Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Wrist circumference in obese children may predict CVD
Capizzi M. Circulation. 2011;123:1757-1762.

A manual measure of wrist circumference was more closely linked to insulin parameters than BMI in a cohort of overweight or obese children and adolescents, according to new study results published in Circulation.

The trial involved 477 overweight or obese children and adolescents aged 10.31 ± 2.80 years from Rome. Each participant’s wrist was manually measured. The researchers also evaluated standard deviation score BMI, fasting biochemical parameters and homeostasis model assessment of insulin resistance in the study population.

A subcohort of 51 randomly selected participants underwent a wrist MRI to assess transversal wrist area at the Lister tubercle level.

Wrist circumference was significantly linked with the parameters of insulin levels (β=0.34) and homeostasis model assessment of insulin resistance (β=0.35), according to the results (P<10-5 for both comparisons).

Standard deviation BMI score yielded a statistical association of β=0.12 with insulin levels and β=0.10 with homeostasis model assessment of insulin resistance (P≤.02 for both comparisons).

In the MRI cohort, the link between wrist circumference and insulin levels was further clarified. Wrist circumference was associated insulin levels or homeostasis model assessment of insulin levels in bone tissue-related areas (P≤.01 for both comparisons) but not in adipose tissue areas (P>.05). MRI explained 20% of the variances in insulin levels and 17% of the variances in homeostasis model assessment of insulin levels.

The researchers noted that excess fat is a key determinant of insulin resistance which representing the metabolic basis for developing future CVD. The aim of the study, they said, was to find a clinical marker of insulin resistance to identify young individuals at increased risk for CVD.

“Our findings suggest a close relationship among wrist circumference, its bone component, and insulin resistance in overweight/obese children and adolescents, opening new perspectives in the prediction of CVD,” the researchers wrote.
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Serum alpha-carotene inversely associated with death from CVD, all-causes
Li C. Arch Intern Med. 2011;171:507-515.

Increasing levels of serum alpha-carotene had an inverse association with rates of death due to CVD and all-cause mortality among participants of the Third National Health and Nutrition Examination Survey.

These findings help to elucidate the role of carotenoids on CVD, as previous research had primarily involved beta-carotene, according to study investigators.

The current analysis included 15,318 US adults aged at least 20 years from the NHANES III, which was conducted from 1988 to 1994. Patients were considered ineligible if they had a follow-up of 1 month or less, missing data on covariates or insufficient identifying information.

The study’s findings revealed a mean alpha-carotene concentration of 4.79 mcg/dL for the entire cohort (men, 4.22 mcg/dL; women, 5.31 mcg/dL). A statistically significant association was found between increasing serum alpha-carotene levels and lower CVD-related mortality (P=.007), which included ischemic heart disease (P=.21), stroke (P=.84), as well as other CVDs (P=.06).

Overall, increasing levels of serum alpha-carotene compared with those in the reference group (0-1 mcg/dL) resulted in a lower risk for death from all-causes: 2 to 3 mcg/dL (RR=0.77; 95% CI, 0.68-0.87), 4 to 5 mcg/dL (RR=0.73; 95% CI, 0.65-0.83), 6 to 8 mcg/dL (RR=0.66; 95% CI, 0.55-0.79) and at least 9 mcg/dL (RR=0.61; 95% CI, 0.51-0.73).

According to researchers, this inverse association was independent of demographic characteristics, lifestyle habits and traditional health risk factors.

“Our results, if replicated in other studies and populations, suggest a need for clinical research into the health benefits of serum alpha-carotene,” they said.
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Combined diet, exercise more beneficial in older obese adults than either intervention alone
Villareal DT. N Engl J Med. 2011;364:1218-1229.

A combination of weight loss and exercise significantly improved physical function of obese older adults vs. either intervention alone, according to 1-year, randomized trial data.

The trial included 107 participants who were aged at least 65 years and considered obese. They were randomly assigned to either a control group (n=27), a weight-management (diet; n=26) group, an exercise group (n=26), or a diet-plus-exercise (diet-exercise; n=28) group. Among these participants, 93 finished the study.

At 1 year, the researchers reported that the study’s primary outcome, the change in Physical Performance Test score, was higher, thus indicating better physical status in individuals from the diet-exercise group (21%) vs. either diet (12%) or exercise (15%) groups, although all three were better than the control group (1%; P<.001 for between group differences).

Similarly, peak oxygen consumption was better in the diet-exercise (increase of 17%) arm compared with diet (10%) or exercise (8%) participants, as were scores on the Functional Status Questionnaire with the diet-exercise arm vs. the diet arm (increase of 10% vs. 4%; P<.001). Conversely, the greatest decrease in body weight was documented in the diet arm compared with those in the diet-exercise group (10% vs. 9%; P=.67), whereas no decreases were found in either the control or exercise arms.

“Our findings suggest that weight loss alone or exercise alone improves physical function and ameliorates frailty in obese older adults; however, a combination of weight loss and regular exercise may provide greater improvement in physical function and amelioration of frailty than either intervention alone,” the researchers concluded. “Therefore, weight loss combined with regular exercise may be beneficial in helping obese older adults maintain their functional independence.”

[Chevychelov]

Reduced physician work hours did not adversely affect patient safety
Moonesinghe S. BMJ. 2011; 342:d1580.

A systematic review published in the British Medical Journal found that reducing doctors’ working time to less than 80 hours a week does not seem to adversely affect patient safety and has limited impact on post-graduate medical training in the US, according to a press release.

The study, led by S. Ramani Moonesinghe, an anesthesiology consultant and honorary senior lecturer at the University College Hospital in London, and colleagues sought to evaluate the impact of work reduction on educational and clinical outcomes by reviewing 72 studies published in the UK and US.

“The impact of reducing hours to less than 56 or 48 a week in the UK has not been sufficiently evaluated in high-quality studies,” the researchers wrote. “Further work is required, particularly in the European Union, using large, multicenter evaluations of the impact of duty hours’ legislation on objective educational and clinical outcomes.”

Of the studies reviewed, 38 reported on training outcomes, 31 noted patient outcomes and three studies reported on both types of outcomes.

The maximum hours per week for trainees can range from 37 hours in Denmark to 80 hours in the US. The European Working Time Directive, initiated in 2004, restricted the weekly training period for doctors in Europe to 48 hours. Since that time, there has been concern in the medical profession about potential adverse effects on postgraduate training for junior doctors and the provision of high-quality care for patients, according to the release.

The authors noted that more high-quality studies are needed to evaluate the impact of restricting work hours using objective measures of medical training and patient safety, particularly in the European Union, according to the release. “Only then can both the public and the profession be reassured that the standard of medical training, and therefore the future care of patients, is of the highest possible quality and will be maintained or improved over time,” they concluded.
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Exclusion of older patients prevalent among trials testing HF treatments

Cherubini A. Arch Intern Med. 2011;171:550-556.
Gurwitz J. Arch Intern Med. 2011;171:557-558.

More than one-quarter of clinical trials that investigated treatment for HF excluded patients with an upper age limit, despite recommendations issued by national and international regulatory agencies against the practice.

The new study appearing in the Archives of Internal Medicine also found that upper age restrictions were significantly more common in the European Union than the United States.

To generate these data, Antonio Cherubini, MD, PhD, and colleagues scrutinized ongoing clinical trials regarding HF registered in the WHO database. Trials were excluded if they were observational in design; did not have HF as the main target condition; did not propose any treatment; involved children; or were registered twice. The final analysis included 251 trials.

Overall, 64 trials (25.5%) excluded patients by what researchers termed an “arbitrary upper age limit,” which varied between 65 and 95 years of age (median age, 80 years). They also found that 109 trials (43.4%) had poorly justified exclusion criteria that may negatively affect inclusion of older individuals in HF trials.

Compared with the trials conducted in the United States, those performed in the European Union more often excluded older patients (32.3% vs. 16.2%; P=.007). Upper age restrictions were also more common in trials sponsored by public institutions vs. private entities (35.6% vs. 13.9%; P=.02).

“Despite the recommendations offered by the Helsinki Declaration of the World Medical Association and by several national and international regulatory agencies … and the best efforts of physicians caring for older patients, the exclusion of older individuals in clinical trials regarding HF continues to be widespread in pharmacologic and nonpharmacologic trials currently ongoing,” Cherubini and colleagues wrote. “To improve care of elderly patients, more older individuals need to be included in clinical trials investigating conditions of relevance to members of this fast-growing age group.”

