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55. 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

61. 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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64. 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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65. American Heart Association Cardiogenic Shock Registry: Design and Implementation.

Author

Morrow, David A., Jessup, Mariell, Abraham, William T., Acker, Michael, Aringo, Angeline, Batchelor, Wayne, Chikwe, Joanna, Costello, Shaina, Drakos, Stavros G., Farmer, Steven, Gelijns, Annetine, Gillette, Nicole, Hochman, Judith S., Isler, Maria, Kapur, Navin K., Kilic, Arman, Kormos, Robert, Lewis, Eldrin F., Lindenfeld, JoAnn, and Lombardi, Pierluca

Abstract

BACKGROUND: Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States. METHODS: Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity. Data are collected through individual reviews of medical records of sequential adult patients with cardiogenic shock. The electronic case record form was collaboratively designed with a core minimum data structure and aligned with Shock Academic Research Consortium definitions. This registry will allow participating health systems to evaluate patientlevel data including diagnostic approaches, therapeutics, use of advanced monitoring and circulatory support, processes of care, complications, and in-hospital survival. Participating sites can leverage these data for onsite monitoring of outcomes and benchmarking versus other institutions. The registry was concomitantly designed to provide a high-quality longitudinal research infrastructure for pragmatic randomized trials as well as translational, clinical, and implementation research. An aggregate deidentified data set will be made available to the research community on the American Heart Association's Precision Medicine Platform. On March 31, 2022, the American Heart Association Cardiogenic Shock Registry received its first clinical records. At the time of this submission, 100 centers are participating. CONCLUSIONS: The American Heart Association Cardiogenic Shock Registry will serve as a resource using consistent data structure and definitions for the medical and research community to accelerate scientific advancement through shared learning and research resulting in improved quality of care and outcomes of shock patients. [ABSTRACT FROM AUTHOR]

Published
2024
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70. 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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74. Implantable Hemodynamic Monitors Improve Survival in Patients With Heart Failure and Reduced Ejection Fraction

Author

Lindenfeld, JoAnn, primary, Costanzo, Maria Rosa, additional, Zile, Michael R., additional, Ducharme, Anique, additional, Troughton, Richard, additional, Maisel, Alan, additional, Mehra, Mandeep R., additional, Paul, Sara, additional, Sears, Samuel F., additional, Smart, Frank, additional, Johnson, Nessa, additional, Henderson, John, additional, Adamson, Philip B., additional, Desai, Akshay S., additional, and Abraham, William T., additional

Published
2024
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78. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies

Author

Lala, Anuradha, primary, Hamo, Carine E., additional, Bozkurt, Biykem, additional, Fiuzat, Mona, additional, Blumer, Vanessa, additional, Bukhoff, Daniel, additional, Butler, Javed, additional, Costanzo, Maria Rosa, additional, Felker, G. Michael, additional, Filippatos, Gerasimos, additional, Konstam, Marvin A., additional, McMurray, John J.V., additional, Mentz, Robert J., additional, Metra, Marco, additional, Psotka, Mitchell A., additional, Solomon, Scott D., additional, Teerlink, John, additional, Abraham, William T., additional, and O’Connor, Christopher M., additional

Published
2023
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80. 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

81. 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

82. Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development

Author

Psotka, Mitchell A., Fiuzat, Mona, Carson, Peter E., Kao, David P., Cerkvenik, Jeffrey, Schaber, Daniel E., Verta, Patrick, Kazmierski, Robert T., Shinnar, Meir, Stockbridge, Norman, Unger, Ellis F., Zuckerman, Bram, Butler, Javed, Felker, G. Michael, Konstam, Marvin A., Lindenfeld, JoAnn, Solomon, Scott D., Teerlink, John R., O'Connor, Christopher M., and Abraham, William T.

Published
2019
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83. Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined HF Population: The GENETIC-AF Trial

Author

Piccini, Jonathan P., Abraham, William T., Dufton, Christopher, Carroll, Ian A., Healey, Jeff S., van Veldhuisen, Dirk J., Sauer, William H., Anand, Inder S., White, Michel, Wilton, Stephen B., Aleong, Ryan, Rienstra, Michiel, Krueger, Steven K., Ayala-Paredes, Felix, Khaykin, Yaariv, Merkely, Bela, Miloradović, Vladimir, Wranicz, Jerzy K., Ilkhanoff, Leonard, Ziegler, Paul D., Davis, Gordon, Emery, Laura L., Marshall, Debra, Kao, David P., Bristow, Michael R., and Connolly, Stuart J.

Published
2019
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88. Comorbidities and clinical response to cardiac resynchronization therapy: Patient‐level meta‐analysis from eight clinical trials.

Author

Fudim, Marat, Dalgaard, Frederik, Friedman, Daniel J., Abraham, William T., Cleland, John G.F., Curtis, Anne B., Gold, Michael R., Kutyifa, Valentina, Linde, Cecilia, Ali‐Ahmed, Fatima, Tang, Anthony, Olivas‐Martinez, Antonio, Inoue, Lurdes Y.T., Al‐Khatib, Sana M., and Sanders, Gillian D.

