August 7th, 2012
Reducing MI Readmissions: Time to Turn Objectives into Practice
Betsy Bradley, Ph.D.
CardioExchange welcome Elizabeth Bradley to discuss her recent paper, Contemporary Evidence about Hospital Strategies for Reducing 30-Day Readmissions, published in JACC. She and her colleagues used a web survey to assess the prevalence of hospital practices in quality improvement and performance monitoring, medication management, and discharge and follow-up for patients with acute MI (AMI). Of the 537 hospitals that responded, 90% reported having an objective to reduce AMI readmissions, but only half had partnered with community physicians, and on average hospitals used about half of the key practices available for reducing AMI readmission.
The evidence published this week in the Journal of the American College of Cardiology demonstrates two findings with one real-world message: we can do better. First, we found tremendous variation in what hospitals are doing to reduce readmissions for patients with heart failure and acute myocardial infarction, and, second, on average, hospitals are implementing less than half of 10 recommended practices to reduce readmissions. Surely, we can do more.
It would be helpful to have definitive studies on what practices are most effective to reduce readmissions. Still, common sense would tell us that when only 36% of hospitals routinely follow up on test results that return after patient discharge, only 26% always send a hospital discharge summary to the primary care physician, and only 11% discharge all patients with an outpatient follow-up appointment already made, we have a problem.
None of these practices are overly expensive, but they require attention to coordination and administrative systems to support the clinical care. And while we need more evidence on their impact, these practices have the potential to make care better and more efficient. The vast majority of hospitals reported that reducing readmissions was an organizational objective and had at least one quality improvement team working on this. The time has come to harness this enthusiasm on practical efforts that can keep discharged patients out of the hospital.
What steps is your institution taking? What is and isn’t working that you have seen?
August 6th, 2012
Hydrochlorothiazide and Nifedipine Linked to Increased Risk for Lip Cancer
Larry Husten, PHD
The antihypertensive drugs hydrochlorothiazide and nifedipine have been linked to a significantly increased risk for lip cancer in a new study published in the Archives of Internal Medicine. The link is plausible, write the authors, since the drugs are known to be photosensitizing.
Using a large cohort from the Kaiser Permanente system, researchers at Kaiser Permanente and Stanford identified 712 patients with lip cancer and 22,904 matched controls. Here are the odds ratios for people with at least a 5-year exposure to antihypertensive drugs compared with no use:
- hydrochlorothiazide: 4.22 (2.82-6.31)
- hydrochlorothiazide-triamterene: 2.82 (1.74-4.55)
- lisinopril: 1.42 (0.95-2.13)
- nifedipine: 2.50 (1.29-4.84)
- atenolol: 1.93 (1.29-2.91)
The atenolol result was no longer significant when the use of other drugs was taken into account. The authors note that because lip cancer is “a relatively infrequent form of cancer, it is not surprising that associations with antihypertensive drugs have not been observed in large clinical trials.”
In their conclusion, the authors say physicians who prescribe “photosensitizing drugs should ascertain whether patients are at high risk of lip cancer because of their fair skin and long-term sun exposure and discuss lip protection with them. Although not confirmed by clinical trials, likely preventive measures are simple: a hat with a sufficiently wide brim to shade the lips and lip sunscreens.”
In an accompanying editor’s note, Mitchell Katz wrote that “it is likely that patients receiving these agents are also at increased risk of basal cell and squamous cell cancers of the skin (these cancers are not tracked by the cancer registry used for this study). The findings are important because simple interventions, such as lip protector, sunscreen, large-brim hats, rash guard swim shirts, and avoiding times of the day when the sun is most intense, are likely to decrease the harmful effects of the sun for everyone, regardless of whether they are receiving a photosensitizing agent. When initiating use of photosensitizing agents for our patients, we need to remind them of these simple measures to avoid sun exposure.”
August 6th, 2012
DOJ Investigating Interventional Cardiology Services at HCA
Larry Husten, PHD
The hospital giant HCA has disclosed that the U.S. Attorney’s Office in Miami is investigating the company and has “requested information on reviews assessing the medical necessity of interventional cardiology services provided at any Company facility (other than peer reviews).” Following its own preliminary investigation, the company said it was aware of such reviews in about 10 of its hospitals, most of which are located in Florida. The company said it did not know the full extent or nature of the investigation. (The disclosure can be found on page 16 of the company’s quarterly report.)