In an accompanying editorial, Jerry H. Gurwitz, MD, and Robert J. Goldberg, PhD, with the Meyers Primary Care Institute, Worcester, Mass., said the guidelines have been ineffective in enhancing the participation of older individuals in clinical trials. As a way to improve the evidence base to guide the care of older patients with CVD, they proposed a multifaceted approach. The four initial steps include:

Eliminating arbitrary age-based exclusions in CV clinical trials.
Requiring strong justification for exclusion criteria that could adversely affect the inclusion of older individuals, including those criteria relating to comorbidity, medication use, and functional and cognitive impairment.
Encouraging the design and conduct of randomized controlled trials specific to older individuals through targeted funding.
Reporting and publicizing trends in the inclusion of elderly patients in CV clinical trials to assess progress in improving the generalizability of research findings to this high-risk population.

[Chevychelov]

ACTIVE I: Irbesartan failed to lower CV events in patients with AF
Yusuf S. N Engl J Med. 2011;364:928-938.

Among patients with atrial fibrillation, irbesartan, an angiotensin-receptor blocker, did not reduce the occurrence of CV events, including MI and death from vascular causes, compared with placebo, according to randomized, clinical trial data.

In the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE-I) trial, investigators enrolled patients (n=9,016; mean age, 69.6 years) who had permanent AF or at least two episodes of intermittent AF in the previous 6 months. Patients were then randomly assigned to receive either irbesartan (Avapro, Sanofi-Aventis/Bristol-Myers Squibb) or placebo. The first coprimary outcome was defined as MI, stroke or death from vascular causes, and the second was this composite outcome plus hospitalization for HF.

During a mean follow-up of 4.1 years, patients taking irbesartan had a mean reduction in systolic BP of 2.9 mm HG and diastolic BP of 1.9 mm Hg. There was no difference in the first coprimary endpoint between groups (5.4% each per 100 patient years), and only nonsignificant reduction in the second coprimary endpoint in the irbesartan group (7.3% vs. 7.7% per 100 patient years; P=.12).

When rates of hospitalization were looked at individually, researchers found that patients given irbesartan had a nominally significant reduction in first hospitalization for HF (HR=0.86; 95% CI, 0.76- 0.98), but not in the risk of hospitalization for AF (HR=0.95; 95% CI, 0.85-1.07).

“Among patients with AF, most of whom had well-controlled hypertension and 60% of whom were receiving an ACE inhibitor, the addition of irbesartan did not reduce the risk of death from CV causes, stroke or MI or this composite outcome plus hospitalization for HF,” the researchers wrote, later adding that it remains to be seen whether more aggressive lowering of BP would be effective in patients with AF.

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APEX-AMI: Age strongest predictor of 90-day mortality
Gharacholou S. Arch Intern Med. 2011;171:559-567.

Patients aged 75 years or older had nearly three times the rate of 90-day mortality after primary percutaneous coronary intervention compared with patients who were aged 65 to 74 years and more than five times the rate found in patients aged younger than 65 years. As a result, age was the strongest predictor of death at 90 days in this study’s population.

Among the patients (n=5,745) in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial, 3,410 were aged younger than 65 years, 1,358 were aged 65 to 74 years, and 977 were aged 75 years or older. Ninety-day mortality and a composite of congestive HF, shock and 90-day death were defined as the study’s main outcome measures.

At baseline, patients aged 75 years or older had higher rates of hypertension, angina, stroke, chronic HF and chronic obstructive pulmonary disease. Overall, 90-day mortality rates were 2.3% in patients aged younger than 65 years, 4.8% in those aged 65 to 74 years and 13.1% in those aged 75 years or older. Composite outcomes shared a similar increase by age group (5.9%, 11.9% and 22.8%, respectively). After adjustment, age was the strongest independent predictor of 90-day mortality with an HR of 2.07 (95% CI, 1.84-2.33) per 10-year increase.

“Despite optimal mechanical reperfusion and high rates of adjunctive medical treatment, age remains the main predictor of 90-day mortality in STEMI patients treated with primary PCI,” the researchers wrote. “Efforts to attenuate this risk and understand reperfusion factors that increase age-associated outcomes are needed.”

[disdas]

Cardiac Imaging after Myocardial Infarction
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In the acute phase of MI, an echo should be obtained as early as possible to assess regional and global left and right ventricular function and to rule out acute mechanical complications; urgent echocardiography is mandatory for patients who experience sudden deterioration, hypotension or shock, acute heart failure, a new murmur, or otherwise experience sudden deterioration. Cardiac imaging after the acute phase of MI has a wealth of valuable information to offer to inform and guide patient management. Given the variety of imaging options for nearly all clinical questions, a rational choice must factor in reliability of a method, potential therapeutic consequences, cost and availability, and finally the risks involved, e.g. radiation exposure and contrast application (Table 1and Table 2). The clinical choice will therefore differ depending on local expertise and resources, patient characteristics and, last but not least, individual experience of the physician. The following recommendations are therefore based on and perhaps to some degree biased by our practice:

An echo should be performed as quickly as possible in every patient with the acute coronary syndrome. As long as reperfusion therapy is not delayed, this may include ST elevation infarction infarction, but requires an immediately available, trained echocardiographer performing a limited emergency study while the patient is prepared for primary intervention. The rationale is that echo allows assessment of regional and global left and right ventricular function and recognition of critical complications, e.g. pericardial effusion possibly signalling impending rupture, papillary muscle rupture, right ventricular infarction, or may alert to unsuspected differential diagnoses such as Type A aortic dissection (e.g. in the presence of aortic regurgitation and a pericardial effusion). While the echo on admission is often performed under emergency conditions and focuses on left ventricular function and potential MI complications, a full echocardiographic examination should be performed during the following weeks to guide further therapy and to serve as a baseline for future comparison. Besides documenting global systolic function (ejection fraction), regional wall motion abnormalities and mitral regurgitation, signs of increased left ventricular filling pressures should be identified, in particular the restrictive mitral inflow pattern. Global strain measurements may be a useful supplement of ejection fraction with some evidence of a lower observer variability. Subtle markers of increased diastolic pressures such as an increase in left atrial size, of the E/e′ ratio or of systolic pulmonary pressure may indicate that the patient perhaps needs more aggressive treatment and a closer follow-up. If large akinetic or dyskinetic left ventricular regions are present, thrombi and spontaneous echo contrast should be identified or excluded.
If identification of inducible ischaemia is clinically warranted, typically in a patient who did not undergo coronary angiography or who has intermediate coronary non-culprit lesions on the acute coronary angiogram, a stress test should be performed after the acute phase of MI once the patient is stable. Imaging stress tests offer substantial advantages over classic ECG and symptom-based exercise tests, which are still the first-line recommendation of current guidelines. However they involve higher costs, higher demands on reader expertise, and, in the case of nuclear perfusion imaging, expose the patient to radiation. Strengths and weaknesses of stress echo, nuclear perfusion imaging, and stress MRI are well documented and should be considered individually according to patient characteristics. The most important point, though, is local availability and expertise, outweighing the modest differences in diagnostic accuracy.
If identification of viable myocardium is of concern, typically in a patient with impaired global left ventricular systolic function and coronary anatomy which is either unknown or amenable to revascularization, the choice is between MRI (with late contrast-enhancement and/or wall motion assessment under dobutamine stimulation), nuclear perfusion imaging, and (usually dobutamine) stress echocardiography. The interpretation of these tests in conjunction with the coronary angiogram to arrive at the decision whether to revascularize or not is frequently very difficult, unless findings are clear cut (transmural scar/no contractile reserve or minimal scar/well-preserved contractile reserve). The test should be performed after the acute phase of MI. In the infarct area, especially after reperfusion therapy, stunned myocardium may be present which will recover spontaneously over the following days and weeks; however, there seems to be a fluid transition between repetitive stunning and classic myocardial hibernation, and the ideal timing of the test is unclear. Similar to the detection of ischaemia, the most crucial issue is local availability and expertise, again outweighing the differences in diagnostic accuracy of the individual test.

