149 results on '"Nativi‐Nicolau, Jose"'
Search Results
102. Sex Differences in the Risk of Pump Thrombosis in Patients Supported with Left Ventricular Assist Devices
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Yin, Michael, primary, Drakos, Stavros, additional, Selzman, Craig, additional, McKellar, Stephen, additional, Kemeyou, Line, additional, Koliopoulou, Antigone, additional, Nativi-Nicolau, Jose, additional, Gilbert, Edward, additional, Stehlik, Joseph, additional, Fang, James, additional, and Wever-Pinzon, Omar, additional
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- 2018
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103. Cardiogenic Shock and Short-Term Mechanical Circulatory Support Options in the Current Era: Focus on Adverse Events
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Taleb, Iosif, primary, Koliopoulou, Antigone, additional, Tandar, Anwar, additional, McKellar, Stephen, additional, Nativi-Nicolau, Jose, additional, Athanasiadis, Dimitrios, additional, Wever-Pinzon, Omar, additional, Gilbert, Edward, additional, Fang, James, additional, Stehlik, Josef, additional, Tonna, Joseph, additional, Ibrahim, Homam, additional, Dranow, Elizabeth, additional, Selzman, Craig, additional, Welt, Frederick, additional, and Drakos, Stavros, additional
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- 2018
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104. Health Related Quality of Life in Heart Failure Patients with Improved Ejection Fraction
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Conte, Jorge, primary, Nativi-Nicolau, Jose, additional, Zhang, Mingyuan, additional, Greene, Tom, additional, Biber, Joshua, additional, Chatelain, Shaun, additional, Hess, Rachel, additional, Wever-Pinzon, Omar, additional, Drakos, Stavros, additional, Gilbert, Edward, additional, Kemeyou, Line, additional, LaSalle, Bernie, additional, Kfoury, Abdallah G., additional, Selzman, Craig, additional, Fang, James C., additional, and Stehlik, Josef, additional
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- 2018
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105. Utilization and Impact of Right Heart Catheterization on In-hospital Mortality, Length of hospital Stay and 30 Day Readmission in Patients Admitted with Cardiogenic Shock - Review of Large, National, Multicenter Database
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Shah, Zubair, primary, Vuddanda, Venkat Venkat, additional, Bischoff, Michelle Michelle, additional, Nativi-Nicolau, Jose, additional, Drakos, Stavros, additional, Wever-Pinzon, Omar, additional, Gilbert, Edward, additional, Fang, James, additional, and Stehlik, Josef, additional
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- 2018
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106. Unmasking Early Wild-Type Transthyretin Amyloidosis Cardiomyopathy in a Patient With Refractory Atrial Fibrillation and Unremarkable Cardiac Imaging
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Varedi, Danny, primary, Kovacsovics, Tibor, additional, Downs Kelly, Erinn, additional, Abraham, Jo, additional, Cowley, Jared, additional, Barrell, Kelsey, additional, Revelo, Monica P., additional, Stehlik, Josef, additional, Drakos, Stavros, additional, Marrouche, Nassir, additional, Wilson, Brent, additional, Swanson, Eric A., additional, Fang, James, additional, and Nativi-Nicolau, Jose, additional
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- 2018
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107. Metaboreceptor activation in heart failure with reduced ejection fraction: Linking cardiac and peripheral vascular haemodynamics
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Barrett-O'Keefe, Zachary, primary, Lee, Joshua F., additional, Berbert, Amanda, additional, Witman, Melissa A. H., additional, Nativi-Nicolau, Jose, additional, Stehlik, Josef, additional, Richardson, Russell S., additional, and Wray, D. Walter, additional
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- 2018
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108. Cardiac Rotational Mechanics As a Predictor of Myocardial Recovery in Heart Failure Patients Undergoing Chronic Mechanical Circulatory Support
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Bonios, Michael J., primary, Koliopoulou, Antigone, additional, Wever-Pinzon, Omar, additional, Taleb, Iosif, additional, Stehlik, Josef, additional, Xu, Weining, additional, Wever-Pinzon, James, additional, Catino, Anna, additional, Kfoury, Abdallah G., additional, Horne, Benjamin D., additional, Nativi-Nicolau, Jose, additional, Adamopoulos, Stamatis N., additional, Fang, James C., additional, Selzman, Craig H., additional, Bax, Jeroen J., additional, and Drakos, Stavros G., additional
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- 2018
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109. CONTINUOUS WEARABLE MONITORING ANALYTICS PREDICT HEART FAILURE DECOMPENSATION: THE LINK-HF MULTI-CENTER STUDY
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Stehlik, Josef, primary, Schmalfuss, Carsten, additional, Bozkurt, Biykem, additional, Nativi-Nicolau, Jose, additional, Wegerich, Stephan, additional, Rose, Kevin, additional, Ray, Ranjan, additional, Schofield, Richard, additional, Deswal, Anita, additional, Sekaric, Jadranka, additional, Anand, Sebastian, additional, Richards, Dylan, additional, Hanson, Heather, additional, Pipke, Matthew, additional, and Pham, Michael, additional
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- 2018
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110. Serum Transthyretin
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Nativi-Nicolau, Jose, primary
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- 2018
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111. Health Informatics Improves Heart Failure Data Capture for Quality Measures, Research and Decision Support in VA
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Garvin, Jennifer H., primary, Kim, Youngjun, additional, Heidenreich, Paul, additional, Nativi-Nicolau, Jose, additional, Inampudi, Chakradhari, additional, Zeng-Treitler, Qing, additional, Gobbel, Glenn T., additional, and Meystre, Stéphane M., additional
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- 2017
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112. Real-Time Assessment of Patient Reported Outcomes in Heart Failure Clinic
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Rodriguez-Correa, Carlos, primary, Biber, Joshua, additional, Hess, Rachel, additional, Spertus, John A., additional, Nativi-Nicolau, Jose, additional, Peritz, David, additional, Walker, Andrew, additional, Hess, Jordan, additional, Drakos, Stavros G., additional, Wever-Pinzon, Omar, additional, McKellar, Stephen, additional, Zickmund, Susan, additional, Gilbert, Edward M., additional, Fang, James, additional, Selzman, Craig H., additional, and Stehlik, Josef, additional
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- 2017
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113. Cardiac Amyloidosis: Current Insights from Patients and Cardiologists Journeying Together
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Castaño, Adam, Bruno, Marianna, Lousada, Isabelle, Finkel, Muriel, O'Donnell, Mary, Abdulsattar, Younos, and Nativi-Nicolau, Jose
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- 2019
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114. Galectin-3 in heart failure with preserved ejection fraction. A RELAX trial substudy (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure)
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AbouEzzeddine, Omar F., Haines, Phillip, Stevens, Susanna, Nativi-Nicolau, Jose, Felker, G Michael, Borlaug, Barry A., Chen, Horng H., Tracy, Russell P., Braunwald, Eugene, and Redfield, Margaret M.
