ICD Investigation: DOJ Sends Resolution Model To Hospitals 1

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare Compliance, that summarized the key details of the novel program.

As reported by ModernHealthcare.com (free registration), the document sent to hospitals contains “instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.” Some hospitals, according to the story, “have been asked to provide information of hundreds of cases each.”

Hospitals are being asked to perform audits on their cases and to estimate damages, “with the severity of penalties based on whether the hospital had medical reasons to violate CMS rules; if patient harm resulted; if the hospital had prior knowledge or a statistical pattern of non-guideline implants; and if a hospital compliance program was in place.”

Here is the DOJ Resolution Model Summary Chart (click to enlarge):


Pilot Study Demonstrates Feasibility Of MRI-Guided Catheterization Reply

A small pilot study has demonstrated that it may one day be possible to replace x-rays with MRI to guide some cardiac catheterization procedures.

As reported in the European Heart Journal, researchers at the National Heart Lung and Blood institute (NHLBI) performed x-ray and MRI-guided transfemoral right heart catheterization in 16 patients (four with shunt, nine with coronary artery disease, three with other indications). Each patient first underwent catheterization under x-ray guidance, which was then repeated twice with MRI, once using an air-filled balloon-tipped catheter and once using a gadolinium-filled balloon-tipped catheter.

In all but one patient complete guidewire-free catheterization was successful with both techniques. The researchers said that MRI using gadolinium-filled balloons was “at least as successful as X-ray in all procedure steps, more successful than MRI using air-filled balloons, and better than both in entering the left pulmonary artery.” Procedure time was not significantly longer with MRI. “Catheter conspicuity was best under X-ray and next-best using gadolinium-filled MRI balloons,” the researchers reported.

“This could be the first chapter of a big story,” said Robert S. Balaban, scientific director of the NHLBI’s Division of Intramural Research, in an NHLBI press release. “It provides evidence that clinical heart catheter procedures are possible without using radiation, which could be especially valuable in areas such as pediatrics.”

The authors acknowledge an important limitation of their research: “We do not believe coronary artery interventional procedures are a realistic possibility because of inadequate spatial and temporal resolution. However, we do believe structural heart interventions to be realistic therapeutic targets, including delivery and repair of cardiac valve devices, non-surgical access and closure of large transthoracic cardiac access ports, repair of other cardiac structural defects, and enhanced image guidance of peripheral artery interventions such as recanalization of chronic occlusion.”

Click here to read the NHLBI press release…

WOEST: Get Rid Of The Aspirin In Triple Therapy 1

According to current guidelines and clinical practice, PCI patients already taking an oral anticoagulant generally end up on triple therapy comprising the anticoagulant plus clopidogrel and aspirin. However, there is no supporting evidence base for this approach and the triple therapy regimen is known to increase bleeding complications. Now a new study– the first randomized trial to address this situation, according to the investigators–  may have a large impact on clinical practice by demonstrating that the omission of aspirin in this context appears to be safe and may reduce adverse events.

Results of the WOEST (What is the Optimal Antiplatelet and Anticoagulant Therapy in Patients with Oral Anticoagulantion and Coronary Stenting) trial were presented by Willem Dewilde at the ESC in Munich today. Investigators in the Netherlands and Belgium randomized 573 patients to triple therapy or dual therapy of an anticoagulant plus clopidogrel for at least one month after implantation of a bare-metal stent or one year after a drug-eluting stent. Two-thirds of the patients were receiving oral anticoagulation for atrial fibrillation.

The primary endpoint, the total number of bleeding events, was dramatically reduced in the dual therapy group at one year:

  • 44.9% in the triple therapy group versus 19.5% (HR 0.36, CI 0.26-0.50)

There were 3 intracranial bleeds in each group. Most of the difference in bleeding occurred in TIMI minor and minimal bleeding. The difference in TIMI major bleeding (3.3% versus 5.8%) did not achieve statistical significance.

Clinical events, the trials’s secondary endpoint, were numerically lower in the dual therapy group. The difference in mortality achieved statistical significance.

  • Mortality: 7 deaths (2.6%) in the dual therapy group versus 18 deaths (6.4%) in the triple therapy group, p=0.027
  • MI: 3.3% versus 4.7%, p=0.382
  • TVR: 7.3% versus 6.8%, p=0.876
  • Stroke: 1.1% versus 2.9%, p=0.128)
  • Stent thrombosis: 1.5% versus 3.2%, p=0.165

“The WOEST study demonstrates that omitting aspirin leads to less bleedings but does not increase the risk of stent thrombosis, stroke or myocardial infarction,” said Dewilde in an ESC press release. “Although the number of patients in the trial is limited, this is an important finding with implications for future treatment and guidelines in this group of patients known to be at high risk of bleeding and thrombotic complications.”

David Holmes said the trial addressed “an incredibly important issue” and predicted that it would “change the way we practice medicine, it will change practice right away.” Keith Fox said that the evidence base prior to WOEST was extremely limited and that the trial showed that there was no hazard in doing without aspirin. The ESC discussant, Marco Valgimigli, said the trial showed it was safe to drop aspirin and provided another demonstration that “we have hit the wall” with anticoagulation.

Republished with permission from CardioExchange, a NEJM group publication.

FAME 2: Can FFR Save PCI From Medical Therapy? 1

Two sharply divergent views have developed about the value of fractional flow reserve (FFR) in PCI. FFR advocates think the new technology can help identify ischemic lesions that will benefit from PCI, thereby helping to salvage or enhance the reputation of PCI. FFR skeptics think that optimal medical therapy is still the preferred option for most patients with stable angina. Both sides find evidence to support their view in the FAME 2 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2) trial presented at the ESC and published simultaneously in the New England Journal of Medicine.

The FAME 2 investigators sought to show that patients who had ischemic lesions as determined by FFR would benefit from the addition of PCI to the best available medical therapy. Patients with stable coronary artery disease under consideration for PCI underwent FFR. Patients who had at least one functionally significant lesion, defined as FFR < .80, were randomized to FFR-guided PCI plus medical therapy or medical therapy alone. Patients with no ischemic lesions were observed in a registry and received best medical therapy.

