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2. 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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8. 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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10. 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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11. Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

Author

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

Published
2024
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16. Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Author

Dimond, Matthew, Khan, Mohammad S, Fiuzat, Mona, Cleland, John G, Bhatt, Ankeet, Psotka, Mitchell, Anker, Stefan D, Butler, Javed, Felker, Michael, Mark, Daniel B, Carson, Peter E, Abraham, William T, Ahmad, Tariq, Lindenfeld, Joann, Vaduganathan, Muthiah, Whellan, David J, Vardeny, Orly, Solomon, Scott, Lewis, Eldrin F, Filippatos, Gerasimos, and OConnor, Christopher M

Published
2023
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22. 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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24. 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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26. 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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27. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

Author

Perl, Leor, Meerkin, David, D'amario, Domenico, Avraham, Binyamin Ben, Gal, Tuvia Ben, Weitsman, Tatyana, Hasin, Tal, Ince, Hüseyin, Feickert, Sebastian, D'ancona, Giuseppe, Schaefer, Ulrich, Sievert, Horst, Leyva, Francisco, Whinnett, Zachary I., Di Mario, Carlo, Jonas, Michael, Glikson, Michael, Habib, Manhal, Caspi, Oren, Koren, Oran, Abraham, William T., Kornowski, Ran, and Crea, Filippo

Published
2022
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31. 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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34. 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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35. 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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36. 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., Friede, Tim, von Bardeleben, Ralph Stephan, Butler, Javed, Khan, Muhammad Shahzeb, Diek, Monika, Heinrich, Jutta, Geyer, Martin, Placzek, Marius, Ferrari, Roberto, Abraham, William T., Alfieri, Ottavio, Auricchio, Angelo, Bayes‐Genis, Antoni, Cleland, John G.F., Filippatos, Gerasimos, Gustafsson, Finn, Haverkamp, Wilhelm, Kelm, Malte, and Kuck, Karl‐Heinz

Subjects
MITRAL valve insufficiency, BRAIN natriuretic factor, HEART failure patients, SODIUM-glucose cotransporter 2 inhibitors, CARDIAC pacing, MITRAL valve surgery, VENTRICULAR ejection fraction
Abstract

Aim: The RESHAPE‐HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE‐HF2 trial compared to those enrolled in the COAPT and MITRA‐FR trials. Methods and results: The RESHAPE‐HF2 study is an investigator‐initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate‐to‐severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8–9.0) and median plasma N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) was 2745 (1407–5385) pg/ml. Most patients were prescribed beta‐blockers (96%), diuretics (96%), angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium–glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end‐diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA‐FR, those enrolled in RESHAPE‐HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT‐proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Conclusion: Patients enrolled in RESHAPE‐HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate‐to‐severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA‐FR trials. The results of RESHAPE‐HF2 will provide crucial insights regarding broader application of the transcatheter edge‐to‐edge repair procedure in clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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