[Chevychelov]

Combination therapy plus LVAD not validated in multicenter trial

ISHLT 31st Annual Meeting and Scientific Sessions

SAN DIEGO – Despite a previous single-center trial indicating sustained survival for patients with nonischemic dilated cardiomyopathy who were treated with a left ventricular assist device plus optimal medical therapy followed by clenbuterol, a new multicenter study showed that this combination treatment in the same population did not confer the same benefit on myocardial recovery.

For Keith D. Aaronson, MD, medical director of the Heart Failure Program at the University of Michigan in Ann Arbor, and study researcher, the study began with some skepticism about whether there was any potential for clinical recovery with this treatment in patients with chronic HF.

“At this point, while I don’t know how much this [treatment] brings out recovery or who will recover, I have to concede that this is a real phenomenon worth pursuing clinically and certainly warrants further study,” Aaronson said in a presentation.

The five-center, US-based study included nonischemic dilated cardiomyopathy bridge-to-transplant patients (n=17; median age, 57 years) who had received HeartMate XVE (Thoratec) and target or maximum tolerated angiotensin receptor antagonist, beta-blocker, ACE inhibitor, digoxin and aldosterone antagonist therapy. Patients were then given clenbuterol and beta-1 selective betablockers for 3 months following either plateau in reverse remodeling or 16 weeks.

Researchers withdrew four patients due to complications before treatment with clenbuterol. Following 4 months of LVAD therapy, the remainder of patients received clenbuterol for a median of 7 months.

Among the 13 patients that entered phase II of the study, 12 had an adverse event, which included muscle spasms and pain, supraventricular tachycardia and sustained ventricular tachycardia requiring cardioversion. Of these 12, three had a reduction in clenbuterol dose.

According to data, at the start of clenbuterol usage, LV ejection fraction was 42.5%, which decreased markedly at 6 months (31%). However, at 18 months, LVEF rose to 45%. Overall, one of the 13 patients were explanted, while two of the 10 evaluable patients without device complication requiring study withdrawal had marked myocardial recovery.

Significant limitations of the study highlighted by Aaronson included the very small sample size as well as loss of patients due to complications unrelated to clenbuterol or study procedures. – by Brian Ellis
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REVEAL registry: PAH exacerbated by presyncope, syncope

ISHLT 31st Annual Meeting and Scientific Sessions

SAN DIEGO – For patients with pulmonary arterial hypertension, a history of presyncope and syncope worsened the severity of disease, according to data from the REVEAL registry.

What this indicates, according to researchers, is the importance of validating the prognosis and effect of syncope among patients with pulmonary arterial hypertension (PAH) as treatment guidelines continue to be defined.

The study featured patients (n=70) who had both PAH and a history of either presyncope or syncope at initial prediagnosis of symptoms (IS) and first PAH-clinic visit from the REVEAL registry, which was a 55-center, observational, US-based longitudinal registry. The study’s objective was to both define the significance of presyncope and syncope in newly diagnosed patients with PAH and determine whether it is linked with clinical and or hemodynamic parameters.

Inclusion criteria for the study was that all patients with PAH must be characterized by having each of the following: mean pulmonary artery pressure <25 mm Hg at rest or <30 mm Hg with exercise; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure no greater than 18 mm Hg; and pulmonary vascular resistance of at least 240 dyn/s/cm-5. Patients were then followed for at least 5 years.

The researchers reported that patients with PAH and a history of presyncope and syncope were younger; had higher mean pulmonary artery pressure and right atrial pressure; had more functional class IV disease; had more right ventricular chamber enlargement; and had higher percent predicted diffusing capacity of carbon dioxide. They also found that 3-year survival was worse for the IS group despite these patients being characterized as younger and having a better capacity for exercise.

“Presyncope/syncope is associated with markers of increased disease severity in newly diagnosed PAH patients. However, it was not predictive of unadjusted survival,” said Rachel Le, MD, with the Mayo Clinic, Rochester, Minn., and investigator on the study, in her presentation.

As directions for future research, Le and colleagues suggested determination of the prognosis of presyncope or syncope as evidence-based PAH treatment guidelines are established; separating out the differences between presyncope or syncope; accessing whether treatment will affect prognosis in these patients; the effect of resolution of these symptoms with therapy; and differentiating pediatric vs. adult patients. – by Brian Ellis
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Elevated adolescent BMI may predict diabetes in adults
Tirosh A. N Engl J Med. 2011;364:1315-1325. S

Individuals with elevated adolescent BMI were at a nearly threefold increased risk for developing diabetes as adults, according to study results.

The prospective study involved 37,674 young men who were apparently healthy. The men were followed for incident angiography-proven CHD and diabetes during 650,000 person-years of follow-up (mean follow-up, 17.4 years). Height and weight measurements were taken at regular intervals starting at age 17 years.

There were 1,173 incident cases of type 2 diabetes and 327 cases of CHD reported.

A multivariate analysis accounted for age, family history, BP, lifestyle factors and biomarkers in blood.

Results indicated that elevated adolescent BMI — the mean range of which, for the first through last deciles, was 17.3 to 27.6 — was significantly linked to diabetes (HR for the highest vs. the lowest decile, 2.76; 95% CI, 2.11-3.58). Elevated adolescent BMI was also associated with angiography-proven CHD (HR=5.43; 95% CI, 2.77-10.62).

The link between BMI and diabetes disappeared when the participants reached adulthood (HR=1.01; 95% CI, 0.75-1.37). However, adult BMI was associated with CHD (HR=6.85; 95% CI, 3.30-14.21).

Results of a further adjustment in which BMI was evaluated as a continuous variable indicated that adult BMI was the only factor significantly associated with diabetes (P=.003).

Angiography-proven coronary heart disease was independently linked to BMI in adolescence (P=.004) and adulthood (P=.03).

“An elevated BMI in adolescence — one that is well within the range currently considered to be normal — constitutes a substantial risk factor for obesity-related disorders in midlife,” the researchers wrote.

[Chevychelov]

Sudden cardiac death risk may be underestimated in NCAA athletes
Harmon K. Circulation. 2011;123:1594-1600.

Sudden cardiac death accounted for more than half of the medical-related fatalities in a cohort of collegiate student-athletes in the US, according to study results.

Researchers from two US sites reviewed all cases of sudden cardiac death among National Collegiate Athletic Association (NCAA) student-athletes from January 2004 to December 2008. The NCAA database was used, as were public media reports and catastrophic insurance claims.

There were 273 deaths in 1,969,663 athlete participant-years. Sixty-eight percent of those deaths were attributed to nonmedical or traumatic causes, 29% were due to medical causes and 2% were the result of unknown causes.

Among the medical cases, CV-related sudden death was the most frequently reported cause, accounting for 56% of the fatalities. CV-related sudden deaths also accounted for 75% of medical-related sudden deaths during exertion.

Sudden cardiac death had an incidence rate of 1:43,770 participants per year, according to the results. That rate was 1:3,100 per year among NCAA Division I male basketball players.

Among the 45 cardiac cases reported, 87% were identified through the NCAA database, 56% were identified through public media reports and 20% were found via catastrophic claims data.

The study was conducted to determine the true incidence of sudden cardiac death among NCAA student-athletes and to assess the accuracy of data collection methods on sudden cardiac death.

“[Sudden cardiac death] is the leading medical cause of death and death during exercise in NCAA student-athletes,” the researchers wrote. “Accurate assessment of [sudden cardiac death] incidence is necessary to shape appropriate health policy decisions and develop effective strategies for prevention.”
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Private-Practice Cardiology is Dead and Mr. Obama Wasn’t the Killer
by L. Samuel Wann, MD
by L. Samuel Wann, MD

OK, the private practice of cardiology certainly isn’t dead or even dying, but it has suffered some serious wounds in the past couple of years. An estimated 50% to 60% of cardiology practices in this country have now been sold to hospitals. This trend toward hospital employment is particularly noticeable for larger cardiology groups, and there is considerable geographic variation in the phenomenon. However, if you are a cardiologist younger than 45 years old living in a medium-sized urban community outside of the South or California, you are probably an employed physician or about to be.
L. Samuel Wann

This is an enormous change from how your father practiced cardiology, and these changes began when Mr. Obama was still living in Indonesia. The past 50 years have brought enormous technical advances to the practice of cardiology, from the introduction of coronary angiography to echocardiography to bypass surgery, as well as stents, statins, SPECT, CTA, CMR, genomic medicine — and on and on. The positive and negative economic impact of these advances has been enormous. While we may have been indiscriminate in adopting some of these expensive technologies before proving their true value to our patients, we owe much of our success to the medical–industrial complex. As we mature as clinician scientists, we are more appreciative of the demands for cost consciousness and appropriate, evidence-based utilization of medical technology.

