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Randomized Controlled Trial
. 2023 Mar 1;8(3):213-221.
doi: 10.1001/jamacardio.2022.5320.

Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial

Margaret Infeld  1 , Kramer Wahlberg  1 , Jillian Cicero  1 , Timothy B Plante  1 , Sean Meagher  2 , Alexandra Novelli  1 , Nicole Habel  1 , Anand Muthu Krishnan  1 , Daniel N Silverman  3 , Martin M LeWinter  1 , Daniel L Lustgarten  1 , Markus Meyer  1   4
Affiliations
Randomized Controlled Trial

Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial

Margaret Infeld et al. JAMA Cardiol. .

Abstract

Importance: Patients with heart failure with preserved ejection fraction (HFpEF) with a pacemaker may benefit from a higher, more physiologic backup heart rate than the nominal 60 beats per minute (bpm) setting.

Objective: To assess the effects of a moderately accelerated personalized backup heart rate compared with 60 bpm (usual care) in patients with preexisting pacemaker systems that limit pacemaker-mediated dyssynchrony.

Design, setting, and participants: This blinded randomized clinical trial enrolled patients with stage B and C HFpEF from the University of Vermont Medical Center pacemaker clinic between June 2019 and November 2020. Analysis was modified intention to treat.

Interventions: Participants were randomly assigned to personalized accelerated pacing or usual care and were followed up for 1 year. The personalized accelerated pacing heart rate was calculated using a resting heart rate algorithm based on height and modified by ejection fraction.

Main outcomes and measures: The primary outcome was the serial change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. Secondary end points were changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, pacemaker-detected physical activity, atrial fibrillation from baseline, and adverse clinical events.

Results: Overall, 107 participants were randomly assigned to the personalized accelerated pacing (n = 50) or usual care (n = 57) groups. The median (IQR) age was 75 (69-81) years, and 48 (48%) were female. Over 1-year follow-up, the median (IQR) pacemaker-detected heart rate was 75 (75-80) bpm in the personalized accelerated pacing arm and 65 (63-68) bpm in usual care. MLHFQ scores improved in the personalized accelerated pacing group (median [IQR] baseline MLHFQ score, 26 [8-45]; at 1 month, 15 [2-25]; at 1 year, 9 [4-21]; P < .001) and worsened with usual care (median [IQR] baseline MLHFQ score, 19 [6-42]; at 1 month, 23 [5-39]; at 1 year, 27 [7-52]; P = .03). In addition, personalized accelerated pacing led to improved changes in NT-proBNP levels (mean [SD] decrease of 109 [498] pg/dL vs increase of 128 [537] pg/dL with usual care; P = .02), activity levels (mean [SD], +47 [67] minutes per day vs -22 [35] minutes per day with usual care; P < .001), and device-detected atrial fibrillation (27% relative risk reduction compared with usual care; P = .04) over 1-year of follow-up. Adverse clinical events occurred in 4 patients in the personalized accelerated pacing group and 11 patients in usual care.

Conclusions and relevance: In this study, among patients with HFpEF and pacemakers, treatment with a moderately accelerated, personalized pacing rate was safe and improved quality of life, NT-proBNP levels, physical activity, and atrial fibrillation compared with the usual 60 bpm setting.

Trial registration: ClinicalTrials.gov Identifier: NCT04721314.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Infeld reported grants from the Cardiovascular Research Institute of Vermont and Heart Rhythm Society Research Award during the conduct of the study. Dr Habel reported grants from Medtronic to the University of Vermont Medical Center. Dr LeWinter reported grants from Medtronic during the conduct of the study. Dr Lustgarten reported personal fees from Medtronic during the conduct of the study. Dr Meyer reported grants from the University of Minnesota and the National Institutes of Health during the conduct of the study and had a patent for pacemakers for HFpEF licensed to Medtronic. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram of myPACE Study Participants Leading to the Analyzed Population
MLHFQ indicates Minnesota Living with Heart Failure Questionnaire. aReasons for patient exclusion are detailed in eMethods in Supplement 2. bSixteen patients with lower rates >60 beats per minute were enrolled as an exploratory cohort and are not included in this analysis, as detailed in Supplement 1.
Figure 2.
Figure 2.. The Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Quality-of-Life Scores, N-Terminal Pro–Brain Natriuretic Peptide (NT-proBNP), and Pacemaker-Detected Physical Activity Levels Between Groups
A, Between-group difference in the change in MLHFQ scores from baseline to 1-month to 1-year follow-up between personalized accelerated pacing and usual care groups (P < .001). Change in scores from baseline are shown as mean (SE). B, Relative percent change in NT-proBNP from baseline to 1-month follow-up between groups (P = .02). The data are presented as mean (SE). C, Between-group difference in the change in pacemaker-detected physical activity level (by accelerometer) from baseline to 6-month and 1-year follow-up (P < .001). The data are presented as mean (SE).
Figure 3.
Figure 3.. Relative Distribution of Pacemaker-Detected Atrial Fibrillation (AF) Burden at Baseline, 6-Month, and 1-Year Follow-up With Personalized Accelerated Pacing and Usual Care
In the personalized accelerated pacing group, AF was detected in 31% of patients at baseline and 18% at 1-year follow-up, whereas the proportion of patients with AF did not change with usual care.
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