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8. Interpretable Survival Analysis for Heart Failure Risk Prediction

Author

Van Ness, Mike, Bosschieter, Tomas, Din, Natasha, Ambrosy, Andrew, Sandhu, Alexander, and Udell, Madeleine

Subjects
Computer Science - Machine Learning, Statistics - Machine Learning
Abstract

Survival analysis, or time-to-event analysis, is an important and widespread problem in healthcare research. Medical research has traditionally relied on Cox models for survival analysis, due to their simplicity and interpretability. Cox models assume a log-linear hazard function as well as proportional hazards over time, and can perform poorly when these assumptions fail. Newer survival models based on machine learning avoid these assumptions and offer improved accuracy, yet sometimes at the expense of model interpretability, which is vital for clinical use. We propose a novel survival analysis pipeline that is both interpretable and competitive with state-of-the-art survival models. Specifically, we use an improved version of survival stacking to transform a survival analysis problem to a classification problem, ControlBurn to perform feature selection, and Explainable Boosting Machines to generate interpretable predictions. To evaluate our pipeline, we predict risk of heart failure using a large-scale EHR database. Our pipeline achieves state-of-the-art performance and provides interesting and novel insights about risk factors for heart failure.

Published
2023

19. Sex-Based Differences in the Epidemiology, Clinical Characteristics, and Outcomes Associated with Worsening Heart Failure Events in a Learning Health System

Author

LEUNG, CHLOE J., BHATT, ANKEET S., GO, Alan S., PARIKH, RISHI V., GARCIA, ELISHA A., LE, KATHY C., LOW, DEBORAH, ALLEN, AMANDA R., FITZPATRICK, JESSE K., ADATYA, SIRTAZ, SAX, DANA R., GOYAL, PARAG, VARSHNEY, ANUBODH S., SANDHU, ALEXANDER T., GUSTAFSON, SHANSHAN E., and AMBROSY, ANDREW P.

Published
2024
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20. Characteristics, treatment, and outcomes of early vs. late enrollees of the STRONG-HF trial

Author

Arrigo, Mattia, Davison, Beth, Edwards, Christopher, Adamo, Marianna, Ambrosy, Andrew P., Barros, Marianela, Biegus, Jan, Celutkiene, Jelena, Čerlinskaitė-Bajorė, Kamilė, Chioncel, Ovidiu, Cohen-Solal, Alain, Damasceno, Albertino, Diaz, Rafael, Filippatos, Gerasimos, Gayat, Etienne, Kimmoun, Antoine, Lam, Carolyn S.P., Metra, Marco, Novosadova, Maria, Pagnesi, Matteo, Pang, Peter S., Ponikowski, Piotr, Saidu, Hadiza, Sliwa, Karen, Takagi, Koji, Ter Maaten, Jozine M., Tomasoni, Daniela, Voors, Adriaan A., Cotter, Gad, and Mebazaa, Alexandre

Published
2024
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38. Low-Dose Oral Minoxidil Initiation for Patients With Hair Loss: An International Modified Delphi Consensus Statement.

Author

Akiska, Yagiz Matthew, Mirmirani, Paradi, Roseborough, Ingrid, Mathes, Erin, Bhutani, Tina, Ambrosy, Andrew, Aguh, Crystal, Bergfeld, Wilma, Callender, Valerie D., Castelo-Soccio, Leslie, Cotsarelis, George, Craiglow, Brittany Gareth, Desai, Nisha S., Doche, Isabella, Duque-Estrada, Bruna, Elston, Dirk M., Goh, Carolyn, Goldberg, Lynne J., Grimalt, Ramon, and Jabbari, Ali

Published
2025
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39. A randomized controlled trial of renin-angiotensin-aldosterone system inhibitor management in patients admitted in hospital with COVID-19

