This just in…FDA has ordered enrollment in the TIDE trial to stop even though the FDA panel voted last week to continue the trial (the panel did not vote on whether to halt enrollment).

MedPage Today has more on the announcement.

This post was authored by former ACC President Alfred Bove, M.D., Ph.D., M.A.C.C. For more blogging from Dr. Bove, visit his blog on CardioSource Communities, which discusses the Heart and Diving.

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As I listen with my stethoscope to the chest of a patient with the Heartmate II® left ventricular assist device (LVAD), I am struck by the absence of the mechanical sounds so familiar with the prior Heartmate I® device that was a pulsatile LVAD.  Instead, there is a soft whine of the high speed rotor of the axial pump that had its origin in the fuel injectors of the rocket engines used for space flight.

The news about former Vice President Dick Cheney receiving a Heartmate II axial LVAD has raised awareness of the fact that there are now hundreds of patients who are alive, waiting for a heart transplant or living with the VAD as a permanent heart assist device.  These devices have added an important tool to our therapy of end stage heart failure.  When we used chronic inotrope infusion to keep patients stable while they waited for a heart transplant, we found a number of patient who ultimately could not maintain their cardiac output, and required an assist device that was usually an intraaortic balloon pump prior to about 1994.  

Since then we have been able to support the end stage failing heart with an assist device that is well tolerated in most patients and has been shown to extend life in these patients.  With the new design that shifted the pumping mechanism from a cyclic pump that would wear out in 12-16 months, to an axial rotating pump with specially designed bearings that last many years, longer term use of the devices became possible. There are patients in the U.S. who are living for more than 3 years with the devices.  Many return to full activity, and seem to tolerate the device quite well.  We have heart patients that ask about avoiding transplant and keeping the VAD to eliminate the need for the complex medication program and the complications of immunosuppression that occur post heart transplantation.

There are still the complications of infection, embolism, and mechanical failure that are not avoided with the new axial VADS, and the activation of Von Willebrand factor due to the high shear rate of the rotating pump.  The patients also need to be on warfarin anticoagulation.  In spite of the side effects and the care needed to avoid infection, maintain charged batteries, perform VAD failure drills, and the constant questions about what is whirring inside their chest, patients appreciate the fact that they can return to a more normal life without heart failure.  Given his circumstances, I believe Mr. Cheney made a good choice for his heart failure therapy.

Quality in the outpatient setting seems to be a topic that is getting more and more attention in the specialty arena. Some of my primary care colleagues have been looking at their quality of outpatient care for several years now.

If the recent New York Times article is any indication, it seems to me that the insurers will steer patients to physicians and practices that can demonstrate their quality.  The article discusses the increasing demand for health plans that limit patient options for providers to save on costs. The article states:

One way insurers say they hope to prevent ... consumer backlash is by emphasizing that they are not choosing doctors on price alone. The insurers say they look to see how quickly a doctor’s patients recover from surgery, for example. But how much the insurers emphasize quality remains to be seen.

The problem (or, more accurately, ONE OF the problems) with this is that frequently physicians get assigned “quality” by measures that are not created by doctors, or maybe were created by doctors but use claims data rather than clinical data.

If we’re going to get measured, then we need to be the ones creating the measurement system. That’s why the ACC put together something called the Cardiovascular Practice Recognition Program (CVRP), which is practice-level assessment and recognition program designed specifically to identify quality in cardiovascular practice. The CVRP will establish legitimate goals and targets for cardiovascular specialists and their practices. I think this is a program that holds great promise for quantifying quality in the outpatient arena, and we’re working to refine the program even further. You can learn more about the pilot program on CardioSource.

A Washington Examiner editorial last week looked at the special influence that trial lawyers have on President Obama. According to the editorial, the president may grant trial lawyers a $1.6 billion special interest tax break without congressional approval. The tax break would allow plaintiffs’ attorneys to deduct litigation costs the same year they file contingency lawsuits. Typicially, these deductions have only been allowed if and when a case is lost. According to the editorial:

“It is unconscionable that ‘spread-the-wealth’ Obama should force taxpaying plumbers, waiters and bus drivers across America to shoulder up to 40 percent of the cost of wealthy trial lawyers’ litigation with this tax break. Worse, the tax break provides an effective reduction in lawsuit expenses, freeing up lawyers to file more suits that have less probability of success.”

