March 1st, 2012
The Growing Number of Observation Stays: How Do You Decide?
Harlan M. Krumholz, MD, SM
The number of observation stays are growing in this country, in part as a response to Medicare audits that are disallowing admissions for some patients – and maybe in part to reduce crowding in the Emergency Medicine Department. The problem is that criteria are not clear, so there is likely a lot of variability across institutions. Also, there may be financial consequences for patients who incur a greater expense than if they were officially admitted.
In many places there is no difference between a short admission and an observation stay. It is also challenging to defend the decisions because clear guidance from Medicare about who needs an admission (or who should have an observation stay) are not available (as far as I know). Here are two recent articles on this issue, from The Wall Street Journal and The Boston Globe.
What is your experience? How are you deciding who should have an observation stay?
February 28th, 2012
FDA Revises the Safety Labeling of Statins
Larry Husten, PHD
The FDA today announced important new changes to the safety language on the labels of statins:
Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect,” according to the FDA. The agency now says that liver enzyme tests only need to be performed before starting statin therapy and “as clinically indicated thereafter.”
Memory loss and confusion will now be included in the label. But, the FDA notes, reports about the cognitive effects of statins have usually “not been serious and the patients’ symptoms were reversed by stopping the statin.” In a story published on Forbes, Matt Herper writes that the “new labeling will lead patients and doctors to take memory issues on the drugs more seriously, and it will also lead patients to link normal lapses of memory to their drugs.”
The increased risk of hyperglycemia and type 2 diabetes will be mentioned in the label. The label will now reflect data showing the small increased risk for type 2 diabetes in people taking statins.
The FDA is also making specific recommendations about lovastatin, noting that when used with some other drugs, lovastatin can increase the risk for muscle injury.
February 28th, 2012
Slow Uptake of Transcatheter Aortic Valves: Learning from History?
Larry Husten, PHD
Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that its introduction would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs — and leading to repeated cycles of criticism, investigations, and pullbacks.
Early signs now indicate that history may not be repeating itself and that the careful and deliberate introduction of TAVR may result in an entirely different pattern. Remember that ACC and STS requested a National Coverage Decision from CMS and, following the initial approval of TAVR, released a critical consensus document offering a roadmap to responsible introduction of the new procedure.
Wells Fargo medical device analyst Larry Biegelsen (email), attending the STS/ACCF Transcatheter Heart Valve (THV) Symposium in Chicago last week, reports that uptake of the Edwards Sapien device has been slow, suggesting that the measured approach advocated by the ACC and STS and others has had an impact.
He cites three reasons for the slow uptake:
- Reimbursement for TAVR has been “spotty” because local Medicare contractors are waiting until May for the final National Coverage Decision (NCD).
- Many surgeons and cardiologists believe that TAVR will not be profitable even when reimbursement is finally settled.
- The high cost of establishing a TAVR center is dampening the enthusiasm of some hospitals.
Biegelsen also reports that cardiologists and surgeons have not yet settled on how to split the approximately $4000 professional fee for each procedure. Finally, Biegelsen notes that TAVR may not be profitable even after the NCD is announced, and that its value may be as a “loss leader” to help hospitals capture more valuable traditional valve procedures:
…there is a perception that many TAVR procedures are not profitable even when reimbursed. One speaker presented data showing that TAVR procedures are only profitable when they fall under two of the five surgical valve DRGs (219 and 216) and that only about 56% of his institution’s TAVR procedures fall under these two profitable DRGs. However, according to this presenter, a TAVR program may be profitable for a hospital when one takes into account the increase in the number of referrals for surgical valve procedures which are very profitable.
Edwards believes that the NCD process has introduced a temporary degree of uncertainty over reimbursement that may hold back usage right now but that the clarity achieved when the NCD is finalized will provide a big boost to Sapien sales.
Sanjay Kaul told CardioExchange that the TAVR consensus document “emphasized rational dispersion” of TAVR and that Edwards appears to be “taking a responsible course up till now.”
Rita Redberg commented about the underlying reasons for this slow uptake:
It is an interesting comment on our health care system that the reason for the projected slow uptake of TAVR is related to the lower than expected profit margin for the procedure and not due to caution that current data is not adequate to establish that longer-term benefits (mortality and quality of life compared to no procedure) will outweigh known risks (stroke, vascular complications, AI, and need for pacemaker).
