Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

Ghrelin levels may be a useful marker for BMI, diabetes in women

American Heart Association Scientific Sessions 2010

CHICAGO — Plasma ghrelin concentrations are inversely associated with BMI and negatively associated with the development of prevalent type 2 diabetes in women, new data suggest.

Researchers presented results of a study that examined 490 nondiabetic women included in the Women’s Health Study who later developed diabetes. The researchers also designated a representative subcohort of 561 women, also from the Women’s Health Study, as controls.

According to the results, there was an inverse relationship between plasma ghrelin levels and BMI in the representative subcohort and in the diabetes cohort across all quartiles of ghrelin levels (P<.0001 for all relationships). Ghrelin levels were also lower in women in the diabetes cohort vs. those in the subcohort (429.1 ng/dL vs. 579.3 ng/L; P<.001). In models adjusted for race and age, the researchers reported a decreasing risk of type 2 diabetes with increasing quartiles of ghrelin (P<.0001 for trend). This relationship persisted, albeit to slightly attenuated degree, in models that also adjusted for BMI and other traditional diabetes risk factors such as smoking, hypertension, cholesterol and hormone therapy (P=.01 for all trends).

“We confirm cross-sectional reports that ghrelin levels have an inverse relationship to BMI, and also have an inverse relationship with circulating leptin levels,” Jacqueline Danik, MD, of Brigham and Women’s Hospital in Boston, concluded in her presentation. “There appeared to be little relationship between ghrelin levels and calories consumed as measured by food frequency questionnaires.”

Danik added that their results suggested lower baseline ghrelin levels were negatively associated with the incident (or development of) type 2 diabetes, in concordance with previously published cross-sectional data. – by Eric Raible

For more information:
Danik J. Abstract 19867. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17, 2010; Chicago.
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Healthy lifestyle in young adulthood leads to low CVD risk profile later in life

American Heart Association Scientific Sessions 2010

CHICAGO — Maintaining a healthy lifestyle from young adulthood to middle age appears to play a significant role in achieving a low CVD risk profile in middle age, according to new research.

Researchers analyzed long-term follow-up of the Coronary Artery Risk Development in Young Adults (CARDIA) study to examine the effects of a healthy lifestyle started early in life. The multicenter, longitudinal study included 2,498 black and white participants who were aged 18 to 30 years at baseline in 1985. The researchers assessed five healthy lifestyle factors at baseline, year 7 and year 20:
Average BMI <25.
Alcohol intake less than 15 g per day for women or less than 30 g per day for men.
High consumption of potassium, calcium and fiber, and lower consumption of saturated fat.
Average physical activity score greater than the 60th percentile of the race- and sex-specific distribution.
Never smoking cigarettes.

After 20 years, more than 60% of people with all five healthy lifestyle factors from young adulthood to middle age had a low CVD risk profile as compared with less than 6% of people with none of the healthy lifestyle factors. The proportion of people with a low-risk CVD profile increases as the number of healthy lifestyle factors increases, the researchers concluded.

“To maximize the benefit of low CVD risk profile in middle age and older adults, more emphasis should be devoted to encourage a healthy lifestyle starting from young adulthood,” the researchers wrote in the study.

For more information:
Liu K. Abstract 12250. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.

[Chevychelov]

Low vitamin D levels not useful as predictive risk marker for mortality

American Heart Association Scientific Sessions 2010

CHICAGO — Low levels of vitamin D were not predictive of increased all-cause mortality or for CVD mortality among participants in the Women’s Health Initiative, results from a study suggested.

Researchers for the study enrolled participants in the Women’s Health Initiative (WHI) recruited from 40 centers between 1993 and 1998. The analytic cohort included 2,429 postmenopausal women with 25(OH) vitamin D levels ascertained in the WHI. Mortality was assessed at annual and semi-annual follow-up, and was collected through a number of methods, including a review of the National Death Index and self-reporting by family members, as well as adjudication of hospitalizations, ED visits, autopsy and coroner’s reports. For the purposes of the study, CVD mortality included coronary disease, cerebrovascular disease, pulmonary embolism, HF and other CV causes. Serum 25(OH) vitamin D was assessed using an immunoassay.

Participants were divided into quartiles of seasonal-adjusted vitamin D to account for differences in sun exposure from season to season, with quartile 1 having the lowest levels of vitamin D and quartile 4 having the highest levels.

