Left atrial appendage occlusion in patients with non-valvular atrial fibrillation and cerebral amyloid angiopathy: insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) international multicenter registry.

Objectives: Oral anticoagulation therapy (OAC) is often contraindicated in patients with atrial fibrillation (AF) and cerebral amyloid angiopathy (CAA) because of the high hemorrhagic risk. Left atrial appendage occlusion (LAAO) can prevent thromboembolic events while avoiding long-term anticoagulation. However, a short period of antithrombotic therapy (AT) is still recommended after LAAO, and, therefore, it is unclear whether patients with CAA can be candidates for LAAO.

Real-world data on the effectiveness of TYRX and TauroPace for preventing CIED infections.

Background: The implantation of cardiac implantable electronic devices (CIEDs) carries a known risk of infection. Two devices (TYRX and TauroPace) have been proposed to reduce this risk.

Methods: The aim of our study was to compare the effectiveness of TauroPace and TYRX.

Tricuspid regurgitation and heart failure: the fate of treated vs. untreated cohort in the percutaneous era.

Aims: Tricuspid regurgitation (TR) is associated with heart failure (HF) and reduced survival. Within a short-time period, transcatheter tricuspid valve repair or replacement (TTVR/TTVr) for TR has evolved from innovation to clinical reality. The present study's aim is to provide 1-year results between TR patients treated with TTVR and TTVr compared with untreated patients, in terms of cardiac survival, rehospitalization, right-side HF symptom development, and New York Heart Association (NYHA) improvement.

Studying the Outcomes in Patients with Tricuspid Regurgitation Treated with Valve Repair or Valve Replacement: Interpreting the Survival Pattern on The Long Term by Application of Artificial Intelligence Methods.

Background: The reconstruction of individual patient data from published Kaplan-Meier survival curves is a new technique (often denoted as the IPDfromKM method) for studying efficacy in cases where multiple trials are available, and the endpoint is long-term mortality. In patients with tricuspid regurgitation, both valve repair and valve replacement have been proposed to improve prognosis; 6 controlled clinical trials (CTs) have been conducted to compare the two therapeutic options mentioned above. The objective of our analysis was to study these six trials through the application of the IPDfromKM method.

Costs and benefits in patients with NYHA class III heart failure treated with CardioMEMS in Italy.

Background: CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA.

Pulsed-field ablation for paroxysmal atrial fibrillation: An indirect comparison of effectiveness among three proprietary devices conducted in the absence of randomized trials.

Introduction: In patients with paroxysmal atrial fibrillation, pulsed-field ablation has been developed as an alternative to thermal ablation. Three devices are currently available: Farawave by Boston, PulseSelect by Medtronic, and Varipulse by Johnson. In the present report, we studied the outcomes at 12 months of these three devices using indirect comparisons.

A Comparison of Statistical Analysis Between "Real" Patients Reported in Kaplan-Meier Curves and "Reconstructed" Patients Estimated Through the IPDfromKM Method: Analysis of Eight Trials Evaluating Catheter Ablation of Ventricular Tachycardia.

Time-to-event endpoints are most widely used in oncology and, to a lesser extent, in cardiology. Typical statistical parameters employed in this context include overall survival, progression-free survival, and recurrence-free survival. The graphical presentation of the results is based on the Kaplan-Meier plot.

Managing Tenders in the Procurement of Advanced Medical Devices: An Original Model Based on the Net Monetary Benefit Combined With Three Clinical Endpoints.

In medical devices, recent studies have proposed original approaches for standardizing competitive tenders with the aim of promoting reproducibility, avoiding discretional decisions, and applying value-based principles. In the framework of tenders' standardization, the net monetary benefit (NMB) method has attracted much interest, but its mathematical complexity has prevented a wide application. In the present work, we developed a procurement model that simplifies clinical information management for high-technology devices purchased for our public hospitals.

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry.

Introduction: The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

Aims: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding.

Methods: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups.

Observed concentrations of amikacin and gentamycin in the setting of burn patients with gram-negative bacterial infections: Preliminary data from a prospective study.

Aim Of The Study: Critically ill populations often have shown subtherapeutic aminoglycosides' concentrations mostly because of unavoidable changes in drug volume distribution and clearance. We present a real life prospective study evaluating plasma concentrations for once-daily dosing for amikacin and gentamycin among a population of severe burn adults.

Methods: We conducted a real life prospective study on the plasma observed concentrations of amikacin and gentamycin among severe burn patients, using aminoglycoside as combination therapy.

Epidemiology, prevalence and risk factors for infections in burn patients: results from a regional burn centre's analysis.

Burn patients are at high risk of infections due to severe impairment of immunity and loss of skin barrier function. We aimed to describe the epidemiology, incidence and risk factors for infection in a cohort of burns patients. Two hundred patients were retrospectively enrolled and subdivided into infected (N = 81) and uninfected groups (N = 119).