April 5th, 2012
When the Feds Come Knocking
Westby G Fisher, MD and John Mandrola, MD, FACC
CardioExchange welcomes this guest post from electrophysiologists Westby Fisher and John Mandrola. This piece originally appeared on their respective blogs, Dr. Wes and Dr. John M.
Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for reasons outside of the criteria set forth in Medicare’s National Coverage Decision (NCD). This investigation occurred just after Al-Khatib and others published a JAMA report on January 4, 2011 that suggested as many as 22.5% of implantable defibrillators implanted for primary prevention of sudden death were not evidence-based. While the physician community took issue with the Al-Khatib paper, the media firestorm it generated — paired with the announcement to the Heart Rhythm Society physician community that a federal investigation was underway — had a chilling effect on ICD implantation nationwide. Drs. Jonathan S. Steinberg and Suneet Mittal have published a report on their experience with DOJ investigators under this heavy regulatory oversight in the Journal of the American College of Cardiology.
Steinberg and Mittal’s diplomatic account carefully describes the challenges of retrospective audits performed by DOJ lawyers and those of their targeted health care facilities. The DOJ identified 229 cases as potentially inappropriate based on Medicare-code criteria. (This represented 8.7% of the de novo non-resynchronization ICD implants done for primary prevention at their institutions). After determining that some of these targeted cases were actually for secondary prevention or other coding transgressions, the authors could medically justify all but thirty-four (15% — or a very low 1.5% of all ICDs implanted for primary prevention of sudden death) at their institution. As has been the case in most reports, the majority of outside NCD-directed ICD implants occurred because of timing violations — too close to the diagnosis of heart failure, heart attack, and coronary intervention. These timing constraints constitute the primary issue before implanting doctors: their professional society guidelines do not — in all cases — recognize similar timing restrictions.
It is surprising that we are not told what sanctions, if any, were levied against their respective institutions. Perhaps the authors felt this important detail was unimportant to disclose or perhaps they were prohibited from doing so. Perhaps their penalty is still being determined: after all, nothing drives behavior like fear. To this end, we found the authors’ compliments of the government’s legal team unusual to report in a scientific manuscript, as if they were suffering from Stockholm Syndrome. We should acknowledge that the authors have added much-needed clarity to the gray area of decision-making surrounding ICD implantation. Their explanations of timing violations highlight problems with coding and confusion around incidental PCI intervention in patients with dilated cardiomyopathy, and demonstrate the overlap decisions that must be made when bradycardia and tachycardia functions might be required for our patients. This kind of clinically relevant nuance was lacking in the impugnable Al-Khatib JAMA piece.
We can only speculate about the large cost of the legal fees and man-hours devoted to this review process. We will never know how many patients died during, and after, the course of this investigation because they were not offered ICDs (because ICDs can only be offered to patients who meet Medicare’s rigid, outdated, and still-to-be-updated NCD for implantable defibrillators). But perhaps this is the price of regulation that America is willing to pay in return for cost savings. Perhaps we should not be concerned that professional guidelines for care delivery should be second fiddle to government mandates for ICD implantation.
With this latest report, a new era for medical practice is now upon us – one where priorities of low-cost care and high quantity of care determined by non-medical personnel supersede the highest quality of medical care to our patients. For regulators, it is easy to be a Monday-morning armchair quarterback evaluating health care delivery. It is far harder, however, to decide prospectively who is likely to die (or not) when they sit before you with a newly-diagnosed cardiomyopathy and ejection fraction of 12%.
When government and legal officials who carry no responsibility for the long-term well-being of our patients have the authority to retrospectively impugn and penalize doctors (and their health care facilities) based merely on retrospective reviews of billing codes and outdated payment mandates, they risk irrevocable harm to patients who might qualify for devices according to updated professional guidelines. Doctors everywhere should stand up collectively to disown the practice of using NCD mandates, rather than updated professional guidelines, to determine appropriate care for patients.
After all, our patients are depending on us.
April 4th, 2012
Suicide and CV Death Increase After Cancer Diagnosis
Larry Husten, PHD
The risks for suicide and cardiovascular death rise sharply after cancer is diagnosed, according to a new study from Sweden published in the New England Journal of Medicine. Fang Fang and colleagues analyzed data from more than 6 million Swedes, including more than half a million who received a first diagnosis of cancer.
