Last night I officially turned over the gavel to David Holmes, MD, FACC, marking the end of my presidency of the ACC. This past year as president has been rewarding, but it’s also been incredibly challenging. When I first took over from Alfred Bove, MD, PhD, MACC, I identified the theme of my presidency as “professionalism,” knowing that the year would bring many changes that would require others in the health care arena to view us as true professionals, not just a guild.

Reflecting on the past year, I feel that we’ve accomplished a lot in proving ourselves as such. We are viewed by many as a forward-thinking, professional society, and as a trusted resource when it comes to cardiovascular science and education expertise. We are also increasingly the go-to organization for issues involving quality assessment, appropriateness of cardiovascular care, and new care delivery and payment models. Our efforts to date have been consistently recognized by the White House, Congress, Medicare, National Institutes of Health, the Agency for Healthcare Research and Quality, FDA, patient advocacy groups and our partners in the medical community.

This is not to say the year has been without struggle. Interventional cardiology has been accused on multiple occasions of overuse of coronary stenting procedures. Electrophysiologists received similar criticism when a JAMA article, based on NCDR ICD Registry data, reported the presence of inappropriate implantation of ICDs for primary prevention of sudden cardiac death in Medicare beneficiaries. Health care reform and other regulatory changes have placed cardiology in an uncertain position – where will the profession be 5, 10, 15 years from now? Will there be “private practice” as we know it today?

The ACC has worked to overcome these challenges by taking a leadership role, rising to the occasion of “knights of cardiology,” and proving to the world that we will not stand by and be simply knaves or pawns. We are quality in action.

Under Holmes’ leadership, we will continue this tradition of professionalism, with Holmes bringing additional focus on education and science. Whether it’s through education, science, quality programming, professionalism or advocacy, we are making a collective difference and saving the lives of countless patients in the process.

Thank you for the past year of my presidency, and for the opportunity to hear your concerns and questions through the ACC in Touch Blog. Although I’ll no longer be an author here, I hope to have frequent “guest blogs” where I can continue to hear your feedback. Thank you for all that you do.

*** Image from Flickr (walknboston). ***  

Tonight, Anthony DeMaria, M.D., M.A.C.C., JACC editor-in-chief, will deliver the 42nd Annual Louis F. Bishop Lecture from 4:45 – 6 p.m in Room 221 in the Convention Center. His lecture discusses a topic of utmost importance to cardiovascular professionals, and one that all ACC.11 & i2 Summit attendees will have to struggle with following the meeting – how do we take the latest clinical trials, with their narrow study populations and design limitations, and apply them to the specific and unique patient sitting before us in our office? It’s a tricky question, and one that I am sure will garner interesting discussion following the presentation. For more about the lecture, read this interview between DeMaria and Cardiology magazine editor Cherie Black in the ACC.11 & i2 Summit Community. I’ll be at the lecture tonight, and I hope you will join me!

Inappropriate stent use made the news again last week, after a Pennsylvania hospital announced it plans to review two cardiologists accused of implanting 141 stents inappropriately. The article came out just two days after the Maryland State House held hearings on new legislation that underscores the need for accreditation & certification of catheterization labs. The bill, the Maryland Cardiovascular Patient Safety Act, was drafted by the ACC, the Maryland Chapter of the ACC and SCAI following meetings with state policymakers. We have been working to get this bill introduced.

Maryland has been at the forefront of the stenting controversy. Larry Dean, M.D., F.A.C.C., SCAI president, Sam Golderg, M.D., F.A.C.C, Maryland Chapter governor, and Mark Turco, M.D., F.A.C.C., Maryland Chapter governor-elect, and I wrote a President’s Page for the Feb. 17 issue of JACC that addressed how we see the situation of procedure overuse, which is neither confined to the state of Maryland or the field of interventional medicine. To be perfectly clear, the ACC does not condone inappropriate use of coronary stenting, overuse or misuse of any cardiovascular technology or therapy.

