August 23rd, 2011
Door-to-Balloon Time Closes In On 1 Hour
Larry Husten, PHD
The door-to-balloon (D2B) time has fallen substantially since the launch of the D2B Alliance campaign in 2006, according to a new report in Circulation. Harlan Krumholz (editor-in-chief of CardioExchange) and colleagues analyzed data reported to CMS from the beginning of 2005 through September 2010.
- D2B dropped from 96 minutes in 2005 to 64 minutes in the first 9 months of 2010.
- The percentage of patients treated within 90 minutes increased from 44.2% to 91.4%.
- The percentage of patients treated within 75 minutes increased from 27.3% to 70.4%.
The investigators reported that the biggest improvements were observed in groups that initially had the highest median times, including patients over 75 years of age, women, and blacks. They noted that the shift toward a 90-minute standard was provoked by the observation that primary PCI was superior to fibrinolytic therapy only if it could be given no later than 1 hour after fibrinolytic therapy would have been delivered.
Opportunities for improvement still remain, the authors write. The best hospitals now regularly achieve D2B times of 60 minutes and “this level of performance may become the new standard.” In addition, many patients experience long delays when they are transferred to a hospital without PCI capability to a PCI-capable hospital.
“At the beginning of these efforts, many said that this level of improvement was impossible to achieve,” Krumholz said, in an AHA press release. “This is an opportunity to reflect on our achievement and to recognize that, when we identify quality issues and problems in our healthcare system, we can work as a community to generate new knowledge to apply to practice and improve care for patients.”
August 22nd, 2011
CNN, ABC, and NBC Dumb Down the News About CV Screening
Larry Husten, PHD
Last Thursday the Lancet published an extraordinarily interesting and complex study looking at the relative value of CRP tests and CAC (coronary artery calcium) scans (see my news report here). Coincidentally, CNN, NBC, and ABC this week ran reports on the same general topic. Exit complexity. Enter stupidity.
Health journalism watchdog Gary Schwitzer and his Health News Review has a definitive takedown on these reports (here, here, and here). I just want to call attention to some of the major flaws of these pieces, and then take a peek behind the curtain to show how these news organizations actually take great effort to dumb down their stories.
The CNN story, “Will you have a heart attack? These tests might tell,” pumps calcium imaging. It relies heavily on cardiologist Arthur Agatston, the South Beach Diet guru and an early advocate of calcium scans. Two of his quotes are perfect examples of what good health journalism should always avoid. Here’s the first:
“Unless you do the imaging, you are really playing Russian roulette with your life,” he said.
And here’s the quote that concludes the story:
“One of the best-kept secrets in the country in medicine is the doctors who are practicing aggressive prevention are really seeing heart attacks and strokes disappear from their practices. It’s doable.
Here’s what the reviewer on Health News Review had to say about this assertion:
The claim that a few screening tests can make heart attacks and strokes disappear flies in the face of even the most optimistic interpretations of recent studies that indicate some incremental advantage to adding coronary calcium scoring to risk fact calculations for certain patients.
The same pattern holds over on ABC. Dr. Richard Besser narrated a short piece that actually focused on an important issue, which is that low cholesterol is no guarantee of safety. But then he offered this advice:
“Before you go on a cholesterol medication, I want you to ask your doctor about this: A coronary artery calcium test.”
Now this is a completely unwarranted recommendation. Responding to criticism from Schwitzer, Besser said on Twitter that his goal was to empower patients, and then he made this claim:
I practice public health from my perch at ABC News. Would I stop at “Experts recommend flu vaccine?” No!
Make no mistake: although there is some dissent, there is a very broad consensus within the medical community about the flu vaccine. Although calcium scans have some very passionate advocates, there is absolutely no consensus within the medical community about their precise role, and Besser does a huge disservice to ABC viewers by pretending otherwise.
