Archive for August 13th, 2008

Fentanyl Patch Recall

AP, (http://www.washingtonpost.com/wp-dyn/content/article/2008/08/12/AR2008081202224.html)

Watson Pharmaceuticals Inc. said one lot of 75 microgram-per-hour Fentanyl Transdermal System patches is being recalled from wholesalers and pharmacies because some of the lot’s patches have leaked fentanyl gel, possibly exposing patients or caregivers directly to the gel. This might lead to serious effects, including difficulty breathing and possible overdose, which may be fatal. No injuries have been reported in connection with this recalled lot, according to the Corona, Calif., company.

The painkiller, made by Watson Laboratories Inc., was sold in the United States. The recalled patches are from lot No. 92461850 and have expiration dates of Aug. 31, 2009. Any reactions should be reported to the Food and Drug Administration’s MedWatch adverse event reporting program at http://www.fda.gov/medwatch/report.htm. For more information, call the FDA at 888-463-6332 or the company at 888-667-1508.

1 in 6 to WalMart clinics

UPI, 8/13/08 reports that a national survey conducted by researchers at the University of Michigan C.S. Mott Children’s Hospital indicates that, “[i]n U.S. communities with retail health clinics, one in six parents have used a clinic to provide their child with medical care.” The pollsters used “a random sample of 2,064 adults weighted to reflect U.S. population figures” to discern just who was frequenting the “retail clinics — staffed by nurse practitioners or physician’s assistants” — to receive treatment for a variety of problems, including “rashes, sore throats, pink eye, and ear infections.”

        The visits were likely to take place in clinics in which 22 percent of parents would pay out of pocket for them, WebMD (8/12, Colihan) added. Still, two out of three “parents who used a retail clinic said they ‘were likely, or very likely,’ to return.” Among caretakers “who had never taken a child to a retail clinic, but who lived near one, one out of seven said they are ‘likely or very likely’ to use one.” Currently, “there are more than 900 such retail clinics in the U.S.”

Marriage/Divorce: Based on Health Insurance

Intro:  Maybe it’s not really John Edwards’ fault that he went a-plowing in another corn field.  Maybe he was trying to avoid health insurance complexities.

 

In a front-page article, the New York Times (8/13, A1, Sack) reports that, “[i]n a country where insurance is out of reach for many, it is not uncommon for couples to marry, or even to divorce, at least partly so one spouse can obtain or maintain health coverage.” While “[t]here is no way to know how often it happens,” the Times notes that “lawyers and patient advocacy groups say they see cases regularly.” A poll conducted by the Kaiser Family Foundation, a health-policy research group, found that “seven percent of adults said someone in their household had married in the past year to gain access to insurance.” And, “[i]n some instances, the need for insurance may prolong unhappy marriages.”

On Ectopics

A Discussion on ectopic pregnancy (http://cme.medscape.com/viewarticle/578988_2):

“…The incidence of ectopic pregnancy is 19.7 per 1000 pregnancies in the United States; however, the prevalence is between 6% and 16% in patients who present with first-trimester bleeding and/or pain.[1] This rate has increased over the last several decades as a result of better surveillance and the increased use of in vitro fertilization techniques to induce conception. The incidence of ectopic pregnancy increases with age, with the highest rates occurring in women aged 35-44 years. Ectopic pregnancies are responsible for approximately 10% of pregnancy-related deaths, because if they are untreated, ectopic pregnancies may lead to eventual rupture and hemodynamic collapse.[2]

The prime window for developing an ectopic pregnancy is approximately 6-8 weeks after the last menstrual period. The classic triad of findings is abdominal pain, vaginal bleeding, and amenorrhea; however, in only 45% of patients are all of these findings present.[3] Hypotension, light-headedness, or other signs or symptoms of hemodynamic instability raise the concern of a rupture.

Ectopic pregnancy occurs as a result of extrauterine implantation of the developing blastocyst. Although the vast majority of ectopic pregnancies occur within the fallopian tubes (95-98%), they may rarely be found in the cervix (1%), abdominal cavity (<1%), or cesarean scar sites (<1%). Risk factors for the development of ectopic pregnancy include current intrauterine device usage, tubal surgery, pelvic inflammatory disease, use of assisted reproductive technology, in utero diethylstilbestrol exposure, infertility, cervicitis, and a history of ectopic pregnancy; however, the majority of patients have no known risk factors.

