Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innovation as an ecosystem.

Long-term outcome and its predictors among patients with ST-segment elevation myocardial infarction complicated by shock: insights from the GUSTO-I trial.

Objectives: This study sought to assess long-term outcome and determine its predictors among 30-day survivors of cardiogenic shock.

Background: Patients with cardiogenic shock have high in-hospital and 30-day mortality, but there are little data about those who survive beyond 30 days.

Methods: We analyzed baseline, in-hospital, and survival data from patients in the U.

Zoledronic acid and clinical fractures and mortality after hip fracture.

Background: Mortality is increased after a hip fracture, and strategies that improve outcomes are needed.

Methods: In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous zoledronic acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture.

Potential applicability and utilization of left atrial appendage occlusion devices in patients with atrial fibrillation.

Background: The WATCHMAN left atrial appendage occluder device (Atritech, Inc, Minneapolis, MN) is currently being tested in a Food and Drug Administration-approved clinical trial, the PROTECT AF trial, for patients who are diagnosed with paroxysmal, persistent, or permanent nonvalvular atrial fibrillation. However, rigorous screening and the study design have resulted in the exclusion of a large number of patients. Hence, the purpose of this study was to assess the potential utility of this device among those who were eligible but excluded for trial criteria and the reasons for exclusion.

Renal and iliac artery stenting by interventional cardiologists and vascular surgeons: the Foundation to Advance Medical Education (FAME) initiative.

The American College of Cardiology, in concert with the Society for Coronary Angiography and Interventions and the Society for Vascular Surgery, planned and implemented an initiative to teach stenting of renal and iliac arteries to their peers in practice. Supported by the Foundation to advance medical Education (FAME), the initiative involved 25 preceptees and 6 preceptors and included a didactic portion (a remote learning exercise), an animal practicum, a procedural simulation, and a preceptor/preceptee training segment, all of which was followed by evaluations by the participants. Assessments of the success of the initiative differed between preceptees, who were positive about the experience, and preceptors, who were more critical of the endeavor (with surgeons more critical than cardiologists).

Conflict of interest.

The clinical research enterprise is increasingly scrutinized, in part because of the issue of conflict of interest. The issue is broad and its implications touch on a wide range of concerns, from the safety of patient care to the viability of a large industry. Numerous constituencies are affected by conflict of interest, and representatives of all of them convened in November 2002 for a one-and-a-half day discussion of the issues as well as possible solutions to both the perception and the actuality of such conflict.