ACC’s pediatric and congenital heart disease cardiologists and nurses have long been lobbying for universal screening for congenital heart disease, including the very inexpensive ‘pulse oximetry’ test for newborns. This approach to early detection of more subtle forms of congenital heart disease can prevent related serious complications and promote early diagnosis and treatment. The ACC has endorsed the recommendations of an HHS working group on pulse oximetry screening for all newborns -- something we helped become a priority for them. In September, an HHS advisory committee finally recommended that pulse ox be added to the list of screenings for 30 core conditions that HHS recommends for all newborns, but requested a special working group look into how it might be implemented. The working group’s recommendations are published in Pediatrics. Former chair of ACC’s Adult Congenital and Pediatric Cardiology (ACPC) Council Gerard Martin, MD, FACC, is one of the authors of the recommendations. Geoffrey Rosenthal, MD, FACC, also deserves special recognition in these efforts. 

Implementation of pulse ox screening helps detect the most common congenital heart defects by measuring blood oxygen levels. The recommendations state that if pulse ox detects low oxygen levels in a newborn, he or she will receive further evaluation, including first being evaluated for other conditions that might cause low oxygen levels (like infection) and would receive an ECG. A pediatric cardiologist would then interpret the ECG. The recommendations note that the biggest concern is the threat of false positives, which would expose the newborn to unnecessary testing, and perhaps unnecessary hospital transfer. As such, the recommendations include strategies to reduce false positives, such as waiting 24 hours after birth to screen and making sure the baby is alert rather than asleep when the test is administered. Following the release of the recommendations, HHS said that a “plan of action” is expected very soon. The recommendations are available online. The ACC is working with Mended Little Hearts on a CardioSource forum to discuss challenges with pulse oximetry screening – check it out here.

The ESC Congress for the first time is having two sessions dedicated to clinical registries in order to highlight the growing number of innovative registries, the data they collect and the conclusions that can be drawn from this data. The sessions focus on “Risk and Treatment Reality” and “Interventions and Devices” and showcase registries from France, Italy and more.

The prominent treatment of the registry data trials at ESC Congress 2011 is a testament to their growing importance. Registry research is unique because it uses real-world data. The patients included in the registry are not chosen because they have limited comorbidities or fit a certain profile, like in clinical trials, but are included simply because they are a patient at a participating hospital. What this means is that we can see what the effects of certain treatments are on patients who may never qualify for a clinical trial. The results are a better understanding of adverse outcomes and better treatment protocols. The ACC frequently requests for FDA to require new drug and device manufacturers to conduct post-market approval studies through registries to ensure that the new drug/device doesn’t have any adverse events not caught in the clinical trials.

Of course, that’s not to say that registries aren’t without limitations. Currently, it’s challenging to connect care between the outpatient and inpatient settings because the U.S. will not implement a unique patient identifier system that could connect a patient’s progress in the hospital to the ambulatory setting and, in some cases, back to the hospital. We’ll need to find a way to work around this. With the growing emphasis on reducing readmissions, hospitals will need to have a better understanding of why and which types of patients are most frequently readmitted. Registries should be able to help fill this gap.

ACC’s registries suite, NCDR (National Cardiovascular Data Registry), has experienced a landmark year in terms of the science researchers have produced. The following studies have been some of the most interesting:

1. Non–Evidence-Based ICD Implantations in the United States (JAMA, 305;1). Researchers found that ICD implantations were not in accordance with practice guidelines in 20+% of patients, most commonly because of newly diagnosed heart failure or an MI within 40 days.
   
   
2. Patterns and Intensity of Medical Therapy in Patients Undergoing PCI (JAMA, 305;18). The authors conclude that optimal medical therapy is underutilized in patients with stable CAD.
   
   
3. Association of Door-In to Door-Out Time with Reperfusion Delays and Outcomes Among Patients for Primary PCI (JAMA, 305;24). Study showing improvement is needed in the treatment of heart attack patients who require transfer to another hospital for primary PCI).
   