In a likely related development, HCA also announced that the New York Times “may be publishing one or more articles about the company. Based upon its questions, the Times appears to be making broad points concerning patient care provided at our company’s affiliated hospitals.” HCA said the articles may focus on “how physician decisions are made regarding when it is medically necessary to perform cardiac procedures, such as cardiac catheterizations and percutaneous coronary interventions (PCI).” The company added that the Times may also address “the volume of cardiac catheterizations and PCIs.”
August 6th, 2012
TAVR and the Price of Innovation
Daniel Mark, Richard A. Lange, MD, MBA and L. David Hillis, MD
In an article published in Circulation, Daniel Mark and Robert Mentz of the Duke Clinical Research Institute and University Medical Center examine the economic and policy implications of the recent validation of transcatheter aortic valve replacement (TAVR) in the PARTNER trials. CardioExchange is fortunate and pleased to present Dr. Mark’s responses to questions about his work posed by Rick Lange and David Hillis, co-moderators of the Interventional Cardiology blog.
Lange and Hillis: In the “inoperable” AS cohort (cohort B in the PARTNER trial), TAVR extended life expectancy (from 1.2 to 3.1 years) and improved quality of life at a cost of $62,000 per quality-adjusted life year, according to a recent study by Reynolds and colleagues. Is this cost effective? How is cost effectiveness determined when no alternative treatment is available? To put it in perspective, how does TAVR compare with recently approved biological cancer therapies?
Mark: Cost effectiveness is a calculation of the efficiency with which a particular therapy of interest produces desired health outcomes. One key assumption in this calculation is that both the health benefits and the relevant costs are incremental. Thus, at least two strategies are always considered in any cost-effectiveness analysis. In the case of inoperable AS, the reference strategy could be termed “usual care,” which is essentially palliative symptomatic therapy. In PARTNER B, a significant proportion of the “usual care” arm also received aortic balloon valvuloplasty. To perform a cost-effectiveness analysis of TAVR in this population, it is necessary to identify all the health benefits that were changed and all the resource use that was affected by TAVR compared with the control arm. This is what we mean when we say that the analysis is incremental. We must also identify the time horizon of the analysis, which, for most chronic disease therapies, is the lifetime of the cohort. Once we know the lifetime incremental health benefits, typically expressed in quality-adjusted life years (QALYs), and the lifetime incremental costs (the dollar value of the incremental resource consumption), the calculation of the cost-effectiveness ratio is simple.
This ratio has no natural interpretation, so accepted benchmarks must be used. One strategy economists use to come up with such benchmarks is to find other therapies for which a clear consensus about value for money exists, and use those to set the context for the new therapy. For many years, hemodialysis was used as such a benchmark because it is a legislatively mandated entitlement and, in at least a loose sense, represents a societal consensus on spending healthcare dollars to save lives. The benchmark is often cited as less than or equal to $50,000 per QALY, but taking the increased cost of hemodialysis therapy and inflation into account, the benchmark probably is more like $100,000 per QALY today. Thus, against this benchmark, TAVR for inoperable AS represents reasonable value for money, or a reasonably efficient method of producing extra health benefits for the population. Notice that the method is indifferent to who benefits from the therapy. How we feel as a society about spending healthcare dollars on particular segments of the population raises all sorts of extra-economic value issues that tend to make physicians uncomfortable. We are trained to relieve suffering and prolong life when we can. In the past, this was done without regard for cost or economic efficiency. We are clearly moving into a new era in which discussions about cost and cost effectiveness are becoming a critical part of the debate about new technologies. The PARTNER investigators have done an excellent job of giving us high-quality comparative effectiveness and cost-effectiveness data to help direct the deployment of TAVR into clinical practice.
Lange and Hillis: New medical technologies are typically evaluated by their cost effectiveness, but in your article, you urge us to consider affordability (i.e., how much will TAVR add to the total healthcare bill, and are funds available to pay for it?). Is TAVR an example of a cost-effective medical breakthrough that is not affordable? Should TAVR be “rationed”?
