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Prospective Cohort Study to Compare Long-Term Lung Cancer-Specific and All-Cause Survival of Clinical Early Stage (T1a-b; ≤20 mm) NSCLC Treated by Stereotactic Body Radiation Therapy and Surgery

Henschke, Claudia I; Yip, Rowena; Sun, Qi; Li, Pengfei; Kaufman, Andrew; Samstein, Robert; Connery, Cliff; Kohman, Leslie; Lee, Paul; Tannous, Henry; Yankelevitz, David F; Taioli, Emanuela; Rosenzweig, Kenneth; Flores, Raja M; ,; ,
INTRODUCTION:We aimed to compare outcomes of patients with first primary clinical T1a-bN0M0 NSCLC treated with surgery or stereotactic body radiation therapy (SBRT). METHODS:We identified patients with first primary clinical T1a-bN0M0 NSCLCs on last pretreatment computed tomography treated by surgery or SBRT in the following two prospective cohorts: International Early Lung Cancer Action Program (I-ELCAP) and Initiative for Early Lung Cancer Research on Treatment (IELCART). Lung cancer-specific survival and all-cause survival after diagnosis were compared using Kaplan-Meier analysis. Propensity score matching was used to balance baseline demographics and comorbidities and analyzed using Cox proportional hazards regression. RESULTS:Of 1115 patients with NSCLC, 1003 had surgery and 112 had SBRT; 525 in I-ELCAP in 1992 to 2021 and 590 in IELCART in 2016 to 2021. Median follow-up was 57.6 months. Ten-year lung cancer-specific survival was not significantly different: 90% (95% confidence interval: 87%-92%) for surgery versus 88% (95% confidence interval: 77%-99%) for SBRT, p = 0.55. Cox regression revealed no significant difference in lung cancer-specific survival for the combined cohorts (p = 0.48) or separately for I-ELCAP (p = 1.00) and IELCART (p = 1.00). Although 10-year all-cause survival was significantly different (75% versus 45%, p < 0.0001), after propensity score matching, all-cause survival using Cox regression was no longer different for the combined cohorts (p = 0.74) or separately for I-ELCAP (p = 1.00) and IELCART (p = 0.62). CONCLUSIONS:This first prospectively collected cohort analysis of long-term survival of small, early NSCLCs revealed that lung cancer-specific survival was high for both treatments and not significantly different (p = 0.48) and that all-cause survival after propensity matching was not significantly different (p = 0.74). This supports SBRT as an alternative treatment option for small, early NSCLCs which is especially important with their increasing frequency owing to low-dose computed tomography screening. Furthermore, treatment decisions are influenced by many different factors and should be personalized on the basis of the unique circumstances of each patient.
PMID: 37806384
ISSN: 1556-1380
CID: 5787612

Cardiogenic Shock in Older Adults: A Focus on Age-Associated Risks and Approach to Management: A Scientific Statement From the American Heart Association

Blumer, Vanessa; Kanwar, Manreet K; Barnett, Christopher F; Cowger, Jennifer A; Damluji, Abdulla A; Farr, Maryjane; Goodlin, Sarah J; Katz, Jason N; McIlvennan, Colleen K; Sinha, Shashank S; Wang, Tracy Y; ,
Cardiogenic shock continues to portend poor outcomes, conferring short-term mortality rates of 30% to 50% despite recent scientific advances. Age is a nonmodifiable risk factor for mortality in patients with cardiogenic shock and is often considered in the decision-making process for eligibility for various therapies. Older adults have been largely excluded from analyses of therapeutic options in patients with cardiogenic shock. As a result, despite the association of advanced age with worse outcomes, focused strategies in the assessment and management of cardiogenic shock in this high-risk and growing population are lacking. Individual programs oftentimes develop upper age limits for various interventional strategies for their patients, including heart transplantation and durable left ventricular assist devices. However, age as a lone parameter should not be used to guide individual patient management decisions in cardiogenic shock. In the assessment of risk in older adults with cardiogenic shock, a comprehensive, interdisciplinary approach is central to developing best practices. In this American Heart Association scientific statement, we aim to summarize our contemporary understanding of the epidemiology, risk assessment, and in-hospital approach to management of cardiogenic shock, with a unique focus on older adults.
PMCID:11067718
PMID: 38406869
ISSN: 1524-4539
CID: 5788462

