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1. Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial

Author

Bohra, Chandrashekar, Asch, Federico M., Lerakis, Stamatios, Little, Stephen H., Redfors, Björn, Zhou, Zhipeng, Li, Yanru, Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Abraham, William T., Lindenfeld, JoAnn, Mack, Michael J., Bax, Jeroen J., and Stone, Gregg W.

Published
2024
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2. Changes in Left Ventricular Function and Outcomes After Trancatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation

Author

Lerakis, Stamatios, Kini, Annapoorna S., Giustino, Gennaro, Anastasius, Malcolm, Asch, Federico M., Weissman, Neil J., Grayburn, Paul A., Kar, Saibal, Lim, D. Scott, Mishell, Jacob M., Whisenant, Brian K., Rinaldi, Michael J., Kapadia, Samir R., Rajagopal, Vivek, Sarembock, Ian J., Brieke, Andreas, Tang, Gilbert H.L., Li, Yanru, Alu, Maria C., Lindenfeld, JoAnn, Abraham, William T., Sharma, Samin K., Mack, Michael J., and Stone, Gregg W.

Published
2024
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3. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials JACC Review Topic of the Week

Author

Fiuzat, Mona, Hamo, Carine E, Butler, Javed, Abraham, William T, DeFilippis, Ersilia M, Fonarow, Gregg C, Lindenfeld, Joann, Mentz, Robert J, Psotka, Mitchell A, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Vardeny, Orly, McMurray, John JV, and O’Connor, Christopher M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Heart Disease, Cardiovascular, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cardiovascular Agents, Clinical Trials as Topic, Heart Failure, Humans, Periodicals as Topic, Stroke Volume, clinical trials, device therapy, drug therapy, FDA, guideline directed, medical therapy, heart failure, HFrEF, medication, guideline directed medical therapy, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.

Published
2022

4. Cross-Validation of Risk Scores for Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation

Author

Estévez-Loureiro, Rodrigo, Shah, Neeraj, Raposeiras-Roubin, Sergio, Kotinkaduwa, Lak N., Madhavan, Mahesh V., Gray, William A., Lindenfeld, JoAnn, Adamo, Marianna, Abraham, William T., Freixa, Xavier, Grayburn, Paul A., Arzamendi, Dabit, Kar, Saibal, Benito-González, Tomas, Lim, D. Scott, Montefusco, Antonio, Redfors, Björn, Pascual, Isaac, Nombela-Franco, Luis, Rodés-Cabau, Josep, Shuvy, Mony, Moñivas, Vanessa, Godino, Cosmo, Mack, Michael J., Bedogni, Francesco, and Stone, Gregg W.

Published
2024
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9. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

Author

Anker, Stefan D, Butler, Javed, Khan, Muhammad Shahzeb, Abraham, William T, Bauersachs, Johann, Bocchi, Edimar, Bozkurt, Biykem, Braunwald, Eugene, Chopra, Vijay K, Cleland, John G, Ezekowitz, Justin, Filippatos, Gerasimos, Friede, Tim, Hernandez, Adrian F, Lam, Carolyn SP, Lindenfeld, JoAnn, McMurray, John JV, Mehra, Mandeep, Metra, Marco, Packer, Milton, Pieske, Burkert, Pocock, Stuart J, Ponikowski, Piotr, Rosano, Giuseppe MC, Teerlink, John R, Tsutsui, Hiroyuki, Van Veldhuisen, Dirk J, Verma, Subodh, Voors, Adriaan A, Wittes, Janet, Zannad, Faiez, Zhang, Jian, Seferovic, Petar, and Coats, Andrew JS

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease, Prevention, Good Health and Well Being, Betacoronavirus, COVID-19, Clinical Trials as Topic, Coronavirus Infections, Europe, Heart Failure, Humans, Informed Consent, Pandemics, Patient Selection, Pneumonia, Viral, Research Design, SARS-CoV-2, Heart failure, Clinical trials, Coronavirus, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Cardiovascular System & Hematology
Abstract

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

Published
2020

11. Percutaneous repair of moderate‐to‐severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE‐HF2 trial and comparison to COAPT and MITRA‐FR trials

