Summary Magnetic sphincter augmentation (MSA)was introduced as an alternative to laparoscopic Nissen fundoplication (LNF). This reproducible, outpatient procedure addresses the etiology of gastroesophageal reflux disease by implanting a ring of magnetic beads across the esophagogastric junction (EGJ). MSA is designed to resist effacement of the lower esophageal sphincter (LES) and, similar to LNF, results in restoration of anti-reflux barrier competency by increasing overall length, intraabdominal length and resting pressure of the sphincter. However, the novel use of magnets to augment the physiology of the LES poses unique challenges to the physiology of the EGJ and esophagus. These impacts are best revealed through manometry. The degree of restrictive forces at the EGJ, as measured by intrabolus pressure and integrated relaxation pressure, is higher after MSA compared with LNF. In addition, contrary to the LNF, which retains neurohormonal relaxation capability during deglutition, the magnetic forces remain constant until forcibly opened. Therefore, the burden of overcoming EJG resistance is placed solely on the esophageal body contractile force, as measured by distal contractile integral and distal esophageal amplitude. The main utility of preoperative manometry is in determining whether a patient’s esophagus has sufficient contractility or peristaltic reserve to adapt to the challenge of an MSA. Manometric thresholds predictive of MSA outcomes deviate from those used to define named Chicago Classification motility disorders. Therefore, individual preoperative manometric characteristics should be analyzed to aid in risk stratification and patient selection prior to MSA.
Introduction Pyloroplasty and gastric peroral endoscopic myotomy (G-POEM) are effective surgeries for gastroparesis. The primary aim of this study was to evaluate outcomes of pyloroplasty and G-POEM in patients with gastroparesis and determine factors associated with favorable outcome. The secondary aim was to assess the utility of clinical response to preoperative pyloric dilation or botulinum toxin injection (Botox) on surgical outcome, a factor conventionally used as a favorable marker. Methods There were 204 patients who underwent pyloroplasty (n = 177) or G-POEM (n = 27) for gastroparesis at our institution from 2014 to 2021. Demographic and clinical parameters were analyzed to assess their impact on surgical outcome. A subgroup of patients who had pyloric dilation or Botox injection were assessed separately. Favorable outcome was defined as patient reported complete resolution of the predominant gastroparesis symptom. Results Favorable outcome was achieved in 78.4% of patients (pyloroplasty: 79.7% and G-POEM: 70.4%, p = 0.274). Among 61 patients where pre- and postoperative gastric emptying studies (GES) were available, mean 4-hour retention significantly improved from 33.5 to 15.0% (p < 0.001) and 77.0% of patients achieved normalization. Favorable outcome was not significantly impacted by etiology of gastroparesis (p = 0.120), GERD (p = 0.518), or primary gastroparesis symptom (p = 0.244). Age ≥ 40 was a significant predictor of favorable surgical outcome on multivariate analysis [OR: 2.476 (1.224–5.008), p = 0.012]. Among the patients who had preoperative dilation (n = 82) or Botox injection (n = 46), response to these interventions was not a predictor of favorable surgical outcome (p = 0.192 and 0.979, respectively). However, preoperative Botox injection, regardless of response to injection, was associated with favorable surgical outcome [OR: 3.205 (CI 1.105–9.299), p = 0.032]. Conclusion Symptomatic improvement after pyloroplasty or G-POEM is independent of etiology of gastroparesis, GERD, and primary symptom. Response to dilation or Botox are not markers of response to surgery. However, patients who receive Botox are 3.2 times more likely to improve postoperatively. Graphical abstract
Introduction The impact of delayed gastric emptying (DGE) on the outcome of anti-reflux surgery (ARS) is controversial. There is concern that poor gastric emptying diminishes outcomes. Magnetic sphincter augmentation (MSA) may have a comparatively mild impact on gastric physiology, but the relationship between DGE and MSA outcomes is unknown. This study aims to evaluate the relationship between objective DGE and MSA outcomes over time. Methods Patients who completed gastric emptying scintigraphy (GES) prior to MSA between 2013 and 2021 were included. DGE was defined as a 4 h retention > 10% or half emptying time > 90 min on GES. Outcomes were compared between DGE and normal gastric emptying (NGE) groups at 6 months, 1 and 2 years. Sub-analysis of patients with severe (> 35%) DGE and correlation analysis between 4-h retention and symptom and acid-normalization were performed. Results The study population consisted of 26 (19.8%) patients with DGE and 105 with NGE. DGE was associated with more 90-days readmissions (18.5 