Following sharp initial increases in suicide and CV death, risks rapidly declined thereafter, but remained elevated during follow-up. The increased risks for suicide and CV death were greatest among people with highly fatal cancers. A second, case-crossover analysis confirmed the broad findings of the nationwide cohort study.
Here are the main results of the cohort study:
Relative risk (RR) compared with cancer-free people and incidence of suicide after cancer diagnosis:
- First week: RR 12.6 (CI 8.6-17.8); incidence rate: 2.50 per 1000 person-years
- First year: RR 3.1 (2.7-3.5); incidence rate: 0.60 per 1000 person-years
RR compared with cancer-free people and incidence of cardiovascular death after cancer diagnosis:
- First week: RR 5.6 (CI 5.2-5.9); incidence rate: 116.80 per 1000 person-years
- First 4 weeks: RR 3.3 (3.1-3.4); incidence rate: 65.81 per 1000 person-years
The authors conclude that their “findings suggest that a cancer diagnosis constitutes a major stressor, one that immediately affects the risk of critical, fatal outcomes. We speculate that our findings show only a portion of the range of effects induced by the emotional distress associated with a cancer diagnosis.”
April 4th, 2012
Medical Societies Release Lists of Overused Tests and Procedures
Larry Husten, PHD
The American College of Cardiology (ACC) and other medical societies have released lists of commonly overused or misused tests and procedures. The action is part of Choosing Wisely, a broad initiative from the ABIM foundation.
Here are the five tests or procedures identified by the ACC:
- Cardiac imaging tests (particularly, stress tests or advanced noninvasive imaging) should not be given if there are no symptoms of heart disease or if high-risk factors like diabetes or peripheral arterial disease are not present.
- Cardiac imaging tests (particularly, stress tests or advanced noninvasive imaging) should not be given as part of a routine annual follow-up in patients who have had no change in signs or symptoms.
- Cardiac imaging tests (particularly, stress tests or advanced noninvasive imaging) should not be given before performing low-risk surgery that is not related to heart disease.
- Echocardiography should not be used as routine follow-up care in adults with mild heart valve disease who have had no change in signs or symptoms.
- Patients experiencing a heart attack and undergoing PCI should not have stents placed in an artery or arteries beyond those responsible for the heart attack.
Here is the list from the American Society of Nuclear Cardiology:
- Don’t perform stress cardiac imaging or coronary angiography in patients without cardiac symptoms unless high-risk markers are present.
- Don’t perform cardiac imaging for patients who are at low risk.
- Don’t perform radionuclide imaging as part of routine follow-up in asymptomatic patients.
- Don’t perform cardiac imaging as a preoperative assessment in patients scheduled to undergo low- or intermediate-risk noncardiac surgery.
- Use methods to reduce radiation exposure in cardiac imaging, whenever possible, including not performing such tests when limited benefits are likely.
Here are some other cardiovascular-related items from other medical societies:
- American College of Physicians: Don’t obtain screening exercise electrocardiogram testing in individuals who are asymptomatic and at low risk for coronary heart disease.
- American College of Physicians: In patients with low pretest probability of venous thromboembolism, obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.
- American College of Radiology: Don’t image for suspected pulmonary embolism without moderate or high pre-test probability.
- American Academy of Family Physicians: Don’t order annual EKGs or any other cardiac screening for low-risk patients without symptoms.
To read two recent posts on the Choosing Wisely campaign by Harlan Krumholz, in which he called for – and received – members’ ideas on ways to cut spending in cardiology, see here and here.
April 3rd, 2012
Why We Should Abandon LDL Cholesterol Targets
Harlan M. Krumholz, MD, SM
In an interview on CurrentMedicine.TV, CardioExchange editor-in-chief Harlan Krumholz discussed an editorial he co-authored with Rodney Hayward on why the NIH’s forthcoming Adult Treatment Panel IV should abandon LDL Targets.
April 2nd, 2012
Improved Survival After Non-Shockable Cardiac Arrest with New CPR Guidelines
Larry Husten, PHD
In recent years, resuscitation guidelines have evolved to emphasize chest compressions. At the same time, a greater proportion of out-of-hospital cardiac arrest (OHCA) cases are now due to “nonshockable” rhythms, defined as asystole and pulseless electrical activity, but the effect of the new guidelines on these type of OHCA cases is unknown.