The differential diagnosis for a pregnant patient with abdominal pain must include obstetric, gynecologic, gastrointestinal, and renal etiologies. The obstetric and gynecologic causes include normal early pregnancy, spontaneous abortion, molar pregnancy, degenerating uterine leiomyoma, pelvic inflammatory disease, ovarian torsion, dysfunctional uterine bleeding, dysmenorrhea, tubo-ovarian abscess, and hemorrhagic corpus luteum cyst. The major gastrointestinal and renal causes include appendicitis, diverticulitis, nephrolithiasis, and urinary tract infections.

The major goals of early detection of ectopic pregnancies are to prevent the major morbidities and mortality associated with an eventual rupture and to allow time for effective medical management of the condition. The diagnostic workup begins with a thorough history, with particular attention focused on the above-described risk factors. Although confirmation or exclusion of an ectopic pregnancy is not possible on physical examination alone, valuable findings, such as adnexal fullness and tenderness, may be appreciated. The vital signs must be closely monitored, because a change in hemodynamic status may be the only overt sign of a rupture. Laboratory and imaging studies are necessary for definitive evaluation. A positive urine hCG will confirm pregnancy status, while a low serum hCG value (for the gestational age) advances the case for an ectopic pregnancy.[4] Low serum progesterone levels indicate a nonviable pregnancy, but they are not helpful in determining the pregnancy location. No serum marker exists to accurately distinguish an ectopic from an intrauterine pregnancy.[5] Transabdominal and/or transvaginal ultrasonographic imaging are the most useful diagnostic tests for evaluating pregnancy. These examinations allow for confirmation of an intrauterine pregnancy and may demonstrate direct signs (eg, a developing blastocyst within a fallopian tube, which is seen in only a minority of cases) or indirect signs (eg, free fluid, lack of intrauterine pregnancy) of an ectopic pregnancy; however, because of the large number of potential alternative foci, it may not be possible to locate an ectopic pregnancy. The concept of a discriminatory zone of the β-hCG level (ie, the level at which an intrauterine pregnancy should be visible; this is 6000-6500 mIU/mL on transabdominal ultrasonography and 1500-1800 mIU/mL for high-resolution, transvaginal ultrasonography) can validate the findings of the ultrasonogram.[6] If ultrasonographic views at these levels do not demonstrate an intrauterine pregnancy, the pregnancy is most likely abnormal (and can either be an abnormal intrauterine pregnancy or an extrauterine pregnancy).

It is also important to recognize that a visualized intrauterine pregnancy does not absolutely exclude an additional ectopic pregnancy. Heterotopic pregnancy is rare, with rate of 1 in 30,000-80,000 cases for spontaneous pregnancy; however, the incidence is greater in patients utilizing assisted reproduction strategies. If the clinical suspicion is very high and an ectopic pregnancy cannot be confirmed or excluded by other means, a direct, intraoperative laparoscopic visualization may then be necessary. The combination of serum hCG and transvaginal ultrasonographic findings, however, is enough to confirm the presence of an ectopic pregnancy. Early consultation with colleagues in obstetrics and gynecology is necessary for cases of suspected ectopic pregnancy, with or without rupture.

The natural history of ectopic pregnancy is balanced between medical interventions and surgical management to reduce the risk of rupture and subsequent morbidity or mortality.[1] If the ectopic pregnancy has not ruptured and the patient is stable, then medical and surgical treatments are available. Medical management of ectopic pregnancy utilizes either single or multiple dose regimens of methotrexate, and it is the preferred alternative whenever possible. Medically managed patients have a slightly increased rate of long-term complications when compared with surgical patients. Surgical intervention usually takes the form of a laparoscopic salpingostomy or salpingectomy, and it has comparable short-term outcomes to medical management; however, in cases of a ruptured ectopic pregnancy, surgical intervention is the most appropriate course of action. It is possible for an ectopic pregnancy to spontaneously regress; in a small subset of patients with very low serum hCG without an identifiable implantation site on ultrasonographic examination (ectopic pregnancy or incomplete spontaneous abortion [SAB] may be possible in this scenario), expectant management may be considered….”

References

  1. Murry H, Baakdah H, Bardell T, Tulandi T. Diagnosis and treatment of ectopic pregnancy. CMAJ. 2005;173:905-12. Abstract
  2. Della-Giustina D, Denny M. Ectopic pregnancy. Emerg Med Clin North Am. 2003;21:565-84. Abstract
  3. Levine D. Ectopic pregnancy. Radiology. 2007;245:385-397. Abstract
  4. Silva C, Sammel MD, Zhou L, Gracia Cl, Hummel AC, Barnhart K. Human chorionic gonadotropin profile for women with ectopic pregnancy. Obstet Gynecol. 2006;107:605-10. Abstract
  5. Sowter MC, Farquhar CM. Ectopic pregnancy: an update. Curr Opin Obstet Gynecol. 2004;16:289-93. Abstract
  6. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 94: Medical management of ectopic pregnancy. Obstet Gynecol. 2008;111:1479-85. Abstract

6-weeks pregnant and with belly pain

The case (http://cme.medscape.com/viewprogram/17086?src=emed_case_nl_0):  A 34-year-old woman presents to the ED with a 2-hour history of severe abdominal pain, 2 episodes of light-headedness, and loss of consciousness. She is about 6 weeks pregnant; the pain started suddenly the morning of presentation. She has a history of a spontaneous abortion that complicated a prior pregnancy 4 years ago.

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The Answer: 

The presentation of severe abdominal pain, hemodynamic instability, and transient loss of consciousness in the setting of a nonconfirmed intrauterine pregnancy raised the suspicion for a ruptured ectopic pregnancy. The demonstration of free fluid in the Morrison pouch on the bedside ultrasonogram confirmed the presence of intra-abdominal hemorrhage, and a confirmatory transvaginal ultrasonogram demonstrated no viable intrauterine pregnancy. The β-hCG was confirmed at 12,200 mIU/mL. At surgery, an ectopic pregnancy was located within the left fallopian tube.

Kids: Greater Placebo Effect

Source:  Rheims S, et al “Greater response to placebo in children than in adults: A systematic review and meta-analysis in drug resistant partial epilepsy” PLoS Med 2008; 5(8): e166.

Full Text:  http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050166

ABSTRACT

Background

Despite guidelines establishing the need to perform comprehensive paediatric drug development programs, pivotal trials in children with epilepsy have been completed mostly in Phase IV as a postapproval replication of adult data. However, it has been shown that the treatment response in children can differ from that in adults. It has not been investigated whether differences in drug effect between adults and children might occur in the treatment of drug-resistant partial epilepsy, although such differences may have a substantial impact on the design and results of paediatric randomised controlled trials (RCTs).

Methods and Findings

Three electronic databases were searched for RCTs investigating any antiepileptic drug (AED) in the add-on treatment of drug-resistant partial epilepsy in both children and adults. The treatment effect was compared between the two age groups using the ratio of the relative risk (RR) of the 50% responder rate between active AEDs treatment and placebo groups, as well as meta-regression. Differences in the response to placebo and to active treatment were searched using logistic regression. A comparable approach was used for analysing secondary endpoints, including seizure-free rate, total and adverse events-related withdrawal rates, and withdrawal rate for seizure aggravation. Five AEDs were evaluated in both adults and children with drug-resistant partial epilepsy in 32 RCTs. The treatment effect was significantly lower in children than in adults (RR ratio: 0.67 [95% confidence interval (CI) 0.51–0.89]; p = 0.02 by meta-regression). This difference was related to an age-dependent variation in the response to placebo, with a higher rate in children than in adults (19% versus 9.9%, p < 0.001), whereas no significant difference was observed in the response to active treatment (37.2% versus 30.4%, p = 0.364). The relative risk of the total withdrawal rate was also significantly lower in children than in adults (RR ratio: 0.65 [95% CI 0.43–0.98], p = 0.004 by metaregression), due to higher withdrawal rate for seizure aggravation in children (5.6%) than in adults (0.7%) receiving placebo (p < 0.001). Finally, there was no significant difference in the seizure-free rate between adult and paediatric studies.

Conclusions

Children with drug-resistant partial epilepsy receiving placebo in double-blind RCTs demonstrated significantly greater 50% responder rate than adults, probably reflecting increased placebo and regression to the mean effects. Paediatric clinical trial designs should account for these age-dependent variations of the response to placebo to reduce the risk of an underestimated sample size that could result in falsely negative trials.

 

More hospitals won’t charge for mistakes

MSNBC, 8/13/08 reports, “Spurred by government and industry actions,” a growing number of hospitals are vowing not to charge patients for so-called “never events.” This “list has more than doubled since February, when an MSNBC.com analysis showed that hospital associations in 11 states urged their members to waive payment for specific errors dubbed ‘never events’ because they should never happen at all.” Currently, “23 states…have approved non-payment policies for specific mistakes, with at least three more expected to do so by fall, a new review shows.” Meanwhile, “[h]ospitals in another eight states have agreed to general guidelines that advise eliminating bills on a case-by-case basis for errors proven to be both serious and preventable.” MSNBC adds, “The idea of cutting payments for avoidable errors has gained considerable momentum in the year since federal officials sparked the shift by announcing that, starting Oct. 1, Medicare will no longer reimburse hospitals for the extra costs of treating certain injuries, infections and complications that occur after admission.”

Catastrophic Cheerleading

MedPage Today, 8/13/08 :  http://www.medpagetoday.com/PrimaryCare/ExerciseFitness/tb/10532:

“…Among young women in high school, 65.1% of all severe sports injuries from 1982 to 2007 were related to cheerleading, and at the college level the percentage was 66.7%, according to the annual report released by the National Center for Catastrophic Sport Injury Research at the University of North Carolina…

Catastrophic cheerleading injuries — which include death, permanent disability, or a severe injury such as fractured vertebrae — are occurring more now than 25 years ago, when the center released its first report.

 

Over the first decade of collecting data, there were 25 catastrophic cheerleading accidents in high school and college, including two deaths. From 1997 through 2007, there were 58 injuries, including one death.

 

Increases in catastrophic injuries coincided with a rise in emergency room visits related to cheerleading. The Consumer Product Safety Commission estimated that the number of visits increased from 4,954 in 1980 to 28,414 in 2004…”

Source: 

Primary source: National Center for Catastrophic Sports Injury Research
Source reference:
Mueller F, Cantu R “Twenty-fifth annual report: Fall 1982 to Spring 2007″ NCCSIR 2008.

Abstract: Cardiac MRI in ER

Cardiac Magnetic Resonance With T2-Weighted Imaging Improves Detection of Patients With Acute Coronary Syndrome in the Emergency Department.
 Journal:  Circulation. 2008 Aug 4.

 

ABSTRACT

BACKGROUND: -Cardiac magnetic resonance (CMR) imaging permits early triage of patients presenting to the emergency department with acute chest pain but has been limited by the inability to differentiate new from old myocardial infarction. Our objective was to evaluate a CMR protocol that includes T2-weighted imaging and assessment of left ventricular wall thickness in detecting patients with acute coronary syndrome in the emergency department.

Methods and Results-In this prospective cohort observational study, we enrolled patients presenting to the emergency department with acute chest pain, negative cardiac biomarkers, and no ECG changes indicative of acute ischemia. The CMR protocol consisted of T2-weighted imaging, first-pass perfusion, cine function, delayed-enhancement magnetic resonance imaging, and assessment of left ventricular wall thickness. The clinical outcome (acute coronary syndrome) was defined by review of clinical charts by a consensus panel that used American Heart Association/American College of Cardiology guidelines. Among 62 patients, 13 developed acute coronary syndrome during the index hospitalization. The mean CMR time was 32+/-8 minutes. The new CMR protocol (with the addition of T2-weighted and left ventricular wall thickness) increased the specificity, positive predictive value, and overall accuracy from 84% to 96%, 55% to 85%, and 84% to 93%, respectively, compared with the conventional CMR protocol (cine, perfusion, and delayed-enhancement magnetic resonance imaging). Moreover, in a logistic regression analysis that contained information on clinical risk assessment (c-statistic=0.695) and traditional cardiac risk factors (c-statistic=0.771), the new CMR protocol significantly improved the c-statistic to 0.958 (P<0.0001).

Conclusions-The present study indicates that a new CMR protocol improves the detection of patients with acute coronary syndrome in the emergency department and adds significant value over clinical assessment and traditional cardiac risk factors.

Cardiac MRI in the ER

HeartWire, 8/12/08:Boston, MA - Harvard researchers have come up with a new and improved cardiac MR protocol they say can be used in the emergency department to screen for ACS [1]. While other MR protocols have been proposed for this setting in the past, Dr Ricardo C Cury (Harvard Medical School, Boston, MA) and colleagues says theirs has the added advantage of being able to differentiate between new and old MI, providing information over and above clinical assessment and traditional cardiac risk factors.

As Cury explained to heartwire, all imaging modalities that have been used to triage possible ACS patients in the emergency setting—MRI as well as cardiac CT and nuclear perfusion imaging—have struggled to distinguish acute from prior MI. For their study, Cury et al were interested specifically in patients with chest pain, negative cardiac biomarkers, and no ECG changes indicative of acute ischemia.

“The patients in this study were all patients who had been in the emergency department for at least 12 hours waiting for changes in cardiac enzymes and waiting for a stress test,” he said. “So by doing MRI early on, we were able to detect myocardial injury before the rise of cardiac enzymes. There were some patients who had increased cardiac enzymes at a later stage, but we were able to detect both edema and necrosis before the increase in cardiac enzymes.”


MR protocol includes information on edema, LV wall thinning
In their protocol, Cury et al used T2-weighted imaging to look for myocardial edema and assessment of left ventricular wall thickness to check for myocardial thinning, in addition to first pass perfusion, cine function, and delayed-enhancement MRI. “The beauty of this is the combination of delayed enhancement looking at myocardial necrosis and T2-weighted imaging looking at myocardial edema,” Cury explained. “By combining this information, we can differentiate patients with acute vs old MI and which patients had unstable angina vs non-STEMI. Unstable angina is very difficult for different modalities to detect, and we were able to detect it in the great majority of cases,” Cury said.

The entire cardiac MR protocol, on average, took just over 30 minutes per patient. A diagnosis of ACS was subsequently confirmed by chart review.

Out of 62 patients presenting with possible ACS symptoms, the new cardiac MR protocol increased the specificity, positive predictive value, and overall accuracy, as compared with the conventional cardiovascular magnetic resonance protocol (which did not include T2-weighted imaging or LV-wall assessment). Cury et al’s protocol also significantly improved on information derived from clinical risk assessment alone or from clinical risk assessment combined with traditional cardiac risk factors.

Diagnostic accuracy of new protocol, vs standard

Diagnostic accuracy Standard MR protocol* (%) Standard MR protocol plus T2-weighted and LV wall thickness (%)
Sensitivity 85 85
Specificity 84 96
Positive predictive value 58 85
Negative predictive value 95 96
Accuracy 84 93

 

*Cine wall motion, perfusion, and delayed-enhancement MRI

 

To download table as a slide, click on slide logo above

 

“At this point, just using initial clinical risk assessment based on ECG and cardiac enzymes, we are not doing a great job, and that’s why many physicians are just admitting patients for catheterization, or, in some cases, 2% to 4% of patients are discharged when they actually have ACS,” he explained. “So we think this is really impressive: MRI remained a significant predictor above and beyond traditional cardiac risk factors and clinical risk assessment. Specifically, if you have a positive MRI, you have 120 times higher likelihood of having ACS as compared with patients with normal MR, after adjusting for traditional cardiac risk factors and clinical risk assessment.”


How MR might fit in
So how would cardiac MR fit into emergency-room triage? Cury told heartwire that if a patient had a positive stress test, he or she would go directly to the cath lab. If not, the patient could undergo MRI and if this turned up myocardial edema or necrosis or a regional wall-motion abnormality, they, too, could go directly to the cath lab. But patients in whom there is no evidence of myocardial injury could likely be sent home or undergo later stress testing, although Cury emphasized that this proposed strategy would require further, prospective testing.

Cury also clarified that MR might carve out its own niche distinct from cardiac CT, which has increasingly been shown to play an important role in emergency-room triage.

“CT will, I think, be the first-line test in the acute chest pain setting for patients with low likelihood of having ACS, whereas MRI, I believe, will be used more in patients with intermediate likelihood of ACS,” he said. “In the future, I can see the emergency physicians stratifying the patient as low, intermediate, or high risk based on risk factors and type of chest pain, etc, and patients with low risk would probably go to CT, whereas in patients with intermediate risk or even high risk but no diagnostic ECG and negative enzymes, MRI would be a better test.”

At present, Cury acknowledged, most hospital emergency departments would not have easy access to MR, but down the road, newer acute chest pain and stroke centers might consider including dedicated MR machines.

Cury disclosed having no conflicts of interest.

 


Full Text: Safety Net Holes

Caught In The Competitive Crossfire:
Safety-Net Providers Balance Margin
And Mission In A Profit-Driven
Health Care Market

ABSTRACT:

This paper describes how intensifying competitive pressures in the health system are simultaneously driving increased demand for safety-net care and taxing safety-net providers’ ability to maintain the mission of serving all, regardless of ability to pay. Although safety-net providers adapted to previous challenges arising from managed care, health system pressures have been more intense and more generalized across different sectors in recent years than in the past. Providers are adopting some of the same strategies being used in the private sector to attract higher-paying patients and changing their “image” as a safety-net provider. [Health Affairs 27, no. 5 (2008): w374-w382 (published online 12 August 2008; 10.1377/hlthaff.27.5.w374)]

http://content.healthaffairs.org/cgi/content/full/hlthaff.27.5.w374/DC1

Holes Widening in Safety Net

Congressional Quarterly, 8/12/08 (http://www.cqpolitics.com/wmspage.cfm?docID=hbnews-000002937403&parm1=5&cpage=2): 

The free clinics, hospitals and community health centers that provide care to people without insurance or other financial means are having to respond to a tougher health care marketplace by adopting the strategies of its more well-heeled competitors, in some cases curtailing free care as a result, according to a new study.

These “safety net” providers “are adopting some of the same strategies being used in the private sector to attract higher-paying patients and changing their ‘image’ as a safety-net provider,” said the study led by researcher Peter Cunningham of the Washington, D.C.-based Center for Studying Health System Change.

Based on interviews in 2007 with hundreds of local doctors, hospital executives and other health care experts in a dozen randomly selected cities around the United States, the study advised policy makers to expand insurance coverage or increase subsidies to safety net providers as a way of offsetting growing market pressures.

A Tougher Marketplace

Changes in the larger health care marketplace are forcing the change in tactics, said the study, which was posted Tuesday on the Web site of the policy journal Health Affairs. It was funded by the Robert Wood Johnson Foundation, a philanthropic organization.

Providers are trying to outdo each other with investments to build up highly profitable services, a “new medical arms race,” the study authors noted. In years past the arms race was more likely to consist of hospitals competing with other by adding more profitable technology-driven services, but now doctors are more likely to be involved in the competition, the study suggested.

In almost all of the communities studied, “we found that physicians are stepping up efforts to build their own diagnostic and ambulatory surgery centers and, therefore, are becoming less dependent on hospitals as their workshops,” the study said. Doctors are providing more ancillary services to boost their revenues and at the same time, “the growth of single-specialty medical groups has allowed physician practices the scale needed to offer services that are more profitable.”

Hospitals have fought back by creating joint ventures with doctors to hold onto at least some of the revenues they would otherwise lose. They’ve built new facilities to house specialty services. And they’ve built new facilities in or relocated to suburban areas “to attract high-income and well-insured patients.”

These added capital investments are harder for providers to recoup with price increases because the consolidation of insurers gives payers more power to control rates. That means some hospitals have to “allocate greater portions of their current and future profits to service growing debt, which in turn means that fewer funds are available to support indigent care.”

Impact on the Safety Net

As these pressures grow, there are signs that providers are less willing to provide uncompensated care. Outlays for uncompensated care are rising but demand is growing too as the uninsured population swells. The number of uninsured increased 13 percent annually between 1996 and 2005, the study said.

American Hospital Association data show that uncompensated care costs grew 28 percent over the past decade after adjusting for inflation, but uncompensated care costs as a percentage of total hospital expenses dropped almost seven percent. “Hospitals’ efforts to limit growth in uncompensated care may be occurring indirectly, by concentrating their expansion activities in more affluent communities and by downsizing or eliminating certain unprofitable services, such as inpatient psychiatric units,” the study said.

