Search Results for: La FDA approva il sistema di riabilitazione dell’ictus

Circulation, Volume 150, Issue Suppl_1, Page A4141001-A4141001, November 12, 2024. Background:Pulsed field ablation (PFA) has emerged as a safe and effective alternative to thermal ablation modalities for treatment of paroxysmal and persistent AF in a de novo procedure.Research Questions:Since the FaraPulse system (Boston Scientific) was approved by FDA, no data was reported on whether PFA can be used in redo procedures.Aims:We reported our initial experience with PFA in patients with recurrent atrial tachyarrhythmias (ATs) who failed at least one thermal ablation of AF.Methods:Consecutive patients receiving redo ablation using PFA (FaraPulse) for recurrent ATs were enrolled. ICE and fluoroscopy were used to guide the placement of FaraWave catheter. Voltage and activation mapping of LA were performed in all patients before ablation using Orion high density mapping catheter and Rhythmia system. Ablation strategy included PV re-isolation as needed, LA posterior wall (PW) isolation if low voltage zone was identified, and ablation of any organized ATs. Procedural endpoints were PVs and LAPW isolation, non-inducibility for ATs and bidirectional block for linear ablation.Results:15 patients (12 male; age 66.3±10.3 years) were included. The median number of prior RF ablations was 2; 2 patients also received one cryoballoon ablation. Patients presented with persistent (80%) AF or paroxysmal (20%) AF with/without documented organized ATs. By using PFA, LAPW isolation was performed and achieved in all patients, while 11 (73.3%) patients required reisolation of at least one PV (Figure). Organized ATs were present/induced in 7 (46.7%) patients including 3 peri-mitral AFL, 3 LA roof-dependent AFL, 3 CTI AFL and 3 atrial tachycardias from LA roof, LA septum and RA roof respectively. RF ablation was required in 2 patients (2/7, 28.5%) to eliminate CTI AFL. Per case total PFA applications number were 48.7±24.4 (46, 22-90); total fluoroscopy time was 6.8±5.6 mins. No major peri-procedural complication was observed except for one case (90 PFA applications) of hemolysis and acute renal failure that completely recovered.Conclusion:PFA of recurrent ATs after failed thermal ablation is feasible and safe acutely if limited the applications. The long-term outcome of this strategy warrants further investigation.

Circulation, Volume 150, Issue Suppl_1, Page A4146689-A4146689, November 12, 2024. Introduction:Mavacamten is a cardiac myosin inhibitor approved by the US FDA for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Under the risk evaluation and mitigation strategy (REMS) program, patients taking mavacamten are required to be monitored for development of systolic heart failure (HF), with interruption if left ventricular ejection fraction (LVEF) decreases to

Circulation, Volume 150, Issue Suppl_1, Page A4144021-A4144021, November 12, 2024. Background:β-3 adrenoceptor (AR) activation is antiarrhythmic in a canine model of ventricular arrhythmia. Na-K ATPase (NKA) expression is higher in female than male rats and is stimulated by β-3 agonist due to an inhibitory oxidative modification.Objective:To test the hypothesis that mirabegron, a β-3 agonist approved by the FDA for treating overactive bladder, has more anti-fibrillatory effects in females than in male rabbit ventricles due to NKA stimulation.Methods:We performed optical mapping studies in 6 male and 6 female Langendorff-perfused rabbit hearts at baseline, then sequentially after adding mirabegron (500 and 1000 nM), followed by ouabain (500 nM), a specific NKA blocker. All hearts underwent 10 attempts of ventricular fibrillation (VF) induction with a ventricular burst pacing (20 Hz for 10 s) at each stage of the experiment.Results:Ashows phase maps during VF. Triangles indicate PSs. Mirabegron 1000 nM significantly decreased VF inducibility (number of VF induced in the 10 attempts) from 4.8±3.2 to 2.2±2.9 (p=0.034) in females but not in males (from 4.5±2.6 to 5.0±2.8, p=0.656) (B). Consistent with our previous reports, Mirabegron 1000 nM decreased PSs/VF (number of phase singularity per VF episode) in females (from 10.5±2.7 to 2.9±3.3, p=0.010) but not in males (from 11.3±2.3 to 9.7±2.6, p=0.167). Adding ouabain did not reverse mirabegron’s effects on PSs/VF (2.4±3.9, p=0.706) in females. However, it decreased PSs/VF significantly in males (3.4±4.0, p=0.038). Mirabegron decreased conduction velocity (CV, activation time-1, /s) in both males (from 40.3±6.5 to 30.4±5.3, p

Bene il nuovo sistema di garanzia, ma non può risolvere tutto

A new analysis of recalled cardiovascular devices published in the Annals of Internal Medicine found that most of them hadn’t gone through clinical testing before they were authorized. And when they were, the evidence was usually based on 1 non–randomized clinical trial. The researchers used data from the US Food and Drug Administration (FDA) Class I recalls from 2013 to 2022. There were 137 recalls involving 157 unique cardiovascular devices.

This potassium-competitive acid blocker recently was FDA approved for this indication, but its high cost is a barrier to routine use.

To the Editor We read with interest the economic evaluation by Raymakers et al estimating the cost of beremagene geperpavec (B-VEC) therapy for dystrophic epidermolysis bullosa (DEB). The authors conclude that US Food and Drug Administration (FDA) approval of B-VEC therapy for DEB will pose a significant cost to payers.

Giornata mondiale,con prevenzione evitabili fino al 90% dei casi

L’Italian Stroke Association lancia un piano d’azione

Introduction
Sedation in mechanically ventilated adults in the intensive care unit (ICU) is commonly achieved with intravenous infusions of propofol, dexmedetomidine or benzodiazepines. Significant limitations associated with each can impact their usage. Inhaled isoflurane has potential benefit for ICU sedation due to its safety record, sedation profile, lack of metabolism and accumulation, and fast wake-up time. Administration in the ICU has historically been restricted by the lack of a safe and effective delivery system for the ICU. The Sedaconda Anaesthetic Conserving Device-S (Sedaconda ACD-S) has enabled the delivery of inhaled volatile anaesthetics for sedation with standard ICU ventilators, but it has not yet been rigorously evaluated in the USA. We aim to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared with intravenous propofol for sedation of mechanically ventilated ICU adults in USA hospitals.

Methods and analysis
INhaled Sedation versus Propofol in REspiratory failure in the ICU (INSPiRE-ICU1) is a phase 3, multicentre, randomised, controlled, open-label, assessor-blinded trial that aims to enrol 235 critically ill adults in 14 hospitals across the USA. Eligible patients are randomised in a 1.5:1 ratio for a treatment duration of up to 48 (±6) hours or extubation, whichever occurs first, with primary follow-up period of 30 days and additional follow-up to 6 months. Primary outcome is percentage of time at target sedation range. Key secondary outcomes include use of opioids during treatment, spontaneous breathing efforts during treatment, wake-up time at end of treatment and cognitive recovery after treatment.

Ethics and dissemination
Trial protocol has been approved by US Food and Drug Administration (FDA) and central (Advarra SSU00208265) or local institutional review boards ((IRB), Cleveland Clinic IRB FWA 00005367, Tufts HS IRB 20221969, Houston Methodist IRB PRO00035247, Mayo Clinic IRB Mod22-001084-08, University of Chicago IRB21-1917-AM011 and Intermountain IRB 033175). Results will be presented at scientific conferences, submitted for publication, and provided to the FDA.

Trial registration number
NCT05312385.