length of stay and complications were also considered. RESULTS: The pH testing was performed in 296 patients, with 17% (50 of 296) demonstrating abnormal esophageal acid exposure. Of this group, only 8% (16 of 201) manifested clinical esophagitis on upper endoscopy. A total of 14% (7 of 50) of patients with abnormal esophageal acid exposure were symptomatic. Total postoperative Eckhardt scores for this cohort were 3 or lower in 92% of patients, with a dysphagia-specific score of 0 in 92%. The technical details of a modified 180-degree anterior fundoplication are described. CONCLUSIONS: The 3-stitch Dor fundoplication is an effective addition to a minimally invasive Heller myotomy, with good palliation of symptoms and an acceptable rate of acid reflux. The simplified construction anticipates the potential progression of esophageal dysmotility in patients with achalasia, and the modified technique is reproducible and readily teachable.

Peroral endoscopic myotomy provides effective palliation in type III achalasia.

BACKGROUND: Type III achalasia outcomes have historically been met with limited success after conventional laparoscopic Heller myotomy (LHM) and pneumatic dilation. Peroral endoscopic myotomy (POEM) has emerged as a promising alterative for a multitude of reasons. Our objective was to investigate POEM outcomes in palliating type III achalasia. METHODS: A retrospective analysis of a prospectively maintained database was conducted in a tertiary care institution between April 2014 and July 2019. The primary outcome was postoperative Eckardt score. We also explored the effect of lower esophageal sphincter (LES) integrated resting pressure (IRP) on manometry, barium column height and width, and complications. Standard statistical methods were applied using R. RESULTS: A total of 518 patients in the achalasia database were identified, with 308 patients undergoing LHM and 210 undergoing POEM during the study period. POEM was used for type III achalasia in 36 patients (median age, 60 years; 61.7% male), with a median operative time of 85 minutes (interquartile range [IQR], 71-115 minutes) and follow-up of 1 year (IQR, 0.16-2.25 years). Within the POEM group, 11 patients (33%) had previous interventions, including Botox injections to the LES (n = 7), pneumatic dilation (n = 1), and LHM (n = 3). A significant decrease in median Eckardt score was observed (7 preoperatively [IQR, 6-8.75] vs 0 postoperatively [IQR, 0-1]; P < .01). Similar improvements after POEM were noted in median LES IRPs (25.5 mmHg vs 4.5 mmgHg; P < .01), 1-minute barium column height (10 cm vs 0 cm; P < .01), and 1-minute barium column width (2 cm vs 0 cm; P < .01). Patients reported a return to activities of daily living in a median of 7 days (IQR, 3-7 days). Three patients experienced complications, including mucosal perforation resolving with conservative management (n = 1), readmission for bleeding duodenal ulcer responding to proton pump inhibitors (n = 1), and readmission for dysphagia and rehydration (n = 1). Postoperative esophageal pH studies were conducted in 21 patients (62%), demonstrating a Demeester score of >14.72 in 13 patients (62%). CONCLUSIONS: POEM provides effective and durable palliation for type III achalasia, as demonstrated by symptom relief, esophageal manometry, and radiographic measurement. Considering its low morbidity profile, POEM should be considered as first-line therapy in this challenging disease subtype.

Per-oral endoscopic myotomy for palliation of achalasia: A video atlas.

Video 1Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 2Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 3Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 4Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 5Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 6Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.Video 7Video available at: https://www.jtcvs.org/article/S2666-2507(21)00513-7/fulltext.