Author

Sharma, Abhinav, Elharram, Malik, Afilalo, Jonathan, Flannery, Alexandria, Afilalo, Marc, Tselios, Chris, Ni, Jiayi, Ezekowitz, Justin A., Cheng, Matthew P., Ambrosy, Andrew P., Zannad, Faiez, Brophy, James M., Giannetti, Nadia, Bessissow, Amal, Kronfli, Nadine, Marelli, Ariane, Aziz, Haya, Alqahtani, Mohammad, Aflaki, Mona, Craig, Morgan, Lopes, Renato D., and Ferreira, João Pedro

Published
2022
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40. Effect of Torsemide Versus Furosemide on Symptoms and Quality of Life Among Patients Hospitalized for Heart Failure: The TRANSFORM-HF Randomized Clinical Trial

Author

Greene, Stephen J., Velazquez, Eric J., Anstrom, Kevin J., Clare, Robert M., DeWald, Tracy A., Psotka, Mitchell A., Ambrosy, Andrew P., Stevens, Gerin R., Rommel, John J., Alexy, Tamas, Ketema, Fassil, Kim, Dong-Yun, Desvigne-Nickens, Patrice, Pitt, Bertram, Eisenstein, Eric L., and Mentz, Robert J.

Published
2023
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41. Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

Author

Ambrosy, Andrew P, Parzynski, Craig S, Friedman, Daniel J, Fudim, Marat, Hernandez, Adrian F, Fonarow, Gregg C, Masoudi, Frederick A, and Al-Khatib, Sana M

Subjects
Cardiovascular, Prevention, Heart Disease, Clinical Research, Aged, Aged, 80 and over, Anti-Arrhythmia Agents, Defibrillators, Implantable, Female, Heart Failure, Hospital Mortality, Hospitalization, Humans, Male, Odds Ratio, Patient Readmission, Primary Prevention, Registries, Time Factors, Treatment Outcome, heart failure, hospitalization, defibrillators, implantable, treatment outcome, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BACKGROUND:Landmark studies have demonstrated the safety and efficacy of implantable cardioverter-defibrillators (ICDs) in selected stable ambulatory patients with heart failure (HF) with a reduced ejection fraction receiving optimal medical therapy. It is not known whether a recent hospitalization for HF before ICD placement is associated with subsequent outcomes. METHODS:A post hoc analysis was performed of Medicare beneficiaries enrolled in the National Cardiovascular Data Registry's ICD Registry with a known diagnosis of HF and an ejection fraction ≤35% underdoing a new ICD placement for primary prevention. Patients were grouped based on the timing of ICD placement from the last hospitalization for HF. The association between timing of ICD placement and outcomes was assessed by using multivariable logistic regression models. RESULTS:The final analytic cohort included 81 180 patients undergoing initial ICD placement for primary prevention who were currently hospitalized for HF (n=11 563, 14%), hospitalized for HF within 3 months (n=6252, 8%), or hospitalized for HF >3 months previously or had no previous hospitalizations for HF (n=63 365, 78%). Patients currently or recently hospitalized for HF had a higher unadjusted composite periprocedural complication rate (2.60% versus 1.71% versus 1.25%, P

Published
2018

42. Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure

Author

Greene, Stephen J, Mentz, Robert J, Fiuzat, Mona, Butler, Javed, Solomon, Scott D, Ambrosy, Andrew P, Mehta, Cyrus, Teerlink, John R, Zannad, Faiez, and O'Connor, Christopher M

Subjects
Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Heart Disease, Cardiovascular Agents, Clinical Trials, Phase II as Topic, Consensus, Drug Development, Endpoint Determination, Heart Failure, Humans, Research Design, Treatment Outcome, biomarkers, clinical trial, drug discovery, endpoint determination, heart failure, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

