The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: Impact of the COVID-19 pandemic

Michael R. Zile, Division of Cardiology, Department of Medicine, RJH Department of Veterans Affairs Medical Center, Medical University of South Carolina, SC, USA.
Akshay S. Desai, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
Maria Rosa Costanzo, Advocate Aurora HealthFollow
Anique Ducharme, Montreal Heart Institute, Université de Montréal, Montreal, QC, Canada.
Alan Maisel, University of California San Diego, La Jolla, CA, USA.
Mandeep R. Mehra, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.
Sara Paul, Catawba Valley Health System, Conover, NC, USA.
Samuel F. Sears, East Carolina University, Greenville, NC, USA.
Frank Smart, School of Medicine, Louisiana State University, New Orleans, LA, USA.
Christopher Chien, Division of Cardiology, University of North Carolina, Chapel Hill, NC, USA.
Ashrith Guha, Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.
Jason L. Guichard, Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, SC, USA.
Shelley Hall, Baylor University Medical Center, Dallas, TX, USA.
Orvar Jonsson, Sanford Health, Sioux Falls, SD, USA.
Nessa Johnson, Abbott, Abbott Park, IL, USA.
Poornima Sood, Abbott, Abbott Park, IL, USA.
John Henderson, Abbott, Abbott Park, IL, USA.
Philip B. Adamson, Abbott, Abbott Park, IL, USA.Follow
JoAnn Lindenfeld, Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.

Affiliations

Advocate Heart Institute

Abstract

Aims: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study.

Methods and results: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups.

Conclusion: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.

Key questions: What factors explain the loss of treatment effect and reduction in heart failure events during COVID-19?

Key findings: The treatment effect change was not due to COVID-19-related events. Patient management was sustained but not intensified during COVID-19. Patient status improved during COVID-19 and pulmonary artery pressure reduced in both groups.

Take home message: Patient behaviour probably improved during COVID-19, given that patient status and pulmonary artery pressure improved during COVID-19 despite fewer medication changes and without increased contact from providers.

Document Type

Article

PubMed ID

35266003

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