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1. The Long Haul to Surgery: Long COVID Has Minimal Burden on Surgical Departments.

Author

Goldhaber, Nicole, Ramesh, Karthik, Horton, Lucy, Longhurst, Christopher, Huang, Estella, Horgan, Santiago, Jacobsen, Garth, Sandler, Bryan, and Broderick, Ryan

Subjects
COVID-19, long COVID, pandemic, post-acute sequelae of SARS-CoV-2, surgical burden, Humans, COVID-19, Male, Female, Middle Aged, SARS-CoV-2, Adult, Aged, Post-Acute COVID-19 Syndrome, Surgery Department, Hospital, Surgical Procedures, Operative
Abstract

Many patients infected with the SARS-CoV-2 virus (COVID-19) continue to experience symptoms for weeks to years as sequelae of the initial infection, referred to as Long COVID. Although many studies have described the incidence and symptomatology of Long COVID, there are little data reporting the potential burden of Long COVID on surgical departments. A previously constructed database of survey respondents who tested positive for COVID-19 was queried, identifying patients reporting experiencing symptoms consistent with Long COVID. Additional chart review determined whether respondents had a surgical or non-routine invasive procedure on or following the date of survey completion. Outcomes from surgeries on patients reporting Long COVID symptoms were compared to those from asymptomatic patients. A total of 17.4% of respondents had surgery or a non-routine invasive procedure in the study period. A total of 48.8% of these patients reported experiencing symptoms consistent with Long COVID. No statistically significant differences in surgical outcomes were found between groups. The results of this analysis demonstrate that Long COVID does not appear to have created a significant burden of surgical disease processes on the healthcare system despite the wide range of chronic symptoms and increased healthcare utilization by this population. This knowledge can help guide surgical operational resource allocation as a result of the pandemic and its longer-term sequelae.

Published
2024

2. Impact of a virtual coaching program for women physicians on burnout, fulfillment, and self-valuation.

Author

Smith, Sunny, Goldhaber, Nicole, Maysent, Kathryn, Lang, Ursula, Daniel, Michelle, and Longhurst, Christopher

Subjects
(3) physician coaching, Burnout, Compassion, Moral injury, Professional fulfillment, Humans, Female, Burnout, Professional, Adult, Mentoring, Middle Aged, Physicians, Women, United States, Job Satisfaction
Abstract

BACKGROUND: Coaching has been demonstrated to be an effective physician wellness intervention. However, this evidence-based intervention has not yet been widely adopted in the physician community. Documentation and implementation research of interventions to address physician burnout in real world settings is much needed. OBJECTIVE: Assess the impact of a virtual physician coaching program in women physicians. DESIGN: Pre- and post-intervention surveys administered to participants enrolled in the program (N = 329). Effect size was calculated comparing pre- and post-intervention paired data (N = 201). PARTICIPANTS: 201 women physicians from 40 states in the United States of America and 3 international participants. INTERVENTIONS: Participants were given access to an 8 week virtual coaching program including eight individual, six small group, and 24 large group sessions. MAIN MEASURES: Stanford Professional Fulfillment Inventory (PFI) containing categories for assessing professional fulfillment, burnout, and the Clinician Self-Valuation (SV) Scale (a measure of self-compassion). KEY RESULTS: Burnout was found in 77.1% (N = 155) of participants at baseline, which reduced to 33.3% (N = 67) at completion with large effect size (Cohens d 1.11). The percentage of participants who endorsed significant professional fulfillment started at 27.4% (N = 55) and improved to 68.2% (N = 137) with a large effect size (Cohens d 0.95). Self-valuation improved from 17.9% (N = 36) of the participants endorsing a compassionate self-improvement perspective to 64% of the same participants eight weeks later. The self-valuation metric showed a very large effect size (Cohens d 1.28). CONCLUSIONS: Virtual physician coaching programs led by physician coaches can decrease burnout, improve professional fulfillment, and increase self-compassion. Non-institution-based opportunities for coaching available to any physician across the United States and internationally can facilitate access to effective physician well-being interventions.

Published
2024

3. Cardiac function is regulated by the sodium-dependent inhibition of the sodium-calcium exchanger NCX1.

Author

Scranton, Kyle, John, Scott, Angelini, Marina, Steccanella, Federica, Umar, Soban, Zhang, Rui, Olcese, Riccardo, Goldhaber, Joshua, and Ottolia, Michela

Subjects
Sodium-Calcium Exchanger, Animals, Myocytes, Cardiac, Male, Sodium, Mice, Action Potentials, Calcium, Myocardial Contraction, Heart, Humans, Mutation, CRISPR-Cas Systems
Abstract

The Na+-Ca2+ exchanger (NCX1) is the dominant Ca2+ extrusion mechanism in cardiac myocytes. NCX1 activity is inhibited by intracellular Na+ via a process known as Na+-dependent inactivation. A central question is whether this inactivation plays a physiological role in heart function. Using CRISPR/Cas9, we inserted the K229Q mutation in the gene (Slc8a1) encoding for NCX1. This mutation removes the Na+-dependent inactivation while preserving transport properties and other allosteric regulations. NCX1 mRNA levels, protein expression, and protein localization are unchanged in K229Q male mice. However, they exhibit reduced left ventricular ejection fraction and fractional shortening, while displaying a prolonged QT interval. K229Q ventricular myocytes show enhanced NCX1 activity, resulting in action potential prolongation, higher incidence of aberrant action potentials, a faster decline of Ca2+ transients, and depressed cell shortening. The results demonstrate that NCX1 Na+-dependent inactivation plays an essential role in heart function by affecting both cardiac excitability and contractility.

Published
2024

4. Call me Ishmael: addressing the white whale of team communication in the operating room with labelled surgical caps at an academic medical centre.

Author

Goldhaber, Nicole, Mehta, Shivani, Longhurst, Christopher, Malachowski, Elizabeth, Jones, Melissa, Clary, Bryan, Schaefer, Robin, McHale, Michael, Rhodes, Lisa, Mekeel, Kristin, and Reeves, J

Subjects
communication, continuous quality improvement, human factors, safety culture, teamwork, Humans, Animals, Operating Rooms, Beluga Whale, Communication, Academic Medical Centers, Postoperative Complications
Abstract

INTRODUCTION: Effective communication in the operating room (OR) is crucial. Addressing a colleague by their name is respectful, humanising, entrusting and associated with improved clinical outcomes. We aimed to enhance team communication in the perioperative environment by offering personalised surgical caps labelled with name and provider role to all OR team members at a large academic medical centre. MATERIALS AND METHODS: This was a quasi-experimental, uncontrolled, before-and-after quality improvement study. A survey regarding perceptions of team communication, knowledge of names and roles, communication barriers, and culture was administered before and after cap delivery. Survey results were measured on a 5-point Likert Scale; descriptive statistics and mean scores were compared. All cause National Surgical Quality Improvement Project (NSQIP) morbidity and mortality outcomes for surgical specialties were examined. RESULTS: 1420 caps were delivered across the institution. Mean survey scores increased for knowing the names and roles of providers around the OR, feeling that people know my name and feeling comfortable communicating without barriers across disciplines. The mean score for team communication around the OR is excellent was unchanged. The highest score both before and after was knowing the name of an interdisciplinary team member is important for patient care. A total of 383 and 212 providers participated in the study before and after cap delivery, respectively. Participants agreed or strongly agreed that labelled surgical caps made it easier to talk to colleagues (64.9%) while improving communication (66.0%), team culture (60.5%) and patient care (56.8%). No significant differences were noted in NSQIP outcomes. CONCLUSIONS: Personalised labelled surgical caps are a simple, inexpensive tool that demonstrates promise in improving perioperative team communication. Creating highly reliable surgical teams with optimal communication channels requires a multifaceted approach with engaged leadership, empowered front-line providers and an institutional commitment to continuous process improvement.

Published
2024

5. Longitudinal assessment of the impact of COVID-19 infection on mask-wearing behaviors

Author

Pham, Danielle, Lomeli, Angel, Goldhaber, Nicole H, Valentine, Holly D, Knight, Rob, Longhurst, Christopher A, Laurent, Louise C, and Jacobs, Marni B

Subjects
Epidemiology, Health Services and Systems, Public Health, Health Sciences, Clinical Research, Emerging Infectious Diseases, Prevention, Infectious Diseases, Coronaviruses Disparities and At-Risk Populations, Coronaviruses, Behavioral and Social Science, Good Health and Well Being, Humans, COVID-19, Masks, Male, Female, Longitudinal Studies, Adult, Middle Aged, SARS-CoV-2, California, Cohort Studies, Surveys and Questionnaires, Aged, Young Adult, Mask use, Risk perception, University-affiliated individuals, Infection status, Public Health and Health Services
Abstract

BackgroundWearing a mask was a crucial component in slowing the COVID-19 pandemic. However, little is known about the intersectionality between mask usage, risk perception, and infection. The purpose of this study was to investigate whether risk perceptions and masking behaviors are associated with contracting SARS-CoV-2 and how contracting SARS-CoV-2 subsequently changes masking behaviors in specific situations.MethodsThis cohort study utilized survey data from the UC San Diego ZAP COVID-19 study (n = 1,230) to evaluate the risk of contracting SARS-CoV-2 in relation to baseline risk perceptions and masking behaviors in various situations and how contracting SARS-CoV-2 affects subsequent masking behavior.ResultsWe found that more consistent self-reported mask use in indoor public spaces (p = 0.03) and in other people's houses (p = 0.002) was associated with remaining free of SARS-CoV-2 infection. We also found that contracting SARS-CoV-2 was associated with a subsequent increase in mask use in other people's houses (p = 0.01).ConclusionsOur findings suggest that consistent mask use is correlated with decreased infection and that contracting SARS-CoV-2 may modify mask use behaviors in high-risk situations. These findings may help inform future public health messaging for infectious disease prevention.Trial registrationThis study has not been previously registered as it is an observational study. There was no pre-registration of the analytic plan for the present study.

Published
2024

6. Is Choosing Wisely Wise for Lobular Carcinoma in Patients Over 70 Years of Age? A National Cancer Database Analysis of Sentinel Node Practice Patterns.

Author

OKeefe, Thomas, Kang, Jessica, Douglas, Sasha, Blair, Sarah, and Goldhaber, Nicole

Subjects
Humans, Female, Aged, Aged, 80 and over, Carcinoma, Lobular, Carcinoma, Ductal, Breast, Neoplasm Staging, Breast Neoplasms, Sentinel Lymph Node, Lymphadenopathy
Abstract

BACKGROUND: Controversy continues in the treatment of breast cancer in women over 70 years of age. In 2016, the Society of Surgical Oncology recommended against routine use of sentinel lymph node biopsy (SLNBx) as part of the Choosing Wisely Campaign. This study examines the oncologic safety of avoidance of routine SLNBx in patients over 70 years of age with invasive lobular carcinoma (ILC). METHODS: The National Cancer Database was used to identify women with invasive ductal carcinoma (IDC) and ILC diagnosed between 2012 and 2020. Clinical and pathological staging, axillary staging, surgery type, and lymph node positivity between patients with IDC or ILC were compared. RESULTS: Among women with T1 tumors, 85,949 (79.6%) patients with IDC and 12,761 (81.5%) patients with ILC underwent SLNBx (p < 0.001). Among patients who underwent SLNBx, those with IDC were more likely to have positive nodes (n = 7535, 8.8%) than those with ILC (n = 1041, 8.2%; p = 0.02). During the time interval of interest, for both IDC and ILC patients, the rate of axillary lymph node dissection decreased and rates of SLNBx or no axillary staging increased. On multivariate analysis, ILC histology was associated with use of SLNBx, but without nodal positivity. CONCLUSION: A trend de-escalation of axillary staging was identified in this study, however the majority of patients meeting the Choosing Wisely criteria are still undergoing SLNBx. No increased risk of nodal positivity was identified among patients with ILC, suggesting that surgeons can continue to choose wisely and limit the use of SLNBx in women over 70 years of age with T1 ILC tumors.

Published
2023

7. Surgery and Anesthesia Preoperative Virtual Huddle: A Pilot Trial to Enhance Communication across the Drape.

Author

Goldhaber, Nicole, Reeves, J, Puri, Dhruv, Berumen, Jennifer, Tran, Minh, Clay, Brian, Longhurst, Christopher, and Fergerson, Byron

Subjects
Pilot Projects, Humans, Communication, Anesthesia, Anesthesiologists, Surgeons, Preoperative Care, Preoperative Period, Patient Care Team
Abstract

OBJECTIVES:  Effective communication between surgeons and anesthesiologists is critical for high-quality, safe, and efficient perioperative patient care. Despite widespread implementation of surgical safety checklists and time-outs, ineffective team communication remains a leading cause of patient safety events in the operating room. To promote effective communication, we conducted a pilot trial of a virtual huddle between anesthesiologists and surgeons. METHODS:  Attending anesthesiologists and surgeons at an academic medical center were recruited by email to participate in this feasibility trial. An electronic health record-based smartphone application was utilized to create secure group chats among trial participants the day before a surgery. Text notifications connected a surgeon/anesthesiologist pair in order to introduce colleagues, facilitate a preoperative virtual huddle, and enable open-ended, text message-based communication. A 5-point Likert scale-based survey with a free-text component was used to evaluate the utility of the virtual huddle and usability of the electronic platform. RESULTS:  A total of 51 unique virtual huddles occurred between 16 surgeons and 12 anesthesiologists over 99 operations. All postintervention survey questions received a positive rating (range: 3.50/5.00-4.53/5.00) and the virtual huddle was considered to be easy to use (4.47/5.00), improve attending-to-attending communication (4.29/5.00), and improve patient care (4.22/5.00). There were no statistically significant differences in the ratings between surgery and anesthesia. In thematic analysis of qualitative survey results, Participants indicated the intervention was particularly useful in interdisciplinary relationship-building and reducing room turnover. The huddle was less useful for simple, routine cases or when participation was one sided. CONCLUSION:  A preoperative virtual huddle may be a simple and effective intervention to improve communication and teamwork in the operating room. Further study and consideration of broader implementation is warranted.

Published
2023

8. Bite by byte: can fitness wearables help bariatric patients lose more weight after surgery?

Author

Huang, Estella Y, Chung, Daniel, Hollandsworth, Hannah M, Goldhaber, Nicole H, Robles, Lorijane, Horgan, Maria, Sandler, Bryan J, Jacobsen, Garth R, Broderick, Ryan C, Grunvald, Eduardo, and Horgan, Santiago

Subjects
Clinical Research, Prevention, Nutrition, Obesity, Oral and gastrointestinal, Cancer, Metabolic and endocrine, Humans, Obesity, Morbid, Gastric Bypass, Gastrectomy, Treatment Outcome, Retrospective Studies, Bariatric Surgery, Weight Loss, Wearable Electronic Devices, Fitness wearable, Bariatric surgery, Lifestyle modification, Clinical Sciences, Surgery
Abstract

BackgroundMultidisciplinary approaches to weight loss have been shown to improve outcomes in bariatric patients. Few studies have been performed assessing the utility and compliance of fitness tracking devices after bariatric surgery. We aim to determine whether use of an activity tracking device assists bariatric patients in improving postoperative weight loss behaviors.MethodsA fitness wearable was offered to patients undergoing bariatric surgery from 2019 to 2022. A telephone survey was conducted to elucidate the impact of the device on the patient's postoperative weight loss efforts 6 to 12 months after surgery. Weight loss outcomes of sleeve gastrectomy (SG) patients receiving the fitness wearable (FW) were compared to those of a group of SG patients who did not receive one (non-FW).ResultsThirty-seven patients were given a fitness wearable, 20 of whom responded to our telephone survey. Five patients reported not using the device and were excluded. 88.2% reported that using the device had a positive impact on their overall lifestyle. Patients felt that using the fitness wearable to keeping track of their progress helped them both to achieve short-term fitness goals and sustain them in the long run. From the patients that utilized the device, 44.4% of those that discontinued felt like it helped them build a routine that they maintained even after they were no longer using it. Demographic data between FW and non-FW groups (age, sex, CCI, initial BMI, and surgery BMI) did not differ significantly. The FW group trended towards greater %EWL at 1 year post-operation (65.2% versus 52.4%, p = 0.066) and had significantly greater %TWL at 1 year post-operation (30.3% versus 22.3%, p = 0.02).ConclusionThe use of an activity tracking device enhances a patient's post-bariatric surgery experience, serving to keep patients informed and motivated, and leading to improved activity that may translate to better weight loss outcomes.

