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2. SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation.

Author

Frantz, Robert P., Desai, Shashank S., Ewald, Gregory, Franco, Veronica, Hage, Antoine, Horn, Evelyn M., LaRue, Shane J., Mathier, Michael A., Mandras, Stacy, Park, Myung H., Ravichandran, Ashwin K., Schilling, Joel D., Wang, I‐wen, Zolty, Ronald, Rendon, Gabriela Gomez, Rocco, Mark A., Selej, Mona, Zhao, Carol, and Rame, J. Eduardo

Subjects
PULMONARY arterial hypertension, BRAIN natriuretic factor, PULMONARY hypertension, ENDOTHELIN receptors, VASCULAR resistance, HEART assist devices
Abstract

Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double‐blind, randomized, placebo‐controlled, parallel‐group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right‐heart catheterization hemodynamic variables, N‐terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty‐seven patients were randomized to macitentan (n = 28) or placebo (n = 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo‐corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58–0.94; p =.0158). No statistically significant differences were observed in secondary endpoints. In a post‐hoc analysis, 66.7% of patients receiving macitentan achieved PVR <3 WU versus 40.0% receiving placebo (p =.0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial

Author

Nassif, Michael E., Windsor, Sheryl L., Tang, Fengming, Khariton, Yevgeniy, Husain, Mansoor, Inzucchi, Silvio E., McGuire, Darren K., Pitt, Bertram, Scirica, Benjamin M., Austin, Bethany, Drazner, Mark H., Fong, Michael W., Givertz, Michael M., Gordon, Robert A., Jermyn, Rita, Katz, Stuart D., Lamba, Sumant, Lanfear, David E., LaRue, Shane J., Lindenfeld, JoAnn, Malone, Michael, Margulies, Kenneth, Mentz, Robert J., Mutharasan, R. Kannan, Pursley, Michael, Umpierrez, Guillermo, Kosiborod, Mikhail, Malik, Ali O., Wenger, Nannette, Ogunniyi, Modele, Vellanki, Priyathama, Murphy, Brenda, Newman, Jonathan, Hartupee, Justin, Gupta, Charu, Goldsmith, Marcela, Baweja, Paramdeep, Montero, Manuel, Gottlieb, Stephen S., Costanzo, Maria Rosa, Hoang, Thanh, Warnock, Alicia, Allen, Larry, Tang, Wilson, Chen, Horng H., and Cox, John M.

Published
2019
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27. Dapagliflozin effects on lung fluid volumes in patients with heart failure and reduced ejection fraction: Results from the DEFINE‐HF trial

Author

Nassif, Michael E., primary, Windsor, Sheryl L., additional, Tang, Fengming, additional, Husain, Mansoor, additional, Inzucchi, Silvio E., additional, McGuire, Darren K., additional, Pitt, Bertram, additional, Scirica, Benjamin M., additional, Austin, Bethany, additional, Fong, Michael W., additional, LaRue, Shane J., additional, Umpierrez, Guillermo, additional, Hartupee, Justin, additional, Khariton, Yevgeniy, additional, Malik, Ali O., additional, Ogunniyi, Modele O., additional, Wenger, Nanette K., additional, and Kosiborod, Mikhail N., additional

Published
2021
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29. Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial

Author

Matlock, Daniel D., primary, McIlvennan, Colleen K., additional, Thompson, Jocelyn S., additional, Morris, Megan A., additional, Venechuk, Grace, additional, Dunlay, Shannon M., additional, LaRue, Shane J., additional, Lewis, Eldrin F., additional, Patel, Chetan B., additional, Blue, Laura, additional, Chaussee, Erin L., additional, Glasgow, Russell E., additional, Walsh, Mary Norine, additional, and Allen, Larry A., additional

Published
2020
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31. The Combination of Tricuspid Annular Plane Systolic Excursion and HeartMate Risk Score Predicts Right Ventricular Failure After Left Ventricular Assist Device Implantation

Author

Raymer, David S., primary, Moreno, Jonathan D., additional, Sintek, Marc A., additional, Nassif, Michael E., additional, Sparrow, Christopher T., additional, Adamo, Luigi, additional, Novak, Eric L., additional, LaRue, Shane J., additional, and Vader, Justin M., additional

