Big news for the last couple of weeks has been FDA’s proposed withdrawal of orthostatic hypotension drug midodrine hydrochloride from the market because its manufacturer didn’t complete post-approval studies verifying the clinical benefit (rather than surrogate end points) of the drug. The drug was approved in 1996 under an accelerated approval process and its manufacturer had agreed to conduct these studies contingent on approval. The company said it had already determined it would remove the drug from the market at the end of next month and had notified the FDA of that decision last year.

The drug, after it’s removed from the market, will be available through an expanded access program. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options. Only about 100,000 use the drug.

The decision to propose to remove the drug from the market for failure to complete post-market studies is a new move for the FDA. The Government Accountability Office last year criticized the FDA for its hesitancy to use its withdrawal authority.

The ACC this week put out 2003 ACC/AHA/ESC Guideline for the Management of Patients With Supraventricular Arrhythmias, page 18), which remains appropriate as long as the drug is available. Should the drug become unavailable, an update will be posted and communicated expediently. The ACC will closely monitor the FDA proceedings and offer updated information as it becomes available.

This is really something to pass out about.

Today's post is from Randal J. Thomas, MD, MS, FAACVPR, FACC, FAHA, chair of the writing committee for the performance measures for cardiac rehabilitation discussed below, and a cardiologist at Mayo Clinic.

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The ACC, American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation on Monday released updated performance measures for cardiac rehabilitation. Cardiac rehab is associated with a 20-30% reduction in all-cause mortality rates and helps promote other significant health benefits in patients after myocardial infarction, CABG surgery, percutaneous coronary intervention, heart valve surgery, and heart transplantation surgery or in those with chronic stable angina.

Despite the significant benefits of cardiac rehabilitation, only one in five eligible patients receives it. 

Why are there so few physician referrals? There appear to be at least four reasons:

1. Lack of awareness of the benefits of cardiac rehabilitation.
2. Lack of awareness of that health insurance policies cover cardiac rehabilitation services.
3. Lack of awareness of the location of cardiac rehabilitation programs in their area for specific patients.

With all the competing demands on a provider’s time—sometimes due to the numerous clinical demands--a provider might simply forget to include referral to cardiac rehabilitation for their patients who are eligible.

On the patient side, there are also significant barriers that keep patients from participating in cardiac rehabilitation.  Some patients aren’t aware of the benefits and the insurance coverage policies for cardiac rehabilitation.  Some have financial, time, or logistical restraints that interfere with their participation in cardiac rehabilitation.

On the health care system side, lack of access to a nearby cardiac rehabilitation program and lack of health care insurance are significant barriers to participation.

While these barriers are significant, there are movements in play that are likely to help reduce these barriers and improve the delivery of cardiac rehabilitation. 

One such activity is the use of cardiac rehabilitation performance measures.  The performance measures include two parts, the first offering a set of measures for the referral of patients to cardiac rehab programs from the inpatient and outpatient settings. Health care providers and health care systems will report the percentage of eligible patients they refer to cardiac rehab programs.  The second set is for the delivery of cardiac rehab services.  Cardiac rehab programs will report on these measures.

The hope behind the performance measures is to increase patient referrals by helping health care providers more easily track referral rates, adopt tools to improve enrollment, and assess and improve the quality of care provided. In particular, the performance measures stress tracking referral rates and then implementing solutions to improve these rates. System-based approaches, such as automatic ordering sets for referring eligible patients to a cardiac rehab program, have been shown to improve referral and enrollment rates. 

Patient Education

To help patients understand cardiac rehab better, ACC’s patient education initiative, CardioSmart, recently released a new video, “Cardiac Rehabilitation: Your Journey Back to Heart Health.” The video follows three recovering heart patients and chronicles how cardiac rehab has help change their lives. The video is available online (www.cardiosmart.org/cardiacrehab.aspx) or you can request a DVD copy from Melissa Ketchum at mketchum[at]acc.org. 

Photo courtesy of the AACPR website. 

See all the guest posts on the ACC in Touch Blog.

Serendipitously timed for ESC 2010: Saudi Arabia has applied for, and been recommended for, Chapter status by the ACC executive committee. Saudi Arabia will become the 8^th ACC International Chapter with many additional countries already having expressed interest in Chapter formation.  The opportunity for “Twinning” and other collaborations between ACC domestic and International chapters will continue to grow. Additionally, ACC national is engaged in educational partnerships, registry development, research collaborations and many other exciting initiatives with its international chapters.

Welcome Saudi Arabia!

