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S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Saeed, Anwaar; Colby, Sarah; Oberstein, Paul Eliezer; Duda, Dan G; Park, Robin; Agarwal, Rajiv; Figueroa-Moseley, Colmar; Vaidya, Riha; Unger, Joseph M; Guthrie, Katherine A; Rocha, Flavio G; Senthil, Maheswari; Safyan, Rachael A; Wainberg, Zev A; Iqbal, Syma; Chiorean, E Gabriela; Philip, Philip A
NCT06203600.
PMID: 40155326
ISSN: 1744-8301
CID: 5817862

The Neurologist's Imperative in Brain Death

Greer, David M; Lewis, Ariane; Kirschen, Matthew P
PMID: 40126488
ISSN: 2168-6157
CID: 5814692

Spinal Cord Stimulation Explantation and Chronic Pain: A Systematic Review and Technology Recommendations

Wahezi, Sayed E; Yener, Ugur; Naeimi, Tahereh; Lewis, Joshua B; Yerra, Sandeep; Sgobba, Philip; Ciftci, Hatice Begum; Vydyanathan, Amaresh; Chiu, Elisa; Cherkalin, Denis; Darji, Jay Y; Masterson, Ryan; Lee, Danielle; Jarusriwanna, Atthakorn; Palee, Suwannika; Ortiz, Nicole R; Caparo, Moorice; Dayon, Eli; Fontaine, Camille; Bikson, Marom; Schatman, Michael E; Pritzlaff, Scott G; Deer, Timothy R; Hunter, Corey W
BACKGROUND/UNASSIGNED:Chronic pain affects 20.5% of the US population, costing $296 billion annually in lost productivity. Spinal cord stimulation (SCS) has become a key treatment for refractory neuropathic and nociceptive pain, with increasing usage due to technological advancements. However, the durability of SCS therapy, including explantation rates, remains a concern. Understanding explantation causes is essential for improving patient selection and device effectiveness. This study aims to analyze SCS explantation rates and reasons, as well as evaluate the financial burden of these procedures on the healthcare system. METHODS/UNASSIGNED:Three primary screening methods were used: manual search with keywords, MeSH term query, and reference list screening. The search covered PubMed, Cochrane, and Web of Science databases from inception to November 2024, yielding 719 articles. After applying eligibility criteria, 72 articles were identified, and 25 were selected for analysis. Data extraction was done by independent reviewers, with a second reviewer ensuring accuracy. Discrepancies were resolved by the corresponding editor. RESULTS/UNASSIGNED:We reviewed data from 13,026 patients who underwent permanent SCS implantation between 1984 and 2024, across 25 studies. A total of 1882 patients (9.82%) underwent explantation. The most common reason was lack of efficacy and inadequate pain relief (38%), followed by lead failure (15%) and infection (14%). While SCS is generally effective, issues related to device longevity and patient satisfaction persist, with explantation rates due to technical failures and lack of efficacy being concerns. CONCLUSION/UNASSIGNED:SCS efficacy varies, with explantation rates reaching up to 38%, often due to inadequate pain relief. Most explantations occur within the first year, despite SCS being a safe and effective treatment. High implantation costs ($35,000 to $70,000) and revision costs ($15,000 to $25,000) raise concerns among payors. The hardware-driven model limits waveform flexibility, highlighting the need for innovation.
PMCID:11929510
PMID: 40124536
ISSN: 1178-7090
CID: 5814642

