April 28th, 2014
Patient-Centered Imaging: How Best to Communicate the Benefits and Risks of Testing
Andrew Einstein, MD, PhD and John Ryan, MD
In a new JACC paper, Andrew Einstein and colleagues detail the recommendations developed at an NIH-NHLBI sponsored symposium titled “Patient-Centered Imaging: Shared Decision Making for Cardiac Imaging Procedures with Exposure to Ionizing Radiation.” CardioExchange’s John Ryan interviews Andrew, who is Herbert Irving Associate Professor of Medicine and the Director of Cardiac CT Research at Columbia University Medical Center, about the clinical relevance and impact of their recommendations.
Ryan: In your paper, you comment that “both the referring and laboratory physician should share responsibility for both justification of the test exposure to ionizing radiation and for patient education.”
How do you think this discussion should be approached with the patient? Personally, I wonder if it should be every time a test is ordered. Or perhaps discussed during a clinic visit in and of itself with the patient?
Einstein: I think that the specifics of the shared responsibility for justification and education need to be tailored to the patient, clinical scenario, and the nature of the test.
For tests with radiation exposure that potentially could be on the higher end of the spectrum of cardiac testing, and certainly for tests with an expected effective dose of at least 20 mSv, the radiation exposure should be discussed with the patient at the time of ordering by the referring provider, in the context of a discussion of benefits and associated risks of testing.
In particular, for a justified test, the patient should be provided with reassurance that benefits outweigh risks. While the referring physician will have the most information to address the test’s justification, in general, the providers performing the study will have more detailed information about the test itself and its radiation exposure. Thus, this discussion should be continued at the point of testing.
Shared responsibility, patient education, transparency, non-alarmism, and openness to questions are some of the principles that should guide such discussions. As we mention in the paper, such discussions are not necessary or feasible for all procedures involving ionizing radiation.
Ryan: The communication tools that you emphasize, including the use of “plain language” and the “teach back” method, were not components of my medical training (either medical school or residency). What is the best way to obtain and retain these skills?
Einstein: As with all patient communication skills, “practice makes perfect.” The use of plain language is a skill that goes well beyond radiation safety — too often we speak in medical jargon that is not completely comprehended by our patients. Asking our patients to teach back is a good way to assess whether they understood the concepts and content we have attempted to convey.
Just like it is challenging the first time we are called upon to break bad news to patients and their families, it can be challenging as we first try to process technical information about radiation and communicate it at the right level to a patient. By taking this responsibility seriously, and getting feedback from colleagues and mentors, we can improve these skills.
Ryan: Should patients carry a radiation record card similar to those carried by power plant or cath lab workers?
Einstein: The issue of radiation tracking has some subtleties and areas of controversy, but I think most people support at least tracking procedures so we can avoid unneeded duplicate studies. In fact, the FDA offers such a card.
April 24th, 2014
Study Details Cardiovascular Events in Cannabis Users
Nicholas Downing, MD
One quarter of cardiovascular events among young cannabis users might be fatal, according to a small study in the Journal of the American Heart Association.
Researchers examined 35 cardiovascular events (1.8% of roughly 2000 adverse events) in cannabis users reported to the French Addictovigilance Network from 2006 to 2010. Nearly half the patients reported using cannabis at least 10 times in the past 30 days, 17% at least once in the past 30 days, and 37% at least once in the past year. Patients’ average age was 34, and most patients were male. The majority of events were acute coronary syndromes or peripheral arteriopathies. Overall, 25% of patients died.
The authors say their findings “indicate cannabis as a possible risk factor for cardiovascular disease in young adults”; however, they note that “events were too few to assess whether [they] were actually due to cannabis use.” Asked to comment, Harlan Krumholz, editor-in-chief of NEJM Journal Watch Cardiology, said the study “should be considered highly preliminary,” given its inability to evaluate causality.
Originally published in Physician’s First Watch
April 23rd, 2014
The Challenges of Early Career Cardiologists in Academic Medicine
John Ryan, MD and Andrew M. Kates, MD
In a recent JACC paper co-authored by CardioExchange Editors John Ryan and Andy Kates, the challenges facing early career cardiologists in academic medicine are discussed. Ryan and Kates delve further into what these issues are and why addressing them is important.