I’m off to Stockholm this weekend for the ESC 2010 Congress. Looks like there’s going to be a lot of great science (check out the coverage from CardioSource starting today). On Monday, ACC President-Elect David Holmes, MD, FACC, ACC Vice President William Zoghbi, MD, FACC, and ACC President Ralph Brindis, MD, FACC, are going a special “meet & greet” at the ACC Booth. This is a good opportunity for us to meet with members of the international community and learn more about the issues that are important to them. With everything that’s going on here in the U.S. with health reform, it’s easy to get distracted from international issues – but ACC’s growing number of international chapters makes connecting with international members of utmost importance.

Not only is there the Meet & Greet session, but as Ralph mentioned in his post on Friday on the ACC in Touch blog, there’s tons of meetings with international cardiovascular societies. This really is a great opportunity to meet international cardiovascular professionals! Not to mention, the science looks like it’s going to be top-notch. If you want real-time updates on ACC’s coverage, follow the ACC on Twitter or “like” us on Facebook. If you don’t know how to do this, ask your teenage kid.

Tomorrow I arrive in Stockholm, Sweden, for the European Society of Cardiology’s (ESC) 2010 Congress, along with immediate past president Fred Bove, MD, MACC, ACC President-Elect David Holmes, MD, FACC, ACC Vice President William Zoghbi, MD, FACC, and Jack Lewin (co-author of this blog and ACC CEO). With the full leadership team present, we’ll meet with the leadership of  other major cardiovascular societies – ESC, SCAI, American Heart Association, the World Heart Federation – other with many smaller international cardiovascular societies, like the Turkish Society of Cardiology, Saudi Heart Association, Israel Heart Society, Society of Cardiology of the Russian Federation, Hellenic Cardiological Society, Mexican Society of Cardiology, among others. Fred and Dick Conte will be performing many interviews for our ACCEL program along with important meetings led by Tony DeMaria for our JACC journal editors.  I also will have the honor of chairing a late breaking trials session on Tuesday: “Hot Line III – Cardiovascular Disease and Rhythm Disturbances.”

It’s bound to be an exciting and informative couple of days. You don’t have to be there to learn about the latest clinical content coming out of the meeting – CardioSource.org will be providing updates each day on the hottest trials to be released. Below are the trials that are expected to be hot:

• ALPHA OMEGA
• CURE ACTIVE
• ART
• AVERROES
• EINSTEIN DVT

Beginning on Sunday, check back to http://www.cardiosource.org/Science-And-Quality.aspx for summaries and presentation slides for these trials.

New fuel to the clopidogrel controversy: A study published online yesterday in JACC found that new P2Y12 inhibitors decrease mortality after PCI compared to clopidogrel, in particular for PCI in STEMI patients. In a meta-analysis involving a total of 48,599 patients in eight studies between 1980 and 2010, new P2Y12 inhibitors significantly reduced odds of death, and in PCI patients, the inhibitors reduced major cardiac events by 18% and stent thrombosis by 40%. Study authors conclude:

“In PCI patients, new P2Y12 inhibitors decrease all-cause mortality and major ischemic events. The net benefit is particularly marked in PCI for STEMI patients, in which there is no significant increase in major bleeding when compared with clopidogrel.”

The FDA earlier this year placed a black box warning on clopidogrel, warning physicians that some patients’ genetic makeup can affect their response and put them at risk for serious adverse events. Given that “no single study has shown a decrease in” the single hard endpoint of “mortality with clopidogrel when used in the setting of PCI or in STEMI patients treated by PCI” (according to the JACC study), cardiovascular professionals may soon find increasing appeal in utilizing these newer P2Y12 inhibitors as they become approved by the FDA. These agents theoretic appeal is that their pharmacological profiles differ from clopidogrel – there’s less concern of genetic variations causing uncertain anti-platelet activity and they have the additional desirable features of reversibility of the anti-platelet effect, and now, most importantly, evidence from this new meta-analysis of decreased mortality post PCI in ACS patients.

How do you think this new study will impact your clinical practice?  Is a single meta-analysis study with its inherent methodological weaknesses enough to cause a major change in the clinical practice of the use of thienopyridines?

With the launch of the re-designed CardioSource.org, the ACC launched a social network for site members, called CardioSource Communities. Several of my Board of Governors’ colleagues have started interesting discussions in the forums that I wanted to share.