But this isn’t what broke the bank for traditional private practice, nor was it conflicts of interest due to physician ownership of imaging equipment, nor was it the fear of malpractice litigation. Conflicts of interest are inseparable from life itself. Physician ownership of equipment can have positive implications for patient service and focus on high-quality diagnostics with direct impact on patient care. Divorcing imaging from users and patients does not automatically reduce waste or inappropriate utilization, but it surely does reduce revenues in many private practice offices that have come to depend on technical fees to support the less remunerative office visits. Moving imaging to the hospital makes it even easier to order more imaging procedures to counter the perceived threat of malpractice litigation. Or, because the hospital electronic medical record doesn’t extend to the private office and the hospitalist in charge, it simply becomes easier to order another study than to track down the old one.

So we hear from politicians of all stripes that the government is out of money and current spending rates can’t continue. Is this what killed private cardiology practice? I don’t think so. We are a wily bunch and can hold our own in a free-for-all if given a chance. Small business — which at some level is what private practice comes down to — is remarkably resilient and continues to provide much of the growth and progress in this country and elsewhere. Larger is not always better. Given that more than half of us are now employed, it is time to take the many good aspects of old-fashioned private practice with us to the new setting and help the professional administrators create something newer and better. Not all private practices will sell, but they will adapt to the new environment by practicing smarter and by creating mutually beneficial relationships with hospitals that allow the physician groups to retain autonomy.

What is the fundamental change taking us away from 100 years of independent practice to the employment model? The cardiologist in the mirror is the real reason traditional private cardiology practice is declining in market share (“declining market share” is the verbiage they use in business school instead of the simpler term “dead” used in the title of this entry). Many of us baby boomers who are thinking of cutting back or retiring, as well as the new crop of female and male cardiologists who have had protected work hours during their residencies and fellowships, simply don’t want to work as hard as the traditional private-practice cardiologist has worked in the past. We do not want the financial responsibility of running a small business that is becoming increasingly complex with the coming of electronic records, accountable care organizations, pre-authorization, accreditation, the need to employ more support personnel, and topped off by negative innuendo related to self-referral. Add to this our desire to practice high-quality subspecialty cardiology in a sophisticated environment of team players, to have a decent family life, to get home before dark and go to a baseball game with the kids on Saturday instead of going to the hospital.

Others have gone there before us. EDs were once covered by rotating medical staff, not specialized ED physicians working a shift. Likewise, hospitalists and extended-practice nurses and physician assistants are doing much of the inpatient hospital work that used to occupy the off-hours of primary care physicians. ED and PCPs also want a better life.

So blame the decline in traditional cardiology private practice on the hope for a sane and balanced life, devotion to family and desire for some life outside medicine. The traditional private practice of cardiology is dead. May it rest in peace.

[Chevychelov]

Calcium supplements implicated in increased risk for CV events
Bolland M. BMJ. 2011;doi:10.1136/bmj.d2040.

Calcium supplements, taken with or without vitamin D, have been shown to modestly increase the risk for CV events, including MI and stroke.

These results, reported in a new study published by the British Medical Journal, incorporated findings from a re-analysis of the Women’s Health Initiative Calcium/Vitamin D Supplementation Study (WHI CaD), as well as a meta-analysis of several additional trials.

Initially, results from WHI CaD, which was a 7-year, randomized, placebo-controlled trial with 36,282 postmenopausal women, showed no adverse effect of calcium and vitamin D on any CV endpoint. The results were obscured, however, because participants had free access to those supplements, according to the researchers. Specifically, at randomization, 54% of the participants were taking personal calcium supplements and 47% personal vitamin D supplements, which researchers said rendered the trial a comparison of higher- and lower-dose calcium and vitamin D for most of those participating.

According to results of their re-analysis, the 46% (n=16,718) of women not taking personal calcium supplements had an HR of 1.13 for any CV endpoint and 1.20 for total MI (P=.07 for both). Results on the other endpoints, including revascularization and stroke, were similar, with the exception of all-cause mortality (HR=0.99). Designation to calcium and vitamin D among women taking personal calcium supplements did not change CV risk.

“By restricting the analyses to women not taking personal calcium supplements, we were able to estimate the effect of calcium and vitamin D on CV events, observing increased risks of these events with calcium and vitamin D,” the researchers wrote.

To gain further insight into this issue, investigators then supplemented these results with data from placebo-controlled trials that examined CV events among individuals taking calcium or calcium and vitamin D. The complete trial-level data were obtained from 28,072 individuals from eight trials, as well as the WHI CaD participants who did not take personal calcium supplements.

Overall, 1,835 died during the mean trial duration of 5.7 years, which was weighted by study size. Researchers reported that 1,384 individuals had an incident MI or stroke, which resulted in RRs of 1.24 (P=.004) for MI and 1.15 (P=.009) for the composite of MI and stroke.

“When [WHI CaD] results are taken together with the results of other clinical trials of calcium supplements, with or without vitamin D, they strongly suggest that calcium supplements modestly increase the risk of CV events, particularly MI,” the researchers concluded. “These data justify a reassessment of the use of calcium supplements in older people.”

The situation seems quite complex to me because there are different reasons to supplement with calcium. For example, there are people who have conditions like osteoporosis, renal disease, and who are receiving treatment under clinical supervision. There are people at varying levels of osteoporosis risk, some of whom take calcium with or without vitamin D on their own prophylactically, and some who take it under clinical supervision based on recommendations from their physicians. There are people who take calcium and other supplements for general health reasons with the belief that anything natural must be good. Some people take calcium as part of antacid preparations — it is not clear to me how this is captured in the studies included in this meta-analysis. It is also unclear to me how antacid use was cross-referenced with calcium use in WHI.
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ICD nonuse in eligible patients may be lower than previously estimated
LaPointe N. Circ Cardiovasc Qual Outcomes. 2011;4:146-151.

Detailed analysis showed that rates of underutilization of implantable cardioverter defibrillators among eligible patients decreased from 41% to 13%, according to newly published data.

“To date, several analyses of claims or registry data have indicated high rates of underutilization of this evidence-based therapy in clinical practice, as well as age, sex and racial disparities in ICD use,” the researchers wrote. “Although we initially identified similar rates of ICD underutilization and disparities within our health care system, after detailed medical record abstraction, we discovered that a majority of those not receiving an ICD had an identified contraindication or patient refusal.”

Their analysis included patients (n=542) with a diagnosis of HF and left ventricular ejection fraction of no more than 30% at a tertiary care center from Jan. 1, 2007, to Aug. 30, 2007. With the use of medical records, researchers determined reasons for nonuse among patients without an ICD.

Overall, 224 eligible patients (41%) did not receive an ICD. Adjusted analysis comparing all ICD recipients with all nonrecipients revealed absence of ventricular arrhythmia or cardiac arrest (OR=3.17; 95% CI, 2.14-4.68), index hospitalization on a noncardiology service (OR=2.64; 95% CI, 1.65-4.21) and female sex (OR=1.90; 95% CI, 1.28-2.81) as being the factors most associated with nonuse.

After performing a detailed chart review on the eligible patients, researchers observed that 117 patients (52%) were ineligible for the device and 38 (17%) refused it, leading to only 69 (13%) patients eligible for an ICD who failed to receive one.

Furthermore, analysis comparing all ICD recipients with nonrecipients without contraindications indicated the following characteristics of nonuse: absence of ventricular arrhythmias (OR=4.93; 95% CI, 2.56-9.5), noncardiology hospital service (OR=3.73; 95% CI, 1.98-7.04) and no health insurance (OR=3.10; 95% CI, 1.48-6.46).

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Omega-3 fatty acid yielded significant reductions in triglycerides

A 4-g daily formulation of omega-3 fatty acid AMR101 was linked to decreases in triglyceride levels of more than 20% compared with placebo, according to recent results.

The aim of the ANCHOR trial was to determine the efficacy of AMR101 (Amarin) in reducing triglyceride levels without increasing LDL cholesterol in 702 individuals with high triglycerides who had experience with background statin therapies, including simvastatin (Zocor, Merck), atorvastatin (Lipitor, Pfizer) or rosuvastatin (Crestor, AstraZeneca). High triglycerides were defined as 200 mg/dL to 500 mg/dL. Eligible participants had mixed dyslipidemia, and 73% were diabetic.