Mark: The question of what we in the U.S. can afford in the way of effective new therapies has no easy answer. Unlike some countries, we do not have a defined budget for all of healthcare. Without a budget, there is no way to decide what we can afford to spend. The amount we spend increases each year, seemingly without limit. In addition, the Institute of Medicine has recently estimated that about 30% of current health spending (about 5% of GDP) is wasted. We are a wealthy country, and we can afford to spend more than many others on healthcare. But we cannot spend without limits, and we cannot throw money at things that provide no value.
Rationing is, of course, an inflammatory word in this country. But, as many have pointed out, we already ration care in a variety of ways. I believe that what people who overreact to the idea of rationing are really concerned about is the loss of control. Some faceless bureaucrat will tell them that they cannot have lifesaving therapy because it is too expensive, or they are too old or in some other way of insufficient value to society, and they will have no recourse, no way to appeal. But, of course, this already happens in the U.S. A fundamental axiom of economics is that we live in a world of scarce resources, and we cannot give everyone what they want or think they need. We can do amazing things in medicine in 2012, things of which we should be very proud. But we have not been good stewards of social resources, and we are paying the price for that neglect in terms of increasing loss of autonomy. The ACC/STS/FDA/CMS-controlled rollout planned for TAVR with mandatory participation in a national registry is actually an exciting new step for us, and I hope it demonstrates a way for us to adopt new technologies into clinical care without the irrational exuberance that has characterized our adoption of some earlier technologies.
Lange and Hillis: In high-risk AS patients who are eligible for surgical AVR or TAVR (cohort A in the PARTNER trial), you refer to the choice as “a therapeutic and policy toss-up,” because a small, nonsignificant early difference favoring TAVR (0.065 more life-years and $2200 lower cost) was noted at 1 year of follow-up. On a population — rather than individual — basis, wouldn’t healthcare costs be lower if all high-risk patients had TAVR rather than surgical AVR?
Mark: Our estimated $2200 per patient might seem like a lot, but it was a very small percentage of total 1-year costs and was not statistically significant. Thus, it remains uncertain whether, when TAVR is deployed across the country, we will continue to see a $2200 1-year cost savings with TAVR. In addition, before we are ready to send surgical AVR to the Smithsonian, we need to be very certain that we understand the lifetime health implications of TAVR in the target population. Unless we are very confident that the health benefits of TAVR are at least as good as surgical AVR over the lifetime of the population, we are not ready to mandate a change in standard of care, regardless of potential cost-saving opportunities.
Lange and Hillis: A comprehensive assessment of a novel therapy looks beyond the questions of economic efficiency and assesses changes created by that technology in the healthcare system. What changes in the healthcare system are created by TAVR that should be considered?
Mark: Ideally, we would understand all the changes that TAVR will create in the healthcare system before we roll it out for general clinical use. Of course, this is not the way things happen in real life. New therapies get introduced on the basis of one or two pivotal clinical trials involving hundreds or thousands of patients, and it is only after clinical use in hundreds of thousands of patients that we become aware of some of the unintended consequences of the technology. Look at all we have learned and continue to learn about stenting for coronary artery disease. Even now, are we ready to say we understand all the ways in which percutaneous coronary intervention has altered the healthcare system? All that we can be certain of at this stage is that we have much more to learn about TAVR and how best to use it in our patients.
August 3rd, 2012
To Repeat — or Not to Repeat — the TEE
Eric Joseph Oligino, M.D. and James Fang, MD
Mrs. K is a physically active 84-year-old woman with a history of hypertension and hyperlipidemia who presented to the ED reporting 1 week of intermittent palpitations, accompanied by dyspnea and atypical chest pain. Physical exam findings were a pulse of 140 bpm, blood pressure 130/80 mm Hg, respirations 10/minute, oxygen saturation 100% on room air, non-distended neck veins, and clear lungs. Cardiac exam revealed irregular/irregular tachycardia with no murmurs or gallops. Mrs. K’s extremities were warm, well-perfused, and without edema. An initial electrocardiogram showed atrial fibrillation with rapid ventricular response.
