Cleveland Clinic Research Articles

Switch to faricimab after initial treatment with aflibercept in eyes with neovascular age-related macular degeneration

PurposeTo investigate the efficacy and outcomes of switching neovascular age-related macular degeneration (nAMD) patients from aflibercept to faricimab, focusing on visual acuity, retinal fluid management, and treatment intervals. The primary aim was to assess the early outcomes in nAMD patients refractory to aflibercept and explore faricimab’s potential as a longer-lasting therapeutic alternative.MethodsA single-center retrospective study was conducted on 50 refractory nAMD patients at Cleveland Clinic Abu Dhabi from September 2022–May 2023. Patients were switched from aflibercept to faricimab, having met specific criteria for refractory nAMD. The study analyzed best-corrected visual acuity (BCVA), central subfield thickness (CST), and fluid changes post-switch, using Optical Coherence Tomography (OCT).ResultsAfter three faricimab injections, significant reductions in CST were observed, with a notable decrease in retinal fluid. The mean BCVA remained stable throughout the study period. Although there was a decrease in the maximum pigment epithelial detachment (PED) height, it was not statistically significant. Treatment intervals post-switch showed that the majority of patients maintained or extended their treatment intervals, with a significant proportion achieving resolution of intraretinal fluid (IRF) and subretinal fluid (SRF).ConclusionsSwitching to faricimab from aflibercept in refractory nAMD patients led to significant improvements in retinal fluid management and CST, with stable BCVA outcomes. Faricimab presents a promising alternative for patients requiring frequent aflibercept injections, potentially offering a more manageable treatment regimen with extended dosing intervals. This study highlights the need for personalized therapeutic strategies in nAMD treatment, though further research is necessary to optimize treatment switches.

What Constitutes High Risk for Venous Thromboembolism? Comparing Approaches to Determining an Appropriate Threshold.

Guidelines recommend pharmacological venous thromboembolism (VTE) prophylaxis only for high-risk patients, but the probability of VTE considered "high-risk" is not specified. Our objective was to define an appropriate probability threshold (or range) for VTE risk stratification and corresponding prophylaxis in medical inpatients. Patients were adults admitted to any of 10 Cleveland Clinic Health System hospitals between December 2020 and August 2021 (N = 41,036). Hospital medicine physicians and internal medicine residents from included hospitals were surveyed between June and November 2023 (N = 214). We compared five approaches to determining a threshold: decision analysis, maximizing the sensitivity and specificity of a logistic regression model, deriving a probability from a point-based model, surveying physicians' understanding of VTE risk, and deriving a probability from physician behavior. For each approach, we determined the probability threshold above which a patient would be considered high-risk for VTE. We applied each threshold to the Cleveland Clinic VTE risk assessment model (CCM) and calculated the percentage of the 41,036 patients in our cohort who would be considered eligible for prophylaxis due to their high-risk status. We compared these hypothetical prophylaxis rates with physicians' observed prophylaxis rates. The different approaches yielded thresholds ranging from 0.3% to 5.4%, corresponding inversely with hypothetical prophylaxis rates of 0.2% to 75%. Multiple thresholds clustered between 0.52% to 0.55%, suggesting an average hypothetical prophylaxis rate of approximately 30%, whereas physicians' observed prophylaxis rates ranged from 48% to 76%. Multiple approaches to determining a probability threshold for VTE prophylaxis converged to suggest an optimal threshold of approximately 0.5%. Other approaches yielded extreme thresholds that are unrealistic for clinical practice. Physicians prescribed prophylaxis much more frequently than the suggested rate of 30%, indicating opportunity to reduce unnecessary prophylaxis. To aid in these efforts, guidelines should explicitly quantify high-risk.

