New Resuscitation Strategies Fail To Improve Outcomes After Cardiac Arrest Reply

Two trials from the Resuscitation Outcomes Consortium (ROC) investigators were unable to demonstrate meaningful improvements to resuscitation strategies after cardiac arrest. The two trials, one testing an impedance threshold device and the other a strategy comparing early and late rhythm analysis, have been published in the New England Journal of Medicine.
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No Benefit for Routine Counterpulsation Found in CRISP AMI Reply

Manesh Patel at the ESC Conference

Routine use of intra-aortic balloon counterpulsation (IABC) in STEMI patients who do not have cardiogenic shock does not reduce infarct size, according to a new trial. Results from the  CRISP AMI (Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction) were presented at the European Society of Cardiology meeting in Paris by Manesh Patel and published simultaneously in JAMA.

337 STEMI patients at 30 sites were randomized to either standard care or routine IABC placement prior to reperfusion. There were no significant differences in infarct size expressed as a percentage of LV mass as measured by MRI 3-5 days after PCI:

  • 42.1% in the IABC group versus 37.5% in the standard care group. This 4.6% difference was not significant (p = .06).

The same pattern was observed in patients with large infarcts (proximal LAD and TIMI flow scores of 0 or 1):

  • 46.7% in the IABC group versus 42.3% in the standard care group. The difference  of 4.4% was not significant (p = .11).

15 patients in the standard care drop crossed over and received IABC. IABC treatment resulted in a short but significant delay to treatment, with the time from first contact to first coronary device increased from 68 minutes in the standard care group to 77 minutes in the IABC group (p=0.04).
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Paris or Orlando? A Tale of Two Cities Reply

Paris, where the European Society of Cardiology is currently holding its annual meeting, is one of the world’s great cities. Orlando is the world capitol of medical meetings. Here are just a few of the differences. (Thanks as indicated for the suggestions.)

Paris has a bewildering variety of long-distance trains, commuter trains, and subways. In Orlando you can take a monorail to Disneyworld.

Air conditioning in Orlando is ubiquitous. There is no French word for “air conditioning.”

Nearly every restaurant in Orlando has waiters dressed in costumes. Waiters in Paris pretend they don’t speak English.

Orlando has amusement parks. Paris has the Louvre.

The average BMI is quite different! (Chris Cannon)

As different as Beaujolais and Coke. You guess which is which. (James Rudd)

In Orlando service is not included in the meal price whereas in Paris it’s included but not evident. (anonymous)

Orlando has oranges, Paris L’Orangerie. (anonymous)

In Orlando you get bottomless cups of bad coffee. In Paris you get a tablespoon of good coffee, and it’s called a large cup. (anonymous)

Take your kids to Orlando. Take your spouse to Paris.

More Emphatic Benefits Found For High Risk Subgroups Taking Eplerenone Reply

Last November the main results of the EMPHASIS-HF trial demonstrated that eplerenone was significantly better than placebo in reducing the risk of death and hospitalization in patients with systolic heart failure and mild symptoms. Now a new analysis of the trial, presented by Bertram Pitt at the European Society of Cardiology meeting in Paris, reinforces the earlier findings, and demonstrates an especially dramatic benefit in multiple high-risk subgroups.

Because EMPHASIS-HF was terminated early for efficacy, there was a possibility that the observed effect seen in the trial might have been exaggerated. In some countries, however, where eplerenone was not commercially available, the blinded study continued. Pitt therefore showed the results for the primary endpoint for an additional 10 months, in which no discernible attenuation of effect was observed:

  • CV death or hospitalization for heart failure until March 2011: 21.2% for eplerenone versus 28.5% for placebo (HR 0.66, CI 0.57-0.77m p<0.0001)

Pitt also showed the results for high risk subgroups, showing large reductions in the primary endpoint:
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Not Shocking: French Studies Evaluate Remote Monitoring of ICDs Reply

Remote monitoring of ICDs can reduce inappropriate shocks, but the overall clinical benefit and cost effectiveness of the technology has not yet been demonstrated, according to two new studies presented in Paris at the European Society of Cardiology meeting.

