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As controversy wanes, efforts shift to implementation of ACC/AHA guidelines
Guidelines receive a lot of attention in the cardiology community upon their release, but, in the end, successful implementation is of utmost importance. One year after publication of the Clinical Guidelines on Cardiovascular Risk Reduction in Adults from the American College of Cardiology and the American Heart Association, efforts are being made to ensure that implementation goes as smoothly as possible.
Thomas A. Pearson, MD, MPH, PhD, FACC, discusses implementation strategies for new cardiology guidelines.
Image provided by: Thomas A. Pearson, MD, MPH, PhD, FACC; printed with permission.
Some cardiologists embraced the new guidelines immediately, some were won over after a few months, whereas others have remained skeptical, primarily due to controversy over the guidelines’ lack of endorsement of treating to LDL target levels and adoption of a 10-year risk calculator that some say overpredicts CVD risk. The guidelines were intensely discussed and debated as soon as they were released, in journals, at conferences, in continuing medical education programs or in private discussions among doctors.
The guidelines app has been downloaded more than 100,000 times, and there are more than 10,000 user sessions per day for those using the app online, based on data from Google Analytics, according to Neil J. Stone, MD, MACP, FAHA, FACC, chair of the expert working group that wrote the guideline on cholesterol management. “It is clear to me when I talk across the country that the people who download the app … seem to feel that this has been a plus,” Stone said in an interview.
The incidence of CVD in the United States has decreased dramatically since the 1960s, and the National Forum for Heart Disease and Stroke Prevention has adopted a goal to make heart disease and stroke combined no longer the leading causes of death in the United States by 2020. Wide implementation of practices based on the best available evidence is the best way to reach that goal, Thomas A. Pearson, MD, MPH, PhD, FACC, co-chair of the Implementation Working Group for the guidelines, told Cardiology Today.
“The fastest way to pound down to the last step of that goal is implementing all the knowledge and tools we already have,” said Pearson, who is executive vice president for research and education and professor of epidemiology and medicine at the University of Florida Health Science Center, Gainesville, Fla. “We just need to use them. That is the whole promise of implementation science: Taking the burden off the physicians and supporting what they want to do — and that is to improve their patients’ health and preventing those recurrent events and first events by implementing what we already know.”
Donald M. Lloyd-Jones
Successful implementation needs to occur on both a systematic and individual level, Pearson and other experts told Cardiology Today. Successful systematic implementation will make it easier for doctors to remember what the guidelines are and how they can be applied to different kinds of patients while encouraging doctors and patients to have discussions about how to a tailor a risk-reduction strategy that will work best for that patient, they said.
“There is an increasing recognition that, despite the initial controversy, these guidelines have tapped into a very important paradigm shift in what we should be doing for our patients,” said Donald M. Lloyd-Jones, MD, ScM, FACC, FAHA, co-chair of the expert working group that wrote the guideline on assessment of CV risk. “And that is in turn engendering a lot more activity in terms of potential adoption.”
New guidance
Four sets of guidelines released in November 2013 outlined best practices for lifestyle management, obesity management, cholesterol management and assessment of CV risk based on the best available evidence from randomized controlled trials. A fifth working group on hypertension management did not have its guideline adopted by the ACC and the AHA because of a controversial recommendation to relax BP goals in most people aged at least 60 years, and instead published the recommendations on its own in JAMA as the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults.
The 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk outlines a heart-healthy eating pattern based on a 2,000 calorie per day diet and recommends 30 to 40 minutes of moderate to vigorous physical activity at least 3 or 4 days per week.
The 2013 AHA/ACC/The Obesity Society Guideline for the Management of Overweight and Obesity in Adults offers tips on how to identify those who need to lose weight and how to counsel overweight and obese adults with CV risk factors, recommendations on which diets to prescribe and which patients should be selected for bariatric surgery.
The 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, in a departure from previous recommendations, does not specify target levels of LDL or non-HDL but identifies four high-risk groups that could benefit from statin therapy: patients with atherosclerotic CVD, those with LDL ≥190 mg/dL, those aged 40 to 75 years with diabetes, and those aged 40 to 75 years with an estimated 10-year risk for CVD of 7.5% or higher. In the fourth category involving lower-risk primary prevention individuals, the guidelines recommend a clinician-patient discussion before a statin is prescribed that addresses other risk factors, lifestyle, the potential for benefit and harm from statin therapy, the potential for drug-drug interactions and patient preferences. The guideline recommended statins because, unlike with other lipid-lowering drugs, there is evidence that their use is associated with reduced risk for CVD.