John Ryan: The physician-scientist serves an important role by bringing advances in research into the clinical arena. To be trained in this role takes time, resources, and mentorship, features which are embedded in most academic cardiology fellowships. However, there is a legitimate concern that once fellowship is over and we take on junior faculty positions, the ability to protect one’s time and continue to develop becomes a major challenge. The challenges have evolved from cuts in research support and decreases in reimbursements from clinical activities. Whereas in the past, early career academic cardiologists were able to have more protected time in the absence of large NIH funding, this is no longer the case with providers spending more and more of their academic time on large volume inpatient and outpatient clinical service. Additionally, with funding lines being at historically low levels, it is difficult for MDs to compete against PhD candidates for the same funding sources – and in many regards PhD researchers are oftentimes at an advantage because of their dedicated research careers with no competing clinical interest. Our survey of early career members within the ACC found that cardiologists were very concerned about their future within the academic sphere and added that financial disincentives and RVU tracking were driving early career cardiologists away from academic medicine. Solutions to address this are admittedly difficult to set in stone, but probably involve developing novel partnerships between university systems and clinical entities to provide stability during early career years.
Andy Kates: Academic cardiologists are a heterogeneous group of professionals, including physician-scientists, clinician-educators, clinician- educator administrators and pure clinicians. Some of the challenges that the clinician-educator and clinician-educator-administrator must deal with are related to the changing face of education. There are new, formal education requirements. For instance, the Next Accreditation System has fundamentally changed how we assess fellows. There are new ideas in curriculum development as well. Skills required to address these and other issues are rarely taught in fellowship. There are limitations to onsite mentoring and training and lack of access to professional education programs. Administrative time needs to be carved out for the early career professional who is seeking to establish a concomitant clinical practice. For fellows who chose the clinician-educator track, formal training in education, curriculum development, and educational assessment is needed. More challenging still is that for many of these early career professionals, these activities are rarely reimbursed. This may represent a significant challenge for the early career professional that is judged based primarily on RVUs. Lastly, traditional measures such as grant support and impact journal publications (with this exception) do not necessarily apply to this group as much so other markers of success must be considered when an evaluation for promotion is in order.
What do you feel are the challenges facing academic cardiologists? How can these be addressed?
April 22nd, 2014
Large French Registry Lends Support To Pharmaco-Invasive Strategy For STEMI
Larry Husten, PHD
It is generally agreed that the best treatment for STEMI patients is immediate reperfusion with PCI. But for many patients primary PCI is not available within the time frame leading to the greatest benefit. Previous studies have found good short-term outcomes in patients who receive a pharmaco-invasive strategy, in which patients first receive fibrinolytic therapy and then later undergo angiography. Now long-term results from a large real-world study show that this strategy may be an acceptable alternative for some patients when immediate primary PCI is not available.
In a paper published in Circulation, French researchers report the 5-year mortality findings from nearly 1,500 STEMI patients enrolled in the 2005 cohort of FAST-MI (The French Registry on Acute ST-Elevation and Non–ST-Elevation Myocardial Infarction).
30% of the patients received fibrinolysis. In two-thirds of these patients fibrinolysis was delivered prior to hospital arrival– a high rate made possible by the common presence of physicians in French ambulances. 97% of patients in the fibrinolysis group underwent subsequent angiography and 84% underwent PCI. For the rest of the patients in the study, 39% received primary PCI and 31% did not undergo reperfusion.
At 5 years the crude survival rate was 88% for patients in the fibrinolysis group, 83% for patients in the primary PCI group, and 59% for patients in the group that did not receive reperfusion. After adjusting for risk factors the hazard ratio was 0.73 (CI 0.50–1.06) in the fibrinolysis group when compared to the primary PCI group. For the subgroup of patients who received prehospital fibrinolysis the hazard ratio achieved statistical significance (0.57, CI 0.36–0.88). Prehospital fibrinolysis was also superior to primary PCI when the latter was delayed beyond 90 minutes in patients who called within 3 hours of the onset of symptoms (HR 0.63, CI 0.34–0.91). There were no significant differences between the two groups in propensity score-matched populations.