Author

Anker, Stefan D., primary, Friede, Tim, additional, von Bardeleben, Ralph Stephan, additional, Butler, Javed, additional, Khan, Muhammad Shahzeb, additional, Diek, Monika, additional, Heinrich, Jutta, additional, Geyer, Martin, additional, Placzek, Marius, additional, Ferrari, Roberto, additional, Abraham, William T., additional, Alfieri, Ottavio, additional, Auricchio, Angelo, additional, Bayes‐Genis, Antoni, additional, Cleland, John G.F., additional, Filippatos, Gerasimos, additional, Gustafsson, Finn, additional, Haverkamp, Wilhelm, additional, Kelm, Malte, additional, Kuck, Karl‐Heinz, additional, Landmesser, Ulf, additional, Maggioni, Aldo P., additional, Metra, Marco, additional, Ninios, Vlasis, additional, Petrie, Mark C., additional, Rassaf, Tienush, additional, Ruschitzka, Frank, additional, Schäfer, Ulrich, additional, Schulze, P. Christian, additional, Spargias, Konstantinos, additional, Vahanian, Alec, additional, Zamorano, Jose Luis, additional, Zeiher, Andreas, additional, Karakas, Mahir, additional, Koehler, Friedrich, additional, Lainscak, Mitja, additional, Öner, Alper, additional, Mezilis, Nikolaos, additional, Theofilogiannakos, Efstratios K, additional, Ninios, Ilias, additional, Chrissoheris, Michael, additional, Kourkoveli, Panagiota, additional, Papadopoulos, Konstantinos, additional, Smolka, Grzegorz, additional, Wojakowski, Wojciech, additional, Reczuch, Krzysztof, additional, Pinto, Fausto J., additional, Zmudka, Krzysztof, additional, Kalarus, Zbigniew, additional, Adamo, Marianna, additional, Santiago‐Vacas, Evelyn, additional, Ruf, Tobias Friedrich, additional, Gross, Michael, additional, Tongers, Joern, additional, Hasenfuß, Gerd, additional, Schillinger, Wolfgang, additional, and Ponikowski, Piotr, additional

Published
2024
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12. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Felker, G. Michael, Jacob, Richard, Kitzman, Dalane W., Leifer, Eric S., Lewis, Eldrin F., Mentz, Robert J., Nkulikiyinka, Richard, Ni, Wei, Schaber, Daniel E., Sharma, Abhinav, Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Whellan, David J., Wittes, Janet, Anker, Stefan D., and O’Connor, Christopher M.

Published
2022
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16. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score–Matched Comparison

Author

Ludwig, Sebastian, Conradi, Lenard, Cohen, David J., Coisne, Augustin, Scotti, Andrea, Abraham, William T., Ben Ali, Walid, Zhou, Zhipeng, Li, Yanru, Kar, Saibal, Duncan, Alison, Lim, D. Scott, Adamo, Marianna, Redfors, Björn, Muller, David W.M., Webb, John G., Petronio, Anna S., Ruge, Hendrik, Nickenig, Georg, Sondergaard, Lars, Adam, Matti, Regazzoli, Damiano, Garatti, Andrea, Schmidt, Tobias, Andreas, Martin, Dahle, Gry, Walther, Thomas, Kempfert, Joerg, Tang, Gilbert H.L., Redwood, Simon, Taramasso, Maurizio, Praz, Fabien, Fam, Neil, Dumonteil, Nicolas, Obadia, Jean-François, von Bardeleben, Ralph Stephan, Rudolph, Tanja K., Reardon, Michael J., Metra, Marco, Denti, Paolo, Mack, Michael J., Hausleiter, Jörg, Asch, Federico M., Latib, Azeem, Lindenfeld, JoAnn, Modine, Thomas, Stone, Gregg W., and Granada, Juan F.

Published
2023
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18. A Composite Score Summarizing Use and Dosing of Evidence-Based Medical Therapies in Heart Failure: A Nationwide Cohort Study

Author

Johansen, Niklas Dyrby, Vaduganathan, Muthiah, Zahir, Deewa, Fiuzat, Mona, DeFilippis, Ersilia M., Januzzi, James L., Butler, Javed, O’Connor, Christopher M., Abraham, William T., Psotka, Mitchell A., McMurray, John J.V., Dewan, Pooja, Claggett, Brian L., Solomon, Scott D., Modin, Daniel, Butt, Jawad H., Jensen, Jens Ulrik Stæhr, Schou, Morten, Torp-Pedersen, Christian, Køber, Lars, Gislason, Gunnar H., and Biering-Sørensen, Tor

Published
2023
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19. In vivo fluid dynamics of the Ventura interatrial shunt device in patients with heart failure.