Salem Kacet presented the ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) study in which 433  ICD patients were randomized to daily remote monitoring follow-up or in-office visits in 43 French centers. The trial found that remote monitoring was noninferior to in-office visits for the primary endpoint of cumulative survival free of major adverse events (HR 0.91, CI 0.68-1.23, p<0.05).

Kacet emphasized the secondary effectiveness endpoint, which found a 52% reduction in the number of patients who had inappropriate shocks.
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Shortfalls in Secondary Prevention Represent a “Colossal Human Tragedy” Reply

It shouldn’t come as a surprise, but an international epidemiological study shows large shortfalls in the use of established drugs for secondary prevention of coronary disease and stroke. The shortfalls are dramatically acute in poor countries, said Salim Yusuf, who presented the results of the Prospective Urban Rural Epidemiological (PURE) study at the ESC in Paris today. The paper was published simultaneously in the Lancet.

The PURE investigators enrolled 153,996 people in 13 countries at different levels of economic development. They identified 5650 people with a history of CHD and 2292 with a history of stroke and ascertained whether they were taking antiplatelet drugs, beta blockers, ACE inhibitors or ARBs, or statins. Antiplatelet drugs were used by 62% of patients in high-income countries compared with 8.8% in low-income countries. A similar pattern was observed with beta blockers (40% versus 9.7%), ACE inhibitors or ARBs (49.8% versus 5.2%) and statins (66.5% versus 3.3%).
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ARISTOTLE Study Finds the Golden Mean of Anticoagulation 8

Chris Granger and Lars Wallentin at the ESC Press Conference

In ancient Greece the philosopher Aristotle thought the golden mean was the desirable middle between two extremes, one of excess and the other of deficiency. In cardiology, apixaban may be the golden mean of anticoagulation, achieving the ideal balance of reduced strokes and deaths without causing any additional bleeding complications.

The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) study compared warfarin to apixaban (5 mg twice daily) in 18,201 patients with AF and at least one additional risk factor for stroke. The overachieving trial demonstrated that apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was not only noninferior to warfarin in efficacy, it was superior. Further, treatment with api

xaban resulted in a statistically significant reduction in mortality, and reduced the risk of major bleeding. The results of ARISTOTLE were presented by Christopher Granger on Sunday morning at the European Society of Cardiology meeting in Paris and published simultaneously in the New England Journal of Medicine.

Here are the key details:

After 1.8 years of followup, stroke or systemic embolism (the primary endpoint) occurred in 212 out of 9120 apixaban-treated patients versus 265 out of 9081 warfarin-treated patients:

  • Yearly rate: 1.27% in the apixaban group versus 1.60% in the warfarin group (HR 0.79, CI 0.66-0.95, p<0.001 for noninferiority, p=0.01 for superiority)

Major bleeding occurred in 327 of the apixaban-treated patients versus 462 of the warfarin-treated patients.
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Ambulatory BP Monitoring Gains NICE Recommendation in UK Reply

Ambulatory blood pressure (ABP) monitoring is receiving a strong endorsement in the UK from NICE (National Institute for Health and Clinical Excellence). The recommendation is based on a cost-effectiveness study published in the Lancet.

Kate Lovibond and colleagues found that compared to additional measurements in the clinic or home measurements, ABP monitoring was highly cost effective in patients 40 years or older with a screening blood pressure measurement over 140/90 mm Hg. The results were consistent in men and women, across all age groups, and across a broad range of assumptions.
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Door-to-Balloon Time Closing In On One Hour 3

The door-to-balloon (D2B) time has fallen substantially since the launch of the D2B Alliance campaign in 2006, according to a new report in Circulation. Harlan Krumholz (editor-in-chief of CardioExchange) and colleagues analyzed data reported to CMS from the beginning of 2005 through September 2010.