Published
2023

9. The physiology of intraoperative error: using electrokardiograms to understand operator performance during robot-assisted surgery simulations.

Author

D'Ambrosia, Christopher, Aronoff-Spencer, Eliah, Huang, Estella Y, Goldhaber, Nicole H, Jacobsen, Garth R, Sandler, Bryan, Horgan, Santiago, Appelbaum, Lawrence G, Christensen, Henrik, and Broderick, Ryan C

Subjects
Humans, Laparoscopy, Operating Rooms, Surgeons, Robotic Surgical Procedures, Minimally invasive surgery, Robotic surgery, Surgical education, Surgical performance, Bioengineering, Clinical Sciences, Surgery
Abstract

BackgroundNo platform for objective, synchronous and on-line evaluation of both intraoperative error and surgeon physiology yet exists. Electrokardiogram (EKG) metrics have been associated with cognitive and affective features that are known to impact surgical performance but have not yet been analyzed in conjunction with real-time error signals using objective, real-time methods.MethodsEKGs and operating console point-of-views (POVs) for fifteen general surgery residents and five non-medically trained participants were captured during three simulated robotic-assisted surgery (RAS) procedures. Time and frequency-domain EKG statistics were extracted from recorded EKGs. Intraoperative errors were detected from operating console POV videos. EKG statistics were synchronized with intraoperative error signals.ResultsRelative to personalized baselines, IBI, SDNN and RMSSD decreased 0.15% (S.E. 3.603e-04; P = 3.25e-05), 3.08% (S.E. 1.603e-03; P

Published
2023

10. A scoping review of distributed cognition in acute care clinical decision-making

Author

Wilson, Eric, Daniel, Michelle, Rao, Aditi, Torre, Dario, Durning, Steven, Anderson, Clare, Goldhaber, Nicole H, Townsend, Whitney, and Seifert, Colleen M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Behavioral and Social Science, Health Services, Health and social care services research, 8.1 Organisation and delivery of services, Management of diseases and conditions, 7.3 Management and decision making, Humans, Cognition, Clinical Decision-Making, Emergency Service, Hospital, Medical Records, Physicians, acute care settings, clinical-decision making, distributed cognition, scoping review, systems-level error, Clinical sciences
Abstract

ObjectivesIn acute care settings, interactions between providers and tools drive clinical decision-making. Most studies of decision-making focus on individual cognition and fail to capture critical collaborations. Distributed Cognition (DCog) theory provides a framework for examining the dispersal of tasks among agents and artifacts, enhancing the investigation of decision-making and error.ContentThis scoping review maps the evidence collected in empiric studies applying DCog to clinical decision-making in acute care settings and identifies gaps in the existing literature.Summary and outlookThirty-seven articles were included. The majority (n=30) used qualitative methods (observations, interviews, artifact analysis) to examine the work of physicians (n=28), nurses (n=27), residents (n=16), and advanced practice providers (n=12) in intensive care units (n=18), operating rooms (n=7), inpatient units (n=7) and emergency departments (n=5). Information flow (n=30) and task coordination (n=30) were the most frequently investigated elements of DCog. Provider-artifact (n=35) and provider-provider (n=30) interactions were most explored. Electronic (n=18) and paper (n=15) medical records were frequently described artifacts. Seven prominent themes were identified. DCog is an underutilized framework for examining how information is obtained, represented, and transmitted through complex clinical systems. DCog offers mechanisms for exploring how technologies, like EMRs, and workspaces can help or hinder clinical decision-making.

Published
2023

11. Acute Fulminant Hepatic Failure in 23-Year-Old Female Taking Homeopathic Remedy.

Author

Barnard Giustini, Abbey, Parekh, Justin, Mekeel, Kristin, Ajmera, Veeral, and Goldhaber, Nicole

Subjects
acute liver failure, drug-induced liver injury, hepatotoxicity, herbal supplement, liver transplant, Female, Humans, Young Adult, Adult, Materia Medica, Liver Failure, Acute, Chemical and Drug Induced Liver Injury, Liver Transplantation, Dietary Supplements
Abstract

Homeopathic remedies made primarily from eggshells, and therefore calcium, can be marketed for treatment of back pain and vaginal discharge. We present a case of a 23-year-old otherwise healthy woman who presented with acute liver failure (ALF) ultimately requiring liver transplantation as a result of taking increased doses of a homeopathic product with the primary ingredient of eggshells. Although relatively uncommon compared with medications such as acetaminophen, herbal supplements have been reported to cause drug-induced liver injury (DILI), thought to be primarily due to contaminants. This is the first known report of DILI resulting from a homeopathic product with the primary ingredient of eggshells, and it demonstrates the importance of early ALF recognition and treatment, as well as the importance of practicing caution when using homeopathic supplements.

Published
2023

12. Virtual interviewing for graduate medical education recruitment and selection: A BEME systematic review: BEME Guide No. 80.

Author

Daniel, Michelle, Gottlieb, Michael, Wooten, Darcy, Stojan, Jennifer, Haas, Mary RC, Bailey, Jacob, Evans, Sean, Lee, Daniel, Goldberg, Charles, Fernandez, Jorge, Jassal, Simerjot K, Rudolf, Frances, Guluma, Kama, Lander, Lina, Pott, Emily, Goldhaber, Nicole H, Thammasitboon, Satid, Uraiby, Hussain, Grafton-Clarke, Ciaran, Gordon, Morris, Pawlikowska, Teresa, Corral, Janet, Partha, Indu, Kolman, Karyn B, Westrick, Jennifer, and Dolmans, Diana

Subjects
Humans, Fellowships and Scholarships, Education, Medical, Graduate, Education, Medical, Internship and Residency, Pandemics, COVID-19, Best evidence medical education, medicine, postgraduate, recruitment and selection, virtual interviews, Quality Education, Education Systems, Curriculum and Pedagogy, Specialist Studies in Education, Medical Informatics
Abstract

BackgroundThe COVID-19 pandemic caused graduate medical education (GME) programs to pivot to virtual interviews (VIs) for recruitment and selection. This systematic review synthesizes the rapidly expanding evidence base on VIs, providing insights into preferred formats, strengths, and weaknesses.MethodsPubMed/MEDLINE, Scopus, ERIC, PsycINFO, MedEdPublish, and Google Scholar were searched from 1 January 2012 to 21 February 2022. Two authors independently screened titles, abstracts, full texts, performed data extraction, and assessed risk of bias using the Medical Education Research Quality Instrument. Findings were reported according to Best Evidence in Medical Education guidance.ResultsOne hundred ten studies were included. The majority (97%) were from North America. Fourteen were conducted before COVID-19 and 96 during the pandemic. Studies involved both medical students applying to residencies (61%) and residents applying to fellowships (39%). Surgical specialties were more represented than other specialties. Applicants preferred VI days that lasted 4-6 h, with three to five individual interviews (15-20 min each), with virtual tours and opportunities to connect with current faculty and trainees. Satisfaction with VIs was high, though both applicants and programs found VIs inferior to in-person interviews for assessing 'fit.' Confidence in ranking applicants and programs was decreased. Stakeholders universally noted significant cost and time savings with VIs, as well as equity gains and reduced carbon footprint due to eliminating travel.ConclusionsThe use of VIs for GME recruitment and selection has accelerated rapidly. The findings of this review offer early insights that can guide future practice, policy, and research.

Published
2022

13. Machine Learning-Based Models Predicting Outpatient Surgery End Time and Recovery Room Discharge at an Ambulatory Surgery Center.

Author

Gabriel, Rodney, Harjai, Bhavya, Simpson, Sierra, Goldhaber, Nicole, Curran, Brian, and Waterman, Ruth

Subjects
Ambulatory Surgical Procedures, Humans, Machine Learning, Neural Networks, Computer, Patient Discharge, Recovery Room
Abstract

BACKGROUND: Days before surgery, add-ons may be scheduled to fill unused surgical block time at an outpatient surgery center. At times, outpatient surgery centers have time limitations for end of block time and discharge from the postanesthesia care unit (PACU). The objective of our study was to develop machine learning models that predicted the following composite outcome: (1) surgery finished by end of operating room block time and (2) patient was discharged by end of recovery room nursing shift. We compared various machine learning models to logistic regression. By evaluating various performance metrics, including F1 scores, we hypothesized that models using ensemble learning will be superior to logistic regression. METHODS: Data were collected from patients at an ambulatory surgery center. The primary outcome measurement was determined to have a value of 1 (versus 0) if they met both criteria: (1) surgery ends by 5 pm and (2) patient is discharged from the recovery room by 7 pm. We developed models to determine if a procedure would meet both criteria if it were scheduled at 1 pm, 2 pm, 3 pm, or 4 pm. We implemented regression, random forest, balanced random forest, balanced bagging, neural network, and support vector classifier, and included the following features: surgery, surgeon, service line, American Society of Anesthesiologists score, age, sex, weight, and scheduled case duration. We evaluated model performance with Synthetic Minority Oversampling Technique (SMOTE). We compared the following performance metrics: F1 score, area under the receiver operating characteristic curve (AUC), specificity, sensitivity, precision, recall, and Matthews correlation coefficient. RESULTS: Among 13,447 surgical procedures, the median total perioperative time (actual case duration and PACU length stay) was 165 minutes. When SMOTE was not used, when predicting whether surgery will end by 5 pm and patient will be discharged by 7 pm, the average F1 scores were best with random forest, balanced bagging, and balanced random forest classifiers. When SMOTE was used, these models had improved F1 scores compared to no SMOTE. The balanced bagging classifier performed best with F1 score of 0.78, 0.80, 0.82, and 0.82 when predicting our outcome if cases were to start at 1 pm, 2 pm, 3 pm, or 4 pm, respectively. CONCLUSIONS: We demonstrated improvement in predicting the outcome at a range of start times when using ensemble learning versus regression techniques. Machine learning may be adapted by operating room management to allow for a better determination whether an add-on case at an outpatient surgery center could be appropriately booked.

Published
2022

14. Mechanisms of Sinoatrial Node Dysfunction in Heart Failure With Preserved Ejection Fraction

Author

Mesquita, Thassio, Zhang, Rui, Cho, Jae Hyung, Lin, Yen-Nien, Sanchez, Lizbeth, Goldhaber, Joshua I, Yu, Joseph K, Liang, Jialiu A, Liu, Weixin, Trayanova, Natalia A, and Cingolani, Eugenio

Subjects
Heart Disease, Nutrition, Cardiovascular, Aetiology, 2.1 Biological and endogenous factors, Animals, Heart Failure, Humans, Rats, Sinoatrial Node, Stroke Volume, arrhythmias, cardiac, heart failure, heart rate, sinoatrial node, arrhythmias, cardiac, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundThe ability to increase heart rate during exercise and other stressors is a key homeostatic feature of the sinoatrial node (SAN). When the physiological heart rate response is blunted, chronotropic incompetence limits exercise capacity, a common problem in patients with heart failure with preserved ejection fraction (HFpEF). Despite its clinical relevance, the mechanisms of chronotropic incompetence remain unknown.MethodsDahl salt-sensitive rats fed a high-salt diet and C57Bl6 mice fed a high-fat diet and an inhibitor of constitutive nitric oxide synthase (Nω-nitro-L-arginine methyl ester [L-NAME]; 2-hit) were used as models of HFpEF. Myocardial infarction was created to induce HF with reduced ejection fraction. Rats and mice fed with a normal diet or those that had a sham surgery served as respective controls. A comprehensive characterization of SAN function and chronotropic response was conducted by in vivo, ex vivo, and single-cell electrophysiologic studies. RNA sequencing of SAN was performed to identify transcriptomic changes. Computational modeling of biophysically-detailed human HFpEF SAN was created.ResultsRats with phenotypically-verified HFpEF exhibited limited chronotropic response associated with intrinsic SAN dysfunction, including impaired β-adrenergic responsiveness and an alternating leading pacemaker within the SAN. Prolonged SAN recovery time and reduced SAN sensitivity to isoproterenol were confirmed in the 2-hit mouse model. Adenosine challenge unmasked conduction blocks within the SAN, which were associated with structural remodeling. Chronotropic incompetence and SAN dysfunction were also found in rats with HF with reduced ejection fraction. Single-cell studies and transcriptomic profiling revealed HFpEF-related alterations in both the "membrane clock" (ion channels) and the "Ca2+ clock" (spontaneous Ca2+ release events). The physiologic impairments were reproduced in silico by empirically-constrained quantitative modeling of human SAN function.ConclusionsChronotropic incompetence and SAN dysfunction were seen in both models of HF. We identified that intrinsic abnormalities of SAN structure and function underlie the chronotropic response in HFpEF.

Published
2022

15. Deep Dive into the Long Haul: Analysis of Symptom Clusters and Risk Factors for Post-Acute Sequelae of COVID-19 to Inform Clinical Care

Author

Goldhaber, Nicole H, Kohn, Jordan N, Ogan, William Scott, Sitapati, Amy, Longhurst, Christopher A, Wang, Angela, Lee, Susan, Hong, Suzi, and Horton, Lucy E

Subjects
Neurosciences, Infectious Diseases, Emerging Infectious Diseases, Prevention, Clinical Research, Health Services, Mental Health, Behavioral and Social Science, Mind and Body, Good Health and Well Being, Humans, Female, COVID-19, Post-Acute COVID-19 Syndrome, SARS-CoV-2, Disease Progression, Anxiety, Long COVID, post-acute sequelae, symptom cluster, neurocognitive, Toxicology
Abstract

Long COVID is a chronic condition characterized by symptoms such as fatigue, dyspnea, and cognitive impairment that persist or relapse months after an acute infection with the SARS-CoV-2 virus. Many distinct symptoms have been attributed to Long COVID; however, little is known about the potential clustering of these symptoms and risk factors that may predispose patients to certain clusters. In this study, an electronic survey was sent to patients in the UC San Diego Health (UCSDH) system who tested positive for COVID-19, querying if patients were experiencing symptoms consistent with Long COVID. Based on survey results, along with patient demographics reported in the electronic health record (EHR), linear and logistic regression models were used to examine putative risk factors, and exploratory factor analysis was performed to determine symptom clusters. Among 999 survey respondents, increased odds of Long COVID (n = 421; 42%) and greater Long COVID symptom burden were associated with female sex (OR = 1.73, 99% CI: 1.16-2.58; β = 0.48, 0.22-0.75), COVID-19 hospitalization (OR = 4.51, 2.50-8.43; β = 0.48, 0.17-0.78), and poorer pre-COVID self-rated health (OR = 0.75, 0.57-0.97; β = -0.19, -0.32--0.07). Over one-fifth of Long COVID patients screened positive for depression and/or anxiety, the latter of which was associated with younger age (OR = 0.96, 0.94-0.99). Factor analysis of 16 self-reported symptoms suggested five symptom clusters-gastrointestinal (GI), musculoskeletal (MSK), neurocognitive (NC), airway (AW), and cardiopulmonary (CP), with older age (β = 0.21, 0.11-0.30) and mixed race (β = 0.27, 0.04-0.51) being associated with greater MSK symptom burden. Greater NC symptom burden was associated with increased odds of depression (OR = 5.86, 2.71-13.8) and anxiety (OR = 2.83, 1.36-6.14). These results can inform clinicians in identifying patients at increased risk for Long COVID-related medical issues, particularly neurocognitive symptoms and symptom clusters, as well as informing health systems to manage operational expectations on a population-health level.

