January 30th, 2014
Selections from Richard Lehman’s Literature Review: January 30th
CardioExchange is pleased to reprint this selection from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
JAMA 22/29 Jan 2014 Vol 311
FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012 (pg. 385): I told you the other day that you could go into the market with any medical device you wanted, from a cotton wool bud to an implantable defibrillator, and you would probably get approval if you had the right glossy brochure. This is called the Premarket Approval (PMA) process. If you are already in the business, it is even easier than that. “Many cardiac implantable electronic device models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.”
Lancet 25 Jan 2014 Vol 383
Aggressive Medical Treatment With or Without Stenting in High-Risk Patients with Intracranial Artery Stenosis (pg. 333): In 2005, the FDA approved the Stryker Wingspan stent system for use in stenosed intracranial arteries, on the basis of a single-arm study of 45 patients. Eleven thousand of these devices have been sold in the USA since then, but the fact is that they can harm patients and should never have been licensed at all. This is shown by the first adequately powered randomized controlled trial of the device, SAMMPRIS. Patients on “aggressive medical treatment”, i.e. statins and antiplatelet agents, did better than those who were stented, yet the FDA has not pulled Wingspan. Just how far does industry capture of regulation extend? See Rita Redberg’s article below.
BMJ 25 Jan 2014 Vol 347
Presumed Safe No More: Lessons from the Wingspan Saga on Regulation of Devices: Rita Redberg, editor of JAMA Intern Med, appears in a terrific piece this week about the Stryker Wingspan device.
Off-Hour Presentation and Outcomes in Patients with Acute Myocardial Infarction: The BMJ is popular in the USA, and getting more so, but there may be a backlash over here if it continues to feature spellings like “color” on its website and run titles like “Off-hour presentation and outcomes of patients with acute myocardial infarction.” I don’t know if “off-hour” is an expression used in the USA: I have never heard it either there or here. In fact all this American systematic review tells us is what we already knew from excellent single studies like Harlan Krumholz’s comprehensive analyses of Medicare data a few years ago: have your heart attack near a hospital on a weekday morning. If you follow your clinical judgement, you will sometimes miss things, patients will suffer, and you will feel guilty. If you follow diagnostic decision aids, the same will happen, perhaps more frequently, perhaps less.