Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study
Francesco Solimene1, Gerardo Nigro2, Michelangelo Canciello3
1Electrophysiology Unit Clinica Montevergine, Mercogliano.
Insights
Multipoint pacing (MPP) may improve cardiac resynchronization therapy (CRT) response in heart failure patients with specific electrical delays. This study investigates MPP's role in reducing non-responders to traditional CRT.
Area of Science:
- Cardiology
- Electrophysiology
- Heart Failure Management
Background:
- Cardiac resynchronization therapy (CRT) is a standard treatment for heart failure patients with prolonged QRS duration, aiming to improve ventricular contraction synchrony.
- However, a significant portion (30-40%) of patients do not respond to conventional CRT.
- This study focuses on a subgroup with specific right ventricle-to-left ventricle (RV-LV) intervals.
Purpose of the Study:
- To investigate the efficacy of multipoint pacing (MPP) in improving CRT response.
- To determine if MPP can decrease left ventricular end-systolic volume (LVESV) in non-responder patients.
- To assess MPP's impact on reverse remodeling and clinical outcomes in selected heart failure patients.
Main Methods:
- An observational, patient-blinded clinical study involving 248 patients.
- MPP activation strategy varied based on RV-LV interval (<80ms ON, ≥80ms OFF).
- Primary endpoint: responder rate at 6 months (≥15% decrease in LV volumes/ejection fraction). Secondary endpoints include LVESV reduction and a composite clinical outcome score.
Main Results:
- The study aims to identify if MPP increases the responder rate compared to traditional CRT.
- It will evaluate the reduction in LV end-systolic volume as a measure of reverse remodeling.
- Analysis will correlate MPP activation with CRT response at 6 months and 12 months.
Conclusions:
- Reducing CRT non-responder rates remains a critical clinical goal.
- MPP shows potential for enhancing reverse remodeling in selected heart failure patients.
- Positive findings could support larger trials on MPP's clinical benefits in CRT non-responders.
Background:
Cardiac resynchronization therapy (CRT) is an established treatment in patients with heart failure and prolonged QRS duration. A biventricular device is implanted to achieve faster activation and more synchronous contraction of the ventricles. Despite the convincing effect of CRT, 30-40% of patients do not respond. We decided to investigate the role of multipoint pacing (MPP) in a selected group of patients with right ventricle (RV)-to-left ventricle (LV) intervals less than 80 ms that do not respond to traditional CRT.
Methods:
We will enrol 248 patients in this patient-blinded, observational, clinical study aiming to investigate if MPP could decrease LV end-systolic volume (ESV) in patients with RV-to-LV interval less than 80 ms. MPP will be activated ON at implant in patients with RV-to-LV delay less than 80 ms and OFF in RV-to-LV at least 80 ms. At follow-up the activation of MPP will be related to CRT response. The primary study endpoint will be the responder rate at 6 months, defined as a decrease in LV ejection fraction, LV end-diastolic volume, LV end-systolic volume (LVESV) at least 15% from baseline. Secondary outcomes include 12 months relative percentage reduction in LVESV and a combined clinical outcome measure of response to CRT defined as the patient being alive, no hospitalization due to heart failure, and experiencing an improvement in New York Heart Association functional class (Composite-Score).
Conclusion:
Reducing the nonresponder rate continues to be an important goal for CRT.If an increase in reverse remodelling can be achieved by MPP, this study supports the conduct of larger trials investigating the role of MPP on clinical outcomes in selected patients treated, right now, only with traditional CRT.
Trial Registration:
ClinicalTrials.gov, NCT02713308. Registered on 18 March 2016.
