Category Archives: Clinical Trials / Studies

Fractional Flow Reserve: A “How-To” Guide for Cardiologists

Fractional Flow Reserve wire in arteryI’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

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Filed under Angiograms, FAME I / FAME II, FFR

From Angioplasty and Stents to Aortic Valve Replacement

Andreas Gruentzig34 years ago, Andreas Gruentzig performed the first coronary angioplasty. Rather than cutting open the chest, sawing through the sternum and sewing a bypass conduit (harvested from the leg or internal mammary artery) into the coronary artery, he elegantly threaded a balloon catheter to the blockage through a small incision in the femoral (groin) artery, in an awake patient. He then inflated the balloon, compressing the plaque against the arterial wall and opening the artery. The procedure was a total success and his first patient, Adolph Bachmann, is alive and well today! (see video clip: ” The 1st Angioplasty”.)

But more importantly than just inventing angioplasty, Gruentzig invented a method for treating patients non-surgically, from the inside-out! What Gruentzig said was: Continue reading

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Filed under Clinical Trials / Studies, FDA, History, Innovators

Angioplasty and Stent Use Cut in Half — Sort of…

Scissors and StentA lost story this past couple of weeks has been an “admission” by the American Heart Association that the number of angioplasties performed in the United States is actually half of what the AHA has been saying all these years.

In their most recent 193-page Heart Disease and Stroke Statistics 2011 Update, published on December 15, the AHA now states that 622,000 percutaneous coronary interventions (PCI) were performed in 2007 (the most recent period for which stats have been compiled). Previously the AHA reported an annual volume of around 1.3 million — double the number. Continue reading

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Filed under COURAGE, Media Coverage, Stent

Stent Accusations: The U.S. Senate Tries to Drum Up COURAGE

Stent and the SenateMonday’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

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Filed under Angiograms, COURAGE, Drug-Eluting Stents, FFR, Interviews, Media Coverage

Fractional Flow Reserve and Stents

William Fearon MDFAMEous interventional cardiologist William Fearon of Stanford sat down with Angioplasty.Org recently to talk about a better way to judge if a patient might benefit from a stent. Instead of looking at the x-ray angiogram and saying, “That’s a 70% blockage — let’s put a stent in there and you’ll feel much better,” Dr. Fearon advocates the use of a thin pressure wire which actually measures the flow through the narrowing. The technology is called Fractional Flow Reserve or FFR.

Turns out that sometimes what looks like a blockage on the x-ray isn’t always restricting the flow enough to cause ischemia (reduced oxygen to the heart muscle which usually, but not always, results in angina). And vice-versa, sometimes ischemia/angina is being caused by an area that doesn’t look so bad on the angiogram. Continue reading

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Filed under FAME I / FAME II, FFR, Interviews

Kick-Ass Stents

XIENCE V StentI wrote about this issue over a month ago (see “To Stent or Not to Stent: That is the Question!“) but today’s newspapers are filled once again with the sad story of Maryland cardiologist Dr. Mark Midei, St. Joseph’s Medical Center and the alleged hundreds of unnecessary stents placed in patients who didn’t need them. This sudden renewed interest comes as the Senate investigational report by Senators Baucus and Grassley into this matter was made available — and into the mix of the story was added a pig roast, the Philadelphia mob, Abbott Vascular’s celebration of Midei implanting 30 of their stents in a single day and an email from a company executive, suggesting that someone take a Baltimore Sun reporter outside and “kick his ass!” Continue reading

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Filed under FAME I / FAME II, FFR, Media Coverage, Stent

The Gene of Damocles — Assessing Heart Disease Risk

Sword of DamoclesA study from the Mayo Clinic presented at this week’s American Heart Association Scientific Sessions in Chicago caught my eye. Researchers looked at the medical records of 1,262 people who had no history of heart disease. Using the standard Framingham Risk Score (FRS) which factors in age, sex, cholesterol levels, blood pressure, diabetes and smoking status, they calculated the ten-year probability of heart attack.

They then performed genetic tests on these patients’ existing blood samples to find if any of 11 genetic variants were present. Called single-nucleotide polymorphisms (SNPs) these variants have been found to be potential risk factors for heart attack. Continue reading

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Filed under Clinical Trials / Studies, Compliance, Heart Attack, Meetings & Conferences, Risk Factors