The trial was stopped early after enrollment of 1,220 patients (888 in the randomized portion and 441 to the medical therapy registry)– about half the number of intended patients– because of a significant reduction in the primary endpoint (the composite of death, MI or urgent revascularization) in the PCI group:

  • 4.3% in the PCI group versus 12.7% in the medical therapy group (HR for PCI 0.32, CI 0.19-0.53, p<0.001)
  • 3% of patients in the registry had a primary endpoint event

There was no difference between the groups in the rate of death or MI. The difference in the primary endpoint was driven entirely by the lower rate of urgent revascularization in the PCI group:

  • 0.7% in the PCI group versus 9.5% in the medical therapy group (HR 0.07, CI 0.02-0.22)

The FAME  2 investigators wrote that PCI was found to be beneficial in their trial, but not in previous trials like COURAGE, because of the demonstrated presence of ischemia in their randomized population. In addition, they noted that despite receiving the best medical therapy available, there were significantly more unplanned hospitalizations with urgent revascularizations in the medical therapy group.

A very different view of the trial is presented in an accompanying editorial by William Boden, the principal investigator of the COURAGE trial, who asks: “Which Is More Enduring– FAME or COURAGE?” The first FAME trial compared angiographic-guided PCI to FFR-guided PCI but did not include a COURAGE-type arm which received optimal medical therapy alone. FAME II was designed to address that question, writes Boden, but it should not be interpreted to mean that FFR-guided PCI is superior to optimal medical therapy. Boden makes the following points:

–There were few “hard” events in FAME 2 and urgent revascularization could be performed without objective evidence  of ischemia or positive biomarkers.

–Since the trial was unblinded, “investigators may have had a lower threshold for recommending revascularization” for patients in the medical group.

–Patients in the FFR group did not have noninvasive testing demonstrating ischemia, so some may have had preserved myocardial perfusion.

–Patients in FAME II were not at very high risk.

–The short followup period (mean followup of 7 months) did not leave enough time for the risk of restenosis to fully emerge.

Boden is highly critical of the early termination of the study, writing that it leaves “more questions than answers…. but the only enduring finding of the FAME 2 trial appears to be that  of a reduced short-term rate of unplanned revascularization with FFR-guided PCI, with little evidence of long-term, incremental benefit on prognostically important clinical outcomes.”

Republished with permission from CardioExchange, a NEJM group publication.

The Return Of Vorapaxar, This Time For Post-MI Patients Reply

The once highly-promising novel antiplatelet agent vorapaxar, widely thought to be dead on arrival after unacceptably high serious bleeding rates were found in two large clinical trials, has now returned to active duty. On Sunday the drug’s sponsor, Merck, announced that it would seek approval of the drug, with a narrower indication than originally planned, based on new data from a prespecified analysis of the TRA 2P-TIMI 50 trial presented at the ESC and published simultaneously in the Lancet.

Merck said it planned to file applications next year in the United States and Europe for an indication for the prevention of CV events in patients with a history of MI and no history or stroke or TIA.

The new hope for the drug is based on an analysis of the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events trial, which was originally presented in March at the ACC and published simultaneously in the New England Journal of Medicine. In the overall trial, which randomized 26,449 patients with a history of MI, ischemic stroke, or peripheral arterial disease to either vorapaxar or placebo in addition to standard therapy, the rate of CV death, MI, or stroke was significantly reduced by vorapaxar, but a doubling of the rate of intracranial bleeding left many convinced the drug was not commercially viable.

The new analysis, presented at the ESC by Ben Scirica,  focused on the subgroup of 17,779 TRA 2P patients– a group larger than usually found in the entire population of most clinical trials, it should be noted– with a history of myocardial infarction. After 2.5 years of followup, the rate of CV death, MI, or stroke was significantly reduced in the vorapaxar group compared to the placebo group, though vorapaxar was also associated with an increased risk of bleeding, but not intracranial bleeding:

  • Primary endpoint: 8.1% versus 9.7%, HR 0.80, CI 0.72-0.89, p<0.0001
  • Moderate or severe bleeding:3.4% versus 2.1%, HR 1.61, CI 1.31-1.97, p<0.0001
  • Intracranial hemorrhage: 0.6% versus 0.4%, p=0.076

The authors acknowledged the limitations of subgroup analysis but proposed that vorapaxar might be beneficial in a population with a history of MI but with no history of stroke or TIA, age below 75, and weight over 60 kg.

In an accompanying comment in the Lancet, Stefan James and Claes Held write that the “results support the addition of long-term antithrombotic treatment for patients who have had a myocardial infarction.” But, they ask, “will doctors, patients, health-care providers, and funding agencies accept use of an expensive drug to reduce the risk of myocardial infarction and possibly death in view of the increased risk of severe bleeding?”

Republished with permission from CardioExchange, a NEJM group publication.
Click here to read the Lancet press release…

ESC: Trial Finds No Benefit For Intraaortic Balloon Counterpulsation In Cardiogenic Shock 2

Despite a lack of evidence, circulatory support with intraaortic balloon counterpulsation (IABP) has a class 1 recommendation in the guidelines and is often used in patients in cardiogenic shock following myocardial infarction for whom early revascularization is planned. That situation may change soon, as no benefit was found for the use of IABP in the first large trial of the strategy.

The IABP-SHOCK II (Intraaortic Balloon Pup in Cardiogenic Shock II) was presented at the ESC and published simultaneously in the New England Journal of Medicine. Trial investigators, led by Holger Thiele, randomized 600 acute MI patients in cardiogenic shock to either IABP or no IABP. At 30 days there were no significant differences in mortality, the primary endpoint of the study:

  • Mortality: 39.7% in the IABP group versus 41.3% in the control group (relative risk with IABP 0.96, CI 0.79-1.17, p=0.69)

There were no significant differences between the groups in secondary endpoints, process-of-care outcomes, or safety endpoints, including stroke and bleeding.

In an accompanying editorial, Christopher O’Connor and Joseph Rogers write that the trial “could have affirmed contemporary clinical practice and guidelines” but, “instead, it revealed surprising results.”

“Members of guidelines committees and clinicians should take note of another example of a recommendation that is based on insufficient data,” they wrote.

Click here to read an interview on CardioExchange with the principal investigator Holger Thiele.

Republished with permission from CardioExchange, a NEJM group publication.