Author

Pfeiffer, Michael, Boehmer, John, Gorcsan, John, Eguchi, Shunsuke, Orihara, Yoshiyuki, Perl, Michal Laufer, Eigler, Neal, Abraham, William T., Villota, Julio Nuñez, Lee, Elizabeth, Bayés‐Genís, Antoni, Moravsky, Gil, Kar, Saibal, Zile, Michael R., Holcomb, Richard, Anker, Stefan D., Stone, Gregg W., Rodés‐Cabau, Josep, Lindenfeld, JoAnn, and Bax, Jeroen J.

Subjects
COMPUTATIONAL fluid dynamics, FLUID dynamics, PROPERTIES of fluids, DISCHARGE coefficient, HEART failure patients, TRANSESOPHAGEAL echocardiography
Abstract

Aims: Interatrial shunts are under evaluation as a treatment for heart failure (HF); however, their in vivo flow performance has not been quantitatively studied. We aimed to investigate the fluid dynamics properties of the 0.51 cm orifice diameter Ventura shunt and assess its lumen integrity with serial transesophageal echocardiography (TEE). Methods and results: Computational fluid dynamics (CFD) and bench flow tests were used to establish the flow‐pressure relationship of the shunt. Open‐label patients from the RELIEVE‐HF trial underwent TEE at shunt implant and at 6 and 12 month follow‐up. Shunt effective diameter (Deff) was derived from the vena contracta, and flow was determined by the continuity equation. CFD and bench studies independently validated that the shunt's discharge coefficient was 0.88 to 0.89. The device was successfully implanted in all 97 enrolled patients; mean age was 70 ± 11 years, 97% were NYHA class III, and 51% had LVEF ≤40%. Patency was confirmed in all instances, except for one stenotic shunt at 6 months. Deff remained unchanged from baseline at 12 months (0.47 ± 0.01 cm, P = 0.376), as did the trans‐shunt mean pressure gradient (5.1 ± 3.9 mmHg, P = 0.316) and flow (1137 ± 463 mL/min, P = 0.384). TEE measured flow versus pressure closely correlated (R2 ≥ 0.98) with a fluid dynamics model. At 12 months, the pulmonary/systemic flow Qp/Qs ratio was 1.22 ± 0.12. Conclusions: When implanted in patients with advanced HF, this small interatrial shunt demonstrated predictable and durable patency and performance. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Dose-limiting, adverse event–associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial

Author

Abraham, William T., Piccini, Jonathan P., Dufton, Christopher, Carroll, Ian A., Healey, Jeffrey S., O’Connor, Christopher M., Marshall, Debra, Aleong, Ryan, van Veldhuisen, Dirk J., Rienstra, Michiel, Wilton, Stephen B., White, Michel, Sauer, William H., Anand, Inder S., Huebler, Sophia P., Connolly, Stuart J., and Bristow, Michael R.

Published
2022
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22. Risk Factor Burden, Heart Failure, and Survival in Women of Different Ethnic Groups: Insights From the Women's Health Initiative.

Author

Breathett, Khadijah, Leng, Iris, Foraker, Randi E, Abraham, William T, Coker, Laura, Whitfield, Keith E, Shumaker, Sally, Manson, JoAnn E, Eaton, Charles B, Howard, Barbara V, Ijioma, Nkechinyere, Cené, Crystal W, Martin, Lisa W, Johnson, Karen C, and Klein, Liviu

Subjects
Humans, Proportional Hazards Models, Risk Factors, Survival Analysis, Aged, Middle Aged, African Americans, Women's Health, Female, Heart Failure, Ethnicity, Racial Groups, ethnic groups, heart failure, risk factors, survival, women, Cardiovascular, Heart Disease, Prevention, Clinical Research, Cardiovascular System & Hematology, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Medical Physiology
Abstract

BackgroundThe higher risk of heart failure (HF) in African-American and Hispanic women compared with white women is related to the higher burden of risk factors (RFs) in minorities. However, it is unclear if there are differences in the association between the number of RFs for HF and the risk of development of HF and death within racial/ethnic groups.Methods and resultsIn the WHI (Women's Health Initiative; 1993-2010), African-American (n=11 996), white (n=18 479), and Hispanic (n=5096) women with 1, 2, or 3+ baseline RFs were compared with women with 0 RF within their respective racial/ethnic groups to assess risk of developing HF or all-cause mortality before and after HF, using survival analyses. After adjusting for age, socioeconomic status, and hormone therapy, the subdistribution hazard ratio (95% confidence interval) of developing HF increased as number of RFs increased (P

