Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.
Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That’s pretty big news! Continue reading
Dr. Habib Samady of Emory in Atlanta at IVUS console
I’ve written before about the use of IVUS in stent and angioplasty procedures in women, most recently in October about a study done at NYU Medical Center. My article, “Intravascular Ultrasound (IVUS) Imaging Reveals Hidden Heart Attack Culprit In Women“, showed how intravascular imaging could detect a type of coronary disease not seen on angiography.
Now a similar tale has been broadcast by CBS affiliate WGCL-TV in Atlanta about how a type of coronary narrowing more typical in women may not be seen on a standard angiogram because it’s evenly distributed along the arterial wall or channel and doesn’t appear as a “spike” or sudden narrowing — yet it may be restricting the flow of blood to the heart just the same. Once again — angiography alone is not enough to accurately diagnose coronary artery disease and guide its treatment. Continue reading
For several years now, I’ve been advocating for expanded use of functional measurement, otherwise known as Fractional Flow Reserve (FFR), as a way of determining whether or not a blocked artery is actually causing ischemia. A new measurement, made possible by recent advances in computer technology, called iFR (instant wave-Free Ratio™) may provide the momentum that pushes this concept into mainstream cardiology. Continue reading
Last week the Superior Court of Massachusetts entered a Final Judgment in the latest round of “Laser Wars” being waged between Volcano Corporation (NASDAQ: VOLC) and St. Jude Medical (NYSE: STJ). Both companies “lasered up” a few years ago…and that has led to their “lawyering up” — remember “Stent Wars“?
In fact, Dr. Julio Palmaz, co-inventor of the first angioplasty balloon exandable Palmaz-Schatz stent, told me last year that the biggest thing an inventor needed to understand was just how much time he’ll be spending in court, defending his patent. That certainly is the case with the laser technology used in a new generation of intravascular imaging catheters, called OCT (Optical Coherence Tomography) which can be used to image the inside of a coronary artery, look at a stent’s positioning, whether it has healed correctly, etc. Continue reading
I’ve written a lot about Fractional Flow Reserve, or FFR, in the past — and the fact that it’s a simple tool that can be used during an angiogram to assess the actual obstruction to the volume of blood flow being caused by an arterial blockage. Sure you can SEE a blockage on the fluoroscopic image, but should you stent it?
The results of the by now well-known FAME study indicate that a third of the blockages between 50% and 90% (as seen on the angiogram) actually had an FFR measurement of greater than 80% (meaning that the obstruction of flow was less than 20%, even though the blockage looked more significant on the angiogram). Most importantly, treating those blockages with angioplasty and stenting resulted in worse outcomes at one year — results which have remained constant now three years later. For more information, read our exclusive interview with Dr. Nico Pijls, co-principal investigator for FAME. Continue reading
Optical Coherence Tomography (OCT) is an exciting new imaging technique that is being used to assess the interior anatomy of coronary arteries during and after angioplasty and stent placement. (Read our exclusive interview with Dr. Giulio Guagliumi for more information about how OCT can aid in measuring the healing of stents.)
This technology is just now beginning to bridge the divide between research tool and clinical aide — for example, OCT can show high resolution pictures of stent struts and show whether they are covered or not. So the future for OCT imaging is definitely of major interest. Continue reading
Monday’s 172-page Senate Finance Committee Staff Report on the overuse of coronary stents by Dr. Mark Midei at St. Joseph’s Hospital in Maryland has been all over the news — over 300 articles to date, claiming fraud, malpractice, pig roasts, threats to reporters — all of which serve to rekindle the “anti-stent” sentiment that followed on the heels of the COURAGE study back in 2007. In fact, Dr. William Boden, principal investigator for COURAGE, was interviewed for the Senate report, which characterized him as follows: Continue reading