  • D2B dropped from 96 minutes in 2005 to 64 minutes in the first 9 months of 2010.
  • The percentage of patients treated within 90 minutes increased from 44.2% to 91.4%.
  • The percentage of patients treated within 75 minutes increased from 27.3% to 70.4%.

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William Kannel, Former Director of the Framingham Heart Study, Dead at 87 Reply

William Kannel, the cardiovascular epidemiologist who helped find most of the major risk factors for cardiovascular disease during his lifelong association with the Framingham Heart Study (FHS), died on Saturday at the age of 87. Indeed, Kannel coined the term “risk factor” in a 1961 article in Annals of Internal Medicine.

Kannel “made the courageous decision to refuse medical interventions for cancer and chose to die with dignity with the help of hospice, family and friends,” according to an obituary published on the Boston University Medical School website.
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Why Health Journalism Shouldn’t Be a Popularity Contest Reply

In response to criticism about TV health journalists by Gary Schwitzer and myself (in a previous post), ABC news health reporter Richard Besser asked his followers on Twitter:

What do you think? Did I get it wrong?

So Besser gives the appearance of being open-minded, and who could find fault with that? But here’s the problem: health journalism shouldn’t be a popularity contest. I guess if you live in the world of television, where you live and die by the ratings, then this might seem like a good way to assess what you do. But it’s not. It’s dangerous. It doesn’t lead to the slippery slope. It is the slippery slope.

Instead of asking his viewers, Besser should ask himself if he got it wrong. He should engage the issues raised by Schwitzer and myself and he should apply the intellectual training he presumably received in medical school, along with the basic, common sense principles of journalism.

CNN, ABC, and NBC Dumb Down the News About CV Screening 2

Last Thursday the Lancet published an extraordinarily interesting and complex study looking at the relative value of CRP tests and CAC (coronary artery calcium) scans (see my report here). Coincidentally, CNN, NBC and ABC this week ran reports on the same general topic. Exit complexity. Enter stupidity.

Health journalism watchdog Gary Schwitzer and his Health News Review has a definitive takedown on these reports (here, here, and here). I just want to call attention to some of the major flaws of these pieces, and then take a peek behind the curtain to show how these news organizations actually take great effort to dumb down their stories.

The CNN story, “Will you have a heart attack? These tests might tell,” pumps calcium imaging. It relies heavily on cardiologist Arthur Agatston, the South Beach Diet guru and an  early advocate of calcium scans. Two of his quotes are perfect examples of what good health journalism should always avoid. Here’s the first:

“Unless you do the imaging, you are really playing Russian roulette with your life,” he said.

And here’s the quote that concludes the story:

“One of the best-kept secrets in the country in medicine is the doctors who are practicing aggressive prevention are really seeing heart attacks and strokes disappear from their practices. It’s doable.

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Is Coronary Calcium Better Than CRP for Predicting CV Events? 1

A new study suggests that people with low LDL levels and high CRP levels may benefit from coronary artery calcium (CAC) scans to identify those who are most likely to benefit from statin therapy. In a paper published in the Lancet, Michael Blaha and colleagues analyzed data from 950 people enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) who met the entry criteria for the JUPITER study.

After 5.8 years of of followup:

• 47% of the subjects had a calcium score of zero. CHD event rates in this group were 0.8 per 1000 person-years. They calculated that in this group 124 patients would need to be treated with rosuvastatin to reduce one cardiovascular event (NNT = 124). Overall, 6% of coronary events and 17% of cardiovascular  events occurred in this group.

• 28% of the subjects had a CAC between 1 and 100. In this group the cardiovascular NNT was 54.

• 25% of the subjects had CAC scores over 100. This group accounted for 74% of all coronary events. The CHD event rate was 20.2 per 1000 person-years and the cardiovascular NNT was 19.

The investigators also report that unlike CAC scores, CRP levels did not predict outcome in this population of patients who already had CRP levels >2 mg/L.