Neil J. Stone
The 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk includes a formula to calculate CVD risk in people without CVD, using the following factors: age, sex, race, total cholesterol, HDL, BP level, BP treatment status, diabetes status and current smoking status. If uncertainly remains, the guideline recommends using any of the following markers: family history of premature CVD, coronary artery calcification, high-sensitivity C-reactive protein and ankle-brachial index. Unlike the Framingham risk score, the tool takes stroke risk into account.
The authors of the guidelines said the recommendations are not intended to be blanket formulas applied uncritically to all patients, but instead should be used as a starting point for discussion between physicians and patients about how best to mitigate CVD risk in that individual patient.
“We are happy that people have finally seen that the risk discussion was included in the guidelines,” Stone, who is Bonow professor of medicine at Northwestern University Feinberg School of Medicine, said in an interview. “It was always part of the workflow diagram. We think the emphasis on a clinician-patient discussion, which is new to the guidelines, is starting to get traction.”
Changes in CVD prevention
C. Noel Bairey Merz
There are not yet widespread data on the effects of implementing the recommendations from the new guidelines, but several trends have emerged regarding how CVD prevention strategies are changing, experts said.
“There is a small group of people who are no longer at high enough risk for treatment, and then there is a higher number of people who were previously not considered eligible and now are,” said C. Noel Bairey Merz, MD, FACC, FAHA, a member of the working group that wrote the guideline on cholesterol management and Cardiology Today Editorial Board member. “That is because we picked up a lot more women, including African-American women, when we put stroke in the CV risk pool, and because we identified a lower threshold for more benefit than risk, so we are treating more older people.”
Another emerging shift is that doctors are prescribing “less of the treatments that have no evidence base” as a result of the new guidelines, Lloyd-Jones, Northwestern Medicine chair of the department of preventive medicine, senior associate dean for clinical and translational research for Northwestern University Feinberg School of Medicine and director of the Northwestern University Clinical and Translational Sciences Institute, said in an interview. “That is a good thing.”
When the guidelines were published, it was predicted by numerous experts that statin prescriptions would rise as a result of the recommendations. Anecdotal evidence suggests that is the case, according to experts Cardiology Today interviewed. There is also emerging evidence that the new guidelines better match statin assignment to total plaque burden compared with the 2001 National Cholesterol Education Program Adult Treatment III (ATP III) recommendations, and that applying the new guidelines in place of ATP III would result in more prevented atherosclerotic CVD events.
Kevin M. Johnson, MD, from Yale University School of Medicine, and David A. Dowe, MD, from Atlantic Medical Imaging, Galloway, N.J., found in an analysis of 3,076 people that the probability of prescribing statins rose with increasing plaque burden under the new guidelines compared with ATP III. Under ATP III, 59% of patients with ≥50% stenosis of the left main coronary artery would not have been treated vs. 19% of patients under the new guidelines. Likewise, under ATP III, 40% of patients with ≥50% stenosis of other branches would not have been treated vs. 10% of patients under the new guidelines. The researchers also found that statin therapy would have been prescribed in 15% more patients under the new guidelines compared with ATP III.
Andre R.M. Paixao, MD, and colleagues performed an analysis of participants from the Dallas Heart Study and determined that applying the new guidelines in place of ATP III would result in 3.6 to 4.9 additional atherosclerotic CVD events prevented for every 1,000 people screened, with 0.5 to 1.5 excess cases of diabetes. Assuming a 30% to 45% relative risk reduction, the number needed to treat to prevent one atherosclerotic CVD event among people newly eligible for statin therapy under the new guidelines is 14 to 21, according to the findings.
Barriers to implementation
A number of challenges remain to achieving widespread adoption and implementation of the guidelines.
The first is “just getting people to read them,” Lloyd-Jones said. “If people don’t read them, maybe they don’t understand why we suggested that LDL goals may not be the best way to treat our patients. Without reading the document, it is hard to just intuit that.”