Five-year experience with titanium mesh for rigid chest wall reconstruction

ObjectiveTo characterize the performance of titanium mesh (TM) (off-label) for rigid chest wall reconstruction at a single institution over a 5-year period. MethodsBetween January 1, 2019, and May 15, 2023, 22 patients (median age, 61 years) underwent chest wall resection with TM reconstruction at Cleveland Clinic. Indications for resection included sarcoma (n = 15), breast cancer (n = 2), lung cancer (n = 2), chondroblastoma (n = 1), and benign neoplasm (n = 2). Patients were followed every 6 months with computed tomography scans for cancer recurrence. Continuous variables are summarized as median (interquartile range [IQR]); categorical variables, as frequency and percentage. Time to mesh fracture was assessed nonparametrically using Kaplan-Meier analysis. ResultsAmong the 22 patients over 21,870 patient-days of TM implantation, 21 (95%) had an R0 resection. The mean area of mesh coverage was 108 cm2 (IQR, 97-180 cm2). No patient experienced respiratory complications or mesh failure postoperatively. Of the 3 reoperations (13.6%), 2 were for delayed regional infection (at 7 and 12 months postoperatively), necessitating localized mesh removal, and the third was for local cancer recurrence. Fifteen implants developed visible fractures on imaging at a median time of 9 months after implantation. There were no adverse sequelae, including migration/erosion or clinical decline in respiratory function. ConclusionsChest wall resections, particularly those for sarcomas, require large margins for optimal oncologic outcomes. Rigid reconstruction of large defects is desirable, yet options are limited. TM reconstruction provides a promising alternative because of its biocompatibility, rigidity, robust incorporation into surrounding structures, and resistance to infection.

Upper Extremity Deep Vein Thrombosis: Incidence, Risk Factors, and Effectiveness of Chemoprophylaxis.

Upper extremity deep vein thrombosis (UEDVT) is associated with pulmonary embolism and other complications, but there are no recommendations for UEDVT prophylaxis. The purpose of this study was to establish incidence and risk factors for UEDVT and to determine efficacy of pharmacologic prophylaxis for UEDVT prevention. For this retrospective cohort study, we identified medical patients aged 18 years and older admitted to 13 Cleveland Clinic hospitals from January 2011 to December 2019. Patients with venous thromboembolism (VTE) on admission, length of stay <1 day, and who received therapeutic anticoagulation were excluded. The potential risk factors included demographics, comorbidities, and medical procedures. Comorbidities were identified via International Classification of Diseases codes, (ICD9 and ICD10), procedures from flowsheets, and prophylaxis from medications administered in the electronic medical record. DVT events were identified by a combination of International Classification of Diseases codes and confirmed by chart review. We performed multivariable logistic regression to identify independent risk factors and the association between VTE prophylaxis and UEDVT. The model's C statistic was obtained using 1000 bootstrap runs. Of 194,809 patients, 496 (0.25% of cohort, 36.8% of all VTE) developed UEDVT by 14 days. In the logistic regression model (bias-corrected C statistic 0.87), 11 risk factors predicted UEDVT, the strongest being peripherally inserted central catheter (odds ratio [OR] 4.62, 95% confidence interval [CI] 3.81-5.60) and central venous catheter (OR 3.57, 95% CI 2.91-4.37). The predicted risk among individuals ranged from 0.02% to 23.4%. Prophylaxis was negatively associated with the development of UEDVT (OR 0.72, 95% CI 0.60-0.87). UEDVT is rare but some patients are high risk. Therefore, UEDVT risk factors should be added to VTE risk assessment models, and patients at high risk for UEDVT should receive chemoprophylaxis.

Comparison of the Efficacy of Laser and Hybrid Seton Methods in the Treatment of Perianal Fistula.

To compare the efficacy and postoperative complications of laser and hybrid seton methods in the treatment of perianal fistula (PF). A descriptive cross-sectional study. Place and Duration of the Study: Department of General Surgery, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkiye, from January 2021 to April 2022. A total of 76 patients, with 46 in the hybrid seton group and 30 in the laser group, were included in the study. Perianal fistula classification was based on preoperative magnetic resonance imaging. The Likert satisfaction scale was assessed for patient satisfaction and the Cleveland Clinic Florida Faecal Incontinence (CCF-FI) scoring system was used for incontinence. Treatment outcome was determined based on success rate and postoperative faecal incontinence. The mean age of the patients was 43 ± 13 years and 59 (78%) of them were male. Forty-seven (62%) patients had simple fistula. Acute and late complications were significantly higher in the hybrid seton group than in the laser group (p <0.001). According to the Likert satisfaction scale, the rate of unsatisfied patients was significantly higher in the laser group than in the hybrid seton group (p = 0.02). According to the CCF-FI scoring system, incontinence was significantly higher in the hybrid seton group than in the laser group (p = 0.01). Treatment failure was higher in the laser group (p = 0.03). The laser method has lower intraoperative / postoperative complications, but higher treatment failure and lower patient satisfaction compared to the hybrid seton method. Anal fistula, Fecal incontinence, Laser therapy, Outcome, Loose seton method.