The investigators concluded:

CAC seems to further stratify risk in patients who meet eligibility criteria for JUPITER, and might be used to target a subgroup of patients expected to derive the most and the least absolute benefit from treatment. Focusing of treatment on the subset of individuals with low LDL cholesterol with measurable atherosclerosis might represent a more appropriate allocation of resources, reduce overall health-care cost, and prevent the occurrence of a similar number of events.

Click to continue reading, including commentary from Paul Ridker, Sanjay Kaul, and the study authors…

Details of Updated UK Heart Failure Guidelines Raise Some Eyebrows Reply

Although the updated heart failure guidelines from the U.K.’s National Institute for Health and Clinical Excellence (NICE) are broadly consistent with similar guidelines from Europe and the U.S., outside experts are questioning several key details of the update. A summary of the new guidelines has been published in the Annals of Internal Medicine, along with an editorial by Pamela Peterson and John Rumsfeld that is broadly supportive of the update, but calls into question several points.

Much of the controversy revolves around the relative weight given to echocardiography and natriuretic peptides in the diagnosis and treatment of heart failure. The updated NICE guidelines recommend that for the diagnosis of heart failure in patients with no history of MI, echocardiography should be used only if natriuretic peptides are raised. Peterson and Rumsfeld point out that both the ESC and ACC/AHA guidelines recommend that all patients with the signs and symptoms of heart failure should have an echocardiogram. The NICE position, they say, “may be questioned because of the utility of echocardiography for not only measuring left ventricular function but also for detecting structural or valvular heart disease, pulmonary hypertension, and pericardial effusion.”
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AHA 2011 in Orlando: Late-Breaking Clinical Trials Reply

Late-Breaking Clinical Trials I.
Sunday, Nov 13, 2011, 3:45 PM – 5:13 PM
West Hall B4
Moderators: Jeffrey Weitz, Hamilton, ON, Canada; Gilles Montalescot, Paris, France

3:45 PM: Intracoronary Compared with Intravenous Bolus Abciximab Application During Primary Percutaneous Coronary Intervention: AIDA STEMI Trial
Holger Thiele, Herzzentrum Leipzig, Leipzig, Germany; Jochen Wöhrle, Univ of Ulm, Ulm, Germany; Rainer Hambrecht, Klnikum Links der Weser, Bremen, Germany; Harald Rittger, Klnikum Coburg, Coburg, Germany; Ralf Birkemeyer, Klnikum Villingen-Schwenningen, Villingen-Schwenningen, Germany; Bernward Lauer, Zentralklinik Bad Berka, Bad Berka, Germany; Petra Neuhaus, Oana Brosteanu, KKSL, Leipzig, Germany; Peter Sick, Krankenhaus Barmherzige Brüder, Regensburg, Germany; Marcus Wiemer, HERHerz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany; Sebastian Kerber, Herz- und Gefäß-Klinik, Bad Neustadt, Germany; Ingo Eitel, Herzzentrum Leipzig, Leipzig, Germany; Klaus Kleinertz, Ambulantes Herzzentrum Chemnitz, Chemnitz, Germany; Gerhard Schuler, Herzzentrum Leipzig, Leipzig, Germany
Discussant: Alice K Jacobs, Boston, MA

4:07 PM:  Abciximab Plus Unfractionated Heparin versus Bivalirudin in Patients with Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention. The ISAR-REACT 4 Randomized Trial
Adnan Kastrati, Deutsches Herzzentrum, Munich, Germany; Franz-Josef Neumann, Herz-Zentrum, Bad Krozingen, Germany; Stefanie Schulz, Steffen Massberg, Deutsches Herzzentrum, Munich, Germany; Karl-Ludwig Laugwitz, Klinikum rechts der Isar, Munich, Germany; Miroslaw Ferenc, Herz-Zentrum, Bad Krozingen, Germany; David Antoniuccu, Azienda Ospedaliero-Univria Careggi, Florence, Italy; Peter B Berger, Geisinger Medical Ctr, Danville, PA; Julinda Mehilli, Albert Schomig, Deutsches Herzzentrum, Munich, Germany
Discussant: Deepak Bhatt, Boston, MA
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Meta-analysis Finds Beta-Blockers May Be Less Effective in US Population Reply

Beta-blockers may not be as effective in the U.S. as in the rest of the world, according to a meta-analysis published in the Journal of the American College of Cardiology. Christopher O’Connor and colleagues analyzed data on patients enrolled in the MERIT-HF, COPERNICUS, CIBIS-II (which did not enroll U.S. patients) and BEST trials. Some 4,200 U.S. patients were included.