The best place to begin is the revised Figure 2 in the cholesterol guidelines, “which shows a nice clinical workflow of how the decision-making should go,” Lloyd-Jones said. “If they only have time for one thing, that revised Figure 2 is a goldmine for practitioners to understand how to implement these things.”
Thomas Bersot
Outreach has been particularly challenging for physicians in private practice, Thomas Bersot, MD, PhD, associate investigator at the David J. Gladstone Institutes at University of California, San Francisco, who participates in continuing medical education programs for physicians in private practice, told Cardiology Today.
“The private practice community is greatly confused because of the controversy about the guidelines,” he said. “I believe that little movement has been made in that community to adopt the guidelines as a result. On the other hand, most physicians in private practice did not do 10-year risk assessment anyway; they did not do a smashing job of implementing the old guidelines and prescribing high-intensity statins. I do not see that changing unless there is a tireless campaign by those who want the guidelines implemented to follow up with and educate the primary care doctors. Until then, the perception is that there is a lot of committee-speak in those documents.”
Another challenge to be overcome is the longstanding practice of setting LDL and/or non-HDL target goals. The new guidelines recommend that instead, the goal should be a ≥50% LDL reduction for those at high risk for CVD and a ≥30% reduction for those at moderate risk for CVD.
Robert H. Eckel
These practices do not have to be mutually exclusive, said Robert H. Eckel, MD, FAHA, co-chair of the expert working group that wrote the guideline on lifestyle management. “My notes always refer to the existing cholesterol guideline, and I will qualify it in my note based on what I feel needs to be done beyond it. This is what I’m saying on this topic when I speak at national or local meetings: I am encouraging physicians to know the guidelines and ultimately do their best to apply the guidelines to their practice, but then if they want to set a goal, just qualify the goal and the rationale for setting it in their note,” Eckel, professor of medicine, physiology and biophysics and Charles A. Boettcher II chair in atherosclerosis at University of Colorado Anschutz Medical Campus, Aurora, Colo., and past president of the AHA, said in an interview.
Another challenge is getting physicians to buy in to the guidelines’ strong endorsement of statin therapy.
“There is a growing reluctance on the part of patients, and to some extent some physicians, about statins,” said Amit Khera, MD, MSc, FACC, associate professor of medicine, director of the preventive cardiology program, program director of the cardiology fellowship and Dallas Heart Ball Chair in hypertension and heart disease at University of Texas Southwestern Medical Center, Dallas, and a co-author of the Dallas Heart Study paper. “That is not necessarily a new thing, but there is ongoing tension about the value and use of statins. I think that has raised a bit of a barrier because there theoretically will be greater use of statins by implementing these guidelines.”
Carl J. Pepine
The risk discussion can be helpful in addressing concerns about statins, Khera said. “We forget sometimes that although we think of statins as a small decision, you are asking a patient to start something for the rest of their life,” he said. “It is worthwhile, but it takes a bit of a risk conversation, and in my experience when that happens, patients are more receptive than they are if they just get a phone call from office staff saying you need to start this medicine.”
Cardiology Today Chief Medical Editor Carl J. Pepine, MD, said it is clear that “better ways to improve implementation of our practice guidelines are needed.
“However, I see this as an ‘industrial engineering’ task and most physicians have no training in this field. Systems are needed to facilitate this implementation process and we just don’t have the training or skill set required to build these systems. This process will require ‘re-education’ of physicians or defaulting this process to those with the needed skills,” Pepine said.
Implementation, execution
Executing the right implementation strategies will be very important in the near future, which is where the efforts of the Implementation Working Group come in. Pearson told Cardiology Today that the group has performed “essentially a systematic review of systematic reviews.” Because there are so many papers, “we took the eight or 10 reviews that pulled the papers together and we did a review of those to come up with some conclusions about the things that work and the things that do not work, the setting in which they do work and also the research gaps that remain,” he said. The review is scheduled to be published soon.
Pearson said the work group identified four areas for review. One is performance monitoring and audit feedback, in which practitioners receive data on how well their patients did on their preventive strategies. The idea is that those who are underperforming can see the data telling them that, which might prompt them to change their practices.