Over on NBC’s Nightly News, Dr. Nancy Snyderman uncritically pumped the value of CRP for women over 40:
“It’s not a new test, it’s not an experimental test, but nonetheless it’s a test not a lot of people know about. And that’s a problem because this simple blood test could save your life.”
Too often, according to Snyderman, women who think they’re at low risk end up having heart attacks. Says Snyderman:
“… that’s because most doctors do not check for C-reactive protein for fear of overtreating them.”
Snyderman concludes:
“If you’re over the age of 40, this is the time to have a conversation with your doctor about this very simple blood test that’s covered by most insurance.”
Once again, Snyderman’s report includes no caveats, and it fails to inform viewers that the role of CRP in preventive cardiology is highly controversial and the subject of intense debate. CRP is certainly not a “very simple blood test,” and until a larger consensus is achieved, TV docs like Snyderman shouldn’t blithely endorse its use.
Case History of a Quotation
In the CNN report discussed above the Agatston quotations struck me as particularly egregious, but I was also bothered by another quotation, which included the incredible assertion that half the population might benefit from a calcium scan. Here’s the entire relevant portion of the CNN article:
High-risk patients already receive such aggressive treatment as cholesterol-lowering statin medication, but many doctors don’t think low-risk patients need to incur the expense or small dose of radiation that comes with a coronary calcium scan.
“There is a large group in the middle called intermediate risk, which may be as much as 50% of the population,” said Dr. Erin Michos, a cardiologist at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins University
A good candidate for a coronary calcium scan, she says, would be a 50-year-old man with slightly elevated cholesterol and a father who had a heart attack.
“Do you put this 50-year-old who has this family history on a statin medication with potential expense (and) side effects for the next four decades of his life, or do you further refine how far at risk he is?” she asked.
A calcium score would answer that question, she says.
I asked Erin Michos about the quote. Here is her response:
My quotes in the CNN article were taken out of a much longer 30-minute interview about prevention (an interview where I tried to be balanced and evidence-based), and I actually did not see the article or get to approve the proofs before it published.
I actually never said that 50% of adults need a CAC scan. I did say, depending on the definition of intermediate risk (see below regarding definitions), that “intermediate risk” can be 50% of a middle-aged to older adult population (i.e., men 45-74, women 51-74).
Actually, Michos’s response was much longer than this, and she sent me a second email with additional clarifications and explanations. Clearly, this is not a person likely to make a broad and completely unqualified statement along the lines that fully half the population might benefit from calcium scans. But clearly the folks at CNN thought Michos’s message was too complex for their audience, and so they extracted the nugget they wanted and ignored everything else.
From conversations I’ve had in the past with many physicians and researchers who have been interviewed and quoted in the press, this is by no means an unusual or atypical occurrence. Unfortunately, it appears to be the norm for health journalism.
August 22nd, 2011
Panel: Coronary Calcium vs. CRP for Predicting Cardiovascular Events
CardioExchange Editors, Staff
Drs. Paul Ridker and Sanjay Kaul offer their perspectives on a new coronary artery calcium/C-reactive protein study, published in the Lancet, and three of the study authors respond. The study showed that people with low LDL levels and high CRP levels may benefit from CAC scans to identify the folks who are most likely to benefit from statin therapy. Data came from 950 people enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) who had met the entry criteria for the JUPITER study. We invite you to read the discussion—and then join it.
Paul Ridker: Participants in MESA were not randomized to statin therapy, and there are no statin trials based on CAC scores (in contrast to high-sensitivity CRP); nor do statins lower CAC. A major lesson learned by the cardiology community is that without direct trial data, we just don’t know whether interventions work or not in a given population. So I congratulate these authors on providing evidence to undertake just such a trial, as has been suggested to the imaging community many times before. But in the absence of formal testing, it is imprudent to use a technology we know is associated with radiation exposure, expense, and a considerable “incidentaloma” rate without knowing that it actually identifies individuals who preferentially benefit from any specific therapy.