With few notable exceptions, drug development for heart failure (HF) has become progressively more challenging, and there remain no definitively proven therapies for patients with acute HF or HF with preserved ejection fraction. Inspection of temporal trends suggests an increasing rate of disagreement between early-phase and phase III trial end points. Preliminary results from phase II HF trials are frequently promising, but increasingly followed by disappointing phase III results. Given this potential disconnect, it is reasonable to carefully re-evaluate the purpose, design, and execution of phase II HF trials, with particular attention directed toward the surrogate end points commonly used by these studies. In this review, we offer a critical reappraisal of the role of phase II HF trials and surrogate end points, highlighting challenges in their use and interpretation, lessons learned from past experiences, and specific strengths and weaknesses of various surrogate outcomes. We conclude by proposing a series of approaches that should be considered for the goal of optimizing the efficiency of HF drug development. This review is based on discussions between scientists, clinical trialists, industry and government sponsors, and regulators that took place at the Cardiovascular Clinical Trialists Forum in Washington, DC, on December 2, 2016.

Published
2018

43. Lessons learned in acute heart failure

Author

Cheema, Baljash, Ambrosy, Andrew P, Kaplan, Rachel M, Senni, Michele, Fonarow, Gregg C, Chioncel, Ovidiu, Butler, Javed, and Gheorghiade, Mihai

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Cardiovascular, Patient Safety, Heart Disease, Good Health and Well Being, Acute Disease, Global Health, Heart Failure, Hospital Mortality, Hospitalization, Humans, Morbidity, Prognosis, Registries, Survival Rate, Acute heart failure, Clinical trial, Registry, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Acute heart failure (HF) is a global pandemic with more than one million admissions to hospital annually in the US and millions more worldwide. Post-discharge mortality and readmission rates remain unchanged and unacceptably high. Although recent drug development programmes have failed to deliver novel therapies capable of reducing cardiovascular morbidity and mortality in patients hospitalized for worsening chronic HF, hospitalized HF registries and clinical trial databases have generated a wealth of information improving our collective understanding of the HF syndrome. This review will summarize key insights from clinical trials in acute HF and hospitalized HF registries over the last several decades, focusing on improving the management of patients with HF and reduced ejection fraction.

Published
2018

44. Is Time of the Essence? The Impact of Time of Hospital Presentation in Acute Heart Failure Insights From ASCEND-HF Trial

Author

Cerbin, Lukasz P, Ambrosy, Andrew P, Greene, Stephen J, Armstrong, Paul W, Butler, Javed, Coles, Adrian, DeVore, Adam D, Ezekowitz, Justin A, Hernandez, Adrian F, Metra, Marco, Starling, Randall C, Tang, Wilson, Teerlink, John R, Voors, Adriaan A, Wu, Angie, O’Connor, Christopher M, and Mentz, Robert J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, Good Health and Well Being, Acute Disease, After-Hours Care, Aged, Dyspnea, Emergency Service, Hospital, Female, Heart Failure, Humans, Male, Middle Aged, Mortality, Nitroglycerin, Patient Readmission, Posture, Prognosis, Proportional Hazards Models, Respiratory Sounds, Sodium Potassium Chloride Symporter Inhibitors, Time Factors, Vasodilator Agents, heart failure, presentation, ASCEND-HF, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

