Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial.

Background: Preliminary work suggests that single-pulse transcranial magnetic stimulation (sTMS) could be effective as a treatment for migraine. We aimed to assess the efficacy and safety of a new portable sTMS device for acute treatment of migraine with aura.

Methods: We undertook a randomised, double-blind, parallel-group, two-phase, sham-controlled study at 18 centres in the USA.

Real-time detection and alerting for acute ST-segment elevation myocardial ischemia using an implantable, high-fidelity, intracardiac electrogram monitoring system with long-range telemetry in an ambulatory porcine model.

Objectives: The purpose of this study was to evaluate feasibility of using real-time, high-fidelity, intracardiac electrogram monitoring from a permanently implantable ischemia detection system (IIDS), with long-range telemetry capability to detect ST-segment shifts associated with acute or subacute coronary occlusion in a porcine model.

Background: Early identification of coronary occlusion with ST-segment elevation could profoundly accelerate the timing of revascularization and improve clinical outcomes.

Methods: This paper reports the first investigation using real-time, high-fidelity, intracardiac electrogram monitoring from a permanently IIDS, with long-range telemetry capability.

Potential of an intracardiac electrogram for the rapid detection of coronary artery occlusion.

Background: Early identification of acute MI and prompt intervention can improve clinical outcomes. It would be valuable to identify a method that could allow the earliest possible detection of myocardial injury or ischemia.

Methods And Results: This article reports one of the first clinical investigations to examine the ability of an intracardiac right ventricular (RV) electrode to identify the early onset of myocardial ischemia/injury in a cohort of patients undergoing balloon occlusion of a coronary artery during percutaneous transluminal coronary angioplasty.

Regulatory affairs as they affect invasive cardiology.

Over the last several years, the United States Food and Drug Administration (FDA) has significantly improved the time required for the approval of PMA and PMA supplement applications. By the year 1999, the average approval time for PMA applications was 12 months and the average approval time for PMA supplements was only 4 months. In spite of this improved performance by the FDA, it is still advantageous for many products to have their first clinical trial outside the United States.

The impact of stent design and delivery upon the long-term efficacy of radioisotope stents.

Both gamma and beta irradiation delivered via a radioactive catheter-based line source have been shown to have efficacy in reducing restenosis. However, these catheter-based treatments have some limitations, including the safety of handling sources ranging from 30 mCi to 500 mCi. Alternatively, one could use a stent as the platform for local radiation delivery as a means to prevent restenosis.