First Detailed Look At Why Aliskiren Failed To Gain ALTITUDE 2

Last December the once-promising direct renin inhibitor aliskiren (Rasilez, Tekturna) suffered a fatal setback with the early termination of the ALTITUDE trial. The trial was stopped when the Data Monitoring Committee (DMC) found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months.

At the ESC in Munich ALTITUDE investigator Hans-Henrik Parving presented the first detailed but preliminary results from the trial, which compared aliskiren to placebo in 8,561 type 2 diabetics at high risk for cardiovascular and renal complications already receiving single RAAS blockade.

After 32 months of followup, the composite endpoint (CV death, resuscitated death, MI, stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease or doubling of baseline creatinine) was not significantly different between the two groups, though Parving noted that the numbers went in the wrong direction for aliskiren, including a trend suggesting more strokes associated with the treatment drug:

  • Composite endpoint: 17.9% for aliskiren versus 16.8% for placebo (HR 1.08, 0.98-1.20, p=0.142)
  • Stroke: 3.4% versus 2.8%, HR 1.25 (o.98-1.60, p=0.70)

Aliskiren-treated patients also had higher potassium levels and were more likely to develop hyperkalemia, hypotension, and diarrhea.

Republished with permission from CardioExchange, a NEJM group publication.

Click here to read the ESC press release…

TRILOGY At ESC: No Advantage For Prasugrel Over Clopidogrel In Medical ACS Patients Reply

The newer antiplatelet agent prasugrel was no better than the old standby clopidogrel for treating patients with acute coronary syndrome (ACS) who are not undergoing revascularization. The results of the TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) trial were presented by Matt Roe at the European Society of Cardiology meeting in Munich and published simultaneously in the New England Journal of Medicine.

In the primary analysis of the trial, prasugrel (10 mg daily) was compared with clopidogrel (75 mg daily) in 7243 ACS patients younger than age 75. At 17 months, the rate of CV death, MI, or stroke did not differ significantly between the two groups:

  • 13.9% in the prasugrel group versus 16.0% in the clopidogrel group (hazard ratio [HR] for prasugrel, 0.91; 95% CI, 0.79-1.05, P=0.21)

The results were similar in a secondary analysis, which also included 2083 patients who were age 75 or older and who received either  low-dose prasugrel (5 mg daily) or the standard clopidogrel dose.

In a separate prespecified analysis, prausgrel patients under age 75 had a decreased risk for multiple recurrent ischemic events (HR, o.85; 95% CI, 0.72-1.00, P=0.04). According to the TRILOGY investigators, this finding is consistent with results from the earlier TRITON trial. TRITON compared prasugrel with clopidogrel in ACS patients undergoing revascularization; recurrent ischemic events in the prasugrel group were reduced by 30%, with most of the reduction occurring later in the trial. “Although this observation is exploratory,” the TRILOGY investigators wrote, ” it raises the question of whether investigation of the multiplicity of ischemic events is warranted in future secondary-prevention trials, rather than solely analyzing the time to the first event, as has been traditional” in previous studies.

The prasugrel and clopidogrel groups did not differ significantly in the rate of severe and intracranial bleeding. However, within the younger subgroup (taking the higher prasugrel dose), prasugrel recipients had more major and minor bleeding complications than clopidogrel recipients did — a reflection, the authors wrote, of “the more intense platelet inhibition with prasugrel.”

An exploratory analysis found that in the main group of patients under the age of 75, the Kaplan-Meier curves for the primary endpoint and for the individual components of the endpoint were not different for the first year but diverged afterward in favor of prasugrel. “The reasons for this finding remain uncertain,” the investigators wrote.

A subgroup analysis suggested the possibility that prasugrel might be more effective than clopidogrel in current or recent smokers, in patients who underwent angiography prior to randomization, and in patients taking a proton-pump inhibitor.

Sanjay Kaul provided the following comment:

“I find the TRILOGY investigators’ focus on time-dependent treatment effect (greater benefit after 12 months of treatment exposure) and recurrent events, both of which favor prasugrel, an attempt at cherry picking the data that portray prasugrel in the best light. The bottom line is that given the lack of a statistically discernible difference in the primary efficacy endpoint coupled with an increase in TIMI major or minor bleeding and increased cost associated with prasugrel, it is hard to make a case for prasugrel over clopidogrel treatment in low- to moderate-risk patients with unstable angina and NSTEMI who do not undergo revascularization. Although TRILOGY was not adequately powered to detect a cancer signal, the lack of increase in new nonbenign neoplasms is somewhat reassuring.”

Republished with permission from CardioExchange, a NEJM group publication.

New Universal Definition Of MI Unveiled At ESC 2012 1

A new universal definition of myocardial infarction (MI) was unveiled today at the European Society of Cardiology meeting in Munich. The document was developed jointly by the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA) and the World Heart Federation (WHF) and will be published in five journals: the European Heart Journal, the Journal of the American College of CardiologyCirculationGlobal Heart and Nature Reviews Cardiology. (The document  was scheduled to go online on Sunday but is now available, along with extensive support material, on the American Heart Association website.)

The third universal definition of MI establishes the troponin levels required to make a diagnosis of MI in various situations. In a press release, Kristian Thygesen, the co-chair of the document task force, discussed the difficulties the task force encountered in reaching a consensus. Setting a troponin level for procedure-related MIs is difficult “because interventional cardiologists and surgeons do not want myocardial infarction as a complication,” he said. “It means that they want to set the levels of troponin as high as possible. It was also difficult to reach a consensus because it’s impossible to conduct a clinical trial to find the answer.”

The Task Force also expects the new definition will be adopted by the FDA and will be used in clinical trial protocols accepted by the FDA. Said Thygesen, “this is significant because it will help to standardize the way myocardial infarction is defined in clinical trials, making comparisons between trials more meaningful. Steering committees that write protocols for clinical trials do follow FDA requirements.”

Here is a summary of the new definition from a FAQ published by the AHA:

The preferred biomarker overall and for each specific category of MI is cardiac troponin (cTn) (I or T), which has high myocardial tissue specificity as well as high clinical sensitivity. An increased cTn concentration is defined as a value exceeding the 99th percentile of a normal reference population (upper reference limit, URL).

