Impact of left ventricular ejection fraction and atrial fibrillation - - PowerPoint PPT Presentation

Impact of left ventricular ejection fraction and atrial fibrillation on Baroreflex Activation Therapy

Results from the BeAT-HF Study Presenter: Michael R. Zile, MD

Charles Ezra Daniel Professor of Medicine, Medical University of South Carolina Chief, Division of Cardiology, RHJ Department of Veterans Affairs MC Charleston, South Carolina, USA

Co-Authors:

William T. Abraham, MD, The Ohio State University Fred A. Weaver, MD, University of Southern California Faiez Zannad, MD, Inserm Centre d'Investigation Elizabeth Galle, MPH, CVRx Inc. Tyson Rogers, MS, NAMSA Inc. JoAnn Lindenfeld, MD, Vanderbilt Heart and Vascular Institute

I will discuss research examining the development of new therapies in my presentation. I have financial relationships to disclose: Employee of: Department of Veterans Affairs, Medical University of SC Consultant for: Abbott, Boston Scientific, Corvia, CVRx, Cyclerion, EBR, Endotronics, Eli Lilly, Janssen, Medtronic, Merck, Myokardia, Novartis, ReCor, V Wave Stockholder in: N/A Research support from: NHLBI, VA, DOD, CVRx, Medtronic, Novartis

Presenter Disclosure Information

6 Month NT-proBNP (% change from Baseline)

p=0.004

Improvement

NT-proBNP

BAT Control Diff

BeAT-HF Top-Line Results

Improvement

6 Month MLWHF (change from Baseline)

p<0.001

Quality of Life

BAT Control Diff

Improvement

6 Month 6MHW (change from Baseline)

p<0.001

Exercise Capacity

BAT Control Diff Zile et al, JACC 2020, in press

Variable N (%) EF 35-25% 201 (76%) EF < 25% 63 (24%) Variable N (%) No AF 169 (64%) Paroxysmal 63 (24%) Permanent 8 (3%) Persistent 22 (8%) Unknown 2 (1%) Atrial Fibrillation Distribution Ejection Fraction Distribution

61% 67% 33% 30% 28%* 37%*

0% 20% 40% 60% 80% 100%

NYHA Class (% improved) Change from Baseline to 6M

• 24%
• 20%
• 1.0%

7%

• 23%
• 25%*
• 40%
• 30%
• 20%
• 10%

0% 10% 20%

NT-proBNP (% Reduction) Change from Baseline to 6M

• 20
• 21
• 8
• 5
• 12*
• 16*
• 25
• 20
• 15
• 10
• 5

MLWHF Quality of Life (Points) Change from Baseline to 6M 50 48

• 8
• 8

67* 57*

• 20

20 40 60 80 100

Six Minute Hall Walk (meters) Change from Baseline to 6M

Outcomes by Baseline AF Status

There were no significant interaction P-values for AF vs no AF for any parameter measured, all > 0.05 AF No AF

BAT Control Diff BAT Control Diff

AF No AF

BAT Control Diff BAT Control Diff

* p<0.05

• 20%
• 25%
• 0.5%

18%

• 20%
• 38%
• 50%
• 40%
• 30%
• 20%
• 10%

0% 10% 20% 30%

NT-proBNP (% Reduction) Change from Baseline to 6M 64% 67% 30% 36% 34%* 31%*

0% 20% 40% 60% 80% 100%

NYHA Class (% improved) Change from Baseline to 6M

• 22
• 17
• 7
• 5
• 13*
• 15*
• 25
• 20
• 15
• 10
• 5

MLWHF Quality of Life (Points) Change from Baseline to 6M 48 52

• 5
• 18

56* 76*

• 40
• 20

20 40 60 80 100

Six Minute Hall Walk (meters) Change from Baseline to 6M

There were no significant interaction P-values for EF 35-25% vs <25% for any parameter measured, all > 0.05

Outcomes by Baseline EF Status

LVEF 35 – 25% LVEF < 25%

BAT Control Diff BAT Control Diff BAT Control Diff BAT Control Diff

LVEF 35 – 25% LVEF < 25%

* p<0.05

6M Improvement BAT vs Control History of AF No History of AF LVEF 25– 35% BAT N=28 Control N=46 BAT N=62 Control N=51 6MHW (meters) 59* 51* MLWHF (points)

• 12*
• 15*

NYHA(% improved) 30%* 37%* NT-proBNP (% Reduction)

• 11%
• 24%

LVEF < 25% BAT N=5 Control N=8 BAT N=25 Control N=20 6MHW (meters) 127* 76* MLWHF (points)

• 16*
• 15*

NYHA(% improved) 10% 38%* NT-proBNP (% Reduction)

• 64%*
• 27%

Outcomes by Baseline EF and AF Status

* p<0.05

Conclusions

➢ BAT significantly improved patient-centered symptomatic endpoints

• quality of life score
• exercise capacity, and
• functional status.

➢ These results were supported by objective evidence of significant reduction of NT-proBNP. ➢ BAT is equally safe and effective in patients with or without Atrial Fibrillation. ➢ BAT is equally safe and effective in patients with ejection fraction 35-25% or < 25%.