Safety and Feasibility of a Nocturnal Heart Rate Elevation—Exploration of a Novel Treatment Concept

Yeshwant, Srinath C.; Zile, Michael R.; Lewis, Michael R.; LeWinter, Martin M.; Meyer, Markus

doi:10.1016/j.cardfail.2018.06.009

Cited by 12 publications

(12 citation statements)

References 8 publications

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“…In acute hemodynamic studies, stroke volumes were reduced in patients with HFpEF at atrial pacing rates of 120 bpm but not at 80 bpm, suggesting that there may be a therapeutic window that optimizes filling pressures and lusitropic effects without compromising cardiac output . Like in our prior hemodynamic and clinical pilot studies, moderately accelerated pacing did not appear to be associated with untoward effects.…”

Section: Discussionsupporting

confidence: 54%

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

et al. 2023

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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 &lt; .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 &lt; .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

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Section: Discussionsupporting

confidence: 54%

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

et al. 2023

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“…Neither pilot study raised safety concerns such as tachycardia-mediated cardiomyopathy. 18,19 myPACE is the first randomized, blinded trial to assess median term effects of pacing-mediated moderate HR acceleration on QoL, natriuretic peptide levels, and clinical outcomes. The algorithm utilized in myPACE provides study participants with an individualized HR that is determined by height and modified by baseline EF.…”

Section: Discussionmentioning

confidence: 99%

“…Additional studies suggest that modest increases in HR using pacemakers may benefit patients with HFpEF or isolated DD ( Supplemental Table 2 ). Pacing studies in a porcine model of hypertensive heart disease, 17 clinical hemodynamic assessments in patients with HFpEF, 14 , 15 and 2 exploratory studies in patients with pacemakers and isolated DD or HFpEF 18 , 19 collectively suggest a benefit of moderately elevated HRs in concentric LV hypertrophy, isolated DD, or HFpEF. Neither pilot study raised safety concerns, such as tachycardia-mediated cardiomyopathy.…”

Section: Discussionmentioning

confidence: 99%

“…This may not be directly harmful, however, as HR variability -like low resting HR -has been shown to be a marker rather than a conveyor of good health. 42 Furthermore, based on prior data 17,18,19 the proposed pacing rates in this study are unlikely to induce clinically relevant eccentric remodeling and tachycardia-mediated cardiomyopathy, however, this is an important safety endpoint that we will track. Based on the studies in our pre-clinical model we expect that the increase in LV end-diastolic volume will remain below 10%.…”

Section: Potential Hazards Of Pacingmentioning

confidence: 92%

“…In the first study, we raised the backup pacing rate to 100 bpm at night for 4 weeks. 18 In the second study, we set the lower rate to 80 bpm for 4 weeks. 19 The moderate HR elevation significantly improved quality of life (QoL), functional capacity, and N-terminal pro–brain natriuretic peptide (NT-proBNP) levels among patients with paced QRS durations <150 ms.…”

Section: Introductionmentioning

confidence: 99%

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Personalized pacing for diastolic dysfunction and heart failure with preserved ejection fraction: Design and rationale for the myPACE randomized controlled trial

et al. 2022

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Anti-bradycardia pacing—impact on patients with HFpEF: a systematic review

Ababei,

Hrib,

Iancu

et al. 2024

Heart Fail Rev

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Heart failure with preserved ejection fraction (HFpEF) has become an emerging concern. The protective effect of bradycardia in patients with reduced ejection fraction using beta-blockers or ivabradine does not improve symptoms in HFpEF. This review aims to assess current data regarding the impact of anti-bradycardia pacing in patients with HFpEF. A search was conducted on PubMed, ScienceDirect, Springer, and Wiley Online Library, selecting studies from 2013 to 2023. Relevant and eligible prospective studies and randomized controlled trials were included. Functional status, quality of life, and echocardiographic parameters were assessed. Six studies conformed to the selection criteria. Four were prospective studies with a total of 90 patients analyzed. Two were randomized controlled trials with a total of 129 patients assessed. The 6-min walk test (6MWT) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score improved in all prospective studies. My-PACE trial showed improvements in MLHFQ score (p < 0.001), significant relative lowering in NT-proBNP levels (p = 0.02), and an increased mean daily activity in the personalized accelerated pacing group compared to usual care. RAPID-HF trial proved that pacemaker implantation to enhance exercise heart rate (HR) did not improve exercise capacity and was associated with increased adverse events. HFpEF requires a more individualized approach and quality of life management. This review demonstrates that higher resting HR by atrial pacing may improve symptoms and even outcomes in HFpEF, while a higher adaptive rate during exertion has not been proven beneficial. Graphical Abstract

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Safety and Feasibility of a Nocturnal Heart Rate Elevation—Exploration of a Novel Treatment Concept

Cited by 12 publications

References 8 publications

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

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

Personalized pacing for diastolic dysfunction and heart failure with preserved ejection fraction: Design and rationale for the myPACE randomized controlled trial

Anti-bradycardia pacing—impact on patients with HFpEF: a systematic review

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