That said, what’s happening in Maryland is a prime example of how a negative situation can be turned into a positive opportunity to improve quality and appropriateness of care. Working with Maryland lawmakers, we were able come up with a solution that allowed state officials to feel that quality in cardiovascular care will being ensured, while allowing physicians to determine the specific manner in which that can best be achieved.

“We are all in the same boat in a stormy sea, and we owe each other a terrible loyalty,” wrote English author G.K. Chesterton. How we react to this overutilization storm will determine our future. We must take stewardship for the health care system into our own hands, so that society will view us as true professionals who can be trusted to practice appropriate use of resources because we are basing our treatments on the latest and best scientific evidence.

You can read more about what the ACC, ACC Maryland Chapter and SCAI have been working on in Maryland in this previous blog post; in particular, the comments section offers great insight into the views of ACC members.

Health and Human Services Secretary Kathleen Sebelius chatted recently with MedPage Today about President Obama’s proposed 2012 budget and the provisions of interest to physicians. As Jack wrote last week, the proposed budget contains enough funding to freeze physician payment under the sustainable growth rate at current 2011 levels for two years. While this certainly is an improvement over having to fight off the massive draconian cuts that the SGR full enactment would entail every year (or every few months, as has happened the last couple of times), this is hardly the permanent fix that the ACC has been pushing for. Sec. Sebelius explains what she feels is the rationale for this limited freeze: pass the 2-year freeze to “start a conversation with Congress,” and then immediately work on a permanent solution. Sebelius notes that there is nothing more important than having doctors in Medicare, and acknowledges that physicians are getting weary of going year-to-year having their pay jeopardized.

She’s right there. There have been several reports in the media of physicians dropping out of Medicare as a result of cuts present in the Physician Fee Schedule and the constant uncertainty of the SGR. However, it’s a little unclear if passing a two-year fix will actually give Congress two years to work on an innovative payment system that rewards high-quality care (what the ACC and other medical societies would like) ... or two years to avoid dealing with the massive cost this type of effort would likely require. I hope that Congress steps up to the plate to truly solve the SGR dilemma for us physicians over the next two years.

Check out the video on the KevinMD blog for Sec. Sebelius’ take on other health care issues, including health IT, the Affordable Care Act, fraud and abuse and the medical loss ratio.

A study in JACC yesterday looked at the inclusion of three new attributes to predict in-hospital mortality following PCI that has implications for public reporting of hospital performance. In Massachusetts, where the study was conducted, reporting of in-hospital PCI mortality rates has been required since 2003 through the NCDR CathPCI Registry. However, since the CathPCI Registry was not built for public reporting and not intended to identify high-risk clinical scenarios, physicians in 2006 recommended inclusion of three additional attributes, which they deemed “compassionate use” (CU) measures. These measures are: coma on presentation, active hemodynamic support during PCI and cardiopulmonary resuscitation at PCI initiation. The purpose of the study was to see if including these measures was feasible and would improve the prediction model for in-hospital PCI mortality.

Researchers divided patients into two categories: those presenting with STEMI or cardiogenic shock (which they called the SOS group), and all others (the non-SOS group). The findings were definitive:

• The unadjusted in-hospital mortality rate was 15.6 times higher for CU patients vs. non-CU patients in the SOS group;
• CU patients only represented 1.6% of all SOS patients, but represented 21% of the overall mortality after PCI for the SOS group; and
• Being designated CU was associated with an odds ratio for in-hospital death of 27.3 relative to the non-CU SOS patients, after adjusting for other known predictors of in-hospital mortality.

The authors conclude:

“The Massachusetts experience demonstrates that a small proportion of patients at extremely high risk of in-hospital mortality can be identified using objective, pre-procedure clinical factors that had not been previously collected as part of traditional quality monitoring efforts. Incorporation of these CU covariates in risk-adjustment models led to significant improvements in model performance as well as reclassification of predicted risk in a substantial proportion of cases.”