Mrs. K was admitted for rate control and sent for a transesophageal echocardiogram (TEE) to guide electrical cardioversion. The TEE revealed a small thrombus in the left-atrial appendage but was otherwise unremarkable—normal ventricular function, no significant valvular disease. The cardioversion was canceled, and Mrs. K was discharged home on therapeutic anticoagulation and rate control. At follow-up, she reported diminished exercise capacity and mild dyspnea on exertion since her hospital discharge. Therefore, the plan was to pursue a rhythm control strategy for symptomatic atrial fibrillation.
To determine whether — before electrical cardioversion — to perform a repeat TEE in a patient with atrial fibrillation, a previously identified thrombus in the left-atrial appendage, and 3 weeks of therapeutic anticoagulation, I turned to the ACUTE (Assessment of Cardioversion Using Transesophageal Echocardiography) trial. Here are the details about this trial:
Investigators randomized 1222 patients with AF of at least 2 days’ duration to undergo either a conventional, non–TEE-guided anticoagulation strategy (lasting 3 weeks prior to cardioversion) or an early TEE-guided strategy. Patients in the TEE-guided group who had a thrombus detected were given 3 weeks of warfarin, followed by a repeat TEE. After the repeat TEE, cardioversion was performed only if no thrombus was detected (thrombi were detected in 13.8% of the TEE-guided group).
During a mean follow-up of 8 weeks, incidence of the composite endpoint — cerebrovascular accident, transient ischemic attack, or peripheral embolism — was similar in the two groups (conventional, 0.5%; TEE-guided, 0.8%). The incidence of any bleeding was significantly higher in the conventional group (5.5% vs. 2.9% in the TEE-guided group), but the two groups were similar in major bleeding, death, and functional status. Normal sinus rhythm was maintained in about half of each group at 8 weeks.
Question:
Given that the conventionally treated and TEE-guided groups in the ACUTE trial had a similar rate of embolism at follow-up and that no trial participants had precisely Mrs. K’s profile — thrombus detected on initial TEE, 3 weeks of anticoagulation, and diminished exercise capacity with dyspnea on follow-up — is cardioversion without a repeat TEE an appropriate management strategy?
Response:
August 16, 2012
For this woman, cardioversion would not be appropriate without a repeat TEE, given that the original TEE documented a thrombus (before prolonged anticoagulation had been initiated). The best randomized-trial evidence we have to guide management of this patient comes from the ACUTE trial, despite some limitations.
The ACUTE protocol mandated a repeat TEE when a thrombus was detected on initial TEE. This strategy, which prompted prolonged anticoagulation in 76 of the 619 patients in the TEE-guided group, kept the thromboembolic rate at a very low <1%. Although the rate in the conventional-therapy arm was similarly low, all patients were treated as if they had a thrombus (i.e., assuming the worst-case scenario) and therefore underwent prolonged anticoagulation (3 weeks before plus 4 weeks after cardioversion), rather than the abbreviated anticoagulation strategy used in the TEE-guided arm. The downside was more bleeding, albeit manageable, and decreased immediate restoration of sinus rhythm.
Alternatively, if symptoms and heart rate could be reasonably managed, the patient could have undergone 3 weeks of anticoagulation and then elective cardioversion followed by anticoagulation without TEE (i.e., conventional management). Relevant to this point is the substantial number of patients who spontaneously converted to sinus rhythm (125/603 in the non-TEE arm; 62/619 in the TEE arm) without direct-current cardioversion.
Thus, the ACUTE trial showed that an accelerated strategy of TEE-guided search for thrombus (to limit the duration of anticoagulation and, therefore, its complications) was safe and effective for achieving sinus rhythm in the short term. However, the trial was not an endorsement of TEE cardioversion over conventional management. In fact, at 8-week follow-up, the two groups were similar in their rates of sinus rhythm, functional capacity, and death.
Finally, keep in mind that the ACUTE trial participants were highly selected—clinical equipoise had to exist for the clinician and the investigator. In fact, the trial was stopped early, given low rates of enrollment and events at the time of the interim analysis.
Follow-Up:
August 22, 2012
Mrs. K. had documented therapeutic anticoagulation lasting more than 3 weeks during her post-discharge follow-up, before returning for electrical cardioversion. However, given the small left-atrial thrombus detected on her previous TEE, a repeat TEE was performed. A small thrombus was again identified in the left-atrial appendage, and the electrical cardioversion was canceled. Mrs. K was discharged home on an increased dose of warfarin with a target INR of 2.5 to 3.5. During follow-up, she continued to be symptomatic but did not have any bleeding complications related to the increased INR goal. Mrs. K. is scheduled to return for electrical cardioversion without a repeat TEE in the upcoming weeks.
