–A sham-controlled trial defies previous expectations. A rigorous sham-controlled trial has failed to demonstrate a significant benefit for patent foramen ovale (PFO) closure in addressing frequent migraine headaches. There has long been a strong suspicion that some migraine headaches may be caused by PFO, but this relationship has never been conclusively demonstrated, and it has…
Pioneering Interventional Cardiologist Defends Unorthodox Practices
August 1, 2016 by 3 Comments
–Bernhard Meier explains why he seals plaques and thinks PFO closure is ‘the best procedure in interventional cardiology’ (Updated) Recently I wrote about an article by Bernhard Meier, a top interventional cardiologist, in which he rejected the idea that evidence based on randomized controlled trials should be the basis for the practice of interventional cardiology….
Controversial PFO Closure Trials Published In NEJM
March 20, 2013 by Leave a Comment
Two controversial trials testing PFO closure with the Amplatzer PFO Occluder (St. Jude Medical) in patients with cryptogenic stroke, first presented last fall at the TCT meeting, have now been published in the New England Journal of Medicine. Both trials missed their primary endpoints but contained suggestions of possible benefit. The results appear unlikely to resolve…
Research And Denial At St Jude Medical
October 26, 2012 by 2 Comments
Research and development is the cornerstone of medical progress, but sometimes R&D turns into its evil twin brother, research and denial. Yesterday I reported on the the RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial presented at the TCT meeting in Miami. The trial missed its primary…
TCT: Two PFO Closure Trials Miss Primary Endpoints
October 25, 2012 by 1 Comment
Two trials presented today at the TCT meeting in Miami testing the benefits of PFO closure in patients with cryptogenic stroke have failed to convincingly demonstrate any significant benefit for the controversial procedure. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial randomized 980 patients to PFO closure…
Recent Comments