Editorial
Eric Peterson, MD, MPH, writes the editorial that accompanies the article. He’s right on in his comments. With patients and the government increasingly demanding transparency in health care outcomes, there is a true risk of unintended consequences if we do not do due diligence in taking into account as many predictors of adverse outcomes as necessary. There are plenty of anecdotes of physicians refusing to perform CABG or PCI because they simply don’t want to have a death on their outcomes report by caring for patients whose clinical status is so extreme that their chance of surviving the hospitalization after the emergent CABG or PCI might be less than 30%.

Although the NCDR has a robust risk adjustment model to “level the playing field” to take account of these very ill patients, Resnic, et al., offer CU risk adjustment measures that appear to be an improvement in accurately risk-adjusting the severity of illness for these infrequent but critically ill patients. The use of the CU measures might hope to mitigate against the negative unintended consequences of public reporting – that is to say, physicians would be more willing to take these ill patients to the cath lab for emergent PCI rather than refusing to do so.

The challenge of the CU risk-adjusted measures is for its accurate “coding” by the data analysts when submitting their registry reports. A robust auditing system of all patients deemed to meet CU criteria is necessary to assure accuracy in the coding of these patients.

What do you think of the study findings? Should (and if so, how) CU criteria be incorporated into public reporting efforts?

ACC.11 and i2 Summit 2011 meeting co-chairs are at Heart House today (or at least some of them are ... DC got quite the snow storm last night and not all could make it in) to discuss details about our upcoming meeting in New Orleans, April 2-5. The meeting co-chairs will be discussing the LBCT submissions and making decisions about what science will, and won’t, make the cut for presentation. Selected LBCTs represent the best of the best: the studies most likely to completely alter clinical practice. The submitted trials are judged on the impact and novelty of their research; rigor of the design/methods; major clinical endpoints; and the quality of the statistical plan.

In addition to presenting their trial, presenters also participate in an unstructured Q & A session called “The Trialist Is In.”  These informal sessions are designed to foster greater interaction between participants and trialists. The Trialist Is In sessions at ACC.10 were popular, well-attended and a marvelous opportunity to “touch the sleeve of the master.”

Finally, a plug for how to stay in touch between now and April: Join the ACC.11 & i2 Summit Community on CardioSource. The community is meant as a space to discuss the science, connect with other attendees, and hear from the meeting co-chairs and other faculty. You can start by introducing yourself in the Introductions forum! Also, follow @ACC_11 on Twitter for updates if you’re on Twitter.

Health blogger Kevin Pho, M.D., wrote recently about radiation risk from CT scans, and how the “best way to help curb the rampant ordering of these tests” is by educating patients about the radiation stemming from the tests. Pho cites an Annals of Emergency Medicine study finding that patients underestimate their radiation risk (no surprise there), disagreeing with the statement that CT scans would up their cancer risk, and ¾ not understanding the differences in radiation between CT scans and traditional chest x-rays. Pho writes:

“The best we can hope for is to explain to patients the risks and benefits of ordering such scans, and together come up with a shared, informed decision. Of course, our health system isn’t set up for such conversations. There is much more incentive — from a reimbursement, malpractice, and customer service standpoint — to simply order the test.”

I agree with Pho on his point that educating patients about the radiation risks involved in ordering CT scans is of utmost importance, but we must balance this concern about radiation with making sure patients get the tests that they need to diagnose and treat a life-threatening condition.  Cardiovascular disease continues to be the number one cause of morbidity and mortality in the U.S. Meanwhile, risk of cancer due to radiation exposure, although a real problem, must be properly balanced against the benefits of our imaging technologies.

Because of the delicate balance that must be maintained, 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 doses include using AUC to eliminate unnecessary scanning procedures; following the principle of "as low as reasonably appropriate" with respect to radiation levels; displaying dose information wherever studies are done; and encouraging facilities to monitor delivered doses and compare them with benchmarks.