Design and Execution of Clinical Trials in the Cardiac Intensive Care Unit

Pierce, Jacob B; Applefeld, Willard N; Senman, Balimkiz; Loriaux, Daniel B; Lawler, Patrick R; Katz, Jason N
Clinical practice in the contemporary cardiac intensive care unit (CICU) has evolved significantly over the last several decades. With more frequent multisystem organ failure, increasing use of advanced respiratory support, and the advent of new mechanical circulatory support platforms, clinicians in the CICU are increasingly managing patients with complex comorbid disease in addition to their high-acuity cardiovascular illnesses. Here, the authors discuss challenges associated with traditional trial design in the CICU setting and review novel clinical trial designs that may facilitate better evidence generation in the CICU.
PMID: 37973354
ISSN: 1557-8232
CID: 5788392

Making hospitals innovative: Macro-level policy to sustain micro-innovations in healthcare

Ramadi, Khalil B; More, Saakshi; Shaji, Anshuman
Successful innovation clusters are notoriously difficult to establish, and many attempts fail. How can we go about designing such systems reliably? We describe how ecosystems can be strengthened through grassroots bottom-up efforts that empower user and community innovation, as opposed to economic policies that dictate innovation. Specifically focusing on the healthcare industry, we advocate that community hospitals which constitute 90% of all hospitals in Canada are the ideal setting for such community innovation efforts. We investigated the distribution of innovation output from hospitals over the past 13 years and found a decrease in predominance of major teaching hospitals, supporting the potential role for community hospitals in this space. We categorize different types of innovations and recommend institutional policies that can sustain bottom-up, micro-level efforts. Such policies could improve and enhance the development of micro-innovations and the creation of health innovation clusters.
PMID: 39150235
ISSN: 0840-4704
CID: 5787942

Characteristics and Outcomes of Adults With Congenital Heart Disease in the Cardiac Intensive Care Unit

Keane, Ryan R; Carnicelli, Anthony P; Loriaux, Daniel B; Kendsersky, Payton; Krasuski, Richard A; Brown, Kelly M; Arps, Kelly; Baird-Zars, Vivian; Dixson, Jeffrey A; Echols, Emily; Granger, Christopher B; Harrison, Robert W; Kontos, Michael; Newby, L Kristin; Park, Jeong-Gun; Shah, Kevin S; Ternus, Bradley W; Van Diepen, Sean; Katz, Jason N; Morrow, David A
BACKGROUND/UNASSIGNED:Little is known regarding the characteristics, treatment patterns, and outcomes in patients with adult congenital heart disease (ACHD) admitted to cardiac intensive care units (CICUs). OBJECTIVES/UNASSIGNED:The authors sought to better define the contemporary epidemiology, treatment patterns, and outcomes of ACHD admissions in the CICU. METHODS/UNASSIGNED:The Critical Care Cardiology Trials Network is a multicenter network of CICUs in North America. Participating centers contributed prospective data from consecutive admissions during 2-month annual snapshots from 2017 to 2022. We analyzed characteristics and outcomes of admissions with ACHD compared with those without ACHD. Multivariable logistic regression was used to assess mortality in ACHD vs non-ACHD admissions. RESULTS/UNASSIGNED: = 0.239). CONCLUSIONS/UNASSIGNED:This study illustrates the unique aspects of the ACHD CICU admission. Further investigation into the best approach to manage specific ACHD-related CICU admissions, such as cardiogenic shock and acute respiratory failure, is warranted.
PMID: 39135920
ISSN: 2772-963x
CID: 5788492

Consensus statements from the International Society for Heart and Lung Transplantation consensus conference: Heart failure-related cardiogenic shock

