November 13th, 2009
AHA, ACC expand two hospital-based CVD initiatives to outpatient care
Larry Husten, PHD
The AHA and the ACC are now collecting data from physicians’ regular office visits with patients as part of a new push to improve the quality of cardiovascular patient care, reports the Wall Street Journal. The new initiatives hope to expand on the successes of the AHA’s “Get With the Guidelines” hospital program and the ACC’s hospital-based National Cardiovascular Data Registry.
November 12th, 2009
Renal Artery Stenting NOT Beneficial
Richard A. Lange, MD, MBA
In patients with atherosclerotic renovascular disease, renal artery stenting carries no benefit when compared to medical therapy, but stenting does carry a substantial risk. In a recently published study, 806 patients were randomly assigned to undergo revascularization (almost exclusively done with stenting) in addition to medications or to medications alone (i.e, statin, antiplatelet agents, and optimal blood pressure medication). Interestingly – but not surprisingly – renal artery stenting did not improve blood pressure control or mortality, nor did it reduce renal or cardiovascular events over a 5 year followup period. In fact, it didn’t even help individuals with bilateral renal artery stenosis or those with the most severe stenosis.
Did you know that renal artery revascularization is performed in 16% of patients with newly diagnosed renal artery disease?
Based on this study, should we stop screening hypertensive patients for renal artery disease?
Are there any patients who benefit from renal artery stenting, and if so, who?
November 12th, 2009
No Clinical Benefits of Revascularization in Atherosclerotic Renal Arteries
Larry Husten, PHD
Revascularization for atherosclerotic renovascular disease, performed in over 15% of such patients in the U.S., shows “no evidence of a worthwhile clinical benefit,” according to a New England Journal of Medicine study.
The ASTRAL investigators studied outcomes in some 800 patients, half of whom had been randomized to undergo revascularization in addition to receiving usual medical therapy. After a median follow-up of almost 3 years, there was less deterioration in renal function among those who underwent revascularization. However, the authors say the benefits “were below levels that would be considered clinically relevant.”
No improvements in blood pressure, or reductions in renal or cardiovascular events or mortality were seen with revascularization. On the other hand, the procedure was associated with severe complications.
One of the main limitations of their study, the authors say, is that they excluded people with severe renal artery stenosis who, in their doctors’ opinion, required revascularization, yet they point out that “the widespread use of such procedures outside of clinical trials can now be questioned.”
November 11th, 2009
CRT May Reverse Remodeling in Heart Failure with Mild Symptoms
Larry Husten, PHD
In the REVERSE trial, 610 patients with NYHA I/II heart failure were randomized to active versus no CRT. At 12 months, active CRT was associated with reduced LV dimensions and increased EF in cases of non-ischemic cardiomyopathy.
November 10th, 2009
Deciding Who Gets Prophylactic ICDs — We Need a Better Way
John Spertus, MD, MPH
The ACC/AHA guidelines endorse prophylactic ICDs for NYHA Class II/III patients with an LV ejection fraction ≤35%, but I’m reluctant to recommend this to my patients who are doing really well. Why put them through the hassle and risk? Will they really benefit, especially if I think they’re just as likely to get an inappropriate shock as a life-saving one? A recent paper in Circulation has caused me to reconsider my approach.
Wayne Levy and colleagues used a modified version of the Seattle Heart Failure Model to identify which patients meeting the ACC/AHA criteria will benefit most from prophylactic ICDs versus medication alone. They found that ICDs offered substantial benefit for patients at low risk for overall mortality — but provided no benefit for those in the highest quintile of risk (i.e., patients with a projected annual mortality rate approaching 20%). This really impressed me, because I’ve been especially reluctant to recommend ICDs to patients who I perceive to have the best prognosis.
Two important insights from this work:
We often presume that the greater a patient’s underlying risk, the greater the benefit of a given intervention. But, in the setting of heart failure, where ICDs protect only against arrhythmic death and not against death from pump failure, the competing risk of death from pump failure can swamp the potential benefits of protection from arrhythmic death. Confirming this was the observation that in the highest-risk patients, there was, in fact, a nonsignificant 24% reduction in sudden cardiac death, despite no benefit in overall mortality.
Risk-prediction models can give us a better sense of how individual patients might respond to a given treatment, so that we can tailor therapy to their individualized estimate of therapeutic benefit, as well as their personal goals and preferences. To do this, however, we need to start developing the infrastructure to implement validated, evidence-based risk stratification at the time of medical decision-making.