Published
2022

16. Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 1: Basic and Translational Aspects

Author

Delisle, Brian P, George, Alfred L, Nerbonne, Jeanne M, Bass, Joseph T, Ripplinger, Crystal M, Jain, Mukesh K, Hermanstyne, Tracey O, Young, Martin E, Kannankeril, Prince J, Duffy, Jeanne F, Goldhaber, Joshua I, Hall, Martica H, Somers, Virend K, Smolensky, Michael H, Garnett, Christine E, Anafi, Ron C, Scheer, Frank AJL, Shivkumar, Kalyanam, Shea, Steven A, and Balijepalli, Ravi C

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Sleep Research, Heart Disease, Cardiovascular, Animals, Circadian Rhythm, Death, Sudden, Cardiac, Humans, National Heart, Lung, and Blood Institute (U.S.), United States, cardiovascular disease, circadian clocks, circadian rhythm, National Heart, Lung, and Blood Institute, sudden cardiac death, National Heart, Lung, and Blood Institute, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Medical Physiology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences, Medical physiology
Abstract

Sudden cardiac death (SCD), the unexpected death due to acquired or genetic cardiovascular disease, follows distinct 24-hour patterns in occurrence. These 24-hour patterns likely reflect daily changes in arrhythmogenic triggers and the myocardial substrate caused by day/night rhythms in behavior, the environment, and endogenous circadian mechanisms. To better address fundamental questions regarding the circadian mechanisms, the National Heart, Lung, and Blood Institute convened a workshop, Understanding Circadian Mechanisms of Sudden Cardiac Death. We present a 2-part report of findings from this workshop. Part 1 summarizes the workshop and serves to identify research gaps and opportunities in the areas of basic and translational research. Among the gaps was the lack of standardization in animal studies for reporting environmental conditions (eg, timing of experiments relative to the light dark cycle or animal housing temperatures) that can impair rigor and reproducibility. Workshop participants also pointed to uncertainty regarding the importance of maintaining normal circadian rhythmic synchrony and the potential pathological impact of desynchrony on SCD risk. One related question raised was whether circadian mechanisms can be targeted to reduce SCD risk. Finally, the experts underscored the need for studies aimed at determining the physiological importance of circadian clocks in the many different cell types important to normal heart function and SCD. Addressing these gaps could lead to new therapeutic approaches/molecular targets that can mitigate the risk of SCD not only at certain times but over the entire 24-hour period.

Published
2021

17. Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 2: Population and Clinical Considerations

Author

Delisle, Brian P, George, Alfred L, Nerbonne, Jeanne M, Bass, Joseph T, Ripplinger, Crystal M, Jain, Mukesh K, Hermanstyne, Tracey O, Young, Martin E, Kannankeril, Prince J, Duffy, Jeanne F, Goldhaber, Joshua I, Hall, Martica H, Somers, Virend K, Smolensky, Michael H, Garnett, Christine E, Anafi, Ron C, Scheer, Frank AJL, Shivkumar, Kalyanam, Shea, Steven A, and Balijepalli, Ravi C

Subjects
Biomedical and Clinical Sciences, Medical Physiology, Cardiovascular Medicine and Haematology, Clinical Sciences, Prevention, Cardiovascular, Sleep Research, Clinical Research, Heart Disease, 2.1 Biological and endogenous factors, Good Health and Well Being, Circadian Rhythm, Death, Sudden, Cardiac, Humans, National Heart, Lung, and Blood Institute (U.S.), Population Surveillance, United States, cardiovascular diseases, circadian clock, circadian rhythm, genetics, National Heart, Lung, and Blood Institute, population, sudden cardiac death, National Heart, Lung, and Blood Institute, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences, Medical physiology
Abstract

Sudden cardiac death (SCD) is the sudden, unexpected death due to abrupt loss of heart function secondary to cardiovascular disease. In certain populations living with cardiovascular disease, SCD follows a distinct 24-hour pattern in occurrence, suggesting day/night rhythms in behavior, the environment, and endogenous circadian rhythms result in daily spans of increased vulnerability. The National Heart, Lung, and Blood Institute convened a workshop, Understanding Circadian Mechanisms of Sudden Cardiac Death to identify fundamental questions regarding the role of the circadian rhythms in SCD. Part 2 summarizes research gaps and opportunities in the areas of population and clinical research identified in the workshop. Established research supports a complex interaction between circadian rhythms and physiological responses that increase the risk for SCD. Moreover, these physiological responses themselves are influenced by several biological variables, including the type of cardiovascular disease, sex, age, and genetics, as well as environmental factors. The emergence of new noninvasive biotechnological tools that continuously measure key cardiovascular variables, as well as the identification of biomarkers to assess circadian rhythms, hold promise for generating large-scale human data sets that will delineate which subsets of individuals are most vulnerable to SCD. Additionally, these data will improve our understanding of how people who suffer from circadian disruptions develop cardiovascular diseases that increase the risk for SCD. Emerging strategies to identify new biomarkers that can quantify circadian health (eg, environmental, behavioral, and internal misalignment) may lead to new interventions and therapeutic targets to prevent the progression of cardiovascular diseases that cause SCD.

Published
2021

18. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

Author

O'Toole, Robert V, Stein, Deborah M, Frey, Katherine P, O'Hara, Nathan N, Scharfstein, Daniel O, Slobogean, Gerard P, Taylor, Tara J, Haac, Bryce E, Carlini, Anthony R, Manson, Theodore T, Sudini, Kuladeep, Mullins, C Daniel, Wegener, Stephen T, Firoozabadi, Reza, Haut, Elliott R, Bosse, Michael J, Seymour, Rachel B, Holden, Martha B, Gitajn, Ida Leah, Goldhaber, Samuel Z, Eastman, Alexander L, Jurkovich, Gregory J, Vallier, Heather A, Gary, Joshua L, Kleweno, Conor P, Cuschieri, Joseph, Marvel, Debra, Castillo, Renan C, and METRC

Subjects
METRC, Humans, Thrombosis, Aspirin, Heparin, Low-Molecular-Weight, Anticoagulants, Orthopedics, Adult, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Venous Thromboembolism, orthopaedic & trauma surgery, thromboembolism, trauma management, Clinical Research, Comparative Effectiveness Research, Patient Safety, Hematology, Clinical Trials and Supportive Activities, Prevention, Injury (total) Accidents/Adverse Effects, Prevention of disease and conditions, and promotion of well-being, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 3.3 Nutrition and chemoprevention, Blood, Good Health and Well Being, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

IntroductionPatients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients.Methods and analysisPREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections.Ethics and disseminationThe PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients.Trial registration numberNCT02984384.

Published
2021

19. Na/Ca exchange in the atrium: Role in sinoatrial node pacemaking and excitation-contraction coupling

Author

Yue, Xin, Hazan, Adina, Lotteau, Sabine, Zhang, Rui, Torrente, Angelo G, Philipson, Kenneth D, Ottolia, Michela, and Goldhaber, Joshua I

Subjects
Medical Physiology, Biomedical and Clinical Sciences, Heart Disease, Cardiovascular, 2.1 Biological and endogenous factors, Aetiology, Animals, Biological Clocks, Calcium, Excitation Contraction Coupling, Heart Atria, Humans, Sinoatrial Node, Sodium, Sodium-Calcium Exchanger, Sodium-calcium exchange, NCX1, Excitation-contraction coupling, Sinoatrial node, Cardiac pacing, Transverse axial tubules, Small K channels, IP3 receptors, Calcium dynamics, IP(3) receptors, Biochemistry and Cell Biology, Physiology, Biochemistry & Molecular Biology, Biochemistry and cell biology, Medical physiology
Abstract

Na/Ca exchange is the dominant calcium (Ca) efflux mechanism in cardiac myocytes. Although our knowledge of exchanger function (NCX1 in the heart) was originally established using biochemical and electrophysiological tools such as cardiac sarcolemmal vesicles and the giant patch technique [1-4], many advances in our understanding of the physiological/pathophysiological roles of NCX1 in the heart have been obtained using a suite of genetically modified mice. Early mouse studies focused on modification of expression levels of NCX1 in the ventricles, with transgenic overexpressors, global NCX1 knockout (KO) mice (which were embryonic lethal if homozygous), and finally ventricular-specific NCX1 KO [5-12]. We found, to our surprise, that ventricular cardiomyocytes lacking NCX1 can survive and function by engaging a clever set of adaptations to minimize Ca entry, while maintaining contractile function through an increase in excitation-contraction (EC) coupling gain [5,6,13]. Having studied ventricular NCX1 ablation in detail, we more recently focused on elucidating the role of NCX1 in the atria through altering NCX1 expression. Using a novel atrial-specific NCX1 KO mouse, we found unexpected changes in atrial cell morphology and calcium handling, together with dramatic alterations in the function of sinoatrial node (SAN) pacemaker activity. In this review, we will discuss these findings and their implications for cardiac disease.

Published
2020

20. Modulation of the cardiac Na+-Ca2+ exchanger by cytoplasmic protons: Molecular mechanisms and physiological implications

Author

Scranton, Kyle, John, Scott, Escobar, Ariel, Goldhaber, Joshua I, and Ottolia, Michela

Subjects
Heart Disease, Cardiovascular, Allosteric Regulation, Animals, Cytoplasm, Humans, Hydrogen-Ion Concentration, Myocardium, Protons, Sodium-Calcium Exchanger, Na+-Ca2+ exchanger, pH regulation, Calcium binding domains, Excitation-contraction coupling, Ca2+ dynamics, Ca(2+) dynamics, Na(+)-Ca(2+) exchanger, Biochemistry and Cell Biology, Physiology, Medical Physiology, Biochemistry & Molecular Biology
Abstract

A precise temporal and spatial control of intracellular Ca2+ concentration is essential for a coordinated contraction of the heart. Following contraction, cardiac cells need to rapidly remove intracellular Ca2+ to allow for relaxation. This task is performed by two transporters: the plasma membrane Na+-Ca2+ exchanger (NCX) and the sarcoplasmic reticulum (SR) Ca2+-ATPase (SERCA). NCX extrudes Ca2+ from the cell, balancing the Ca2+entering the cytoplasm during systole through L-type Ca2+ channels. In parallel, following SR Ca2+ release, SERCA activity replenishes the SR, reuptaking Ca2+ from the cytoplasm. The activity of the mammalian exchanger is fine-tuned by numerous ionic allosteric regulatory mechanisms. Micromolar concentrations of cytoplasmic Ca2+ potentiate NCX activity, while an increase in intracellular Na+ levels inhibits NCX via a mechanism known as Na+-dependent inactivation. Protons are also powerful inhibitors of NCX activity. By regulating NCX activity, Ca2+, Na+ and H+ couple cell metabolism to Ca2+ homeostasis and therefore cardiac contractility. This review summarizes the recent progress towards the understanding of the molecular mechanisms underlying the ionic regulation of the cardiac NCX with special emphasis on pH modulation and its physiological impact on the heart.

Published
2020

21. Canonical Wnt signaling promotes pacemaker cell specification of cardiac mesodermal cells derived from mouse and human embryonic stem cells.

Author

Liang, Wenbin, Han, Pengcheng, Kim, Elizabeth H, Mak, Jordan, Zhang, Rui, Torrente, Angelo G, Goldhaber, Joshua I, Marbán, Eduardo, and Cho, Hee Cheol

Subjects
Mesoderm, Animals, Humans, Mice, Cell Differentiation, Wnt Signaling Pathway, Human Embryonic Stem Cells, Mouse Embryonic Stem Cells, cardiac, cell biology, cell culture, cellular therapy, stem cells, Heart Disease, Regenerative Medicine, Cardiovascular, Stem Cell Research - Nonembryonic - Non-Human, Stem Cell Research, Stem Cell Research - Embryonic - Human, Stem Cell Research - Embryonic - Non-Human, Aetiology, 2.1 Biological and endogenous factors, 1.1 Normal biological development and functioning, Underpinning research, Biological Sciences, Technology, Medical and Health Sciences, Immunology
Abstract

Cardiac differentiation of embryonic stem cells (ESCs) can give rise to de novo chamber cardiomyocytes and nodal pacemaker cells. Compared with our understanding of direct differentiation toward atrial and ventricular myocytes, the mechanisms for nodal pacemaker cell commitment are not well understood. Taking a cue from the prominence of canonical Wnt signaling during cardiac pacemaker tissue development in chick embryos, we asked if modulations of Wnt signaling influence cardiac progenitors to bifurcate to either chamber cardiomyocytes or pacemaker cells. Omitting an exogenous Wnt inhibitor, which is routinely added to maximize cardiac myocyte yield during differentiation of mouse and human ESCs, led to increased yield of spontaneously beating cardiomyocytes with action potential properties similar to those of native sinoatrial node pacemaker cells. The pacemaker phenotype was accompanied by enhanced expression of genes and gene products that mark nodal pacemaker cells such as Hcn4, Tbx18, Tbx3, and Shox2. Addition of exogenous Wnt3a ligand, which activates canonical Wnt/β-catenin signaling, increased the yield of pacemaker-like myocytes while reducing cTNT-positive pan-cardiac differentiation. Conversely, addition of inhibitors of Wnt/β-catenin signaling led to increased chamber myocyte lineage development at the expense of pacemaker cell specification. The positive impact of canonical Wnt signaling on nodal pacemaker cell differentiation was evidenced in direct differentiation of two human ESC lines and human induced pluripotent stem cells. Our data identify the Wnt/β-catenin pathway as a critical determinant of cardiac myocyte subtype commitment during ESC differentiation: endogenous Wnt signaling favors the pacemaker lineage, whereas its suppression promotes the chamber cardiomyocyte lineage.

Published
2020

22. Cardiac TRPV1-afferent signaling promotes arrhythmogenic ventricular remodeling after myocardial infarction

Author

Yoshie, Koji, Rajendran, Pradeep S, Massoud, Louis, Mistry, Janki, Swid, M Amer, Wu, Xiaohui, Sallam, Tamer, Zhang, Rui, Goldhaber, Joshua I, Salavatian, Siamak, and Ajijola, Olujimi A

Subjects
Heart Disease, Cardiovascular, Neurosciences, Heart Disease - Coronary Heart Disease, Aetiology, 2.1 Biological and endogenous factors, Afferent Pathways, Animals, Disease Models, Animal, Diterpenes, Heart, Humans, Myocardial Infarction, Myocardium, Neurotoxins, Signal Transduction, Swine, TRPV Cation Channels, Ventricular Remodeling, Arrhythmias, Cardiology, Cardiovascular disease, Innervation, Neuroscience
Abstract

Chronic sympathoexcitation is implicated in ventricular arrhythmogenesis (VAs) following myocardial infarction (MI), but the critical neural pathways involved are not well understood. Cardiac adrenergic function is partly regulated by sympathetic afferent reflexes, transduced by spinal afferent fibers expressing the transient receptor potential cation subfamily V member 1 (TRPV1) channel. The role of chronic TRPV1 afferent signaling in VAs is not known. We hypothesized that persistent TRPV1 afferent neurotransmission promotes VAs after MI. Using epicardial resiniferatoxin (RTX) to deplete cardiac TRPV1-expressing fibers, we dissected the role of this neural circuit in VAs after chronic MI in a porcine model. We examined the underlying mechanisms using molecular approaches, IHC, in vitro and in vivo cardiac electrophysiology, and simultaneous cardioneural mapping. Epicardial RTX depleted cardiac TRPV1 afferent fibers and abolished functional responses to TRPV1 agonists. Ventricular tachycardia/fibrillation (VT/VF) was readily inducible in MI subjects by programmed electrical stimulation or cesium chloride administration; however, TRPV1 afferent depletion prevented VT/VF induced by either method. Mechanistically, TRPV1 afferent depletion did not alter cardiomyocyte action potentials and calcium transients, the expression of ion channels, or calcium handling proteins. However, it attenuated fibrosis and mitigated electrical instability in the scar border zone. In vivo recordings of cardiovascular-related stellate ganglion neurons (SGNs) revealed that MI enhances SGN function and disrupts integrated neural processing. Depleting TRPV1 afferents normalized these processes. Taken together, these data indicate that, after MI, TRPV1 afferent-induced adrenergic dysfunction promotes fibrosis and adverse cardiac remodeling, and it worsens border zone electrical heterogeneity, resulting in electrically unstable ventricular myocardium. We propose targeting TRPV1-expressing afferent to reduce VT/VF following MI.

