Background: Patients with heart failure with reduced ejection fraction (HFrEF) have varying responses to device-based heart failure therapies.
Objective: Evaluate the symptomatic response rate to baroreflex activation therapy at 6 months.
Methods: In a trial in subjects with NYHA class II (recently III) or III HFrEF, left ventricular ejection fraction ≤ 35, stable optimal guideline direct medical HF therapy (GDMT), no Class 1 indication for cardiac resynchronization therapy (CRT), and NT-proBNP<1600 pg/ml, a total of 264 subjects were randomized to either BAROSTIM therapy plus GDMT (BAT) or GDMT alone (Control). Six-minute hall walk distance (6MHW), Minnesota Living with HF Questionnaire (QOL) and NYHA Class (NYHA) was analyzed. Responders were defined by a 6-month improvement in 6MHW of >10%, QOL improvement of >5 points and/or improvement of one NYHA; super-responders were defined by an improvement in 6MHW of >20%, QOL improvement of >10 points and/or improvement to NYHA class I.
Results: Of the 264 randomized, 120 BAT and 125 Control had 6-month data. As shown in the Table 1, responder and super-responder rates were significantly higher in BAT versus Control subjects for all endpoints. In BAT subjects, 72% responded to at least two symptomatic endpoints compared to 29% of Control subjects (p<0.001). For super-responders, 28% of BAT subjects had large improvements in at least two symptomatic endpoints versus 10% of Control subjects.
Conclusion: Among subjects with symptomatic HFrEF, treatment with BAT resulted in high responder and super-responder rates of 72% and 28%, respectively. These responder and super-responder rates are similar to those seen with CRT, in CRT-indicated patients.
Responder Rate by Randomized GroupResponder
| BAT | Control | P-value |
| 6MHW>10% | 73 (62%) | 37 (31%) | <0.001 |
| NYHA Improve≥1 Class | 78 (65%) | 39 (31%) | <0.001 |
| QOL>5 Points | 82 (68%) | 55 (44%) | <0.001 |
| At least 2 of the following: 6MHW>10%, NYHA Improve≥1, QoL>5 | 85 (72%) | 35 (29%) | <0.001 |
| Super Responder | BAT | Control | P-value |
| 6MHW>20% | 40 (34%) | 22 (18%) | 0.006 |
| NYHA Improve to Class I | 19 (16%) | 3 (2.4%) | <0.001 |
| QOL>10 Points | 73 (61%) | 45 (36%) | <0.001 |
| At least 2 of the following: 6MHW>20%, NYHA Class 1, QOL>10 | 33 (28%) | 12 (10%) | <0.001 |