Efficacy and Safety of Mepolizumab in Patients With Eosinophilic Granulomatosis With Polyangiitis: A Single-Center Experience.

Eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome, is a systemic vasculitis characterized by eosinophil-rich, necrotizing granulomatous inflammation primarily affecting the respiratory tract with necrotizing vasculitis of small- to medium-sized arteries. In this case series, we retrospectively evaluated the efficacy and safety of mepolizumab in seven patients diagnosed with EGPA who presented to the Department of Allergy and Clinical Immunology at Cleveland Clinic Abu Dhabi.The variables assessed before and after mepolizumab treatment included Birmingham Vasculitis Activity Score (BVAS), prednisolone dose, Asthma Control Test (ACT) score, and blood eosinophil count (BEC).We found a significant reduction in BVAS and prednisolone dosage with clinical improvements in asthma symptoms after treatment with mepolizumab.Our case series, the first from the Middle East on the use of mepolizumab in EGPA, demonstrates that mepolizumab is a safe and effective treatment for patients with EGPA.

The Relationship Between Income Inequality and Economic Growth: A Comparative Case Study

This research explores the pivotal role of transformational leadership in fostering organizational innovation. Transformational leadership, characterized by its ability to inspire and motivate followers beyond their own self-interests, has been identified as a key driver of innovation within organizations. The study delves into the core components of transformational leadership—idealized influence, inspirational motivation, intellectual stimulation, and individualized consideration—and examines how these elements contribute to creating a culture of innovation. Through real-world case studies of organizations like Apple Inc. and Cleveland Clinic, the research demonstrates the significant impact of transformational leadership on promoting risk-taking, learning from failure, and driving continuous improvement. Moreover, the study highlights the challenges and criticisms associated with transformational leadership, emphasizing the need for a balanced approach to sustain innovation in the long term. The research concludes that as organizations face increasingly complex challenges in the 21st century, transformational leadership will remain crucial in driving sustainable innovation and organizational success.

Gut microbiota and myocardial infarction: A bibliometric analysis from 2004 to 2023

BackgroundIn recent years, numerous studies have suggested that the gut microbiota and its metabolites are closely related to myocardial infarction. Utilizing insights from these research findings may be advantageous in the prevention, treatment, and prognosis of myocardial infarction. We have employed bibliometric methodology to summarize the progress made in this research area over the past 20 years, identify the hotspots, and highlight the developmental tendencies, providing a reference for future research in this field. MethodsWe searched the content related to this field in the Web of Science Core Collection database, with a time range from 2001 to 2023. We used VOSviewer, CiteSpace, and Scimago Graphica software to visualize the search results. ResultsWe included 889 reports in this study. The country with the most publications was China, while the country with the greatest influence was the United States. An analysis of institutions showed that the Chinese Academy of Medical Sciences had the largest volume of publications, whereas the Cleveland Clinic had the most influential ones. An author analysis showed Stanley L Hazen to have published the most and to also have been the most influential researcher. An analysis of all the journals publishing articles related to the search terms showed that PLoS One journal had the highest number of publications (18 articles), while Atherosclerosis journal had the most influential articles. The results of our reference analysis showed a strong association between Trimethylamine N-oxide and myocardial infarction. We found that increased intestinal permeability may be related to the progression of cardiovascular diseases, a high-fiber diet may help in the prevention of diseases such as myocardial infarction, and populations with a high intake of red meat may have an increased risk of myocardial infarction. Keyword analysis suggested that ‘cardiac fibrosis’ and ‘major bleeding’ were promising research directions in the future, and supplementing food intake with short-chain fatty acids was looked upon as a promising approach to treating coronary heart disease. ConclusionThe gut microbiota are closely related to myocardial infarction, and investigating this relationship is crucial for the prevention and treatment of myocardial infarction, where interdisciplinary research and international cooperation are indispensable.