One other thing worth considering: the CORONA, GISSI-HF, 4D, and AURORA trials all failed to show any benefit of statin therapy. What do these trials all have in common? Severe underlying atherosclerosis with presumably high coronary calcium scores. So we just can’t make the assumption that people with high CAC scores benefit from statin therapy—we have to do real trials. Remember that the imaging community also assumed for years that statins would reduce coronary calcium, but when trials were finally done, that turned out to be a completely wrong assumption.
Sanjay Kaul: The finding that, compared with CRP, CAC is more strongly associated with CHD or CVD extends previous observations. However, I would like to have seen the comparative effects on a more clinically relevant risk-prediction metric, such as reclassification, that can help guide treatment decisions.
The NNT results are based on exploratory analysis using assumptions that are not verifiable in the MESA cohort—for example, 46% risk reduction in outcomes with rosuvastatin observed in JUPITER, which is likely to be an overestimate.
The observation that 75% of the events were clustered in the 25% of patients with a CAC score of >100 does not necessarily mean that selective therapeutic targeting of such patients (test all, treat few) would be more cost-effective than unconditional treatment (test none, treat all). It is a defensible hypothesis in dire need of validation.
The Study Authors Respond
Michael J. Blaha, Roger S. Blumenthal, and Khurram Nasir (study authors): We thank Drs. Ridker and Kaul for their insightful comments and agree that our paper is best considered a provocative exploratory analysis — one demanding follow-up investigation. Most agree that this should include a clinical trial with random allocation of statins after CAC testing. The NHLBI is currently considering such an RCT. Unfortunately, the results would not be available for many years, and the design of such as trial is immensely challenging (see Blumenthal and Hasan, J Am Coll Cardiol 2011; 57:1601). The complex trial design continues to be the main barrier to definitive evidence of the benefit of subclinical atherosclerosis testing.
We would like to highlight the two distinct aims of our paper. First, and most important, we sought to determine whether CAC testing could further risk-stratify the “JUPITER-eligible” population. Such patients are known to benefit from rosuvastatin, as per the JUPITER trial results. Within this group, CAC discriminates risk up to 20-fold, identifying JUPITER-eligible patients both at very low risk and very high risk. Expressed as a predicted 5-year number needed to treat (NNT-5), we see that JUPITER-eligible individuals with CAC=0 are unlikely to gain a net benefit from statin treatment, whereas those with measurable CAC, especially CAC >100, have a highly favorable NNT. We believe this has important potential public health implications for statin allocation in primary prevention. Regarding Dr. Kaul’s concern about the optimistic 46% event reduction from JUPITER, we agree, and our paper includes sensitivity analyses with more “real-world” expectations about statin benefit.
The second aim directly compares CAC vs. hsCRP for risk prediction among all patients with “normal” cholesterol (LDL<130). CAC is clearly superior here in the MESA cohort. Dr. Ridker brings up the critical point that we don’t know whether CAC “identifies individuals who preferentially benefit from any specific therapy.” This is true, but it is probably also true for hsCRP. Without a low-hsCRP arm, JUPITER could be considered a lipid-lowering trial, not just a biomarker trial. Studies from the Heart Protection Study and some secondary analyses from JUPITER show that higher hsCRP does not necessarily identify preferential benefit with statin (similar relative risk reduction across hsCRP levels). As Dr. Ridker has previously noted, the value of hsCRP is in identifying higher absolute cardiovascular risk among people not eligible for statins according to current guidelines. JUPITER was indeed a landmark achievement and has greatly expanded the population eligible for statin therapy.
Our data from the MESA cohort indicated that CAC is likely a better predictor of absolute risk than hsCRP, but CAC testing necessitates the need for low levels of ionizing radiation and the challenges of dealing with incidental findings that necessitate a follow-up CT scan (5%–10% of subjects in some prior studies.) We agree wholeheartedly that demonstration of improved risk prediction does not necessarily translate to cost-effectiveness of CAC testing. Incidental findings remain a critical issue.
