Author + information
- Michael R. Zile, MDa,b,∗ (, )@zile_md,
- JoAnn Lindenfeld, MDc,
- Fred A. Weaver, MDd,
- Faiez Zannad, MDe,
- Elizabeth Galle, MPHf,
- Tyson Rogers, MSg and
- William T. Abraham, MDh
- aMedical University of South Carolina, Charleston, South Carolina
- bRalph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina
- cVanderbilt Heart and Vascular Institute, Nashville, Tennessee
- dDivision of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California
- eInserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France
- fCVRx, Inc., Minneapolis, Minnesota
- gNAMSA, Inc., Minneapolis, Minneapolis
- hDivision of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio
- ↵∗Address for correspondence:
Dr. Michael R. Zile, Division of Cardiology, Department of Medicine, Medical University of South Carolina, Thurmond/Gazes, Room 323, 30 Courtenay Drive, Charleston, South Carolina 29425.
Background This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF).
Objectives The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group).
Methods Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy. Effectiveness endpoints were the change from baseline to 6 months in 6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The safety endpoint included the major adverse neurological or cardiovascular system or procedure-related event rate (MANCE).
Results Results from, timeline and rationale for, cohorts A, B, and C are presented in detail in the text. Cohort D, which represented the intended use population that reflected the U.S. Food and Drug Administration−approved instructions for use (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group versus the control group, QOL score decreased (Δ = −14.1; 95% confidence interval [CI]: −19 to −9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = −25%; 95% CI: −38% to −9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001).
Conclusions BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196)
This study was supported by CVRx, Inc. Dr. Zile has been a consultant to CVRx; and has received fees for being a member of the BeAT-HF trial executive steering committee. Dr. Lindenfeld has been a consultant to CVRx; has received fees for being a member of the BeAT-HF trial executive steering committee; and has been a consultant to AstraZeneca, Boehringer Ingelheim, Edwards, Impulse Dynamic, Volumetrix, Sensible Medical, and V Wave. Dr. Weaver has been a consultant to CVRx; has received fees for being a member of the BeAT-HF trial executive steering committee; and has been a member of the Executive Committee of CVRx Barostim. Dr. Zannad has been a consultant to CVRx; and has received fees for being a member of the BeAT-HF trial executive steering committee. Mr. Rogers has been a consultant to CVRx. Ms. Galle is an employee of CVRx. Dr. Abraham has been a consultant to CVRx; and has received fees for being a member of the BeAT-HF Trial Executive Steering Committee.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received April 1, 2020.
- Accepted May 4, 2020.
- 2020 The Authors