Circulating Gut Microbe-Derived Metabolites Are Associated with Hepatocellular Carcinoma.

Forty-one patients with HCC and 96 healthy controls were enrolled from surgical clinics at the Cleveland Clinic from 2016 to 2020. Gut microbiota-derived circulating metabolites detectable in plasma were compared between patients with HCC and healthy controls. Hierarchical clustering was performed for generating heatmaps based on circulating metabolite concentrations using ClustVis, with Euclidean and Ward settings and significant differences between metabolite concentrations were tested using a binary logistic regression model. In patients with HCC, 25 (61%) had histologically confirmed cirrhosis. Trimethylamine (TMA)-related metabolites were found at higher concentrations in those with HCC, including choline (p < 0.001), betaine (p < 0.001), carnitine (p = 0.007), TMA (p < 0.001) and trimethylamine N-oxide (TMAO, p < 0.001). Notably, concentrations of P-cresol glucuronide (p < 0.001), indole-lactic acid (p = 0.038), 5-hydroxyindoleacetic acid (p < 0.0001) and 4-hydroxyphenyllactic acid (p < 0.001) were also increased in those with HCC compared to healthy controls. Hierarchical clustering of the metabolite panel separated patients based on the presence of HCC (p < 0.001), but was not able to distinguish between patients with HCC based on the presence of cirrhosis (p = 0.42). Gut microbiota-derived metabolites were differentially abundant in patients with HCC versus healthy controls. The observed perturbations of the TMAO pathway in HCC seem particularly promising as a target of future research and may have both diagnostic and therapeutic implications.

Building expert consensus regarding sharing of individual research results in Alzheimer’s disease research: a Delphi study protocol

IntroductionInformed decisions to enrol in the clinical investigations of Alzheimer’s disease and related dementias (ADRD) require careful consideration of complex risks and uncertain benefits. Decisions regarding whether to receive information...

Association between geospatial disparities in food security with weight loss and nutritional outcomes of metabolic surgery

BackgroundFood insecurity has been linked to higher rates of obesity. It has also been shown to diminish the effectiveness of weight loss strategies, including intensive lifestyle interventions. One essential component of food insecurity is having a geospatial disadvantage in access to healthy, affordable food, such as living within a food desert. This study aims to determine if food insecurity also impacts weight loss and nutritional outcomes in patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).MethodsClinical outcomes of patients who underwent RYGB or SG at Cleveland Clinic or affiliate regional hospitals in the United States from 2010 to 2018 were collected. Modified Retail Food Environmental Index (mRFEI) data was collected from the Center for Disease Control and merged with patient census tract data, allowing the patient cohort to be divided into those living in areas identified as food secure (mRFEI > 10%), food swamps (mRFEI = 1–10%), or food deserts (mRFEI = 0). Postoperative weight change was evaluated with quadratic growth mixture models and stratified by surgery type.ResultsA total of 5097 patients were included in this study cohort, including 3424 patients who underwent RYGB and 1673 who underwent SG. The median duration of follow-up was 2.3 years (IQR 0.89–3.6 years). Food security status was not associated with postoperative weight change (RYGB p = 0.73, SG p = 0.60), weight loss nadir (RYGB p = 0.60, SG p = 0.79), or weight regain (RYGB p = 0.93, SG p = 0.85). Deficiencies in nutritional markers at 1–2 years after surgery were also not significantly different between food security groups.ConclusionDespite the established relationship between food insecurity and obesity, food insecurity does not negatively impact weight loss or nutritional outcomes following RYGB or SG, demonstrating metabolic surgery as a powerful and equitable tool for treating obesity.Level of EvidenceIV.