Published
2019
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34. Effectiveness of an Intervention Supporting Shared Decision Making for Destination Therapy Left Ventricular Assist Device

Author

Allen, Larry A., primary, McIlvennan, Colleen K., additional, Thompson, Jocelyn S., additional, Dunlay, Shannon M., additional, LaRue, Shane J., additional, Lewis, Eldrin F., additional, Patel, Chetan B., additional, Blue, Laura, additional, Fairclough, Diane L., additional, Leister, Erin C., additional, Glasgow, Russell E., additional, Cleveland, Joseph C., additional, Phillips, Clifford, additional, Baldridge, Vicie, additional, Walsh, Mary Norine, additional, and Matlock, Daniel D., additional

Published
2018
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37. The Heartmate Risk Score Predicts Morbidity and Mortality in Unselected LVAD Recipients and Risk Stratifies INTERMACS Class 1 Patients

Author

Adamo, Luigi, Nassif, Michael, Tibrewala, Anjan, Novak, Eric, Vader, Justin, Silvestry, Scott C., Itoh, Akinobu, Ewald, Gregory A., Mann, Douglas L., and LaRue, Shane J.

Subjects
Cohort Studies, Heart Failure, Male, Treatment Outcome, ROC Curve, Humans, Female, Heart-Assist Devices, Kaplan-Meier Estimate, Middle Aged, Risk Assessment, Article
Abstract

This study evaluated the Heartmate Risk Score (HMRS) and its potential benefits in clinical practice.The HMRS has been shown to correlate with mortality in the cohort of patients enrolled in the Heartmate II trials, but its validity in unselected, "real world" populations remains unclear.This study identified a cohort of 269 consecutive patients who received a Heartmate II left ventricular assist device at our institution, the Barnes-Jewish Hospital in St. Louis, Missouri, between June 2005 and June 2013. Ninety-day and 2-year mortality rates, as well as frequency of several morbid events, were compared by retrospectively assigned HMRS category groups. The analysis was repeated within the subgroup of INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) class 1 patients.Receiver operating curve analysis showed that the HMRS correlated with 90-day mortality with an area under the curve of 0.70. Stratification in low, mid, and high HMRS groups identified patients with increasing hazard of 90-day mortality, increasing long-term mortality, increasing rate of gastrointestinal bleeding events, and increasing median number of days spent in the hospital in the first year post implant. Within INTERMACS class 1 patients, those in the highest HMRS group were found to have a relative risk of 90-day mortality 5.7 times higher than those in the lowest HMRS group (39.1% vs. 6.9%, p = 0.029).HMRS is a valid clinical tool to stratify risk of morbidity and mortality after implant of Heartmate II devices in unselected patients and can be used to predict short-term mortality risk in INTERMACS class 1 patients.

Published
2015

38. Effect of Oral Iron Repletion on Exercise Capacity in Patients With Heart Failure With Reduced Ejection Fraction and Iron Deficiency: The IRONOUT HF Randomized Clinical Trial.

Author

Lewis, Gregory D, Malhotra, Rajeev, Hernandez, Adrian F, McNulty, Steven E, Smith, Andrew, Felker, G Michael, Tang, W H Wilson, LaRue, Shane J, Redfield, Margaret M, Semigran, Marc J, Givertz, Michael M, Van Buren, Peter, Whellan, David J, Anstrom, Kevin J, Shah, Monica R, Desvigne-Nickens, Patrice, Butler, Javed, Braunwald, Eugene, Lewis, Gregory D, Malhotra, Rajeev, Hernandez, Adrian F, McNulty, Steven E, Smith, Andrew, Felker, G Michael, Tang, W H Wilson, LaRue, Shane J, Redfield, Margaret M, Semigran, Marc J, Givertz, Michael M, Van Buren, Peter, Whellan, David J, Anstrom, Kevin J, Shah, Monica R, Desvigne-Nickens, Patrice, Butler, Javed, and Braunwald, Eugene