In a study published in Circulation, Peter J. Kudenchuk and colleagues report on more than 10 years of experience treating nearly 4000 out-of-hospital patients with nonshockable OHCA treated in King County, Washington. Midway through the study period, the new AHA guidelines came into effect. Overall, outcomes were poor throughout the study, but several important measures were significantly improved during the second half of the study:
- 1-year survival: 2.7% in the first half versus 4.9% in the second half (adjusted hazard ratio: 1.85, CI 1.29-2.66)
- Return of spontaneous circulation: 27% versus 34% (HR 1.50, CI 1.29–1.74)
- Discharged from hospital: 4.6% versus 6.8% (HR 1.53, CI 1.14–2.05)
- Favorable neurological outcome: 3.4% versus 5.1 (HR 1.56, CI 1.11–2.18)
“By any measure — such as the return of pulse and circulation or improved brain recovery — we found that implementing the new guidelines in these patients resulted in better outcomes from cardiac arrest,” said Kudenchuk, in an AHA press release. He calculated that 2500 lives could be saved each year in North America by fully implementing the new guidelines.
April 2nd, 2012
Federal Audit of ICD Implants? Preparation Is Key
Jonathan Simon Steinberg, MD
CardioExchange welcomes Dr. Jonathan Steinberg, a Columbia University-affiliated electrophysiologist who also directs the EP program at a large suburban nonteaching hospital. A co-author of a JACC special article that describes the federal audit of his hospital’s ICD implants, Dr. Steinberg answers our questions about the audit process.
What should cardiologists do to avoid a federal audit?
It is necessary to be compulsively compliant with the CMS National Coverage Determination (NCD) for ICD indication. Systems should be established so that cardiologists are fully aware of the inclusion and exclusion criteria, and it may be valuable to require concurrent completion of checklists at implant to ensure compliance.
Nonetheless, circumstances may arise that suggest the benefit of an ICD implant, despite potential violation of the NCD. These instances may be judged acceptable upon subsequent review if based on sound published evidence supporting the indication and — very importantly — if there is thorough documentation in the medical record. Our paper outlines several scenarios that fit into this category. It is unwise to perform procedures that fall outside of accepted guidelines for implantation.
What should cardiologists do if they are audited?
Each case should be thoroughly reviewed from the source medical record, even though this is very time consuming. Clinical circumstances that would justify implantation should be identified in the record. If there are cases that clearly violated the NCD without mitigating factors they will need to be conceded.
What practical steps can you recommend for establishing the peer-review oversight mentioned at the end of the article?
It is helpful to have other colleagues who perform implants comment on the appropriateness of ICD implantation prior to surgery — particularly if there is any ambiguity. This can be done on a routine basis to avoid bias. Local quality assurance systems should be employed to provide retrospective review and to present cases that can be used to educate physicians on potential problems with indications or documentation.
April 2nd, 2012
Selections from Richard Lehman’s Literature Review: Week of April 2nd
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
Week of April 2nd
JAMA 28 Mar 2012 Vol 307
Sinners in the Hands of Angry Heart Disease (pg. 1273): Look into your hearts, my brothers and sisters! How few of you are saved from the perdition of cardiovascular risk! Just 1.2% of Americans can count themselves truly upright, by not smoking; being physically active; having normal blood pressure, blood glucose and total cholesterol levels, and weight; and eating a healthy diet. The rest are mired in sin – by genetic predestination or moral turpitude; and the world grows ever less righteous. According to the John Calvin of epidemiology, the late Geoffrey Rose, cardiovascular disease should have doubled since 1992, when he published his book The Strategy of Preventive Medicine. Instead it has halved. How depressing it must be for the Calvinists when so many sinners fail to die.
Cardiovascular Risk in Statin-Treated Patients (pg. 1302): One reason that so many sinners survive is the widespread use of statins in high-risk patients. Wistful for the enormous profits that these drugs brought in during the last two decades, pharma companies continue to search for a lipid-lowering drug which will add to the effect of HMG co-reductase inhibition. So what is the lipid subfraction that most predicts risk in people taking statins? Here’s a painstaking individual patient data meta-analysis showing that it is not low-density lipoprotein cholesterol alone, nor apolipoprotein B, but the totality of non-high-density lipoprotein cholesterol. Lower this, and you may have the next lipid-lowering blockbuster; or you may have nothing; or you may kill people.