Myocardial infarction is determined by the specified cTn value, and at least one of the five following diagnostic criteria:

  1. Symptoms of ischemia
  2. New (or presumably new) significant ST/T wave changes or LBBB
  3. Development of pathological Q waves on ECG
  4. Imaging evidence of new loss of viable myocardium or regional wall motion abnormality
  5. Identification of intracoronary thrombus by angiography or autopsy

NHLBI Announces 7000 Patient Trial Testing Inflammation Hypothesis 2

The National Heart, Lung, and Blood Institute (NHLBI) has announced the launch of a large  clinical trial testing the inflammation hypothesis. Paul Ridker is the principal investigator of the trial, which will be known as  the Cardiovascular Inflammation Reduction Trial (CIRT).

CIRT will enroll 7,000 patients who are stable following a heart attack but are at high risk for a recurrent event because they have either type 2 diabetes or metabolic syndrome. Trial subjects will be randomized to low dose methotrexate or placebo. The primary outcome measure is the rate of recurrent major cardiovascular events (MI, stroke, and cardiovascular death). Low dose methotrexate is now used to treat rheumatoid arthritis.

“If this generic drug, which is already on the market at low cost, proves effective for reducing risk of heart attacks, stroke, or death, it has the potential for broad public health impact in saving lives and reducing disease,” said Ridker, in an NHLBI press release.

The NHLBI said that site selection will begin in November 2012 and patient recruitment will start in March 2013. Patients will be followed for an average of 2.5 years.


Click here to read the NHLBI press release…

Cardiovascular Risk Prediction: Two More Studies, Little Progress Reply

Two studies published in JAMA provide new data — and, perhaps, some additional clarity — about using additional markers to help improve risk prediction for coronary heart disease (CHD) and cardiovascular disease (CVD).

In one study, Joseph Yeboah and colleagues used data from 1330 intermediate-risk participants in the Multi-Ethnic Study of Atherosclerosis (MESA)  to analyze the prognostic value of 6 risk markers: coronary artery calcium (CAC), carotid intima-media thickness (CIMT), ankle-brachial index (ABI), brachial flow-mediated dilation (FMD), high-sensitivity C-reactive protein (CRP), and family history of CHD.

After a median follow-up of 7.6 years, four risk markers (CAC, ABI, CRP, and family history) were found to be independent risk factors for CHD. CAC provided “the highest improvement in discrimination” over traditional risk scores. “The present study,” wrote the authors, “provides additional support for the use of CAC as a tool for refining cardiovascular risk prediction in individuals classified as intermediate risk.” However, “broad recommendations” about CAC should not be made until the associated problems of radiation exposure and incidental findings are addressed, they cautioned.

In the other study, Hester Den Ruijter and colleagues focused on CIMT, performing a meta-analysis in which they analyzed individual patient data from 14 studies and 45,828 patients. They found that adding CIMT provided only a small improvement in net reclassification which, they concluded, was “unlikely to be of clinical importance.”

In an accompanying editorial, J. Michael Gaziano and Peter Wilson write that “although there has been a great deal of work on the improvement in prediction modeling, less work has been done in 2 areas: the cost and risk in the screened population and risk prediction over time.” Using the example of an intermediate-risk patient who is a possible candidate for lipid-lowering therapy, they note that although CAC improves classification “at a single point in time,” most physicians evaluate patients over time and will often repeat tests to track trends over time. In this context, radiation exposure and costs may limit the utility of CAC.

Click to continue reading…

Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

 New Questions About Latest Generation ICD Leads From St. Jude

by Edward J. Schloss

A highly anticipated study analyzing failures of St. Jude Durata and Riata ST Optim ICD leads was published online today in Europace by prominent electrophysiologist and ICD critic Dr. Robert Hauser along with associates from the Minneapolis Heart Institute.

Over the last year St. Jude Medical has been beset with bad news about their ICD leads.  Until recently, the criticism has been confined to issues surrounding their older generation Riata and Riata ST leads (see my coverage in Cardiobrief).  These leads have been shown to be prone to both structural and electrical failures at an increased rate compared to competitive leads.  St. Jude has staunchly defended their newer generation Durata and Riata ST Optim leads, which have an additional layer of Optim copolymer insulation coating which they believe will decrease failures by improving abrasion resistance.  Last week, however, FDA issued a new request for post-market studies including X-ray surveillance of these leads, calling them “sufficiently similar” to Riata and Riata ST to merit increased scrutiny.

Today’s study from Hauser serves as another blow to St. Jude, and may affect implanter confidence in current generation Durata leads.  In the study, Hauser queried the FDA MAUDE database for “abrasion analysis” and reported detailed results.  He found 15 Riata ST Optim and 37 Durata reports.  The predominant abnormality in both groups was external abrasion (i.e. can/lead, or lead/lead), although several internal abrasions were also found.  Most of these abrasions resulted in clinically relevant electrical abnormalities such as low voltage oversensing resulting in inappropriate shocks.  One high voltage failure during a spontaneous ventricular arrhythmia resulted in an ineffective shock and subsequent patient death.

Hauser shied away from making comparisons to other leads in the current study and did not make any attempt to calculate an incidence of lead failure, recognizing the limitations inherent in analysis of a voluntary database.  This stands in contrast to his last Riata/Riata ST MAUDE analysis which provoked a firestorm of criticism including a request for article retraction from St. Jude Medical.
Click to continue reading…

TNF Inhibitors Linked To MI Reduction In Psoriasis Patients 1

Psoriasis patients who take TNF inhibitors have a significant reduction in the risk for myocardial infarction (MI), according to a retrospective cohort study published in Archives of Dermatology. Although previous research suggested that the anti-inflammatory effects of methotrexate, an older therapy, may be beneficial in this population, the cardiovascular effects of TNF inhibitors had not been well studied.

Researchers identified 8845 patients who were diagnosed with psoriasis or psoriatric arthritis within the Kaiser Permanente Southern California health plan. After a median of 4.3 years of observation, the overall rate of MI was 5.21 per 1000 patient-years.

  • In the 1673 patients who received a TNF inhibitor (etanercept, infliximab, or adalimumab), the MI rate was 3.05 per 1000 patient-years.
  • In the 2097 patients who received oral therapy or phototherapy, the MI rate was 3.85 per 1000 patient-years.
  • In the 5075 patients who received topical therapy, the MI rate was 6.73 per 1000 patient-years.

