Blog Archives

May 26th, 2010

Do Hundreds of Left Atrial Burns Reduce Dementia Risk?

CardioExchange welcomes this guest post reprinted with permission from Dr. John M, a blog by private-practice electrophysiologist and CardioExchange member, Dr. John Mandrola.

“No data are better than bad data…If you can’t see it, don’t call it,” Dr Feigenbaum often admonished us young fellows during the old Thursday Echo conference at IU.

Calling more than is actually there seems to be increasingly prevalent in this era of sensational, but often misleading medical headlines. Take the case of AF, AF ablation, and Dementia as the most recent example.

Atrial fibrillation remains one of the most common cardiac diagnosis, and dementia is one of Neurology’s most frequent diagnosis.  Recently, as background, a study from a Utah group of electrophysiologists showed that AF predisposes to all forms of dementia, especially the specifically defined Alzheimer’s disease.

The study involved 37,000 patients, and was published in the prominent and well respected Heart Rhythm Journal. Although the mechanism is speculative, it comes as little surprise to those of us who care for AF patients that it could be associated with an increased risk of dementia. Excluding the very young, “lone AF” patient, this arrhythmia is—like dementia–a disease of birthdays, a disease of wear and tear.  Associated conditions like high blood pressure, obesity, disordered sleep, sedentarism and diabetes all predispose to both dementia and AF.

However, the most recent headlines from this same group, suggesting that AF ablation may reduce the risk of dementia is troublesome. A prominent cardiac website had the AF ablation-dementia connection as its lead story most of the week.

Denver, CO – Treating atrial fibrillation (AF) with radiofrequency catheter ablation significantly reduces the risk of Alzheimer’s disease and reduces the risk of developing all forms of dementia, according to the results of a new study [1]. In addition to these findings, researchers showed that catheter ablation reduced the risk of mortality and stroke at three years [2].

Unlike the previous peer-reviewed report chronicling a statistical, not causative, relationship between AF and dementia, this claim of AF ablation reducing dementia risk stems from an abstract presented at a meeting.  The distinction between an abstract and a peer reviewed journal are critically important.  The over-publicizing of abstract (preliminary) data from medical journalists is chronicled here.

Abstracts are preliminary data presented at scientific meetings, before the usual peer-review. For instance, the general public should know that nearly a third of presented abstracts never get published in a peer-reviewed journal.  Also, due to space and time limitations, abstracts are often presented without important details of methodology.  Nonetheless, these preliminary data often make headlines as if they were just published in the NEJM.

A few specific comments on this particular study highlight some of the important distinctions between peer-reviewed journal publications and abstract presentations at scientific meetings.  As background, it seems fair to accept as a given that if one is claiming an extremely complex and invasive procedure–AF ablation–will diminish a disease as widespread as dementia, a high bar of evidence should be required. Moreover, in this case the headlines do not say maybe, they say AF ablation does reduce dementia.

Some specific issues with this particular study (abstract presentation) on AF ablation and dementia are as follows:

First, this group reports an amazing 80% of their AF ablation patients are free of AF, and off drugs at three years of follow-up.  These results are pretty unbelievable; much better than the 60-70 percent reports from many other respected centers.  No, I am not accusing them of dishonesty, rather their remarkable success suggests that their ablation cohort must have been a healthy bunch of intermittent AF patients—rather than the more challenging cohort of persistent or permanent fibrillators.  They say that their patients were age and sex matched, and that AF ablation patients were more likely to have high blood pressure, CHF or valvular disease, but an abstract cannot give us the details.  I would suggest that a likely reason why fewer of their AF ablation patients developed dementia is simply because they were less ill, and had fewer co-morbid medical problems than the more chronically ill long-standing AF patients who were not offered ablation.

Study any EP doctors AF patient population, and it will be obvious that those patients offered ablation are a much healthier cohort than those felt too ill for successful ablation.  So, of course, the cohort defined by their unsuitability for AF ablation would be more likely to also develop dementia.

Maybe the data are true: patients who underwent AF ablation are less likely to develop dementia, but the ablation had nothing to do with it. Rather, the ablation was just a marker for a healthier cohort.

The senior author, Dr Day, is on the Heart Rhythm Meeting Organizing Committee. Did this have anything to do with the extensive media coverage?  Also, nearly all the readily available data on AF ablation and dementia arise from this one group of researchers.  Are these facts worthy of reporting?

I am not saying the study is dishonest or false, just preliminary.

The troubling aspect for a provider of AF care is the obvious and overt sensationalism. Taking an abstract and proclaiming that AF ablation reduces dementia risk is irresponsible and misleading.

Shouldn’t the storyline read something closer to this:

An observational, single-center, uncontrolled and un-blinded preliminary report—presented in abstract form only—suggested that a cohort of AF patients who were healthy enough to undergo AF ablation had a lower risk of dementia.  The data are yet to be published in a peer reviewed journal, and the dementia-preventative effects of AF ablation, if any, are yet to be defined.

AF therapy is complicated enough already.  Over-sensationalized misinformation in the lay press make it even harder to explain the issues at hand to patients.

JMM


May 26th, 2010

• Endarterectomy or Stenting?
• Growing FAME at 2 Years

Endarterectomy or Stenting? The results of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), which compared carotid endarterectomy to carotid stenting in 2,502 patients at centers in the U.S. and Canada, have now been published in the New England Journal of Medicine. The CREST investigators report that the 30-day rate of stroke, death, and MI combined with the rate of ipsilateral stroke over the next 4 years was similar in the two groups, occurring in 7.2% of patients in the stent group and 6.8% of patients in the surgery group (HR with stenting, 1.11; CI, 0.81-1.51; P=0.51). The 4-year rate of stroke or death was higher with stenting than with surgery (6.4% vs. 4.7%, P=0.03). In the periprocedural period, stroke occurred more often with stenting, while MI occurred more often with surgery.

In an accompanying editorial, Stephen Davis and Geoffrey Donnan conclude that although “individualization of treatment choices is appropriate,” surgery “remains the preferred treatment for most patients with symptomatic carotid stenosis.”

Note to readers: Following the initial presentation of CREST at a meeting earlier this year, Rick Lange launched a fascinating discussion on the Interventional Cardiology Blog by asking readers: “If it’s your carotid, endarterectomy or stenting?”

Growing FAME at 2 Years: New results from FAME (Fractional Flow Reserve [FFR] vs. Angiography for Multivessel Evaluation) demonstrate increasing benefits for FFR over time. Previously, early results of FAME had found that use of FFR reduced the rate of death, nonfatal MI, and repeat revascularization at 1 year. Now, Nico Pijls and the FAME Study Investigators report in the Journal of the American College of Cardiology that at 2 years, the rate of death or MI was 12.9% in the angiography-guided group versus 8.4% in the FFR-guided group (P=0.02). The finding, write the investigators, “supports the evolving paradigm of revascularization of ischemic lesions and medical treatment of nonischemic ones.”

May 25th, 2010

• Hypertension — Good News and Bad
• Breaking Press Releases from EuroPCR

Hypertension — Good News and Bad: New results from the National Health and Nutrition Examination Survey (NHANES), published in JAMA, show that although hypertension control improved dramatically from1988-1994 to 2007-2008 (from 27.3%  to 50.1%), the overall rate of hypertension increased (from 23.9% to 28.5% ) over the same period. Of note, hypertension control was lower in adults under 40 years of age and in Hispanics.

In an accompanying editorial, Aram Chobanian writes that the improvement in control of hypertension “should be a cause for celebration,” but cautions that the prevalence of hypertension will almost certainly increase. “Although lifestyle changes can reduce BP and the risk of developing hypertension, successful behavioral approaches to modify lifestyles on a population basis have lagged far behind the advances in the drug treatment of hypertension,” he writes. “In the long run, the far superior approach to controlling hypertension and cardiovascular diseases will be prevention rather than treatment.”

Breaking Press Releases from EuroPCR: The EuroPCR meeting is now underway in Paris. Here are some links to company press releases, but beware that these press releases have not undergone peer review:

Abbott’s Groundbreaking Bioresorbable Technology Continues to Demonstrate Exceptional Clinical Results: New Six-Month Data on Abbott’s Bioresorbable Vascular Scaffold Reinforces Its Potential to Be the Next Revolution in Interventional Cardiology

NEVO™ Sirolimus-Eluting Coronary Stent Continues to Demonstrate Excellent Safety and Efficacy Outcomes in New Twelve-Month Data

Medtronic’s Resolute® Drug-Eluting Stent Matches Market-Leading Rival in Large Head-to-Head Study: One-Year Clinical Results from Innovative RESOLUTE All Comers Trial Show Excellent Performance for Resolute DES in Challenging Patient Population

New Data Reinforces Safety Profile of Abbott’s Market-Leading XIENCE V® Drug Eluting Stent: In XIENCE V USA Study, XIENCE V Demonstrates Low Blood Clot Rate at One Year in Real-World Patient Population. In SPIRIT V Diabetes Trial, XIENCE V Demonstrates Zero Cases of Stent Thrombosis at One Year in Patients with Diabetes

Abbott’s Investigational MitraClip® System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves: Preliminary Results Also Show MitraClip Device Maintains Durability through Two Years in Patients Treated for Mitral Regurgitation

Edwards SAPIEN Transcatheter Heart Valve Shows Positive One-Year Outcomes in Rigorous Post-Market Study

May 24th, 2010

• Beta-Blockers May Benefit COPD Patients
• Evaluation of ALLHAT ‘Academic Detailing’

Beta-Blockers May Benefit COPD Patients: Although many physicians prefer not to prescribe beta-blockers to patients with COPD, a new observational study from the Netherlands suggests that COPD patients — even those who don’t have overt cardiovascular disease — may benefit from beta-blocker therapy. In their paper in Archives of Internal Medicine, Rutten and colleagues analyzed records of 2,230 COPD patients and found that beta-blocker usage was associated with reduced mortality and fewer exacerbations of COPD.

In an accompanying editorial, Don Sin and SF Paul Man agree with Rutten et al. that a large, randomized trial is needed before the findings can be fully accepted, but add that the data “provide a rationale for the practicing clinicians to use β-blockers … cautiously in their patients with COPD who also have a coexisting cardiovascular condition for which a β-blocker is required.” The new data, they write, “has turned the story of β-blockers in COPD into a curious case of a foe becoming a potential friend to millions of patients with COPD worldwide.”

Evaluation of ALLHAT ‘Academic Detailing’: In response to concerted efforts to blunt the impact of the controversial Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), the NHLBI initiated a dissemination project that utilized “academic detailing” to communicate the results to practicing physicians. Now, in a report in Archives of Internal Medicine from the ALLHAT Collaborative Research Group, the impact of that project is evaluated. Stafford et al. report an increase in use of diuretics in areas where academic detailing was most active, in contrast to small decreases or a smaller increase in areas where little or no detailing occurred.

In an accompanying commentary, Jerry Avorn, who in 1983 invented the concept and coined the term “academic detailing,” praises the intentions of the effort but points out a number of reasons for the modest observed effect, including the absence of the “interactive, one-on-one presentation of a message to a practicing clinician by an experienced change agent,” which is the hallmark of successful pharmaceutical company marketing. Avorn writes that budget limitations may have limited the ability of the project to perform real academic detailing.

May 21st, 2010

The Perils of Multitasking

How often do you find yourself trying to do so many things at once that you either make, or come close to making, a mistake in patient care? In an article recently published in the Archives of Internal Medicine, nurses who were interrupted during medication administration were more likely to make a medication error. Is this just another example of research supporting common sense, or are there implications here for fellows and faculty alike?

I’m currently on service in the CCU, traveling to give a talk at the AHA’s Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke meeting, finalizing our rank list, and trying to get our research group’s abstracts ready for submission…. Oh, and I’m also late getting this blog posted for CardioExchange! Is it any surprise that I sometimes have to stop myself from multitasking while seeing a patient?

We faculty ask our fellows to multitask as well. We give you major service obligations — and expect you to read and actively learn, move your research projects forward, and prepare a series of formal presentations. Meanwhile, your pagers beep incessantly.

How many errors of judgment are due to this frenetic pace and the multitasking that seems to be required? Would fellows (and faculty) learn and perform better if we eliminated the distractions caused by multitasking? Is this just an inevitable byproduct of modern society? Or do solutions exist to minimize patient risk?

We’d love to learn your thoughts on this very modern problem.

May 21st, 2010

Statins in the Real World: The Good and the Bad

To ascertain unintended effects of statins, researchers in the U.K. analyzed data from more than 2 million patients, including 200,000 patients taking statins for the first time. In a paper in BMJ, the researchers found a reduced risk for esophageal cancer among statin users, and an increased risk for moderate or serious liver dysfunction, acute renal failure, moderate to serious myopathy, and cataracts, as well as evidence of a dose-response effect for acute renal failure and liver dysfunction. The NNT to prevent one case of cardiovascular disease over 5 years was 37 for women and and 33 for men. In an accompanying editorial, Alawi Alsheikh-Ali and Richard Karas, conclude that “when used according to current guidelines, the benefits outweigh the risks,” and write that “it would be wise to interpret the present observations in the context of the confirmed cardioprotective effects of statins and remind ourselves and our patients that these drugs, although considered safe, are, like any intervention in medicine, not entirely free of adverse events. We should neither overstate the size of the benefit of statins, nor exaggerate their side effects.”

May 20th, 2010

Endovascular Repair of AAA: DREAM and Reality

Confirming the recent finding of the EVAR 1 trial, the DREAM Study Group reports the results of 351 patients who underwent open or endovascular repair of abdominal aortic aneurysm (AAA). The report appears in the New England Journal of Medicine along with the print publication of the EVAR 1 and 2 trials. The six-year survival rate was similar in both groups (69.9% for open repair versus 68.9% for endovascular repair). However, open repair proved more durable: 81.9% of open-repair patients were free of secondary interventions versus 70.4% of endovascular-repair patients (P=0.03).

In an accompanying editorial, K. Craig Kent notes that in the U.S.  “more than 60% of infrarenal aneurysms are repaired by endovascular techniques.” He writes that “patients with a favorable life expectancy should consider open repair” and that “all patients should be informed of the advantages and disadvantages of endovascular repair.”

May 19th, 2010

Novel Platinum Chromium Alloy Stent Found Safe and Effective 

Novel Platinum Chromium Alloy Stent Found Safe and Effective: The Taxus Element paclitaxel-eluting stent (PES), which features a novel, thin-strut platinum chromium alloy “designed to enhance radiopacity, radial strength, and conformability,” was found safe and effective in the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse trial. In an expedited publication in the Journal of the American College of Cardiology, Kereiakes and colleagues report on 1,262 patients with typical de novo coronary lesions who were randomized on a 3:1 basis to the Taxus Element or the Taxus Express PES. At one year, the rate of target lesion failure was 5.57% for Taxus Element and 6.14% for Taxus Express, a difference that met the predefined Bayesian criteria for noninferiority. No significant differences in clinical outcome were observed between the two groups.

 

May 18th, 2010

• AHA and Wii: A Controversial Relationship
• Getting With the Guidelines Reduces Disparities in Treatment

AHA and Wii: A Controversial Relationship: A deal struck between the American Heart Association and Nintendo of America was the subject of a critical news report on ABC’s “Good Morning America.” AHA president Clyde Yancy told GMA that Nintendo was giving $1.5 million over 3 years to the AHA, prompting Columbia University’s David Rothman to say: “Sooner rather than later, the public is going to understand that this is a commercial transaction.”

The AHA issued a response to the GMA segment, saying the story gave the wrong impression that the AHA is endorsing all Wii games, even those that are sedentary. The AHA said: “This is not accurate. The AHA and Nintendo logos, along with the statement defining our relationship, ‘Working together to promote physically active play as part of a healthy lifestyle’, will be on boxes for the Wii Fit™ Plus and Wii Sports Resort™ software and for the Wii™ system that plays them beginning this summer.” In the blogosphere, two cardiologists, Dr. Westby Fisher and Dr. John Mandrola, expressed concern over the AHA’s willingness to partner with Nintendo. A more detailed account of the episode can be found on CardioBrief.

Getting With the Guidelines Reduces Disparities in Treatment: Over time, hospitals participating in the “Get With the Guidelines” program not only improved their overall treatment of MI patients but eliminated racial and ethnic disparities of care, according to a report by Mauricio Cohen and colleagues in Circulation. In an accompanying editorial, Nakela Cook asks: “Will achieving 100 percent defect-free care in all patients also eliminate disparities in clinical outcomes, or do we need specific initiatives targeted at contributors or sub-populations to move toward the true elimination of health disparities? The question will not be easy to answer …”

May 17th, 2010

• Can Two Million Kidneys Be Wrong?
• What Is the Clinical Utility of CTA?

Can Two Million Kidneys Be Wrong? A new meta-analysis in the Lancet offers strong evidence that glomerular filtration rate and albuminuria are powerful independent predictors of all-cause and cardiovascular mortality in the general population. Members of the Chronic Kidney Disease Prognosis Consortium used data from over 100,000 participants in studies utilizing urine albumin-to-creatinine ratio (ACR) measurements and more than 1.1 million participants in studies utilizing urine protein dipstick measurements.

In studies utilizing ACR measurements, all-cause mortality was unrelated to eGFR when it was in the optimal range, but the risk of death increased as eGFR decreased. When eGFR reached 15 mL/min/1.7 m(2), the mortality risk was tripled. Findings were comparable for cardiovascular mortality. In the studies utilizing dipstick measurements, a similar pattern was observed.

The new data “confirm beyond doubt that the current thresholds are indicative of increased all-cause and cardiovascular mortality risk,” write Giovanna Leoncini and colleagues in an accompanying Comment.

What Is the Clinical Utility of CTA? Weustink and colleagues performed a stress test and CT angiography (CTA) on 517 patients, more than half of whom also had invasive coronary angiography (ICA). In their paper in the Annals of Internal Medicine, they found that stress tests were less accurate than either CTA or ICA, while CTA results were very close to ICA results. They concluded that stress testing was sufficient for low-risk patients and that high-risk patients should proceed directly to ICA. For intermediate-risk patients, however, CTA might be useful to help “distinguish which patients require invasive testing.”