Former Governor of Colorado Gene Sherman, M.D., F.A.C.C., (and current ACC PAC Vice Chair) talks about the ACC PAC in his post “Getting Involved in Health Care Reform is Easier Than You Think!!” He writes: “Since discussions of health care reform heated up before the 2008 Elections, health care professionals have become increasingly nervous and frustrated.  At times, it is easy to feel marginalized and to feel that physicians and other members of our care team are not respected for our experiences and opinions.” Read the rest of his post and continue the discussion.

Thad Waites, governor of the Mississippi Chapter, writes about statins and ESRD: “The nephrologists in our center have requested that the cardiologists stop prescribing statins for dialysis patients.  This request is based on two studies that indicated there is no benefit in this group.  As cardiologists, my group is uncomfortable with this request.  And, as I ‘google’ the subject, there are mixed opinions in the published studies, but no forums discussing it.” What do you think?

The forums are a great way to ask questions of your peers in a more un-structured way. Check out all the forums, and leave your thoughts.

A lot is going on in with professional liability these days.

1. InsideHealthPolicy.com recently reported that it is not looking like Congress will fund a tort reform provision of the health reform law (PPACA). The provision authorized $50 million to be spent on medical liability demonstration grants to test out ways to improve the tort system. However, the Senate’s final 2011 HHS appropriations bill does not include this funding, and some following the House process (the actual details are still embargoed) don’t believe they’ll include it either. Senate HHS Appropriations Subcommittee Chair Tom Harkin (D-IA) said that the Senate didn’t include the funding because it wasn’t requested. HOWEVER, in a separate project by the Agency for Healthcare Research and Quality, $25 million has been awarded for a project with similar goals.
2. Given that Congress isn’t exactly moving at a speedy pace with tort reform, the ACC launched a resource on Friday to help practices and physicians reduce their claims risk. The ACCF’s Risk Management Institute (ACCRMI) provides case-based risk management education tools and information to reduce the risk of medical professional liability claims (by increasing patient safety). ACCRMI’s education tools draw from real life in cardiovascular medicine because they are built from data regarding trends analysis gathered from closed medical professional liability claims involving cardiovascular disease treatment. To help develop the ACCRMI, the Physician Insurers Association of America (PIAA) shared information with ACC from closed claims between 1986 and 2008. Learn more about the ACCRMI at http://CardioSource.org/RMI.
3. Finally, the House Energy and Commerce Committee back in July approved H.R. 1745, the “Family Health Care Accessibility Act.” The bill amends the Public Health Service Act to provide tort liability protection for volunteer practitioners at community health centers. The ACC is developing a liability law proposal that would be broader than H.R. 1745, which would at least be one step in the right direction to lowering liability protection premium costs.

The ACC last week announced its partnership with the Society for Cardiovascular Angiography and Interventions (SCAI) to provide accreditation of hospitals where invasive cardiac and endovascular procedures happen. The Accreditation for Cardiovascular Excellence (ACE) organization will review hospitals and then accredit those that achieve predetermined benchmarks for quality care that have been shown by the literature to improve patient care. Right now, ACE is providing accreditation for hospitals that do carotid artery stenting, but it plans to expand to other procedures like PCI. The accreditation lasts for two years, and then hospitals must be reviewed again. Several hospitals have already applied for the accreditation. 

SCAI and ACC have formed a board to oversee the project, which SCAI Past President Bonnie Weiner, who has very much championed this project from the beginning of its inception, will chair.

Recent studies have shown accreditation improves patient outcomes and enhances patient safety standards, and ACE is designed to transfer those academic findings into a real-world application. By developing accreditation standards in this area, we are taking further steps toward our goal of providing excellent care in all facilities where invasive cardiac procedures are performed. The ink is just beginning to dry on the Agreement between ACC and SCAI to establish ACE.  You’ll be hearing a lot more about the ACE offerings as we begin to roll out the program. Facilities seeking ACE accreditation can obtain more information and complete the application process at www.cvexcel.org.

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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A few years ago, I had the occasion to call one of our patients who was waiting for a heart transplant with a left ventricular assist device (LVAD). He had been on multiple inotropic agents, but was showing progressive deterioration in his status, with a very low serum sodium, low cardiac output, diminishing renal function and beginning obtundation. He needed the LVAD, and received a Heartmate-I® pulsatile LVAD as a bridge to transplant. Immediately post-op, his skin color was better, urine output increased, mental status improved and his serum sodium and creatinine quickly corrected over a few days. He was discharged to home 2 weeks later.

