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Volcano Corp. CEO Issues Statement About George W. Bush's Stent Procedure
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Scott Huennekens |
August 10, 2013 -- When news reports about former President George W. Bush
receiving a coronary stent were published this past Tuesday, the blogosphere and twitterverse erupted. Much of the ensuing commentary and critique was directed at the circumstances and diagnostic pathway that led to Bush's angioplasty.
(My commentary on the subject quickly became Angioplasty.Org's most popular blog post of the year and was retweeted scores of times worldwide.)
What concerned many healthcare professionals was the fact that former President Bush had been a "poster boy" for living a healthy lifestyle, conducting long and vigorous bike rides around his Texas home. Even in-shape reporters and Secret Service have had difficulty keeping up with him.
So when an irregularity occurred in Bush's EKG during his routine annual stress test on Monday, a CT angiogram was done and a blockage was found in one of his coronary arteries. Even though, as Bush spokesman Freddy Ford stated, Bush had experienced no symptoms such as angina, he was transferred to an angioplasty-capable hospital and the next morning a stent was implanted in his coronary artery to open up the blockage.
The reaction from the medical community was swift and, for the most part, negative. Although in unstable patients with emergency or urgent heart problems, like a heart attack or acute coronary syndrome, angioplasty/stenting is considered the gold standard of treatment and needs to be performed as quickly as possible, this is not the case with stable patients.
Bush was not an emergency situation and details about the precise nature of the EKG changes and the severity and location of the blockage are not known, prompting many in the medical profession to question the necessity for the stent, given that there has been a significant movement in the interventional cardiology community in the past few years toward a more conservative approach with stable patients: prescribing medical therapy before moving to an intervention.
For example, Dr. Steve Nissen, Chairman of Cardiovascular Medicine at the Cleveland Clinic, criticized Bush's treatment, telling Liz Szabo of USA Today that Bush "got the classical thing that happens to VIP patients, when they get so-called executive physicals and they get a lot of tests that aren't indicated. This is American medicine at its worst." An Op-Ed in the Washington Post, penned by two non-cardiologist physicians, was titled, "President Bush's unnecessary heart surgery." And so on.
More details about Bush's medical situation have not been forthcoming, but one technology that we at Angioplasty.Org have reported on regularly is Fractional Flow Reserve (FFR), a simple way to test the functional significance of a coronary blockage. FFR is performed during the diagnostic catheterization. If the reading is above a pre-determined cut-point, usually 0.80, then the blockage is considered insignificant and stenting is not indicated. Below that point, the blockage is judged significant or "ischemia-producing" and stenting is considered appropriate and beneficial. Unfortunately, only about 15% of all stent procedures utilize this important measurement.
We don't know whether or not Bush got an FFR. We do know that he received a CT Angiogram (CTA) which showed a blockage -- we just don't have more information than that.
Reacting to the many comments critiquing the decision to put a stent in Bush's artery, Scott Huennekens, the President and CEO of Volcano Corporation, one of two manufacturers of FFR catheters (St. Jude is the other), put out the following statement on Friday:
Statement by Volcano President and Chief Executive Officer, Scott Huennekens, on Public Discussion Surrounding Former President George W. Bush's Stent Procedure
August 9, 2013 -- San Diego -- "On behalf of all my colleagues at Volcano Corporation (NASDAQ: VOLC), I send former President George W. Bush best wishes for a speedy recovery and a return to the active lifestyle that has set a powerful example for our nation and provided inspiration to millions of Americans.
The disclosure of health conditions by public figures offers an opportunity to drive awareness and dialogue around critical health issues of concern to us all. Every year, about 715,000 Americans have a heart attack, and about 600,000 people die from heart disease in the United States each year.[1] That is one out of every four deaths, making it the leading cause of death for both men and women in the U.S. There has been significant public debate as to whether the procedure in this case was medically necessary or followed well-established clinical guidelines on the use of stents to open heart vessel blockages in patients with stable disease. This discussion is particularly important because the placement of unnecessary stents can pose serious safety concerns and potentially long-term repercussions for patients who receive them.
Volcano is committed to educating the physician community and the public at large about the clinical and economic benefits of Fractional Flow Reserve (FFR), a brief diagnostic test that is widely available to cardiologists in catheterization laboratories across the country to provide quantitative measurement of a blockage to help cardiologists in determining whether to stent — establishing documentation of the need or absence of need to stent and ultimately helping to drive better patient care.
In certain clinical studies, the use of FFR was associated with improvement in patient outcomes.[2] Additional studies have demonstrated that the use of FFR was associated with changes in diagnostic decisions for patients nearly half the time when compared to assessment using visual modalities such as angiography.[3] From a financial perspective, a study has shown that use of FFR reduced stent use by one-third as compared to use of angiography alone.[4] In short, we believe that using FFR can offer a rare opportunity to improve clinical outcomes and save money.
Despite these facts, we do not believe that the adoption of FFR has been commensurate with this evidence and clinical experience. If we are to achieve the desired goals of providing appropriate treatment, improving patient outcomes, and reducing our nation's medical bill, we must ensure that beneficial, safe and cost-effective technologies such as FFR are being utilized in cases where their use is medically appropriate."
About Volcano Corporation
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information—using light and sound as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together. For more information, visit the company's website at www.volcanocorp.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered "forward-looking statements." including statements regarding the potential benefits of FFR use. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include: unexpected new data, safety and technical issues and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
- http://www.cdc.gov/features/heartmonth/
- Tonino PA, et al. FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24.
- Van Belle, E., et al. Impact of the use of FFR on the coronary revascularization strategy: insights from a large French multicenter FFR registry. Archives of Cardiovascular Diseases Supplements (2011) 3, 1-25.
- Fearon WF, et al. Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50.
Reported by Burt Cohen, August 10, 2013
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