February 28th, 2012
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
Larry Husten, PHD
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk for cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months, instead of 10 months, to the December 29 submission of the sNDA.
The application is based on the results of the ATLAS ACS 2-TIMI 51 study — the first trial to show a benefit with an anticoagulant in ACS. Previous trials testing anticoagulants in the setting of ACS had all failed. One key difference highlighted by many experts was the low doses of rivaroxaban used in the trial. The addition of 2.5 mg bid of rivaroxaban to standard therapy (versus standard therapy alone) resulted in a significant reduction in the combined rate of cardiovascular death, MI, or stroke, as well as significant reductions in death from cardiovascular causes (2.7% vs. 4.1%, p=0.002) and all-cause mortality (2.9% vs. 4.5%, p=0.002). The last two benefits were not found with the higher dose of rivaroxaban (5 mg bid) studied in the trial. Rivaroxaban also caused significant increases in bleeding complications, but not fatal bleeding.
Priority reviews are granted to treatments that offer an advance in care or that provide a treatment where no adequate therapy exists, the companies said.
February 27th, 2012
Meta-Analysis Finds No Advantages for PCI Over Medical Therapy in Stable Patients
Larry Husten, PHD
Patients with stable coronary artery disease (CAD) today do no better with stents than with medical therapy, according to a new meta-analysis published in the Archives of Internal Medicine. Kathleen Stergiopoulos and David Brown identified 8 trials with 7,229 patients comparing stents to medical therapy in which stents were used in the majority of PCI cases. ”By limiting the analysis to studies in which stent implantation was the predominant form of PCI,” they explained, their meta-analysis “compares contemporary versions of PCI and medical therapy. The exclusion of studies using balloon angioplasty as the primary form of PCI shifted the years of enrollment forward by almost a decade during which time optimal medical therapy evolved to the current regimen that includes aspirin, β-blockers, ACE-inhibitors (or angiotensin receptor blockers) and statins.”
After a mean followup of 4.3 years, there were no significant differences between the stent and medical therapy groups:
- Death: 8.9% for PCI versus 9.1% for medical therapy (OR 0.98, CI 0.84-1.16)
- Nonfatal MI: 8.9% versus 8.1% (OR 1.12,CI 0.93-1.34)
- Unplanned revascularization: 21.4% versus 30.7% (OR 0.78, CI 0.57-1.06)
- Persistent angina: 29% versus 33% (OR 0.80; CI 0.60-1.05)
The authors write that their study “suggests that up to 76% of patients with stable CAD can avoid PCI altogether if treated with optimal medical therapy, resulting in a lifetime savings of approximately $9450 per patient in health care costs.”
In an accompanying editorial, William Boden writes that “the inescapable fact is that it is increasingly harder to justify use of PCI solely for angina relief in such patients — especially as an initial approach to management, and if medical therapy has not been first instituted (or if efforts to optimize pharmacologic treatment in those treated initially medically are not undertaken).”
Boden responds to the failure of clinical trials like BARI-2D and his own COURAGE trial to effect change in clinical practice:
While physicians outwardly worship at the altar of evidence-based medicine, in reality, we more often tend to practice selective evidence-based medicine by adopting and embracing those trials and studies with results that reinforce our existing clinical practice preferences or biases, while we ignore or disdain the results of studies with results that are unpopular, conflict with our existing clinical practice beliefs, or collide with the conventional wisdom.
Archives editor Rita Redberg places the study in the journal’s “Less Is More” category and writes that, despite the evidence, “fewer than half of Americans with stable CAD who undergo stent placement have received medical therapy first.”
February 27th, 2012
Selections from Richard Lehman’s Weekly Review: Week of February 27th
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 February 27th
JAMA 22 Feb 2012 Vol 307
MIs without Chest Pain? (pg. 813): When an Italian team of physicists reported that they had detected neutrinos traveling faster than light, the televisual physicist Jim Al-Khalili promised to eat his boxer shorts if it proved to be true. It turns out to have been a measurement error due to faulty wiring. Unbelievable results either shatter the laws of the known universe, or else they are wrong. So if a study tells us that 42% of women and 31% of men presenting with myocardial infarction do not have chest pain (or even pain in the arm or jaw), this either overturns clinical medicine as we know it – from experience and from several other large cohort studies – or else it is due to lousy recording. Guess which. This retrospective study is based on a single tick in a box completed by busy physicians looking after over a million patients coming into American hospitals with heart attacks between 1994 and 2006. It could be that they had better things to do than record the obvious. If these figures are true, then I will eat my elegant black Marks & Spencer long johns. These thermal underpants have proved very effective at protecting my lower parts from the ravages of winter on the eastern seaboard of America, and I just wish journal editors were as effective at protecting us against the ravages of bad data.