Until the results of a CAC RCT are available, use of either CAC or hsCRP as “tie-breakers” for determining statin benefit is reasonable. The 2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults gives CAC scoring a IIa recommendation in the intermediate risk group and hsCRP measurement a IIa recommendation in those meeting the JUPITER entry criteria. However, we posit this provocative question: What is the future of primary prevention — treating based on direct measurement of the disease we propose to treat (coronary atherosclerosis) or treating based on a single blood test? We look forward to future research in this area.
Khurram Nasir (personal view): In my opinion, the major aim of our study was to assess a key question: whether we can identify a subset of individuals meeting JUPITER criteria using CAC testing who are less likely to derive any significant benefit.
As our study clearly demonstrates, nearly half of individuals within this nationally representative and ethnically diverse cohort meeting eligibility for statin therapy according to JUPITER criteria had no CAC and experienced an extremely low event rate during almost 6 years of follow-up, with a very high estimated number needed to treat for 5 years to prevent one cardiovascular event. This has very important implications: If all individuals meeting JUPITER eligibility criteria can be further stratified by CAC testing prior to committing them to long-term statin therapy, we can identify one out of every other individual in this group from whom we can safely withhold pharmacotherapy and focus on lifestyle modification.
I believe in the setting of such a low risk for CVD events with absence of CAC, the burden of proof that this specific subset of individuals will benefit from statin therapy in the setting of meeting any criteria for lipid-lowering pharmacotherapy lies with those who advocate for it. In the current environment of rising health care costs and shrinking resources, we cannot afford to treat a large number of individuals to prevent few events.
The next challenge for us is definitely to engage all pertinent stakeholders to urgently consider the feasibility of a strategy supplemented by CAC testing, to separate out the subset of individuals with absent, thus, a very low CVD risk, and focus on a small subset of individuals with high atherosclerotic burden of subclinical atherosclerosis in whom the majority of events occur.
August 19th, 2011
Is Coronary Calcium Better Than CRP for Predicting CV Events?
Larry Husten, PHD
A new study suggests that people with low LDL levels and high CRP levels may benefit from coronary artery calcium (CAC) scans to identify those who are most likely to benefit from statin therapy. In a paper published in the Lancet, Michael Blaha and colleagues analyzed data from 950 people enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) who met the entry criteria for the JUPITER study.
After 5.8 years of of follow-up:
• 47% of the subjects had a calcium score of zero. CHD event rates in this group were 0.8 per 1000 person-years. They calculated that in this group 124 patients would need to be treated with rosuvastatin to reduce one cardiovascular event (NNT = 124). Overall, 6% of coronary events and 17% of cardiovascular events occurred in this group.
• 28% of the subjects had a CAC between 1 and 100. In this group the cardiovascular NNT was 54.
• 25% of the subjects had CAC scores over 100. This group accounted for 74% of all coronary events. The CHD event rate was 20.2 per 1000 person-years, and the cardiovascular NNT was 19.
The investigators also report that unlike CAC scores, CRP levels did not predict outcome in this population of patients who already had CRP levels ≥2 mg/L.
The investigators concluded:
CAC seems to further stratify risk in patients who meet eligibility criteria for JUPITER, and might be used to target a subgroup of patients expected to derive the most and the least absolute benefit from treatment. Focusing of treatment on the subset of individuals with low LDL cholesterol with measurable atherosclerosis might represent a more appropriate allocation of resources, reduce overall health-care cost, and prevent the occurrence of a similar number of events.
In an accompanying comment, Axel Schmermund and Thomas Voigtländer write that “although definitive proof of treatment effects is scarce, CAC identifies high cardiovascular risk, and statin therapy is most effective in high-risk patients. In our practice, we therefore focus on CAC… for expanded risk stratification in asymptomatic patients.”
To join the panel discussion about this study, click here.