According to the study results, there was an approximately 62% increased risk for all-cause mortality from the lowest quartile compared with the highest quartile (HR=1.62; 95% CI, 1.11-2.36), but the relationship did not attain statistical significance when adjusting for confounding variables such as age, ethnicity, hypertension, smoking, CVD, diabetes and others (HR=1.27; 95% CI, 0.81-1.99). For CV mortality, the same relationship was observed between the lowest and highest quartiles prior to adjustment (HR=1.92; 95% CI, 1.03-3.58), but also was not statistically significant after adjusting for confounding variables (HR=1.30; 95% CI, 0.83-2.03).

Limitations of the study included potential misclassification of cause-specific mortality, non-random sampling, unmeasured confounding bias and possible misclassification of 25(OH) vitamin D exposure.

“Low vitamin D levels are not an independent prospective risk marker for increased all-cause, CVD or cancer mortality in the WHI,” Charles B. Eaton, MD, of Brown University in Pawtucket, RI, said in a presentation. “Waist circumference appears to be an important confounding factor and shows effect modification of the relationship of vitamin D and all-cause mortality.” – by Eric Raible
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Nontraditional CV risk factors common in overweight black youth

American Heart Association Scientific Sessions 2010

CHICAGO — Unconventional risk factors may point to the development of CVD in overweight and obese black adolescents, researchers found in a new study.

“Childhood obesity is linked to the development of CVD and death in adulthood,” Patricia A. Cowan, PhD, associate professor in the College of Nursing at University of Tennessee Health Science Center, and colleagues said. “However, black youth are not routinely assessed for CV risk factors.”

In an effort to determine the number of cardiac risk factors in a population of 122 black adolescents (average age, 15 years), the researchers focused on the roles of severe obesity, insulin resistance, family history of MI, and diet and physical activity in CVD development.

Cowan presented their results at the American Heart Association Scientific Sessions 2010.

Data suggest that the average number of risk factors that were predictive of CVD in overweight and obese black adolescents was four, although 36% of the cohort had at least five. Common risk factors included hypertension, observed in 55% of the children, and low LDL, observed in 47.5%. Risk factors for inflammation and clots, which are not routinely checked in this age group, were detected in more than 50%.

The number of risk factors appeared dependent on age, pubertal status, family history of MI, severity of obesity and insulin resistance. The researchers noted that the children’s high fat intake and low exercise levels may have prevented diet and physical activity from being predictors.

Results indicated that younger children who are at an earlier pubertal stage are likely to have more CVD risk factors, as are severely obese children and those with greater insulin resistance. A positive family history of MI may also increase the number of risk factors.

“Doctors should assess youth for insulin resistance, family history of early heart attack and use blood pressure percentile charts to determine hypertension,” the researchers said. “Incorporating screenings for inflammation and thrombosis will aid in risk stratification and earlier intervention.”

For more information:
Cowan PA. Abstract 17353. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17, 2010; Chicago.

[Chevychelov]

Propoxyphene withdrawn due to risk for cardiac toxicity

The FDA has notified health care professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene from the US market after new data have suggested that the drug may cause serious toxicity to the heart, even at therapeutic doses.

Propoxyphene, an opioid pain reliever for the treatment of mild to moderate pain and sold as Darvon, Darvocet and generics, was shown in a recent study to increase the risk for serious abnormal heart rhythms that may lead to death. The drug, which was first approved by the FDA in 1957, had received two requests to be removed from the market since 1978, but until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks.

“These new heart data significantly alter propoxyphene’s risk-benefit profile,” John Jenkins, MD, director, Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research, said in a press release. “The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

According to the release, the FDA recommends that health care professionals stop prescribing and dispensing propoxyphene-containing products; contact and request patients currently taking propoxyphene-containing products to discontinue use of the drug; inform patients of the risks associated with propoxyphene; and discuss alternative pain-management strategies.
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Cardiac troponin T levels associated with HF, CV mortality in older patients
deFilippi CR. JAMA. 2010;doi:10.1001/jama.2010.1708.

Cardiac troponin T levels at baseline, as well as subsequent changes to levels, may predict patients at an increased risk for incident HF and CV mortality, data from a study published in the Journal of the American Medical Association involving a cohort of older patients revealed.

“Elderly individuals comprise the largest subgroup of patients hospitalized for HF, accounting for 80% of the more than 1.1 million US admissions per year,” the researchers said in their study. “Blood-based biomarkers, including CRP, natriuretic peptides and troponins, have been advocated as adjuncts to clinical risk factors to identify community-dwelling older patients at high risk for adverse CV outcomes, but studies examining the additive prognostic value of these markers have reported inconsistent results.”