vs 2.9%, p = 0.009). At 6 months patients with DGE had higher median (IQR) GERD-HRQL total [17.0(10–29) vs 5.5(3–16), p = 0.0013], heartburn [1(1–3) vs 0(0–1), p = 0.0010) and gas-bloat [4(2–5) vs 2(1–3), p = 0.033] scores. Outcomes at 1 and 2 years follow-up were comparable (p > 0.05). From 6 months to 1-year the gas-bloat score decreased from 4(2–5) to 3(1–3), p = 0.041. Total and heartburn scores decreased, but not significantly. Severe DGE (n = 4) patients had lower antiacid medication freedom at 6 months (75 vs 87%, p = 0.014) and 1-year (50 vs 92%, p = 0.046). There were non-significant trends for higher GERD-HRQL scores, dissatisfaction, and removal rates in severe DGE at 6 months and 1-year. There was a weak correlation between 4-h retention and 6-month GERD-HRQL total score [R = 0.253, 95%CI (0.09–0.41), p = 0.039], but not acid-normalization (p > 0.05). Conclusion Outcomes after MSA are diminished early on in patients with mild-to-moderate DGE, but comparable by 1 year and durable at 2 years. Severe DGE outcomes may be suboptimal. Graphical abstract
Neurodegenerative diseases are one of the most important contributors to morbidity and mortality in the elderly. In Europe, over 14 million people are currently living with dementia, at a cost of over 400 billion EUR annually. Recent advances in diagnostics and approval for new pharmaceutical treatments for Alzheimer’s disease (AD), the most common etiology of dementia, heralds the beginning of precision medicine in this field. However, their implementation will challenge an already over-burdened healthcare systems. There is a need for innovative digital solutions that can drive the related clinical pathways and optimize and personalize care delivery. Public-private partnerships are ideal vehicles to tackle these challenges. Here we describe the Innovative Health Initiative (IHI) public-private partnership project PROMINENT that has been initiated by connecting leading dementia researchers, medical professionals, dementia patients and their care partners with the latest innovative health technologies using a precision medicine based digital platform. The project builds upon the knowledge and already implemented digital tools from several collaborative initiatives that address new models for early detection, diagnosis, and monitoring of AD and other neurodegenerative disorders. The project aims to provide support to improvement efforts to each aspect of the care pathway including diagnosis, prognosis, treatment, and data collection for real world evidence and cost effectiveness studies. Ultimately the PROMINENT project is expected to lead to cost-effective care and improved health outcomes.
Background Magnetic sphincter augmentation (MSA) erosion, disruption or displacement clearly requires device removal. However, up to 5.5% of patients without anatomical failure require removal for dysphagia or recurrent GERD symptoms. Studies characterizing these patients or their management are limited. We aimed to characterize these patients, compare their outcomes, and determine the necessity for further reflux surgery. Methods This is a retrospective review of 777 patients who underwent MSA at our institution between 2013 and 2021. Patients who underwent device removal for persistent dysphagia or recurrent GERD symptoms were included. Demographic, clinical, objective testing, and quality of life data obtained preoperatively, after implantation and following removal were compared between removal for dysphagia and GERD groups. Sub-analyses were performed comparing outcomes with and without an anti-reflux surgery (ARS) at the time of removal. Results A total of 40 (5.1%) patients underwent device removal, 31 (77.5%) for dysphagia and 9 (22.5%) for GERD. After implantation, dysphagia patients had less heartburn (12.9-vs-77.7%, p = 0.0005) less regurgitation (16.1-vs-55.5%, p = 0.0286), and more pH-normalization (91.7-vs-33.3%, p = 0.0158). Removal without ARS was performed in 5 (55.6%) GERD and 22 (71.0%) dysphagia patients. Removal for dysphagia patients had more complete symptom resolution (63.6-vs-0.0%, p = 0.0159), freedom from PPIs (81.8-vs-0.0%, p = 0.0016) and pH-normalization (77.8-vs-0.0%, p = 0.0455). Patients who underwent removal for dysphagia had comparable symptom resolution (p = 0.6770, freedom from PPI (p = 0.3841) and pH-normalization (p = 0.2534) with or without ARS. Those who refused ARS with removal for GERD had more heartburn (100.0%-vs-25.0%, p = 0.0476), regurgitation (80.0%-vs-0.0%, p = 0.0476) and PPI use (75.0%-vs-0.0%, p = 0.0476). Conclusions MSA removal outcomes are dependent on the indication for removal. Removal for dysphagia yields excellent outcomes regardless of anti-reflux surgery. Patients with persistent GERD had worse outcomes on all measures without ARS. We propose a tailored approach to MSA removal-based indication for removal. Graphical abstract
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