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Male ,Heart Failure, Diastolic ,Exercise Tolerance ,Galectin 3 ,Enzyme-Linked Immunosorbent Assay ,Stroke Volume ,Middle Aged ,Phosphodiesterase 5 Inhibitors ,Article ,Ventricular Function, Left ,Quality of Life ,Humans ,Female ,Aged - Abstract
This study hypothesized that elevated galectin-3 (Gal-3) levels would identify patients with more advanced heart failure (HF) with preserved ejection fraction (HFpEF) as assessed by key pathophysiological domains.Gal-3 is implicated in the pathogenesis of cardiac fibrosis but is also increased with normal aging and renal dysfunction. Cardiac fibrosis may contribute to cardiac dysfunction, exercise intolerance, and congestion in HFpEF.Two hundred eight patients from the RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure) trial of sildenafil in HFpEF had Gal-3 measured at enrollment. Pathophysiological domains assessed included biomarkers of neurohumoral activation, fibrosis, inflammation and myocardial necrosis, congestion severity and quality of life, cardiac structure and function, and exercise performance. Analysis adjusted for age, sex, and/or cystatin-C levels. Potential interaction between baseline Gal-3 and treatment (sildenafil) effect on the RELAX study primary endpoint (change in peak oxygen consumption) was tested.Gal-3 levels were associated with age and severity of renal dysfunction. Adjusting for age, sex, and/or cystatin-C, Gal-3 was not associated with biomarkers of neurohumoral activation, fibrosis, inflammation or myocardial necrosis, congestion or quality-of-life impairment, cardiac remodeling or dysfunction, or exercise intolerance. Gal-3 did not identify patients who responded to phosphodiesterase type 5 (PDE-5) inhibitors (interaction p = 0.53).In overt HFpEF, Gal-3 was related to severity of renal dysfunction and accounting for this, was not independently associated with severity of pathophysiological derangements or response PDE-5 inhibition. These findings underscore the need to adjust for renal function when interpreting Gal-3 levels, and call into question the value of Gal-3 to quantify disease severity in overt HFpEF.
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- 2014
115. Immunologic effects of continuous-flow left ventricular assist devices before and after heart transplant
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Ko, Byung-Soo, primary, Drakos, Stavros, additional, Kfoury, Abdallah G., additional, Hurst, Denise, additional, Stoddard, Gregory J., additional, Willis, Carrie A., additional, Delgado, Julio C., additional, Hammond, Elizabeth H., additional, Gilbert, Edward M., additional, Alharethi, Rami, additional, Revelo, Monica P., additional, Nativi-Nicolau, Jose, additional, Reid, Bruce B., additional, McKellar, Stephen H., additional, Wever-Pinzon, Omar, additional, Miller, Dylan V., additional, Eckels, David D., additional, Fang, James C., additional, Selzman, Craig H., additional, and Stehlik, Josef, additional
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- 2016
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116. Amyloidosis Cardiomyopathy Demonstrates Distinct Echocardiographic Patterns Compared to Patients with Heart Failure with Preserved Ejection Fraction
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Nativi-Nicolau, Jose, primary, Morales, Javier Jaramillo, additional, Whipple, Melissa, additional, Al-Dulaimi, Ragheed, additional, Stehlik, Josef, additional, Ryan, John, additional, Drakos, Stavros, additional, Gilbert, Edward M.M., additional, Wever-Pinzon, Omar, additional, Wilson, Brent, additional, Han, Frederick, additional, Maurer, Mathew S., additional, and Fang, James, additional
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- 2016
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117. Automated Heart Failure Quality Measurement with Natural Language Processing
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Garvin, Jennifer H., primary, Kim, Youngjun, additional, Gobbel, Glenn T., additional, Matheny, Michael E., additional, Redd, Andrew, additional, Bray, Bruce E., additional, Heidenreich, Paul, additional, Kalsy, Megha, additional, Goldstein, Mary K., additional, Bolton, Dan, additional, Nativi-Nicolau, Jose, additional, and Meystre, Stephane M., additional
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- 2016
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118. FEASIBILITY AND EFFECTIVENESS OF A MULTIDISCIPLINARY TEAM APPROACH IN REFRACTORY CARDIOGENIC SHOCK: A PROSPECTIVE PILOT STUDY
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Ko, Byung-Soo, primary, Tandar, Anwar, additional, Kang, Tae Soo, additional, McKellar, Stephen, additional, Stehlik, Josef, additional, Stoddard, Greg, additional, Morshedzadeh, Jack, additional, Koliopoulou, Antigone, additional, Gilbert, Edward, additional, Nativi-Nicolau, Jose, additional, Wever-Pinzon, Omar, additional, Shah, Rashmee, additional, Fang, James, additional, Selzman, Craig, additional, Welt, Frederick, additional, and Drakos, Stavros, additional
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- 2016
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119. ISHLT pathology antibody mediated rejection score correlates with increased risk of cardiovascular mortality: A retrospective validation analysis
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Hammond, M. Elizabeth H., primary, Revelo, Monica P., additional, Miller, Dylan V., additional, Snow, Gregory L., additional, Budge, Deborah, additional, Stehlik, Josef, additional, Molina, Kimberly M., additional, Selzman, Craig H., additional, Drakos, Stavros G., additional, Rami A., Alharethi, additional, Nativi-Nicolau, Jose N., additional, Reid, Bruce B., additional, and Kfoury, Abdallah G., additional
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- 2016
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120. Cardiac Rotational Mechanics as a Predictor of Favorable Functional and Structural Response After Mechanical Unloading With Cardiac Assist Devices in Advanced Heart Failure Patients
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Bonios, Michael J., primary, Pinzon, James Wever, additional, Stehlik, Josef, additional, Kfoury, Abdallah, additional, Gilbert, Edward M., additional, Alharethi, Rami, additional, Nativi-Nicolau, Jose, additional, Selzman, Craig H., additional, Alsari, Mohammad, additional, Reid, Bruce, additional, McKellar, Stephen H., additional, Koliopoulou, Antigone, additional, Caine, William, additional, Li, Dean Y., additional, Fang, James, additional, and Drakos, Stavros G., additional
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- 2015
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121. Galectin-3 in Heart Failure With Preserved Ejection Fraction
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AbouEzzeddine, Omar F., primary, Haines, Phillip, additional, Stevens, Susanna, additional, Nativi-Nicolau, Jose, additional, Felker, G. Michael, additional, Borlaug, Barry A., additional, Chen, Horng H., additional, Tracy, Russell P., additional, Braunwald, Eugene, additional, and Redfield, Margaret M., additional
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- 2015
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122. Diagnostic Tools for Cardiac Amyloidosis: A Pragmatic Comparison of Pathology, Imaging and Laboratories.
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Joury, Abdulaziz, Faaborg-Andersen, Christian, Quintana, Raymundo A., daSilva-deAbreu, Adrian, and Nativi-Nicolau, Jose
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Cardiac amyloidosis (CA) is a complex disease considered to be the most common underdiagnosed form of restrictive cardiomyopathy. Accumulation of misfolded proteins called amyloid fibrils in the extracellular space results in clinical deterioration and late diagnosis is associated with morbidity and mortality. Both types of this disease, light chain CA and transthyretin-related CA share many cardiac and extracardiac features that compromise multiple organs such as kidneys, musculoskeletal system, autonomic nervous system, and gastrointestinal tract. Early diagnosis and detection of CA are imperative. Clinicians should maintain a high degree of suspicion among patients with unexplained diastolic heart failure to implement different disease-altering therapies at the early stages of the disease. In this article, we provided a comprehensive review of multiple invasive and non-invasive cardiac imaging modalities with their respective degrees of sensitivities and specificity. [ABSTRACT FROM AUTHOR]
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- 2023
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123. Hemodynamic responses to small muscle mass exercise in heart failure patients with reduced ejection fraction
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Barrett-O'Keefe, Zachary, primary, Lee, Joshua F., additional, Berbert, Amanda, additional, Witman, Melissa A. H., additional, Nativi-Nicolau, Jose, additional, Stehlik, Josef, additional, Richardson, Russell S., additional, and Wray, D. Walter, additional
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- 2014
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124. Determinants of Waiting List Time for Heart Transplantation: Is It All About Sensitization?