Published
2020

23. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author

Sawhney, Jitendra PS, Kothiwale, Veerappa A, Bisne, Vikas, Durgaprasad, Rajashekhar, Jadhav, Praveen, Chopda, Manoj, Vanajakshamma, Velam, Meena, Ramdhan, Vijayaraghavan, Govindan, Chawla, Kamaldeep, Allu, Jagan, Pieper, Karen S, Camm, A John, Kakkar, Ajay K, Bassand, Jean-Pierre, Fitzmaurice, David A, Goldhaber, Samuel Z, Goto, Shinya, Haas, Sylvia, Hacke, Werner, Mantovani, Lorenzo G, Misselwitz, Frank, Turpie, Alexander GG, van Eickels, Martin, Verheugt, Freek WA, Kayani, Gloria, Fox, Keith AA, Gersh, Bernard J, Luciardi, Hector Lucas, Gibbs, Harry, Brodmann, Marianne, Cools, Frank, Barretto, Antonio Carlos Pereira, Connolly, Stuart J, Spyropoulos, Alex, Eikelboom, John, Corbalan, Ramon, Hu, Dayi, Jansky, Petr, Nielsen, Jørn Dalsgaard, Ragy, Hany, Raatikainen, Pekka, Le Heuzey, Jean-Yves, Darius, Harald, Keltai, Matyas, Kakkar, Sanjay, Sawhney, Jitendra Pal Singh, Agnelli, Giancarlo, Ambrosio, Giuseppe, Koretsune, Yukihiro, Díaz, Carlos Jerjes Sánchez, Cate, Hugo Ten, Atar, Dan, Stepinska, Janina, Panchenko, Elizaveta, Lim, Toon Wei, Jacobson, Barry, Oh, Seil, Viñolas, Xavier, Rosenqvist, Marten, Steffel, Jan, Angchaisuksiri, Pantep, Oto, Ali, Parkhomenko, Alex, Mahmeed, Wael Al, Fitzmaurice, David, Hu, DY, Chen, KN, Zhao, YS, Zhang, HQ, Chen, JZ, Cao, SP, Wang, DW, Yang, YJ, Li, WH, Yin, YH, Tao, GZ, Yang, P, Chen, YM, He, SH, Wang, Ying, Wang, Yong, Fu, GS, Li, X, Wu, TG, Cheng, XS, Yan, XW, Zhao, RP, Chen, MS, Xiong, LG, and Chen, P

Subjects
Hematology, Prevention, Cardiovascular, Clinical Research, Heart Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Atrial Fibrillation, Electrocardiography, Female, Follow-Up Studies, Humans, Incidence, India, Male, Prevalence, Prognosis, Prospective Studies, Registries, Risk Assessment, Risk Factors, Survival Rate, Thromboembolism, Time Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, GARFIELD-AF Investigators, Cardiovascular System & Hematology
Abstract

BackgroundThe Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry.Methods and resultsA total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P

Published
2018

24. Reverse electrical remodeling in rats with heart failure and preserved ejection fraction.

Author

Cho, Jae Hyung, Kilfoil, Peter J, Zhang, Rui, Solymani, Ryan E, Bresee, Catherine, Kang, Elliot M, Luther, Kristin, Rogers, Russell G, de Couto, Geoffrey, Goldhaber, Joshua I, Marbán, Eduardo, and Cingolani, Eugenio

Subjects
Heart Ventricles, Myocytes, Cardiac, Myoblasts, Cardiac, Animals, Rats, Inbred Dahl, Humans, Rats, Death, Sudden, Cardiac, Disease Models, Animal, Sodium, Dietary, Echocardiography, Stroke Volume, Electrocardiography, Transplantation, Homologous, Action Potentials, Ventricular Remodeling, Male, Shal Potassium Channels, Arrhythmias, Cardiac, Heart Failure, Arrhythmias, Cardiology, Heart failure, Stem cell transplantation, Stem cells, Stem Cell Research, Heart Disease, Cardiovascular
Abstract

Sudden death is the most common mode of exodus in patients with heart failure and preserved ejection fraction (HFpEF). Cardiosphere-derived cells (CDCs) reduce inflammation and fibrosis in a rat model of HFpEF, improving diastolic function and prolonging survival. We tested the hypothesis that CDCs decrease ventricular arrhythmias (VAs) and thereby possibly contribute to prolonged survival. Dahl salt-sensitive rats were fed a high-salt diet to induce HFpEF. Allogeneic rat CDCs (or phosphate-buffered saline as placebo) were injected in rats with echo-verified HFpEF. CDC-injected HFpEF rats were less prone to VA induction by programmed electrical stimulation. Action potential duration (APD) was shortened, and APD homogeneity was increased by CDC injection. Transient outward potassium current density was upregulated in cardiomyocytes from CDC rats relative to placebo, as were the underlying transcript (Kcnd3) and protein (Kv4.3) levels. Fibrosis was attenuated in CDC-treated hearts, and survival was increased. Sudden death risk also trended down, albeit nonsignificantly. CDC therapy decreased VA in HFpEF rats by shortening APD, improving APD homogeneity, and decreasing fibrosis. Unlike other stem/progenitor cells, which often exacerbate arrhythmias, CDCs reverse electrical remodeling and suppress arrhythmogenesis in HFpEF.

Published
2018

25. Exosome-Mediated Benefits of Cell Therapy in Mouse and Human Models of Duchenne Muscular Dystrophy.

Author

Aminzadeh, Mark A, Rogers, Russell G, Fournier, Mario, Tobin, Rachel E, Guan, Xuan, Childers, Martin K, Andres, Allen M, Taylor, David J, Ibrahim, Ahmed, Ding, Xiangming, Torrente, Angelo, Goldhaber, Joshua M, Lewis, Michael, Gottlieb, Roberta A, Victor, Ronald A, and Marbán, Eduardo

Subjects
Muscle, Skeletal, Myocardium, Myocytes, Cardiac, Animals, Mice, Inbred C57BL, Mice, Inbred mdx, Humans, Mice, Muscular Dystrophy, Duchenne, Disease Models, Animal, Muscular Dystrophy, Animal, Dystrophin, Female, Male, Exosomes, Induced Pluripotent Stem Cells, Cell- and Tissue-Based Therapy, cardiomyopathy, cardiosphere-derived cells, dystrophin, exosomes, microRNA, muscular dystrophy, Heart Disease, Regenerative Medicine, Intellectual and Developmental Disabilities (IDD), Pediatric Research Initiative, Stem Cell Research, Brain Disorders, Stem Cell Research - Induced Pluripotent Stem Cell, Muscular Dystrophy, Rare Diseases, Duchenne/ Becker Muscular Dystrophy, Cardiovascular, Pediatric, Development of treatments and therapeutic interventions, Aetiology, 2.1 Biological and endogenous factors, 5.2 Cellular and gene therapies, Musculoskeletal, Biochemistry and Cell Biology, Clinical Sciences
Abstract

Genetic deficiency of dystrophin leads to disability and premature death in Duchenne muscular dystrophy (DMD), affecting the heart as well as skeletal muscle. Here, we report that clinical-stage cardiac progenitor cells, known as cardiosphere-derived cells (CDCs), improve cardiac and skeletal myopathy in the mdx mouse model of DMD. Injection of CDCs into the hearts of mdx mice augments cardiac function, ambulatory capacity, and survival. Exosomes secreted by human CDCs reproduce the benefits of CDCs in mdx mice and in human induced pluripotent stem cell-derived Duchenne cardiomyocytes. Surprisingly, CDCs and their exosomes also transiently restored partial expression of full-length dystrophin in mdx mice. The findings further motivate the testing of CDCs in Duchenne patients, while identifying exosomes as next-generation therapeutic candidates.

Published
2018

26. Next-generation pacemakers: from small devices to biological pacemakers.

Author

Cingolani, Eugenio, Goldhaber, Joshua I, and Marbán, Eduardo

Subjects
Heart Conduction System, Animals, Humans, Treatment Outcome, Cardiac Pacing, Artificial, Cell Transplantation, Equipment Design, Gene Transfer Techniques, Pacemaker, Artificial, Biological Clocks, Action Potentials, Heart Rate, Miniaturization, Arrhythmias, Cardiac, Genetic Therapy, Cellular Reprogramming, Cellular Reprogramming Techniques, Cardiovascular System & Hematology, Cardiorespiratory Medicine and Haematology
Abstract

Electrogenesis in the heart begins in the sinoatrial node and proceeds down the conduction system to originate the heartbeat. Conduction system disorders lead to slow heart rates that are insufficient to support the circulation, necessitating implantation of electronic pacemakers. The typical electronic pacemaker consists of a subcutaneous generator and battery module attached to one or more endocardial leads. New leadless pacemakers can be implanted directly into the right ventricular apex, providing single-chamber pacing without a subcutaneous generator. Modern pacemakers are generally reliable, and their programmability provides options for different pacing modes tailored to specific clinical needs. Advances in device technology will probably include alternative energy sources and dual-chamber leadless pacing in the not-too-distant future. Although effective, current electronic devices have limitations related to lead or generator malfunction, lack of autonomic responsiveness, undesirable interactions with strong magnetic fields, and device-related infections. Biological pacemakers, generated by somatic gene transfer, cell fusion, or cell transplantation, provide an alternative to electronic devices. Somatic reprogramming strategies, which involve transfer of genes encoding transcription factors to transform working myocardium into a surrogate sinoatrial node, are furthest along in the translational pipeline. Even as electronic pacemakers become smaller and less invasive, biological pacemakers might expand the therapeutic armamentarium for conduction system disorders.

Published
2018

27. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy.

Author

Gibson, C, Korjian, Serge, Chi, Gerald, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel, Hull, Russel, Hernandez, Adrian, Lopes, Renato, Gold, Alex, Cohen, Alexander, and Harrington, Robert

Subjects
death, intracranial hemorrhage, ischemic stroke, myocardial infarction, pulmonary embolism, venous thromboembolism, Acute Disease, Adult, Aged, Anticoagulants, Benzamides, Cardiovascular Diseases, Double-Blind Method, Enoxaparin, Factor Xa Inhibitors, Female, Hemorrhage, Humans, Inpatients, Intracranial Hemorrhages, Kaplan-Meier Estimate, Male, Middle Aged, Proportional Hazards Models, Pyridines, Risk Factors, Time Factors, Treatment Outcome, Venous Thromboembolism
Abstract

BACKGROUND: Extended-duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. METHODS AND RESULTS: This was a post hoc analysis of the APEX trial-a multicenter, double-blind, randomized controlled trial comparing extended-duration betrixaban versus standard-of-care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time-to-first event analysis. In patients with positive D-dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [P=0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [P=0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [P=0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [P=0.002]). CONCLUSIONS: Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01583218.

Published
2017

28. Cost-effectiveness of edoxaban for the treatment of venous thromboembolism based on the Hokusai-VTE study

Author

Preblick, Ronald, Kwong, W Jacqueline, White, Richard H, and Goldhaber, Samuel Z

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Cost Effectiveness Research, Hematology, Comparative Effectiveness Research, Clinical Research, Health Services, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Anticoagulants, Cost-Benefit Analysis, Dose-Response Relationship, Drug, Drug Administration Schedule, Factor Xa Inhibitors, Female, Hemorrhage, Humans, Male, Middle Aged, Pyridines, Randomized Controlled Trials as Topic, Thiazoles, Treatment Outcome, Venous Thromboembolism, Warfarin, Cost effectiveness, Edoxaban, Novel oral anticoagulants, Venous thromboembolism, Cardiovascular medicine and haematology, Clinical sciences, Health services and systems
Abstract

ObjectiveVenous thromboembolism (VTE) is associated with almost 300,000 deaths per year in the United States. Novel oral anticoagulants (NOACs) offer an alternative to warfarin-based therapy without monitoring requirements and with fewer drug and food interactions. Edoxaban, a direct Xa inhibitor, is approved by the Food and Drug Administration (FDA), based upon results of the Hokusai-VTE Phase 3 trial. The trial demonstrated that edoxaban administered once daily after initial treatment with heparin was non-inferior in reducing the risk of VTE recurrence and caused significantly less major and clinically relevant non-major (CRNM) bleeding compared to warfarin. The objective of this study was to evaluate the cost-effectiveness of edoxaban versus warfarin for the treatment of adults with VTE.MethodsA cost-effectiveness model was developed using patient-level data from the Hokusai-VTE trial, clinical event costs from real-world databases, and drug acquisition costs for warfarin of $0.36 and edoxaban of $9.24 per tablet.ResultsFrom a U.S. health-care delivery system perspective, the incremental cost-effectiveness ratio (ICER) was $22,057 per quality adjusted life year (QALY) gained. Probabilistic sensitivity analysis showed that edoxaban had an ICER

Published
2015

29. Na+/Ca2+ exchange and Na+/K+‐ATPase in the heart

Author

Shattock, Michael J, Ottolia, Michela, Bers, Donald M, Blaustein, Mordecai P, Boguslavskyi, Andrii, Bossuyt, Julie, Bridge, John HB, Chen-Izu, Ye, Clancy, Colleen E, Edwards, Andrew, Goldhaber, Joshua, Kaplan, Jack, Lingrel, Jerry B, Pavlovic, Davor, Philipson, Kenneth, Sipido, Karin R, and Xie, Zi-Jian

Subjects
Medical Physiology, Biomedical and Clinical Sciences, Heart Disease, Cardiovascular, Action Potentials, Animals, Arrhythmias, Cardiac, Congresses as Topic, Humans, Myocytes, Cardiac, Sodium-Calcium Exchanger, Sodium-Potassium-Exchanging ATPase, Biological Sciences, Medical and Health Sciences, Physiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

This paper is the third in a series of reviews published in this issue resulting from the University of California Davis Cardiovascular Symposium 2014: Systems approach to understanding cardiac excitation-contraction coupling and arrhythmias: Na(+) channel and Na(+) transport. The goal of the symposium was to bring together experts in the field to discuss points of consensus and controversy on the topic of sodium in the heart. The present review focuses on cardiac Na(+)/Ca(2+) exchange (NCX) and Na(+)/K(+)-ATPase (NKA). While the relevance of Ca(2+) homeostasis in cardiac function has been extensively investigated, the role of Na(+) regulation in shaping heart function is often overlooked. Small changes in the cytoplasmic Na(+) content have multiple effects on the heart by influencing intracellular Ca(2+) and pH levels thereby modulating heart contractility. Therefore it is essential for heart cells to maintain Na(+) homeostasis. Among the proteins that accomplish this task are the Na(+)/Ca(2+) exchanger (NCX) and the Na(+)/K(+) pump (NKA). By transporting three Na(+) ions into the cytoplasm in exchange for one Ca(2+) moved out, NCX is one of the main Na(+) influx mechanisms in cardiomyocytes. Acting in the opposite direction, NKA moves Na(+) ions from the cytoplasm to the extracellular space against their gradient by utilizing the energy released from ATP hydrolysis. A fine balance between these two processes controls the net amount of intracellular Na(+) and aberrations in either of these two systems can have a large impact on cardiac contractility. Due to the relevant role of these two proteins in Na(+) homeostasis, the emphasis of this review is on recent developments regarding the cardiac Na(+)/Ca(2+) exchanger (NCX1) and Na(+)/K(+) pump and the controversies that still persist in the field.

Published
2015

30. Embryonic Stem Cell–Derived Cardiac Myocytes Are Not Ready for Human Trials

Author

Anderson, Mark E, Goldhaber, Joshua, Houser, Steven R, Puceat, Michel, and Sussman, Mark A

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Animals, Embryonic Stem Cells, Heart, Humans, Male, Myocardial Infarction, Myocytes, Cardiac, Regeneration, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

Recently a preclinical report assessed the efficacy, safety, and feasibility of using human embryonic stem cells to regenerate infarcted myocardium in a non-human primate model. This commentary evaluates that study by pointing out key weaknesses, offering an alternative perspective, and summarizing major unresolved issues. Our conclusion is that significant challenges remain before human embryonic stem cells are ready for use in clinical trials.