   
4. Appropriateness of Percutaneous Coronary Intervention (JAMA, 306;1): This study concluded that although the majority of patients are appropriately selected for PCI procedures, there are opportunities for improvement, especially in the non-emergency setting.
   
   
5. Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography (JACC, 58;8). Former ACC Prez Pam Douglas, MACC, et al., find that hospitals vary greatly when it comes to the rate at which obstructive CAD is found in patients without known heart disease undergoing elective diagnostic coronary angiography or catheterization.

These are just five of the hundreds of studies using NCDR data that have been published over the registries’ 14-year history. We may not always like what the studies find, but it’s the measurement that pushes cardiology as a profession to move forward and to find ways to more consistently implement best practices and guidelines. By measuring patient care in an appropriate and actionable way, registries bring to light the invaluable improvements being made by physicians and care teams.

I commend ESC for bringing registry data to the forefront of their meeting. I think we’ll see more and more about registry data in the future, as it addresses some of the gaps left by clinical trial data.

The European Society of Cardiology kicks off its annual Congress on Sunday. The theme of the Congress is “controversial issues in cardiology.” The Hot Line & Clinical Trial Updates sessions address CV risk and complications, drug treatment, interventional and device treatments, heart rate and rhythm, and acute coronary syndromes. The trial we’ve been hearing the most about is ARISTOTLE (Efficacy and Safety of Apixaban Compared to Warfarin for Prevention of Stroke and Systemic Embolism in 18,202 Patients with Atrial Fibrillation), but I’m sure there will be other big news along the way. CardioSource Science & Quality Editor Chris Cannon, MD, FACC, has a video overview of the ESC science on CVN.

I’m looking forward to the trip to Paris. The ACC has many meetings planned with other cardiovascular societies, which we use to strengthen our relationships and build global bridges. We can never forget that cardiovascular disease isn’t just an American problem, or even a first world country problem. As the U.N. has noted of late, cardiovascular risk factors and disease are a huge problem in many developing nations as well. By building relationships worldwide, the ACC is better enabling the spread of science and education to improve patient care globally.

CardioSource is your source of coverage from ESC. Visit our meeting coverage page for trial summaries, slide sets, video coverage and comments from your colleagues. Follow @ACCinTouch on Twitter to know exactly when these are live and get direct links. Video coverage and photos will be available from our Facebook page as well.

Going to ESC? Visit the ACC Booth (E200) to learn about the latest international offerings, save 15% on education products purchased onsite and register for ACC.12 in Chicago. On Sunday, there will be a members-only meet-and-greet with ACC leadership (including me) at our stand. If interested, please RSVP.

 

By Harlan Krumholz, MD, SM, FACC

 

Krumholz is the lead author of the paper discussed below and a member of the ACC Board of Trustees.

 

It is with great pride and some awe that I report on the findings of a new paper published today in Circulation on door-to-balloon (D2B) times. In a comprehensive assessment of patients of all ages and across virtually all institutions providing primary percutaneous coronary intervention (PCI), we report that median D2B times have declined from 96 minutes in 2005 to 64 minutes in 2010. This is over a 30% reduction. The percent of patients treated within 90 minutes increased from 44% to 91% over those same years. Even more remarkably, the percent of patients treated within 75 minutes increased from 27% to 70%. The story of this success began with the identification of a quality problem with consequence. The benefit of primary PCI depends on its timely application, and in 2002, only one-third of patients received PCI in less than 90 minutes. NIH-funded research helped characterize the problem, while qualitative and quantitative studies revealed the secrets of top performers. Then, the ACC, with the American Heart Association and many other stellar partners, sought to translate that research into action with cardiology leadership throughout the country. The D2B Alliance was launched by the ACC in November 2006. Meanwhile, the Centers for Medicare and Medicaid Services were beginning to publicly report D2B times and, a year later, the AHA launched Mission: Lifeline, with its focus on systems of care. 