Until this additional research is accomplished, how will you apply the insights of Dr. Levy’s study in your practice? Do you think the modified Seattle Heart Failure model is the best way to stratify risk, or are there other mortality estimates that you might use? If so, which ones? How will you routinely incorporate these into your practice?
November 10th, 2009
Duty Hours – What are your thoughts?
Andrew M. Kates, MD
Fellows: Do you feel like you spend too much — or not enough — time in the hospital? Over the last several years, there have been dramatic changes to the number of hours that residents and fellows are permitted to spend in the hospital during a given period of time, during both the day and the work week.
A letter from Thomas Nasca, M.D., the CEO of ACGME and the Vice Chair of the Task Force for the Revision of the Duty Hour Standards, provides an interesting perspective on the rationale behind the changes in duty hours and the effects (both positive and negative) that these changes have had.
So, what do you think?
Do the changes in duty hours leave the physician-in-training more or less prepared to handle the challenges of practicing medicine in the “real world,” where duty hours do not exist?
What do you see as the positive and negative effects of these changes?
Can you describe times when your training was limited due these changes?
Can you describe times you felt pressured to not comply with these requirements? How did you handle this?
How do you think these changes affect cardiology differently than the other subspecialites? Or do they?
November 6th, 2009
Darbepoetin–Trick or Treat? Part II
philipmarsden and Andrew M. Kates, MD
(SEE PART 1 OF SERIES) I was amazed by three things when the results from Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) were presented Friday October 30th, 2009 at the American Society of Nephrology Annual Meeting in San Diego:
- Thousands of atttendees came to hear TREAT presented by Dr M. Pfeffer–The room was tense with anticipation!
- This is the first time since I joined the NEJM’s editorial board in 2002 that I remember a presentation at ASN being concurrently published in the journal.
- With some 4000 patients from more than 600 sites across 24 countries, the size of this trial makes me numb. You cardiologists may consider this an average sized study–Poor nephrologists!
Relative to other randomized clinical trials in nephrology, TREAT is unique in that it is refreshingly simple, large and effective. TREAT was designed to determine in patients with CKD, type 2 diabetes mellitus, and moderate anemia whether the treatment of anemia with darbepoetin alfa would reduce the risk of death, major cardiovascular events and renal events. Within weeks the hemoglobin levels for the groups separated. The median achieved hemoglobin concentrations were 12.5 and 10.6 for darbepoetin alfa and placebo, respectively. The authors found no differences in the overall rate of the primary cardiovascular or renal composite endpoints. Of patients assigned to darbepoetin, 101 patients experienced a stroke compared to 53 patients assigned to placebo (hazard ratio 1.92).
The neutral effect on either the primary composite of cardiovascular endpoints and renal endpoints, together with the observed increased rates of stroke, was not predicted. The clinical importance of an increased rate of stroke, clearly a serious adverse event, must be considered in the context of the population studied. Even though the trial excluded patients with a history of a cardiovascular event in the preceding three months, the risk of death or a major cardiovascular event was 31% in the entire cohort over the course of the trial. Such data serves to remind us about the incredible burden of cardiovascular disease in patients with CKD. The authors conclude that the use of darbepoetin alfa in patients with non-dialysis diabetic CKD with moderate anemia did not reduce either the primary composite cardiovascular or renal outcome and was associated with an increased risk of stroke. They also reported change in FACIT fatigue from baseline to week 25, noting the difference between the darbepoetin alfa group and the placebo group was a humble improvement at best. Let us be clear that this trial did not address patients on dialysis. TREAT did not study patients with severe anemia! The study did not confirm CHOIR.
Treating physicians and patients will recognize the need to balance trade-offs—namely the risk of increased risk of stroke, higher rates of venous thromboembolic events, and possibly deaths from cancer versus the perception of improved quality of life. I am sensitive to the challenge of quality of life versus the quantity of life. Remembering that “the supreme irony of life is that hardly anyone gets out of it alive”, I am also mindful that I will be a patient at some future date. Most of us can empathize with patients on this truly personal measure of one’s own life. Physicians and patients will need to come to terms with this issue.
With all of this in mind, what would we say to a patient who prioritizes quality of life over morbidity risk? How will this influence your treatment choices? What will you recommend to your next patient with CKD, diabetes and moderate anemia?
November 6th, 2009
This May Be of Interest…
Andrew M. Kates, MD
Along with James, I would like to welcome you to this new endeavor. One of our goals for this site is to provide fellows with access to important articles — be they cutting-edge technology or reviews of important issues within cardiology — from a wide array of sources. We may refer to stories from various journals as well as the other areas of CardioExchange.