Four grams of AMR101 was associated with a 21.5% decrease in triglyceride levels (P<.0001). The 2-g formulation reduced triglycerides by 10.1% (P=.0005).

Both doses of the drug yielded decreases in LDL that met predetermined noninferiority criteria. Compared with placebo, a 6.2% decrease in LDL was observed from baseline among patients receiving the 4-g dose. Among patients receiving 2 g per day, LDL was reduced by 3.6% compared with placebo (P=.0867).

Secondary endpoint results indicated that, compared with placebo, non-HDL cholesterol decreased by 13.6% in the 4-g per day group (P<.0001) and by 5.5% in the 2-g per day group (P =.0054).

Adverse event profiles were similar between treatment and placebo groups, and no drug-related adverse events were reported.

The primary outcome measure was the percentage change in triglyceride levels from baseline among patients on the AMR101 compared with placebo after 12 weeks. The trial was also powered to demonstrate a lack of LDL-elevating effect of the study drug compared with placebo. Secondary endpoints included the difference in other lipid and biomarker levels between treatment and placebo groups.
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Racial disparity observed in survival after heart transplantation
Liu V. Circulation. 2011;123:1642-1649.

During a 22-year interval, black recipients of a heart transplant had higher rates of mortality compared with white recipients, according to retrospective cohort study data.

The study included 39,075 adult recipients of a heart transplant between 1987 and 2009. Among this population, 79.3% of the recipients were white and 12.8% black, with the remaining 7.9% either Latino, Asian, American Indian or Alaskan native, Pacific Islander or multiracial; although the number of nonwhite recipients increased over time.

Overall, median waiting list time was 66 days for nonwhite recipients vs. 92 days for white recipients. There were 16,880 total deaths after transplantation during the study period.

After multivariate adjustment for recipient, socioeconomic and transplant factors, only blacks had an increased mortality risk compared with whites (HR=1.34; 95% CI, 1.21-1.47). This equated to a 5-year mortality rate of 35.7% (95% CI, 35.2-38.3) among blacks and 26.5% (95% CI, 26-27) among whites.

Also, blacks were more likely to die of graft failure or a CV cause than whites (57.9% vs. 37.8%) or other nonwhites (44.1%), but they were less likely to die of an infection or malignancy than whites (19.9% vs. 33%) or other nonwhites (28.2%).

“Although long-term survival has improved for all recipients, the racial gap in survival among blacks has persisted over 2 decades, and may be related in inadequate immunosuppression,” the researchers concluded. “Additional research aimed at identifying the source of this disparity is necessary.”

These are extremely interesting observations. The difference in outcomes between white and black heart transplant recipients is substantial. Moreover, graft failure and CV causes appear to be the cause although the mechanism(s) involved remain speculative. Given the high and increasing number of blacks who receive heart transplants in the US each year, these results provide strong motivation for further research efforts directed at identifying the cause of the higher rate of graft failure in blacks and, most importantly, providing direction for new treatment algorithms to solve this problem.
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Screen time shown harmful on retinal microvascular structure of children
Gopinath B. Arterioscler Thromb Vasc Biol. 2011;doi:10.1161/ATVBAHA.110.219451.

Among 6-year-old students in Australian schools, screen time was found to have a negative effect on their retinal microvascular structure, whereas physical activity had a positive influence.

The random sample of 34 schools in Sydney, Australia, featured 1,492 6-year-old students. Researchers collected data during a pre-organized visit to each school and excluded children if they had missing or incomplete data or retinal conditions. Afterward, parents completed a comprehensive questionnaire that assessed the physical and sedentary activities of their children.

Researchers reported that the children spent a mean of 1.9 hours per day of screen time — which incorporated TV viewing, using a computer or playing a videogame — whereas only 36 minutes per day were spent in physical activity.

After adjustment for variables, including age, ethnicity, eye color, axial length, BMI and mean arterial BP, children in the highest tertile of outdoor sporting activity had a wider mean retinal arteriolar caliber by 2.2 mcm compared with those in the lowest tertile (P=.004). When researchers increased quartiles of time spent watching TV, the result was a narrower mean retinal arteriolar caliber of roughly 2.3 mcm (P=.003).

“We show for the first time that engaging in higher levels of outdoor activity is associated with modestly wider retinal arterioles in children. However, increased screen time was associated with narrowing of retinal arteriolar caliber,” the researchers wrote. “As retinal arteriolar narrowing could be a potential subclinical marker of future CVD risk, the presence of this risk factor may indicate a need for closer monitoring and lifestyle modifications to decrease the time schoolchildren spend watching the TV and increasing the time they spend in physical activity.”

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Study: CABG use decreased between 2001 and 2008
Epstein A. JAMA. 2011;305:1769-1776.

Results from an analysis published in JAMA suggested that CABG use decreased between 2001 and 2008, but also that percutaneous coronary intervention remained at stable levels.

Researchers for the cross-sectional study examined time trends in patients undergoing CABG or PCI between 2001 (n=77,952 for CABG; n=55,483 for PCI) and 2008 (n=151,893 for CABG; n=153,800 for PCI) in the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample. The data were supplemented by Medicare outpatient hospital claims.

According to the results, there was a 15% decrease in coronary revascularizations, from 5,569 (95% CI, 5,315-5,835) procedures/million-adults in 2001-2002 to 4,748 (95% CI, 4,532-4,975) procedures/million-adults in 2007-2008 (P<.001). Annual rates of annual CABG surgery decreased by 38%, from 1,742 (95% CI, 1,663-1,825) procedures/million-adults in 2001 to 1,081 (95% CI, 1,032-1,133) procedures/million-adults in 2008 (P<.001). The decreases were observed across sex, age racial and regional subgroups.

By contrast, annual rates of PCI decreased by 4%, from 3,827 (95% CI, 3,578-4,092) procedures/million-adults in 2001-2002 to 3,667 (95% CI, 3,429-3,922) procedures/million-adults in 2007-2008 (P=.74).

“Although the total rate of US coronary revascularization decreased modestly between 2001 and 2008, there was a substantial decrease in the CABG surgery rate,” the researchers concluded. “Between 2001 and 2008, the rate of PCI did not significantly change; however, there were continual changes in the frequency of stent types used for PCI.”

As we move forward into an era of limited health care resources, it will become increasingly important to have an accurate estimation of the clinical need and utilization of medical procedures. This information will enable forecasting of needs for resource allocation and decision-making about future investments in clinical infrastructure and training of future physicians.

In the study published by JAMA, Epstein et al estimate that rates of CABG have declined steadily by 15%, while PCI rates have declined only slightly, with a non-significant 4% decrease in 2008 compared with 2001. Although they claim that PCI volumes remained steady, their data show PCI procedures increased from 2001 to 2004, but decreased by 10% from 2005 to 2008.

Our similar study published in Circulation: Cardiovascular Quality and Outcomes also found a steady decrease in CABG, but a more complicated trend in PCI procedures. We reported annual CABG and PCI revascularization rates in the entire Medicare population from the beginning of 2000 through the end of 2009 and found an early increase in PCI procedures from 2000 to the end of 2004, but a steady decrease in PCI procedures from 2004 through 2009. Epstein et al also suggest a rise in multivessel stenting. Our data show that any increase multivessel stenting peaked in 2006, before publication of the SYNTAX study, and has since declined. Based on the rate of decrease in PCI, we concluded the decrease in CABG volume could not be entirely accounted for by a preferential use of PCI.

Epstein et al’s conclusion that PCI rates have remained unchanged must be evaluated closely. Both their study and ours show the changes in PCI volume were not steady over the 2000 to 2008 time period. However, their comparison between the 2001 and 2008 data assumes a linear change and, therefore, does not accurately reflect the trends that occurred in the intervening years.

The minor differences in the procedure rates published in our study result from use of different billing datasets and methodology. We utilized nearly complete Medicare physician billing data on inpatient and outpatient procedures, whereas Epstein et al evaluated all insurance types, but did not have data on outpatient procedures and made estimations of rates for their sample based on the US population, rather than the number of patients actually eligible for treatment in this subset of hospitals.