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McCubrey, Raymond O., primary, Alharethi, Rami A., additional, Horne, Benjamin D., additional, Stehlik, Joseph, additional, Reid, Bruce, additional, Everitt, Melaine, additional, Drakos, Stavros D., additional, Budge, Deborah, additional, Nativi-Nicolau, Jose, additional, Nixon, Jennifer L., additional, Fang, James, additional, Caine, William, additional, and Kfoury, Abdallah G., additional
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- 2014
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125. Pharmacologic therapies for acute cardiogenic shock
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Nativi-Nicolau, Jose, primary, Selzman, Craig H., additional, Fang, James C., additional, and Stehlik, Josef, additional
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- 2014
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126. 265 - Automated Heart Failure Quality Measurement with Natural Language Processing
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Garvin, Jennifer H., Kim, Youngjun, Gobbel, Glenn T., Matheny, Michael E., Redd, Andrew, Bray, Bruce E., Heidenreich, Paul, Kalsy, Megha, Goldstein, Mary K., Bolton, Dan, Nativi-Nicolau, Jose, and Meystre, Stephane M.
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- 2016
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127. 129 - Amyloidosis Cardiomyopathy Demonstrates Distinct Echocardiographic Patterns Compared to Patients with Heart Failure with Preserved Ejection Fraction
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Nativi-Nicolau, Jose, Morales, Javier Jaramillo, Whipple, Melissa, Al-Dulaimi, Ragheed, Stehlik, Josef, Ryan, John, Drakos, Stavros, Gilbert, Edward M.M., Wever-Pinzon, Omar, Wilson, Brent, Han, Frederick, Maurer, Mathew S., and Fang, James
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- 2016
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128. Decreased Myocardial Inflammatory Markers in the Failing Human Heart after Continuous Flow Left Ventricular Assist Device-Induced Mechanical Unloading
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Diakos, Nikos A., primary, Selzman, Craig H., additional, Yen, Chi-Gang, additional, Kfoury, Abdallah G., additional, Reid, Bruce B., additional, Budge, Deborah, additional, Nativi-Nicolau, Jose, additional, McKellar, Stephen, additional, High, Craig A., additional, Li, Dean Y., additional, Stehlik, Josef, additional, and Drakos, Stavros G., additional
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- 2013
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129. Regional Structural Uniformity of Left Ventricular Remodeling in Patients with Advanced Non Ischemic Cardiomyopathy
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Passi, Samuel F., primary, Diakos, Nikos A., additional, Kfoury, Abdallah G., additional, Selzman, Craig H., additional, Yen, Chi-Gang, additional, Reid, Bruce B., additional, Wever-Pinzon, Omar, additional, Gilbert, Edward M., additional, Budge, Deborah, additional, Nativi-Nicolau, Jose, additional, Hammond, Elizabeth H., additional, High, Craig A., additional, Li, Dean Y., additional, Stehlik, Josef, additional, and Drakos, Stavros G., additional
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- 2013
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130. Abstract 12264: Insurance Type is Associated With Health-related Quality of Life in Heart Failure
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Mondesir, Favel L, Mohanty, April, Hong, Jennifer, Hess, Rachel, Zhang, Mingyuan, Greene, Tom, Steinberg, Benjamin A, Nativi-Nicolau, Jose, Drakos, Stavros G, Fang, James C, Wohlfahrt, Peter, Biber, Joshua, Wever-Pinzon, Omar, Selzman, Craig, Spertus, John, and Stehlik, Josef
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Introduction:Sociodemographic factors (SDFs) are known to influence clinical outcomes in patients treated for various diseases. To what extent SDFs affect health-related quality of life (HRQoL) in heart failure (HF) has not been fully described.Methods:HRQoL impairment was assessed in consecutive patients in a large HF clinic using patient reported outcome (PRO) instruments - the HF specific Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the generic Visual Analogue Scale (VAS); scales 0-100. We dichotomized both scales based on severity of QoL impairment: severe to very severe (0-50) and mild to moderate (51-100). The SDFs of interest were age (continuous), sex, race (white vs non-white), partnership status (partnered vs not partnered) and health insurance type (Medicare vs Medicaid vs self-pay vs commercial). We examined associations of SDFs with KCCQ-12 and VAS in univariate analyses and multivariable adjusted logistic regression models.Results:A total of 1,016 patients were included, of whom 52.3% had severe to very severe QoL limitation by KCCQ-12 and 50.6% by VAS. After adjusting for covariates including type of HF, substance abuse and a comorbidity score, health insurance was the only SDF independently associated with HRQoL. Compared to commercial insurance, patients enrolled in Medicaid (OR = 2.58; 95% CI: 1.57, 4.25) and Medicare (OR = 1.86; 95% CI: 1.31, 2.65) had higher odds of severe to very severe HF related QoL impairment as measured by KCCQ-12. Similarly, patients enrolled in Medicaid (OR = 1.72; 95% CI: 1.21, 2.44) and Medicare (OR = 1.99; 95% CI: 1.23, 3.22) had higher odds of severe to very severe general HRQoL impairment as measured by VAS.Conclusions:In a large cross-sectional sample of HF patients, health insurance type was a SDF independently associated with HRQoL. Understanding potentially modifiable factors linked to health insurance type may identify targets to improve HRQoL in HF for Medicare and Medicaid enrollees.
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- 2019
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131. Abstract 14637: Demographic Characteristics of Medicare Beneficiaries With Diagnosis of Wild-Type Amyloidosis Cardiomyopathy
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Nativi-Nicolau, Jose, Vieira, Maria Cecilia, Bruno, Marianna, Chen, Yong, Levin, Rebecca, Alvir, Jose, and Judge, Daniel P
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Background:Transthyretin amyloid cardiomyopathy (ATTR-CM) is caused by the deposition of amyloid fibrils in the myocardium. ATTRCM can develop by the deposition of wild type transthyretin protein (ATTRwt) or inherited as an autosomal dominant mutation in the TTR gene. There is little data on prevalence and diagnosis of this disease. Epidemiological and clinical research increasingly relies on administrative claim data using the International Classification of Diseases (ICD) codes to understand disease and population health management. There have been no specific codes to identify ATTR-CM until the Tenth Revision code (ICD-10) introduced in October 2017 to identify ATTRwt. The adoption of the code is likely to facilitate research on ATTRwt.Objective:To characterize the demographic and patient characteristics of Medicare patients classified as ATTRwt by the new ICD code.Methods:A retrospective study was conducted using Medicare fee-for-service claims available from 2010 until October 2018. Eligible patients were adults (> 65 yrs) diagnosed with ATTRwt (ICD-10 E85.82). The index date was defined as the date of the first diagnosis of ATTRwt or amyloidosis (277.3x or E85.xx). Patients had to be enrolled for at least 6-month pre and post index date. Baseline patient data were collected: demographics and health care utilization.Results:Among the 726 ATTRwt patients identified, mean age was 77.6 yrs ? 6.8; 85% were male; 80% were White. Geographically, 35% lived in the NE, 25% in the S, 21% in the MW and 18% in the W. For most patients, ATTRwt was their first amyloidosis diagnosis (59%), but 10% of them were first diagnosed with amyloidosis in the period 2010-3 and the rest in 2014-6. Most patients (55%) had a Charlson comorbidity index (CCI) above 2. 98% of the patients had outpatient visits and 39% had hospitalizations.Conclusion:Patient with diagnosis of ATTRwt were predominantly older white males with several comorbidities and frequent health resource utilization. The frequency of ATTRwt diagnosis is increasing over the years, however is more prevalent in some geographical areas suggesting under-diagnosis in other areas. The adoption of a new ICD code for ATTRwt will facilitate research on prevalence, diagnosis and treatment patterns in this rare disease.