The occasion of my call was to answer several questions he posed to our practice, and his wife told me that he couldn’t come to the phone just then because he was on the roof of his house installing new shingles. I was first tempted to order him down immediately, but thought that the reason for the LVAD was to restore a reasonable quality of life, and that was his interpretation of a reasonable quality of life. He finished the job uneventfully in a few days, was non-the-worse for the effort and received his transplant a few months later.

Working with end stage heart failure patients in a transplant center provided the opportunity to witness the value of an LVAD when a patient was at the extremes of heart failure and efforts to maintain stability were failing. The patients quickly realized the value of the device, and began to ask for its use even when transplant was not possible. The REMATCH trial (N Engl J Med 2001; 345:1435-1443) confirmed the concept that we could use the LVAD for destination therapy, and we began to select patients for this therapy. These patients seemed to be highly grateful for this new opportunity for a reasonable life, and rarely complained about the rigors of living with the LVAD. We even discovered that some LVAD patients, who were not acceptable for transplant for social reasons, reorganized their lives to the point where we reconsidered them and recommended them for transplant.

In spite of the optimism, we encountered patients who did no thrive on the LVAD, and when they were comatose with little hope of survival due to overwhelming sepsis, end stage renal failure, or active cancer, we discussed the need to terminate LVAD support, and after concurrence with all involved, turned off the pump. Resolving this ethical issue became a necessity for our VAD program, as there is nothing worse that having a patient with no brain or heart function continuing with a normal blood pressure and no hope of recovery.

Because of the ethical issues involved in terminating LVAD support, it’s no surprise that the issue of turning off a heart support device is becoming increasingly public. ACC BOG Chair Dick Kovacs, MD, FACC, recently wrote about a New York Times piece examining one family’s struggle to have a pacemaker turned off. The experience was traumatizing for all those involved and, as Dick wrote, is a good reminder that the wishes of the patients need to be fully appreciated. With artificial technology increasingly being used to prolong life, and with VAD technology improving so that more patients will likely have these implants, these questions are going to rise in importance.

Recognizing this, researchers at Mayo recently published a review of 14 cases where patients who were being kept alive by an LVAD requested that it be turned off. Mayo researchers concluded that turning off the LVAD was “ethically and legally permissible” because practitioners were not introducing a “new pathology” to induce death; rather, turning off the LVAD allows the heart failure to take its course. As long as the patients and their family understand what will happen when the device is turned off, physicians should respect their decision. All the patients had serious complications that limited their chances of survival even with the VAD, and they or their families appropriately requested that the VAD be turned off.

The study authors conclude:

Patients have the right to refuse or request the withdrawal of any unwanted treatment, and we argue that this right extends to VAD support. We also argue that the cause of death in these cases is the underlying heart disease, not assisted suicide or euthanasia. Therefore, patients with heart failure supported with VADs or their surrogates may request withdrawal of this treatment. In our view, carrying out such requests is permissible in accordance with the principles that apply to withdrawing other life-sustaining treatments.

The Mayo study will help clarify what physicians should do in one very tricky situation. If you are involved with care of VAD patients, this issue should be addressed as a program policy so that one physician will not be left to resolve this dilemma.

After years of efforts with courts and regulators, UnitedHealth Group has settled claims that it used a flawed database operated by Ingenix (a UnitedHealth Group subsidiary) to determine out-of-network payment rates, increasing insurer profits at the expense of patients and providers. Over $350 million is available as part of the settlement to any and all providers who submitted “non-network” claims to UnitedHealth Group between 1994 and 2010. Providers who wished to be excluded from the settlement must have opted out as of July 27. 

This is the only opportunity for providers to obtain any retribution for lost revenue. For this reason -- and given the fast-approaching submission deadline -- the ACC is teaming up with the Managed Care Advisory Group (MCAG) to help members in obtaining data, identifying eligible claims and submitting all necessary paperwork to the settlement administrator by the October deadline. Given the 15-year window for eligible claims, providers must contact MCAG by Sept. 21.

How it works: MCAG retains a small percentage of the money recovered as payment for services. As part of the ACC/MCAG partnership, ACC and American Medical Association (AMA) members will receive discounts on MCAG services. It is important when contacting MCAG to let them know that you are an ACC and/or an AMA member to receive the discounted rates. The MCAG phone number is 800-355-0466. 

MCAG resources for ACC members:

• United Health Group Settlement Information
• UHC Payers Involved In Class Action Settlement

We’ve been waiting a long time for this settlement... If you qualify, you should take this opportunity to file for lost revenue.