Importantly, Epstein et al acknowledge that the present study does not provide sufficient patient-level data to form any conclusions regarding procedural appropriateness. These revascularization rates may reflect changing patient demographics and clinical comorbidity within this sample of hospitals, rather than operator or patient preferences. An increase in acute coronary syndromes in numbers of patients with inoperable/high-risk surgical disease or low-risk non-surgical disease or the migration of patients from one hospital to another may explain their findings.
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FDA committees evaluate recent safety data on contrast agents

Members of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met today to interpret and discuss safety data for the two approved ultrasound contrast agents, Definity and Optison, as well as the investigational agent SonoVue. The FDA was not seeking advice on a vote to approve or revoke any of the agents but a discussion on current labeling.

The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) had previously gathered in 2008 to examine efficacy and safety issues of those three agents.

According to background provided by the FDA, despite the appearance of a low overall adverse event rate with ultrasound contrast agents, serious adverse events and even fatalities still persist with all three agents. Although the organization noted the difficulty in distinguishing adverse events related to ultrasound contrast agents from concomitant medications and complications due to underlying comorbidities, it also said there is reason to believe ultrasound contrast agents play a contributory role.

In today’s meeting, both the CRDAC and the Drug Safety and Risk Management Advisory Committee convened at the request of the FDA to discuss in detail the safety data that have come to light in the 3 years since the meeting.

During the morning session, industry members from Lantheus Medical Imaging (Definity), GE Healthcare (Optison) and Bracco Diagnostics (SonoVue) presented post-marketing results on the safety studies performed on their respective agents. All of the studies presented showed minimal risk for serious adverse events related to usage of the agents, while also being consistent with the data presented at the previous meeting. As a result, both GE and Lantheus requested changes to the black box warnings, which they said are a barrier to use. The requested changes were either to remove the black lines or remove the warning completely.

Responding to this concern, Allan Coukell, BScPharm, director of medical safety, the Pew Health Group, Washington DC, said during the meeting, “It does seem there was a dip in use [of contrast agents] after the black box warning, but it’s come back up. It also seems clear that these agents are going to be used in ever-expanding settings by more and more people using them for the first time. So it seems to me that you would want them to know there is this [risk for a] rare but potentially very serious event.”

This led to one of the main issues discussed in the afternoon portion of the meeting which was the extent to which the new safety information presented justified modification of the boxed warnings. A consensus was not reached among members.

“The most positive thing I’ve heard today is of the impact of the black box warnings, in that it actually did something, maybe, which is unusual compared to drugs,” said Brian Strom, MD, MPH, chair and professor of biostatistics and epidemiology, University of Pennsylvania, Philadelphia. “But it’s important to keep in mind that black box warnings do not prohibit use. They are simply a way to clarify the risk/benefit balance. We are also in a climate now when more and more black box warnings are being added. Clearly, if you look at now, as opposed to five years ago, there is a lot more of them. To take it away now sends a clear message that we’ve seen data that changes the risk/benefit from what it was before seeing the data, and we haven’t. We’re all very clear on that. So if we haven’t seen anything to change it, it would send a really bad message that these agents are safer than we thought.”

However, Henry Black, MD, clinical professor of medicine, New York University School of Medicine, New York, was still not convinced there was a need for the warning and questioned why the black boxes were even added in the first place.

“It’s like an inflation creep, a grade creep. That’s why there are more black box warnings and why their impact becomes less and less; because they are not used appropriately,” he said. “I wasn’t at the 2008 meeting, [but the labeling’s] already been softened and there isn’t anything here. And I think it has an impact based on what we saw. I don’t think it’s going to affect things very much except in the legal environment we’re in where risk management to a hospital’s lease is so important that they are not going to go against this for obvious reasons that I think we ought to take this away.” – by Brian Ellis

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Shocks for AF, ventricular rhythms increased risk of death

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO – Among patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy-defibrillator, those who received shocks for atrial fibrillation and ventricular rhythms had a significantly greater likelihood of death compared with those who did not receive a shock, according to data presented here.

“The overall findings suggest that the increased risk of death after inappropriate shock is related to the underlying arrhythmia and the associated disease process with it as opposed to a adverse effect from the shock itself,” said Brian Powell, MD, electrophysiologist at the Mayo Clinic, Rochester, Minn., and the study’s primary investigator, in an interview with Cardiology Today.

In the study, all ICD and cardiac resynchronization therapy-defibrillator (CRT-D) patients (n=3,809) involved were enrolled in the Latitude remote monitoring system (Boston Scientific) through January 1, 2010. A group of seven electrophysiologists adjudicated the first shock episode rhythms for these patients and matched them to patients without a shock (n=3,630).

During a mean follow-up of 25 ± 17 months after the first shock, 36% experienced a shock as the result of sustained monomorphic ventricular tachycardia (SMVT), 18% resulted from atrial fibrillation/flutter, 17% from sinus tachycardia/supraventricular tachycardia (SVT), 5% from noise/artifact/oversensing, and 1% from non-sustained ventricular tachycardia (NSVT).

Overall, mortality in the shock group was significantly higher compared with the no shock group for ventricular fibrillation/polymorphic ventricular tachycardia (PMVT; HR=2.10, P<.0001), SMVT (HR=1.65; P<.0001), SMVT and PMVT (HR=2.77; P<.0001) and AF (HR=1.61; P=0.003). No difference in mortality was reported among those who received a shock for sinus tachycardia/SVT (HR=0.97; P=0.86) or noise/artifact/oversensing (HR=0.91; P=0.76) when compared with those who did not experience a shock.

As a result of these findings, Powell said that electrophysiologists can have some reassurance that the shock itself may not affect the patient’s survival. “This is something that electrophysiologists have been concerned about based on previous studies,” he said. “This is the first study that is large enough to look at the subgroups within the inappropriate shock category to see what exactly is driving that increased risk of death among patients who receive inappropriate shocks. It appears that AF and its associated comorbidities account for the increased risk of death after an inappropriate shock.” – by Brian Ellis
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CRT found superior to right ventricular apical pacing in patients with permanent AF

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO – Patients with permanent atrial fibrillation who, on top of atrioventricular junction ablation, were treated with cardiac resynchronization therapy had lower rates of worsening HF and hospitalizations for HF compared with those treated with right ventricular apical pacing, according to new data presented at the Heart Rhythm Society’s 32nd Annual Scientific Sessions.

According to Michele Brignole, MD, the study’s primary investigator andhead of the department of cardiology, Ospedali del Tigullio, Lavagna, Italy, the prospective study began as an attempt to add to the current level of understanding of right ventricular apical pacing vs. cardiac resynchronization therapy (CRT) in patients with AF, which he said only consisted of a few small short-term trials.

“So there is a lack of knowledge,” Brignole told Cardiology Today. “For this reason, current guidelines in America (2008) and Europe (2010) on CRT have ranked CRT pacing as Class IIa level of evidence B and only for a subgroup of patients with AF, specifically the subgroup of patients with large QRS, low ejection fraction and NYHA Class 3 or 4.”

To bring further clarification to this issue on a larger scale, Brignole and fellow researchers randomly assigned 186 patients from 19 hospitals to receive either optimized echo-guided CRT (n=97) or right ventricular apical pacing (n=89). All patients had previous atrioventricular junction and CRT implantation performed successfully. The study’s primary endpoint was a composite of death from HF, hospitalization due to HF or worsening HF.

During a median follow-up of 20 months, the primary endpoint proved to be significantly lower in the CRT group vs. those in the right ventricular group (11% vs. 26%; sub-HR=0.37; 95% CI, 0.18-0.73). This was due primarily to significantly lower rates of worsening HF (sub-HR=0.27; 95% CI, 0.12-0.58) and hospitalizations for HF (sub-HR=0.20; 95% CI, 0.06-0.72) in the CRT group because the rates of mortality between groups were similar. As a result, the CRT mode was an independent predictor of the absence of clinical failure (OR=0.19; 95% CI, 0.05-0.67).

For Brignole, two important implications can be taken from this trial. “The first is that this trial confirms the Class IIa indication of the most recent guidelines,” he said. “This indication was mainly based on an expert consensus opinion, rather than based on real studies. This is the first study that gives evidence of clinical benefit of therapy in patients who already have a IIa indication. In other words, this study could serve to upgrade the current recommendation from IIA to Class I.”