Published
2018

24. Interatrial shunt therapy in advanced heart failure: Outcomes from the open‐label cohort of the RELIEVE‐HF trial

Author

Rodés‐Cabau, Josep, primary, Lindenfeld, JoAnn, additional, Abraham, William T., additional, Zile, Michael R., additional, Kar, Saibal, additional, Bayés‐Genís, Antoni, additional, Eigler, Neal, additional, Holcomb, Richard, additional, Núñez, Julio, additional, Lee, Elizabeth, additional, Perl, Michal Laufer, additional, Moravsky, Gil, additional, Pfeiffer, Michael, additional, Boehmer, John, additional, Gorcsan, John, additional, Bax, Jeroen J., additional, Anker, Stefan, additional, and Stone, Gregg W., additional

Published
2024
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33. Extracorporeal Ultrafiltration for Fluid Overload in Heart Failure Current Status and Prospects for Further Research

Author

Costanzo, Maria Rosa, Ronco, Claudio, Abraham, William T, Agostoni, Piergiuseppe, Barasch, Jonathan, Fonarow, Gregg C, Gottlieb, Stephen S, Jaski, Brian E, Kazory, Amir, Levin, Allison P, Levin, Howard R, Marenzi, Giancarlo, Mullens, Wilfried, Negoianu, Dan, Redfield, Margaret M, Tang, WH Wilson, Testani, Jeffrey M, and Voors, Adriaan A

Subjects
Kidney Disease, Heart Disease, Cardiovascular, Renal and urogenital, Blood Volume, Diuretics, Heart Failure, Hemofiltration, Humans, Pilot Projects, Randomized Controlled Trials as Topic, biomarkers, creatinine, diuretics, glomerular filtration rate, venous congestion, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients' vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration.

Published
2017

38. Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure Collaboratory and Academic Research Consortium

Author

Abraham, William T., Psotka, Mitchell A., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Mehran, Roxana, Ambardekar, Amrut V., Carson, Peter E., Jacob, Richard, Januzzi, James L., Jr., Konstam, Marvin A., Krucoff, Mitchell W., Lewis, Eldrin F., Piccini, Jonathan P., Solomon, Scott D., Stockbridge, Norman, Teerlink, John R., Unger, Ellis F., Zeitler, Emily P., Anker, Stefan D., and O’Connor, Christopher M.

Published
2020
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40. Physician‐directed patient self‐management in heart failure using left atrial pressure: Interim insights from the VECTOR‐HF I and IIa studies.

Author

Meerkin, David, Perl, Leor, Hasin, Tal, Petriashvili, Shalva, Kurashvili, Levan, Metreveli, Mikheil, Ince, Hüseyin, Feickert, Sebastian, Habib, Manhal, Caspi, Oren, Jonas, Michael, Amat‐Santos, Ignacio J., Bayes‐Genis, Antoni, Codina, Pau, Koren, Oran, Frydman, Shir, Pachino, Rachel M., Anker, Stefan D., and Abraham, William T.

Subjects
PATIENT compliance, HEART failure patients, LEFT heart atrium, MEDICAL personnel, HEART failure, PRESSURE sensors
Abstract

Aims: Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self‐management (PSM) of haemodynamics in HF has the potential to personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden. Methods and results: The VECTOR‐HF I and IIa studies are prospective, single‐arm, open‐label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)‐guided HF management using PSM in New York Heart Association class II and III HF patients. Physician‐prescribed LAP thresholds trigger patient self‐adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure‐ or device‐related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6‐min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement. Conclusions: Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Endpoints in Heart Failure Drug Development: History and Future

Author

Fiuzat, Mona, Lowy, Naomi, Stockbridge, Norman, Sbolli, Marco, Latta, Federica, Lindenfeld, JoAnn, Lewis, Eldrin F., Abraham, William T., Teerlink, John, Walsh, Mary, Heidenreich, Paul, Bozkurt, Biykem, Starling, Randall C., Solomon, Scott, Felker, G. Michael, Butler, Javed, Yancy, Clyde, Stevenson, Lynne W., O'Connor, Christopher, Unger, Ellis, Temple, Robert, and McMurray, John

Published
2020
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49. Center of excellence for mobile sensor data-to-knowledge (MD2K)

