Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance

Aaronson, Keith D.; Stewart, Garrick C.; Pagani, Francis D.; Stevenson, Lynne Warner; Palardy, Maryse; McNamara, Dennis M.; Mancini, Donna; Grady, Kathleen L.; Gorcsan, John; Kormos, Robert L.; Jeffries, Neal; Taddei-Peters, Wendy C.; Richards, Blair; Khalatbari, Shokoufeh; Spino, Cathie; Baldwin, J. Timothy; Mann, Douglas L.; Investigators, Revival

doi:10.1016/j.healun.2019.09.008

Cited by 15 publications

(7 citation statements)

References 14 publications

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“…Full details of the rationale and design have been described previously. 19 Funded by the National Institutes of Health, REVIVAL was a 2-year study of 400 ambulatory systolic HF patients recruited from 21 US VAD centers from all major geographic regions of the county representing 16 different states between July 2015 and June 2016 that sought to gain a better understanding of the clinical trajectory of patients with HF with high-risk features. An independent Observational Study Monitoring Board oversaw the conduct of the REVIVAL study.…”

Section: Data Sourcementioning

confidence: 99%

Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study

Cascino

Colvin

Lanfear

et al. 2023

Circ: Heart Failure

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Background: Racial disparities in access to advanced therapies for heart failure (HF) patients are well documented, although the reasons remain uncertain. We sought to determine the association of race on utilization of ventricular assist device (VAD) and transplant among patients with access to care at VAD centers and if patient preferences impact the effect. Methods: We performed an observational cohort study of ambulatory chronic systolic HF patients with high-risk features and no contraindication to VAD enrolled at 21 VAD centers and followed for 2 years in the REVIVAL study (Registry Evaluation of Vital Information for VADs in Ambulatory Life). We used competing events cause-specific proportional hazard methodology with multiple imputation for missing data. The primary outcomes were (1) VAD/transplant and (2) death. The exposures of interest included race (Black or White), additional demographics, captured social determinants of health, clinician-assessed HF severity, patient-reported quality of life, preference for VAD, and desire for therapies. Results: The study included 377 participants, of whom 100 (26.5%) identified as Black. VAD or transplant was performed in 11 (11%) Black and 62 (22%) White participants, although death occurred in 18 (18%) Black and 36 (13%) White participants. Black race was associated with reduced utilization of VAD and transplant (adjusted hazard ratio, 0.45 [95% CI, 0.23–0.85]) without an increase in death. Preferences for VAD or life-sustaining therapies were similar by race and did not explain racial disparities. Conclusions: Among patients receiving care by advanced HF cardiologists at VAD centers, there is less utilization of VAD and transplant for Black patients even after adjusting for HF severity, quality of life, and social determinants of health, despite similar care preferences. This residual inequity may be a consequence of structural racism and discrimination or provider bias impacting decision-making. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01369407.

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Section: Data Sourcementioning

confidence: 99%

Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study

Cascino

Colvin

Lanfear

et al. 2023

Circ: Heart Failure

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“…REVIVAL is a prospective, observational, multicenter cohort of ambulatory patients with advanced HF that also includes caregivers. 14 Patients and caregivers were enrolled from 21 centers between July 2015 and June 2016. Patients enrolled were aged 18 to 80 years with New York Heart Association functional class II to IV limitations for at least 45 of the previous 60 days, left ventricular ejection fraction ≤35%, and a HF diagnosis >12 months.…”

Section: Methodsmentioning

confidence: 99%

Caregiver Health‐Related Quality of Life, Burden, and Patient Outcomes in Ambulatory Advanced Heart Failure: A Report From REVIVAL

Gilotra

Pamboukian

Mountis

et al. 2021

JAHA

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Background Heart failure (HF) imposes significant burden on patients and caregivers. Longitudinal data on caregiver health‐related quality of life (HRQOL) and burden in ambulatory advanced HF are limited. Methods and Results Ambulatory patients with advanced HF (n=400) and their participating caregivers (n=95) enrolled in REVIVAL (Registry Evaluation of Vital Information for VADs [Ventricular Assist Devices] in Ambulatory Life) were followed up for 24 months, or until patient death, left ventricular assist device implantation, heart transplantation, or loss to follow‐up. Caregiver HRQOL (EuroQol Visual Analog Scale) and burden (Oberst Caregiving Burden Scale) did not change significantly from baseline to follow‐up. At time of caregiver enrollment, better patient HRQOL by Kansas City Cardiomyopathy Questionnaire was associated with better caregiver HRQOL ( P =0.007) and less burden by both time spent ( P <0.0001) and difficulty ( P =0.0007) of caregiving tasks. On longitudinal analyses adjusted for baseline values, better patient HRQOL ( P =0.034) and being a married caregiver ( P =0.016) were independently associated with better caregiver HRQOL. Patients with participating caregivers (versus without) were more likely to prefer left ventricular assist device therapy over time (odds ratio, 1.43; 95% CI, 1.03–1.99; P =0.034). Among patients with participating caregivers, those with nonmarried (versus married) caregivers were at higher composite risk of HF hospitalization, death, heart transplantation or left ventricular assist device implantation (hazard ratio, 2.99; 95% CI, 1.29–6.96; P =0.011). Conclusions Patient and caregiver characteristics may impact their HRQOL and other health outcomes over time. Understanding the patient‐caregiver relationship may better inform medical decision making and outcomes in ambulatory advanced HF.

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“…1) REVIVAL Cohort: The REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life) registry contains information on 400 patients with advanced systolic HF from 21 US medical centers [25]. As part of the registry, patients were evaluated at up to 6 pre-specified time points over a 2-year period and underwent relevant examinations.…”

Section: B Heart Failure Datasetmentioning

confidence: 99%

“…In the INTERMACS dataset, the distribution of INTERMACS levels 1-2 (critical), 3 (stable), 4-7 (ambulatory) are 45.0%, 37.4%, 17.6%, respectively; in REVIVAL dataset, the distribution of INTERMACS levels 1-2 (critical), 3 (stable), 4-7 (ambulatory) are 0.1%, 1.3%, 98.6%, respectively. The REVIVAL registry was specifically designed to evaluate an ambulatory population [25].…”

Section: Appendix B Data Split On the Heart Failure Applicationmentioning

confidence: 99%

A Novel Tropical Geometry-Based Interpretable Machine Learning Method: Pilot Application to Delivery of Advanced Heart Failure Therapies

Yao

Derksen

Golbus

et al. 2023

IEEE J. Biomed. Health Inform.

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A model's interpretability is essential to many practical applications such as clinical decision support systems. In this article, a novel interpretable machine learning method is presented, which can model the relationship between input variables and responses in humanly understandable rules. The method is built by applying tropical geometry to fuzzy inference systems, wherein variable encoding functions and salient rules can be discovered by supervised learning. Experiments using synthetic datasets were conducted to demonstrate the performance and capacity of the proposed algorithm in classification and rule discovery. Furthermore, we present a pilot application in identifying heart failure patients that are eligible for advanced therapies as proof of principle. From our results on this particular application, the proposed network achieves the highest F1 score. The network is capable of learning rules that can be interpreted and used by clinical providers. In addition, existing fuzzy domain knowledge can be easily transferred into the network and facilitate model training. In our application, with the existing knowledge, the F1 score

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Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance

Cited by 15 publications

References 14 publications

Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study

Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study

Caregiver Health‐Related Quality of Life, Burden, and Patient Outcomes in Ambulatory Advanced Heart Failure: A Report From REVIVAL

A Novel Tropical Geometry-Based Interpretable Machine Learning Method: Pilot Application to Delivery of Advanced Heart Failure Therapies

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