 

All this focus on D2B came together to change medical performance. I doubt that any voluntary effort to improve care has ever progressed with such speed and effect. This success reflects directly on the cardiologists, emergency medicine physicians, other clinicians, nurses, technicians, transporters, administrators and so many others who declared that patient care would improve and took the steps necessary to improve the timeliness of care for patients. I particularly cite the interventional cardiologists who embraced this effort even as they knew it entailed more work, including having to endure the false alarms that are unavoidable in a system built for speed.

ACC’s D2B Alliance also played an important role in the reduction. Cardiology leaders John Brush, MD, FACC, Eva Kline-Rogers, RN, Wayne Batchelor, MD, FACC, Brahmajee Nallamothu, MD, FACC, and Henry Ting, MD, FACC, among many others, were instrumental in getting the D2B Alliance off the ground. The Board of Governors and ACC chapters launched into action and delivered volunteers and hospitals throughout the country. At the ACC, the D2B Alliance was led by Amy Stern, with support from Jason Byrd, Matthew Fitzgerald and Karen Collishaw. They have left the ACC, but their made an indelible contribution to this effort.  Betsy Bradley, MBA, PhD, at Yale was also critical to the effort. More than 1,000 hospitals enrolled – including many that participate in NCDR – and there is evidence that many other hospitals participated even if they did not formally join.  In the end, it was truly people in each location that made the difference.

The improvements that were made are now embedded in the way the work is conducted. New trainees know no other way to treat patients with STEMI than with rapid, delay-free care. This project provides us with a sterling example of what can be achieved when we work together, learn from each other, and collaborate in the best interests of patients.

However, there is still work to be done. Some exceptional hospitals are regularly achieving D2B times of ~60 minutes by strategies such as coordinating with Emergency Medical Services and dissemination of a prehospital ECG. These strategies and others should be implemented nationwide to make 60 minutes the new standard of care. Additionally, studies have shown that time is lost in the transfer of patients from hospitals without PCI capabilities to PCI-capable hospitals. We need to identify and implement strategies that can reduce transfer time.

The results of the study reflect a level of performance that would have been considered impossible a decade ago. And it was achieved not by large investment, not by financial incentive, not by the application of a new technology, but by local efforts to adopt best practices and a drive to succeed on behalf of patients.

Related Resources:

Full Circulation article

CardioSource journal scan

D2B: Sustain the Gain website 

Things are changing incredibly fast in health care -- even before the future implementation of the Affordable Care Act (ACA).  A colleague this week introduced me to a new phrase to describe a lot of what’s happening -- it’s the irresistible urge to ‘agglutinate’, he said. By this is meant that market, economic, and demographic forces are together pushing hospitals, doctors, payers, and suppliers to integrate, merge, consolidate and organize differently to survive. The huge increases in physician employment reflect this, and particularly in cardiology and CV medicine, where more than half of private practices have now shifted to employment, mostly in hospital settings. Will non-agglutinators be losers? 

There are many examples of ‘winner and loser’ dichotomies to consider in these tumultuous times. Academic hospitals, insurers and health-related venture capitalists are having banner years of profit and success, while many physicians, public hospitals and the pharma and device industries are relatively hurting. Virtually all major academic centers are full with waiting lines, and are flush with cash. When these hospital systems are hiring doctors they probably mostly are doing so to better manage care across their geographies in preparation for population-based quality and value insurance incentives -- they don’t need more patient referrals. Smaller community hospitals, however, may be more often hiring docs to capture referrals and protect their current bottom line (a strategy that will NOT work in the long run). Meanwhile, public hospitals are rightfully very worried -- they have increasing numbers of uninsured persons and bad debt, and the current political environment is very scary for their future --and for disadvantaged populations.

 Physicians employed in expanding medical groups and physician networks are increasingly in demand, are in a good position. Systems that are not preparing for more emphasis on population-based global budgets are going to be very disadvantaged at some point, I believe. 

