Optimizing CRT Lead Placement Accuracy With CMR-Guided On-Screen Targeting: A Randomized Controlled Trial (ADVISE-CRT III).

Abstract

Background: To improve cardiac resynchronization therapy (CRT) an on-screen image-guidance platform, CARTBox-Suite (CART-Tech B.V.), was developed to identify left ventricular pacing electrode (LVPE) implantation sites and facilitate precise LVPE placement. This multicenter randomized trial evaluated the efficacy of image guidance on LVPE implantation accuracy and its impact on left ventricular end-systolic volume (LVESV) reduction 6 months after CRT.

Objectives: The aim of this trial is to improve the accuracy and efficacy of LVPE placement in CRT.

Methods: A total of 131 heart failure patients (80% with Class I CRT indication) were enrolled across 7 hospitals in the Netherlands. CARTBox-Suite, which utilizes a cloud-based AI algorithm, was used to identify a target area with late mechanical activation based on cardiac magnetic resonance imaging. Scarred areas marked by late gadolinium enhancement were excluded. Patients were randomized to image-guided implantation, with on-screen guidance during the procedure or conventional implantation.

Results: The primary endpoint, LVPE implantation in the target area, was achieved significantly more often in the image-guided group (66.7% vs 29.2%; P < 0.001). The secondary endpoint was fewer LVPE placed in scarred areas in the image-guided group (7.1% vs 36.4%; P = 0.006). Mean LVESV reduction was greater in the image-guided group (43.2% vs. 37.6%), although not significantly (P = 0.166). Patients with myocardial scar showed greater LVESV reduction with image guidance (40.7% vs 27.7%; P = 0.028).

Conclusions: Image-guided implantation resulted in significantly more LVPE placed in the target area and greater LVESV reduction in patients with myocardial scar.