Baran, David A; Billia, Filio; Randhawa, Varinder; Cowger, Jennifer A; Barnett, Christopher M; Chih, Sharon; Ensminger, Stephan; Hernandez-Montfort, Jaime; Sinha, Shashank S; Vorovich, Esther; Proudfoot, Alastair; Lim, Hoong Sern; Blumer, Vanessa; Jennings, Douglas L; Reshad Garan, A; Renedo, Maria Florencia; Hanff, Thomas C; Kanwar, Manreet K; ,
The last decade has brought tremendous interest in the problem of cardiogenic shock. However, the mortality rate of this syndrome approaches 50%, and other than prompt myocardial revascularization, there have been no treatments proven to improve the survival of these patients. The bulk of studies have been in patients with acute myocardial infarction, and there is little evidence to guide the clinician in those patients with heart failure cardiogenic shock (HF-CS). An International Society for Heart and Lung Transplant consensus conference was organized to better define, diagnose, and manage HF-CS. There were 54 participants (advanced heart failure and interventional cardiologists, cardiothoracic surgeons, critical care cardiologists, intensivists, pharmacists, and allied health professionals) with vast clinical and published experience in CS, representing 42 centers worldwide. This consensus report summarizes the results of a premeeting survey answered by participants and the breakout sessions where predefined clinical issues were discussed to achieve consensus in the absence of robust data. Key issues discussed include systems for CS management, including the "hub-and-spoke" model vs a tier-based network, minimum levels of data to communicate when considering transfer, disciplines that should be involved in a "shock team," goals for mechanical circulatory support device selection, and optimal flow on such devices. Overall, the document provides expert consensus on some important issues facing practitioners managing HF-CS. It is hoped that this will clarify areas where consensus has been reached and stimulate future research and registries to provide insight regarding other crucial knowledge gaps.
PMID: 38069919
ISSN: 1557-3117
CID: 5788412

Hepatology consultation is associated with decreased early return to alcohol use after discharge from an inpatient alcohol use disorder treatment program

Blaney, Hanna L; Khalid, Mian B; Yang, Alexander H; Asif, Bilal A; Vittal, Anusha; Kamal, Natasha; Wright, Elizabeth C; Abijo, Tomilowo; Koh, Chris; George, David; Goldman, David; Horneffer, Yvonne; Diazgranados, Nancy; Heller, Theo
BACKGROUND:Alcohol cessation is the only intervention that both prevents and halts the progressions of alcohol-associated liver disease. The aim of this study was to assess the relationship between a return to alcohol use and consultation with hepatology in treatment-seeking patients with alcohol use disorder (AUD). METHODS:Two hundred forty-two patients with AUD were enrolled in an inpatient treatment program, with hepatology consultation provided for 143 (59%) patients at the request of the primary team. Patients not seen by hepatology served as controls. The primary outcome was any alcohol use after discharge assessed using AUDIT-C at 26 weeks after discharge. RESULTS:For the primary endpoint, AUDIT at week 26, 61% of the hepatology group and 28% of the controls completed the questionnaire (p=0.07). For the secondary endpoint at week 52, these numbers were 22% and 11% (p = 0.6). At week 26, 39 (45%) patients in the hepatology group versus 31 (70%) controls (p = 0.006) returned to alcohol use. Patients evaluated by hepatology had decreased rates of hazardous alcohol use compared to controls, with 36 (41%) versus 29 (66%) (p = 0.008) of the patients, respectively, reporting hazardous use. There were no significant differences in baseline characteristics between groups and no difference in rates of prescribing AUD therapy. There was no difference in outcomes at 52 weeks. CONCLUSIONS:Patients evaluated by hepatology had significantly lower rates of return to alcohol use and lower rates of hazardous drinking at 26 weeks but not at 52 weeks. These findings suggest that hepatology evaluation during inpatient treatment of AUD may lead to decreased rates of early return to alcohol use.
PMCID:11019822
PMID: 38619432
ISSN: 2471-254x
CID: 5787022

Development of hepatic fibrosis in common variable immunodeficiency-related porto-sinusoidal vascular disorder