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- 2019
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132. 066 - Real-Time Assessment of Patient Reported Outcomes in Heart Failure Clinic.
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Rodriguez-Correa, Carlos, Biber, Joshua, Hess, Rachel, Spertus, John A., Nativi-Nicolau, Jose, Peritz, David, Walker, Andrew, Hess, Jordan, Drakos, Stavros G., Wever-Pinzon, Omar, McKellar, Stephen, Zickmund, Susan, Gilbert, Edward M., Fang, James, Selzman, Craig H., and Stehlik, Josef
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- 2017
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133. 315 - Health Informatics Improves Heart Failure Data Capture for Quality Measures, Research and Decision Support in VA.
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Garvin, Jennifer H., Kim, Youngjun, Heidenreich, Paul, Nativi-Nicolau, Jose, Inampudi, Chakradhari, Zeng-Treitler, Qing, Gobbel, Glenn T., and Meystre, Stéphane M.
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- 2017
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134. Annual Cardiovascular-Related Hospitalization Days Avoided with Tafamidis in Patients with Transthyretin Amyloid Cardiomyopathy.
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Rozenbaum, Mark H., Tran, Diana, Bhambri, Rahul, and Nativi-Nicolau, Jose
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LENGTH of stay in hospitals , *DRUG efficacy , *STATISTICS , *RELATIVE medical risk , *CARDIOMYOPATHIES , *CARDIOVASCULAR agents , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *SERUM albumin , *HOSPITAL care , *DATA analysis , *STATISTICAL sampling , *PATIENT safety , *EVALUATION - Abstract
Background: Patients with transthyretin amyloid cardiomyopathy (ATTR-CM) experience infiltrative cardiomyopathy and heart failure symptoms requiring costly hospitalizations. The Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) demonstrated the efficacy of tafamidis on the frequency of cardiovascular (CV)-related hospitalizations in patients with ATTR-CM. Purpose: As length of stay can affect the total hospitalization burden, our study aimed to better understand the impact of tafamidis on the number of CV-related hospital days avoided in the management of ATTR-CM patients. Methods: Data from ATTR-ACT were used to calculate the total burden of CV-related hospitalization (days) by treatment arm in this post hoc analysis. Results: In the total trial population, patients receiving tafamidis had significantly fewer CV-related hospitalizations per year (relative risk reduction [RRR] 0.68; 0.4750 vs. 0.7025, p < 0.0001) and a shorter mean length of stay per CV-related hospitalization event (8.6250 vs. 9.5625 days) than patients receiving placebo. Taken together, tafamidis prevented 2.62 CV-related hospitalization days per patient per year. A subgroup analysis showed that with earlier treatment initiation of tafamidis, the annual number of CV-related hospitalizations was significantly lowered by 52% compared with placebo (RRR 0.48; 0.3378 vs. 0.7091, p < 0.0001). With 1.14 fewer days per hospitalization, tafamidis reduced the annual number of CV-related hospitalization days by 3.96 days per New York Heart Association class I/II patient. Conclusions: In patients with ATTR-CM, tafamidis was associated with a lower rate of CV-related hospitalizations and shorter length of hospital stay. Timely diagnosis and treatment with tafamidis could further decrease the total number of CV-related hospitalization days per year. CLINICALTRIALS.gov Identifier: NCT01994889. [ABSTRACT FROM AUTHOR]
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- 2022
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135. Expert opinion on monitoring symptomatic hereditary transthyretin-mediated amyloidosis and assessment of disease progression.
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Adams, David, Algalarrondo, Vincent, Polydefkis, Michael, Sarswat, Nitasha, Slama, Michel S., and Nativi-Nicolau, Jose
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DISEASE progression , *MEDICAL personnel , *SYMPTOMS , *AMYLOIDOSIS , *HEART diseases , *DISABILITIES - Abstract
Background: Hereditary transthyretin-mediated amyloidosis, also known as ATTRv amyloidosis (v for variant), is a rare, autosomal dominant, fatal disease, in which systemic amyloid progressively impairs multiple organs, leading to disability and death. The recent approval of disease-modifying therapies offers the hope of stabilization or eventual reversal of disease progression, and yet highlights a lack of disease-management guidance. A multidisciplinary panel of expert clinicians from France and the US came to consensus on monitoring the disease and identifying progression through a clinical opinion questionnaire, a roundtable meeting, and multiple rounds of feedback.Monitoring Disease and Progression: A multidisciplinary team should monitor ATTRv amyloidosis disease course by assessing potential target organs at baseline and during follow-up for signs and symptoms of somatic and autonomic neuropathy, cardiac dysfunction and restrictive cardiomyopathy, and other manifestations. Variability in penetrance, symptoms, and course of ATTRv amyloidosis requires that all patients, regardless of variant status, undergo regular and standardized assessment in all these categories. Progression in ATTRv amyloidosis may be indicated by: worsening of several existing quantifiable symptoms or signs; the appearance of a new symptom; or the worsening of a single symptom that results in a meaningful functional impairment.Conclusions: We suggest that a multisystem approach to monitoring the signs and symptoms of ATTRv amyloidosis best captures the course of the disease. We hope this work will help form the basis of further, consensus-based guidance for the treatment of ATTRv amyloidosis. [ABSTRACT FROM AUTHOR]- Published
- 2021
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136. Management and Outcomes of Cardiogenic Shock in Cardiac ICUs With Versus Without Shock Teams.
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Papolos, Alexander I., Kenigsberg, Benjamin B., Berg, David D., Alviar, Carlos L., Bohula, Erin, Burke, James A., Carnicelli, Anthony P., Chaudhry, Sunit-Preet, Drakos, Stavros, Gerber, Daniel A., Guo, Jianping, Horowitz, James M., Katz, Jason N., Keeley, Ellen C., Metkus, Thomas S., Nativi-Nicolau, Jose, Snell, Jeffrey R., Sinha, Shashank S., Tymchak, Wayne J., and Van Diepen, Sean
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CARDIOGENIC shock , *PULMONARY artery catheters , *ARTIFICIAL blood circulation , *INTRA-aortic balloon counterpulsation , *CORONARY care units , *RESEARCH , *RESEARCH methodology , *ACQUISITION of data , *MEDICAL cooperation , *EVALUATION research , *COMPARATIVE studies , *HEALTH care teams , *QUESTIONNAIRES - Abstract
Background: Single-center studies suggest that implementation of multidisciplinary cardiogenic shock (CS) teams is associated with improved CS survival.Objectives: The aim was to characterize practice patterns and outcomes in the management of CS across multiple centers with versus without shock teams.Methods: The Critical Care Cardiology Trials Network is a multicenter network of cardiac intensive care units (CICUs) in North America. All consecutive medical admissions to each CICU (n = 24) were captured during annual 2-month collection periods (2017-2019; n = 6,872). Shock management and CICU mortality among centers with versus without shock teams were compared using inverse probability weighting.Results: Ten of the 24 centers had shock teams. Among 1,242 CS admissions, 44% were at shock team centers. The groups were well-balanced with respect to demographics, shock etiology, Sequential Organ Failure Assessment score, biochemical markers of end organ dysfunction, and invasive hemodynamics. Centers with shock teams used more pulmonary artery catheters (60% vs 49%; adjusted odds ratio [OR]: 1.86; 95% CI: 1.47-2.35; P < 0.001), less overall mechanical circulatory support (MCS) (35% vs 43%; adjusted OR: 0.74; 95% CI: 0.59-0.95; P = 0.016), and more advanced types of MCS (53% vs 43% of all MCS; adjusted OR: 1.73; 95% CI: 1.19-2.51; P = 0.005) rather than intra-aortic balloon pumps. The presence of a shock team was independently associated with lower CICU mortality (23% vs 29%; adjusted OR: 0.72; 95% CI: 0.55-0.94; P = 0.016).Conclusions: In this multicenter observational study, centers with shock teams were more likely to obtain invasive hemodynamics, use advanced types of MCS, and have lower risk-adjusted mortality. A standardized multidisciplinary shock team approach may improve outcomes in CS. [ABSTRACT FROM AUTHOR]- Published
- 2021
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137. Impact of Delayed Diagnosis and Misdiagnosis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM): A Targeted Literature Review.