TNF inhibitors and oral therapy/phototherapy were each superior to topical therapy, but the difference between TNF inhibitors and oral therapy/phototherapy was not significant. Compared with topical agents, TNF inhibitors and oral agents/phototherapy had hazard ratios (adjusted for other risk factors) of 0.50 and 0.54, respectively.

The authors write, “This is the first large scale retrospective cohort study to show that the use of TNF inhibitors for psoriasis is associated with a clinically and statistically significant reduction in MI risk and incident rate compared with psoriatic patients treated with topical agents.” However, they note that “prospective studies are needed and warranted to determine whether the use of TNF inhibitors may reduce the risk of major adverse cardiovascular events in patients with systemic inflammatory conditions.”

Click here to read the press release from Archives of Dermatology…

Guest Post: FDA Clarifies Riata Imaging Recommendations 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Additional clarity regarding yesterday’s St. Jude Riata/Riata ST imaging recommendations has arrived in the form of another FDA Safety Communication available at the FDA web site.

According to the FDA, Riata and Riata ST leads “have an increased risk of premature insulation failure that can impact the lead’s ability to function properly.”  They add that there is currently insufficient information to determine the natural history of these insulation failures and risk factors that lead to failure.

FDA recommends physicians perform systematic imaging of their patients with Riata and Riata ST leads because”

“We believe that assessing the current condition of Riata and Riata ST leads is likely to help health care providers develop individualized plans for their patients, which may include recommendations on the frequency of remote monitoring and the necessity and frequency of repeat imaging.”

Specific recommendations of imaging are also spelled out.  Acceptable techniques include:

  • 2 view Chest X-Ray.  OK to use study obtained in last 3-6 months.  Recommend working with radiologist to obtain and interpret images.
  • Fluoroscopy

FDA also suggests that after this initial imaging, physicians “may consider performing fluoroscopy of the lead at the time of the generator replacement to check the lead condition.”  They also believe it is reasonable to repeat imaging to follow up manifest visual abnormalities.

Guidelines for management of specific clinical scenarios generally distill down to providing close follow up with attention to device performance.  They do not recommend extraction or replacement of leads with normal electrical function.

So where does this leave doctors and patients?  In an excellent perspective, cardiac electrophysiologist Dr. John Mandrola probably speaks for many of us when he writes of his frustration with these new mandates.  In medical school, we were taught never to get a test unless it influenced the subsequent management of the patient.  As John writes, “nobody knows the best way to manage these leads. Not the professors, not us masters of obvious in the clinical world, and surely not the amalgamizers in cubicles at the FDA.”  FDA indicates that physicians should develop “individualized plans for their patients.”  No room, however, is given to the thoughtful provider who may feel that his individualized treatment plan might best not include performing routine x-ray imaging.

Guest Post: Why Is The National Library Of Medicine Still Indexing Reviews In Cardiovascular Medicine? Reply

The following guest post by Kevin Lomangino was originally published on HealthNewsReview.org. Lomangino is an independent medical journalist and editor who is currently Editor-in-Chief of Clinical Nutrition Insight, a monthly evidence-based newsletter which reviews the scientific literature on nutrition for physicians and dietitians. He tweets as@Klomangino.

Why Is the National Library of Medicine Still Indexing Reviews in Cardiovascular Medicine?

by Kevin Lomangino 

Last week, a study looking at off-label drug promotion reported a finding that was considered “unsurprising and disturbing” by some observers: Only 15% of physicians and scientists touting such off-label uses disclosed that they had relevant financial relationships with the manufacturers who produced the drugs.

I’ll admit to some surprise at the extent to which these authors appear to have systematically hoodwinked their readers. But it’s true that the basic problem identified by the study – that scientific authors sometimes fail to disclose financial relationships that might influence their writing – is nothing new. In fact, the study brought to mind a troubling example of inadequate disclosure I wrote about here in February. And it inspired me to complete this follow-up post that I’ve been putting off for some time.

First, some background: The piece I wrote in February focused on a cardiology journal, Reviews in Cardiovascular Medicine (RICM), that engages in questionable editorial practices that promote commercial interests. The journal was first flagged by blogger Marilyn Mann for publishing an article, sponsored and reviewed prior to publication by pharmaceutical manufacturer Abbott, extolling the benefits of Abbott drugs for the prevention of cardiovascular disease.  After some more poking around, I found that the RICM editors also repeatedly failed to disclose—and in some cases, appeared to be actively concealing through misleading statements—relationships with other manufacturers whose products they were writing about in the journal. (I continue to welcome any attempt by these editors to explain the discrepancies identified, in case I’ve got the wrong idea.)

As far as I know, there haven’t been any negative repercussions for RICM or its editors stemming from my post or other critical coverage. (In fact, the editors are so unconcerned that they didn’t even bother to update their disclosure statements on the RICM website, which as I pointed out months ago are woefully out of date and inaccurate. ) This isn’t all that unusual, really, considering that even authors who participate in fraudulent research don’t face much in the way of consequences for their actions. It seems that the dollar value these authors bring to their institutions trumps any ethical qualms about their publishing activities.

If RICM were a subscription-based business, readers might have an opportunity to lodge a protest by refusing to renew their subscriptions. RICM, however, is sent out free of charge through support from industry sponsors. And it seems that companies are all too happy to have RICM’s editors serving as their pitchmen.

There is one organization, though, that I had hoped would have more than a passing interest in meting out some discipline to RICM: the National Library of Medicine (NLM).  As the curator of PubMed, the world’s foremost index of the scientific literature, the NLM has an obvious stake in assuring that the journals it indexes adhere to high editorial and ethical standards. And as it turns out, NLM even has a specific policy that seems designed to prevent the kinds of shenanigans that RICM engages in.
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Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements.  For the first time, the newer generation Durata and Riata ST Optim leads have been placed under enhanced review.

The problems with St. Jude’s ICD leads date back to the first reports of Riata model lead externalization in 2010.  By December 2011, FDA had issued a class I recall of both Riata and Riata ST models based on the growing body of evidence that these leads had potential for insulation breakdown.  Additional studies have now also shown increased electrical abnormalities of these leads.  Next generation Durata leads, while sharing significant structural similarities to Riata and Riata ST have thus far performed well in prospective trials (See my earlier post about the full scope of the problem.)

