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- Title
Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial.
- Authors
Reddy, Yogesh N. V.; Koepp, Katlyn E.; Carter, Rickey; Win, Sithu; Jain, Christopher Charles; Olson, Thomas P.; Johnson, Bruce D.; Rea, Robert; Redfield, Margaret M.; Borlaug, Barry A.
- Abstract
Key Points: Question: Lower exertional heart rate is associated with worse exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF), but does increasing exercise heart rate with atrial pacing improve exercise tolerance? Findings: Atrial pacing increased early and peak exercise heart rate, but there was no improvement in exercise performance or quality of life. Despite a higher exercise heart rate, there was no increase in exercise cardiac output, due to a decrease in stroke volume. Pacemaker implantation was associated with adverse events. Meaning: In patients with HFpEF and inadequate response of heart rate to exertion (chronotropic incompetence), implantation of a pacemaker to enhance exercise heart rate did not improve exercise capacity, symptoms, or exercise cardiac output. Importance: Reduced heart rate during exercise is common and associated with impaired aerobic capacity in heart failure with preserved ejection fraction (HFpEF), but it remains unknown if restoring exertional heart rate through atrial pacing would be beneficial. Objective: To determine if implanting and programming a pacemaker for rate-adaptive atrial pacing would improve exercise performance in patients with HFpEF and chronotropic incompetence. Design, Setting, and Participants: Single-center, double-blind, randomized, crossover trial testing the effects of rate-adaptive atrial pacing in patients with symptomatic HFpEF and chronotropic incompetence at a tertiary referral center (Mayo Clinic) in Rochester, Minnesota. Patients were recruited between 2014 and 2022 with 16-week follow-up (last date of follow-up, May 9, 2022). Cardiac output during exercise was measured by the acetylene rebreathe technique. Interventions: A total of 32 patients were recruited; of these, 29 underwent pacemaker implantation and were randomized to atrial rate responsive pacing or no pacing first for 4 weeks, followed by a 4-week washout period and then crossover for an additional 4 weeks. Main Outcomes and Measures: The primary end point was oxygen consumption (V̇o2) at anaerobic threshold (V̇o2,AT); secondary end points were peak V̇o2, ventilatory efficiency (V̇e/V̇co2 slope), patient-reported health status by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Results: Of the 29 patients randomized, the mean age was 66 years (SD, 9.7) and 13 (45%) were women. In the absence of pacing, peak V̇o2 and V̇o2 at anaerobic threshold (V̇o2,AT) were both correlated with peak exercise heart rate (r = 0.46-0.51, P <.02 for both). Pacing increased heart rate during low-level and peak exercise (16/min [95% CI, 10 to 23], P <.001; 14/min [95% CI, 7 to 21], P <.001), but there was no significant change in V̇o2,AT (pacing off, 10.4 [SD, 2.9] mL/kg/min; pacing on, 10.7 [SD, 2.6] mL/kg/min; absolute difference, 0.3 [95% CI, −0.5 to 1.0] mL/kg/min; P =.46), peak V̇o2, minute ventilation (V̇e)/carbon dioxide production (V̇co2) slope, KCCQ-OSS, or NT-proBNP level. Despite the increase in heart rate, atrial pacing had no significant effect on cardiac output with exercise, owing to a decrease in stroke volume (−24 mL [95% CI, −43 to −5 mL]; P =.02). Adverse events judged to be related to the pacemaker device were observed in 6 of 29 participants (21%). Conclusions and Relevance: In patients with HFpEF and chronotropic incompetence, implantation of a pacemaker to enhance exercise heart rate did not result in an improvement in exercise capacity and was associated with increased adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02145351 This randomized crossover trial assessed if implanting and programming a pacemaker for rate-adaptive atrial pacing improved exercise performance in patients with heart failure with preserved ejection fraction and chronotropic incompetence at a single US tertiary referral center.
- Subjects
KANSAS City (Mo.); ROCHESTER (Minn.); RATE of perceived exertion; CARDIAC pacing; BRAIN natriuretic factor; CARDIAC pacemakers; HEART failure; VENTRICULAR ejection fraction; AEROBIC capacity
- Publication
JAMA: Journal of the American Medical Association, 2023, Vol 329, Issue 10, p801
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.2023.0675