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Rozenbaum, Mark H., Large, Samuel, Bhambri, Rahul, Stewart, Michelle, Whelan, Jo, van Doornewaard, Alexander, Dasgupta, Noel, Masri, Ahmad, and Nativi-Nicolau, Jose
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- *
DELAYED diagnosis , *TRANSTHYRETIN , *MEDICAL personnel , *DIAGNOSTIC errors , *LITERATURE reviews , *CARDIAC amyloidosis - Abstract
Introduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, fatal and under-recognized disease. This targeted literature review assessed the extent and consequences of diagnostic delay and misdiagnosis in ATTR-CM. Methods: The Embase database was searched together with proceedings of eight cardiology conferences to identify publications or abstracts on ATTR-CM. Outcomes of interest were time from symptom onset to diagnosis, rates of delayed diagnosis and misdiagnosis, and costs, healthcare resource use or clinical outcomes whilst undiagnosed/misdiagnosed. Results: Twenty-three articles were included. Weighted means of reported mean and median diagnostic delays were 6.1 and 3.4 years for wild-type (ATTRwt-CM) and 5.7 and 2.6 years for hereditary (ATTRv-CM). Misdiagnosis occurred in 34–57% of patients when reported. Evaluation and misdiagnosis by multiple healthcare providers before receiving an ATTR-CM diagnosis was common, and there was evidence that patients undergo unnecessary or inappropriate evaluations or treatments while misdiagnosed. Diagnostic "red flags" were reported to be underused. Data on the consequences of delay for patients and health systems were sparse, but given the progressive nature of ATTR-CM, delay is likely to have adverse consequences. Conclusion: ATTR-CM patients commonly experience diagnostic delay and misdiagnosis. Efforts are required to provide timely diagnosis so that patients can benefit from earlier access to new disease-modifying therapies. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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138. ATTR amyloidosis during the COVID-19 pandemic: insights from a global medical roundtable.
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Brannagan III, Thomas H., Auer-Grumbach, Michaela, Berk, John L., Briani, Chiara, Bril, Vera, Coelho, Teresa, Damy, Thibaud, Dispenzieri, Angela, Drachman, Brian M., Fine, Nowell, Gaggin, Hanna K., Gertz, Morie, Gillmore, Julian D., Gonzalez, Esther, Hanna, Mazen, Hurwitz, David R., Khella, Sami L., Maurer, Mathew S., Nativi-Nicolau, Jose, and Olugemo, Kemi
- Subjects
- *
COVID-19 pandemic , *COVID-19 , *AMYLOIDOSIS , *SARS-CoV-2 - Abstract
Background: The global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection causing the ongoing coronavirus disease 2019 (COVID-19) pandemic has raised serious concern for patients with chronic disease. A correlation has been identified between the severity of COVID-19 and a patient's preexisting comorbidities. Although COVID-19 primarily involves the respiratory system, dysfunction in multiple organ systems is common, particularly in the cardiovascular, gastrointestinal, immune, renal, and nervous systems. Patients with amyloid transthyretin (ATTR) amyloidosis represent a population particularly vulnerable to COVID-19 morbidity due to the multisystem nature of ATTR amyloidosis.Main Body: ATTR amyloidosis is a clinically heterogeneous progressive disease, resulting from the accumulation of amyloid fibrils in various organs and tissues. Amyloid deposition causes multisystem clinical manifestations, including cardiomyopathy and polyneuropathy, along with gastrointestinal symptoms and renal dysfunction. Given the potential for exacerbation of organ dysfunction, physicians note possible unique challenges in the management of patients with ATTR amyloidosis who develop multiorgan complications from COVID-19. While the interplay between COVID-19 and ATTR amyloidosis is still being evaluated, physicians should consider that the heightened susceptibility of patients with ATTR amyloidosis to multiorgan complications might increase their risk for poor outcomes with COVID-19.Conclusion: Patients with ATTR amyloidosis are suspected to have a higher risk of morbidity and mortality due to age and underlying ATTR amyloidosis-related organ dysfunction. While further research is needed to characterize this risk and management implications, ATTR amyloidosis patients might require specialized management if they develop COVID-19. The risks of delaying diagnosis or interrupting treatment for patients with ATTR amyloidosis should be balanced with the risk of exposure in the health care setting. Both physicians and patients must adapt to a new construct for care during and possibly after the pandemic to ensure optimal health for patients with ATTR amyloidosis, minimizing treatment interruptions. [ABSTRACT FROM AUTHOR]- Published
- 2021
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139. Post-transplant outcome in patients bridged to transplant with temporary mechanical circulatory support devices.
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Yin, Michael Yaoyao, Wever-Pinzon, Omar, Mehra, Mandeep R., Selzman, Craig H., Toll, Alice E., Cherikh, Wida S., Nativi-Nicolau, Jose, Fang, James C., Kfoury, Abdallah G., Gilbert, Edward M., Kemeyou, Line, McKellar, Stephen H., Koliopoulou, Antigone, Vaduganathan, Muthiah, Drakos, Stavros G., and Stehlik, Josef
- Subjects
- *
HEART assist devices , *EXTRACORPOREAL membrane oxygenation , *HEART transplantation , *LUNG transplantation , *BODY mass index - Abstract
The new heart allocation system in the United States prioritizes patients supported by temporary mechanical circulatory support (TMCS) devices over those with uncomplicated durable continuous-flow left ventricular assist devices (CF-LVADs), which may increase the number of patients bridged to transplant with TMCS. Limited data are available in guiding post-transplant outcomes with various TMCS devices. We sought to describe post-transplant outcome and identify clinical variables associated with post-transplant outcome in patients bridged to transplant with TMCS. Using data from the International Society for Heart and Lung Transplantation Thoracic Transplant Registry, we included subjects who underwent transplantation between 2005 and 2016 with known use of mechanical circulatory support. Pre-transplant recipient, donor, and transplant-specific variables were abstracted. The primary outcome was patient survival at 1-year post-transplant. Outcomes of patients bridged to transplant with TMCS were compared with those of patients bridged with CF-LVADs. Cox regression analyses were performed to identify clinical variables associated with the outcomes. There were 6,528 patients bridged to transplant with the following types of mechanical circulatory support: durable CF-LVADs (n = 6,206), extracorporeal membrane oxygenation (ECMO, n = 134), percutaneous temporary CF-LVADs (n = 75), surgically implanted temporary CF-LVADs (n = 38) or surgically implanted temporary BiVAD (n = 75). Bridging with ECMO (hazard ratio 3.79, 95% confidence interval [CI] 2.69–5.34, p < 0.001) or percutaneous temporary CF-LVADs (hazard ratio 1.83, 95% CI 1.09–3.08, p = 0.02) was independently associated with higher risk of mortality. Additional risk factors included older donor age, female/male donor-recipient match, older recipient age, higher recipient body mass index, higher recipient creatinine, and prolonged ischemic time. This analysis of a large international cohort of patients bridged to transplant with mechanical circulatory support identified ECMO and percutaneous temporary CF-LVADs as predictors of mortality after transplant, along with additional donor and recipient clinical characteristics. These findings may provide guidance to clinicians in decisions on mechanical circulatory support device selection, transplant eligibility, and timing of transplant. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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140. Transthyretin Stabilization by AG10 in Symptomatic Transthyretin Amyloid Cardiomyopathy.
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Judge, Daniel P., Heitner, Stephen B., Falk, Rodney H., Maurer, Mathew S., Shah, Sanjiv J., Witteles, Ronald M., Grogan, Martha, Selby, Van N., Jacoby, Daniel, Hanna, Mazen, Nativi-Nicolau, Jose, Patel, Jignesh, Rao, Satish, Sinha, Uma, Turtle, Cameron W., and Fox, Jonathan C.
- Subjects
- *
CARDIOMYOPATHIES , *TRANSTHYRETIN , *AMYLOID , *FLUORESCENT probes , *THERAPEUTICS , *HEART failure , *AMYLOIDOSIS - Abstract
Transthyretin (TTR) amyloidosis is an underdiagnosed disease caused by destabilization of TTR due to pathogenic mutations or aging. Both pathogenic and protective mutations illuminate mechanisms of disease and potential interventions. AG10 is a selective, oral TTR stabilizer under development for transthyretin amyloidosis cardiomyopathy (ATTR-CM) that mimics a protective TTR mutation. This randomized, double-blind, placebo-controlled study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of AG10 in ATTR-CM patients with symptomatic, chronic heart failure. ATTR-CM, New York Heart Association functional class II to III subjects (n = 49, mutant or wild-type) were randomized 1:1:1 to AG10 400 mg, AG10 800 mg, or placebo twice daily for 28 days. Safety and tolerability were assessed by clinical and laboratory criteria. AG10 plasma levels were measured. TTR stability was assessed by changes in serum TTR, and 2 established ex vivo assays (fluorescent probe exclusion and Western blot). AG10 treatment was well-tolerated, achieved target plasma concentrations and demonstrated near-complete stabilization of TTR. TTR stabilization was more complete and less variable at the higher dose with stabilization by fluorescent probe exclusion of 92 ± 10% (mean ± SD) at trough and 96 ± 9% at peak (both p < 10−12 vs. placebo). Average serum TTR increased by 36 ± 21% and 51 ± 38% at 400 and 800 mg, respectively (both p < 0.0001 vs. placebo). Baseline serum TTR in treated subjects was below normal in 80% of mutant and 33% of wild-type subjects. AG10 treatment restored serum TTR to the normal range in all subjects. AG10 has the potential to be a safe and effective treatment for patients with ATTR-CM. A phase 3 trial is ongoing. (Study of AG10 in Amyloid Cardiomyopathy; NCT03458130) [ABSTRACT FROM AUTHOR]
- Published
- 2019
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141. Donation after circulatory death: A transplant cardiologist’s take on neuroprognostication
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Lyle, Melissa A., English, Stephen W., Goswami, Rohan M., Leoni Moreno, Juan C., Nativi-Nicolau, Jose, Yip, Daniel S., and Patel, Parag C.
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142. Six-minute walk test as clinical end point in cardiomyopathy clinical trials, including ATTR-CM: a systematic literature review.
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Nativi-Nicolau J, Yilmaz A, Dasgupta N, Macey R, Cochrane J, Peatman J, Summers C, Luth J, and Zolty R
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- Humans, Hospitalization statistics & numerical data, Amyloid Neuropathies, Familial diagnosis, Amyloid Neuropathies, Familial physiopathology, Clinical Trials as Topic methods, Heart Failure physiopathology, Heart Failure diagnosis, Walk Test methods, Cardiomyopathies physiopathology, Cardiomyopathies diagnosis
- Abstract
Aim: The six-minute walk test (6MWT) is a common measure of functional capacity in patients with heart failure (HF). Primary clinical study end points in cardiomyopathy (CM) trials, including transthyretin-mediated amyloidosis with CM (ATTR-CM), are often limited to hospitalization and mortality. Objective: To investigate the relationship between the 6MWT and hospitalization or mortality in CM, including ATTR-CM. Method: A PRISMA-guided systematic literature review was conducted using search terms for CM, 6MWT, hospitalization and mortality. Results: Forty-one studies were identified that reported 6MWT data and hospitalization or mortality data for patients with CM. The data suggest that a greater 6MWT distance is associated with a reduced risk of hospitalization or mortality in CM. Conclusion: The 6MWT is an accepted alternative end point in CM trials, including ATTR-CM.
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- 2024
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143. Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy.
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Gillmore JD, Judge DP, Cappelli F, Fontana M, Garcia-Pavia P, Gibbs S, Grogan M, Hanna M, Hoffman J, Masri A, Maurer MS, Nativi-Nicolau J, Obici L, Poulsen SH, Rockhold F, Shah KB, Soman P, Garg J, Chiswell K, Xu H, Cao X, Lystig T, Sinha U, and Fox JC
- Subjects
- Humans, Heart, Hospitalization, Treatment Outcome, Double-Blind Method, Natriuretic Peptide, Brain analysis, Functional Status, Amyloidosis drug therapy, Amyloidosis pathology, Cardiomyopathies drug therapy, Cardiomyopathies pathology, Prealbumin drug effects, Prealbumin therapeutic use, Cardiovascular Agents adverse effects, Cardiovascular Agents pharmacology, Cardiovascular Agents therapeutic use
- Abstract
Background: Transthyretin amyloid cardiomyopathy is characterized by the deposition of misfolded monomeric transthyretin (TTR) in the heart. Acoramidis is a high-affinity TTR stabilizer that acts to inhibit dissociation of tetrameric TTR and leads to more than 90% stabilization across the dosing interval as measured ex vivo., Methods: In this phase 3, double-blind trial, we randomly assigned patients with transthyretin amyloid cardiomyopathy in a 2:1 ratio to receive acoramidis hydrochloride at a dose of 800 mg twice daily or matching placebo for 30 months. Efficacy was assessed in the patients who had an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m
2 of body-surface area. The four-step primary hierarchical analysis included death from any cause, cardiovascular-related hospitalization, the change from baseline in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and the change from baseline in the 6-minute walk distance. We used the Finkelstein-Schoenfeld method to compare all potential pairs of patients within strata to generate a P value. Key secondary outcomes were death from any cause, the 6-minute walk distance, the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the serum TTR level., Results: A total of 632 patients underwent randomization. The primary analysis favored acoramidis over placebo (P<0.001); the corresponding win ratio was 1.8 (95% confidence interval [CI], 1.4 to 2.2), with 63.7% of pairwise comparisons favoring acoramidis and 35.9% favoring placebo. Together, death from any cause and cardiovascular-related hospitalization contributed more than half the wins and losses to the win ratio (58% of all pairwise comparisons); NT-proBNP pairwise comparisons yielded the highest ratio of wins to losses (23.3% vs. 7.0%). The overall incidence of adverse events was similar in the acoramidis group and the placebo group (98.1% and 97.6%, respectively); serious adverse events were reported in 54.6% and 64.9% of the patients., Conclusions: In patients with transthyretin amyloid cardiomyopathy, the receipt of acoramidis resulted in a significantly better four-step primary hierarchical outcome containing components of mortality, morbidity, and function than placebo. Adverse events were similar in the two groups. (Funded by BridgeBio Pharma; ATTRibute-CM ClinicalTrials.gov number, NCT03860935.)., (Copyright © 2024 Massachusetts Medical Society.)- Published
- 2024
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144. Screening for ATTR amyloidosis in the clinic: overlapping disorders, misdiagnosis, and multiorgan awareness.
