Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement

Participatory simulation to foster social learning on coastal flooding prevention

International audienceDue to the increase in coastal flooding risk associated with sea-level rise and increasing population along the coasts, there is a strong need to develop efficient and long-term management strategies. In partnership with the local administration of Oléron Island in France, a participatory simulation model was developed to foster social learning about coastal risk prevention measures with local authorities and managers. This simulation integrates a coastal flooding model and a spatially explicit agent-based model that simulates the development of the area and the management of prevention measures. The participatory set-up includes an immersive environment for participants to remember the coastal flooding simulation displayed and a role game mechanism that simulates the coordination issues between the different decision bodies involved in coastal risk management. A first application proved that participants learn about the water expansion dynamics during flood events and the effects of building, raising and restoring dikes

Evaluating multisite pacing strategies in cardiac resynchronization therapy in the preclinical setting

BACKGROUND Multisite pacing strategies that improve response to cardiac resynchronization therapy (CRT) have been proposed. Current available options are pacing 2 electrodes in a multipolar lead in a single vein (multipoint pacing [MPP]) and pacing using 2 leads in separate veins (multizone pacing [MZP]). OBJECTIVE The purpose of this study was to compare in a systematic manner the acute hemodynamic response (AHR) and electrophysiological effects of MPP and MZP and compare them with conventional biventricular pacing (BiVP). METHODS Hemodynamic and electrophysiological effects were evaluated in a porcine model of acute left bundle branch block (LBBB) (n = 8). AHR was assessed as LVdP/dtmax. Activation times were measured using.100 electrodes around the epicardium, measuring total activation time (TAT) and left ventricular activation time (LVAT). RESULTS Compared to LBBB, BiVP, MZP, and MPP reduced TAT by 26% +/- 10%, 32% +/- 13%, and 32% +/- 14%, respectively (P5NS between modes) and LVAT by 4% +/- 5%, 11% +/- 5%, and 12% +/- 5%, respectively (P <.05 BiVP vs MPP and MZP). On average, BiVP increased LVdP/dtmax by 8% +/- 4%, and optimal BiVP increased LVdP/dtmax by 13% +/- 4%. The additional improvement in LVdP/ dtmax by MZP and MPP was significant only when its increase during BiVP and decrease in TAT were poor (lower 25% of all sites in 1 subject). The increase in LVdP/dtmax was larger when large interelectrode distances (> 5 cm vs < 2.2 cm) were used. CONCLUSION In this animal model of acute LBBB, MPP and MZP create similar degrees of electrical resynchronization and hemodynamic effect, which are larger if interelectrode distance is large. MPP and MZP increase the benefit of CRT only if the left ventricular lead used for BiVP provides poor response

Participatory simulation of coastal flooding: building social learning on prevention measures with decision-makers

International audienc

A randomized study of defibrillator lead implantations in the right ventricular mid-septum versus the apex: the SEPTAL study.

International audienceINTRODUCTION: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid-septal versus apical implantable defibrillator (ICD) lead placement. METHODS AND RESULTS: SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid-septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all-cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid-septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1-year rate of lead-related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid-septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All-cause mortality was 7.9% in the RV mid-septal versus 2.9% in the RV apical group (ns). CONCLUSION: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid-septum versus the apex