Combining these three approaches with patient education is the best way that we can reduce radiation risk while still making sure patients get needed tests. Maybe the only way.

Check out Pho’s full post here. For more on ACC’s views on radiation safety, read a JACC’s President Page I wrote with ACC leader Pam Douglas, MD, FACC.

Yesterday, an article was released in JAMA that will, without a doubt, have major implications for physicians and hospitals in their evaluation of their practice patterns related to ICD implantation for primary prevention of sudden cardiac death. Using data from ACC’s NCDR (National Cardiovascular Data Registry) ICD Registry, the article’s authors completed a retrospective analysis of 111,707 patients enrolled in the registry between 2006-2009 to examine if ICD implantation followed evidence-based based practice guidelines. The ICD implant was considered non-evidence-based if one of the following criterions was present:

• MI within 40 days of the implant;
• Coronary bypass graft surgery within 3 months of the implant;
• New York Heart Association class IV heart failure symptoms; or
• Newly diagnosed heart failure.

Researchers found that ICD implantations were not in accordance with practice guidelines in 22.5% of patients, most commonly because of newly diagnosed heart failure (62%) or an MI within 40 days (37%). The risks of in-hospital death and complications were significantly lower when the ICD implant was consistent with practice guidelines (0.18% and 2.4%, respectively) than when it was not (0.57% and 3.2%, respectively). CardioSource has a journal scan of the article for more details.

Implications
Although the article offers sobering findings, it also highlights the extreme value of registry participation. Participation in the ICD Registry is mandated by the Centers for Medicare and Medicaid Services, and every U.S. hospital that implants ICDs for the purpose of primary prevention of sudden cardiac death participates. The ICD Registry recently has developed the ability to connect longitudinal Medicare administrative data of ICD patient outcomes -- such as mortality and repeat hospitalizations -- with our in-patient hospital registry data. This longitudinal follow-up assessment will extent our knowledge base substantially. It will be particularly fascinating, for example, to assess longitudinal outcomes for the patients highlighted in this week’s JAMA study.

Many colleagues have already written correctly about the important role of physician judgment that, at times, may overrule a practice guideline recommendation; the litigious concerns involved physician-decision making; and issues surrounding accuracies of the clinical subtleties that the registry may not fully assess related to clinical variables for the decision-making in ICD implanting. What we all cannot overlook, however, was the marked variability between hospitals related to ICD implantation inappropriateness ranging from 0% to 40%! Even to the skeptics among us, this implies a tremendous opportunity to improve cardiovascular care.

As the famous quote goes: “If you can’t measure it, you can’t manage it.” NCDR is the measurement system for managing the quality of care we provide patients. The evaluation of what clinicians are doing through the collection of the data can help us not only better learn practice patterns and have a better understanding how clinical practice guidelines are applied but also potentially extend our knowledge and evidence base.

I’ve been involved in the NCDR since its inception, serving as its chief medical officer for a number of years. We may not like what this study uncovered, but I think all of us can agree that without this data, we would not be able to move forward as a high-quality specialty. This data gives us the chance to improve: for providers, that means practicing greater adherence to our practice guidelines, and for the ACC, that means using this data to understand how guidelines are used in clinical practice and to improve the strategies we offer our members to implement the guidelines in everyday practice, such as the development of useful continuous quality improvement programs. We are proud of the NCDR ICD Registry for the incredible value it offers to the medical community and our health care system as a whole in improving quality of care for our nation's patients.

For additional perspective on the study, read a blog post by ACC Board of Trustees member and Hospital to Home leader Harlan Krumholz, MD, FACC, on the Forbes Science Business Blog. His blog is a  superb piece and goes to the heart of the matter for most of the doctors doing the inappropriate implanting. Their desire to serve their patients to the best of their ability at times blinds them to evidence-based recommendations.

Also, don't miss the ACC/HRS joint statement. 

