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Randomized Controlled Trial
. 2025 Jun;18(6):e012754.
doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.

Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure

Michael R Zile  1 , William T Abraham  2 , Lynne W Stevenson  3 , Maria Rosa Costanzo  4 , Christiane E Angermann  5 , Mandeep R Mehra  6 , Akshay S Desai  6 , Anique Ducharme  7 , Nessa Johnson  8 , John Henderson  8 , JoAnn Lindenfeld  3
Affiliations
Randomized Controlled Trial

Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure

Michael R Zile et al. Circ Heart Fail. 2025 Jun.

Abstract

Background: Hemodynamically guided management of patients with chronic heart failure (HF), using a remote, ambulatory pulmonary artery (PA) pressure monitor, has been shown to reduce mortality and morbidity. These improved outcomes were associated with a reduction in PA pressure. However, several pivotal questions remain unanswered: do systolic, diastolic, or mean PA pressures each predict all-cause mortality? Do PA pressures predict mortality across the ejection fraction (EF) spectrum? Do increases or decreases in PA pressure over time predict increases or decreases in mortality?

Methods: Retrospective analyses of data from CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients; n=550), GUIDE-HF (Hemodynamic-GUIDEed management of Heart Failure; n=2358), US PAS (CardioMEMS HF System Post Approval Study; n=1200), and MEMS-HF (CardioMEMS Monitoring Study for Heart Failure; n=234) were performed, including all enrolled patients regardless of treatment assignments (Total N=4342). PA systolic, PA diastolic, and PA mean pressures were examined in patients with HF and reduced EF (<50%, n=2562) and preserved EF (≥50%, n=1454). Baseline pressure (averaged over 14 days after implantation) and change in pressure (increase/decrease/no change) from baseline to 6 months (averaged over 14 days just before the 6-month time point) were related to all-cause mortality over a 2-year follow-up period.

Results: Baseline PA diastolic, independent of other covariates, was a significant predictor of mortality (hazard ratio, 1.04 [95% CI, 1.03-1.05]; P<0.0001). Change in PA diastolic from baseline to 6 months (assessed as a continuous variable) was an independent predictor of mortality after 6 months (landmark analysis; hazard ratio, 1.03 [95% CI, 1.01-1.05]; P=0.0042). Change in PA diastolic from baseline to 6 months(assessed as a categorical variable) decrease or increase of >2 mm Hg compared with no change predicted a 14.7% decrease and 26.7% increase in mortality, respectively (P=0.0237). PA systolic and PA mean pressures in both HF with reduced EF and HF with preserved EF patients, for both baseline and change from baseline to 6 months, were also predictive of all-cause mortality.

Conclusions: Baseline PAP (systolic, diastolic, and mean) and change in PAP (systolic, diastolic, and mean) from baseline to 6 months were independent predictors of 2-year mortality in patients with chronic HF in both preserved and reduced EF.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: CHAMPION, NCT00531661; GUIDE-HF, NCT03387813; USPAS, NCT02279888; MEMS-HF, NCT02693691.

Keywords: heart failure; humans; morbidity; pulmonary artery; stroke volume.

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Conflict of interest statement

Dr Zile is a consultant for Eli Lily, Medtronic, and Novartis. Dr Abraham is a consultant for Abbott Vascular, AquaPass, CVRx, Impulse Dynamics, Medtronic, Sensible Medical Innovations, V-Wave, and Zoll Respicardia. Dr Stevenson is a consultant for Abbott Laboratories and Endotronix. Dr Costanzo is a consultant for Abbott Laboratories, is employed by Midwest Cardiovascular Institute, and is on the board of directors for Nuwelis. Dr Angermann is a consultant for Abbott Fund, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and Vifor Pharma. Dr Mehra is a consultant for Abbott Laboratories, Broadview Ventures, Cadrenal, FIRE-1, Natera, Paragonix, and Second Heart Assist, has stock options in FineHeart, Leviticus, NupulseCV, and Transmedics, and is on the end-point review committee for Moderna. Dr Desai is a consultant for Abbott Pharmaceuticals, Alnylam Pharmaceuticals, AstraZeneca, Avidity Biopharma, Axon Therapies, Biofourmis, Boston Scientific, CVS Caremark, DTX Plus, Endotronix, GlaxoSmithKline, iRhythm Tehnologies, Medpace, Medtronic, Merck, New Amsterdam, Novartis, Parexel, Regeneron Pharmaceuticals, Relypsa, River2Renal, Roche Diagnostics, SCPharma, Verily, Veristat, and Zydus Pharmaceuticals and is on the end-point review committee for Baim Institute for Clinical Research and Stanford Center for Clinical Research. Dr Ducharme is a consultant for Abbott, AstraZeneca, and Novo Nordisk. Dr Johnson is employed by Abbott Laboratories. J. Lindefeld is a consultant for Abbott, AstraZeneca, Boehringer Ingelheim, CVRx, Edwards Lifesciences, and V-Wave. J. Henderson has nothing to disclose.