August 18th, 2011
Are Interventionalists Getting Too Far “A Head”?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Nallamothu and colleagues have performed an observational analysis of Medicare data on fee-for-service beneficiaries undergoing carotid stenting between 2005 and 2007 in 306 hospital referral regions (HRRs). First, they determined how often carotid stenting was performed by different specialists (i.e., cardiologists, surgeons, radiologists) within each HRR, then they compared utilization rates and 30-day outcomes of the procedure across HRRs.
What did they find?
- Although only about one-third of the operators were cardiologists, they performed over half (52%) of the procedures; surgeons performed 28%, and radiologists performed 18% (see the graph in the report published in Archives of Internal Medicine).
- Utilization rates for carotid stenting were significantly higher in HRRs where cardiologists performed most of the procedures than in HRRs where most of the procedures were performed by other specialists (P<0.001).
- Risk-standardized outcomes did not differ across HRRs based on physician specialty.
Conclusion: Hospital referral regions where cardiologists perform most procedures have higher population-based utilization rates with similar outcomes.
Are markets where cardiologists are performing most procedures overutilizing carotid stenting, or are markets where surgeons or radiologists perform most of them underutilizing it (i.e., does involvement of cardiologists in the care of these patients lead to a greater recognition of carotid disease in the general population and subsequent referral for carotid stenting)?
Which is it?
A “Heart Team” approach is advocated for decisions regarding surgical versus percutaneous treatment of multivessel CAD and aortic stenosis. Should we adopt such an approach to promote multidisciplinary decision making about carotid stenting (i.e., the “Head Team Approach”)?
August 17th, 2011
E-doctoring?
Heather M Johnson, MD, MS
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog, Dr John M.
One of the coolest things about keeping a medical blog is interacting with people. It’s immensely gratifying to hear from folks who stumble upon my site.
Take this example: While cooling down after tonight’s ride, a cycling friend and ER doc mentioned that my website turned up on his Google search of the new blood-thinner Pradaxa. I was delighted to hear that my posts gave him what he needed for the care of the patient. Hearing that meant more to me than having good legs on the ride.
It’s also gratifying, and at the same time humbling, that so many contact me about their heart rhythm (most commonly, AF) experience. Gosh, there’s a lot of AF out there, and AFibbers are an educated, information-hungry crowd. There is little doubt in my mind that – for many – AF is an overachiever’s disease.
Patients tell me their AF stories; ask great questions; seek to understand the mysteries of an infinitely mysterious disease. I try to read and respond to anyone who takes the time to write. But with tapping the “send” button comes a big, bad, scary conflict.
What conflict?
On the one hand, AF treatment options are finite and knowable. “Just give the answer, John; it’s easy,” I think to myself. I’d like to tell patients to have an ablation, or stop worrying about one AF episode, or take the blood thinner because strokes are horrible. Like I was their doctor.
But these kinds of specific responses would constitute medical advice. And I’m not my readers’ doctor. I have not sat in the same room with them. I haven’t seen their expressions, listened to their hearts, or watched how well they walk around — a good measure of how well one tolerates having 50-plus burns made in the heart. Without seeing a patient, there’s no gestalt, no nuance. Even worse, I haven’t seen the ECG – and there’s a lot of helpful information buried in those squiggles. Call me old-fashioned, but I think interacting human-to-human and looking at an ECG are on the checklist of good doctoring.
But on the other hand, information is so vitally important in AF treatment. Information rocks! Though I know far less than most, I do know AF. I live and breathe this disease. I have even had the dang butterfly heartbeat myself. It stunk. (AF caused me to get dropped by a person of size going uphill.)
Though limited in scope, I could easily tap out a couple suggestions for a reader’s problem. It’s tempting. For instance, in writing to an AF patient tonight, I offered this bottom lime: “Ultimately, an AF patient ends up choosing from just three options: live with AF, take drugs, or have a procedure(s). And sometimes, no check that, often, AF treatment involves combination platters of all three.” Statements like this are general advice, which hold true for many medical conditions. I could not tell her which of the three options to choose, though I knew – from her words – which one I leaned toward.