Physicians and medical professionals see first-hand the overwhelming influence that trial lawyers can have over politicians in the back-and-forth struggle to pass tort reform. There are proven strategies that work to reduce the burden that unnecessary malpractice suits have on the legal and medical systems, but we are unable to implement them because of politics. Of course, the lawyers invest more in their PACs than we do, folks! If we were a bit more willing to defend ourselves, we could prevent this $1.6 billion tax break, which arguably would be better spent on health care.

And get this: About nine in 10 physicians said doctors order more tests and procedures than patients need so they can protect themselves against lawsuits, according to a study in the June 28 Archives of Internal Medicine. A story by American Medical News examines the study, which noted that the cost of defensive medicine is estimated to be $60 billion annually. What a waste. Let’s get some tort reform in a cleanup bill in 2011. The ACC is building a coalition to do just that!

This post is authored by ACC Health IT Committee Vice-Chair James Tcheng, M.D., F.A.C.C., and Committee member Jeffrey Westcott, M.D., F.A.C.C.

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Earlier this week, CMS completed a crucial step toward the goal of universal use of electronic health records (EHR) by all practitioners for all patients across the nation. The event?  CMS released its final rule that defines how eligible providers and hospitals can successfully participate in its EHR Incentive Program. This program provides payments – up to $44,000 over five years under Medicare and $63,750 under Medicaid – to providers who can meet its requirements of being a “meaningful user” of a certified EHR system.

According to the final rule, to be a “meaningful user,” you will need to use a certified EHR system and satisfy a series of measures, including 15 core requirements and five out of 10 optional requirements (for a list of these requirements, read this perspective piece by David Blumenthal, M.D., M.P.P., director of the Office of the National Coordinator, or ONC). These include a key core requirement – quality reporting – that builds on the remarkable achievements of the past several decades of the cardiovascular community in improving outcomes of our cardiovascular patients.

The Proposed vs. the Final Rule
CMS received nearly 2,000 comments on its initial “notice of proposed rulemaking” for the program, including extensive feedback authored by the ACC on your behalf.  We were deeply concerned about how CMS proposed to define meaningful use, as the first version included difficult and complex requirements that would have made it virtually impossible for you to participate in the program.

CMS and ONC have clearly been listening. They made extensive changes to the proposed rule in the final rule. For example, in the proposed rule, physicians would have had to meet 25 very specific requirements in their entirety to qualify for the program. This was changed to 15 “core set” requirements, plus your choice of five out of 10 “menu set” optional requirements.

And the metrics for achieving compliance with most of the requirements have been scaled back.  A prime example is computerized physician order entry (CPOE). The initial proposal would have required physicians to use CPOE for 80% of all orders.  Although the Final Rule requires a CPOE system that is able to capture orders for medication prescriptions, laboratory, and radiology / imaging studies, the performance measure for Stage 1 is only that physicians will have used CPOE to author 30 percent or more of medication prescriptions – a significantly reduced requirement.

Additional flexibility has also been added with respect to clinical quality measurement. Rather than requiring practitioners to report on three core measures and a rigid, pre-defined set of 3-5 specialty measures, the Final Rule requires reporting on a total of six measures – a combination of three core measures AND any three additional measures of the providers choosing. There are even alternative core measures that can be substituted for the base core measures.

CMS and ONC did remove several requirements (primarily administrative transactions) from the list of requirements. The proposed rule required professionals to submit claims electronically, as well as to perform the HIPAA eligibility transaction. The ACC and other professional associations successfully argued that these requirements were inappropriate at this time, especially with respect to the HIPAA eligibility transaction, which most health plans, including Medicare, have not fully implemented at this time.

The large number of changes reflects that they listened to the feedback they received. Their changes will help make the program goals – improved quality and patient care – attainable to a larger number of physicians. More...

An FDA advisory panel yesterday voted 20-12 to keep rosiglitazone (Avandia) on the market. The panel vote came after two days of intensive data review. Of the 20 members who voted not to remove the drug, the overwhelming majority recommended the drug include stricter labeling. Half of those votes suggested that rosiglitazone be restricted to prescription only by physicians with special knowledge in use of the drug. Some panelists also indicated that additional patient education is needed. Only three of the panelists voted to keep rosiglitazone on the market without additional product labeling. The 12 members recommending removal of rosiglitazone argued that pioglitazone works just as well without the added risks of ischemic events. 

