Continuous On-Demand Diaphragm Neurostimulation to Prevent Diaphragm Inactivity During Mechanical Ventilation: A Phase 1 Clinical Trial (STIMULUS).

Rationale: Diaphragm inactivity during invasive mechanical ventilation may predispose the lung and diaphragm to injury, and is associated with adverse clinical outcomes.

Objectives: Assess the feasibility of continuous on-demand diaphragm neurostimulation-assisted mechanical ventilation to maintain diaphragm activity in the absence of respiratory drive for at least 24 hours of mechanical ventilation.

Methods: In a single center phase 1 clinical trial, patients receiving invasive mechanical ventilation for acute hypoxemic respiratory failure or after thoracic surgery underwent transvenous diaphragm neurostimulation delivered in synchrony with mechanical ventilation.

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure-Trial design of the REDUCE FMR study.

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device.

Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings.

Background: To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT).

Methods: Cost-utility analysis using a combination of a decision tree and Markov process was performed.