One of my goals in writing about medical matters is to mesh real-world experience and my take on the scientific data with words that all can understand. If successful, readers are more informed. There’s a large difference, however, between providing general information and giving specific medical advice.
This notion seems inherent, understood (smart people might say “tacit”), but I am going to make it overt: Medical recommendations for treatment should come from the patient’s doctor.
I plan to continue writing about my life’s work. I hope to keep on hearing from readers.
JMM
August 17th, 2011
How Cardiologists Think
John E Brush, MD
Today on CardioExchange, we launch a new mini-series of blog posts on decision making in cardiology. Dr. John E. Brush explores the conscious and unconscious mental strategies that cardiologists use in their everyday work and asks you to examine your own decision-making processes. The aim: to foster a rich dialogue about how we do what we do so that we ultimately improve the care of patients.
A 60-year-old man with systolic heart failure is admitted to the hospital for shortness of breath. You are making rounds when the nurse calls out that the man has collapsed in his room. You look at the telemetry monitor at the nursing station and immediately recognize that the patient is in ventricular tachycardia. After you shock the patient, normal sinus rhythm is restored and the patient recovers.
Another patient comes to the emergency room with chest pain. An urgently performed electrocardiogram shows ST-segment elevation in 3 leads. Without further questioning, the cardiac catheterization laboratory team and the interventional cardiologist are called in for an emergency procedure.
A third patient is admitted with unexplained fever and night sweats. She has new diastolic murmur on exam but also has some enlarged lymph nodes and a 1-week history of diarrhea. After a thorough evaluation and a careful weighing of the evidence, the patient is ultimately diagnosed with subacute bacterial endocarditis.
As these examples demonstrate, cardiology is a field that employs a variety of decision-making strategies. Some tasks demand instantaneous decisions; others require a more deliberative, logical approach. And many of our daily medical decisions are “best guesses” because of the uncertainty surrounding complex diagnostic dilemmas or therapeutic decisions that aren’t directly guided by a basic scientific principle or data from a clinical trial. For the rapid decisions, we frequently use mental shortcuts called heuristics. For the complicated but routine daily decisions, we often use intuition, inductive reasoning, and inference.
How doctors think is fascinating, yet the field of medical reasoning seems to be either ignored or assumed in medical education and practice. In my opinion, because there is enormous variation in how we all make medical decisions, many of those decisions may be suboptimal. Placing greater emphasis on medical decision making in medical education and research represents a big opportunity to improve the quality of medical care.
To examine medical decision making, one must start by evaluating the role of intuition. Whether using intuition is good or bad and whether we should allow our rational mind or our intuition to dominate our thinking has been a source of debate since the days of Plato and Aristotle. The debate raged through the era of the Enlightenment between Descartes and Hume, and through every age and generation since. In recent decades, the fields of cognitive psychology, behavioral economics, and evolutionary psychology have revealed insights into the structure of decision making and have renewed interest in the role of intuition and the value of heuristics. Many popular books such as Blink by Malcolm Gladwell and How We Decide by Jonah Lehrer have brought the research findings about intuition to a larger audience.
The wisdom of the ancient philosophers and the research findings of modern psychologists elucidate the complexities of human cognition in ways that could greatly improve the quality and consistency of medical decision making. As the educator and pragmatic philosopher John Dewey wrote in his book titled How We Think, “The aim of education should be to teach us rather how to think, than what to think — rather to improve our minds, so as to enable us to think for ourselves, than to load the memory with the thoughts of other men.”
Three recent books have raised awareness specifically about medical decision making. Jerome Groopman attracted much media attention with How Doctors Think, where he exposed the use of heuristics in medicine. The fact that we frequently use these cognitive shortcuts was news to much of the lay public, who may have assumed that medical decisions are exactly and precisely defined by rigorous science. In another book also titled How Doctors Think, Kathryn Montgomery posits that medicine is not a science, like Newtonian physics, but is rather a practice, where custom and routines enable doctors to think through the uncertain decisions that are part of their everyday work. She emphasized how doctors use narrative to construct a mental picture and employ abductive or retroductive reasoning to make clinical diagnoses. In Learning Clinical Reasoning, Jerome Kassirer and his coauthors offer numerous examples of the variety of thinking styles that doctors use, as well as the many fallacies and the biased reasoning that can often come into play in medical practice.
