Key result
Automatic CRT optimization with SonR proves noninferior to echo guidance for 12-month clinical response.
Why the study?
Does weekly automatic CRT optimization with a contractility sensor improve clinical response in patients with systolic heart failure undergoing CRT compared to Echo-guided optimization?
RCT (n=998)
Double-blind
2:1
Yes
Does weekly automatic CRT optimization with a contractility sensor improve clinical response in patients with systolic heart failure undergoing CRT compared to Echo-guided optimization?
Mean Difference: 4.6 (95% CI -1.4–10.6)
Absolute Event Rate: 75% vs 70.4%
p-value: p=< 0.001 for non-inferiority margin -10.0%
Automatic AV and VV optimization using a contractility sensor is non-inferior to Echo-guided optimization for clinical response to CRT and is associated with a reduction in heart failure hospitalizations.
Supports automatic SonR optimization as a convenient alternative to echo guidance in CRT; confirms noninferiority for clinical response in an RCT.
AIMS: Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT. METHODS AND RESULTS: RESPOND-CRT was a prospective, randomized, double-blinded, multicentre, non-inferiority trial. Patients were randomized (2:1, respectively) to receive weekly, automatic CRT optimization with SonR vs. an Echo-guided optimization of AV and VV timings. The primary efficacy endpoint was the rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in New York Heart Association class or quality of life), at 12 months. The study randomized 998 patients. Responder rates were 75.0% in the SonR arm and 70.4% in the Echo arm (mean difference, 4.6%; 95% CI, -1.4% to 10.6%; P < 0.001 for non-inferiority margin -10.0%) (Table 2). At an overall mean follow-up of 548 ± 190 days SonR was associated with a 35% risk reduction in HF hospitalization (hazard ratio, 0.65; 95% CI, 0.46-0.92; log-rank P = 0.01). CONCLUSION: Automatic AV and VV optimization using the contractility sensor was safe and as effective as Echo-guided AV and VV optimization in increasing response to CRT. CLINICALTRIALS.GOV NUMBER: NCT01534234.
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Brugada et al. (2016) conducted an RCT in Systolic heart failure (n=998). Automatic CRT optimization with SonR vs. Echo-guided optimization of AV and VV timings was evaluated on Rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in NYHA class or quality of life) at 12 months (MD 4.6, 95% CI -1.4 to 10.6, p=< 0.001 for non-inferiority margin -10.0%). Automatic CRT optimization with SonR was noninferior to Echo-guided optimization for the rate of clinical responders at 12 months (75.0% vs 70.4%; P<0.001 for noninferiority).
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