Insurers are also doing very well right now as well (check Wall Street performances). Why? In tough economic times, people are avoiding care, probably to save on higher co-payments. Per capita visits to doctors and to pharmacies to pick up medicines are way down in the past three years (pharmacies are worried about these trends, which also will increase unnecessary admissions for chronic diseases). Big labs like Quest Diagnostics also note a decline in business related to people not willing to spend money on their co-pays or doctor visits. These trends raise profits for payers. And, as in Kaiser Permanente’s recent experience, significant reductions in office visits result from new Internet patient-physician connections that allow people to be treated virtually -- at major cost savings and increased convenience.  

Meanwhile, the pharma and device industries are shifting their workforces and focusing offshore to expanding markets and away from what they experience as a semi-hostile regulatory environment and focus on price controls here.  

The thing about all of the above is -- it’s all subject to change. Today’s winner could be tomorrow’s losers, and vice versa.  We’re managing through uncertainty. It’s stressful, and largely based on what happens to spending and access to care in the political environment. And a lot will be determined based on the circus-like debt ceiling negotiations. Ouch.

 

Last Monday, I was surprised but pleased to see that a letter to the editor I quickly whipped off was actually published in USA Today responding to a series of articles finding that many hospitals rated highly by patients and/or consumer groups nonetheless had high rates of MI, heart failure or pneumonia.  

I wrote that the articles “show the dangers and potential for using administrative data care comparisons without backing up presumptions with clinical data.” For instance, when comparing death and readmission rates among hospitals, it must be considered that some excellent hospitals, because of the communities they serve, take sicker patients with fewer resources for community follow-up care once they are discharged, resulting in higher rates of readmission or morbidity.  

I touted the value of the ACC’s NCDR registries in reducing D2B times (door-to-balloon times measuring speed of treatment of heart attacks) and identifying potential overuse or underuse of some treatments, and noted that clinical data is far superior to claims/administrative data in these regards (administrative data, which has the ability to point to outliers but not clinical care differences, was used in the USA Today stories).

The prestigious Institute of Medicine (IOM) earlier this month opined concerned that most medical devices are cleared for sale without sufficient evidence that they are safe and effective -- even though we tend to delay approvals of devices far longer than the EU, Canada and most of the developed world. IOM’s assessment should give everyone pause -- particularly because they declared the current regulatory approach (related to the FDA 510K approval process) to be so messed up that we should scrap it and start over. FDA reacted immediately that they disagreed, stating they would instead work to fix the problems acknowledged in the 510K regulatory system.

The IOM committee found no major new horror stories related to existing devices on the market, but worried that FDA and the public have no good way to determine where risk may exist because there is virtually no good clinical data to rely on. Hello. The NCDR has the clinical data they seek; and if we could get the feds to offer incentives to help us diffuse the PINNACLE Registry across more outpatient practices, we could track post-approval performance and look for even low-signal adverse events incredibly effectively!

The IOM committee commented specifically on what they termed "highest-risk" CV devices, such as implantable defibrillators and replacement heart valves. They noted that clinical trials with relatively few enrolled patients are used to demonstrate safety and effectiveness of such devices, deeming that they afford only a “moderate risk,” based on having the manufacturer show that they are “substantially equivalent” to devices previously cleared. The added concern is that those devices in turn may have been cleared because they were “substantially equivalent” to earlier devices that may no longer be in use -- a ‘house of cards’ process.

IOM deserves credit for spotlighting the issues. But, not only the FDA objected to IOM’s recommendations: the device industry, already frustrated with the cumbersomeness of the 35-year old 510K process, are yet even more worried about and opposed to completely scrapping the process. They want to see it streamlined instead. What we need to do is show FDA, IOM and industry what the broad use of registries could do to carefully track ALL patients who are device recipients. That’s what needs to happen! Upcoming FDA hearings on the IOM recommendations and the future of the 510K process will give us an opportunity to promote this potential of using our registries to provide more rigorous and effective surveillance of CV devices after they are on the market.

Tort reform has significantly improved the medical liability environment in Mississippi, a new study in the journal Obstetrics and Gynecology concludes. I wrote not too long ago about the types of reforms that took place in my state in 2003. Previously published research has noted a drop in the number of malpractice claims by 91 percent between 2004 and 2009.