The second implication, however, according to Brignole, is even more important. “This study, if confirmed by others, would expand the indication of guidelines to all patients with severe symptomatic AF, independently for ejection fraction, length and duration of QRS and so on,” he said, but adding that this study must be regarded as somewhat preliminary. – by Brian Ellis

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CRT found superior to right ventricular apical pacing in patients with permanent AF

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO – Patients with permanent atrial fibrillation who, on top of atrioventricular junction ablation, were treated with cardiac resynchronization therapy had lower rates of worsening HF and hospitalizations for HF compared with those treated with right ventricular apical pacing, according to new data presented at the Heart Rhythm Society’s 32nd Annual Scientific Sessions.

According to Michele Brignole, MD, the study’s primary investigator andhead of the department of cardiology, Ospedali del Tigullio, Lavagna, Italy, the prospective study began as an attempt to add to the current level of understanding of right ventricular apical pacing vs. cardiac resynchronization therapy (CRT) in patients with AF, which he said only consisted of a few small short-term trials.

“So there is a lack of knowledge,” Brignole told Cardiology Today. “For this reason, current guidelines in America (2008) and Europe (2010) on CRT have ranked CRT pacing as Class IIa level of evidence B and only for a subgroup of patients with AF, specifically the subgroup of patients with large QRS, low ejection fraction and NYHA Class 3 or 4.”

To bring further clarification to this issue on a larger scale, Brignole and fellow researchers randomly assigned 186 patients from 19 hospitals to receive either optimized echo-guided CRT (n=97) or right ventricular apical pacing (n=89). All patients had previous atrioventricular junction and CRT implantation performed successfully. The study’s primary endpoint was a composite of death from HF, hospitalization due to HF or worsening HF.

During a median follow-up of 20 months, the primary endpoint proved to be significantly lower in the CRT group vs. those in the right ventricular group (11% vs. 26%; sub-HR=0.37; 95% CI, 0.18-0.73). This was due primarily to significantly lower rates of worsening HF (sub-HR=0.27; 95% CI, 0.12-0.58) and hospitalizations for HF (sub-HR=0.20; 95% CI, 0.06-0.72) in the CRT group because the rates of mortality between groups were similar. As a result, the CRT mode was an independent predictor of the absence of clinical failure (OR=0.19; 95% CI, 0.05-0.67).

For Brignole, two important implications can be taken from this trial. “The first is that this trial confirms the Class IIa indication of the most recent guidelines,” he said. “This indication was mainly based on an expert consensus opinion, rather than based on real studies. This is the first study that gives evidence of clinical benefit of therapy in patients who already have a IIa indication. In other words, this study could serve to upgrade the current recommendation from IIA to Class I.”

The second implication, however, according to Brignole, is even more important. “This study, if confirmed by others, would expand the indication of guidelines to all patients with severe symptomatic AF, independently for ejection fraction, length and duration of QRS and so on,” he said, but adding that this study must be regarded as somewhat preliminary. – by Brian Ellis
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Infection incidence for pacemaker implants increased from 1993 to 2008

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO — The burden of infection among recipients of cardiac implantable electronic devices has increased between 1993 and 2008 for pacemakers, but not for implantable cardioverter defibrillators, according to new research.

Researchers for the study reviewed data from the National Inpatient Sample to identify patients receiving pacemakers and ICD between 1993 and 2008. They used ICD-9-CM procedure codes to identify the specific patients, including the codes for primary pacemaker, primary ICD, pacemaker removal and ICD removal. Patient comorbidities and the national incidence for pacemakers and ICDs were evaluated.

A total of 3.2 million patients received pacemakers and 1.1 million received ICDs from 1993 to 2008, and a total of 73,000 of them were diagnosed with infection (1.88% for pacemakers and 1.13% for ICDs). A 224% increase in the infection rate was reported in pacemaker patients from 1993 (1.6%) to 2008 (3.5%), while ICD infection rates remained constant over time. The incidence of infection was also 75% higher in patients with pacemakers vs. those with ICDs (P<.001). The incidence in infection rose in ICD patients with HF (OR=1.28), renal failure (OR=2.18) and respiratory failure (OR=1.30), while pacemaker infection rose in patients with diabetes (OR=1.12), HF (OR=1.46), renal failure (OR=2.38) and respiratory failure (OR=2.25).

The researchers also noted that in 2008, over 32% of patients with infected ICDs or pacemakers were diagnosed with renal failure, which was an increase from 1993.

“The dimensions of the national cardiac implantable electronic device infection burden are changing due to the increasing prevalence of comorbidities, particularly renal failure,” the researchers concluded in their abstract. “Strategies for decreasing cardiac implantable electronic device infection should include a better understanding of periprocedural risk factors.”
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Primary prevention ICD yielded higher overall mortality in women than men

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO — Women who received an implantable cardioverter defibrillator for primary prevention of sudden death experienced a similar arrhythmic death rate but a mortality rate nearly 10% higher than in men, according to findings presented at the Heart Rhythm Society’s 32nd Annual Scientific Sessions.

Data on the survival benefit of ICD for women with cardiomyopathy to prevent sudden death are unclear. The current retrospective analysis measured the effect of gender on the appropriate use of ICD therapy and associated mortality rates in 525 consecutive patients. Eligible patients had ischemic or nonischemic cardiomyopathy and had undergone ICD implantation for primary prevention of sudden death.

Overall, there were 160 deaths. The mortality rate was 38.9% among 121 women and 30% among 404 men.

Appropriate ICD therapies were administered to 14.9% of women and 17.1% of men. Four-year survival rates were different between the groups (P=.039), but there was no difference in the rate of appropriate ICD therapy, according to results of a Kaplan-Meier analysis.

Mortality was the primary endpoint, along with appropriate ICD therapy at the 4-year mark. The mean duration of follow-up was 3.8 years.

The researchers assessed demographic information and data for comorbid illnesses and medications for all patients. The 121 women in the study accounted for 23.1% of the population and had similar baseline characteristics as men. Women were aged 61 years and men were aged 62.5 years. Women also had similar ejection fraction (25%) and comorbidities and medication use as men.

Regarding baseline characteristics that were not similar, 81% of men were white vs. 63% of women (P<.001). The tobacco use rate was 63% among men and 43% among women (P<.001). Fifty percent of men had undergone prior coronary bypass surgery vs. 26% of the women (P<.001).

“Women who received an ICD for prevention of [sudden death] had a similar arrhythmic event rate as men,” the researchers wrote. “However, the impact of primary prevention ICD therapy is attenuated by increased mortality rate in female patients.”
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SCD-HeFT: Frequency of non-sustained ventricular tachycardia associated with mortality

Heart Rhythm Society 32nd Annual Scientific Sessions

SAN FRANCISCO — The number of non-sustained ventricular tachycardia episodes that patients with HF experience is linked with mortality, results from a study presented at the Heart Rhythm Society’s 32nd Annual Scientific Sessions indicated.

Researchers for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) enrolled 2,521 patients with NYHA Class II or III HF and with an ejection fraction of at least 35%, of whom 2,040 had readable 24-hour Holter monitoring data. Holter monitoring data were obtained 2 weeks before randomization to placebo, amiodarone or an implantable cardioverter defibrillator. The researchers evaluated the Holter data and characterized non-sustained (≥3 beats in <30 seconds) ventricular tachycardia (NSVT), identifying it as at least 120 beats/minute. Holter staff and physician readers were blinded to clinical parameters, randomization and status outcomes. Cox regression models were used to identify prognostic baseline covariates such as age, ejection fraction and NYHA Class.

According to the researchers, no NSVT was observed in 1,367 (67%) patients on baseline monitoring; at least one 1 episode was seen in 673 (33%) patients; at least two episodes were seen in 402 (20%) patients; and at least three episodes in 291 patients (14%). The mean NSVT rate was 155 beats/minute, with a mean duration of 4.5 beats. They determined that at least two NSVT episodes were predictive of overall mortality.

“The presence of only one episode of NSTV on the baseline Holter monitoring did not confer an increase in overall mortality, whereas >2 NSVT episodes did confer increased overall mortality compared to less frequent NSVT episodes,” the researchers concluded in an abstract.

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Time of day of acute MI shown influential on infarct size
Suárez-Barrientos A. Heart. 2011;doi:10.1136/hrt.2010.212621. S

Researchers have found that the time of day of acute MI had a significant effect on infarct size in patients with STEMI, with 6 a.m. to noon associated with the largest infarct size.