The panel was also tasked with making recommendations in eight additional areas, including safety of rosiglitazone as compared to pioglitazone and other hypoglycemic drugs. In evaluating whether rosiglitazone presents greater risk compared to non-thiazolidinedione (TZD) diabetes drugs and pioglitazone, the panel voted 18-6 in favor of the notion that sufficient evidence exists to support an increased risk of ischemic cardiac events as compared to non-TZDs. Nine voting members were unable to make a decision on this specific point. The panel also voted 21-4 when asked to determine whether rosiglitazone is less safe than pioglitazone. Eight panel members were unable to decide.

In addition to voting on whether or not the drug should remain on the market and specific safety concerns relative to comparable drugs, the panel was charged with recommending whether or not TIDE, the ongoing international trial designed to compare rosiglitazone to pioglitazone with respect to risk of MI, should continue. In a 20-10 vote, the panel recommended that TIDE carry on (one panelist did not vote and another two were no longer present).

Though the FDA panelists failed to reach a unanimous consensus on any of the nine recommendations, they agreed the available data are confusing and additional information is needed. They also seemed to agree that many flaws exist in the data.

The FDA is expected to make a final decision on the fate of rosiglitazone in the coming weeks. Though the agency is not obligated to follow the recommendations of its panel, it often does. Stay tuned for updates as we learn more.

Mainstream Coverage:

• Washington Post
• USA Today
• Los Angeles Times
• Wall Street Journal 

UPDATE (7/19): Check out the coverage the ACC received in the WSJ's Health Blog, which talks about the difficulty doctors will face making recommendations about the drug to patients.

An FDA panel just moments ago voted on whether diabetes drug Avandia increases the risk of heart attack, stroke and death. By a majority, the panel voted that there is SUFFICIENT evidence to indicate that Avandia, compared to its competitor Actos and other oral hypoglycemic drugs, does increase the risk of heart attack and stroke. However, there is INSUFFICIENT evidence that the drug causes an increased risk of death.

Today's vote is just one of nine recommendations the panel must issue, including whether the drug should remain on the market, be removed or have a stronger warning. It also will determine whether an international trial that compared Avandia and Actos should continue. (See our discussion of a Boston Globe article from late last month on the topic).

The ACC appreciates the deliberation and comments regarding Avandia from the FDA panelists today. The safety and well being of patients is of the utmost importance to the ACC and our members and the panelists today expressed reasons for concern in respect to the drug's safety.

By the panelists' comments, it is also clear more research and independent study would be helpful to fully understand and know the risks associated with this drug. Patients should speak with their physicians about all treatment options available.

This post comes to us from Jeffrey Anderson, M.D., F.A.C.C., chair-elect of the ACC/American Heart Association Task Force on Practice Guidelines and Vice Chair of the 2010 UA/NSTEMI Focused Update. Dr. Anderson also is the Associate Chief of Cardiology at Intermountain Medical Center in Murray, UT.

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Angiotensin-receptor blocker (ARB) agents drugs have shown substantial reductions in the risk of cardiovascular mortality, myocardial infarction and stroke in patients with hypertension and heart disease. However, a recent article in Lancet Oncology that looks at a pooled analysis of studies focused on the cardiovascular effects of ARBS, suggests these drugs may modestly increase the risk of a new cancer diagnosis. It should be noted that the absolute risk is small, the study is retrospective and exploratory, and that the question of class effect versus specific drug effect for the potential cancer risk is uncertain.

The article, while not definitive, has generated a good deal of discussion within the cardiovascular community about how best to react in terms of both further study and in discussing with patients.

As with any product used in the care of patients with cardiovascular disease, the ACC is a huge proponent of understanding both the product’s effectiveness and safety. In this particular case, the College is supportive of efforts to further clarify the association of ARBs and cancer and put the study’s potential findings into better perspective. For example, do the proven benefits of ARBs outweigh the risk of cancer? That being said, these new data should not warrant overreaction.