August 2nd, 2012
Survival Better with a Radial (vs. Femoral) PCI Approach: Sleight of Hand?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Patients with an ST-segment-elevation acute coronary syndrome treated with primary (or rescue) PCI have better survival when the procedure is performed using a radial approach rather than a femoral approach.
That’s one of the findings of the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) multicenter trial, in which 1001 participants with ST-segment-elevation ACS undergoing primary or rescue PCI were randomized to either a radial or a femoral approach at 4 high-volume centers.
The primary composite endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as cardiac death, stroke, MI, target-lesion revascularization, or bleeding. The individual NACE components were secondary endpoints.
Results:
|
Event (30 days) |
Radial approach |
Femoral approach |
P value |
| NACEs |
13.6% |
21.0% |
0.003 |
| Cardiac death |
5.2% |
9.2% |
0.02 |
| MI |
1.2% |
1.4% |
1.00 |
| Stroke |
0.8% |
0.6% |
0.725 |
| Target-lesion revascularization |
1.2% |
1.8% |
0.604 |
| Bleeding | |||
| — access site |
2.6% |
6.8% |
0.002 |
| — major |
1.8% |
2.8% |
0.399 |
| — fatal |
0.6% |
0.6% |
0.684 |
The radial and femoral groups were similar with respect to:
– baseline and clinical variables
– periprocedural anticoagulant and antithrombotic therapies
– symptom-to-presentation and door-to-balloon times
– postprocedure MI, stroke, or target-lesion revascularization
– major or fatal bleeding
We can’t think of a plausible explanation for why the radial approach was associated with lower mortality than the femoral approach in this clinical population. Can you? Are they pulling our leg?
August 1st, 2012
RIFLE-STEACS: Radial Access Improves Outcomes in Early Invasive Therapy
Larry Husten, PHD
For early invasive therapy for ST-segment elevation acute coronary syndrome (STEACS), the use of radial access instead of femoral access reduces bleeding complications and improves outcomes, according to the first large, randomized trial testing the two approaches in this population. The results of the Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome (RIFLE-STEACS) study were published online today in the Journal of the American College of Cardiology.
Investigators in Italy and the Netherlands randomized 1001 patients with acute STEACS to either the radial or femoral approach. At 30 days, the composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding (net adverse clinical events, or NACEs) was significantly lower in the radial group than in the femoral group. Cardiac death and bleeding complications were also reduced in the radial group, although there were no significant differences in MI, target lesion revascularization, or stroke. Hospital stay was shorter in the radial group.
- NACEs: 13.6% in the radial group vs. 21.0% in the femoral group, p=0.003
- cardiac deaths: 5.2% vs. 9.2%, p=0.020
- bleeding: 7.8% vs. 12.2%, p=0.026
- hospital stay: 5 vs. 6 days , p =0.03
The door-to-balloon time was similar in the two groups, but radial access slightly prolonged the time from artery puncture to first balloon inflation.
The result, say the authors, “corroborates the link between mortality and ‘clinically relevant’ access site bleeding.” They speculate that the beneficial effect of the radial approach may be due to reductions in bleeding-related hemodynamic compromise, the need for blood transfusion, and lifesaving drug discontinuation. More rapid mobilization of the patient may also play a role.
Radial access, the authors conclude, “should become the recommended approach in these patients, provided adequate operator and center expertise is present.”
July 31st, 2012
TAVI: Belgian Researchers Slam Evidence Base and Overuse in Europe
Larry Husten, PHD
The growing and enthusiastic adoption of transcatheter aortic valve implantation (TAVI) in Europe has no justification, according to three researchers who performed a health technology assessment for the Belgian government. In a paper published in BMJ, the authors from the Belgian Health Care Knowledge Centre conclude that TAVI should only be used in patients “who are deemed inoperable for technical reasons,” which is about 10% of patients “currently considered for treatment.”