Published
2014

31. A Pharmacogenetic versus a Clinical Algorithm for Warfarin Dosing

Author

Kimmel, Stephen E, French, Benjamin, Kasner, Scott E, Johnson, Julie A, Anderson, Jeffrey L, Gage, Brian F, Rosenberg, Yves D, Eby, Charles S, Madigan, Rosemary A, McBane, Robert B, Abdel-Rahman, Sherif Z, Stevens, Scott M, Yale, Steven, Mohler, Emile R, Fang, Margaret C, Shah, Vinay, Horenstein, Richard B, Limdi, Nita A, Muldowney, James AS, Gujral, Jaspal, Delafontaine, Patrice, Desnick, Robert J, Ortel, Thomas L, Billett, Henny H, Pendleton, Robert C, Geller, Nancy L, Halperin, Jonathan L, Goldhaber, Samuel Z, Caldwell, Michael D, Califf, Robert M, and Ellenberg, Jonas H

Subjects
Hematology, Genetics, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Adult, Aged, Algorithms, Anticoagulants, Aryl Hydrocarbon Hydroxylases, Cytochrome P-450 CYP2C9, Double-Blind Method, Female, Follow-Up Studies, Genotype, Hemorrhage, Humans, International Normalized Ratio, Male, Pharmacogenetics, Thromboembolism, Treatment Failure, Vitamin K Epoxide Reductases, Warfarin, COAG Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results.MethodsWe randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy.ResultsAt 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], -0.2; 95% confidence interval, -3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy.ConclusionsGenotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG ClinicalTrials.gov number, NCT00839657.).

Published
2013

32. Integrins protect cardiomyocytes from ischemia/reperfusion injury

Author

Okada, Hideshi, Lai, N Chin, Kawaraguchi, Yoshitaka, Liao, Peter, Copps, Jeffrey, Sugano, Yasuo, Okada-Maeda, Sunaho, Banerjee, Indroneal, Schilling, Jan M, Gingras, Alexandre R, Asfaw, Elizabeth K, Suarez, Jorge, Kang, Seok-Min, Perkins, Guy A, Au, Carol G, Israeli-Rosenberg, Sharon, Manso, Ana Maria, Liu, Zheng, Milner, Derek J, Kaufman, Stephen J, Patel, Hemal H, Roth, David M, Hammond, H Kirk, Taylor, Susan S, Dillmann, Wolfgang H, Goldhaber, Joshua I, and Ross, Robert S

Subjects
Biochemistry and Cell Biology, Medical Physiology, Biomedical and Clinical Sciences, Biological Sciences, Heart Disease, Cardiovascular, Heart Disease - Coronary Heart Disease, 2.1 Biological and endogenous factors, Amino Acid Sequence, Animals, Calcium, Cell Hypoxia, Cells, Cultured, Humans, Integrins, Male, Membrane Potential, Mitochondrial, Mice, Mice, Inbred C57BL, Mice, Transgenic, Molecular Sequence Data, Myocardial Ischemia, Myocardial Reperfusion Injury, Myocytes, Cardiac, Peptide Fragments, Phosphorylation, Protein Binding, Protein Interaction Domains and Motifs, Protein Processing, Post-Translational, Protein Stability, Protein Subunits, Rats, Rats, Sprague-Dawley, Ryanodine Receptor Calcium Release Channel, Medical and Health Sciences, Immunology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Ischemic damage is recognized to cause cardiomyocyte (CM) death and myocardial dysfunction, but the role of cell-matrix interactions and integrins in this process has not been extensively studied. Expression of α7β1D integrin, the dominant integrin in normal adult CMs, increases during ischemia/reperfusion (I/R), while deficiency of β1 integrins increases ischemic damage. We hypothesized that the forced overexpression of integrins on the CM would offer protection from I/R injury. Tg mice with CM-specific overexpression of integrin α7β1D exposed to I/R had a substantial reduction in infarct size compared with that of α5β1D-overexpressing mice and WT littermate controls. Using isolated CMs, we found that α7β1D preserved mitochondrial membrane potential during hypoxia/reoxygenation (H/R) injury via inhibition of mitochondrial Ca2+ overload but did not alter H/R effects on oxidative stress. Therefore, we assessed Ca2+ handling proteins in the CM and found that β1D integrin colocalized with ryanodine receptor 2 (RyR2) in CM T-tubules, complexed with RyR2 in human and rat heart, and specifically bound to RyR2 amino acids 165-175. Integrins stabilized the RyR2 interdomain interaction, and this stabilization required integrin receptor binding to its ECM ligand. These data suggest that α7β1D integrin modifies Ca2+ regulatory pathways and offers a means to protect the myocardium from ischemic injury.

Published
2013

33. Virtual interviewing for graduate medical education recruitment and selection

Author

Michelle Daniel, Michael Gottlieb, Darcy Wooten, Jennifer Stojan, Mary R. C. Haas, Jacob Bailey, Sean Evans, Daniel Lee, Charles Goldberg, Jorge Fernandez, Simerjot K. Jassal, Frances Rudolf, Kama Guluma, Lina Lander, Emily Pott, Nicole H. Goldhaber, Satid Thammasitboon, Hussain Uraiby, Ciaran Grafton-Clarke, Morris Gordon, Teresa Pawlikowska, Janet Corral, Indu Partha, Karyn B. Kolman, Jennifer Westrick, and Diana Dolmans

Subjects
medicine, Education Systems, Education, Medical, postgraduate, COVID-19, Internship and Residency, General Medicine, Education, recruitment and selection, Quality Education, Education, Medical, Graduate, Medical, Specialist Studies in Education, Humans, Best evidence medical education, Fellowships and Scholarships, Graduate, Pandemics, virtual interviews, Curriculum and Pedagogy, Medical Informatics
Abstract

BACKGROUND: The COVID-19 pandemic caused graduate medical education (GME) programs to pivot to virtual interviews (VIs) for recruitment and selection. This systematic review synthesizes the rapidly expanding evidence base on VIs, providing insights into preferred formats, strengths, and weaknesses. METHODS: PubMed/MEDLINE, Scopus, ERIC, PsycINFO, MedEdPublish, and Google Scholar were searched from 1 January 2012 to 21 February 2022. Two authors independently screened titles, abstracts, full texts, performed data extraction, and assessed risk of bias using the Medical Education Research Quality Instrument. Findings were reported according to Best Evidence in Medical Education guidance. RESULTS: One hundred ten studies were included. The majority (97%) were from North America. Fourteen were conducted before COVID-19 and 96 during the pandemic. Studies involved both medical students applying to residencies (61%) and residents applying to fellowships (39%). Surgical specialties were more represented than other specialties. Applicants preferred VI days that lasted 4-6 h, with three to five individual interviews (15-20 min each), with virtual tours and opportunities to connect with current faculty and trainees. Satisfaction with VIs was high, though both applicants and programs found VIs inferior to in-person interviews for assessing 'fit.' Confidence in ranking applicants and programs was decreased. Stakeholders universally noted significant cost and time savings with VIs, as well as equity gains and reduced carbon footprint due to eliminating travel. CONCLUSIONS: The use of VIs for GME recruitment and selection has accelerated rapidly. The findings of this review offer early insights that can guide future practice, policy, and research.

Published
2022
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34. Protection against Omicron from Vaccination and Previous Infection in a Prison System

Author

Elizabeth T. Chin, David Leidner, Lauren Lamson, Kimberley Lucas, David M. Studdert, Jeremy D. Goldhaber-Fiebert, Jason R. Andrews, and Joshua A. Salomon

Subjects
COVID-19 Vaccines, SARS-CoV-2, Prisoners, Vaccination, Immunization, Secondary, COVID-19, Vaccine Efficacy, General Medicine, California, Police, Prisons, Reinfection, Humans, Retrospective Studies
Abstract

Information regarding the protection conferred by vaccination and previous infection against infection with the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is limited.We evaluated the protection conferred by mRNA vaccines and previous infection against infection with the omicron variant in two high-risk populations: residents and staff in the California state prison system. We used a retrospective cohort design to analyze the risk of infection during the omicron wave using data collected from December 24, 2021, through April 14, 2022. Weighted Cox models were used to compare the effectiveness (measured as 1 minus the hazard ratio) of vaccination and previous infection across combinations of vaccination history (stratified according to the number of mRNA doses received) and infection history (none or infection before or during the period of B.1.617.2 [delta]-variant predominance). A secondary analysis used a rolling matched-cohort design to evaluate the effectiveness of three vaccine doses as compared with two doses.Among 59,794 residents and 16,572 staff, the estimated effectiveness of previous infection against omicron infection among unvaccinated persons who had been infected before or during the period of delta predominance ranged from 16.3% (95% confidence interval [CI], 8.1 to 23.7) to 48.9% (95% CI, 41.6 to 55.3). Depending on previous infection status, the estimated effectiveness of vaccination (relative to being unvaccinated and without previous documented infection) ranged from 18.6% (95% CI, 7.7 to 28.1) to 83.2% (95% CI, 77.7 to 87.4) with two vaccine doses and from 40.9% (95% CI, 31.9 to 48.7) to 87.9% (95% CI, 76.0 to 93.9) with three vaccine doses. Incremental effectiveness estimates of a third (booster) dose (relative to two doses) ranged from 25.0% (95% CI, 16.6 to 32.5) to 57.9% (95% CI, 48.4 to 65.7) among persons who either had not had previous documented infection or had been infected before the period of delta predominance.Our findings in two high-risk populations suggest that mRNA vaccination and previous infection were effective against omicron infection, with lower estimates among those infected before the period of delta predominance. Three vaccine doses offered significantly more protection than two doses, including among previously infected persons.

Published
2022
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35. Influence of body mass index on clinical outcomes in venous thromboembolism: Insights from GARFIELD‐VTE

Author

Henri Bounameaux, Harry Gibbs, Sebastian Schellong, Alexander G.G. Turpie, Ajay K. Kakkar, Peter MacCallum, Alfredo E. Farjat, Garfield-Vte investigators, Pantep Angchaisuksiri, Shinya Goto, Samuel Z. Goldhaber, Lorenzo G. Mantovani, Gloria Kayani, Marc Carrier, Jeffrey I. Weitz, Sylvia Haas, Walter Ageno, Paolo Prandoni, Weitz, J, Farjat, A, Ageno, W, Turpie, A, Haas, S, Goto, S, Goldhaber, S, Angchaisuksiri, P, Gibbs, H, Maccallum, P, Carrier, M, Kayani, G, Schellong, S, Bounameaux, H, Mantovani, L, Prandoni, P, and Kakkar, A

Subjects
obesity, medicine.medical_specialty, pulmonary embolism, venous thromboembolism, Hemorrhage, body mass index, Overweight, Internal medicine, medicine, Risk of mortality, Humans, Prospective Studies, anticoagulation, business.industry, Hazard ratio, Anticoagulants, nutritional and metabolic diseases, Hematology, medicine.disease, Obesity, Pulmonary embolism, medicine.symptom, Underweight, business, Body mass index, Venous thromboembolism
Abstract

Background: There is limited information on the influence of body mass index (BMI) on clinical outcomes in patients with venous thromboembolism (VTE). Objectives: Investigate the influence of BMI on baseline characteristics, treatment patterns, and 24-month outcomes in VTE patients. Methods: GARFIELD-VTE is a prospective, non-interventional study of 10869 patients with objectively confirmed VTE. Patients were grouped according to BMI

Published
2021
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36. The physiology of intraoperative error: using electrokardiograms to understand operator performance during robot-assisted surgery simulations

Author

Christopher D’Ambrosia, Eliah Aronoff-Spencer, Estella Y. Huang, Nicole H. Goldhaber, Garth R. Jacobsen, Bryan Sandler, Santiago Horgan, Lawrence G. Appelbaum, Henrik Christensen, and Ryan C. Broderick

Subjects
Surgeons, Surgical education, Operating Rooms, Robotic Surgical Procedures, Minimally invasive surgery, Clinical Sciences, Humans, Laparoscopy, Robotic surgery, Bioengineering, Surgery, Surgical performance
Abstract

Background No platform for objective, synchronous and on-line evaluation of both intraoperative error and surgeon physiology yet exists. Electrokardiogram (EKG) metrics have been associated with cognitive and affective features that are known to impact surgical performance but have not yet been analyzed in conjunction with real-time error signals using objective, real-time methods. Methods EKGs and operating console point-of-views (POVs) for fifteen general surgery residents and five non-medically trained participants were captured during three simulated robotic-assisted surgery (RAS) procedures. Time and frequency-domain EKG statistics were extracted from recorded EKGs. Intraoperative errors were detected from operating console POV videos. EKG statistics were synchronized with intraoperative error signals. Results Relative to personalized baselines, IBI, SDNN and RMSSD decreased 0.15% (S.E. 3.603e−04; P = 3.25e−05), 3.08% (S.E. 1.603e−03; P P = 5.66e−06), respectively, during error. Relative LF RMS power decreased 1.44% (S.E. 2.337e−03; P = 8.38e−10), and relative HF RMS power increased 5.51% (S.E. 1.945e−03; P Conclusions Use of a novel, on-line biometric and operating room data capture and analysis platform enabled detection of distinct operator physiological changes during intraoperative errors. Monitoring operator EKG metrics during surgery may help improve patient outcomes through real-time assessments of intraoperative surgical proficiency and perceived difficulty as well as inform personalized surgical skills development. Graphical abstract

Published
2023

37. Cost-Effectiveness Analysis and Microsimulation of Serial Multiparametric Magnetic Resonance Imaging in Active Surveillance of Localized Prostate Cancer

Author

Christopher J. Magnani, Tina Hernandez-Boussard, Laurence C. Baker, Jeremy D. Goldhaber-Fiebert, and James D. Brooks

Subjects
Image-Guided Biopsy, Male, Cost-Benefit Analysis, Urology, Humans, Prostatic Neoplasms, Prospective Studies, Multiparametric Magnetic Resonance Imaging, Watchful Waiting, Magnetic Resonance Imaging, Article
Abstract

PURPOSE: Many localized prostate cancers will follow an indolent course. Management has shifted toward active surveillance (AS), yet an optimal regimen remains controversial especially regarding expensive multiparametric magnetic resonance imaging (MRI). We aimed to assess cost-effectiveness of MRI in AS protocols. MATERIALS AND METHODS: A probabilistic microsimulation modeled individual patient trajectories for men diagnosed with low-risk cancer. We assessed no surveillance, up-front treatment (surgery or radiation), and scheduled AS protocols incorporating transrectal ultrasound-guided (TRUS) biopsy or MRI based regimens at serial intervals. Lifetime quality-adjusted life-years and costs adjusted to 2020 US$ were used to calculate expected net monetary benefit at $50,000/quality-adjusted life-year and incremental cost-effectiveness ratios. Uncertainty was assessed with probabilistic sensitivity analysis and linear regression metamodeling. RESULTS: Conservative management with AS outperformed up-front definitive treatment in a modeled cohort reflecting characteristics from a multi-institutional trial. Biopsy decision conditional on positive imaging (MRI triage) at 2-year intervals provided the highest expected net monetary benefit (incremental cost-effectiveness ratio $44,576). Biopsy after both positive and negative imaging (MRI pathway) and TRUS biopsy based regimens were not cost-effective. MRI triage resulted in fewer biopsies while reducing metastatic disease or cancer death. Results were sensitive to test performance and cost. MRI triage was the most likely cost-effective strategy on probabilistic sensitivity analysis. CONCLUSIONS: For men with low-risk prostate cancer, our modeling demonstrated that AS with sequential MRI triage is more cost-effective than biopsy regardless of imaging, TRUS biopsy alone or immediate treatment. AS guidelines should specify the role of imaging, and prospective studies should be encouraged.

Published
2022
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38. Temporal trends in abdominal aortic aneurysmal disease: a nationwide cohort study on cardiovascular morbidity and medical cardioprotective therapy

Author

Chalotte W Nicolajsen, Mette Søgaard, Nikolaj Eldrup, Martin Jensen, Torben B Larsen, Samuel Z Goldhaber, and Peter B Nielsen

Subjects
Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use, Epidemiology, Cardiovascular disease, Cohort Studies, Stroke, myocardial infarction, Cardiovascular Diseases, Aortic Aneurysm, Abdominal/epidemiology, Risk Factors, Disease Progression, Humans, Abdominal aortic aneurysm, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Medical cardioprotective treatment, Cardiology and Cardiovascular Medicine, Cardiovascular Diseases/diagnosis, Aortic Aneurysm, Abdominal, Aged
Abstract

Aims Abdominal aortic aneurysmal disease is associated with increased risk of cardiovascular morbidity and death, which potentially can be reduced with cardioprotective medical therapy. The aim of this study was to observe temporal trends in prevalence and incidence of cardiovascular comorbidity as well as use of medical cardioprotective treatment in patients diagnosed with abdominal aortic aneurysmal disease. Methods and results This was a population-based cohort study based on data from national health registries, including all patients diagnosed with abdominal aortic aneurysms between 1998 and 2018. Data were stratified into four time periods (1999–2003, 2004–2008, 2009–2013, and 2014–2018) to illustrate trends over time. Outcome measures were (i) cardiovascular comorbidity and medical cardioprotective therapy at time of diagnosis, (ii) new admissions for atherosclerotic cardiovascular disease, and (iii) all-cause mortality after 2-year follow-up. The study cohort included 33 296 individuals. Mean age was 74 years. Prevalence of atherosclerotic cardiovascular comorbidity at diagnosis decreased from 41.5 to 32.6%. Use of statins increased from 17.9 to 66.9%, antiplatelets from 45.6 to 63.3%, and combined therapy with both antiplatelets and statins from 11.3 to 44.8%, and from 12.1 to 50.7% when anticoagulant therapy was included. Developments in medication use plateaued after 2013. Prevalence and incidence of atherosclerotic cardiovascular disease decreased through all four time periods. The same applied to all-cause mortality, which decreased from 24.3 to 12.4 deaths (per 100 person-years). Conclusion In patients diagnosed with abdominal aortic aneurysm, cardiovascular comorbidity at diagnosis, risk of future cardiovascular events, and all-cause mortality is decreasing. Nevertheless, cardiovascular burden and mortality rates remain substantial, and medical cardioprotective therapy can be further improved.