Figures

Figure 1.
Figure 1.
Kaplan-Meier survival: effects of baseline pulmonary artery (PA) pressure on subsequent mortality in all enrolled patients (all ejection fractions). Kaplan-Maier survival curves describing the effects of baseline PA pressure on all-cause mortality over 2 years of follow-up for all enrolled patients, all ejection fractions. Survival was examined using baseline PA diastolic, systolic, and mean pressure divided into patients greater than or equal to the median pressure (red) or less than the median pressure (blue). Differences in each case are statistically significant with log rank scores.
Figure 2.
Figure 2.
Effects of baseline pulmonary artery (PA) pressure on subsequent mortality in all enrolled patients (all ejection fractions). Spline analysis examining the probability of all-cause death at 2 years after CardioMems implant predicted by baseline PA pressure for all enrolled patients, all ejection fractions. Survival was examined using baseline PA diastolic, systolic, and mean pressure. The relationship of baseline PA pressure and mortality was modeled using Cox regression with baseline PA pressure as the single covariate with a natural cubic spline effect and 8 degrees of freedom to allow for nonlinearity. Across physiological ranges of PA pressure, there was nearly a linear relationship between PA pressure and all-cause mortality.
Figure 3.
Figure 3.
Kaplan-Meier survival: effects of baseline pulmonary artery (PA) pressure on subsequent mortality. Kaplan-Maier survival curves describing the effects of baseline PA pressure on all-cause mortality over 2 years of follow-up divided into 2 groups: ejection fraction (EF) ≥50% and EF <50%. Survival was examined in heart failure with a preserved EF (HFpEF; top 3 curves) and heart failure with a reduced EF (HFrEF; bottom 3 curves) using baseline PA diastolic, systolic, and mean pressure divided into patients greater than or equal to the median pressure (red) or less than the median pressure (blue). Differences in each case are statistically significant with log rank scores.
Figure 4.
Figure 4.
Effects of baseline pulmonary artery (PA) pressure on subsequent mortality. Spline analysis examining the probability of all-cause death at 2 years after CardioMems implant predicted by baseline PA pressure divided into 2 groups ejection fraction (EF) ≥50% and EF <50%. Survival was examined in heart failure with a preserved ejection fraction (HFpEF; top 3 curves) and heart failure with a reduced ejection fraction (HFrEF; bottom 3 curves) using baseline PA diastolic, systolic, and mean pressure. The relationship of baseline PA pressure and mortality was modeled using Cox regression with baseline PA pressure as the single covariate with a natural cubic spline effect and 8 degrees of freedom to allow for nonlinearity. Across physiological ranges of PA pressure, there was nearly a linear relationship between PA pressure and all-cause mortality. Because of the small difference in the range of PA systolic pressures between patients with HFpEF and HFrEF, there are slight differences in the vertical axis of the middle 2 panels.
Figure 5.
Figure 5.
Kaplan-Meier survival stratified by baseline and 6-month pulmonary artery (PA) diastolic pressure compared with baseline median. Kaplan-Meier survival curves were created that stratified the change from baseline to 6 months into 4 categories. Patients with baseline pressures below the median and 6-month pressure that remained below the median had the highest survival probability; baseline below the median but 6-month pressure rose above the median had an intermediate survival probability; baseline above the median, 6-month pressure fell below the median had an intermediate survival probability; baseline above the median that remained above the median at 6 months had the lowest survival probability.
Figure 6.
Figure 6.
Effects of change from baseline pulmonary artery (PA) pressure on subsequent mortality. Using a Cox regression analysis the effects of an increase of 1 mm Hg PA pressure from baseline to 6 months after CardioMEMS implant on subsequent mortality risk using PA systolic, diastolic, and mean pressure in patients with heart failure with a reduced ejection fraction (HFrEF) vs heart failure with a preserved ejection fraction (HFpEF) was examined. In the continuous analysis method, estimates from Cox multivariable model were made with the inclusion of covariates for change in pressure at 6 months (continuous or categorical), baseline pressure, study, and relevant baseline characteristics.
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