Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation.

INTRODUCTION: Achieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here. METHODS AND ANALYSIS: A multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05053568; Trial NL8666.

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.

INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed. EXPERT OPINION: LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a 'last resort' treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.