FDA Calls for X-Ray Screening of Riata and Riata ICD Leads

Today FDA issued a press release calling for patients to undergo “x-ray or other imaging alternatives” to look for externalization of St. Jude Riata and Riata ST leads.  Specific timing and frequency of testing is not stated and no recommendations are given as to how to act on abnormal findings.  In the release, FDA indicates that x-ray information “will help health care providers develop individualized patient treatment plans.” These recommendations may come as a bit of a surprise to the electrophysiology community.  Routine screening for externalization, while favored in some centers, has not been recommended by St. Jude Medical or the Heart Rhythm Society.  At the Riata Leads Summit this past January, only about half of physician attendees polled planned to do this screening, as I previously reported. 

The link between externalization and lead failure remains uncertain.  During a St. Jude’s sponsored webinar posted last month, Dr. Neal Kay reported “more than 85% of the externalized conductors continue to function normally.”  Later in the lectures, numerous discussants referred to Riata externalization as “cosmetic.”  St. Jude’s data from the Riata Lead Evaluation Study showed externalization rates of 24% in Riata and 9.3% in Riata ST based on prospective fluoroscopic data, but electrical data from that trial is still being collected and has not yet been reported.  A recent VA trial reported increased electrical failures in these leads, but did not include x-ray evaluations.
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Observational Study Fills Gaps In Understanding AF Patients With Kidney Disease Reply

Although people with atrial fibrillation (AF) and people with chronic kidney disease (CKD) are both at elevated risk for stroke and other vascular events, people with both conditions have not been well studied, since patients with CKD have been excluded from most clincial trials of stroke prevention for AF. The problem is further compounded because the presence of CKD increases the risk of bleeding associated with anticoagulation. Now, a large new observational study from Denmark published in the New England Journal of Medicine provides new evidence to better estimate risk and to help determine a treatment strategy for patients with both AF and CKD. Jonas Bjerring Olesen and colleagues analyzed data from 132,372 Danish patients and found 3587 who also had chronic CKD and 901 who received dialysis or a transplant. Compared to patients with no renal disease, patients with CKD were at significantly elevated risk of stroke or thromboembolism, bleeding, MI, and death: Stroke or thromboembolism (event rate per 100 person-years):

  • No renal disease: 3.61
  • Chronic CKD: 6.44
  • CKD requiring renal replacement therapy: 5.61

Stroke or thromboembolism (event rate per 100 person-years):

  • No renal disease: 3.61
  • Chronic CKD: 6.44
  • CKD requiring renal replacement therapy: 5.61

Bleeding (event rate per 100 person-years):

  • No renal disease: 3.54
  • Chronic CKD :8.77
  • CKD requiring renal replacement therapy: 8.89

Myocardial infaction(event rate per 100 person-years):

  • No renal disease: 1.88
  • Chronic CKD: 5.81
  • CKD requiring renal replacement therapy: 5.98

Death(event rate per 100 person-years):

  • No renal disease: 11.21
  • Chronic CKD: 38.65
  • CKD requiring renal replacement therapy: 29.35

The investigators found that warfarin but not aspirin reduced the risk of stroke or thromboembolism in the patients with CKD. Both warfarin and aspirin were associated with an increased risk for bleeding, however. “Thus,” the authors wrote, “the net clinical effect of warfarin treatment requires careful assessment in patients with chronic kidney disease, and the data do not provide clear guidance regarding indications for anticoagulant therapy in patients with both atrial fibrillation and chronic kidney disease. Certainly, close monitoring of the international normalized ratio is required when warfarin is administered.”  

Guest Post: Children Should Have Their Cholesterol Checked Reply

Editor’s Note: CardioBrief is pleased to publish this guest post written by Samuel Gidding, the head of the cardiology division at the Nemours Cardiac Center at A. I. DuPont Hospital for Children and a professor of pediatrics at Jefferson Medical College. CardioBrief invited Gidding, a member of the NHLBI panel that recommended universal lipid screening at ages 9-11 years, to respond to James Stein’s critique of those guidelines.

Children Should Have Their Cholesterol Checked

Samuel S. Gidding, MD

Dr. Stein, in his post, presents several arguments against cholesterol screening  in childhood.  I would like to present the view of those who drafted the document and suggest that some of Dr. Stein’s arguments are incorrect.

First, since conflicts of interest were part of his argument, I must be transparent about mine.  I have never participated in a drug industry sponsored trial of a cholesterol lowering medication.  I had no conflicts with industry until late 2009, after the main work on the guideline was complete.  Both of these are related to evidence gaps identified in the literature review for the guideline.  The first is as a member of the Data and Safety Monitoring Board for a trial of losartan to lower blood pressure in severely hypertensive children less than 6 years of age. The reimbursement for this work is deposited into a research fund to support medical students and residents performing research without another source of support.  The second is to conduct a clinical trial of fish oil for elevated triglycerides in adolescents.  There is no clinical trial data regarding medication use for elevated triglycerides in children and no recommendations were made regarding use of medications for this purpose in the NHLBI sponsored statement.  This money is provided as a grant, the trial is completely of my design and my research program manages the trial without input from the company.  There is no oversight by the company of the trial other than I have to recruit a specified number of patients and complete a manuscript to receive payment.   My reimbursement from the grant is for managing the coordinating center of the trial (there are 3 sites), analyzing the data, and for performance of various medical duties in conducting the trial.

The NHLBI guideline was strictly conducted according to the recommendations of the Institute of Medicine and other bodies that have been interested in guideline integrity. Several thousand research papers meeting preselected criteria as evidence were considered in the evaluation of recommendations for 14 different risk factors.  A paper describing the panel’s process has recently been published. (Gidding SS et al, Pediatrics, 2012)  The Lipid section of the guideline was drafted by the three members of the panel with the most knowledge about lipids.  However the recommendation of this group was debated and voted upon by the entire committee, which had a diverse composition consistent with the Institute of Medicine recommendations.  NHLBI officials cognizant of conflict of interest issues were also present and contributed to the discussion.  With one exception, none of the other 11 committee members had participated in an industry sponsored cholesterol drug trial.