Kidney Biopsy Findings Among Patients With Diabetes in the Cleveland Clinic Kidney Biopsy Epidemiology Project

Rationale & ObjectiveDiabetic Kidney Disease (DKD) is a significant complication of diabetes mellitus, often leading to kidney failure. The absence of well-defined factors prevents distinguishing DKD from Non-Diabetic Kidney Disease (non-DKD; alternative primary diagnosis identified on kidney biopsy). Study DesignRetrospective cohort study. Setting& Participants: 1,242 patients with a history of diabetes from the Cleveland Clinic Kidney Biopsy Epidemiology Project between January 2015 and September 2021. ExposureProteinuria, retinopathy, A1c and eGFR. OutcomesNon-DKD, defined as an alternative primary diagnosis identified on kidney biopsy other than DKD. Analytical ApproachMultivariate logistic regression model with backward elimination method. ResultsAt the time of biopsy, the median (IQR) age was 63 (53-71) years, 58.8% were male, hemoglobin A1c was 6.7% (6.0-8.1), and serum creatinine was 2.5 (1.6-3.9) mg/dL. Among 1,242 patients, 462 (37.2%) had DKD alone, and 780 (62.8%) had non-DKD. Among those with non-DKD, the most common diagnoses were focal segmental glomerulosclerosis (24%), global glomerulosclerosis NOS (13%), acute tubular necrosis (9%), IgA nephropathy (8%), ANCA vasculitis (7%), and membranous nephropathy (5%). Factors associated with having non-DKD on biopsy were having no retinopathy (vs retinopathy) (adjusted odds ratio [aOR], 3.98; 95% CI, 2.69-5.90), lower A1c (<7% vs. ≥7%) (aOR, 3.08; 95%CI, 2.16-4.39), higher eGFR (≥60 vs. <60 ml/min/1.73m2) (aOR, 2.39; 95%CI 1.28-4.45), microalbuminuria (<300 vs. macroalbuminuria ≥300 [mg/g]) (aOR; 2.94; 95%CI, 1.84-4.72), and lower protein to creatinine ratio in random urine (<3 vs. ≥3mg/mg) (aOR; 1.80; 95%CI, 1.24-2.61). LimitationsSelection bias of clinically indicated biopsies, not protocol biopsies, which likely represent a ceiling (maximum) for non-DKD. ConclusionsAmong diabetic patients undergoing kidney biopsy, 63% have findings in addition to DKD on biopsy. We identified clinical parameters associated with non-DKD in the setting of diabetes. This provides valuable information for clinicians when kidney biopsy should be considered among diabetic patients to capture all etiologies of proteinuria and kidney dysfunction.

Effect of thumbtack needle on functional constipation: A pragmatic randomized controlled trial

ObjectiveThumbtack Needling (TN) has been employed in the treatment of functional constipation (FC), although the existing evidence supporting its effectiveness is limited. This study is to evaluate the efficacy of TN in ameliorating FC. MethodA total of 482 eligible patients were recruited and randomly assigned to the TN group or the Mosapride Citrate (MC) group. The TN was buried once for three days, rest for one day after two consecutive burials, followed by a 4-week follow-up. The primary outcome measure was the score for Complete and spontaneous bowel movement score (CSBMs). Secondary outcome measures included the Bristol Stool Form Scale (BSFS), Cleveland Clinic Score (CCS), and the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). ResultsOut of the 482 patients randomized, 241 were allocated to each group. Of these, 216 patients (89.6 %) in both groups completed the intervention and follow-up. Compared with the baseline, the differences of CSBMs in TN group [1.76(95 % CI, 1.61 to 1.91)] and MC group [1.35(95 % CI, 1.20 to 1.50)] at week 4 meet the threshold for minimal clinically important difference (MCID). However, there were no clinical difference from baseline at week 2 and week 8 in both groups. Mean CSBMs at week 4 was 3.35 ± 0.99 in the TN group and 3 ± 1.03 in the MC group (adjusted difference between groups, 0.37 points [95 % CI, 0.18 to 0.55]; P < 0.001), although differences between the two groups did not meet the MCID threshold. ConclusionCompared with mosapride citrate, thumbtack needling produced a greater improvement in CSBMs, although the difference from control was not clinically significant. ClinicalTrials.gov identifierChiCTR2100043684

Integrating lifestyle medicine into cancer care: A new paradigm.

179 Background: Amid rising global cancer rates and obesity-related cancer risks, oncology must blend traditional cancer treatments with evidence-based lifestyle medicine (LM) to enhance patient outcomes. LM—evidence-based interventions in nutrition, exercise, sleep, avoiding substances, and social connection —emerges as a critical tool in the care spectrum. ASCO and ACS guidelines incorporating lifestyle interventions are limited, and existing ones have notable implementation gaps. This study advocates for integration of LM into cancer care. Such interventions, supported by growing research, offer significant promise in reducing cancer treatment side effects and improving outcomes, highlighting an urgent need for their incorporation into oncological protocols. Methods: The Department of Preventive Medicine at Cleveland Clinic Abu Dhabi (CCAD) launched an LM program at the Oncology Institute. Oncologists refer to LM physicians who assess patients using an LM-validated questionnaire. Cardiometabolic risk factors: body composition, waist circumference, lipid profile, hemoglobin A1c, high-sensitivity CRP, liver function, and liver elastography are tested at baseline and 3 months. Patients receive personalized LM treatment by certified physicians, dieticians, physiatrists, and psychologists, aimed at reducing treatment side effects and enhancing cancer outcomes while improving cardiometabolic health. Follow-ups at 6 weeks and 3 months post-intervention ensure progress tracking and reassessment. Results: Initiated in January 2021, it began as a pilot program for breast cancer patients and has since expanded to all cancer patients. To date, it enrolled 425 patients, evidencing sustainability and acceptance within the patient community. Referral rates from oncologists have shown a steady increase, reflecting the program's growing credibility and utility. Patient satisfaction levels are reported to be high. Preliminary outcomes indicate improvements in both physical and psychological health metrics, suggestive of the program's comprehensive impact. Conclusions: The pioneering oncology LM program at CCAD established a transformative model that seamlessly integrates LM into traditional oncology care and acts as a bridge to survivorship. By ensuring sustained access to lifestyle interventions from the point of diagnosis through post-treatment, the program aligns with the latest research and ASCO/ACS guidelines, pioneering a new standard in cancer treatment. It can effectively address cardiometabolic risks, including obesity, and reduce treatment-related adverse outcomes. This program demonstrates the feasibility and a replicable global model, one that merges evidence-based lifestyle practices with standard oncological care to create a unified approach that could be adopted by healthcare systems worldwide, marking a significant step in the evolution of patient-centered cancer care.

Evaluation of the Appropriateness and Readability of ChatGPT-4 Responses to Patient Queries on Uveitis

To compare the utility of ChatGPT-4 as an online uveitis patient education resource with existing patient education websites. Evaluation of technology. Not applicable. The term "uveitis" was entered into the Google search engine, and the first 8 nonsponsored websites were selected to be enrolled in the study. Information regarding uveitis for patients was extracted from Healthline, Mayo Clinic, WebMD, National Eye Institute, Ocular Uveitis and Immunology Foundation, American Academy of Ophthalmology, Cleveland Clinic, and National Health Service websites. ChatGPT-4 was then prompted to generate responses about uveitis in both standard and simplified formats. To generate the simplified response, the following request was added to the prompt: 'Please provide a response suitable for the average American adult, at a sixth-grade comprehension level.' Three dual fellowship-trained specialists, all masked to the sources, graded the appropriateness of the contents (extracted from the existing websites) and responses (generated responses by ChatGPT-4) in terms of personal preference, comprehensiveness, and accuracy. Additionally, 5 readability indices, including Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, Coleman-Liau Index, and Simple Measure of Gobbledygook index were calculated using an online calculator, Readable.com, to assess the ease of comprehension of each answer. Personal preference, accuracy, comprehensiveness, and readability of contents and responses about uveitis. A total of 497 contents and responses, including 71 contents from existing websites, 213 standard responses, and 213 simplified responses from ChatGPT-4 were recorded and graded. Standard ChatGPT-4 responses were preferred and perceived to be more comprehensive by dually trained (uveitis and retina) specialist ophthalmologists while maintaining similar accuracy level compared with existing websites. Moreover, simplified ChatGPT-4 responses matched almost all existing websites in terms of personal preference, accuracy, and comprehensiveness. Notably, almost all readability indices suggested that standard ChatGPT-4 responses demand a higher educational level for comprehension, whereas simplified responses required lower level of education compared with the existing websites. This study shows that ChatGPT can provide patients with an avenue to access comprehensive and accurate information about uveitis, tailored to their educational level. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Outcome of gastric electrical stimulator with and without pyloromyotomy for refractory gastroparesis