The French investigators concluded that “the pharmaco-invasive strategy yielded results that were at least as good as those of primary PCI.” Given the difficulty of implementing widespread, 24-hour emergency PCI services, “a pharmaco-invasive strategy seems to represent a safe alternative to primary PCI.”
In an accompanying editorial, Peter Sinnaeve and Frans Van de Werf point out that “it remains uncertain whether the high 5-year survival rates can be obtained” in other healthcare systems, especially those that don’t use physicians in the ambulance. Nevertheless, they conclude that “a contemporary pharmaco-invasive management appears to be at least as good as primary PCI in STEMI patients presenting early after symptom onset when a timely PCI is not an option.”
April 21st, 2014
The CoreValve Trial: What Do You Say to Your Patients?
Harlan M. Krumholz, MD, SM
This post from CardioExchange Editor Harlan Krumholz asks: How do you communicate with your patients about cutting-edge research findings that are very complex or controversial? Your patients may have questions about the latest guideline or study that they hear about on the news. How do you interpret the nuances of the findings and explain how they may — or may not — apply to their care? If this blog generates valuable discussion, it may be the start of a new series on communicating with your patients about the latest research.
The CoreValve High Risk Study reported that, of 795 patients with severe aortic stenosis who were at increased surgical risk, those who were randomized to have transcatheter aortic-valve replacement (TAVR) with a self-expanding transcatheter aortic-valve bioprosthesis had a significantly higher survival at one year than did those randomized to have surgery. However, the finding was marginally significant and Sanjay Kaul suggested that a couple of extra deaths would have eliminated the finding. Also, the mortality difference did not appear until after two months of follow-up, which also raises a question of what might have accounted for the difference.
A patient comes to see you for a consultation. She is scheduled for surgical AVR with an experienced surgeon — and her clinical profile is identical to that of the patients involved in the CoreValve trial. She asks you if she can expect to live longer if she has TAVR instead of surgery.
The patient is bright but not a medical person.
What do you say to your patient?
April 17th, 2014
FDA Grants Fast Track Status to Ivabradine
Larry Husten, PHD
Amgen announced yesterday that its new chronic heart failure drug ivabradine had been granted fast track status by the FDA. The company said the fast track designation, which is for drugs that treat serious conditions and fill an unmet medical need, will aid the development and speed the review of the drug.
The company said it planned to file for FDA approval in the second half of this year. The drug has been marketed for several years in Europe by Servier under the brand name of Procoralan. Amgen has licensed the drug for commercial use in the U.S.
Ivabradine slows the rate of the heart by inhibiting the so-called “funny” current within the sinoatrial node. The main basis for Amgen’s application will be the SHIFT trial, published in the Lancet in 2010. In that trial, 6558 patients with heart failure and a heart rate > 70 bpm were randomized to ivabradine or placebo. After a median 22 months of followup, the rate of cardiovascular death or hospital admission for worsening heart failure was 24% in the ivabradine group and 29% in the placebo group (HR 0.82, 95% CI 0.75–0.90, p<0.0001). The SHIFT investigators concluded that the beneficial effect of ivabradine was due to its heart-rate lowering effect.
However, in an accompanying comment, John Teerlink was critical of the trial, noting that many patients had not received optimal medical therapy, especially high dose beta blockers. “Whether ivabradine can improve outcomes in addition to optimally managed heart failure therapies or its benefits relative to other therapies, especially beta blockers, remains unknown,” he wrote.
April 15th, 2014
Case: Assessment of Cardiac Risk and Need for Preventive Medications
Seth Shay Martin, MD and James Fang, MD
A 68-year-old white woman with a history of obesity and depression is seen for cardiac risk assessment. The quality of her diet varies greatly, and she admits to many dietary indiscretions. She has tried several different diets, including low-carbohydrate/high-fat diets. She does not use the treadmill or stationary bicycle in her house or routinely exercise elsewhere. There is no family history of premature atherosclerotic cardiovascular disease. She quit smoking 25 years ago, having previously smoked 1 pack per day for several years. Her current medications include aspirin 81 mg daily, a multivitamin, a calcium/vitamin D supplement, and escitalopram as needed.