NEJM 29 Mar 2012 Vol 366
Mobility in Type II Diabetes (pg. 1209): I have written a lot about patient-important outcomes in type 2 diabetes, but one that we can easily overlook is mobility. In obese people with T2DM, loss of mobility leads to a downward spiral of diminished energy loss, muscle atrophy and increase in adiposity: worsening glycaemic control then leads to all the problems of insulin therapy in people who cannot exercise and are insulin resistant. We have all seen this happen to our patients, and it is likely to become a commoner sight throughout the world unless we can find an effective intensive lifestyle intervention – one that can be applied to millions of individuals. The Look AHEAD trial enrolled more than 5,000 patients and achieved a 40% reduction in loss of mobility over 4 years in its intensive intervention arm. This could be of generalizable importance. Methodology buffs will also be impressed with the sophistication of the analysis: “We used hidden Markov models to characterize disability states and mixed-effects ordinal logistic regression to estimate the probability of functional decline.” A worthwhile paper.
Lancet 31 Mar 2012 Vol 379
Interleukin-6 Receptor Signalling and Cardiovascular Disease (pg. 1205): The Higher Calvinism of cardiology is a terrifying religious system of predestination by genomics. Someone needs to write a satirical novel about it, like James Hogg’s grim tale of Scottish Calvinism gone mad in Private Memoirs and Confessions of a Justified Sinner (1824). The latest focus of genomic theology is interleukin-6 receptor (IL6R) signalling, one of the many ways by which the wrathful gene-god dooms the unworthy to suffer cardiovascular disease. Never mind that we know many other important ways, and that this one is just an aspect of general inflammation. The Church of Genomics demands that we must not pit our humble understanding against a list of authors and investigators which covers two pages of small print. The entire priesthood proclaim that by analysing 82 studies, they can affirm that “large-scale human genetic and biomarker data are consistent with a causal association between IL6R-related pathways and coronary heart disease.” Aye, consistent with. What more can the faithful believer require?
BMJ 31 Mar 2012 Vol 344
Promoting exercise: Encouraging physical activity in sedentary patients is undoubtedly a worthwhile endeavour, but that does not mean we know how to do it effectively. A bit of exhortation now and again is unlikely to work, so the temptation is to refer patients elsewhere, and I have certainly written out lots of exercise prescriptions to local gyms. Unfortunately we don’t really know if this tactic works either. This systematic review from the Cambridge primary care department reaches a rather downbeat conclusion.
March 29th, 2012
Final Note from ACC: Insights on Board (Re)Certification
John Ryan, MD
On Sunday night, CardioExchange hosted a discussion of the ABIM board certification process. Some 40 fellows and several practitioners and academics from around the country gathered at Spiaggia on Michigan Avenue in Chicago to socialize, enjoy good food and hear from a panel of ABIM board members and recent board passers.
Pictured from left: Kyle McIver, Drs. John Gordon Harold, Benjamin Freed, Harlan Krumholz, and Susan Cheng
The View from the Stands: Drs. John Gordon Harold (President-Elect, American College of Cardiology) and Harlan Krumholz (Editor-in-Chief of CardioExchange) both spoke as members of ABIM Board of Directors. Dr. Harold has maintained 4 ABIM certifications despite being “grandfathered,” and he did so even before joining the ABIM board, so he’s certainly put his money where his mouth is. Dr. Krumholz himself just recently recertified in cardiology. Together, they emphasized the role of the board and the goals of the certification process. Take-home messages included:
- ABIM emphasizes the importance of self-regulation and the leadership of physicians in developing programs to assess other physicians. The ABIM is not a governmental organization. Physicians know best what physicians need to know, but ABIM’s accountability is to the public.
- Physicians have the responsibility to maintain the highest level of competence that they can achieve. That’s the goal of the certification process.
- Fellows taking the boards are at the start of a process in continued, life-long learning. Thus, taking the boards gives way to maintaining certification, which is evolving into a rolling, continuous process. ACC is working to develop many options for cardiologists to earn maintenance of certification points.
- Most of the learning required to sit for the boards can be obtained by “being the best clinical cardiologist you can be every day” and by learning from our patients.