Abstract

Importance: Iron deficiency is present in approximately 50% of patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and is an independent predictor of reduced functional capacity and mortality. However, the efficacy of inexpensive readily available oral iron supplementation in heart failure is unknown. Objective: To test whether therapy with oral iron improves peak exercise capacity in patients with HFrEF and iron deficiency. Design, Setting, and Participants: Phase 2, double-blind, placebo-controlled randomized clinical trial of patients with HFrEF ( Interventions: Oral iron polysaccharide (n = 111) or placebo (n = 114), 150 mg twice daily for 16 weeks. Main Outcomes and Measures: The primary end point was a change in peak oxygen uptake (V̇o2) from baseline to 16 weeks. Secondary end points were change in 6-minute walk distance, plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and health status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ, range 0-100, higher scores reflect better quality of life). Results: Among 225 randomized participants (median age, 63 years; 36% women) 203 completed the study. The median baseline peak V̇o2 was 1196 mL/min (interquartile range [IQR], 887-1448 mL/min) in the oral iron group and 1167 mL/min (IQR, 887-1449 mL/min) in the placebo group. The primary end point, change in peak V̇o2 at 16 weeks, did not significantly differ between the oral iron and placebo groups (+23 mL/min vs -2 mL/min; difference, 21 mL/min [95% CI, -34 to +76 mL/min]; P = .46). Similarly, at 16 weeks, there were no significant differences between treatment groups in changes in 6-minute walk distance (-13 m; 95% CI, -32 to 6 m), NT-proBNP levels (159; 95% CI, -280 to 599 pg/mL), or KCCQ score (1; 95% CI, -2.4 to 4.4), all P > .05. Conclusions and Relevance: Among participants with HFrEF with iron deficiency, high-dose oral iron did not improve exercise capacity over 16 weeks. These results do not s

Published
2017

40. A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD

Author

McIlvennan, Colleen K., primary, Thompson, Jocelyn S., additional, Matlock, Daniel D., additional, Cleveland, Joseph C., additional, Dunlay, Shannon M., additional, LaRue, Shane J., additional, Lewis, Eldrin F., additional, Patel, Chetan B., additional, Walsh, Mary Norine, additional, and Allen, Larry A., additional

Published
2016
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44. Diagnosis of Left Ventricular Assist Device (LVAD) Pump Thrombosis Using Fibrin-Specific 99mTc Imaging Agent

Author

Ewald, Gregory A., primary, Cui, Grace, additional, Scott, Michael, additional, Nassif, Michael E., additional, LaRue, Shane J., additional, Vader, Justin M., additional, Raymer, David S., additional, Akers, Walter, additional, Silvestry, Scott, additional, Itoh, Akinobu, additional, Achilefu, Samuel, additional, and Lanza, Gregory, additional

Published
2015
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50. Prevalence of lactic acidaemia in patients with advanced heart failure and depressed cardiac output.

Author

Adamo, Luigi, Nassif, Michael E., Novak, Erik, LaRue, Shane J., and Mann, Douglas L.

Subjects
LACTIC acid, HEART failure patients, HEART failure treatment, DISEASE prevalence, CARDIAC output, HEART assist devices
Abstract

Aims Heart failure ( HF) has been defined classically as a condition in which the heart is unable to deliver sufficient oxygen to match the needs of the metabolizing tissues. Surprisingly, this definition has never been validated. The goal of this study was to determine the prevalence of elevated lactate levels in a cohort of patients with advanced heart failure. Methods and results We retrospectively analysed the arterio-venous oxygen difference (A-V O2), haemodynamics, and plasma lactate levels in stage D heart failure patients who were being evaluated for a left ventricular assist device ( LVAD). We identified 359 patients with a right heart catheterization ( RHC) performed prior to LVAD implantation. Plasma lactate was available for 96 patients. RHC showed that 93% of the patients had an A-V O2 above the upper limit of normal (>5 mL/100 mL). Among patients with measured lactate levels, the prevalence of elevated lactate (>2.1 mmol/L) was 25% (95% confidence interval 16.7-34.9). The A-V O2 was widened in all patients with elevated lactate, but plasma lactate did not correlate with A-V O2 ( r = 0.02) and only 27% of patients with increased A-V O2 had elevated plasma lactate. Conclusions Lactate levels were normal in ∼75% of the patients with advanced heart failure and a widened A-V O2, suggesting that the cardiac output was sufficient to meet the metabolic needs of the peripheral metabolizing tissues. Given that ∼4% of heart failure patients are in NYHA class IV, these findings suggest that the classic definition of heart failure pertains to ∼1% of patients with HF. [ABSTRACT FROM AUTHOR]

Published
2017
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