OBJECTIVES:As the largest acute heart failure (AHF) trial conducted to date, the global ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial database presented an opportunity to systematically describe the relationship among time of hospital presentation, clinical profile, inpatient management, and outcomes among patients admitted with AHF. BACKGROUND:Time of hospital presentation has been shown to impact outcomes among patients hospitalized with many conditions. However, the association among time of presentation and patient characteristics, management, and clinical outcomes among patients hospitalized with AHF has not been well characterized. METHODS:A post hoc analysis of the ASCEND-HF trial was performed, which enrolled 7,141 patients hospitalized for AHF. Patients were divided based on when they presented to the hospital; regular hours were defined as 9 am to 5 pm, Monday through Friday, and off hours were defined as 5 pm to 9 am, Monday through Friday and weekends. Clinical characteristics and outcomes were compared by time of presentation. RESULTS:Overall, 3,298 patients (46%) presented during off hours. Off-hour patients were more likely to have orthopnea (80% vs. 74%, respectively) and rales (56% vs. 49%, respectively) than regular-hour patients. Off-hour patients were more likely to receive intravenous (IV) nitroglycerin (18% vs. 11%, respectively) and IV loop diuretics (92% vs. 86%, respectively) as initial therapy and reported greater relief from dyspnea at 24 h (odds ratio [OR]: 1.14; 95% confidence interval [CI]: 1.04 to 1.24; p = 0.01) than regular-hour patients. After adjustment, off-hour presentation was associated with significantly lower 30-day mortality (OR: 0.74; 95% CI: 0.57 to 0.96; p = 0.03) and 180-day mortality (hazard ratio [HR]: 0.82; 95% CI: 0.72 to 0.94; p = 0.01) but similar 30-day rehospitalization rates (p = 0.40). CONCLUSIONS:In this AHF trial, patients admitted during off hours exhibited a distinct clinical profile, experienced greater dyspnea relief, and had lower post-discharge mortality than regular-hour patients. These findings have implications for future AHF trials.

Published
2018

47. A randomized trial of icosapent ethyl in ambulatory patients with COVID-19

Author

Kosmopoulos, Andrew, Bhatt, Deepak L., Meglis, Gus, Verma, Raj, Pan, Yi, Quan, Adrian, Teoh, Hwee, Verma, Maya, Jiao, Lixia, Wang, Robert, Juliano, Rebecca A., Kajil, Mahesh, Kosiborod, Mikhail N., Bari, Basel, Berih, Abdullahi A., Aguilar, Mallory, Escano, Antonnette, Leung, Andrew, Coelho, Idelta, Hibino, Makoto, Díaz, Rafael, Mason, R. Preston, Steg, Ph. Gabriel, Simon, Tabassome, Go, Alan S., Ambrosy, Andrew P., Choi, Richard, Kushner, Arthur M., Leiter, Lawrence A., Al-Omran, Mohammed, Verma, Subodh, and Mazer, C. David

Published
2021
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48. Pre‐discharge and early post‐discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial

Author

Greene, Stephen J, Butler, Javed, Fonarow, Gregg C, Subacius, Haris P, Ambrosy, Andrew P, Vaduganathan, Muthiah, Triggiani, Marco, Solomon, Scott D, Lewis, Eldrin F, Maggioni, Aldo P, Böhm, Michael, Chioncel, Ovidiu, Nodari, Savina, Senni, Michele, Zannad, Faiez, Gheorghiade, Mihai, and Investigators and Coordinators, for the ASTRONAUT