- There aren’t any trick questions on the exam: the difficult scenarios you’ll find there are the same ones that you’ll find in your practice. The ABIM posts their exam blueprints online. The cardiology blueprint for certification can be found here.
Neither Dr. Harold nor Dr. Krumholz would comment on specific board prep courses or programs, and they noted that different learners prepare for exams in different ways.
The View from the Finish Line: Drs. Susan Cheng (Instructor of Medicine at Harvard) and Ben Freed (Cardiology Imaging Fellow at University of Chicago) provided valuable first-hand information regarding exam registration, preparation and advice for how to handle the two-day exam.
- Whatever you did to pass all the exams you have taken up until now — do that again.
- Take the boards as at the end of your clinical years rather than after completing your research. Everyone has a tendency to procrastinate, but acting while the clinical experience is fresh is far better than putting it off.
- Both the Mayo and ACC prep materials and courses are widely seen as being helpful. Some programs send one fellow to these events to bring back information to share with the group.
- The night before the test, get a good night’s sleep.
- Consider relaxing and putting the books and study tools aside 3 to 4 days before the exam. “Let all of the information settle in your brain.”
The evening did a lot to motivate, reassure and inform those in attendance about the boards. But perhaps more important, it offered a great opportunity to socialize, debrief regarding ACC, and network with fellows from dozens of U.S. programs. Facebook tells us that the world is connected by 3.74 degrees of separation (as opposed to the oft quoted “six degrees”), and hopefully through this CardioExchange event we have brought that number down a little lower.
Thanks to all of the panelists and to the ABIM for providing guidance and to Kyle McIver, from the ABIM, who was on hand to answer logistical questions and provide literature on the process.
Looking forward to seeing you all at AHA!
March 28th, 2012
Proof-of-Concept for Bedside Rapid Genotyping Test of CYP2C19
Larry Husten, PHD
A new point-of-care test can rapidly identify people with a common genetic variant associated with impaired clopidogrel function. The authors claim that this is the first study to demonstrate the feasibility of delivering a genetic test at bedside.
In an article published online in the Lancet, Jason Roberts and colleagues report on a new point-of-care test that can identify people who have a common variant of the CYP2c19 gene associated with reduced clopidogrel effectiveness. In their “proof-of-concept” study, 200 patients undergoing PCI were randomized to standard therapy with clopidogrel or to the new test. Patients found to have the CYP2C19*2 allele received prasugrel instead of clopidogrel.
Each group had 23 patients who carried at least one CYP2C19*2 allele. Among these patients, no patients in the test group, and 7 patients (30%) in the control group, were found to have high on-treatment platelet reactivity (PRU) after 1 week of treatment. At 7 and 30 days, there were no ischemic events in either group and no significant differences in major or minor bleeding.
The investigators write that their study “confirms the potential clinical benefits associated with a personalised approach to antiplatelet treatment with selective use of P2Y12 inhibitors in patients at increased risk of adverse events with clopidogrel,” but they also noted that the “major limitation” of their study “was use of a surrogate endpoint to assess clinical efficacy.”
In an accompanying comment, Amber L. Beitelshees notes that “many clinicians do not know what action to take, if any” until the completion of large trials that are in progress. Earlier studies testing the platelet hypothesis may have failed, she says, because new evidence suggests that benefits of genotyping or platelet function tests may be confined to the PCI population. The new rapid genotyping test will make it easier “for incorporation into clinical care in the catheterisation laboratory.”
March 28th, 2012
20 Deaths Linked to New Problem with Riata Leads
Larry Husten, PHD
Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm.
Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or Riata ST lead failure. By contrast, only five deaths were caused by failure of the more widely implanted Quattro Secure lead. The authors report that the Riata deaths “were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.” Hauser has played an important role in gathering and disseminating information about ongoing concerns about the Riata leads.
“The deaths are rare, but more frequent than you would expect. It’s another example of our flawed regulatory system,” Hauser told the Wall Street Journal. St. Jude told the Wall Street Journal that Hauser’s article contained several errors. Two deaths were counted twice, reducing the total number of lead-related deaths to 20, according to the company. In addition, St. Jude’s chief medical officer, Mark Carlson, said that some of the deaths were “from well-known causes, including wires that were coiled during surgery and ended up rubbing against the defibrillator.”
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