Published
2022
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39. Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism: Rationale and design of the SERIOUS-PE study

Author

Behnood Bikdeli, Gregory Piazza, David Jimenez, Alfonso Muriel, Yun Wang, Candrika D. Khairani, Rachel P. Rosovsky, Ghazaleh Mehdipoor, Michelle L. O'Donoghue, Primavera Spagnolo, Rachel P. Dreyer, Laurent Bertoletti, Luciano López-Jiménez, Manuel Jesús Núñez, Ángeles Blanco-Molina, Shannon M. Bates, Marie Gerhard-Herman, Samuel Z. Goldhaber, Manuel Monreal, and Harlan M. Krumholz

Subjects
Male, Sex Characteristics, Pharmaceutical Preparations, Risk Factors, Humans, Female, Registries, Venous Thromboembolism, Hematology, Medicare, Pulmonary Embolism, United States, Aged
Abstract

Sex is an important factor associated with pulmonary embolism (PE) disease presentation and outcomes, which may be related to pathobiological, social, and treatment-based differences. We are seeking to illuminate sex differences in pulmonary embolism presentation, care, and outcomes using an international registry and a national US database of people 65 years and older, the age group in which the majority of these events occur.The Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism (SERIOUS-PE) study has been designed to address knowledge gaps in this area. This study will use data from the Registro Informatizado Enfermedad TromboEmbolica (RIETE) registry and the US Medicare Fee-For-Service beneficiaries. RIETE is a large international registry of patients with venous thromboembolism with data collected on PE presentation, risk factors, co-morbidities, drug and interventional therapies, as well as 30-day and 1-year outcomes (including recurrent VTE, major bleeding, and mortality). Data from US Medicare Fee-For-Service beneficiaries will be used to understand the sex differences in PE hospitalizations, advanced therapies, and outcomes at 30-day and 1-year follow-up. Assessment of outcomes in both databases will be performed in unadjusted models, as well as those adjusted for demographics, co-morbidities, and treatments, to understand whether the potential sex differences in outcomes are related to differences in risk factors and co-morbidities, potential disparities in treatment, or a plausible biological difference in women versus men. Linear trends will be assessed over time.RIETE data from March 2001 through March 2021 include 33,462 elderly patients with PE, of whom 19,294 (57.7%) were women and 14,168 (42.3%) were men. In the Medicare Fee-For-Service database, between January 2001 and December 31, 2019, 1,030,247 patients were hospitalized with a principal discharge diagnosis of PE, of whom 599,816 (58.2%) were women and 430,431 (41.8%) were men.Findings from the SERIOUS-PE study will help address important knowledge gaps related to sex differences in presentation and risk factors, treatment patterns, and outcomes of older adults with PE. The results may guide changes in prognostic prediction rules based on sex-specific findings, identify sex-based disparities in care delivery that should be addressed by quality improvement, or uncover potential differences in response to available therapies that warrant testing in dedicated randomized trials.

Published
2022
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40. Early Detection and Management of Venous Thrombosis in Skull Base Surgery: Role of Routine Doppler Ultrasound Monitoring

Author

Abdullah M, Abunimer, Asad M, Lak, Paola, Calvachi, Timothy R, Smith, Linda S, Aglio, Kaith K, Almefty, Ian F, Dunn, Wenya Linda, Bi, Samuel Z, Goldhaber, and Ossama, Al-Mefty

Subjects
Adult, Skull Base, Venous Thrombosis, Incidence, Anticoagulants, Ultrasonography, Doppler, Venous Thromboembolism, Postoperative Complications, Risk Factors, Humans, Surgery, Neurology (clinical), Pulmonary Embolism, Retrospective Studies
Abstract

Venous thromboembolism (VTE), encompassing deep venous thrombosis (DVT) and pulmonary embolism (PE), causes postoperative morbidity and mortality in neurosurgical patients. The use of pharmacological prophylaxis for DVT prevention in the immediate postoperative period carries increased risk of intracranial hemorrhage, especially after skull base surgeries.To investigate the impact of routine Doppler ultrasound monitoring in prevention and tiered management of VTE after skull base surgery.We retrospectively analyzed a large cohort of consecutive adult patients who were prospectively and uniformly managed with routine monitoring by Doppler ultrasound for DVT after resection of a skull base tumor.A total of 389 patients who underwent 459 surgeries for intracranial tumor resection were analyzed. Skull base meningioma was the most common pathology. Forty-four (9.59%) postoperative VTEs were detected: 9 (1.96%) with PE with or without DVT and 35 (7.63%) with DVT alone. Four cases of subsegmental PE were diagnosed without evidence of lower extremity DVT, possibly in the setting of peripherally inserted central catheters maintenance. One patient had a preoperative proximal DVT and underwent a prophylactic inferior vena cava filter but expired from PE after discharge. Prior history of VTE (risk ratio [RR] 5.13; 95% CI 2.76-7.18; P.01), anesthesia duration (RR 1.14; 95% CI 1.03-1.27; P = .02), and blood transfusion (RR 1.95; 95% CI 1.01-3.37; P = .04) were associated with VTE development on multivariate analysis.Routine postoperative venous ultrasound monitoring detects asymptomatic DVT guiding management. This is an alternative strategy to prescribing pharmacological VTE prophylaxis immediately after lengthy surgeries for intracranial tumors. Peripherally inserted central catheters were associated with subsegmental PE.

Published
2022
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41. Optimal patient selection for simultaneous heart-kidney transplant: A modified cost-effectiveness analysis

Author

Kiran K. Khush, Brian Wayda, Jeremy D. Goldhaber-Fiebert, and Xingxing S. Cheng

Subjects
Oncology, medicine.medical_specialty, Tissue and Organ Procurement, Cost-Benefit Analysis, Economic shortage, Kidney, Kidney transplant, Article, Clinical decision making, Internal medicine, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Native kidney, Selection (genetic algorithm), Aged, Transplantation, Deceased donor, business.industry, Patient Selection, Kidney dysfunction, Cost-effectiveness analysis, Kidney Transplantation, Tissue Donors, United States, Heart Transplantation, business
Abstract

Increasing rates of simultaneous heart-kidney (SHK) transplant in the United States exacerbate the overall shortage of deceased donor kidneys (DDK). Current allocation policy does not impose constraints on SHK eligibility, and how best to do so remains unknown. We apply a decision-analytic model to evaluate options for heart transplant (HT) candidates with comorbid kidney dysfunction. We compare SHK with a "Safety Net" strategy, in which DDK transplant is performed 6 months after HT, only if native kidneys do not recover. We identify patient subsets for whom SHK using a DDK is efficient, considering the quality-adjusted life year (QALY) gains from DDKs instead allocated for kidney transplant-only. For an average-aged candidate with a 50% probability of kidney recovery after HT-only, SHK produces 0.64 more QALYs than Safety Net at a cost of 0.58 more kidneys used. SHK is inefficient in this scenario, producing fewer QALYs per DDK used (1.1) than a DDK allocated for KT-only (2.2). SHK is preferred to Safety Net only for candidates with a lower probability of native kidney recovery (24%-38%, varying by recipient age). This finding favors the implementation of a Safety Net provision and should inform the establishment of objective criteria for SHK transplant eligibility.

Published
2022
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42. Acute Management of High-Risk and Intermediate-Risk Pulmonary Embolism in Children

Author

Christina VanderPluym, Riten Kumar, Kevin G. Friedman, Marie-Claude Pelland-Marcotte, Samuel Z. Goldhaber, Diego Porras, Muhammad B. Ghbeis, Catherine E. Ross, Francis Fynn-Thompson, Shivani Mehta, Leonardo R. Brandão, Monica E. Kleinman, and Ravi R. Thiagarajan

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, medicine.medical_treatment, Pediatric advanced life support, Embolectomy, Critical Care and Intensive Care Medicine, Risk Factors, medicine.artery, Intensive care, medicine, Humans, Thrombolytic Therapy, Child, Intensive care medicine, business.industry, Thrombolysis, medicine.disease, Pulmonary embolism, Catheter, Treatment Outcome, Shock (circulatory), Acute Disease, Pulmonary Vascular: CHEST Reviews, Pulmonary artery, medicine.symptom, Pulmonary Embolism, Cardiology and Cardiovascular Medicine, business
Abstract

Severe forms of pulmonary embolism (PE) in children are rare but cause significant morbidity and mortality. In this article, we review the pathophysiology of severe (high- and intermediate-risk) PE and suggest novel pediatric-specific risk stratifications and an acute treatment algorithm to expedite emergent decision making. We define pediatric high-risk PE as causing cardiopulmonary arrest, sustained hypotension or normotension with signs or symptoms of shock. Rapid primary reperfusion should be pursued with either surgical embolectomy or systemic thrombolysis in conjunction with a heparin infusion and supportive care as appropriate. We define pediatric intermediate-risk PE as those without systemic hypotension nor compensated shock but with evidence of right ventricular strain by imaging and/or myocardial necrosis by elevated cardiac troponin levels. The decision to pursue primary reperfusion in this group is complex and should be reserved for patients with more severe disease; anticoagulation alone may also be appropriate in some cases. If primary reperfusion is pursued, catheter-based therapies may be beneficial. In summary, acute management of severe PE in children may include systemic thrombolysis, surgical embolectomy, catheter-based therapies or anticoagulation alone, and may depend on patient and institutional factors. Pediatric emergency and intensive care physicians should be familiar with the risks and benefits of each therapy in order to expedite care. PE Response Teams may also have added benefit in streamlining care during these critical events.

Published
2022
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43. Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial

Author

Azita H. Talasaz, Parham Sadeghipour, Hooman Bakhshandeh, Babak Sharif-Kashani, Farid Rashidi, Mohammad Taghi Beigmohammadi, Keivan Gohari Moghadam, Somaye Rezaian, Ali Dabbagh, Seyed Hashem Sezavar, Mohsen Farrokhpour, Atefeh Abedini, Rasoul Aliannejad, Taghi Riahi, Mahdi Yadollahzadeh, Somayeh Lookzadeh, Parisa Rezaeifar, Samira Matin, Ouria Tahamtan, Keyhan Mohammadi, Elnaz Zoghi, Hamid Rahmani, Seyed Hossein Hosseini, Seyed Masoud Mousavian, Homa Abri, Pardis Sadeghipour, Elahe Baghizadeh, Farnaz Rafiee, Sepehr Jamalkhani, Ahmad Amin, Bahram Mohebbi, Seyed Ehsan Parhizgar, Mahshid Soleimanzadeh, Maryam Aghakouchakzadeh, Vahid Eslami, Pooya Payandemehr, Hossein Khalili, Hamed Talakoob, Taranom Tojari, Shadi Shafaghi, Sanaz Tabrizi, Hessam Kakavand, Alireza Kashefizadeh, Atabak Najafi, David Jimenez, Aakriti Gupta, Mahesh V. Madhavan, Sanjum S. Sethi, Sahil A. Parikh, Manuel Monreal, Naser Hadavand, Alireza Hajighasemi, Khalil Ansarin, Majid Maleki, Saeed Sadeghian, Stefano Barco, Bob Siegerink, Erica S. Spatz, Gregory Piazza, Ajay J. Kirtane, Benjamin W. Van Tassell, Gregory Y. H. Lip, Frederikus A. Klok, Samuel Z. Goldhaber, Gregg W. Stone, Harlan M. Krumholz, and Behnood Bikdeli

Subjects
Adult, Atorvastatin/therapeutic use, Male, Intensive Care Units, Treatment Outcome, Double-Blind Method, COVID-19, Humans, Thrombosis/drug therapy, Female, Hematology, Middle Aged
Abstract

Background In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days. Methods This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale. Results In the primary analysis, 587 patients were included (age: 57 [Q1–Q3: 45–68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60–1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42–0.86, p interaction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal: 0.64, 95% CI: 0.41–1.01, p = 0.05). Conclusion Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset. (NCT04486508).

Published
2023
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44. Cost-Effectiveness of Dapagliflozin for Non-diabetic Chronic Kidney Disease

Author

Rebecca L. Tisdale, Marika M. Cusick, Kelly Zhang Aluri, Thomas J. Handley, Alice Kate Cummings Joyner, Joshua A. Salomon, Glenn M. Chertow, Jeremy D. Goldhaber-Fiebert, and Douglas K. Owens

Subjects
Adult, Glucose, Diabetes Mellitus, Type 2, Glucosides, Sodium-Glucose Transporter 2, Cost-Benefit Analysis, Sodium, Internal Medicine, Humans, Quality-Adjusted Life Years, Benzhydryl Compounds, Renal Insufficiency, Chronic, Sodium-Glucose Transporter 2 Inhibitors
Abstract

In the USA, chronic kidney disease (CKD) affects 1 in 7 adults and costs $100 billion annually. The DAPA-CKD trial found dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, to be effective in reducing CKD progression and mortality in patients with diabetic and non-diabetic CKD. Currently, SGLT2 inhibitors are not considered standard of care for patients with non-diabetic CKD.Determine the cost-effectiveness of adding dapagliflozin to standard management of patients with non-diabetic CKD.Markov model with lifetime time horizon and US healthcare sector perspective.Patients with non-diabetic CKD INTERVENTION: Dapagliflozin plus standard care versus standard care only.Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3% annually; total incidence of kidney failure on kidney replacement therapy; average years on kidney replacement therapy.Adding dapagliflozin to standard care improved life expectancy by 2 years, increased discounted QALYS (from 6.75 to 8.06), and reduced the total incidence of kidney failure on kidney replacement therapy (KRT) (from 17.4 to 11.0%) and average years on KRT (from 0.77 to 0.43) over the lifetime of the cohort. Dapagliflozin plus standard care was more effective than standard care alone while increasing lifetime costs (from $245,900 to $324,8900, or $60,000 per QALY gained). Results were robust to variations in assumptions about dapagliflozin's efficacy over time and by CKD stage, added costs of kidney replacement therapy, and expected population annual CKD progression rates and sensitive to the cost of dapagliflozin. The net 1-year budgetary implication of treating all US patients with non-diabetic CKD could be up to $21 billion.Dapagliflozin improved life expectancy and reduced progression of CKD, the proportion of patients requiring kidney replacement therapy, and time on kidney replacement therapy in patients with non-diabetic CKD. Use of dapagliflozin meets conventional criteria for cost-effectiveness.

