Haemodynamic-GUIDEed management of Heart Failure - GUIDE-HF

Dec 23, 2022
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott
Date Presented:
11/06/2021
Date Published:
10/12/2022
Date Updated:
12/23/2022
Original Posted Date:
08/27/2021
References

Contribution To Literature:

Highlighted text has been updated as of December 23, 2022.

The GUIDE-HF trial showed that there is no difference in CV outcomes among stable outpatients with chronic HF when comparing hemodynamic-guided management (monitored by CardioMEMS HF system) to usual care.

Description:

The goal of the trial was to assess the safety and efficacy of management based on pulmonary artery (PA) pressures measured by the CardioMEMS heart failure (HF) system compared with usual care.

Study Design

All patients had a CardioMEMS monitor implanted. Patients were then randomized in a single-blind 1:1 fashion to either hemodynamic monitoring and titration based on PA pressures (n = 497) or standard of care HF management (n = 503).

  • Total screened: 1,484
  • Total number of enrollees: 1,000
  • Duration of follow-up: 12 months
  • Mean patient age: 71 years
  • Percentage female: 38%

Inclusion criteria:

  • New York Heart Association (NYHA) class II-IV HF patients
  • Elevated N-terminal pro–B-type natriuretic peptide (NT-proBNP) or BNP, and/or prior HF hospitalization

Exclusion criteria:

  • Patients likely to receive a heart transplant or left ventricular assist device in the next 12 months
  • Patients with stage D HF
  • Those who required inotropes within the past 6 months 

Other salient features/characteristics:

  • NYHA class III: 65%
  • Atrial fibrillation/flutter: 59%
  • Baseline PA pressures: 45/22 mm Hg
  • Left ventricular ejection fraction (LVEF): 39%
  • Baseline cardiac index: 2.1 L/min/m2

Principal Findings:

The primary endpoint of all-cause mortality, HF hospitalization, or urgent HF visits, for hemodynamic monitoring vs. usual care, was: 0.56 events/person-year (PY) vs. 0.64/PY (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.74-1.05, p = 0.16).

Secondary analyses for hemodynamic monitoring vs. usual care:

  • HF hospitalizations: HR 0.83, 95% CI 0.68-1.01 (p = 0.06)
  • Change in PA pressures from baseline to follow-up: -2.4 vs. -1.7 (p = 0.033)
  • All-cause mortality: 0.09/PY vs. 0.09/PY (p = 0.71)

72% of follow-up and 74% of events occurred prior to the COVID-19 outbreak in March 2020. Pre-COVID-19, the primary endpoint was significantly reduced in favor of CardioMEMS (HR 0.81, 95% CI 0.66-1.00, p = 0.05), including HF hospitalizations (HR 0.72, 95% CI 0.57-0.92, p = 0.007). During COVID-19, these differences were not significant (p for interaction = 0.11). PA pressure transmission compliance was >85% in the CardioMEMS arm.

Outcomes based on EF (using the prespecified COVID-19 analysis): EF <50%: HR for primary endpoint 0.85, 95% CI 0.66-1.09 (p = 0.20), HR for HF hospitalization 0.77, 95% CI 0.59-1.00 (p = 0.051); EF ≥50%: HR for primary endpoint 0.70, 95% CI 0.47-1.03 (p = 0.07), HR for HF hospitalization 0.72, 95% CI 0.48-1.07 (p = 0.11).

Effect of baseline EF (pre–COVID-19 cohort): HF with reduced EF (HFrEF: EF ≤40%; n = 531); HF with moderately reduced EF (HFmEF: EF 41-49%; n = 71); HF with preserved EF (HFpEF: EF ≥50%, n = 398). In this cohort, irrespective of baseline EF, there appeared to be a reduction in the primary endpoint (p for interaction = 0.71) and HF hospitalizations (p for interaction = 0.95) in favor of CardioMEMS.

Interpretation:

The results of this trial indicate that there is no difference in cardiovascular outcomes among stable outpatients with chronic HF when comparing management based on PA pressures (measured by CardioMEMS HF system) to usual care. PA pressures were lower during follow-up in the CardioMEMS arm. The COVID-19 pandemic may have contributed to this overall null finding, as there was a suggestion of benefit irrespective of baseline EF in the cohort enrolled prior to the pandemic but will need to be confirmed in future trials. Findings were similar among patients with HFrEF and HFpEF.

References:

Zile MR, Mehra MR, Ducharme A, et al. Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: The GUIDE-HF Trial. JACC Heart Fail 2022;10:931-44.

Editorial Comment: Abraham J. The Pressure for Progress in Heart Failure. JACC Heart Fail 2022;10:945-7.

Presented by Dr. Joann Lindenfeld at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, Orlando, FL, November 6, 2021.

Lindenfeld J, Zile MR, Desai AS, et al. Hemodynamic-guided management of heart failure (GUIDE-HF): a randomized controlled trial. Lancet 2021;398:991-1001.

Editorial Comment: Cleland JG. To master heart failure, first master congestion. Lancet 2021;398:935-6.

Presented by Dr. Joann Lindenfeld at the European Society of Cardiology Virtual Congress, August 27, 2021.

Clinical Topics: Arrhythmias and Clinical EP, COVID-19 Hub, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: ESC Congress, ESC21, Atrial Fibrillation, COVID-19, Geriatrics, Heart Failure, Hemodynamics, Natriuretic Peptide, Brain, Outpatients, Standard of Care, Stroke Volume, TCT21, Transcatheter Cardiovascular Therapeutics, Ventricular Function, Left


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