Hercun, Julian; Asif, Bilal; Vittal, Anusha; Ahmed, Abdel; Gopalakrishna Pillai, Harish Kumar; Bergerson, Jenna R E; Holland, Steven; Uzel, Gulbu; Strober, Warren; Fuss, Ivan J; Koh, Christopher; Kleiner, David E; Heller, Theo
BACKGROUND AND AIMS/OBJECTIVE:Liver involvement is an increasingly recognised complication of common variable immunodeficiency (CVID). Nodular regenerative hyperplasia (NRH), a subgroup of porto-sinusoidal vascular disorder, and manifestations of portal hypertension (PH) unrelated to cirrhosis are the most common findings. Nonetheless, the evolution of liver disease over time remains unknown. METHODS:Retrospective review of patients followed at the National Institutes of Health with CVID-related liver disease and liver biopsy from 1990 to 2020. Clinical, imaging and histological follow-up were recorded as part of clinical research protocols. RESULTS:/L, spleen size 19.5 cm, hepatic venous pressure gradient 9.5 mmHg and 37.5% of patients had signs of PH. Cumulative incidence of PH was 65% at 5 years. In a subgroup of 16 patients, a follow-up liver biopsy, performed at a median time of 3 years after the index biopsy, revealed an increase in fibrosis by ≥2 stages in 31% of cases and an increase to an overall stage of 2.2 (p = 0.001). No clinical or histological factors were associated with progression of fibrosis. CONCLUSIONS:In this CVID cohort, NRH is the most common initial histological finding; however, unexpectedly fibrosis progresses over time in a subgroup of patients. A better understanding of the underlying causal process of liver disease CVID might lead to improved outcomes.
PMID: 39090843
ISSN: 1365-2036
CID: 5787032

Inadequacy of the eighth edition of the American Joint Committee on Cancer pancreatic cancer staging system for invasive carcinoma associated with premalignant lesions in the pancreas: an analysis using the National Cancer Database

Jung, Hye-Sol; Lee, Mirang; Han, Youngmin; Thomas, Alexander S; Yun, Won-Gun; Cho, Young J; Kluger, Michael D; Jang, Jin-Young; Kwon, Wooil
BACKGROUND:Invasive carcinomas arising from premalignant lesions are currently staged by the same criteria as conventional pancreatic ductal adenocarcinoma. METHODS:Clinicopathologic information and survival data were extracted through a thorough search of histology codes from National Cancer Database (2006-2016). A total of 723 patients with invasive intraductal papillary mucinous neoplasm and mucinous cystic neoplasm were analyzed. RESULTS:The median age was 67 years, and 351 patients (48.5%) were male. There were 212 (29.3%), 232 (32.1%), 272 (37.6%), and 7 (1.0%) patients with T1, T2, T3, and T4 classification. Extrapancreatic extension (EPE) was present in 284 (39.3%). Age (HR = 1.504, 95% CI 1.196-1.891), R1 or R2 resection (HR = 1.585, 95% CI 1.175-2.140), and EPE (HR = 1.598, 95% CI 1.209-2.113) were independent prognostic factors for overall survival. Size criteria did not significantly affect survival. The median survival was 115.9 months for patients without EPE, compared to 34.2 months for those with EPE. EPE discriminated survival better than tumor size. DISCUSSION:The T classification of the eighth edition AJCC staging system is not adequate for invasive carcinomas associated with premalignant lesions of the pancreas. They merit a separate, dedicated staging system that uses appropriate prognostic factors.
PMID: 38114399
ISSN: 1477-2574
CID: 5786992

Chronic Liver Disease in Patients with Prolidase Deficiency: A Case Series [Case Report]

Gopalakrishna, Harish; Asif, Bilal; Rai, Anjali; Conjeevaram, Hari S; Mironova, Maria; Kleiner, David E; Freeman, Alexandra F; Heller, Theo
INTRODUCTION/UNASSIGNED:gene. Patients usually have multi-organ involvement and a wide range of clinical features including recurrent skin ulcers, dysmorphic facial features, recurrent infections, intellectual disability, and splenomegaly. Studies have shown that patients with prolidase deficiency may have hepatic manifestations including hepatomegaly and abnormal liver enzymes. However, there is no detailed description of liver disease in this patient population. CASE PRESENTATION/UNASSIGNED:Here, we present 3 patients with prolidase deficiency with varying extents of hepatic involvement. CONCLUSION/UNASSIGNED:Prolidase deficiency patients with liver disease should be followed up long term to understand more about the pathophysiology and the impact of liver disease on long-term outcomes.
PMCID:10834036
PMID: 38304571
ISSN: 1662-0631
CID: 5787012