Author

Kumar, Santosh, Abowd, Gregory D, Abraham, William T, al’Absi, Mustafa, Beck, J Gayle, Chau, Duen Horng, Condie, Tyson, Conroy, David E, Ertin, Emre, Estrin, Deborah, Ganesan, Deepak, Lam, Cho, Marlin, Benjamin, Marsh, Clay B, Murphy, Susan A, Nahum-Shani, Inbal, Patrick, Kevin, Rehg, James M, Sharmin, Moushumi, Shetty, Vivek, Sim, Ida, Spring, Bonnie, Srivastava, Mani, and Wetter, David W

Subjects
Data Management and Data Science, Information and Computing Sciences, Health Services and Systems, Health Sciences, Prevention, Networking and Information Technology R&D (NITRD), Generic health relevance, Good Health and Well Being, Biomedical Research, Datasets as Topic, Geographic Information Systems, Humans, National Institutes of Health (U.S.), Telemedicine, Telemetry, United States, mobile health, wearable sensors, big data, data science research, knowledge discovery, Engineering, Medical and Health Sciences, Medical Informatics, Biomedical and clinical sciences, Health sciences, Information and computing sciences
Abstract

Mobile sensor data-to-knowledge (MD2K) was chosen as one of 11 Big Data Centers of Excellence by the National Institutes of Health, as part of its Big Data-to-Knowledge initiative. MD2K is developing innovative tools to streamline the collection, integration, management, visualization, analysis, and interpretation of health data generated by mobile and wearable sensors. The goal of the big data solutions being developed by MD2K is to reliably quantify physical, biological, behavioral, social, and environmental factors that contribute to health and disease risk. The research conducted by MD2K is targeted at improving health through early detection of adverse health events and by facilitating prevention. MD2K will make its tools, software, and training materials widely available and will also organize workshops and seminars to encourage their use by researchers and clinicians.

Published
2015

50. Association of BNP and Troponin Levels with Outcome among Cardiac Resynchronization Therapy Recipients

Author

SHALABY, ALAA A, ABRAHAM, WILLIAM T, FONAROW, GREGG C, BERSOHN, MALCOLM M, GORCSAN, JOHN, LEE, LI‐YIN, HALILOVIC, JASMINA, SABA, SAMIR, MAISEL, ALAN, SINGH, JAGMEET P, SONEL, ALI, and KADISH, ALAN

Subjects
Clinical Research, Heart Disease, Rehabilitation, Prevention, Cardiovascular, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Aged, Biomarkers, Cardiac Resynchronization Therapy, Cardiomyopathies, Female, Humans, Male, Natriuretic Peptide, Brain, Prospective Studies, Surveys and Questionnaires, Survival Analysis, Treatment Outcome, Troponin, biomarkers, BNP, cardiac resynchronization therapy, congestive heart failure, troponin, Biomedical Engineering, Clinical Sciences, Cardiovascular System & Hematology
Abstract

BackgroundWe conducted a prospective multicenter study to assess the prognostic value of combined baseline preimplant plasma levels of the biomarkers cardiac troponin T (TnT) and B-type natriuretic peptide (BNP) among cardiac resynchronization therapy (CRT) with or without defibrillator capability (CRT-D) recipients.MethodsAt CRT-D implant, patients were stratified based on detectable TnT (≥0.01 ng/mL) and elevated BNP (predefined as >440 pg/mL) levels. Patients were classified into three groups: high (both detectable TnT and high BNP), intermediate (either detectable TnT or high BNP), or low (nondetectable TnT and low BNP). Patients were followed for 12 months. Survival curves free from mortality or heart failure hospitalizations (HFH) were assessed. To assess the predictive value of biomarker category, we constructed a multivariate Cox regression model, including the covariates of age, New York Heart Association class, left ventricular ejection fraction (LVEF), and QRS duration.ResultsA total of 267 patients (age 66 ± 12 years, males 80%, LVEF 25% ± 8%, ischemic cardiomyopathy 52%, QRSd 155 ± 26 ms) were studied. After 1 year, there were 13 deaths and 25 HFH events. A significant difference in event-free survival among the three groups was observed, with high and intermediate categories having worse survival than low (log-rank test, P < 0.001). In the multivariate model, risk category was a significant predictor of outcome: hazard ratios were 7.34 (95% confidence interval [CI]: 2.48-21.69) and 2.50 (95% confidence interval [CI]: 1.04-6.04) for high-risk and intermediate-risk groups, respectively (P < 0.0001).ConclusionAmong CRT-D recipients, baseline TnT and BNP values alone or in combination provide significant prognostic value for the outcome of mortality or HFH.

Published
2015

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