“I do not think this is a matter of paying people or shaming them,” Pearson said. “The responsible clinicians say, ‘I thought I was doing better than that, I have to find ways to do better.’ What the literature shows is that it is generally effective [other than in] some exceptional contexts in which it has been less effective, which we need to understand more.”
The second area is academic detailing and educational outreach, including continuing education programs. “Those are generally effective, both in terms of process-of-care outcomes as well as clinical outcomes,” Pearson said.
The third area is automated reminders in clinical support systems. “With electronic medical records, you can have a reminder system that pops up on the screen and ties the guidelines to what are essentially action items,” he said. “In terms of process of outcomes, those are generally effective, if a little more mixed in terms of actually reducing [CV events].”
The fourth area is pay-for-performance and other financial incentives. “My own reading of that literature is that this has been quite successful at the health-system level; influencing of the bottom line obviously has changed system and clinic behavior,” Pearson said. “It is much more mixed when looking at a clinic paying the providers. It has been very specific to the kind of incentives that have been put in there.” Pay need not be the major driver of physician behavior, as evidenced by the audit-and-feedback literature, he noted.
Workflow integration is key
Integrating the guidelines into a clinician’s everyday workflow will play a large role in successful implementation, experts said.
“For example, the Kaiser Northwest system has built in an entire decision support system that adopts all of the risk assessment and cholesterol approaches recommended by the guidelines,” Lloyd-Jones said.
Bairey Merz, who is the Women’s Guild Endowed Chair in Women’s Health, director of the Barbra Streisand Women’s Heart Center, director of the Linda Joy Pollin Women’s Heart Health Program, director of the preventive cardiac center and professor of medicine at Cedars-Sinai Heart Institute, said practitioners at her institution have the ClinCalc app (ClinCalc LLC), which has the new risk calculator, on their smartphones.
By showing the results of risk calculation to patients, the app facilitates “an important teachable moment that CVD is the leading killer of women and men,” she said. “We can show them their lifetime risk and start a discussion about how to reduce that risk.”
What may ultimately promote widespread adoption is when word gets out how much easier it is to follow the new guidelines than the old ones, Bairey Merz said.
“If we could be as good in primary prevention as we are in secondary prevention with getting doctors to prescribe at the right intensity and then offer good compliance enhancement and see them twice a year, and if we can get patients to understand that this is in their best interests, then we will have done our job,” she said. – by Erik Swain
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C. Noel Bairey Merz, MD, FACC, FAHA, can be reached at Cedars-Sinai Heart Institute, 127 S. San Vincente Blvd., Suite 3206, Los Angeles, CA 90048; email: noel.baireymerz@cshs.org.
Thomas Bersot, MD, PhD, can be reached at 1650 Owens St., San Francisco, CA 94158; email: tbersot@gladstone.ucsf.edu.
Robert H. Eckel, MD, can be reached at the University of Colorado Anschutz Medical Campus, 12801 E. 17th Ave., Aurora, CO 80045: robert.eckel@ucdenver.edu.
Amit Khera, MD, MSc, FACC, can be reached at University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390; email: amit.khera@utsouthwestern.edu.
Donald M. Lloyd-Jones, MD, ScM, can be reached at 680 N. Lake Shore Drive, Suite 1400, Chicago, IL 60611; email: dlj@northwestern.edu.
Thomas A. Pearson, MD, MPH, PhD, FACC, can be reached at PO Box 100014, Gainesville, FL 32610; email: tapearson@ufl.edu.
Carl J. Pepine, MD, can be reached at the Cardiology Today office, 6900 Grove Road, Thorofare, NJ 08086; email: carl.pepine@medicine.ufl.edu.
Neil J. Stone, MD, MACP, FAHA, FACC, can be reached at Northwestern Memorial Hospital/Arkes Family Pavilion Suite 600, 676 N. Saint Clair, Chicago, IL 60611; email: nstonemd1@gmail.com.
Disclosures: Bersot reports consulting for multiple pharmaceutical companies who make lipid-lowering agents. Pearson reports consulting for Bayer on an aspirin trial. Bairey Merz, Eckel, Khera, Lloyd-Jones, Pepine and Stone report no relevant financial disclosures.