Ann Intern Med 21 Feb 2012 Vol 156
Cardiovascular Family History Taking (pg. 253): I can’t think of many studies from British primary care that have appeared in the Annals, and this one receives a rave review in the editorial: “That this study was done at all speaks to the better support for high-quality research in primary care in the United Kingdom; finding support for a study like this would be extraordinarily difficult in the United States.” It’s not that easy in the UK either, and the praise is deserved: a 4-university collaborative did a cluster-randomized trial of cardiovascular family history taking by patient-completed questionnaire. It had a 98% uptake and showed that this is useful and practicable and resulted in a 4.5% increase in patients categorized as high risk.
February 24th, 2012
A Call for Help to Reduce Readmissions
Harlan M. Krumholz, MD, SM
The national focus on readmissions (e.g., Partnership for Patients) has yet to yield improvements in performance. Many clinicians and hospitals are seeking help in their efforts to reduce readmission rates.
Hospital to Home, a national quality improvement initiative led by the American College of Cardiology and the Institute for Healthcare Improvement, has posted a list of links to programs and tools that might be helpful to you.
Most recently we posted a link to resources organized by the VA. The VA toolkit includes order sets, pathways, and guidelines. We will only make progress by sharing what we learn and creating learning communities in which we share our experience. If you have tools or experiences to share, please let us know. And consider contributing them to the H2H community.
February 23rd, 2012
FDA Grants MI Indication for Drug-Eluting Stents
Larry Husten, PHD
Boston Scientific announced on Wednesday that the FDA had approved the use of its Ion and Taxus Liberte paclitaxel-eluting stents for the treatment of patients with MI. These are the first drug-eluting stents to receive a specific indication for MI.
The new indication is based on data from the Taxus clinical program and the HORIZONS-AMI trial. Acute MI accounts for about 10% of coronary interventions, according to the company.
February 23rd, 2012
Reality Check: Do 42% of Women with AMI Present Without Chest Pain?
Harlan M. Krumholz, MD, SM
I am reading the new paper from NRMI in JAMA on the association of age and sex with AMI symptom presentation and am struck by the finding that 35% of the patients did not present with chest pain. This percentage is higher than I have seen elsewhere.
In our recent studies, spanning many sites, we have found that almost 90% of the patients present with typical or atypical chest pain. In the GRACE registry, “chest pain was the most common symptom for both men (94%) and women (92%).” The NRMI study reported that 42% of women presented without chest pain. They do not report why the patients did present or what other symptoms they experienced.
I wonder how this result compares with the clinical experience of our readers. Have you noted that more than 2 in 5 women in your practice who are admitted with an AMI do not have chest pain? The number seems at odds with my experience and my reading of the recent literature. What are your thoughts?
February 23rd, 2012
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
Larry Husten, PHD
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this would have to be completed prior to approval.
Birth defects associated with Qnexa were another source of concern. The panel expressed strong support for a risk evaluation and mitigation strategy (REMS) to accompany any approval. But the panel ultimately was impressed by data showing a 10% weight loss at 2 years for people taking the drug.
Of all the obesity drugs, this one “has the highest efficacy in terms of weight loss,” panel member Sanjay Kaul told Bloomberg News. “That shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” .
Kaul told CardioExchange that the 20-2 vote appears more enthusiastic than the actual sentiment of the panel. Panel members remain concerned about the uncertainty regarding cardiovascular risk, including the possible adverse effects on blood pressure and heart rate. Kaul said the panel was impressed by the company’s proposed REMS, but there is little evidence demonstrating that even a strong REMS can significantly reduce adverse outcomes like birth defects.
Two other diet drugs, Contrave, the combination of naltrexone and bupropion, from Orexigen, and locaserin, from Arena, have been struggling to gain FDA approval in recent years. No new diet drug has been approved for marketing in the U.S. since 1999.
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