Most safety net providers reported increasing demand for their services, particularly by patients who were uninsured or covered by Medicaid. The closure of other local facilities, a rise in the number of uninsured, and a growing refusal among other providers to accept uninsured or Medicaid patients were among the factors driving growing demand.

Bivalirudin

Bivalirudin versus Unfractionated Heparin during Percutaneous Coronary Intervention
A. Kastrati and Others

ABSTRACT 

Background Whether bivalirudin is superior to unfractionated heparin in patients with stable or unstable angina who undergo percutaneous coronary intervention (PCI) after pretreatment with clopidogrel is unknown. Methods We enrolled 4570 patients with stable or unstable angina (with normal levels of troponin T and creatine kinase MB) who were undergoing PCI after pretreatment with a 600-mg dose of clopidogrel at least 2 hours before the procedure; 2289 patients were randomly assigned in a double-blind manner to receive bivalirudin, and 2281 to receive unfractionated heparin. The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization.

Results The incidence of the primary end point was 8.3% (190 patients) in the bivalirudin group as compared with 8.7% (199 patients) in the unfractionated-heparin group (relative risk, 0.94; 95% confidence interval [CI], 0.77 to 1.15; P=0.57). The secondary end point occurred in 134 patients (5.9%) in the bivalirudin group and 115 patients (5.0%) in the unfractionated-heparin group (relative risk, 1.16; 95% CI, 0.91 to 1.49; P=0.23). The incidence of major bleeding was 3.1% (70 patients) in the bivalirudin group and 4.6% (104 patients) in the unfractionated-heparin group (relative risk, 0.66; 95% CI, 0.49 to 0.90; P=0.008).

Conclusions In patients with stable and unstable angina who underwent PCI after pretreatment with clopidogrel, bivalirudin did not provide a net clinical benefit (i.e., it did not reduce the incidence of the composite end point of death, myocardial infarction, urgent target-vessel revascularization, or major bleeding) as compared with unfractionated heparin, but it did significantly reduce the incidence

 of major bleeding.

OMNI Postings of 8/13/08

A hungry African lion was roaming through the jungle looking for something to eat.
He came across two men.
One was sitting under a tree and reading a book; the other was typing away on his typewriter. The lion quickly pounced on the man reading the book and devoured him.
Why did he eat the reader and not the writer?
Even the king of the jungle knows that readers digest and writers cramp.
But I digress…
1)  Here is an EKG to re-acquaint you with what Brugada’s Syndrome looks like.
2)  The FDA has recently approved a new IV anti-hypertensive: Cleviprex.  Extremely short-acting.  It’s the latest-generation IV dihydropyridine calcium channel blocker. It’s most common adverse reactions (greater than 2%) are headache, nausea and vomiting.
3)  This is an abstract having to do with a series of traumatic internal decapitations (occipitocervical dissociation injuries).  This, BTW, is what happened to John Edwards after he told his wife about Rielle.  But I digress again.  A link to the complete text and images is included.  The resting osseous relationships and vertebral alignment at the time of imaging evaluation may be deceivingly normal. Prevertebral soft tissue swelling was apparent in all cases. MRI seems to be the optimal test for revealing the magnitude of the injury.
4)  Now, they’re talking about using D-dimers to rule out aortic dissections.  Apparently, the assay is elevated in this clinical condition, but the bottom line is that the jury is still “out.”  Order the test if you want but rely on the usual diagnostic studies.  References are contained if you want to research this further.
5)  Naltrexone is given parenterally as an IM medication in alcoholics.  Unfortunately, problems can arise from the injection.  The FDA has received 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Sixteen patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.  This is enough to drive a man to drink!
Paul R

EKG: Brugada Syndrome

The classic finding here is the “j-wave” found in V1->V3 at the end of the QRS complex. The “J-point” is where the QRS ends and the ST segment begins. This EKG is classic for a profoundly positive (>2 mm) J wave (not just J point) with its associated convex-up ST segment, followed by a negative last 1/2 of the T wave, suggestive of a Type I Brugada syndrome (Source: http://drwes.blogspot.com/2008/01/ekg-du-jour.html).

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