In designing a typical medical education curriculum, we tend to focus on the content of medicine: what is known and what is new. We often deny the fact that much is unknown and that many decisions are made under conditions of uncertainty. No common curriculum prepares physicians for the uncertainty of practice, and few courses explicitly teach the mental processes that help us cope with uncertainty. Greater focus on medical reasoning strategies in both primary and continuing medical education would help create a common vocabulary and structure that could improve those strategies and enhance consistency. In addition, greater emphasis on medical reasoning in real-world clinical practice could yield new opportunities for research that uncovers the components of good decisions and allows us to disseminate the best practices.
I started this commentary with three examples of decision making from cardiology practice. The first makes use of the recognition heuristic. The second uses a “take the best answer” heuristic. And the final example synthesizes a variety of cognitive processes, with the ultimate decision likely resulting from the use of either the anchoring and adjusting or the tallying heuristic. In the next several blog posts, I will expound further on these and other medical decision-making strategies.
As this series on decision making in cardiology progresses, I ask you, as CardioExchange members, to engage in dialogue — both with me and with one another — about this important topic. My hope is that together we will become more aware of our decision-making processes and ultimately use that understanding to improve practice. Please join the conversation.
August 17th, 2011
Details of Updated U.K. Heart Failure Guidelines Raise Some Eyebrows
Larry Husten, PHD
Although the updated heart failure guidelines from the U.K.’s National Institute for Health and Clinical Excellence (NICE) are broadly consistent with similar guidelines from Europe and the U.S., outside experts are questioning several key details of the update. A summary of the new guidelines has been published in the Annals of Internal Medicine, along with an editorial by Pamela Peterson and John Rumsfeld that is broadly supportive of the update, but calls into question several points.
Much of the controversy revolves around the relative weight given to echocardiography and natriuretic peptides in the diagnosis and treatment of heart failure. The updated NICE guidelines recommend that for the diagnosis of heart failure in patients with no history of MI, echocardiography should be used only if natriuretic peptides are raised. Peterson and Rumsfeld point out that both the ESC and ACC/AHA guidelines recommend that all patients with the signs and symptoms of heart failure should have an echocardiogram. The NICE position, they say, “may be questioned because of the utility of echocardiography for not only measuring left ventricular function but also for detecting structural or valvular heart disease, pulmonary hypertension, and pericardial effusion.”
The editorialists also take issue with the NICE assertion that serial natriuretic peptide monitoring is cost-effective only when performed by specialists and only when used in select heart failure patients. They write: “Some may argue that natriuretic peptide monitoring should be used more broadly.”
Finally, Peterson and Rumsfeld point out that because the updated NICE guidelines base their recommendations regarding ICDs on cost-effectiveness calculations as well as on clinical trial evidence, they therefore “differ from guidelines from other organizations that do not explicitly incorporate economic factors.”
August 16th, 2011
Meta-analysis: Beta-Blockers May Be Less Effective in U.S. Than Elsewhere
Larry Husten, PHD
Beta-blockers may not be as effective in the U.S. as in the rest of the world, according to a meta-analysis published in the Journal of the American College of Cardiology. Christopher O’Connor and colleagues analyzed data on patients enrolled in the MERIT-HF, COPERNICUS, CIBIS-II (which did not enroll U.S. patients) and BEST trials. Some 4,200 U.S. patients were included.