The ACC this week published its first CardioSurve Newsletter, which presents some interesting findings from several surveys of a group of 350 U.S. cardiologists. It covers a couple of different topics, including electronic health record adoption, use of guidelines and treating atrial fibrillation, but I think the most interesting finding of the last couple of months of CardioSurve data is what the panelists said about the effects of declining reimbursements and rising costs.

The survey asked panelists what actions they’ve done in the following 30 days:

• 58% said they reduced staff to save expenses
• 17% said they’ve limited services
• 8% said they’ve reduced office hours and availability
• 4% said they retired and
• 4% said they limited the number of new Medicare patients

Another 28% said they have done none of the above, and 20% reported “other.”

Private practices appear to be extremely affected by the changing landscape, with private practices 2.5 times more likely to report having taken some form of cost-cutting action in the past 30 days compared to other practices. In addition, private practices surveyed reported looking to hospital integration as a potential solution to their current woes, with 30% of migration plans focused on hospital integration (as compared with merging with another practice).

These findings show that cardiology is making changes to keep up with the current health care environment – some not necessarily for the better. Congress may think that we can sustain the increasing reimbursement cuts, whereas in fact, we have to make real changes to the way we practice (cutting necessary staff, limiting services) that affect the patient experience.

The ACC is in the process of compiling a larger, more robust survey of more than 2,000 cardiologists that appears to be even more damning. Keep your ears open in mid September for the results.

How do the results of this survey reflect your experiences? Have you done any of the above?

 

The ACC and the Duke Clinical Research Institute (DCRI) are recruiting hospitals enrolled in ACC’s NCDR® CathPCI Registry® to participate in an observational study -- the TRANSLATE-ACS Study -- to examine longitudinal outcomes, treatment patterns and health care costs for 15,000 patients with AMI treated with PCI and antiplatelet medications.

This is a very exciting study for NCDR because it has several interesting components: 1) It’s longitudinal and will follow patients for 15 months, and 2) it’s going to provide quarterly feedback reports to hospitals about 30-day readmission rates and rates of outpatient adherence to CV medications. This method of study aims to connect what happens in the hospital with the outpatient setting, which should provide powerful data for participating hospitals and us clinicians to use to improve their quality.

The hope is, of course, that the findings of the study will benefit patient care, hospital quality improvement and nationwide quality of care, and we’re very excited for the outcomes. Learn more and/or enroll in the TRANSLATE-ACS study.

With the passage of federal health reform, states are preparing for the most sweeping changes in health care in 30 years. Now the hard work begins.

At the recent ACC Board of Trustees meeting in Maine there was a lot of discussion about ways the College can help members navigate this new environment, including developing quality tools that fit into the workflow of the office and provide real-time feedback to members. Supporting the practice of cardiology with efforts to link life-long learning to quality, growing longitudinal outpatient registries, honing appropriate use tools and stimulating careers are other ways the ACC can meet the needs of members regardless of practice setting.

There are also key questions that the ACC can and should play a role in answering, including: What is an accountable care organization? Can a cardiology practice be a medical home? What does a reformed payment system look like?

The College also needs to continue to develop programs and tools to help practices assess their practice options. For those practices that are moving to integrated systems, we need to focus on recruiting hospital-based practice administrators into the ACC and show them the value the ACC brings in terms of quality, education and advocacy. For those continuing with private practice we need to provide ways to maintain practice viability, whether that’s through tools to help meet federal incentive program requirements or working with health plans on innovative programs and/or resources that meet their needs, while reducing the administrative burdens on providers and practices for things like medical imaging.

As we roll up our sleeves and get to work, we need explore these and other possibilities to the fullest extent possible. It won’t be easy, but given the dedication of ACC’s leaders, staff and members we can continue to transform the practice of cardiology and fulfill our mission of ensuring evidence-based, high-quality care for patients with heart disease. 

A recent article in the Wall Street Journal (“Americans Cut Back on Visits to Doctor”) examined the declining use of medical services. Health insurers report in the article that utilization of medical services is dropping, as does CVS Caremark and Quest Diagnostics.  According to the article:  “Insured Americans are using fewer medical services, raising questions about whether patients are consuming less health care as they pick up a greater share of the costs.”

Is this really any surprise? The recession continues and health care costs are rising. Use of high deductible plans, which require a greater upfront expenditure, also is rising, leaving more and more patients to pony up large sums of cash for care. Not shockingly, they are choosing to forgo care rather than pay for all of it themselves. Who can blame them. The article notes one upside to this trend: patients using less care means insurers are making more profit. The more profit insurers make, the less likely they’ll be to raise their rates next year (hey, maybe they’ll even lower them -- although I wouldn’t put any money on that).