Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.

Inclusion Criteria:

• Implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) RV pacing <2% and paced QRS duration <150ms

• Clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on:

  • dyspnea with exertion
  • or NYHA Class ≥ II heart failure
  • or pulmonary edema on prior chest imaging or documented on exam
  • or is taking loop diuretics for heart failure
  • or had NTproBNP >400 ng/ml in the last 24 months
  • or a heart failure hospitalization in the last 2 years
  • or has diastolic dysfunction on echo
  • or has left ventricular hypertrophy on echo
  • or has left atrial (LA) dilation (LA volume/BSA index >28ml/m2)

Exclusion Criteria:

• Left ventricular ejection fraction < 50%
• Life expectancy < 12 months
• Symptomatic pulmonary disease on home oxygen
• Uncontrolled hypertension as defined by blood pressure >160/100 mmHg on two checks ≥15 minutes apart
• Hypertrophic cardiomyopathy
• More than moderate valvular disease
• Aortic valve replacement < 1 year
• Angina pectoris
• Creatinine > 2
• Hemoglobin < 8 g/dL
• Participation in another clinical trial or registry study
• Inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study
• Pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation