Emergency PCI for STEMI is Dead?

This somewhat befuddling study tries desperately to create a problem where there probably truly wasn’t – but as soon as the conflict-of-interest disclosures come up, it’s clear why.

This is the 1-year outcomes from STREAM, a prospective, open-label, parallel-group trial enrolling participants with acute STEMI, but unlikely to undergo primary PCI within 1 hour of diagnosis.  Participants were then randomized to either still undergo emergency PCI, or to fibrinolysis followed by urgent or emergency rescue PCI.  The initial 1-month composite outcome, despite an excess of deaths secondary to intracranial hemorrhage in the fibrinolysis group, did not demonstrate any disadvantage to fibrinolysis with delayed PCI.  There was actually a 2% absolute decrease in the composite outcome favoring fibrinolysis – and thus the 1-year follow-up, hoping this small advantage in morbidity would translate into a measurable mortality advantage.

This was, however, not the case – as cardiac mortality was 4.0% with fibrinolysis vs. 4.1% with PCI.  Adding in the ICH and other non-cardiac deaths, the all-cause mortality rose to 6.7% with fibrinolysis vs. 5.9% with PCI.  Baseline characteristics probably favored the fibrinolysis group, so there’s actually a reasonable chance the mortality disadvantage owed to the fibrinolysis strategy might indeed be durable if properly powered and balanced.

Ostensibly, the authors claim to be addressing a problem of resource scarcity.  Using their fibrinolysis strategy, they seem to suggest, allows elimination of the expensive healthcare delivery models predicated on timely PCI.  However, a full 36% of patients failed to re-establish flow and still required emergency rescue angiography.  Then, all remaining patients still underwent urgent angiography, with greater than 95% receiving a stent.  So, in essence, the trade-off for increased flexibility in the timing of angiography is the added expenditure of tenecteplase – and possibly an increase in long-term mortality.

Certainly, there are many remote or resource austere settings where revascularization by thrombolysis is appropriate.  However, Boehringer Ingelheim and their sponsored collaborators have produced this scientific work simply in a transparent attempt at promoting an expansion of the pharamacoinvasive group (read: sell more tenecteplase) – and, frankly, failing.

"STEMI Patients Randomized to a Pharmaco-Invasive Strategy or Primary PCI: The STREAM 1-Year Mortality Follow-Up"
http://www.ncbi.nlm.nih.gov/pubmed/25161043

Emergency PCI for STEMI is Dead?

This somewhat befuddling study tries desperately to create a problem where there probably truly wasn’t – but as soon as the conflict-of-interest disclosures come up, it’s clear why.

This is the 1-year outcomes from STREAM, a prospective, open-label, parallel-group trial enrolling participants with acute STEMI, but unlikely to undergo primary PCI within 1 hour of diagnosis.  Participants were then randomized to either still undergo emergency PCI, or to fibrinolysis followed by urgent or emergency rescue PCI.  The initial 1-month composite outcome, despite an excess of deaths secondary to intracranial hemorrhage in the fibrinolysis group, did not demonstrate any disadvantage to fibrinolysis with delayed PCI.  There was actually a 2% absolute decrease in the composite outcome favoring fibrinolysis – and thus the 1-year follow-up, hoping this small advantage in morbidity would translate into a measurable mortality advantage.

This was, however, not the case – as cardiac mortality was 4.0% with fibrinolysis vs. 4.1% with PCI.  Adding in the ICH and other non-cardiac deaths, the all-cause mortality rose to 6.7% with fibrinolysis vs. 5.9% with PCI.  Baseline characteristics probably favored the fibrinolysis group, so there’s actually a reasonable chance the mortality disadvantage owed to the fibrinolysis strategy might indeed be durable if properly powered and balanced.

Ostensibly, the authors claim to be addressing a problem of resource scarcity.  Using their fibrinolysis strategy, they seem to suggest, allows elimination of the expensive healthcare delivery models predicated on timely PCI.  However, a full 36% of patients failed to re-establish flow and still required emergency rescue angiography.  Then, all remaining patients still underwent urgent angiography, with greater than 95% receiving a stent.  So, in essence, the trade-off for increased flexibility in the timing of angiography is the added expenditure of tenecteplase – and possibly an increase in long-term mortality.

Certainly, there are many remote or resource austere settings where revascularization by thrombolysis is appropriate.  However, Boehringer Ingelheim and their sponsored collaborators have produced this scientific work simply in a transparent attempt at promoting an expansion of the pharamacoinvasive group (read: sell more tenecteplase) – and, frankly, failing.

"STEMI Patients Randomized to a Pharmaco-Invasive Strategy or Primary PCI: The STREAM 1-Year Mortality Follow-Up"
http://www.ncbi.nlm.nih.gov/pubmed/25161043

Why Should Patients Be Denied Access to Results?

Interestingly, even though patients have long had full access to their medical record – laborious as it might be to obtain – just recently the Department of Health and Human Services issued a ruling stating patients could directly obtain their laboratory results from medical laboratories.

The real question – why did this take so long?  Are lab results, excepting a few exceptional cases, truly dangerous?  And, are patients not essentially the true owner of their medical testing?  Certainly, where the patient has directly purchased diagnostics, there should be no obstacle in providing them with information.  One can make a technical case that, when the results are purchased by a third-party – government or health insurance provider – those entities are the true owner of the result, but that hardly holds up to ethical scrutiny.

Regardless, this step is just one part of what is increasingly a growing movement towards transparency in medicine.  I think this is a good thing – patients ought be involved at each step of testing and interpretation, and, ideally should be provided with their results in real time.  It is outdated paternalism in medicine patients cannot be trusted with their own test results; is it reasonable to expect patients are a “threat” to themselves by using alternative information sources to self-educate?  If this is truly so, the answer is not to hide the results – but rather to improve how we as professionals educate patients, and improve the lines of communication.

“Direct-to-Patient Laboratory Test Reporting”
http://jama.jamanetwork.com/article.aspx?articleid=1882585 (free fulltext)

Appropriate Resource Utilization Can Be Taught!

At least, that is the implication of this paper – and even though it’s probably not the most reliable demonstration of such an effect, its observations are likely valid.

This is a very convoluted study design aiming to comment upon whether residents trained in “conservative” practice environments differed from residents trained in “aggressive” practice environments.  However, “conservative” and “aggressive” were defined by utilizing a Medicare database to calculate the “End-of-Life Visit Index”.  Residents trained in a region where elderly patients received greater frequency of inpatient and outpatient care at the end-of-life were judged to have trained in an “aggressive” environment.

Then, to measure whether residents themselves had tendencies towards “conservative” or “aggressive” management, the authors reviewed American Board of Internal Medicine board certification examination questions.  Questions regarding management strategy were divided into "conservative" or "aggressive" strategies, based on the correct answers.  Finally, examinees were measured on how many correct and incorrect answers were provided on these questions featuring the two management strategies.  Correlating these test answers with the end-of-life environment presumes to measure an association between training and practice.

After all these calisthenics – yes, residents training in the lower-intensity environments were more likely to perform better on the “conservative” management questions.  Thus, the authors make the expected extrapolation: trainees apparently learn to mimic inappropriately aggressive care.

This is probably true.  Whether this study – with its limitations and surrogates – adequately supports such conclusions is another matter entirely.

“The Association Between Residency Training and Internists’ Ability to Practice Conservatively”
http://www.ncbi.nlm.nih.gov/pubmed/25179515

Patient Satisfaction: It’s Door-to-Room Times (Duh)

As customer satisfaction becomes rapidly enshrined as our reimbursement overlord, we are all eager to improve our satisfaction scores.  And, by scores, I mean: Press Ganey.

So, as with all studies attempting to describe patient satisfaction, we unfortunately depend on the validity of the proprietary Press Ganey measurement instrument.  This limitation acknowledged, these authors at Oregon Health and Science University have conducted a single-center study, retrospectively linking survey results with patient characteristics, and statistically evaluating associations using a linear mixed-effects model.  They report three survey elements:  overall experience, wait time before provider, and likelihood to recommend.

Which patients were most pleased with their experience?  Old, white people who didn’t have to wait very long.  Every additional decade in age increased satisfaction, every hour wait decreased satisfaction, and there was a smattering of other mixed effects based on payor source, ethnicity, and perceived length of stay.  What’s interesting about these results – despite the threats to validity and limitations inherent to a retrospective study – is how much the satisfaction outcomes depend upon non-modifiable factors.  You can actually purchase patient experience consulting from Press Ganey, and they’ll come teach you and your nurses a handful of repackaged common-sense tricks – but I’m happy to save your department the money:  door-to-room times.

Or change your client mix.

Done.

“Associations Between Patient and Emergency Department Operational Characteristics and Patient Satisfaction Scores in an Adult Population”
http://www.ncbi.nlm.nih.gov/pubmed/25182541

Still Adrift in Ignorance Over Blood Cultures

While supervising residents, one of the frequent diagnostic suggestions in undifferentiated febrile patients is: blood cultures.  As an Emergency Physician, the utility of blood cultures – short of diagnosing endocarditis or another primary hematogenous source – is vanishingly small.  After all, the source of infection is nearly universally somewhere else – lung, urine, CSF, skin & soft tissue – and relying on the blood to give you the answer two days later is an unreliable and impractical proposition.

This study is yet another attempt at identifying patients with high likelihood of bacteremia, retrospectively analyzing 5,499 patients at Odense University Hospital for whom blood cultures were drawn.  This cohort, representing roughly half of all patients presenting to the Emergency Department, had positive blood culture results 7.6% of the time.  CRP, temperature, and SIRS criteria were evaluated as potential predictive variables – and, unfortunately, the positive likelihood ratios of each were only between 2 and 3, and the negative likelihood ratios associated with each were all 0.4.  The authors combine these criteria and promote their absence as a rule-out, with a negative predictive value of 99.5% – but, common sense ought obviate trying to diagnose bacteremia in an afebrile patient with no SIRS criteria, and the NPV performance is more related to the low prevalence of disease than the utility of their criteria.

Really, the most interesting element of this study: the massive volume of blood cultures performed, with 92% of them true negative or false positive.  Costs for blood cultures vary by facility, and range from $15-$50, with patient charges typically a significant multiplier beyond.  A low yield might be important if the diagnoses were changing management and improving outcomes, but the vast majority of culture results are clinically unimportant.  These authors have not described particularly strong positive predictors – but they’ve illustrated the massive scope of the problem.

“How do bacteraemic patients present to the emergency department and what is the diagnostic validity of the clinical parameters; temperature, C-reactive protein and systemic inflammatory response syndrome?”