On the prevention group site is a great example of a topic important to us all — the role of aspirin in primary prevention of coronary disease. The blog by Dr. Foody provides a great starting point for discussion as well as several links to a great deal of information.
From a fellow perspective, this is a great time to explore why we do what we do and what data supports standard (or what we think is standard) practice. In addition to aspirin for primary prevention – who should or should not get it – many other controversies abound: the duration of antiplatelet therapy post PCI, the timing of ICD implantation post MI, and how we apply available data to both the general and to an aging population, just to name a few.
I hope that these pages will give fellows a forum to discuss their thoughts on these issues and others.
November 4th, 2009
What, Me Worry? Radiation Exposure from Medical Imaging
Brahmajee Kartik Nallamothu, MD, MPH
Three weeks ago, Cedars-Sinai Medical Center in Los Angeles revealed that since February 2008, 206 patients undergoing CT brain perfusion scans at their hospital routinely received radiation doses 8 times what they should have been. The hospital only became aware of the problem after a patient complained of patchy hair loss. The good news is that the scans were performed in older patients, making it less likely that significant long-term complications, such as brain cancer, will result. While much of what happened remains unclear, the error appears to have resulted when the factory settings were reconfigured to perform this relatively distinct procedure. To its credit, Cedars-Sinai has been forthcoming with details both to patients and the media, even as it conducts its own internal investigation.
I find this story troubling for several reasons. First, the rapid increase in imaging is something we are all familiar with, especially in cardiology. In fact, imaging use has become almost casual in contemporary medicine. Recently, my friend, cardiologist Reza Fazel at Emory University, demonstrated the potential implications of this phenomenon on radiation exposure in the general population. However, I’m also troubled because I’ve become highly sensitive to how dependent I am on others to ensure the safety of CT scanners and similar imaging equipment, especially since Reza’s study. I’ve always felt lucky to practice in an environment where highly trained experts in radiation physics free me from day-to-day worry about this issue — but should I be reassured? And are others so lucky?
Of course, this last issue is critical. When something like this can happen at Cedars-Sinai, it’s hard not to worry about the rest of us. One can only imagine what is going on at the approximately 8000 CT scanners currently in operation across this country, many associated with free-standing centers (including the 45% of cardiology practices that reportedly lease or own a CT scanner). Kimberly Applegate, a radiologist at Emory University and an expert in radiation safety, noted that quality assurance and control regulations for CT scanners vary substantially by state. While the American College of Radiology and the American Association for Physicists in Medicine have taken leadership roles in defining CT safety and quality standards for accredited facilities, these are optional. For example, the Cedars-Sinai CT scanners were not accredited.
So what does all this mean? Drs. Fazel and Applegate have an ongoing bet about whether (or when) U.S. patients will need to provide informed consent for CT scans. While such a debate would have seemed far-fetched a few years ago, it is hard to imagine this idea not gaining traction in light of recent events. I suspect this will be especially true for populations particularly susceptible to long-term complications of radiation exposure, like young children. And if you don’t agree, ask yourself, would it matter to me where my child went for a head CT?
In your practice, do you routinely discuss radiation exposure risks with patients undergoing cardiac CTA?
Do you ever adjust imaging protocols to the weight of the patient?
Do you know if bismuth shields are used on the thyroid during CT scans?
November 4th, 2009
Have We Been Off Track With Off-Pump CABG?
Richard A. Lange, MD, MBA
Off-pump CABG has been heralded as being superior to on-pump CABG, with the contention that it reduces the occurrence of the dreaded complications of cardiopulmonary bypass (stroke and neurocognitive deficits) and utilizes fewer medical resources. However, the data supporting this contention are scant.
Now, a large randomized study of off-pump versus on-pump CABG in 2203 patients at 18 Veterans Affairs medical centers shows a worse outcome with the off-pump procedure. After 1 year, the off-pump CABG patients were more likely to experience death, myocardial infarction, or required repeat revascularization and were less likely to have complete revascularization and patent grafts when compared to those undergoing traditional on-pump surgery. Furthermore, off-pump CABG did not improve neuropsychological outcomes or result in reduced time on a ventilator or stay in the ICU or hospital.
Is this the death of off-pump CABG?
Should we discourage our patients from having off-pump CABG?
Is this a problem with the off-pump procedure or just inadequate experience by the surgeon(s)? An accompanying editorial raises this issue.