I look forward to reading your responses and counsel in the comment section below.

The WSJ Health Blog featured an interesting discussion yesterday about using mediation to settle health care malpractice lawsuits rather than going to trial. In a study of 31 malpractice cases from non-profit hospitals in New York City, 16 were settled through mediation, five were settled afterward and 10 were not settled. Of those who agreed to go to mediation, the patients bringing the complaint, the hospitals representatives, insurers and lawyers reported being satisfied with the process. At Kaiser Permanente where I am employed, we use mediation with great success and general happiness by all parties. The study notes that no physicians accused of malpractice participated in the mediations, with their lawyers citing full work schedules as a reason for not attending the mediation.

There’s plenty of talk these days about how we can reduce the costs associated with defensive medicine. In fact, as Jack pointed out, cardiology has one of the higher rates of malpractice across the board (49.4% ever sued; 29.8% sued two or more times; 3.3% sued in the last 12 months; 110 claims/100 doctors). While the ACC strongly believes that defensive medicine can be reduced with tort reform (see some specific suggestions here), I’d be interested to hear your thoughts on using mediation as a method. Would you ever participate in mediation for a malpractice suit?

Larry Dean, president of SCAI, and I just sent out an e-mail to our memberships regarding a series of articles that have appeared in the mainstream press about overuse of stents and the opportunity this offers for professional associations like the ACC & SCAI to take a proactive approach to quality issues. Please see the full text below, and leave your comments at the end of the article.

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The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) are deeply disturbed by findings in a new U.S. Senate Finance Committee report concerning the ongoing investigation into alleged inappropriate use of percutaneous coronary intervention (PCI) and overutilization of stents at St. Joseph Medical Center, in Towson, MD. While the ACC and SCAI cannot comment on the merits of ongoing investigations, the use of inappropriate or unnecessary procedures is intolerable and a violation of both organizations strict codes of ethics (.pdf) as well as the Hippocratic Oath.

Over the last several months the Maryland Chapter of the ACC and SCAI, working closely with the national ACC, have been proactively addressing the issues raised by these allegations. ACC and SCAI representatives have met with state policymakers and have, at the request of Maryland officials, drafted comprehensive legislation that would require accreditation for all state hospitals performing PCIs.

Meanwhile, the overarching issue of quality and appropriate use of medical procedures is not just confined to the state of Maryland and the use of stents. In fact the Senate Finance report has generated national media coverage in the New York Times, Wall Street Journal and other papers. The investigations and subsequent media coverage provide an opportunity for professional societies like the ACC and SCAI to take the lead locally, regionally and nationally to ensure patients receive the right care at the right time.

Collectively, these developments underscore the need for internal peer-review that is clear, rigorous and objective. A standardized internal process must be followed by independent external oversight performed by an external body, such as the Accreditation for Cardiovascular Excellence (ACE) program. ACE has an independent governing board, allowing for removal of any perceived or real conflicts of interest in oversight of hospital and physician quality performance. ACE accreditation criteria also calls for use of registries like the National Cardiovascular Data Registry (NCDR) and adherence to appropriate use criteria -- both of which are already widely accepted and respected by professional and regulatory communities nationwide.

In addition, quality tools produced by both the ACC and SCAI can provide states, payers and purchasers of care with critical, transparent metrics with which to evaluate quality of care, especially as the health care community adopts a National Quality Strategy and shifts from a fee-for-service reimbursement model to one more focused on outcomes-based care and commensurate reimbursement.

The ACC and SCAI have the knowledge base and expertise as cardiovascular leaders to advise and implement such programs. The efforts under way in Maryland to address quality and appropriate care have far-reaching implications. Addressing them proactively will allow the field of cardiology to remain ahead of the curve and avoid future allegations like those outlined by the Senate Finance Committee. Working together we can ensure our patients receive high quality and effective cardiovascular care delivery driven by physician oversight and leadership.