The patient’s blood pressure is 118/72 mm Hg, and her body-mass index is 32 kg/m2. A recent fasting lipid panel shows total cholesterol of 250 mg/dL, an HDL level of 77 mg/dL, a triglyceride level of 163 mg/dL, a Friedewald-estimated LDL level of 140 mg/dL, and a non–HDL-cholesterol level of 173 mg/dL. The patient’s hemoglobin A1C level was 5.8%. Her primary care provider recommended starting simvastatin 20 mg daily. She is hesitant to take medications and asks whether she should use red palm oil instead.
Questions:
1. How would you assess this patient’s risk of heart attack and stroke?
2. Would you recommend a statin for this patient?
3. What would be your advice about red palm oil?
4. Would you recommend that the patient stay on aspirin?
5. What dietary and exercise recommendations do you have?
Response:
April 24, 2014
1. Despite the recent debate about the latest cholesterol guidelines, I personally find the recommendations to be straightforward, practical, and intelligent. According to the risk-calculator app on my phone, this patient’s 10-year risk is 6.5% (or 5.6% if risk factors are optimized). The app recommends that the care provider consider a moderate-intensity statin (essentially half the maximal dose of currently available statins) with multiple disclaimers, including the addition of lifestyle modifications, a detailed risk-benefit discussion with the patient, and consideration of other factors (e.g., LDL >160 mg/dL, family history of premature atherosclerotic CVD, C-reactive protein (CRP) >2 mg/L, coronary artery calcium (CAC) >300, ankle-brachial index (ABI) <0.9, or elevated lifetime risk). Among the other factors to consider are the patient’s beliefs about taking medications to prevent heart disease.
2. At the first visit, I would not initiate a statin but, rather, discuss the issues with the patient and schedule a follow-up visit to assess progress (e.g., on weight loss, exercise, etc.). If progress was not significant at follow-up, I would consider statin therapy (in light of the risk calculator’s recommendation). Other risk-assessment instruments (e.g., CRP, CAC, ABI) may be useful adjuncts to provide this patient with more data about her risk.
3. I generally do not endorse alternative therapies, such as red palm oil, without an evidence base to support their use. The assumption that such therapies simply cause no harm is flawed, particularly when one considers potential drug interactions, the lack of regulatory control, unanticipated adverse effects, and so on.
4. Weighing this patient’s risk for bleeding (which appears low) against her modest CV risk (6.5%), I would consider continuing the aspirin but at a lower dosing level, such as every other day. The evidence base for aspirin in primary CV prevention in women is complex and driven largely by the Women’s Health Study. This large-scale randomized trial did not meet its primary endpoint of a first major CV event, but the risk for ischemic stroke was reduced by 25% in aspirin recipients. A subgroup analysis also suggested that aspirin lowered the risk for all CV endpoints in women older than age 65.
5. ACCF/AHA guidelines have outlined dietary and exercise recommendations. The U.S. Department of Health and Human Services currently recommends 150 minutes of moderate-intensity exercise or 75 minutes of vigorous exercise per week. The patient’s depression also needs to be addressed diligently. Although not common, bringing family into the discussion may be helpful as well.
Follow-up:
May 2, 2014
We used the ACC/AHA smartphone app to estimate a 10-year risk of MI or stroke of 6.5%. However, the estimation did not account for her prior history of smoking, poor diet, and physical inactivity. As recommended by the guidelines, we considered other factors and performed a coronary artery calcium scan. Her LDL-C was <160 mm/dL, and she had no family history of premature ASCVD; however, her CAC score was 601 — in the 95th percentile for a 68 year-old white woman and consistent with much higher risk than was suggested by traditional risk factors alone.
We engaged the patient in a detailed discussion about the options for statin therapy as an adjunct to lifestyle changes, and she decided to start rosuvastatin 40 mg daily. I recommended against red palm oil, which she had become curious about because of the Dr. Oz show; I’m glad she asked my opinion, which gave us the opportunity to focus on evidence-based therapy. The patient remains on aspirin 81 mg daily, which seems reasonable, given her high absolute risk of ASCVD, and apparently low risk of bleeding.
The patient viewed the very high CAC score as a motivator to improve her diet and physical activity level, and we reviewed the lifestyle guideline recommendations. In addition, the patient elected to join mActive, a trial of digital activity-tracking and mobile phone-based text message coaching. Her depression has been mild and intermittent and is well managed by her PCP; it is our hope that her mood will improve with lifestyle change.