The mortality benefit of beta-blockade was smaller in the U.S. than in the rest of the world, and the beneficial effect was not significant in the U.S. By contrast, the effect remained significant elsewhere.
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Bare Metal Stents: The Next New Thing? Reply

Although drug-eluting stents (DES) have largely supplanted bare metal stents (BMS) in clinical practice, a new study published in Circulation suggests that using these devices in all patients  may represent an inefficient use of healthcare resources. Lakshmi Venkitachalam and colleagues analyzed data from 10,144 PCI patients enrolled in the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry.

Largely in response to concerns about the possible risks of DES, the use of DES decreased from 92% to 68% from 2004 to 2007, according to the registry. However, the rates of death and MI did not change over time, although the rate of target lesion revascularization (TLR) increased by 1%, rising from 4.1% to 5.1%. Total cardiovascular cost per patient decreased by $401. The authors estimated that the risk-adjusted incremental cost-effectiveness ratio for the more liberal compared with selective use of DES was $16,000 per TLR avoided, $27,000 per repeat revascularization avoided, and $433,000 per quality-adjusted life-year gained.
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Guest Post: When Patients Can’t Afford a Medication 2

Editor’s Note: The following guest post by Beth Waldron is reprinted with permission from ClotConnect, a valuable resource for patients about blood clots and clotting disorders. Waldron is the program director of the UNC-Chapel Hill Blood Clot Outreach Program.

Prescription Assistance: When Patients Can’t Afford a Medication

Beth Waldron, Program Director of the Clot Connect project, writes….

Approximately 1 in 5 people don’t take a medication prescribed to them because they can’t afford to pay for it [ref 1]. While the cost of some outpatient anticoagulation therapies can be substantial, failure to take an anticoagulant medication as prescribed can have serious, even deadly, consequences.

What can a patient do when prescribed an anticoagulant that they cannot afford?

Help is available for some patients. Many pharmaceutical companies have Patient Assistance Programs (PAP) designed to help patients who cannot afford their medications obtain the medicine they need at either no or very low cost.

There is great variance among the programs offered because each pharmaceutical company establishes its own eligibility criteria for their Patient Assistance Programs along with deciding which medications are included. Most programs have some form of income guideline, require the patient complete an application form, and require a valid prescription and physician signature.

Most Patient Assistance Programs have reimbursement counselors who can answer questions about the application process over the phone.

Below is information on Prescription Assistance Programs for several commonly prescribed brand-name anticoagulants. In addition to the industry sponsored Patient Assistance Programs, several nonprofit organizations are also listed which help patients obtain discounted prescription drugs.
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Danger of Cigarettes Greater in Women Than in Men 1

When compared with men, women have a significant 25% increase in risk for coronary heart disease caused by cigarettes, according to a large meta-analysis published in the Lancet.

Rachel Huxley and Mark Woodward analyzed data from 2.4 million participants in studies that adjusted for cardiovascular risk factors and found that the female-to-male relative risk ratio (RRR) of smoking compared to not smoking was 1.25 (CI 1.12-1.39, p<0.0001).For every additional year of followup the researchers found an additional 2% increase in the RRR for women (p=0.03).
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Rivaroxaban (Xarelto) Compared to Warfarin in AF Patients 1

The ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) trial tested rivaroxaban (20 mg/day) against warfarin in 14,264 patients with atrial fibrillation (AF).  The results of the trial, which were first presented last November at the American Heart Association, have now been published in the New England Journal of Medicine.