Subjects
CARDIAC pacing, HEART failure, CLINICAL trials, CORONARY artery disease, ATRIAL fibrillation, MORTALITY
Abstract

Aims: Patients with heart failure usually have several other medical conditions that might alter the effects of interventions. We investigated whether the burden of comorbidity modified the clinical response to cardiac resynchronization therapy (CRT). Methods and results: Original patient‐level data from eight randomized trials exploring the effects of CRT versus no CRT were pooled (BLOCK‐HF, MIRACLE, MIRACLE‐ICD, MIRACLE‐ICD II, RAFT, COMPANION, MADIT‐CRT and REVERSE). A prior history of the following comorbidities was considered: episodic or persistent atrial fibrillation (n = 920), coronary artery disease (n = 3732), diabetes (n = 2171), and hypertension (n = 3353). Patients were classified into three groups based on the number of comorbidities: 0, 1–2, or ≥3. The outcomes of interest were time to all‐cause mortality and time to the composite outcome of heart failure hospitalization (HFH) or all‐cause mortality. Outcomes were evaluated within each comorbidity group using a Bayesian hierarchical Weibull survival regression model. Of 6324 patients, 970 (15%) had no comorbidities, 4052 (64%) had 1–2 and 1302 (21%) had ≥3 comorbidities. The adjusted hazard ratio (aHR) for CRT versus no CRT for all‐cause mortality in the overall cohort was 0.79 (95% credible interval [CI] 0.68–0.93) (p = 0.010); for no comorbidities the aHR was 0.54 (95% CI 0.34–0.86), for 1–2 comorbidities was 0.81 (95% CI 0.67–0.97) and for ≥3 comorbidities was 0.83 (95% CI 0.64–1.07) (no significant interaction between CRT and comorbidity burden: p = 0.13). For the endpoint of HFH or all‐cause mortality, the aHR for the overall cohort was 0.74 (95% CI 0.65–0.84) (p = 0.001), for no comorbidities was 0.69 (95% CI 0.50–0.94), for 1–2 comorbidities was 0.77 (95% CI 0.66–0.90) and for ≥3 comorbidities was 0.68 (95% CI 0.55–0.82) (no significant interaction between CRT and comorbidity burden: p = 0.081). Conclusion: In a meta‐analysis of patient‐level data from eight major trials, the totality of evidence suggests that CRT reduces HFH and/or all‐cause mortality even when several comorbid diseases are present. Clinical Trial Registration: NCT00271154, NCT00251251, NCT00267098, NCT00180271. [ABSTRACT FROM AUTHOR]

Published
2024
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90. Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC)

Author

Waksman, Ron, primary, Pahuja, Mohit, additional, van Diepen, Sean, additional, Proudfoot, Alastair G., additional, Morrow, David, additional, Spitzer, Ernest, additional, Nichol, Graham, additional, Weisfeldt, Myron L., additional, Moscucci, Mauro, additional, Lawler, Patrick R., additional, Mebazaa, Alexandre, additional, Fan, Eddy, additional, Dickert, Neal W., additional, Samsky, Marc, additional, Kormos, Robert, additional, Piña, Ileana L., additional, Zuckerman, Bram, additional, Farb, Andrew, additional, Sapirstein, John S., additional, Simonton, Charles, additional, West, Nick E.J., additional, Damluji, Abdulla A., additional, Gilchrist, Ian C., additional, Zeymer, Uwe, additional, Thiele, Holger, additional, Cutlip, Donald E., additional, Krucoff, Mitchell, additional, and Abraham, William T., additional

Published
2023
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91. Comorbidities and clinical response to cardiac resynchronization therapy: patient‐level meta‐analysis from eight clinical trials

Author

Fudim, Marat, primary, Dalgaard, Frederik, additional, Friedman, Daniel J., additional, Abraham, William T., additional, Cleland, John G.F., additional, Curtis, Anne B., additional, Gold, Michael R., additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Ali‐Ahmed, Fatima, additional, Tang, Anthony, additional, Olivas‐Martinez, Antonio, additional, Inoue, Lurdes Y.T., additional, Al‐Khatib, Sana M., additional, and Sanders, Gillian D., additional

Published
2023
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93. Bucindolol Decreases Atrial Fibrillation Burden in Patients With Heart Failure and the ADRB1 Arg389Arg Genotype

Author

Piccini, Jonathan P., Dufton, Christopher, Carroll, Ian A., Healey, Jeff S., Abraham, William T., Khaykin, Yaariv, Aleong, Ryan, Krueger, Steven K., Sauer, William H., Wilton, Stephen B., Rienstra, Michiel, van Veldhuisen, Dirk J., Anand, Inder S., White, Michel, Camm, A. John, Ziegler, Paul D., Marshall, Debra, Bristow, Michael R., and Connolly, Stuart J.

Published
2021
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95. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation

Author

Abraham, William T., Kuck, Karl-Heinz, Goldsmith, Rochelle L., Lindenfeld, JoAnn, Reddy, Vivek Y., Carson, Peter E., Mann, Douglas L., Saville, Benjamin, Parise, Helen, Chan, Rodrigo, Wiegn, Phi, Hastings, Jeffrey L., Kaplan, Andrew J., Edelmann, Frank, Luthje, Lars, Kahwash, Rami, Tomassoni, Gery F., Gutterman, David D., Stagg, Angela, Burkhoff, Daniel, and Hasenfuß, Gerd

Published
2018
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98. A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial

Author

Piccini, Jonathan P., Connolly, Stuart J., Abraham, William T., Healey, Jeff S., Steinberg, Benjamin A., Al-Khalidi, Hussein R., Dignacco, Patricia, van Veldhuisen, Dirk J., Sauer, William H., White, Michel, Wilton, Stephen B., Anand, Inder S., Dufton, Christopher, Marshall, Debra A., Aleong, Ryan G., Davis, Gordon W., Clark, Richard L., Emery, Laura L., and Bristow, Michael R.

Published
2018
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