Endometriosis: assessment on O-RADS and risk of malignant transformation

Suarez-Weiss, Krista Elise; Patel-Lippmann, Krupa; Phillips, Catherine; Burk, Kristine; Tong, Angela; Arif, Hina; Nicola, Refky; Jha, Priyanka
Endometriosis is a common disease, affecting approximately 10% of women of reproductive age. Several intersecting guidelines and consensus statements provide information on imaging diagnosis and surveillance strategies for endometriomas. SRU consensus panel recommendations provide information on initial detection of endometriosis on routine pelvic imaging. Revised American Society of Reproductive Medicine (rASRM) classification, the #ENZIAN classification, and the deep pelvic endometriosis index (dPEI) aim to assess the overall extent of disease and assist in presurgical planning. The Ovarian-Adnexal Reporting and Data System (O-RADS) aims to risk stratify lesions evaluated with US or MR based on their imaging morphology, from typical benign lesions to atypical presentations and malignant transformation. Emerging data shows increased risk of ovarian cancer in patients with endometriosis, especially following menopause and in those patients with long standing endometriosis. (Chen et al. in Front Oncol. 14:1329133, 2024;Streuli et al. in Climacteric. 20:138-143, 2017;Secosan et al. in Diagnostics (Basel). 10:134, 2020;Inceboz in Womens Health (Lond Engl). 11:711-715, 2015;Cassani et al. in Maturitas. 190, 2024;Gemmell et al. in Hum Reprod Update. 23:481-500, 2017;Giannella et al. in Cancers (Basel). 13:4026, 2021;) Current O-RADS guidelines mandate follow-up of endometriomas up to 2 years with further follow-up based on clinical factors. No consensus guidelines exist for imaging surveillance of patients with deep endometriosis from a malignancy standpoint. This review explores the imaging appearance of endometriomas, imaging features of malignant transformation, surveillance strategies and gaps in current literature, and attempts to better understand the risk of malignancy and to encourage further research for long-term imaging surveillance of endometriosis patients.
PMID: 40137947
ISSN: 2366-0058
CID: 5815832

"FATAL Graft": A Diagnostic Algorithm for the Workup of Anterior Cruciate Ligament Reconstruction Graft Failure

Bi, Andrew S; Pianka, Mark A; Jazrawi, Laith M; Alaia, Michael J
There are multiple etiologies for revision anterior cruciate ligament reconstruction (ACLR), including but not limited to infection, arthrofibrosis, and graft failure, which should be distinguished before revision ACLR. Graft failure occurs when the reconstructed ligament does not restore knee stability, and it includes both graft rupture and functional failure in the setting of an intact graft. The causes of graft failure following ACLR can be divided into surgeon-controllable factors (ie, tunnel position, graft choice, alignment) and patient-centric factors (ie, patient age, tissue quality from systemic disease or smoking, compliance/traumatic reruptures). The purpose of this review is to propose an organized, easy-to-remember algorithm for the workup of surgeon-controlled ACLR graft failure etiologies, represented by the acronym "FATAL Graft."
PMID: 40138439
ISSN: 1940-5480
CID: 5815912

Invasive vs Conservative Management of Patients With Chronic Total Occlusion: Results From the ISCHEMIA Trial

Bangalore, Sripal; Mancini, G B John; Leipsic, Jonathan; Budoff, Mathew J; Xu, Yifan; Anthopolos, Rebecca; Brilakis, Emmanouil S; Dwivedi, Aeshita; Spertus, John A; Jones, Phil G; Cho, Yoon Joo; Mark, Daniel B; Hague, Cameron J; Min, James K; Reynolds, Harmony R; Elghamaz, Ahmed; Nair, Rajesh Goplan; Mavromatis, Kreton; Gosselin, Gilbert; Banerjee, Subhash; Pejkov, Hristo; Lindsay, Steven; Grantham, J Aaron; Williams, David O; Stone, Gregg W; O'Brien, Sean M; Hochman, Judith S; Maron, David J; ,
BACKGROUND:Randomized trials of chronic total occlusion (CTO) revascularization vs medical therapy have yielded inconsistent results. OBJECTIVES/OBJECTIVE:The aim of this study was to evaluate outcomes with an initial invasive strategy (INV) vs an initial conservative strategy (CON) in patients with coronary computed tomographic angiography (CCTA)-determined CTO in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial. METHODS:Participants in ISCHEMIA who underwent CCTA evaluated for CTO by the core laboratory (3,113 of 5,179 randomized patients [60%]) were categorized into subgroups with (100% stenosis) and without (<100% stenosis) CTO. Primary analysis compared outcomes in those randomized to INV vs CON using an intention-to-treat approach. Secondary analyses compared outcomes using inverse probability weighting to model successful CTO revascularization (REV) in all INV participants vs CON participants. RESULTS:Of the 3,113 CCTA-evaluable participants, 1,470 had at least 1 CTO (752 INV and 718 CON). INV did not reduce cardiovascular (CV) death or myocardial infarction (MI) (5-year difference -3.5%; 95% CI: -7.8% to 0.8%) and resulted in more procedural MIs (2.5%; 95% CI: 1.0%-4.0%) but fewer spontaneous MIs (-6.3%; 95% CI: -9.7% to -3.2%) than CON. CTO REV modeled across INV had a high probability (>90%) of any lower CV death or MI, MI, spontaneous MI, unstable angina, and heart failure counterbalanced by a higher rate of procedural MI. CTO REV significantly improved angina-related quality of life (mean difference 4.6 points), Rose Dyspnea Scale score (rescaled) (mean difference 5.3 points), and EQ-5D visual analog scale score (4.6 points). CONCLUSIONS:In the ISCHEMIA trial, the risks and benefits of INV compared with CON were similar among patients with and without CCTA-determined CTO (more frequent procedural MI, less frequent spontaneous MI, and significantly improved angina and dyspnea-related quality of life). In an observational comparison, successful CTO REV was associated with a high probability of lower CV death or MI (driven by lower MI) compared with CON. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
PMID: 40139890
ISSN: 1558-3597
CID: 5816262