April 15th, 2014
CoreValve Availability In U.S. Threatened By Court Decision
Larry Husten, PHD
A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery.
The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the field of transcatheter aortic valve replacement with its Sapien devices, has sought to hinder Medtronic from competing in the U.S. and international markets. This particular case was initiated in 2008. In 2010 a federal jury decided that Medtronic had infringed Edwards’ Andersen transcatheter aortic valve replacement patent. The decision was affirmed by the Court of Appeals. The Supreme Court declined to review the case.
Although the judge accepted Medtronic’s contention that CoreValve has important clinical benefits he ultimately sided with Edwards. Here is the key passage in the judge’s oral decision on Friday.
Regarding the public interest factor, the Court is persuaded that there are patients who cannot be served by either the Sapien or Sapien XT and who need the CoreValve Generation 3. The Court is also convinced that the CoreValve Generation 3 is a safer device and that patients in whom it is implanted have better outcomes with a lower risk of death. At the same time, the Court cannot downplay the strong public interest favoring enforcement of patent rights. Thus, the Court finds that the public interest weighs in favor of granting Edwards a preliminary injunction, but that Medtronic must be allowed to sell its devices to those patients who cannot be helped by Edwards’devices.
The judge ordered the two companies to negotiate an arrangement so that CoreValve could continue to be used in U.S. centers currently trained on CoreValve. The judge also agreed to postpone implementation of the injunction for one week in order to allow Medtronic a chance to appeal the injunction. (On Monday, according to Fierce Medical Devices, Medtronic filed its motion to postpone the injunction and appeal the ruling.)
Wells Fargo analyst Larry Biegelsen estimated that if the injunction is upheld CoreValve will be limited to about 15% of the U.S. market until patent expiration in March 2016.
The Wall Street Journal interviewed John Carroll, the director of interventional cardiology at the University of Colorado Hospital, which uses the Sapien valve but had planned to start training to use the CoreValve as well. Carroll told the WSJ that Medtronic had put the training program on hold. “It’s a shock because the device has been approved and is being used commercially,” said Carroll.
I asked David Kandzari, the director of international cardiology at the Piedmont Heart Institute, for some additional perspective. He noted that there are additional patent cases that could threaten CoreValve. “In short, the story is not over, even after this story is over,” he said.
Referring to the historical precedent of drug-eluting stents, Kandzari suggested the two companies might ultimately reach a financial arrangement which would allow CoreValve a significant presence on the market. Edwards, he suggested, could damage itself by seeking extreme limitations on CoreValve availability:
As much as this is unfavorable for Medtronic, it also represents a public relations dilemma for Edwards. In other words, do they appear to be suppressing a valuable technology for their own self-interest, or alternatively, do they show goodwill with some agreement for CoreValve to remain on the US market?
For additional perspective on recent TAVR studies, visit the following CardioExchange blogs:
April 15th, 2014
Cardiology and the Medicare Data Avalanche
Harlan M. Krumholz, MD, SM
The avalanche of data released by Medicare on Wednesday was followed shortly by an outpouring of news reports. Here’s a review of some of the more significant cardiology-related details that came out in these stories.
Cardiology was the third in a New York Times list of total Medicare payments received by the highest-paid 2% of doctors. This 2% accounted for nearly one-fourth of total Medicare payments. There were 2,176 cardiologists in the top 2% group and they received more than 1.6 billion dollars from Medicare. Ahead of cardiologists at the top of the list were ophthalmologists (2,995 providers who received more than $3.3 billion) and hematologists/oncologists (1,831 providers who received more than $2 billion).
The Washington Post‘s Wonkblog furthered the discussion by asking the top 10 Medicare billers to explain their charges.
What are your thoughts on this recent data? Has there been a discussion between you, your colleagues and/or patients about the information released to the public?
NEJM Journal Watch — Recent Cardiology Articles- Major and Intracranial Hemorrhage Risk with Direct Oral Anticoagulants vs. Aspirin
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- Estimating Heart Failure Risk in the U.S. Population with the PREVENT Calculator
- Atrial Fibrillation and Stable Coronary Artery Disease — What Is the Optimal Anticoagulation–Antiplatelet Regimen?
- β-Blockers After Myocardial Infarction