Published
2022
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45. Mechanisms of Sinoatrial Node Dysfunction in Heart Failure With Preserved Ejection Fraction

Author

Thassio Mesquita, Rui Zhang, Jae Hyung Cho, Yen-Nien Lin, Lizbeth Sanchez, Joshua I. Goldhaber, Joseph K. Yu, Jialiu A. Liang, Weixin Liu, Natalia A. Trayanova, and Eugenio Cingolani

Subjects
Heart Failure, sinoatrial node, cardiac, Clinical Sciences, Stroke Volume, Cardiorespiratory Medicine and Haematology, Cardiovascular, Article, Rats, Heart Disease, Cardiovascular System & Hematology, Physiology (medical), heart rate, Public Health and Health Services, Animals, Humans, 2.1 Biological and endogenous factors, Aetiology, Cardiology and Cardiovascular Medicine, arrhythmias, Sinoatrial Node, Nutrition
Abstract

Background: The ability to increase heart rate during exercise and other stressors is a key homeostatic feature of the sinoatrial node (SAN). When the physiological heart rate response is blunted, chronotropic incompetence limits exercise capacity, a common problem in patients with heart failure with preserved ejection fraction (HFpEF). Despite its clinical relevance, the mechanisms of chronotropic incompetence remain unknown. Methods: Dahl salt-sensitive rats fed a high-salt diet and C57Bl6 mice fed a high-fat diet and an inhibitor of constitutive nitric oxide synthase (Nω-nitro-L-arginine methyl ester [L-NAME]; 2-hit) were used as models of HFpEF. Myocardial infarction was created to induce HF with reduced ejection fraction. Rats and mice fed with a normal diet or those that had a sham surgery served as respective controls. A comprehensive characterization of SAN function and chronotropic response was conducted by in vivo, ex vivo, and single-cell electrophysiologic studies. RNA sequencing of SAN was performed to identify transcriptomic changes. Computational modeling of biophysically-detailed human HFpEF SAN was created. Results: Rats with phenotypically-verified HFpEF exhibited limited chronotropic response associated with intrinsic SAN dysfunction, including impaired β-adrenergic responsiveness and an alternating leading pacemaker within the SAN. Prolonged SAN recovery time and reduced SAN sensitivity to isoproterenol were confirmed in the 2-hit mouse model. Adenosine challenge unmasked conduction blocks within the SAN, which were associated with structural remodeling. Chronotropic incompetence and SAN dysfunction were also found in rats with HF with reduced ejection fraction. Single-cell studies and transcriptomic profiling revealed HFpEF-related alterations in both the “membrane clock” (ion channels) and the “Ca 2+ clock” (spontaneous Ca 2+ release events). The physiologic impairments were reproduced in silico by empirically-constrained quantitative modeling of human SAN function. Conclusions: Chronotropic incompetence and SAN dysfunction were seen in both models of HF. We identified that intrinsic abnormalities of SAN structure and function underlie the chronotropic response in HFpEF.

Published
2022
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46. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author

Jitendra PS. Sawhney, Veerappa A. Kothiwale, Vikas Bisne, Rajashekhar Durgaprasad, Praveen Jadhav, Manoj Chopda, Velam Vanajakshamma, Ramdhan Meena, Govindan Vijayaraghavan, Kamaldeep Chawla, Jagan Allu, Karen S. Pieper, A. John Camm, Ajay K. Kakkar, Jean-Pierre Bassand, David A. Fitzmaurice, Samuel Z. Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Lorenzo G. Mantovani, Frank Misselwitz, Alexander G.G. Turpie, Martin van Eickels, Freek W.A. Verheugt, Gloria Kayani, Keith A.A. Fox, Bernard J. Gersh, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Frank Cools, Antonio Carlos Pereira Barretto, Stuart J. Connolly, Alex Spyropoulos, John Eikelboom, Ramon Corbalan, Dayi Hu, Petr Jansky, Jørn Dalsgaard Nielsen, Hany Ragy, Pekka Raatikainen, Jean-Yves Le Heuzey, Harald Darius, Matyas Keltai, Sanjay Kakkar, Jitendra Pal Singh Sawhney, Giancarlo Agnelli, Giuseppe Ambrosio, Yukihiro Koretsune, Carlos Jerjes Sánchez Díaz, Hugo Ten Cate, Dan Atar, Janina Stepinska, Elizaveta Panchenko, Toon Wei Lim, Barry Jacobson, Seil Oh, Xavier Viñolas, Marten Rosenqvist, Jan Steffel, Pantep Angchaisuksiri, Ali Oto, Alex Parkhomenko, Wael Al Mahmeed, David Fitzmaurice, D.Y. Hu, K.N. Chen, Y.S. Zhao, H.Q. Zhang, J.Z. Chen, S.P. Cao, D.W. Wang, Y.J. Yang, W.H. Li, Y.H. Yin, G.Z. Tao, P. Yang, Y.M. Chen, S.H. He, Ying Wang, Yong Wang, G.S. Fu, X. Li, T.G. Wu, X.S. Cheng, X.W. Yan, R.P. Zhao, M.S. Chen, L.G. Xiong, P. Chen, Y. Jiao, Y. Guo, L. Xue, F.Z. Wang, H. Li, Z.M. Yang, C.L. Bai, J. Chen, J.Y. Chen, X. Chen, S. Feng, Q.H. Fu, X.J. Gao, W.N. Guo, R.H. He, X.A. He, X.S. Hu, X.F. Huang, B. Li, J. Li, L. Li, Y.H. Li, T.T. Liu, W.L. Liu, Y.Y. Liu, Z.C. Lu, X.L. Luo, T.Y. Ma, J.Q. Peng, X. Sheng, X.J. Shi, Y.H. Sun, G. Tian, K. Wang, L. Wang, R.N. Wu, Q. Xie, R.Y. Xu, J.S. Yang, L.L. Yang, Q. Yang, Y. Ye, H.Y. Yu, J.H. Yu, T. Yu, H. Zhai, Q. Zhan, G.S. Zhang, Q. Zhang, R. Zhang, Y. Zhang, W.Y. Zheng, B. Zhou, Z.H. Zhou, X.Y. Zhu, S. Kakkar, J.P.S. Sawhney, P. Jadhav, R. Durgaprasad, A.G. Ravi Shankar, R.K. Rajput, K. Bhargava, R. Sarma, A. Srinivas, D. Roy, U.M. Nagamalesh, M. Chopda, R. Kishore, G. Kulkarni, P. Chandwani, R.A. Pothiwala, M. Padinhare Purayil, S. Shah, K. Chawla, V.A. Kothiwale, B. Raghuraman, G. Vijayaraghavan, V.M. Vijan, G. Bantwal, V. Bisne, A. Khan, J.B. Gupta, S. Kumar, D. Jain, S. Abraham, D. Adak, A. Barai, H. Begum, P. Bhattacharjee, M. Dargude, D. Davies, B. Deshpande, P. Dhakrao, V. Dhyani, S. Duhan, M. Earath, A. Ganatra, S. Giradkar, V. Jain, R. Karthikeyan, L. Kasala, S. Kaur, S. Krishnappa, A. Lawande, B. Lokesh, N. Madarkar, R. Meena, P. More, D. Naik, K. Prashanth, M. Rao, N.M. Rao, N. Sadhu, D. Shah, M. Sharma, P. Shiva, S. Singhal, S. Suresh, V. Vanajakshamma, S.G. Panse, Y. Koretsune, S. Kanamori, K. Yamamoto, K. Kumagai, Y. Katsuda, K. Sadamatsu, F. Toyota, Y. Mizuno, I. Misumi, H. Noguchi, S. Ando, T. Suetsugu, M. Minamoto, Hiroshi Oda, K. Shiraishi, S. Adachi, K. Chiba, H. Norita, M. Tsuruta, T. Koyanagi, H. Ando, T. Higashi, K. Okada, S. Azakami, S. Komaki, K. Kumeda, T. Murayama, J. Matsumura, Y. Oba, R. Sonoda, K. Goto, K. Minoda, Y. Haraguchi, H. Suefuji, H. Miyagi, H. Kato, Tadashi Nakamura, Tsugihiro Nakamura, H. Nandate, R. Zaitsu, Yoshihisa Fujiura, A. Yoshimura, H. Numata, J. Ogawa, H. Tatematsu, Y. Kamogawa, K. Murakami, Y. Wakasa, M. Yamasawa, H. Maekawa, S. Abe, H. Kihara, S. Tsunoda, Katsumi Saito, Kazuyuki Saito, T. Fudo, K. Obunai, H. Tachibana, I. Oba, T. Kuwahata, S. Higa, M. Gushiken, T. Eto, H. Yoshida, D. Ikeda, Yoshitake Fujiura, M. Ishizawa, M. Nakatsuka, K. Murata, C. Ogurusu, M. Shimoyama, M. Akutsu, I. Takamura, F. Hoshino, N. Yokota, T. Iwao, K. Tsuchida, M. Takeuchi, Y. Hatori, Y. Kitami, Yoichi Nakamura, R. Oyama, M. Ageta, Hiroyuki Oda, Y. Go, K. Mishima, T. Unoki, S. Morii, Yuhei Shiga, H. Sumi, T. Nagatomo, K. Sanno, K. Fujisawa, Y. Atsuchi, T. Nagoshi, T. Seto, T. Tabuchi, M. Kameko, K. Nii, K. Oshiro, H. Takezawa, S. Nagano, N. Miyamoto, M. Iwaki, Yuichiro Nakamura, M. Fujii, M. Okawa, Masahiko Abe, Masatake Abe, Mitsunori Abe, T. Saito, T. Mito, K. Nagao, J. Minami, T. Mita, I. Sakuma, T. Taguchi, S. Marusaki, H. Doi, M. Tanaka, T. Fujito, M. Matsuta, T. Kusumoto, S. Kakinoki, K. Ashida, N. Yoshizawa, J. Agata, O. Arasaki, M. Manita, M. Ikemura, S. Fukuoka, H. Murakami, S. Matsukawa, Y. Hata, T. Taniguchi, T. Ko, H. Kubo, M. Imamaki, M. Akiyama, M. Inagaki, H. Odakura, T. Ueda, Y. Katsube, A. Nakata, H. Watanabe, M. Techigawara, M. Igarashi, K. Taga, T. Kimura, S. Tomimoto, M. Shibuya, M. Nakano, K. Ito, T. Seo, S. Hiramitsu, H. Hosokawa, M. Hoshiai, M. Hibino, K. Miyagawa, Hajime Horie, N. Sugishita, Yukio Shiga, A. Soma, K. Neya, Tetsuro Yoshida, Tomoki Yoshida, M. Mizuguchi, M. Ishiguro, T. Minagawa, M. Wada, H. Mukawa, F. Okuda, S. Nagasaka, Y. Abe, Sen Adachi, Susumu Adachi, T. Adachi, K. Akahane, T. Amano, K. Aoki, T. Aoyama, H. Arai, S. Arima, T. Arino, H. Asano, T. Asano, J. Azuma, T. Baba, T. Betsuyaku, H. Chibana, H. Date, J. Doiuchi, Y. Emura, M. Endo, Y. Fujii, R. Fujiki, A. Fujisawa, Y. Fujisawa, T. Fukuda, T. Fukui, N. Furukawa, T. Furukawa, W. Furumoto, T. Goto, M. Hamaoka, N. Hanazono, K. Hasegawa, T. Hatsuno, Y. Hayashi, K. Higuchi, K. Hirasawa, H. Hirayama, M. Hirose, S. Hirota, M. Honda, Hideki Horie, T. Ido, O. Iiji, H. Ikeda, K. Ikeda, K. Ikeoka, M. Imaizumi, H. Inaba, T. Inoue, F. Iseki, A. Ishihara, N. Ishioka, N. Ito, T. Iwase, H. Kakuda, J. Kamata, H. Kanai, H. Kanda, M. Kaneko, H. Kano, T. Kasai, T. Kato, Y. Kato, Y. Kawada, K. Kawai, K. Kawakami, S. Kawakami, T. Kawamoto, S. Kawano, J. Kim, T. Kira, H. Kitazawa, H. Kitazumi, T. Kito, T. Kobayashi, T. Koeda, J. Kojima, H. Komatsu, I. Komatsu, Y. Koshibu, T. Kotani, T. Kozuka, Y. Kumai, T. Kumazaki, I. Maeda, K. Maeda, Y. Maruyama, S. Matsui, K. Matsushita, Y. Matsuura, K. Mineoi, H. Mitsuhashi, N. Miura, S. Miyaguchi, S. Miyajima, H. Miyamoto, A. Miyashita, S. Miyata, I. Mizuguchi, A. Mizuno, T. Mori, O. Moriai, K. Morishita, O. Murai, Sho Nagai, Shunichi Nagai, E. Nagata, H. Nagata, A. Nakagomi, S. Nakahara, M. Nakamura, R. Nakamura, N. Nakanishi, T. Nakayama, R. Nakazato, T. Nanke, J. Nariyama, Y. Niijima, H. Niinuma, Y. Nishida, Y. Nishihata, K. Nishino, H. Nishioka, K. Nishizawa, I. Niwa, K. Nomura, S. Nomura, M. Nozoe, T. Ogawa, N. Ohara, M. Okada, K. Okamoto, H. Okita, M. Okuyama, H. Ono, T. Ono, Y. Onuki Pearce, S. Oriso, A. Ota, E. Otaki, Y. Saito, H. Sakai, N. Sakamoto, Y. Sakamoto, Y. Samejima, Y. Sasagawa, H. Sasaguri, A. Sasaki, T. Sasaki, Kazuki Sato, Kiyoharu Sato, M. Sawano, S. Seki, Y. Sekine, Y. Seta, K. Sezaki, N. Shibata, Y. Shiina, H. Shimono, Y. Shimoyama, T. Shindo, H. Shinohara, R. Shinohe, T. Shinozuka, T. Shirai, T. Shiraiwa, Y. Shozawa, T. Suga, C. Sugimoto, Kazuo Suzuki, Keita Suzuki, Shu Suzuki, Shunji Suzuki, Susumu Suzuki, Y. Suzuki, M. Tada, A. Taguchi, T. Takagi, Y. Takagi, K. Takahashi, S. Takahashi, H. Takai, C. Takanaka, S. Take, H. Takeda, K. Takei, K. Takenaka, T. Tana, G. Tanabe, K. Taya, H. Teragawa, S. Tohyo, S. Toru, Y. Tsuchiya, T. Tsuji, K. Tsuzaki, H. Uchiyama, O. Ueda, Y. Ueyama, N. Wakaki, T. Wakiyama, T. Washizuka, M. Watanabe, T. Yamada, T. Yamagishi, H. Yamaguchi, Kenichi Yamamoto, Kentaro Yamamoto, Kunihiko Yamamoto, T. Yamamoto, M. Yamaura, M. Yamazoe, K. Yasui, Y. Yokoyama, K. Yoshida, T.W. Lim, C.K. Ching, C.G. Foo, J.H. Chow, D.D. Chen, F.R. Jaufeerally, Y.M. Lee, G. Lim, W.T. Lim, S. Thng, S.Y. Yap, C. Yeo, S. Oh, H.N. Pak, J.-B. Kim, J.H. Kim, S.-W. Jang, D.H. Kim, D.R. Ryu, S.W. Park, D.-K. Kim, D.J. Choi, Y.S. Oh, M.-C. Cho, S.-H. Kim, H.-K. Jeon, D.-G. Shin, J.S. Park, H.K. Park, S.-J. Han, J.H. Sung, J.-G. Cho, G.-B. Nam, Y.K. On, H.E. Lim, J.J. Kwak, T.-J. Cha, T.J. Hong, S.H. Park, J.H. Yoon, N.-H. Kim, K.-S. Kim, B.C. Jung, G.-S. Hwang, C.-J. Kim, D.B. Kim, J.J. Ahn, H.J. An, H. Bae, A.L. Baek, W.J. Chi, E.A. Choi, E.H. Choi, H.K. Choi, H.S. Choi, S. Han, E.S. Heo, K.O. Her, S.W. Hwang, E.M. Jang, H.-S. Jang, S. Jang, H.-G. Jeon, S.R. Jeon, Y.R. Jeon, H.K. Jeong, I.-A. Jung, Hyeon Jeong Kim, Hyun Ju Kim, Ji Seon Kim, Jung Sook Kim, J.A. Kim, K.T. Kim, M.S. Kim, Sang Hee Kim, Sang Hyun Kim, Y.-I. Kim, C.S. Lee, E.H. Lee, G.H. Lee, H.Y. Lee, H.-Y. Lee, K.H. Lee, K.R. Lee, M.S. Lee, M.-Y. Lee, R.W. Lee, S.E. Lee, S.H. Lee, S. Lee, W.Y. Lee, I.K. Noh, A.R. Park, B.R. Park, H.N. Park, J.H. Park, M. Park, Y. Park, S.-Y. Seo, J. Shim, J.H. Sim, Y.M. Sohn, W.S. Son, Y.S. Son, H.J. Song, H.K. Wi, J.J. Woo, S. Ye, K.H. Yim, K.M. Yoo, E.J. Yoon, S.Y. Yun, P. Angchaisuksiri, S. Chawanadelert, P. Mongkolwongroj, K. Kanokphatcharakun, S. Cheewatanakornkul, T. Laksomya, S. Pattanaprichakul, T. Chantrarat, S. Rungaramsin, S. Silaruks, W. Wongcharoen, K. Siriwattana, K. Likittanasombat, P. Katekangplu, W. Boonyapisit, D. Cholsaringkarl, B. Chatlaong, P. Chattranukulchai, Y. Santanakorn, P. Hutayanon, P. Khunrong, T. Bunyapipat, S. Jai-Aue, P. Kaewsuwanna, P. Bamungpong, S. Gunaparn, S. Hongsuppinyo, R. Inphontan, R. Khattaroek, K. Khunkong, U. Kitmapawanont, C. Kongsin, B. Naratreekoon, S. Ninwaranon, J. Phangyota, A. Phrommintikul, P. Phunpinyosak, K. Pongmorakot, S. Poomiphol, N. Pornnimitthum, S. Pumprueg, S. Ratchasikaew, K. Sanit, K. Sawanyawisuth, B. Silaruks, R. Sirichai, A. Sriwichian, W. Suebjaksing, P. Sukklad, T. Suttana, A. Tangsirira, O. Thangpet, W. Tiyanon, Y. Vorasettakarnkij, T. Wisaratapong, W. Wongtheptien, A. Wutthimanop, S. Yawila, A. Oto, A. Altun, I. Ozdogru, K. Ozdemir, O. Yilmaz, A. Aydinlar, M.B. Yilmaz, E. Yeter, Z. Ongen, M. Cayli, H. Pekdemir, M. Ozdemir, M. Sucu, T. Sayin, M. Demir, H. 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Edén, M. Fanuele, F. Fernandez Voena, M. Foa Torres, C. Funosas, M.P. Giacomi, C.H. Gimenez, E.P. Gurfinkel, M. de L.M. Had, V. Hansen, A.D. Hrabar, M. Ingratta, A. Lopez, G. Maehara, L. Maffei, A. Martinelli, C. Martinelli, J. Matkovich, B. Mautner, A. Meirino, R. Munguia, A. Navarro, V. Novas, G. Perez Prados, J. Pontoriero, R.N. Potito, C. Ricotti, M.A. Rodriguez, F. Rolandi, M.E. Said Palladino, M. Salinger, L.S. Sanziani, P.O. Schygiel, A. Sossich, J.F. Tinto, L. Tonelli, A.L. Tufare, M. Vallejo, M.E. Yunis, M. Zillo, F.J. Zurbrigk, A.C.P. Barretto, D.C. Sobral Filho, J. Jaber, D. Armaganijan, J. Faria Neto, A. Steffens, W. Kunz Sebba Barroso de Souza, J.D. de Souza Neto, J.M. Ribeiro, M. Silveira Teixeira, P.R. Ferreira Rossi, L. Pires, D. Moreira, J.C. Moura Jorge, A. Menezes Lorga Filho, L.C. Bodanese, M. Westerlund Montera, C.H. Del Carlo, T. Da Rocha Rodrigues, F.A. Alves da Costa, A. Lopes, R. Lopes, G.R. Araújo, E.R. Fernandes Manenti, J.F. Kerr Saraiva, J.C. 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M., Martini, G., Tessitori, M., Cappelli, R., Poli, D., Quintavalla, R., Melone, F., Cosmi, F., Pizzini, A., Piseddu, G., Fanelli, R., Latella, C., Santi, R., Pancaldi, L., De Cristofaro, R., Palareti, G., De Blasio, A., Salerno Uriarte, J., Minetti, F., Pogliani, E. M., Lonati, L. M., Accogli, M., Ciampani, N., Malengo, S., Feola, M., Raisaro, A., Fattore, L., Grilli, P., Germini, F., Settimi, M., Alunni, M., Duranti, G., Tedeschi, L., Baglioni, G., Avanzino, G., Berardi, M., Pannacci, V., Giombolini, A., Nicoli, S., Scarponi, T., Allasia, B., Ricciarini, P., Nasorri, R., Argena, A., Bossolasco, P., Ronchini, P., Filippi, A., Tradati, F., Bulla, C., Donzelli, L., Foppa, L., Bottarelli, M. L., Tomasello, A., Mauric, A., Femiano, C., Reggio, R., Lillo, F., Mariani, A., Forcignanò, F., Volpe, M., D'Avino, M., Bongiorni, M. 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Subjects
Registrie, Male, Time Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, 030204 cardiovascular system & hematology, Electrocardiography, 0302 clinical medicine, Risk Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, Aged, Atrial Fibrillation, Female, Follow-Up Studies, Humans, Incidence, India, Prevalence, Prognosis, Prospective Studies, Survival Rate, Thromboembolism, Registries, Risk Assessment, Medicine, 030212 general & internal medicine, Prospective cohort study, Incidence (epidemiology), cardiovascular system, medicine.symptom, Cardiology and Cardiovascular Medicine, Risk assessment, Human, medicine.medical_specialty, Time Factor, RD1-811, Prognosi, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Diseases of the circulatory (Cardiovascular) system, cardiovascular diseases, Risk factor, Survival rate, Fibrillation, business.industry, Risk Factor, ta3121, medicine.disease, Clinical trial, Prospective Studie, RC666-701, Surgery, Clinical and Preventive Cardiology, business
Abstract

Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. Methods and results: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012–2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P

Published
2018
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47. Comparison of Strategies for Typhoid Conjugate Vaccine Introduction in India: A Cost-Effectiveness Modeling Study

Author

Gagandeep Kang, Nathan Lo, Jacob John, Dilesh Kumar, Yanjia Cao, Theresa Ryckman, Arun S Karthikeyan, Jason R. Andrews, and Jeremy D. Goldhaber-Fiebert

Subjects
medicine.medical_specialty, Vaccines, Conjugate, Immunization Programs, business.industry, Cost effectiveness, Cost-Benefit Analysis, Typhoid-Paratyphoid Vaccines, Vaccination, India, medicine.disease, Typhoid fever, Infectious Diseases, Conjugate vaccine, Humans, Immunology and Allergy, Medicine, Typhoid Fever, Child, business, Intensive care medicine, Enteric fever
Abstract

Background Typhoid fever causes substantial global mortality, with almost half occurring in India. New typhoid vaccines are highly effective and recommended by the World Health Organization for high-burden settings. There is a need to determine whether and which typhoid vaccine strategies should be implemented in India. Methods We assessed typhoid vaccination using a dynamic compartmental model, parameterized by and calibrated to disease and costing data from a recent multisite surveillance study in India. We modeled routine and 1-time campaign strategies that target different ages and settings. The primary outcome was cost-effectiveness, measured by incremental cost-effectiveness ratios (ICERs) benchmarked against India’s gross national income per capita (US$2130). Results Both routine and campaign vaccination strategies were cost-saving compared to the status quo, due to averted costs of illness. The preferred strategy was a nationwide community-based catchup campaign targeting children aged 1–15 years alongside routine vaccination, with an ICER of $929 per disability-adjusted life-year averted. Over the first 10 years of implementation, vaccination could avert 21–39 million cases and save $1.6–$2.2 billion. These findings were broadly consistent across willingness-to-pay thresholds, epidemiologic settings, and model input distributions. Conclusions Despite high initial costs, routine and campaign typhoid vaccination in India could substantially reduce mortality and was highly cost-effective.

Published
2021
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48. Outbreaks of COVID-19 variants in US prisons: a mathematical modelling analysis of vaccination and reopening policies

Author

David Leidner, Jeremy D. Goldhaber-Fiebert, Theresa S Ryckman, Fernando Alarid-Escudero, Jason R. Andrews, Elizabeth T Chin, David M. Studdert, Lea Prince, Joshua A. Salomon, and Elizabeth Long

Subjects
media_common.quotation_subject, Psychological intervention, Public Policy, Prison, Disease Outbreaks, Environmental health, Humans, Medicine, Baseline (configuration management), media_common, SARS-CoV-2, business.industry, Transmission (medicine), Public Health, Environmental and Occupational Health, COVID-19, Outbreak, Articles, medicine.disease, Vaccination, Substance abuse, Prisons, Public Health, Public aspects of medicine, RA1-1270, Risk assessment, business
Abstract

Summary: Background: Residents of prisons have experienced disproportionate COVID-19-related health harms. To control outbreaks, many prisons in the USA restricted in-person activities, which are now resuming even as viral variants proliferate. This study aims to use mathematical modelling to assess the risks and harms of COVID-19 outbreaks in prisons under a range of policies, including resumption of activities. Methods: We obtained daily resident-level data for all California state prisons from Jan 1, 2020, to May 15, 2021, describing prison layouts, housing status, sociodemographic and health characteristics, participation in activities, and COVID-19 testing, infection, and vaccination status. We developed a transmission-dynamic stochastic microsimulation parameterised by the California data and published literature. After an initial infection is introduced to a prison, the model evaluates the effect of various policy scenarios on infections and hospitalisations over 200 days. Scenarios vary by vaccine coverage, baseline immunity (0%, 25%, or 50%), resumption of activities, and use of non-pharmaceutical interventions (NPIs) that reduce transmission by 75%. We simulated five prison types that differ by residential layout and demographics, and estimated outcomes with and without repeated infection introductions over the 200 days. Findings: If a viral variant is introduced into a prison that has resumed pre-2020 contact levels, has moderate vaccine coverage (ranging from 36% to 76% among residents, dependent on age, with 40% coverage for staff), and has no baseline immunity, 23–74% of residents are expected to be infected over 200 days. High vaccination coverage (90%) coupled with NPIs reduces cumulative infections to 2–54%. Even in prisons with low room occupancies (ie, no more than two occupants) and low levels of cumulative infections (ie, 20% of residents infected) are substantially higher if infections are repeatedly introduced. Interpretation: Balancing benefits of resuming activities against risks of outbreaks presents challenging trade-offs. After achieving high vaccine coverage, prisons with mostly one-to-two-person cells that have higher baseline immunity from previous outbreaks can resume in-person activities with low risk of a widespread new outbreak, provided they maintain widespread NPIs, continue testing, and take measures to protect the medically vulnerable. Funding: Horowitz Family Foundation, National Institute on Drug Abuse, Centers for Disease Control and Prevention, National Science Foundation, Open Society Foundation, Advanced Micro Devices.

Published
2021
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49. Deep Dive into the Long Haul: Analysis of Symptom Clusters and Risk Factors for Post-Acute Sequelae of COVID-19 to Inform Clinical Care

Author

Nicole H. Goldhaber, Jordan N. Kohn, William Scott Ogan, Amy Sitapati, Christopher A. Longhurst, Angela Wang, Susan Lee, Suzi Hong, and Lucy E. Horton

Subjects
Long COVID, post-acute sequelae, SARS-CoV-2, Prevention, Health, Toxicology and Mutagenesis, Neurosciences, Public Health, Environmental and Occupational Health, COVID-19, symptom cluster, neurocognitive, Anxiety, Health Services, Toxicology, Post-Acute COVID-19 Syndrome, Emerging Infectious Diseases, Mental Health, Infectious Diseases, Good Health and Well Being, Clinical Research, Behavioral and Social Science, Disease Progression, Humans, Female, Mind and Body
Abstract

Long COVID is a chronic condition characterized by symptoms such as fatigue, dyspnea, and cognitive impairment that persist or relapse months after an acute infection with the SARS-CoV-2 virus. Many distinct symptoms have been attributed to Long COVID; however, little is known about the potential clustering of these symptoms and risk factors that may predispose patients to certain clusters. In this study, an electronic survey was sent to patients in the UC San Diego Health (UCSDH) system who tested positive for COVID-19, querying if patients were experiencing symptoms consistent with Long COVID. Based on survey results, along with patient demographics reported in the electronic health record (EHR), linear and logistic regression models were used to examine putative risk factors, and exploratory factor analysis was performed to determine symptom clusters. Among 999 survey respondents, increased odds of Long COVID (n = 421; 42%) and greater Long COVID symptom burden were associated with female sex (OR = 1.73, 99% CI: 1.16–2.58; β = 0.48, 0.22–0.75), COVID-19 hospitalization (OR = 4.51, 2.50–8.43; β = 0.48, 0.17–0.78), and poorer pre-COVID self-rated health (OR = 0.75, 0.57–0.97; β = −0.19, −0.32–−0.07). Over one-fifth of Long COVID patients screened positive for depression and/or anxiety, the latter of which was associated with younger age (OR = 0.96, 0.94–0.99). Factor analysis of 16 self-reported symptoms suggested five symptom clusters—gastrointestinal (GI), musculoskeletal (MSK), neurocognitive (NC), airway (AW), and cardiopulmonary (CP), with older age (β = 0.21, 0.11–0.30) and mixed race (β = 0.27, 0.04–0.51) being associated with greater MSK symptom burden. Greater NC symptom burden was associated with increased odds of depression (OR = 5.86, 2.71–13.8) and anxiety (OR = 2.83, 1.36–6.14). These results can inform clinicians in identifying patients at increased risk for Long COVID-related medical issues, particularly neurocognitive symptoms and symptom clusters, as well as informing health systems to manage operational expectations on a population-health level.

Published
2022

50. Durable functional limitation in patients with coronavirus disease-2019 admitted to intensive care and the effect of intermediate-dose vs standard-dose anticoagulation on functional outcomes

Author

Sadeghipour, P., Talasaz, A.H., Barco, S., Bakhshandeh, H., Rashidi, F., Rafiee, F., Rezaeifar, P., Jamalkhani, S., Matin, S., Baghizadeh, E., Tahamtan, O., Sharif-Kashani, B., Beigmohammadi, M.T., Farrokhpour, M., Sezavar, S.H., Payandemehr, P., Dabbagh, A., Moghadam, K.G., Jimenez, D., Monreal, M., Maleki, M., Siegerink, B., Spatz, E.S., Piazza, G., Parikh, S.A., Kirtane, A.J., Tassell, B.W. van, Lip, G.Y.H., Goldhaber, S.Z., Klok, F.A., Krumholz, H.M., Bikdeli, B., and Inspiration Investigators

Subjects
Hospitalization, Male, The post-COVID-19 functional status scale, Patient health questionnaire-2, Anticoagulation, Critical Care, SARS-CoV-2, Internal Medicine, Anticoagulants, Humans, COVID-19, Female, Middle Aged
Abstract

Introduction: Patients affected with severe forms of coronavirus disease 2019 (COVID-19) suffer from a wide range of sequelae, from limited airway diseases to multiple organ failure. These sequelae may create exercise limitation, impair the daily activity and thus impact the mental health and the social life. However, the extent of functional limitations and depressive symptoms are understudied especially in patients with COVID-19 after intensive care unit (ICU) hospitalization. Methods: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) was a clinical trial that randomized ICU patients with COVID-19 to intermediate-dose vs standard-dose anticoagulation. In the current study, we assessed the interval change in 30-day and 90-day functional limitations based on the post-COVID-19 functional status scale (PCFS) and depressive symptoms based on the Patient Health Questionnaire-2 (PHQ-2) in the trial participants. We also assessed the effect of intermediate-dose vs standard-dose prophylactic anticoagulation on the functional outcomes and depressive symptoms. Results: Of 600 randomized patients in INSPIRATION, 375 (age: 62 years; 42% women) participated in the functional status study. 195 patients died during the 90-day follow up (191 by day 30). Among survivors, between day 30 and day 90, the proportion of patients with moderate-to-severe functional limitation (PCSF grade 3-or-4) decreased from 20.0% to 4.8% (P = 3 decreased from 25.5% to 16.6% (P = 0.05). The proportion of patients with no functional limitations (PCFS grade 0) increased (4.2% to 15.4%, P= 3 (17.9% vs 15.3%; OR, 1.14, [95% CI, 0.79-1.65]; P = 0.14), with similar results when accounting for study center. Conclusion: In patients with COVID-19 admitted to the ICU, functional limitations and depressive symptoms were common at 30-day follow-up and had some improvement by 90-day follow-up among survivors. Intermediate-dose compared to standard-dose prophylactic anticoagulation did not improve functional outcomes.

Published
2022
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