The primary per protocol analysis demonstrated that rivaroxaban (Xarelto, Johnson & Johnson) was noninferior to warfarin: the rate of stroke or systemic embolism occurred in 1.7% of the rivaroxaban group compared with 2.2% in the warfarin group (HR for rivaroxaban: 0.70, CI 0.66-0.96, p<0.001 for noninferiority).
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A Failure to COOPERATE: Wall Street Journal Looks at Flawed Papers Reply

Today’s Wall Street Journal has a decent feature article by Gautam Naik about mistakes in science and retracted journal articles, although I don’t think it contains any important new information. The article is well worth reading, but it should be pointed out that most its content– and much more as well– has been covered extensively on the indispensable Retraction Watch blog, which gets a brief shout-out in the WSJ story but probably deserves even more credit.

The main example cited in the story is the long saga of the COOPERATE trial which was first published in the Lancet in 2003. Despite a number of reasons to be skeptical early on, the Lancet did not withdraw the trial until October 2009. Here is the CardioBrief story from that time:
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New Study Finds Wide Variation Among Hospitals in Diagnostic Yield for Angiography Reply

Last year a report in the New England Journal of Medicine from the National Cardiovascular Data Registry (NCDR) raised concerns about the low diagnostic yield for diagnostic coronary angiography. Now a new analysis of the NCDR registry appearing in the Journal of the American College of Cardiology finds a great deal of variability between hospitals in the diagnostic yield.

Pamela Douglas and colleagues analyzed data from 565,504 patients without known coronary disease who underwent elective angiography at 691 hospitals in the US from 2005 to 2008. The rate of obstructive disease identified upon angiography ranged from 23% to 100% (median 45%; interquartile range: 39% to 52%). Hospitals with a low diagnostic yield performed angiography on patients who were younger, had lower risk, had no or atypical symptoms, or did not have a noninvasive assessment of ischemia. Hospitals with a better diagnostic yield were more likely to prescribe optimal medical therapy, including aspirin, beta-blockers, antiplatelets, and statins. Hospitals that performed fewer procedures had a lower diagnostic yield.
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Bernadine Healy, Former Head of NIH and American Red Cross, Dead of a Brain Tumor 2

CardioBrief has received a report that Bernadine Healy, a cardiologist who served as the first woman to head the NIH and as a president of the American Red Cross, died on Saturday from complications of a brain tumor. She was married to cardiac surgeon Floyd Loop, a former CEO of the Cleveland Clinic. She had two daughters, one from a previous marriage.

Healy was born in 1944 and grew up in New York City.  She went to Hunter College High School, Vassar College and Harvard Medical School. She completed her training in internal medicine and cardiology at Johns Hopkins, where she eventually joined the faculty after a stint at the NHLBI. She was chosen by President Reagan in 1984 to be  the deputy director of the White House Office of Science and Policy.
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USA Today Finds Disparity Between Hospital Performance and Public Perception 1

Patients may think they’re going to a high quality hospital when in fact they’re not, according to an analysis of Medicare data appearing in USA Today by reporters Steve Sternberg and Christopher Schnaars. The USA Today website also contains an interactive graphic with a user-friendly interface to help readers compare hospital death rates and readmission rates for MI, HF, and pneumonia.

A pointed example of the gap between perception and performance is Maimonides Medical Center in Brooklyn, NY. Although it gets low rankings from patients, who think it’s dirty and noisy, the article notes:

Medicare data released today shows that Maimonides is one of 13 of more than 4,700 hospitals nationwide with below-average death rates for all three conditions: 11.2% for heart attacks, compared with a national average of 15.9%; 7.3% for heart failure, compared with 11.3%; and 6.8% for pneumonia, compared with 11.9%.

By contrast, the USA Today writers also identified more than 120 hospitals with outcomes significantly below the national average for MI, HF, and pneumonia that nevertheless received high praise from patients.