BackgroundSurgical treatments of refractory gastroparesis include pyloromyotomy and gastric electrical stimulator (GES). It is unclear if patients may benefit from a combined approach with concomitant GES and pyloromyotomy.MethodsRetrospective cohort analysis of all patients with refractory gastroparesis treated with GES implantation with and without concomitant pyloromyotomy at Cleveland Clinic Florida from January 2003 to January 2023. Primary endpoint was efficacy (clinical response duration and success rate) and secondary endpoints included safety (postoperative morbidity) and length of stay. Success rate was defined as the absence of one of the following reinterventions during follow-up: Roux-en-Y gastric bypass (RYGB), pyloromyotomy, GES removal.ResultsDuring a period of 20 years, 134 patients were treated with GES implantation. Three patients with history of previous surgical pyloromyotomy or RYGB were excluded from the analysis. Median follow-up was 31 months (IQR 10, 72). Forty patients (30.5%) had GES with pyloromyotomy, whereas 91 (69.5%) did not have pyloromyotomy. Most of the patients had idiopathic (n = 68, 51.9%) or diabetic (n = 58, 43.3%) gastroparesis. Except for preoperative use of opioids (47.5 vs 14.3%; p < 0.001), patient’s characteristics were similar in both groups. There were no significant differences between the two groups in terms of overall postoperative complications (17.5% vs 14.3%; p = 0.610), major postoperative complications (0% vs 2.2%; p = 1), and length of stay (2(IQR 1, 2) vs 2(IQR 1, 3) days; p = 0.068). At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066). Especially patients with diabetic gastroparesis seemed to benefit from pyloromyotomy during GES (100% versus 67%, p = 0.053). In an adjusted Cox regression, GES implantation without pyloromyotomy was associated with a 2.66 times higher risk of treatment failure compared to GES implantation with pyloromyotomy (HR 2.66, 95% CI 1.03–6.94, p = 0.044).ConclusionPyloromyotomy during GES implantation for gastroparesis seems to be associated with a longer clinical response with similar postoperative morbidity and length of hospital stay than GES without pyloromyotomy. Patient with diabetic gastroparesis might benefit from a combination of GES implantation and pyloromyotomy.

American Association for Thoracic Surgery Quality Gateway: A surgeon case study of its application in adult cardiac surgery for quality assurance

ObjectiveTo demonstrate the application of American Association for Thoracic Surgery Quality Gateway (AQG) outcomes models to a Surgeon Case Study of quality assurance in adult cardiac surgery. MethodsThe case study includes 6989 cardiac and thoracic aorta operations performed in adults at Cleveland Clinic by a single surgeon between 2001 and 2023. AQG models were used to predict expected probabilities for operative mortality and major morbidity and to compare hospital outcomes, surgery type, risk profile, and individual risk factor levels using virtual (digital) twin causal inference. These models were based on postoperative procedural outcomes after 52,792 cardiac operations performed in 19 hospitals of 3 high-performing hospital systems with overall hospital mortality of 2.0%, analyzed by advanced machine learning for rare events. ResultsFor individual surgeons, their patients, hospitals, and hospital systems, the Surgeon Case Study demonstrated that AQG provides expected outcomes across the entire spectrum of cardiac surgery, from single-component primary operations to complex multicomponent reoperations. Actionable opportunities for quality improvement based on virtual twins are illustrated for patients, surgeons, hospitals, risk profile groups, operations, and risk factors vis-à-vis other hospitals. ConclusionsUsing minimal data collection and models developed using advanced machine learning, this case study shows that probabilities can be generated for operative mortality and major morbidity after virtually all adult cardiac operations. It demonstrates the utility of 21st century causal inference (virtual [digital] twin) tools for assessing quality for surgeons asking “how am I doing?,” their patients asking “what are my chances?,” and the profession asking “how can we get better?”

Reliability of MR Enterography Features for Describing Fibrostenosing Crohn Disease.