In the interim, patients should not stop taking ARBs based upon these data, but should work with their care providers to determine the best medication regimen. (If you're looking for a good article to give your patients on the topic, see this CardioSmart article.) The study does not diminish the importance of treating hypertension or left ventricular systolic dysfunction with effective regiments prescribed by their physicians, which may include the use of ARBs. Current UA/NSTEMI and STEMI guidelines, as well as performance measures for heart failure at AMI, remain current in that they generally support ACE inhibitors as first-line therapy where appropriate. ARBs are recommended for patients who cannot tolerate ACE inhibitors. 

What do you think?

- Jeffrey Anderson, M.D., F.A.C.C.

The New York Times Magazine recently featured an interesting article that looked at clinical decision making from a patient/caregiver perspective. “What Broke My Father's Heart” highlights what the author feels was a device that kept her demented father alive beyond what he or the family wished for. If you haven’t read it, I recommend it. We may agree or disagree with the author, but the perspective of our patients and their families is a view we should appreciate. I suspect we have all dealt with situations like this.

Have you had a similar situation? How have you handled it?

Recently, Jack wrote about his views on radiation risks and the need to balance concerns about radiation dose with getting a test done that could reverse a life-threatening condition. Yesterday, a study came out in JACC that finds that cardiac imaging procedures increased risk of radiation exposure and effective doses for those in the study.

Of the 952,420 patients in the study, which were nonelderly adults with continuous enrollment in United HealthCare, 9.5% underwent at least one cardiac imaging procedure associated with radiation exposure over the three years of the study. The mean cumulative effective dose for these patients was 23.1 mSv, with a median dose of 15.6 mSv.

However, as the authors note in their discussion:

“The public health and clinical implications of radiation exposure from cardiac imaging are not easily determined. Clinicians and patients must consider tradeoffs between the benefits of cardiac imaging procedures and their potential long-term risks due to radiation.”

They also note that while “radiation exposure from cardiac imaging procedures may be worth the risk for many patients,” many of the younger patients in the study “may be candidates for alternative imaging modalities that do not use ionizing radiation but provide similar clinical information for informed decision making.”

Editorial Comment
Accompanying the JACC article is an editorial comment that questions the assumptions of the study. The authors write:

“...[T]he entire premise that radiation doses from medical testing causes cancers remains hypothetical. ... [T]he relationship between low-dose medical imaging and harm has never been established.”

They conclude: “We need to move beyond radiation models, with so many assumptions, to studies documenting the real risk (if any) to the cardiac patient.”

My Thoughts
Each of the articles raises important points. On the one hand, patients are being exposed to long-term risks associated with radiation. On the other, we’re not really sure how much of a problem these risks are. Clearly, more research is needed to understand radiation risks in patients: how much radiation puts them at increased cancer risk; how much is the increased risk; and are the tests being performed appropriate.

The ACC has taken a multi pronged approach to ensuring radiation safety, including:

1. Setting standards through laboratory accreditation programs, appropriate use criteria (AUC), clinical practice guidelines and other standards documents;
2. Developing requirements for training programs and competency, including  how to minimize radiation doses during testing and procedures; and
3. Implementing quality improvement programs aimed at lowering the dose for each scan or procedure performed. Approaches to minimizing dose include using AUC to eliminate unnecessary scanning procedures; following the principle of “as low as reasonably appropriate” (ALARA) with respect to radiation levels; displaying dose information wherever studies are done; and encouraging facilities to monitor delivered doses and compare them with benchmarks.

Through these efforts, and by working with the American College of Radiology (ACR) and other specialties, we can ensure that patients are receiving the most appropriate and safe treatment possible.

Patient Involvement
Meanwhile, patients need to become more involved in their care, in particular understanding the risks of undergoing imaging and weighing their imaging options. The more patients are able and willing to be involved, the more they are able to weigh the risks and benefits. The ACC currently has its patient education portal, CardioSmart, to assist providers with educating patients about their different imaging options. We hope to include more about radiation risks in the future.

Ultimately, the idea is for physicians and patients to work together to determine the appropriate treatment or test. Such decisions would include a discussion of radiation-related concerns as compared to the risks and benefits of the different diagnosis or treatment options and could lead to better patient understanding of potential side effects.

For more about ACC’s commitment to patient safety in medical imaging, read ACC’s patient safety briefing on CardioSource.

Your turn: Do you think that imaging procedures put patients at undue risk? What’s the best way to mitigate these risks?

UPDATE (7/9): Two mainstream news articles covered the article:

• CNBC
• Sunjay Gupta's blog on CNN