In their paper, the writers do not identify any new concerns about TAVI, but they weave together the various threads of criticism that have been directed at the dissemination of TAVI. Hans Van Brabandt, Mattias Neyt, and Frank Hulstaert also charge that the evidence base for TAVI is deeply flawed as a result of an unpublished negative trial, serious baseline imbalances between controls and TAVI patients in the PARTNER trial, and unreported conflicts of interest by the principal investigator of PARTNER.
By the end of 2011, approximately 40,000 TAVI procedures had been performed, they write. Nearly all of the procedures were performed in Europe, where devices do not undergo the same regulatory scrutiny as drugs, needing only a CE mark to go on the market, “putting them on the same footing as domestic appliances such as toasters.” They note that TAVI was used in Europe for 4 years before the FDA approved its use in the U.S., but only for patients who were not surgical candidates and only when the transfemoral approach was used.
Despite the greater rigor of the U.S. regulatory process, the authors write that after their careful review of all the available evidence, “we remain far from convinced that it is adequate” and that “the arguments supporting the widespread use of TAVI do not stand up to scrutiny.”
Although in the PARTNER A trial TAVI met the predefined criteria for noninferiority when compared with surgery, the authors write that strokes, TIAs, and major vascular complications occurred more often with TAVI. TAVI performed better in the PARTNER B trial, which studied patients who were not eligible for surgery, but TAVI was still associated with a higher rate of stroke and vascular events. Results of the two trials “suggest that TAVI can be justified for inoperable patients on clinical grounds,” but, write the authors, this conclusion is weakened because the FDA, Edwards (manufacturer of the Sapien TAVI device), and trial investigators have failed to provide data to the authors, despite repeated requests, about a follow-up study comparing TAVI with standard therapy in 90 patients. The failure to share the data, they write, “is both ethically and scientifically unacceptable and should be legally regulated in future.”
The authors also maintain that the principal investigator of the PARTNER trial, Martin Leon, did not fully disclose his financial interest in TAVI. Although it was disclosed in the NEJM papers that Leon had received $6.9 million from Edwards when it purchased Percutaneous Valve Technologies, which Leon had cofounded, the articles did not mention that Leon “was to receive three further payments on the achievement of three milestones: successful treatment of 50 patients, regulatory approval in Europe, and limited approval in the US.”
The biggest concern about TAVI, write the authors, is widespread use of the transapical appraoch in patients in Europe, despite what they term a “dearth of evidence.” Overall, there is an absence of evidence to support usage patterns in Europe, they write. They note that the British Cardiovascular Intervention Society and the Society of Cardiothoracic Surgeons have called for randomized trials of TAVI, but “only when centres in the UK have got ‘beyond their learning curve.'” They go on to write: “Patients may be surprised to hear that trials are being delayed to allow cardiologists and surgeons time to learn the technique.”
July 30th, 2012
USPSTF Maintains Recommendation Against ECG Screening of Asymptomatic, Low-Risk Adults
Larry Husten, PHD
The U.S. Preventive Services Task Force (USPSTF) has reaffirmed its 2004 recommendation against ECG screening for asymptomatic adults who are already at low risk for coronary heart disease (CHD). The task force also concluded that there was insufficient evidence to assess the risks and benefits of ECG screening in asymptomatic people at intermediate or high risk for CHD. The report has been published in the Annals of Internal Medicine.
For asymptomatic people at low risk, the report concludes that additional information obtained from resting or exercise ECG tests would be unlikely to change their risk assessment or to improve their health outcomes. By contrast, the tests are associated with “significant possible harms,” most importantly related to “exposure to potential adverse effects of invasive tests.”
The USPSTF weighed the evidence of the risks and benefits of ECG screening, but it did not include the cost of ECG screening as part of its analysis. The task force also recommends that physicians “individualize decision making to the specific patient or situation.”
The USPSTF notes that their recommendations differ slightly from current ACCF/AHA guidelines, which state that resting ECGs are “reasonable for cardiovascular risk assessment in asymptomatic adults with hypertension or diabetes.” In addition, an exercise ECG “may be considered for cardiovascular risk assessment in intermediate-risk asymptomatic adults (including sedentary adults considering starting a vigorous exercise program), particularly when attention is paid to non-ECG markers such as exercise capacity.”
