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

Abstract

ImportancePatients 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsParticipants 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 MeasuresThe 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.ResultsOverall, 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT04721314

Rate-Adaptive Pacing for Heart Failure With Preserved Ejection Fraction

“…The current report demonstrates how a moderately sized but well-executed trial can provide definitive results that disprove conventional paradigms and should prompt reconsideration of current clinical management guidelines. There are other ongoing pacing trials in HFpEF (NCT04546555; NCT03338374), and a recent trial suggested benefit from a higher backup pacing rate among patients with subclinical or overt HFpEF who already had pacemaker implantation for other indications . However, a recent meta-analysis of pacing for heart failure supports the results of the presently reported trial, furthering the case for abandoning rate-adaptive pacing for most patients with HFpEF, despite their chronotropic incompetence.…”

Comments on the myPACE Randomized Clinical Trial—Reply

“…In Reply We thank Camilli and colleagues for their interest in the myPACE trial . We agree that the reduction in atrial fibrillation (AF) with moderately accelerated pacing in patients with heart failure with preserved ejection fraction (HFpEF) requires further study and confirmation.…”

Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction

“…In contrast, the recently published myPACE study randomized 107 patients with HFpEF (ejection fraction >50%) and an existing pacemaker to a nominal lower rate or a personalized lower rate . Patients were not required to have chronotropic incompetence or to be programmed with rate-adaptive atrial pacing.…”