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Nativi-Nicolau JN, Karam C, Khella S, and Maurer MS
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- Amyloid, Diagnostic Errors, Humans, Male, Amyloid Neuropathies, Familial complications, Amyloid Neuropathies, Familial diagnosis, Prealbumin
- Abstract
Amyloid transthyretin (ATTR) amyloidosis is a clinically heterogeneous and fatal disease that results from deposition of insoluble amyloid fibrils in various organs and tissues, causing progressive loss of function. The objective of this review is to increase awareness and diagnosis of ATTR amyloidosis by improving recognition of its overlapping conditions, misdiagnosis, and multiorgan presentation. Cardiac manifestations include heart failure, atrial fibrillation, intolerance to previously prescribed antihypertensives, sinus node dysfunction, and atrioventricular block, resulting in the need for permanent pacing. Neurologic manifestations include progressive sensorimotor neuropathy (e.g., pain, weakness) and autonomic dysfunction (e.g., erectile dysfunction, chronic diarrhea, orthostatic hypotension). Non-cardiac red flags often precede the diagnosis of ATTR amyloidosis and include musculoskeletal manifestations (e.g., carpal tunnel syndrome, lumbar spinal stenosis, spontaneous rupture of the distal tendon biceps, shoulder and knee surgery). Awareness and recognition of the constellation of symptoms, including cardiac, neurologic, and musculoskeletal manifestations, will help with early diagnosis of ATTR amyloidosis and faster access to therapies, thereby slowing the progression of this debilitating disease., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)
- Published
- 2022
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145. De Novo vs Acute-on-Chronic Presentations of Heart Failure-Related Cardiogenic Shock: Insights from the Critical Care Cardiology Trials Network Registry.
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Bhatt AS, Berg DD, Bohula EA, Alviar CL, Baird-Zars VM, Barnett CF, Burke JA, Carnicelli AP, Chaudhry SP, Daniels LB, Fang JC, Fordyce CB, Gerber DA, Guo J, Jentzer JC, Katz JN, Keller N, Kontos MC, Lawler PR, Menon V, Metkus TS, Nativi-Nicolau J, Phreaner N, Roswell RO, Sinha SS, Jeffrey Snell R, Solomon MA, Van Diepen S, and Morrow DA
- Subjects
- Critical Care, Hospital Mortality, Humans, Registries, Shock, Cardiogenic diagnosis, Shock, Cardiogenic epidemiology, Shock, Cardiogenic etiology, Cardiology, Heart Failure diagnosis, Heart Failure epidemiology, Heart Failure therapy
- Abstract
Background: Heart failure-related cardiogenic shock (HF-CS) accounts for an increasing proportion of cases of CS in contemporary cardiac intensive care units. Whether the chronicity of HF identifies distinct clinical profiles of HF-CS is unknown., Methods and Results: We evaluated admissions to cardiac intensive care units for HF-CS in 28 centers using data from the Critical Care Cardiology Trials Network registry (2017-2020). HF-CS was defined as CS due to ventricular failure in the absence of acute myocardial infarction and was classified as de novo vs acute-on-chronic based on the absence or presence of a prior diagnosis of HF, respectively. Clinical features, resource use, and outcomes were compared among groups. Of 1405 admissions with HF-CS, 370 had de novo HF-CS (26.3%), and 1035 had acute-on-chronic HF-CS (73.7%). Patients with de novo HF-CS had a lower prevalence of hypertension, diabetes, coronary artery disease, atrial fibrillation, and chronic kidney disease (all P < 0.01). Median Sequential Organ Failure Assessment (SOFA) scores were higher in those with de novo HF-CS (8; 25th-75th: 5-11) vs acute-on-chronic HF-CS (6; 25th-75th: 4-9, P < 0.01), as was the proportion of Society of Cardiovascular Angiography and Intervention (SCAI) shock stage E (46.1% vs 26.1%, P < 0.01). After adjustment for clinical covariates and preceding cardiac arrest, the risk of in-hospital mortality was higher in patients with de novo HF-CS than in those with acute-on-chronic HF-CS (adjusted hazard ratio 1.36, 95% confidence interval 1.05-1.75, P = 0.02)., Conclusions: Despite having fewer comorbidities, patients with de novo HF-CS had more severe shock presentations and worse in-hospital outcomes. Whether HF disease chronicity is associated with time-dependent compensatory adaptations, unique pathobiological features and responses to treatment in patients presenting with HF-CS warrants further investigation., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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146. Efficacy of Tafamidis in Patients With Hereditary and Wild-Type Transthyretin Amyloid Cardiomyopathy: Further Analyses From ATTR-ACT.