Female gender and racial minority status is associated with Poor clinical outcomes and higher healthcare resource utilization in necrotizing fasciitis: Analysis of a Nationwide database in the United States

Nadeem, Muhammad Ahmad; Quazi, Mohamed A; Sulaiman, Samia Aziz; Sohail, Amir Humza; Munir, Aqsa; Khan, Abdullah; Hanif, Hamza; Sultan, Sulaiman; Joseph, D'andrea K; Sheikh, Abu Baker
INTRODUCTION/BACKGROUND:Necrotizing fasciitis is a rapidly progressive infection associated with high mortality and complications. It mainly involves subcutaneous tissue and fascia. More quality data on disparities in clinical outcomes of necrotizing fasciitis must be provided. Our study aims to identify gender and racial disparities in necrotizing fasciitis outcomes. METHODS:We used data from the Nationwide Inpatient Sample database from 2016 to 2020. As appropriate, the Chi-square and t-test were used to test for associations between categorical and continuous variables. Multivariate logistic regression models, adjusted for key confounders, were used to obtain odds ratios for in-hospital mortality and various complications. Similarly, multivariate linear regression models were created for continuous outcome variables. RESULTS:Among 118,775 patients with necrotizing fasciitis, women (adjusted odds ratio [aOR] 1.18, 95 ​% confidence interval [CI]: 1.07-1.30, p ​= ​0.001), Asian (aOR 1.49 (95 ​% CI: 1.10-2.02, p ​= ​0.01), and Hispanic (aOR: 1.16; 95 ​% CI: 1.0-1.35; p ​= ​0.045) patients had significantly higher in-hospital mortality than White patients. In comparison with men, women were more likely to require invasive mechanical ventilation and blood transfusions and develop ARDS. They are less likely to develop AKI, acute myocardial infarction, or venous thromboembolism and require non-invasive mechanical ventilation (p ​< ​0.05 for all comparisons). Similarly, certain racial minority groups were also at a heightened risk for complications, such as AKI requiring hemodialysis, ARDS, venous thromboembolism, sudden cardiac arrest, and need for blood transfusion, among others (p ​< ​0.05 for all comparisons). As compared to white patients, African American (1.7 days longer, p ​< ​0.001), Asian (4.3 days longer, p ​< ​0.001), and Hispanic (0.6 days longer, p ​= ​0.048) patients had a significantly longer length of hospital stay. Asian, African American, and Hispanic patients also had substantially higher hospitalization costs, amounting to an additional $17,596.07 (p ​< ​0.001), $5899.60 (p ​< ​0.001), and $4356.55 (p ​< ​0.01), respectively, versus White patients. Native American patients did not have any significant difference in the cost of hospitalization as compared to White patients. CONCLUSION/CONCLUSIONS:Females and racial minorities are at increased risk of mortality and higher healthcare resource utilization in necrotizing fasciitis. There is a need to develop equitable management strategies and health policy interventions to address these disparities effectively.
PMID: 40147168
ISSN: 1879-1883
CID: 5816872

Society of Family Planning Clinical Recommendation: Management of undesired pregnancy of unknown location and abortion at less than 42 days of gestation