The mortality benefit of beta-blockade was smaller in the U.S. than in the rest of the world, and the beneficial effect was not significant in the U.S. By contrast, the effect remained significant elsewhere:
Relative risk for mortality with beta-blockers:
- U.S.: 0.92 (CI 0.82-1.02, p<0.106)
- Rest of world: 0.64 (CI 0.56-0.72, p<0.0001)
The authors speculate about a number of different explanations for the finding, but conclude that “whatever the cause, geographic differences are reported frequently in the literature, and these findings support the need to re-evaluate the conduct, methodology, and analysis procedures of international trials to ensure that the generalizability of study findings can accurately be determined.”
In an accompanying editorial, Barry Massie points out that 81% of the deaths in the U.S. occurred in the BEST trial, and that “the deaths in the latter 2 trials are evenly split, with wide confidence intervals that do not exclude a meaningful mortality benefit of >20% in the U.S. patients.”
Although Massie argues that the findings of the meta-analysis should not be completely dismissed, he thinks that “based on the totality of data with beta-blockers and their experience, few heart failure physicians would withhold carvedilol or metoprolol from their patients.”
August 15th, 2011
Drug Eluting Stents: It Pays To Be Picky
Richard A. Lange, MD, MBA and L. David Hillis, MD
Why buy the most expensive stent when the cheaper one works just as well?
Two recent studies suggest that a more selective use of stents has merits.
In an analysis of pooled data from 4 trials (SPIRIT II-IV and COMPARE) comparing the more-expensive everolimus-eluting stent (EES) with the less-expensive paclitaxel eluting stent (PES), Stone and colleagues identified a substantial interaction between diabetes and stent type with regard to clinical outcomes after PCI.
In patients without diabetes, EES were superior to PES for the incidence of death, MI, stent thrombosis, and ischemia-driven target lesion revascularization (TLR) during the 2 years after stent implantation; in contrast, no significant differences in safety or efficacy outcomes were present in diabetic patients. In fact, in diabetics treated with insulin, the 2-year rate of ischemia-driven TLR was higher with EES than with PES, whereas the opposite trend was observed in those not treated with insulin.
|
2 Yr Event Rates (%) |
|||
|
EES |
PES |
P value |
|
| Non diabetics (n=4911) | |||
| Death |
1.9 |
3.1 |
0.01 |
| MI |
2.5 |
5.8 |
<0.0001 |
| Stent thrombosis |
0.3 |
2.4 |
<0.0001 |
| Ischemia-driven TLR |
3.6 |
6.9 |
<0.0001 |
| Combined death, MI or TLR |
6.2 |
11.4 |
<0.0001 |
| Diabetics (n=1869) | |||
| Death |
3.9 |
2.9 |
0.88 |
| MI |
4.2 |
4.9 |
0.49 |
| Stent thrombosis |
1.6 |
2.0 |
0.50 |
| Ischemia-driven TLR |
5.5 |
6.1 |
0.60 |
| Combined death, MI or TLR |
10.1 |
10.3 |
0.86 |
(Data from Circulation 2011; 124:893.)
In a separate analysis of 10,144 PCI patients enrolled in the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry, investigators found that DES use decreased from 92% to 68% from 2004 to 2007 (largely because of concerns about stent thrombosis). During that time, no change in the rate of death or MI was noted, and TLR increased only slightly (4.1% to 5.1%). Importantly, total cardiovascular costs decreased by $401/patient. With nearly 1 million PCI procedures performed annually in the United States, adoption of a more selective DES strategy could result in ~$400 million/year in annual cost savings to the U.S. healthcare system.
Do you think most interventionalists consider healthcare costs when choosing a stent?
Should they?
NEJM Journal Watch — Recent Cardiology Articles- Exercise as Medicine for Preventing Colon Cancer Recurrence
- Intensive Blood Pressure Control: Do the Benefits and Harms Vary with Baseline Cardiovascular Risk?
- Lifestyle Modifications in the Treatment of Atrial Fibrillation
- Shingles Vaccination Probably Protects Against Heart Disease
- Is Routine Defibrillation Testing Necessary for Patients Undergoing Subcutaneous ICD Implantation?