A loss in treatment effect and reduction in heart failure (HF)–related events were reported during the COVID-19 pandemic, with patient-dependent factors possibly playing a key role in these outcomes. These results were published in the European Heart Journal.
The randomized controlled Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF) trial (ClinicalTrials.gov identifier: NCT03387813) was conducted between March 15, 2018, and December 20, 2019. A randomized arm of the GUIDE-HF study explored HF management guided by pulmonary artery (PA) pressures that were obtained remotely via an implanted sensor. Recognizing that sparse data have addressed the potential causes for changes in HF event rates during the COVID-19 pandemic, the investigators sought to examine several possibilities. GUIDE-HF tested the theory that hemodynamically guided management of patients with chronic HF is associated with improvements in outcomes among those with New York Heart Association class II to IV HF with elevated brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-pro-BNP) levels or a prior hospitalization for HF.
After the successful implantation of a PA pressure sensor, all patients were randomly assigned in a 1:1 ratio to 1 of 2 groups: the treatment group, in which management of the participants was based on PA pressure information derived from a remote monitor; and the control group, in which the management of participants was based on usual clinical care (eg, signs, symptoms, weight) with no knowledge of PA pressure information. The primary study endpoint was all-cause mortality plus HF events.
Prior to the COVID-19 pandemic, the primary endpoint rate in the treatment vs the control arm was 0.553 vs 0.682 events per patient-year, respectively (hazard ratio [HR], 0.81; 95% CI, 0.66-1.00; P =.049). During the COVID-19 pandemic, however, this treatment effect was no longer evident, with no change in the treatment group and a 21% decrease reported in the control group (0.597 vs 0.536 events per patient-year, respectively; HR, 1.11; 95% CI, 0.80-1.55; P =.526).
The researchers evaluated data reflective of provider-, disease-, and patient-dependent factors that might be responsible for the change in the primary endpoint rate during COVID-19. Participant contact frequency was similar in the treatment and the control arms both prior to and during the COVID-19 pandemic. Further, during COVID-19, the monthly rate of changes in medication declined 19.2% in the treatment arm vs 10.7% in the control arm, with the levels not differing significantly between the groups (P =.362).
PA pressure area under the curve decreased by -98 mm Hg-days in the treatment arm compared with -100 mm Hg-days in the control arm (P =.867). During COVID-19, patient compliance with the study protocol was maintained in both of the study groups.
Limitations of the study include the fact that GUIDE-HF was designed and initiated well before the beginning of the COVID-19 pandemic. Therefore, the data points that were measured were not intended to comprehensively and specifically answer the following question: Why did HF event rates change during the COVID-19 pandemic?
The investigators wrote, “Patient behavior 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.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Zile MR, Desai AS, Costanzo MR, et al. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. Published online March 10, 2022. doi:10.1093/eurheartj/ehac114