Nippita, Siripanth; Cansino, Catherine; Goldberg, Alisa B; Qasba, Neena; White, Katharine; Goyal, Vinita; Ti, Angeline; ,; Boraas, Christy
Pregnancy of unknown location is a condition in which a pregnancy test is positive, but no intrauterine or extrauterine pregnancy is visualized using transvaginal ultrasonography. We recommend using standardized nomenclature and definitions to describe intrauterine pregnancy (IUP), probable IUP, pregnancy of unknown location (PUL), probable ectopic pregnancy (probable EP), and ectopic pregnancy (EP) (Best Practice). Among abortion-seeking patients found to have a PUL, the incidence of ectopic pregnancy (EP) is 4-8%. We recommend clinical judgment in assessing the risk for EP in the setting of PUL; the absence of an intrauterine gestational sac (GS) or yolk sac should not delay care (GRADE 1B). In asymptomatic individuals with an undesired PUL who prefer to proceed with immediate treatment (medication or procedural management without delay) and have a low risk of EP, as determined by the clinician based on history, symptoms, and all other available data, we recommend medication management with mifepristone and misoprostol or procedural management via uterine aspiration and clear plans for ensuring pregnancy resolution in a timely fashion (GRADE 1B). While both medication and procedural management of undesired PUL are associated with earlier pregnancy resolution and identification of EP, the two main risks of inadequate follow-up include ongoing pregnancy and missing or delaying a subsequent diagnosis of EP. For individuals with PUL choosing immediate treatment with medication management, we recommend clinicians obtain a baseline serum quantitative hCG at the time of medication provision to aid in diagnosis and follow-up (GRADE 1A). Following medication management of PUL with mifepristone and misoprostol, we suggest a repeat serum quantitative hCG level, with pregnancy resolution defined as either a 50% decline or greater at 48-72 hours after misoprostol or an 80% decline or greater at seven days after mifepristone or 5-10 days after misoprostol (GRADE 2B). We recommend against direct extrapolation of follow-up recommendations from no-test abortion clinical protocols to individuals with a documented PUL treated with mifepristone and misoprostol, given the higher risk of EP among individuals with a known PUL (GRADE 1C). When uterine aspiration is performed at less than 42 days of gestation, including for individuals with PUL or probable IUP, and both chorionic villi and GS are not visualized, we recommend repeat ultrasonography (if an IUP or probable IUP was seen initially), serum quantitative hCG follow-up, or both (GRADE 1B). When both chorionic villi and GS are not visualized after uterine aspiration and serial serum hCG follow-up is warranted, we recommend testing on the day of the procedure and 24-72 hours later, with pregnancy resolution defined as greater than 50% decline 24 hours after aspiration, greater than 70% by 48 hours, or greater than 80% by approximately 72 hours (GRADE 1B).
PMID: 40122324
ISSN: 1879-0518
CID: 5814582

The Efficacy of Outpatient Swallowing Therapy: A Retrospective Longitudinal Cohort Study

Crosby, Tyler W; Molfenter, Sonja; Balou, Matina; Ezeh, Uche C; Amin, Milan R
Oropharyngeal dysphagia is an independent predictor of poor outcomes in many health conditions and can be targeted directly through swallowing therapy. This study aims to explore the outcomes of outpatient swallowing therapy in clinical practice across a diverse cohort of patients. This was a retrospective, single-site longitudinal cohort study. Patients 18 years or older with dysphagia who completed 7-8 weeks of outpatient swallowing therapy with a pre- and post-treatment videofluoroscopy were included. Therapy employed a progressive swallowing exercise regimen based on the Systematic Exercise for Treatment of Swallowing (SETS) protocol. Outcome measures included the pharyngeal components of the Modified Barium Swallow Impairment Profile, penetration-aspiration scale scores, and diet recommendations using the International Dysphagia Diet Standardization Initiative. 152 patients were included. Swallowing therapy improved all MBSImP component scores except 1, 7, and 13. Therapy improved total pharyngeal impairment scores by 2.66 points (p < .001) and total oral impairment score by 1.41 points (p < .001). Odds of elevated aspiration risk were reduced by 49% (p < .001). Patients were more likely to be on an unmodified food consistency after completion of therapy (OR 26, p = .004), but liquid consistency was not altered (OR 2.0, p = .57). Overall, 44% of patients in the cohort with an efficiency issue improved, and 50% of patients at risk for aspiration pre-therapy improved. Completing a 7-8 week course of exercise-based outpatient swallowing therapy is effective at improving multiple measures of swallowing physiology, safety and efficiency. It can also enable relaxation of diet consistency restrictions based on the IDDSI framework.
PMID: 40148536
ISSN: 1432-0460
CID: 5817032

ATVB Journal Awards at Vascular Discovery

Schmidt, Ann Marie
PMID: 40138443
ISSN: 1524-4636
CID: 5815952