All the arguments discussed in critiques of the guideline emerged in this debate, in fact, the committee felt so strongly about the evidence limitations that a specific chapter of the guideline was written to include them, particularly the cost issue.  Nonetheless, the committee, with one exception, voted for universal screening because the weight of the evidence review favored this decision despite evidence gaps.  The fact that atherosclerosis begins in the second decade of life, that this atherosclerosis (including future atherosclerosis) is strongly related to non HDL cholesterol levels, that a small but significant number of children can be identified with high cardiovascular risk, that treatments highly likely to be successful are available, and that genetic  diseases causing both high and low LDL cholesterol were highly suggestive of the risk of high LDL cholesterol and the benefit of  lifetime low LDL cholesterol levels provided this weight.   It is inaccurate of Dr. Stein to say that the evidence evaluation for the cholesterol treatment recommendation does not reflect the types of studies included to support the recommendation.  The grade given is B (not A), evidence from clinical trials with potential flaws, high quality and consistent observational studies, and Mendelian Randomization (genetic research).  Hopefully, an outcome of the guideline will be high quality clinical trials of lipid lowering treatment that have been initiated by sponsors other than industry.
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Troponin Test May Allow Rapid MI Rule-Out in the Emergency Department Reply

More than three-quarters of people with chest pain can be triaged within an hour of arrival at the emergency department with a novel strategy utilizing high-sensitivity cardiac troponin (hs-cTnT), according to a study from Switzerland published in the Archives of Internal Medicine. The strategy is promising, according to anaccompanying editorial, but much work remains before it can be implemented in clinical practice.

Tobias Reichlin and colleagues first studied 436 patients and developed a treatment algorithm utilizing hs-cTnT baseline changes and absolute changes over the initial hour. The algorithm was then tested in a second validation cohort of 436 patients, with the following results:

  • 60% were classified as “rule-out”
  • 17% were classified as “rule-in”
  • 23% required further observation
  • Overall sensitivity and negative predictive value: 100% for rule-out
  • Specificity for rule-in: 97%
  • Positive predictive value for rule-in: 84%
  • Prevalence of MI in the observational group:  8%
  • 30-day survival: 99.8% in the rule-out group, 98.6% in the observational group, and 95.3% in the rule-in group

The authors claim that their strategy “may obviate the need for prolonged monitoring and serial blood sampling in 3 of 4 patients.”

In an accompanying comment, L. Kristin Newby writes that the Swiss study “is a major advance in understanding the application of hsTn testing that with continued development could substantially improve evaluation of ED patients with suspected MI.” However, she notes that the excellent results obtained in this initial study will probably not be equalled in the real world. In addition, she writes, “although touted as ‘simple’ by the authors, the need for multicomponent algorithms that are different for rule-in and rule-out and that vary by age group or other parameters will challenge application by busy clinicians unlikely to remember or accurately process the proposed algorithm. As such, it will be imperative that hsTn algorithms, if validated, are built into clinical decision support layered onto electronic health records so that testing results are provided electronically to physicians along with the algorithmic interpretation to allow systematic application in triage and treatment.”
Click here to read the press release from Archives…

Guest Post: Is It The Right Time To Introduce Real Supervision Into Medical Practice? 1

Editor’s Note: Dr. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, originally submitted the following post as a comment on my previous post in which I compared HCA to Barclays and JP Morgan. I’d be very eager to hear responses from other physicians about this subject.

Is It The Right Time To Introduce Real Supervision Into Medical Practice?

by Dr. Edward J. Schloss

One thing hospitals and banks have in common is that the quality of their work is obscure and not easily measured by the consumer. Systematic abuses can go undetected without direct supervision and public reporting.

At least a banker’s work is directly supervised by their peers. In a hospital, there is no direct supervision on the actions of the doctors. It is quite easy to work alongside another doctor for years without really knowing how good or bad they are. Current quality measures are easily gamed and do not really measure what they are intended to measure. Any practicing physician will tell you that.

Because our patients are not able to evaluate the quality of their care and external quality metrics are so poor, I wonder if the time might be right to introduce real supervision into medical practice. In his excellent piece in the New Yorker this week, Atul Gawande spends some time discussing ICU doctor supervision via the electronic ICU system. It may be time to extend this type of “check and balance” system into more clinical arenas. Imagine a physician supervisor making rounds into cath labs and ORs, reviewing charts and interviewing MDs. This sort of thing would likely be resisted by many doctors, but would be a better way to pick up outliers than computerized checklists.

Now that most doctors are employees of hospital systems, it would be feasible to set up such a supervision system (assuming federal privacy rules don’t get in the way).

Why HCA Is Like Barclays And JP Morgan 3

Earlier this week the New York Times reported on a pattern of seriously deficient cardiac care at a number of hospitals owned by HCA. Understandably, the most common reaction is simple disgust over more bad cardiology behavior. After the Mark Midei case, after subsequent and even worse cases in Maryland, Pennsylvania, and elsewhere, the easy thing is to say that many cardiologists, and especially interventional cardiologists, are corrupt and greedy.

But the larger significance of the HCA story has not been generally understood.

The real problem at HCA wasn’t so simple. Yes, some interventional cardiologists may have been acting like teenagers on spring break, and many may well have been guilty of poor medical judgement, and in some cases much worse. But that’s not what’s at the root of the HCA case.

And the real problem at HCA wasn’t that the hospital had no mechanism to deal with bad cardiologists. In fact, as readers of the Times article discovered, HCA had all sorts of internal and external controls and reviews. Time after time these reviews worked as intended and correctly identified the problem at hand.

The real problem at HCA was that all the oversight in the world meant nothing compared to the bottom line, and that power and authority flowed with the money. The problem is best exemplified by one anecdote in the Times story about a doctor at one HCA hospital:

Dr. Prasad Chalasani… was highlighted by the hospital in a 2009 business plan as being the most profitable doctor at the facility. “Our leading EBDITA MD,” the plan described him. (Ebitda, or earnings before interest, taxes, depreciation and amortization, is a measure of corporate earnings.) Just a few months earlier, hospital executives had received an outside review that characterized Dr. Chalasani as too quick to perform catheterizations, often without first doing the stress tests necessary to determine whether a patient needed the invasive and costly test.

Another example, featured prominently in the Times article, is the story of a nurse whose contract was not renewed after he reported  that unnecessary procedures were being performed at his hospital, although an internal HCA investigation had substantiated his allegations.