The new research supports these findings. The author examines data from the Medical Assurance Company of Mississippi (MACM), which is the largest medical liability insurer in the state, from years before and after the tort reform legislation was enacted. The author found that there was a steep drop in lawsuits against physicians insured by the company after implementation (a 227% drop across all specialties). Additionally, medical liability premiums have been reduced and refunded each year between 2006 and 2010.  The author concludes that the findings “indicate an association between the implementation of tort reform legislation in Mississippi and a sharp reduction in the number of medical negligence lawsuits.”

Part of the reforms that were implemented was a cap on non-economic damages. The constitutionality of this provision has been legally challenged (Sears v. Learmonth), and oral arguments were heard by the Mississippi Supreme Court in mid-June. The court has yet to make a decision, but it would seem (from my perspective) that the cap is an integral part of the success of the reforms. To remove it would be to remove a lot of progress that we’ve seen over the past five years in terms of medical liability insurance.

What do you think? Do you support caps on non-economic damages?

The Board of Governors’ listserv has been active of late with discussions and excitement surrounding ACC’s 2011 Legislative Conference, which is coming up Sept. 11-13 in Washington, DC. Registration has been extended to August 17, so if you haven’t already registered, you should do so now.

Gen. Stanley McChrystal is our speaker for Sunday night, and he will discuss “Plywood Leadership.” Learn more about what the conference is about and why you should attend in the brief video with Gen. McChrystal below.

On Monday I had the opportunity to speak on CBS Radio to respond to a Consumer Reports article on “The Business of Healing Hearts.” The article provides a critical look at how heart disease is treated across the country. The basic points of the article are as follows:

• People often get the wrong tests
• Angioplasty is overused
• Consumers don’t have enough information on cardiologists
• Heart disease is often misunderstood

The article discusses how financial incentives, such as direct-to-consumer advertising or fee-or-service payments, drive patients to seek care that is not necessary and drive physicians to subject patients to “fancy tests” and aggressive treatment that aren’t necessarily the best care. The report notes that PCI procedures are often overused in the nonemergency setting and that patients cannot find useful information about interventional cardiologists.

In general, the report underscores why reform of our current payment system is so needed. The current focus on volume and episodic care without regard to improved quality, better patient outcomes or patient satisfaction limits communication and creates hurdles to achieving the triple aim of better health care quality, better health and lower costs. It’s why the ACC is proactively advocating for a new payment system (or systems) that rewards improved coordination of care, team-based care delivery, appropriate use of tests and procedures and improved medication adherence to treatment therapies.

In my interview with CBS radio, I also noted the growing importance of “appropriate use criteria” (AUC) in helping allay some of the fears noted in the report. AUC are developed in partnership with key specialty societies to help define “when to do” and “how often to do” a given procedure in the context of scientific evidence, the health care environment, the patient’s profile and a physician’s judgment. Appropriate Use Criteria for Coronary Revascularization were developed in 2009 by the ACC using a combination of clinical science, knowledge and expert opinion to help understand when PCI is appropriate, not appropriate or uncertain. However, it can be challenging to implement AUC into practice. The ACC is looking at new ways to harness technology that can place the documents and other clinical documents like guidelines at the point of care.

Registries are also a key component of high-quality, cardiovascular care. The ACC strongly believes in the power of registries to improve the patient care experience. The Consumer Reports article notes that patients should ask their hospital if it participates in the NCDR because participation in the registry can help the hospital to monitor their performance and adopt quality improvement initiatives to optimize the care they deliver. Fred Masoudi, MD, FACC, is quoted in the article and says that NCDR is working to make NCDR metrics more accessible.

The majority of CV professionals are doing the right thing, but the ACC recognizes as with any industry, there are outliers and that there is always room for improvement. The ACC is proactively working to identify innovative ways – along with all the tools we already use, like NCDR registries, clinical documents and quality programs – to ensure high quality, cost-effective care for every patient.

I look forward to hearing your thoughts in the comments section below.