Background Clinical decision making and drug development for fibrostenosing Crohn disease is constrained by a lack of imaging definitions, scoring conventions, and validated end points. Purpose To assess the reliability of MR enterography features to describe Crohn disease strictures and determine correlation with stricture severity. Materials and Methods A retrospective study of patients with symptomatic terminal ileal Crohn disease strictures who underwent MR enterography at tertiary care centers (Cleveland Clinic: September 2013 to November 2020; Mayo Clinic: February 2008 to March 2019) was conducted by using convenience sampling. In the development phase, blinded and trained radiologists independently evaluated 26 MR enterography features from baseline and follow-up examinations performed more than 6 months apart, with no bowel resection performed between examinations. Follow-up examinations closest to 12 months after baseline were selected. Reliability was assessed using the intraclass correlation coefficient (ICC). In the validation phase, after five features were redefined, reliability was re-estimated in an independent convenience sample using baseline examinations. Multivariable linear regression analysis identified features with at least moderate interrater reliability (ICC ≥0.41) that were independently associated with stricture severity. Results Ninety-nine (mean age, 40 years ± 14 [SD]; 50 male) patients were included in the development group and 51 (mean age, 45 years ± 16 [SD]; 35 female) patients were included in the validation group. In the development group, nine features had at least moderate interrater reliability. One additional feature demonstrated moderate reliability in the validation group. Stricture length (ICC = 0.85 [95% CI: 0.75, 0.91] and 0.91 [95% CI: 0.75, 0.96] in development and validation phase, respectively) and maximal associated small bowel dilation (ICC = 0.74 [95% CI: 0.63, 0.80] and 0.73 [95% CI: 0.58, 0.87] in development and validation group, respectively) had the highest interrater reliability. Stricture length, maximal stricture wall thickness, and maximal associated small bowel dilation were independently (regression coefficients, 0.09-3.97; P < .001) associated with stricture severity. Conclusion MR enterography definitions and scoring conventions for reliably assessing features of Crohn disease strictures were developed and validated, and feature correlation with stricture severity was determined. © RSNA, 2024 Supplemental material is available for this article. See also the article by Rieder and Ma et al in this issue. See also the editorial by Galgano and Summerlin in this issue.

Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease.

Background Standardized methods to measure and describe Crohn disease strictures at CT enterography are needed to guide clinical decision making and for use in therapeutic studies. Purpose To assess the reliability of CT enterography features to describe Crohn disease strictures and their correlation with stricture severity. Materials and Methods A retrospective study was conducted in 43 adult patients with symptomatic terminal ileal Crohn disease strictures who underwent standard-of-care CT enterography at a tertiary care center at the Cleveland Clinic between January 2008 and August 2016. After training on standardized definitions, four abdominal radiologists blinded to all patient information assessed imaging features (seven continuous measurements and nine observations) of the most distal ileal stricture in two separate sessions (separated by ≥2 weeks) in random order. Features with an interrater intraclass correlation coefficient (ICC) of 0.41 or greater (ie, moderate reliability or better) were considered reliable. Univariable and multivariable linear regression analysis identified reliable features associated with a visual analog scale of overall stricture severity. Significant reliable features were assessed as components of a CT enterography-based model to quantitate stricture severity. Results Examinations in 43 patients (mean age, 52 years ± 16 [SD]; 23 female) were evaluated. Five continuous measurements and six observations demonstrated at least moderate interrater reliability (interrater ICC range, 0.42 [95% CI: 0.25, 0.57] to 0.80 [95% CI: 0.67, 0.88]). Of these, 10 were univariably associated with stricture severity, and three continuous measurements-stricture length (interrater ICC, 0.64 [95% CI: 0.42, 0.81]), maximal associated small bowel dilation (interrater ICC, 0.80 [95% CI: 0.67, 0.88]), and maximal stricture wall thickness (interrater ICC, 0.50 [95% CI: 0.34, 0.62])-were independently associated (P value range, <.001 to .003) with stricture severity in a multivariable model. These three measurements were used to derive a well-calibrated (optimism-adjusted calibration slope = 1.00) quantitative model of stricture severity. Conclusion Standardized CT enterography measurements and observations can reliably describe terminal ileal Crohn disease strictures. Stricture length, maximal associated small bowel dilation, and maximal stricture wall thickness are correlated with stricture severity. © RSNA, 2024 Supplemental material is available for this article. See also the article by Rieder et al in this issue. See also the editorial by Galgano and Summerlin in this issue.

Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol

IntroductionGiven the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers.Methods and analysisWe present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson’s Disease, or Alzheimer’s disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants’ neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses.PerspectivesThe MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease.Trial registrationThe trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.