All patients (n=811) in the study were admitted to the coronary care unit of Hospital Clínico San Carlos in Madrid, Spain, for STEMI between March 2003 and September 2009. Investigators split patients into one of four groups depending on occurrence of infarction — midnight to 6 a.m. (n=141), 6 a.m. to noon (n=269), noon to 6 p.m. (n=240) and 6 p.m. to midnight (n=161) — and estimated infarct size by peak enzyme release.

According to their results, there was a circadian variation in infarct size across time of day as determined by concentrations of troponin I (P=.012) and peak creatine kinase (P=.015). Similar curves were found with both biomarkers and showed a global maximum from the 6 a.m. to noon and a local minimum from noon to 6 p.m.

To further support this, researchers conducted additional analysis and found the largest infarct size in those who experienced STEMI during the dark-to-light transition period (6 a.m.-noon), as evidenced by increases in concentrations of peak troponin I of 24.6% (P=.033) and peak creatine kinase of 18.3% (P=.031) compared with the three other time periods.

“Overall, there is an expected increase of about 20% in infarct size in patients with STEMI onset in the dark-to-light transition period compared with any other time of day,” the researchers wrote, adding that these results “advocate the inclusion of ‘time of acute MI onset’ as an important variable in clinical trials testing novel cardioprotective strategies with MI size as an endpoint.” – by Brian Ellis

Circadian rhythms are biologic clocks that regulate body processes over a 24-hour cycle in response to daylight or darkness. In recent years light stimulated alterations in gene expression and protein translation have been identified that cause neurohumoral alterations highly relevant to human physiology and pathophysiology. Some of these are relevant to CVDs. These include circadian variations in proteins critical to fibrinolysis, regulation of BP and heart rate, and modulation of lipid and glycogen metabolism.

It has been known for many years that MIs are most common in the early morning hours. This is likely due to a predisposition due to circadian changes. Results of a recent study done in mice exposed to ischemia and reperfusion have supported the concept that myocardial infarct size may be dependent on time dependent light and darkness alterations.

Lawrence Horwitz, MD

The clinical study by Suarez-Barrientos et al in Heart this year retrospectively examines infarct size, estimated by cardiac enzyme levels, according to time-of-day in 811 patients, most of whom were treated with percutaneous coronary intervention. They concluded that the largest infarcts occurred between 6 AM and noon, which is often termed the “light-to-dark transition period.” There was a relatively small difference in infarct size between 6 a.m. to noon and 6 p.m. to midnight periods, but infarcts during the other two time periods were substantially less. There was some inconsistency between the estimates of infarct size and measurements of left ventricular ejection fraction among groups. These discrepancies; the many other factors that may influence infarct size; the limitations of the enzyme technique for estimating infarct size; and the relatively small population examined in this study limit the strength of its conclusions.

Nevertheless, it offers some support to the concept that in addition to the well-established circadian variation in the timing of MIs, there may be a similar variation in the severity of the infarctions. The existence of such variations raise the issue of whether preventive measures focused on the timing of neurohumoral changes could decrease incidence or improve outcomes of MIs. For example, could certain drugs be more effective given in the evening than in the morning, or could drugs that alter the photosensitivity of the biological clock decrease time-of-day dependent increases in the incidence or severity of MI?
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Low health literacy cause for concern among patients with HF
Peterson PN. JAMA. 2011;305:1695-1701.

Retrospective cohort study data have shown that among patients with HF, low health literacy correlated with a significantly higher risk for all-cause mortality. This, however, did not translate to an increased risk for hospitalization.

Pamela N. Peterson, MD, MSPH, and a group of researchers conducted the study by surveying outpatients with HF enrolled at Kaiser Permanente of Colorado. All patients (n=2,156) were diagnosed from 2001 to 2008 and were mailed a survey that consisted of three brief questions assessing health literacy skill, from which they were graded on a five-point scale.

Of those surveyed, 1,547 responded and 1,494 were included in the final analysis. Overall, 262 patients had low health literacy. Characteristics that identified patients as having low health literacy included old age, higher rates of coexisting illnesses and low socioeconomic status.

During the 1.2-year median follow-up, 124 deaths were reported, with a significantly higher rate found in the low health literacy group vs. the adequate health literacy group (17.6% vs. 6.3%; adjusted HR=1.97; 95% CI, 1.3-2.97). Despite this finding, rates of hospitalization were only modestly higher in the low literacy group and did not reach statistical significance (30.5% vs. 23.2%; adjusted HR=1.05, 95% CI, 0.8-1.37).

According to the researchers, the study’s finding “supports efforts to determine whether interventions to screen for and address low health literacy can improve important health outcomes in patients with HF.”

[Chevychelov]

HIV infection may elevate risk for HF
Butt A. Arch Intern Med. 2011;171:737-743.

Among more than 8,000 male veterans, HIV infection proved to be an important risk factor for HF, even after adjusting for traditional risk factors, according to a study appearing in the Archives of Internal Medicine.

In the study, researchers examined 8,486 participants (28.2% HIV-infected; median age, 48 years) who were enrolled in the Veterans Aging Cohort Study Virtual Cohort and the 1999 Large Health Study of Veteran Enrollees from January 2000 to July 2007. Participants were excluded if they were diagnosed with cancer, with the exception of non-melanoma skin cancer, or if they were female, due to the small number of women enrolled (n=276).

Adeel A. Butt, MD, MS

Over the study’s median follow-up of 7.3 years, 286 incident HF events were reported. After adjusting for age, race and ethnicity, the incidence of HF was 7.12 per 1,000 person-years among those infected with HIV and 4.82 per 1,000 person-years among those not infected. This led to a notably higher risk for HF among those with HIV infection (HR=1.81; 95% CI, 1.39-2.36), which remained similar among veterans who did not have a CHD event or alcohol dependency before the incident HF event.

Additionally, compared with HIV-uninfected participants, ongoing viral replication (HIV-1 RNA level ≥500 copies/mL) among those with HIV infection was linked with a higher risk for developing HF (HR=2.28; 95% CI, 1.57-3.32), whereas infected veterans with baseline and recent HIV-1 RNA level of less than 500 copies/mL did not have an increased risk for HF.

For future research, the study authors suggested that additional work be done to fully characterize the association between HIV infection and HF, and to understand the underlying mechanisms.
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Particle traps benefited CV health in men exposed to diesel exhaust
Lucking A. Circulation. 2011;123:1721-1728.

Exhaust particle traps, which are used to reduce particle emissions from diesel engines, are not only beneficial to the environment but may even confer a health benefit by reducing CV events among those exposed to the exhaust, a new study suggested.

“There is a robust and consistent association between air pollution and CV morbidity and mortality,” the researchers wrote. “Using complementary and relevant measures of CV health, we have reconfirmed the adverse effects of exposure to diesel engine exhaust on endothelial function and ex vivo thrombosis.”

The randomized, double blind study involved 19 healthy male volunteers (mean age, 25 years). Researchers used an exposure facility led by technical staff to expose participants for 1 hour to filtered air and diesel exhaust in either the presence or absence of a particle trap. Investigators then measured forearm blood flow and plasma fibrinolytic factors and assessed ex vivo thrombus formation.

They found that diesel exhaust compared with filtered air correlated with increased ex vivo thrombus formation and reduced vasodilatation under both low- and high-shear conditions. Overall, diesel exhaust particulate number and mass were substantially reduced with the particle trap (P<.001 for both), which resulted in reduced thrombus formation, increased vasodilatation and an increase in tissue-type plasminogen activator release.

This led the researchers to conclude by supporting the application of particle traps to diesel-powered vehicles for reducing urban particulate concentrations, as well as limiting a range of adverse CV effects related to exposure to traffic-derived air pollution.

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Treatment with angiotensin receptor blockers before stroke could exert a favourable effect in acute cerebral infarction
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Left atrial appendage closure with Amplatzer Cardiac Plug for prevention of stroke in atrial fibrillation: in-vivo imaging
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Community Stroke Prevention Programs: An Overview
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The Effect of Balance Training on Balance Performance in Individuals Poststroke: A Systematic Review
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Heterogeneity of the Phenotypic Definition of Coronary Artery Disease and Its Impact on Genetic Association Studies
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Short-term high-dose atorvastatin for periprocedural myocardial infarction prevention in patients with renal dysfunction
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