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Rapezzi C, Elliott P, Damy T, Nativi-Nicolau J, Berk JL, Velazquez EJ, Boman K, Gundapaneni B, Patterson TA, Schwartz JH, Sultan MB, and Maurer MS
- Subjects
- Benzoxazoles therapeutic use, Humans, Prealbumin genetics, Cardiomyopathies drug therapy, Cardiomyopathies genetics, Heart Failure
- Abstract
Objectives: Tafamidis is an effective treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), this study aimed to determine whether there is a differential effect between variant transthyretin amyloidosis (ATTRv) and wild-type transthyretin (ATTRwt)., Background: ATTR-CM is a progressive, fatal disorder resulting from mutations in the ATTRv or the deposition of denatured ATTRwt., Methods: In pre-specified analyses from ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial), baseline characteristics, all-cause mortality, and change from baseline to month 30 in 6-min walk test distance and Kansas City Cardiomyopathy Questionnaire Overall Summary score were compared in patients with ATTRwt and ATTRv., Results: There were 335 patients with ATTRwt (201 tafamidis, 134 placebo) and 106 with ATTRv (63 tafamidis, 43 placebo) enrolled in ATTR-ACT. Patients with ATTRwt (vs. ATTRv) had less advanced disease at baseline and a lower rate of disease progression over the study. The reduction in all-cause mortality with tafamidis compared with placebo was not different between ATTRwt (hazard ratio: 0.706 [95% confidence interval (CI): 0.474 to 1.052]; p = 0.0875) and ATTRv (hazard ratio: 0.690 [95% CI: 0.408 to 1.167]; p = 0.1667). Tafamidis was associated with a similar reduction (vs. placebo) in the decline in 6-min walk test distance in ATTRwt (mean ± SE difference from placebo, 77.14 ± 10.78; p < 0.0001) and ATTRv (79.61 ± 29.83 m; p = 0.008); and Kansas City Cardiomyopathy Questionnaire Overall Summary score in ATTRwt (12.72 ± 2.10; p < 0.0001) and ATTRv (18.18 ± 7.75; p = 0.019)., Conclusions: Pre-specified analyses from ATTR-ACT confirm the poor prognosis of untreated ATTRv-related cardiomyopathy compared with ATTRwt, but show the reduction in mortality and functional decline with tafamidis treatment is similar in both disease subtypes. (Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy [ATTR-ACT]; NCT01994889)., Competing Interests: Funding Support and Author Disclosures Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual anonymized participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information. This study was sponsored by Pfizer. Dr. Rapezzi has received unrestricted research grants and fees for advisory board meetings from Pfizer. Dr. Elliott has received consultancy fees from Pfizer and Alnylam. Dr. Damy has served on a scientific advisory board for Pfizer; has received funding from Pfizer for scientific meeting expenses; and his institution has received grant support from Pfizer. Dr. Nativi-Nicolau’s institution has received funding for clinical trials from Pfizer, Akcea, and Eidos; and has received educational grants from Pfizer. Dr. Nativi-Nicolau has been a consultant for Pfizer, Eidos, Akcea, and Alnylam. Dr. Berk has received consultancy fees from Alnylam Pharmaceutical, Akcea Therapeutics, Intellia Therapeutics, and Corino Therapeutics. Dr. Boman has served on scientific advisory boards for Pfizer; and has received funding for scientific meetings. Mr. Gundapaneni, Drs. Patterson and Sultan are employees of and hold stock options with Pfizer. At the time of this analysis, Dr. Schwartz was an employee of Pfizer; holds stock and stock options with Pfizer, and is now retired. Dr. Maurer has received grant support from the National Institutes of Health (HL HL139671-01, AG R21AG058348, and AG K24AG036778); his institution has received funding for clinical trials from Pfizer, Prothena, Eidos, and Alnylam; and he has received consulting income from Pfizer, GlaxoSmithKline, Eidos, Prothena, Akcea, and Alnylam. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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147. Utility of Biomarkers in Cardiac Amyloidosis.
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Pregenzer-Wenzler A, Abraham J, Barrell K, Kovacsovics T, and Nativi-Nicolau J
- Subjects
- Biomarkers, Humans, Amyloidosis, Cardiomyopathies, Heart Failure
- Abstract
Cardiac amyloidosis is a growing field, with advancements in diagnosis and management. Cardiac biomarkers are used to predict survival and to develop severity staging systems. Cardiac biomarkers are also used in clinical practice to stratify patients for treatment and to evaluate response to therapies. The current review summarizes the major clinical utility of current biomarkers in patients with cardiac amyloidosis and provides insights about future areas of investigation., (Published by Elsevier Inc.)
- Published
- 2020
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148. Impact of Shared Care in Remote Areas for Patients With Left Ventricular Assist Devices.
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Yin MY, Strege J, Gilbert EM, Stehlik J, McKellar SH, Elmer A, Anderson T, Aljuaid M, Nativi-Nicolau J, Koliopoulou AG, Davis E, Fang JC, Drakos SG, Selzman CH, and Wever-Pinzon O
- Subjects
- Aged, Female, Follow-Up Studies, Heart Failure physiopathology, Humans, Male, Middle Aged, Retrospective Studies, Risk Factors, Delivery of Health Care methods, Heart Failure therapy, Heart Ventricles physiopathology, Heart-Assist Devices, Quality of Life, Ventricular Function, Left physiology
- Abstract
Objectives: The aim of this study was to evaluate the impact of a shared-care model on outcomes in patients with left ventricular assist devices (LVADs) living in remote locations., Background: Health care delivery through shared-care models has been shown to improve outcomes in patients with chronic diseases. However, the impact of shared-care models on outcomes in patients with LVAD is unknown., Methods: LVAD recipients in the authors' program (2007 to 2018) were classified based on the levels of care provided and training and resources used: level 1, was defined as outpatient primary care without LVAD-specific care; level 2 was level 1 services and outpatient LVAD-specific care; level 3 was level 2 services and inpatient LVAD-specific care and implantation center (IC). The Kaplan-Meier method was used to compare rates of survival, bleeding, pump thrombosis, infection, neurologic events, and readmissions among levels of care., Results: A total of 336 patients were included, with 255 patients (75.9%) cared for in shared-care facilities. Median follow-up was 810 (interquartile range: 321 to 1,096) days. In comparison to patients cared for by IC, patients at levels 2 and 3 shared-care centers had similar rates of death, bleeding, neurologic events, pump thromboses, and infections. However, the rates of death, pump thromboses, and infections were higher for level 1 patients than in IC patients., Conclusions: Shared health care is an effective strategy to deliver care to patients with LVAD living in remote locations. However, patients in shared-care facilities unable to provide LVAD-specific care are at higher risk of unfavorable outcomes. Availability of LVAD-specific care should be strongly considered during patient selection and every effort made to ensure LVAD-specific training and resources are available at shared-care facilities., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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149. Hemodynamic responses to small muscle mass exercise in heart failure patients with reduced ejection fraction.
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Barrett-O'Keefe Z, Lee JF, Berbert A, Witman MA, Nativi-Nicolau J, Stehlik J, Richardson RS, and Wray DW
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- Aged, Blood Flow Velocity, Case-Control Studies, Female, Hand Strength, Heart Failure diagnosis, Humans, Lower Extremity, Male, Middle Aged, Regional Blood Flow, Upper Extremity, Exercise, Exercise Tolerance, Heart Failure physiopathology, Hemodynamics, Muscle Contraction, Muscle, Skeletal blood supply, Muscle, Skeletal physiopathology, Stroke Volume
- Abstract
To better understand the mechanisms responsible for exercise intolerance in heart failure with reduced ejection fraction (HFrEF), the present study sought to evaluate the hemodynamic responses to small muscle mass exercise in this cohort. In 25 HFrEF patients (64 ± 2 yr) and 17 healthy, age-matched control subjects (64 ± 2 yr), mean arterial pressure (MAP), cardiac output (CO), and limb blood flow were examined during graded static-intermittent handgrip (HG) and dynamic single-leg knee-extensor (KE) exercise. During HG exercise, MAP increased similarly between groups. CO increased significantly (+1.3 ± 0.3 l/min) in the control group, but it remained unchanged across workloads in HFrEF patients. At 15% maximum voluntary contraction (MVC), forearm blood flow was similar between groups, while HFrEF patients exhibited an attenuated increase at the two highest intensities compared with controls, with the greatest difference at the highest workload (352 ± 22 vs. 492 ± 48 ml/min, HFrEF vs. control, 45% MVC). During KE exercise, MAP and CO increased similarly across work rates between groups. However, HFrEF patients exhibited a diminished leg hyperemic response across all work rates, with the most substantial decrement at the highest intensity (1,842 ± 64 vs. 2,675 ± 81 ml/min; HFrEF vs. control, 15 W). Together, these findings indicate a marked attenuation in exercising limb perfusion attributable to impairments in peripheral vasodilatory capacity during both arm and leg exercise in patients with HFrEF, which likely plays a role in limiting exercise capacity in this patient population.
- Published
- 2014
- Full Text
- View/download PDF
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