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Cardiovascular, Clinical Research, Good Health and Well Being, Aged, Biomarkers, Cause of Death, Europe, Female, Follow-Up Studies, Heart Failure, Humans, Male, Middle Aged, Patient Discharge, Prognosis, Prospective Studies, Risk Factors, Stroke Volume, Survival Rate, Time Factors, Troponin, United States, Heart failure, Post-discharge, Outcomes, Hospitalization, ASTRONAUT Investigators and Coordinators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsTroponin levels are commonly elevated among patients hospitalized for heart failure (HF), but the prevalence and prognostic significance of early post-discharge troponin elevation are unclear. This study sought to describe the frequency and prognostic value of pre-discharge and post-discharge troponin elevation, including persistent troponin elevation from the inpatient to outpatient settings.Methods and resultsThe ASTRONAUT trial (NCT00894387; http://www.clinicaltrials.gov) enrolled hospitalized HF patients with ejection fraction ≤40% and measured troponin I prior to discharge (i.e. study baseline) and at 1-month follow-up in a core laboratory (elevation defined as >0.04 ng/mL). This analysis included 1469 (91.0%) patients with pre-discharge troponin data. Overall, 41.5% and 29.9% of patients had elevated pre-discharge [median: 0.09 ng/mL; interquartile range (IQR): 0.06-0.19 ng/mL] and 1-month (median: 0.09 ng/mL; IQR: 0.06-0.15 ng/mL) troponin levels, respectively. Among patients with pre-discharge troponin elevation, 60.4% had persistent elevation at 1 month. After adjustment, pre-discharge troponin elevation was not associated with 12-month clinical outcomes. In contrast, 1-month troponin elevation was independently predictive of increased all-cause mortality [hazard ratio (HR) 1.59, 95% confidence interval (CI) 1.18-2.13] and cardiovascular mortality or HF hospitalization (HR 1.28, 95% CI 1.03-1.58) at 12 months. Associations between 1-month troponin elevation and outcomes were similar among patients with newly elevated (i.e. normal pre-discharge) and persistently elevated levels (interaction P ≥ 0.16). The prognostic value of 1-month troponin elevation for 12-month mortality was driven by a pronounced association among patients with coronary artery disease (interaction P = 0.009).ConclusionsIn this hospitalized HF population, troponin I elevation was common during index hospitalization and at 1-month follow-up. Elevated troponin I level at 1 month, but not pre-discharge, was independently predictive of increased clinical events at 12 months. Early post-discharge troponin I measurement may offer a practical means of risk stratification and should be investigated as a therapeutic target.

Published
2018

50. Influence of atrial fibrillation on post‐discharge natriuretic peptide trajectory and clinical outcomes among patients hospitalized for heart failure: insights from the ASTRONAUT trial

Author

Greene, Stephen J, Fonarow, Gregg C, Solomon, Scott D, Subacius, Haris P, Ambrosy, Andrew P, Vaduganathan, Muthiah, Maggioni, Aldo P, Böhm, Michael, Lewis, Eldrin F, Zannad, Faiez, Butler, Javed, Gheorghiade, Mihai, and Investigators and Coordinators, for the ASTRONAUT

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Heart Disease, Aged, Amides, Antihypertensive Agents, Atrial Fibrillation, Atrial Flutter, Disease Progression, Female, Fumarates, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Natriuretic Peptide, Brain, Peptide Fragments, Prognosis, Randomized Controlled Trials as Topic, Heart failure, Natriuretic peptide, Atrial fibrillation, Outcomes, ASTRONAUT Investigators and Coordinators, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsChange in NT-proBNP level is a common surrogate endpoint in early phase heart failure (HF) trials, but whether this endpoint is influenced by atrial fibrillation/flutter (AFF) is unclear.Methods and resultsThis analysis included 1358 patients from the ASTRONAUT trial, which randomized patients hospitalized for HF with EF ≤40% to aliskiren or placebo in addition to standard care. Patients were stratified by presence of AFF on baseline ECG. NT-proBNP was measured longitudinally by a core laboratory at baseline, 1 month, 6 months, and 12 months. Compared with non-AFF patients, AFF patients experienced greater reduction from baseline in log-transformed NT-proBNP (interaction P < 0.001), but this difference was not significant after adjustment (interaction P = 0.726). The ability of aliskiren to lower NT-proBNP during follow-up differed by AFF status (interaction P = 0.001), with aliskiren lowering NT-proBNP more than placebo among non-AFF patients only. After adjustment, baseline AFF was not associated with mortality or HF hospitalization at 12 months (all P ≥ 0.152).ConclusionIn this hospitalized HF cohort, AFF status did not influence post-discharge NT-proBNP trajectory or clinical outcomes after adjustment for patient characteristics. Aliskiren lowered follow-up NT-proBNP levels in patients without AFF, but had no influence among patients with AFF. This study generates the hypothesis that the ability of a HF trial to meet an NT-proBNP defined endpoint may be influenced by the prevalence of AFF in the population. Because aliskiren did not improve outcomes in patients without AFF, this analysis suggests changes in NT-proBNP induced by investigational therapies may be dissociated from clinical effects.

Published
2017

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