“…This study was a prospective, blinded, parallel-group, randomized clinical trial conducted at the University of Vermont Medical Center. The myPACE heart rate algorithm and study rationale have previously been published, and the trial protocol is detailed in Supplement 1. We consecutively screened adult patients scheduled at the University of Vermont Medical Center pacemaker clinic.…”
Section: Methodsmentioning
confidence: 99%
“…The myPACE algorithm, study flow, and follow-up schedule are provided in section 5.1.4 of Supplement 1. The personalized accelerated heart rate algorithm for myPACE is derived from the averaged resting heart rates of healthy adults according to height and modified by ejection fraction. Enrolled participants completed baseline assessments and were then randomized 1:1 to either a personalized backup heart rate setting (myPACE) or left at the nominal 60 beats per minute (bpm) setting (usual care) for 1 year.…”
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
“…This study was a prospective, blinded, parallel-group, randomized clinical trial conducted at the University of Vermont Medical Center. The myPACE heart rate algorithm and study rationale have previously been published, and the trial protocol is detailed in Supplement 1. We consecutively screened adult patients scheduled at the University of Vermont Medical Center pacemaker clinic.…”
Section: Methodsmentioning
confidence: 99%
“…The myPACE algorithm, study flow, and follow-up schedule are provided in section 5.1.4 of Supplement 1. The personalized accelerated heart rate algorithm for myPACE is derived from the averaged resting heart rates of healthy adults according to height and modified by ejection fraction. Enrolled participants completed baseline assessments and were then randomized 1:1 to either a personalized backup heart rate setting (myPACE) or left at the nominal 60 beats per minute (bpm) setting (usual care) for 1 year.…”
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
“…The HR was significantly lower in normal W 97.4 bpm compared to overweight 100.5 bpm and obese patients 106.7 bpm. Infeld et al [10] reported a H-HR relationship on 4795 individuals using linear regression and obtained the linear formula: HR re−0.22 × H ig114 demonstrating a 0.22 bpm reduction in the HR for every 1 centimeter increase in H. In univariate analysis only BMI was a positive predictor of HR whereas W was not a predictor. We also found in our study a significant correlation between H and high rate: R an0.125; P .1.0001 with a linear formula: HR 00−0.11 × H ig101 showing a 0.11 bpm reduction in HR for every 1 cm increase in H.…”
Previous research established age-related normal limits for children's heart rates (HRs). However, children of the same age can have significantly different HRs, depending on whether they are overweight or underweight, tall or short. Studies on children HR have failed to find a clear correlation between HR and body size. The goal of our study was to create Z scores for HR based on weight (W), height (H), body mass index (BMI), and body surface area (BSA) and compare them to normal age-related HR limits. Electrocardiograms were recorded from a total of 22,460 healthy children ranging in age from 6 to 18 years old using BTL machines. A comparison was made between different age groups, in function of W, H, BMI, and BSA, based on the HR that was automatically detected by using the digitally stored electrocardiogram. Z scores were computed for each of the categories that were mentioned. Incremental Z score values between −2.5 and 2.5 were calculated to establish upper and lower limits of HR. The BSA's estimation of HR is the most accurate of the available methods and can be utilized with accuracy in clinical practice. Z scores for HR in children differ in function of the age, W, H, BMI and BSA. The best estimation is based on BSA. The novelty of our study is that we developed Z scores for HR in relation to body size, age and sex, producing a standardized, consistent, and reproducible result without requiring practitioners to learn and remember cutoff values for a wide range of variables across age groups and sexes. Z scores minimize observer and institutional bias, hence generating uniform and reproducible standards.
“…For my PACE, we developed a personalized HR algorithm based on physiological resting HRs in healthy individuals to provide a customized lower rate setting for pacemaker patients. The rationale and validation of the underlying height–HR relationship have been previously described, 26 and additional details about the HR algorithm are available in the Supplemental Appendix . The my PACE personalized HR algorithm ( Figure 2 ) is as follows: Figure 2 Personalized heart rate (HR) algorithm in my PACE.…”
Section: Methods and Analysismentioning
confidence: 99%
“…The pacemaker backup rate typically is left at or near the factory setting of 60 bpm. 23 This one-size-fits-all approach does not consider that the average adult resting HR is between 71 and 79 bpm 26 or that 60 bpm may not be the optimal resting HR for pacemaker-reliant patients with isolated DD or HFpEF. The primary aim of my PACE is to evaluate the effects of a higher, individualized pacemaker backup rate in patients with isolated DD or HFpEF on changes in symptoms and QoL compared with the standard rate of 60 bpm.…”
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