Remote Hemodynamic Monitoring of Pulmonary Artery Pressures in Patients With Chronic Heart Failure - MONITOR-HF

Aug 26, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.
Date Published:
05/11/2024
Date Updated:
08/26/2024
Original Posted Date:
07/18/2023
References

Contribution To Literature:

Highlighted text has been updated as of August 26, 2024.

The MONITOR-HF trial demonstrated improved overall quality of life and reduction in HF hospitalization in HF patients undergoing remote invasive hemodynamic monitoring with the CardioMEMS-HF system versus standard of care in a European health system cohort.

Description:

The goal of the trial was to compare the therapeutic effect(s) and safety profile of remote invasive hemodynamic monitoring with the CardioMEMS-HF system versus standard of care in New York Heart Association (NYHA) functional class III heart failure (HF) irrespective of left ventricular ejection fraction (LVEF).

Study Design

  • Randomized
  • Open-label
  • Multicenter

Patients diagnosed with chronic HF (≥3 months) per European Society of Cardiology (ESC) definitions, NYHA functional class III symptoms, and ≥1 HF hospitalization or urgent health care visit requiring intravenous (IV) diuretics were randomized to undergo CardioMEMS-HF implantation (n = 176) or standard of care alone (n = 172). Control patients did not undergo a sham procedure. Although both groups had identical scheduled follow-up to at least 12 months, providers were able to adjust diuretic and vasodilator therapy in the CardioMEMS-HF group based on changes in mean pulmonary artery pressure (mPAP) readings.

  • Total number of enrollees: 348
  • Duration of follow-up: 48 months
  • Median patient age: 69 years
  • Percentage female: 24.4%

Inclusion criteria:

  • Age ≥18 years
  • Chronic HF irrespective of LVEF
  • NYHA functional class III symptoms
  • ≥1 HF hospitalization or urgent health care visit requiring IV diuresis
  • If HF with reduced EF (HFrEF), must receive maximally tolerated guideline-directed medical therapy (GDMT) and evaluation for implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) if applicable
  • Body mass index ≤35 kg/m2 or axillary chest circumference <65 inches

Exclusion criteria:

  • Active infection
  • History of recurrent (>1) venous thromboembolism
  • Major cardiovascular (CV) event (myocardial infarction [MI], cardiac surgery, stroke) <2 months prior to enrollment
  • CRT implantation <3 months prior to enrollment
  • Glomerular filtration rate <25 mL/min despite diuretic therapy or on dialysis
  • Complex congenital heart disease
  • Presence of mechanical valve prosthesis
  • Pulmonary hypertension (World Health Organization groups 1, 4, or 5)
  • Scheduled or potential heart transplant or ventricular assist device implantation within next 6 months
  • Coagulopathy or inability to take aspirin or clopidogrel

Other salient features/characteristics:

  • Percentage with ischemic cardiomyopathy: 50%
  • Percentage with LVEF ≥40%: 27.9%
  • Median N-terminal pro-B-type natriuretic peptide (NT-proBNP) for CardioMEMS-HF vs. control: 2,377 and 1,905 pg/mL
  • Mean baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score for CardioMEMS-HF vs. control: 55.8 vs. 54.9
  •  Angiotensin-receptor neprilysin inhibitor (ARNI) use: 46.6%
  • Sodium-glucose co-transporter 2 (SGLT2) inhibitor use: 9.5%

Principal Findings:

The primary outcome, mean change in KCCQ overall summary score at 12 months for CardioMEMS-HF vs. standard of care, was +7.05 (95% confidence interval [CI] 2.77 to 11.33) vs. -0.08 (95% CI -3.76 to 3.60); p = 0.013.

Secondary outcomes for CardioMEMS-HF vs. standard of care:

  • ≥5-point improvement in KCCQ score at 12 months: 47.7% vs. 38.1% (p = 0.046)
  • Total HF hospitalizations or urgent visits requiring IV diuresis, events per patient-year: 117 vs. 212 (hazard ratio [HR] 0.56, 95% CI 0.38-0.84, p = 0.0053).
  • CV death, events per patient-year: 25 vs. 31 (HR 0.83, 95% CI 0.49-1.39, p = 0.485)
  • All-cause death, events per patient-year: 42 vs. 45 (HR 0.96, 95% CI 0.63-1.46, p = 0.846)
  • Change in median NT-proBNP at 12 months: -669 (p = 0.013) vs. -300 pg/mL (p = 0.81)
  • Change in mean 6-minute walk test distance at 12 months from baseline: +29.3 (p = 0.033) vs. +9.8 m (p = 0.52)

Other outcomes of interest:

Prespecified subgroup analyses of the primary outcome, adjusted for multiple comparisons:

  • Age: p for interaction = 0.33
  • LVEF: p for interaction = 1.00
  • Diabetes: p for interaction = 0.06
  • Mean baseline vs. 12-month mPAP, CardioMEMS-HF group: 33.3 vs. 24.9 mm Hg (p < 0.0001)
  • Frequency of daily CardioMEMS-HF uploads: 84.3%
  • Freedom from device- or safety-related complications, CardioMEMS-HF group: 97.7%
  • Freedom from sensor failure, CardioMEMS-HF group: 98.8%

Interpretation:

The MONITOR-HF trial is the first study to demonstrate improved quality of life and functional status associated with remote invasive hemodynamic monitoring using the CardioMEMS-HF system in HF irrespective of LVEF. The CardioMEMS-HF group also experienced fewer HF hospitalizations, an association previously observed in both the CHAMPION and the pre-COVID-19 analysis of the GUIDE-HF trials. As the overall GUIDE-HF analysis yielded a neutral result, current American HF guidelines assign remote invasive hemodynamic monitoring a Class 2b recommendation. The current findings provide clinical- and patient-centered outcomes data to support the utility of the CardioMEMS-HF system in the management of class III HF, even in the setting of high rates of optimal GDMT for HFrEF. No significant interactions with prespecified subgroups, including LVEF, were observed on multiplicity-adjusted analyses of the primary outcome or with respect to HF hospitalization rates.

Furthermore, these are the first data studying the device in a European health care system. As remote monitoring requires sustainable infrastructure to coordinate patient care outside the immediate clinic setting, additional data across different health care delivery and payer systems provide important information. Unlike CHAMPION and GUIDE-HF, this was an open-label study with no sham implantation in control patients. However, the positive results observed in both HF hospitalization and objective markers of congestion such as NT-proBNP and mPAP reduce the likelihood of a clinically significant placebo effect in the treatment arm.

References:

Clephas PR, Zwartkruis VW, Malgie J, et al. Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial. Eur Heart J 2024;45:2954-64.

Brugts JJ, Radhoe SP, Clephas PR, et al., on behalf of the MONITOR-HF Investigators. Remote hemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomized clinical trial. Lancet 2023;401:2113-23.

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure

Keywords: Cardiac Resynchronization Therapy, Defibrillators, Implantable, Heart Failure, Hemodynamic Monitoring, Quality of Life


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