TY - JOUR
T1 - Rationale and design of the PACE HFpEF trial
T2 - Physiologic accelerated pacing as a holistic treatment of heart failure with preserved ejection fraction
AU - Habel, Nicole
AU - Infeld, Margaret
AU - Bernknopf, Jacob
AU - Meyer, Markus
AU - Lustgarten, Daniel
N1 - Publisher Copyright:
© 2023 Heart Rhythm Society
PY - 2024/1
Y1 - 2024/1
N2 - Background: In heart failure with preserved ejection fraction (HFpEF), it has been assumed that pharmacologic heart rate suppression should provide clinical benefits through an increase in diastolic filling time. Contrary to this assumption, heart rate lowering in patients with preserved left ventricular ejection fraction and hypertension or coronary artery disease results in adverse outcomes and suggests that the opposite may be beneficial. Namely, shortening the diastolic filling time with a higher heart rate might normalize the elevated filling pressures that are the sine qua non of HFpEF. Initial clinical studies that assessed the effects of accelerated heart rates in pacemaker patients with preclinical and overt HFpEF provide support for this latter hypothesis, having shown improvements in quality of life, natriuretic peptide and activity levels, and atrial fibrillation burden. Objective: The study sought to determine the effects of continued resting heart rate elevation with and without superimposed nocturnal pacing in HFpEF patients without standard pacing indication. Methods: The physiologic accelerated pacing as treatment for heart failure with preserved ejection fraction (PACE HFpEF) trial is an investigator-initiated, prospective, patient-blinded multiple crossover pilot study that assesses the impact of accelerated pacing on quality of life, physical activity, N-terminal pro–B-type natriuretic peptide, and echocardiographic measures of cardiac structure and function. Results: Twenty patients were enrolled and underwent dual-chamber pacemaker implantation under U.S. Food and Drug Administration investigational device exemption with both atrial and ventricular physiologic lead placement targeting the Bachmann bundle and the His bundle. Conclusion: This manuscript describes the rationale and design of the PACE HFpEF trial, which tests the safety and feasibility of continuous accelerated physiological pacing as a treatment strategy in HFpEF.
AB - Background: In heart failure with preserved ejection fraction (HFpEF), it has been assumed that pharmacologic heart rate suppression should provide clinical benefits through an increase in diastolic filling time. Contrary to this assumption, heart rate lowering in patients with preserved left ventricular ejection fraction and hypertension or coronary artery disease results in adverse outcomes and suggests that the opposite may be beneficial. Namely, shortening the diastolic filling time with a higher heart rate might normalize the elevated filling pressures that are the sine qua non of HFpEF. Initial clinical studies that assessed the effects of accelerated heart rates in pacemaker patients with preclinical and overt HFpEF provide support for this latter hypothesis, having shown improvements in quality of life, natriuretic peptide and activity levels, and atrial fibrillation burden. Objective: The study sought to determine the effects of continued resting heart rate elevation with and without superimposed nocturnal pacing in HFpEF patients without standard pacing indication. Methods: The physiologic accelerated pacing as treatment for heart failure with preserved ejection fraction (PACE HFpEF) trial is an investigator-initiated, prospective, patient-blinded multiple crossover pilot study that assesses the impact of accelerated pacing on quality of life, physical activity, N-terminal pro–B-type natriuretic peptide, and echocardiographic measures of cardiac structure and function. Results: Twenty patients were enrolled and underwent dual-chamber pacemaker implantation under U.S. Food and Drug Administration investigational device exemption with both atrial and ventricular physiologic lead placement targeting the Bachmann bundle and the His bundle. Conclusion: This manuscript describes the rationale and design of the PACE HFpEF trial, which tests the safety and feasibility of continuous accelerated physiological pacing as a treatment strategy in HFpEF.
KW - Accelerated pacing
KW - Bachmann bundle
KW - Conduction system pacing
KW - Heart failure with preserved ejection fraction
KW - His bundle
KW - Individualized heart rate
KW - Nocturnal pacing
KW - Personalized heart rate
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U2 - 10.1016/j.hroo.2023.12.001
DO - 10.1016/j.hroo.2023.12.001
M3 - Article
C2 - 38312209
AN - SCOPUS:85181844252
SN - 2666-5018
VL - 5
SP - 41
EP - 49
JO - Heart Rhythm O2
JF - Heart Rhythm O2
IS - 1
ER -