Medical judgement, the needs of patients, the responsibility to payers: these were all secondary. Oversight was blown away like so many  autumn leaves. Time and again, HCA executives ignored the reports of their own investigations or failed to implement programs and systems that would prevent them from recurring.

Now I don’t mean to suggest that the bad actions of individual physicians should not be taken seriously But there will always be incompetence, and there will always be individuals who seek to game the system to get more than their fair share. The question is whether the encompassing system is designed to encourage or hinder that behavior. Problems may arise even in the strictest systems, but they probably won’t lead to a federal investigation.

I think the best way to understand HCA is to look at the banks, since in many respects HCA acted like Barclays or JP Morgan, two banks whose inner workings have been exposed by recent scandals.  I’m not a financial journalist by any means, but several clear lessons have emerged from these scandals.
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Reports From JUPITER And Taiwan: Benefits Of Statins Outweigh Risk Of Diabetes 1

Two new papers provide further evidence that statin usage is associated with an increased risk of diabetes, but both studies also find that the benefits of statins still outweigh the risks.

In the first report, published in the Lancet, Paul Ridker and colleagues analyze data from the JUPITER trial, which compared rosuvastatin to placebo in a primary prevention population.

Among the 17,603 patients randomized in the trial, 11,508 had at least one major risk factor for developing diabetes. In this group, the primary endpoint (MI, stroke, hospitalization for unstable angina, revascularization, or CV death) was reduced by 39% in the statin group (hazard ratio 0·61, CI 0.47–0.79, p=0·0001). The authors calculated that in the statin group 134 vascular events or deaths were avoided  for every 54 new cases of diabetes. For the 6,095 patients without a major risk factor for diabetes, the primary endpoint was reduced by 52%  (HR 0·48, CI 0.33–0.68, p=0·0001). No increase in diabetes was observed. In this group, 86 vascular events or deaths were avoided.

During the JUPITER trial 486 subjects developed diabetes  (270 in the rosuvastatin group and 216 in the placebo group). The risk reduction in this group was consistent with the overall reduction observed in the trial.

“Our results show that in participants with and without diabetes risk, the absolute benefits of statin therapy are greater than the hazards of developing diabetes,” said Paul Ridker, in a press release issued by the Lancet. “We believe that most physicians and patients would regard heart attack, stroke and death to be more severe outcomes than the onset of diabetes, and so we hope that these results ease concern about the risks associated with statin therapy when these drugs are appropriately prescribed – in conjunction with improved diet, exercise and smoking cessation – to reduce patients’ risk of cardiovascular disease.”

The findings from JUPITER were echoed in a large observational study from Taiwan published in the Journal of the American College of Cardiology that compared 8,412 people receiving statins with 33,648 matched controls. The Taiwan investigators found that although, over a median of 7.2 years, the rate of diabetes was significantly higher among statin users  (2.4% vs. 2.1%, p < 0.001), statins were associated with a significant reduction in cardiovascular events (HR 0.91, CI 0.84 to 0.99, p = 0.031).
Click here to read the Lancet press release…

Risks and Benefits Of Pediatric Ventricular Assist Device Explored Reply

Few options besides extracorporeal membrane oxygenation (ECMO) have been available for children with systolic heart failure awaiting transplantation. Now a new report by Charles Fraser, Jr and colleagues published in the New England Journal of Medicine provides important new information about a ventricular assist device (VAD) designed for children.

Trial investigators implanted 48 patients with the Excor Pediatric  VAD (the Berlin Heart) and compared them to matched historical controls who had received ECMO. The VAD group was composed of two 24-patient cohorts based on body-surface area. Survival was dramatically and significantly longer in both VAD cohorts:

  • Cohort 1 (<0.7 m2):  median survival time had not been reached at 174 days in the VAD group, compared with 13 days in the ECMO group (p<0.001)
  • Cohort 2 (0.7 to <1.5 m2): 114 days versus 10 days (p<0.001)

However, VAD treatment was associated with clinically significant adverse events. Major bleeding occurred in 42% of cohort 1 patients and 50% of cohort 2 patients, infection in 63% and 50%, and stroke occurred in 29% of patients in both cohorts.

In an accompanying editorial, Linda Addonizio observes that the development of pediatric VADs has been markedly slower than the development of adult VADs, although “the potential number of years of life saved for each person is much greater for children.” However, because of the high rate of neurological complications she urges caution before “extending the current practice in adults of early implementation of ventricular assist devices to children.” VADs, she writes, “should remain, at present, a last resort in small children.”

Survey Finds Significant Drop In Cholesterol Levels In Youths Reply

New data from the National Health and Nutrition Examination Survey (NHANES), published in JAMA, show significant and perhaps surprising  improvements over the last 20 years in the lipid profile of youths aged 6-19 years. Among the key lipid parameters measured by the survey from 1988-1994 to 2007-2010:

  • Total cholesterol decreased from 165 mg/dL to 160 mg/dL (p<0.001)
  • Prevalence of elevated total cholesterol declined from 11.3% to 8.1% (p<0.002)
  • HDL increased from 50.5 mg/dL to 52.2 mg/dL (p<0.001)
  • Non-HDL decreased from 115 mg/dL to 107 mg/dL (p<0.001)

“Generally,” the authors report, “the sex-, age-, and race/ethnicity-specific trends for TC, HDL-C, and non– HDL-C were similar in direction to the overall trends and consistent with a favorable trend, although for each group, the magnitude was not the same and the trend was not always significant.”

The change over time in lipids in youths was paralleled by similar changes in adults, according to the investigators. They also note that the improvement in lipids occurred “despite an increase in obesity prevalence during the study period.”

The changes recorded in the survey are “clinically meaningful” and a “cause for optimism,” writes Sarah de Ferranti in an accompanying editorial. “But,” she asks, in the face of the increase in obesity, the decline in exercise, and other adverse trends, “why would childhood cholesterol improve?” She briefly considers several possible explanations for the improvement, including improved interventions and healthier lifestyles, but then finds “a more plausible explanation” to be “dietary shifts at a population level”:

Dietary intake of fat has declined over the past several decades and some studies suggest substitution of carbohydrates for dietary fat, particularly poor quality carbohydrates, might both promote obesity and explain some of the lipid changes reported [here].

Another less concerning cause may be the reduction in the use of trans fats over the study period, she writes.

Click here to read the press release from JAMA…