This led the Maryland- and Texas-based researchers to conduct a longitudinal nationwide cohort study of 4,221 community-dwelling adults of at least 65 years of age without prior HF. They measured cardiac troponin T (cTnT) levels with a highly sensitive assay (Elecsys 2010, Roche Diagnostics) at baseline and repeated between 2 to 3 years later in 2,918 patients.

Levels of cTnT of at least 3 pg/mL were detected in 2,794 patients (66.2%). During a median follow-up of 11.8 years, researchers reported new-onset HF in 1,279 patients and 1,103 CV deaths. Highest cTnT concentrations (>12.94 pg/mL) when compared with undetectable concentrations produced an incident rate per 100 person-years of 6.4 (95% CI, 5.8-7.2; adjusted HR=2.48; 95% CI, 2.04-3.00) for HF and 4.8 (95% CI, 4.3-5.4; adjusted HR=2.91; 95% CI, 2.37-3.58) for CV death.

Further analysis revealed that in patients with initially detectable cTnT, a subsequent increase of more than 50% (n=393, 22%) was associated with a greater risk for HF (adjusted HR=1.61; 95% CI, 1.32-1.97) and CV death (adjusted HR=1.65; 95% CI, 1.35-2.03), whereas a decrease of more than 50% (n=247, 14%) was associated with a lower risk for HF (adjusted HR=0.73; 95% CI, 0.54-0.97) and CV death (adjusted HR=0.71; 95% CI, 0.52-0.97) vs. individuals with a 50% or less change.

Among the study’s limitations were the possibility that the increase in use of medications such as statins over the long follow-up time blunted the predictive value of cTnT, as well as the possibility of unmeasured and residual confounding to have influenced the results.

“Detectable cTnT levels as measured by a highly sensitive assay were present in the majority of community-dwelling older adults in this cohort, and higher concentrations — within a normal range established for a younger general population — reflect a greater burden of CV risk factors and imaging evidence of cardiac disease,” the researchers concluded. “Independent of these comorbidities, cTnT concentrations were associated with risk of new-onset HF and CV death.”

Furthermore, they said, longitudinal changes in cTnT concentrations were common in this cohort and correspond with a dynamic change in risk over time.

[Chevychelov]

Telmisartan improved outcome in patients with hemodialysis, chronic HF
Cice G. J Am Coll Cardiol. 2010;56:1701-1708.

All-cause and CV mortality, as well as HF-associated hospital stays, were significantly lower in patients with hemodialysis and chronic HF who were treated with telmisartan, new data suggested.

“To the best of our knowledge, our results are the first to provide evidence that the addition of an [angiotensin II type 1 receptor blocker], namely telmisartan, to regimens, including various combination of ACE inhibitor, digitalis, and beta-blockers, is feasible and beneficial in end-stage renal disease patients with chronic HF receiving dialysis treatment,” the researchers wrote.

The 3-year, randomized, double blind, placebo-controlled, multicenter trial was performed in 30 Italian clinics featuring hemodialysis patients with chronic HF (NYHA Class II to III; left ventricular ejection fraction ≤40%). Besides ACE inhibitor therapy, patients were randomly assigned telmisartan (Micardis, Boehringer Ingelheim; n=165; target dose, 80 mg) or placebo (n=167).

During a mean follow-up of 35.5 ± 8.5 months, researchers reported a significant reduction for all three primary endpoints in patients taking telmisartan vs. placebo: all-cause mortality (35.1% vs. 54.4%; P<.001), CV death (30.3% vs. 43.7%; P<.001) and hospital admission for chronic HF (33.9% vs. 55.1%; P<.0001).

Additionally, Cox proportional hazards analysis revealed telmisartan to be an independent determinant of all-cause mortality (HR=0.51; 95% CI, 0.32-0.82), CV mortality (HR=0.42; 95% CI, 0.38-0.61) and hospital stay for chronic HF decompensation (HR=0.38; 95% CI, 0.19-0.51).

Such beneficial effects of telmisartan as seen in the trial, the researchers noted, “were evident within 6 months from the beginning of the treatment and persisted for the entire treatment period. … Although further larger trials in hemodialyzed patients with [chronic] HF are desirable, our experience could offer clinicians an opportunity to make additional improvements in the poor prognosis of end-stage renal disease patients with chronic HF.”

“Although the power calculations in the present study showed 90% power, this was to detect a 50% hazard reduction in death, not a commonly seen magnitude of benefit with most agents in any clinical trial setting,” Ilke Sipahi, MD, and James C. Fang, MD, of the Harrington-McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, wrote in an accompanying editorial. “Given this aggressive target of event-reduction benefit and a modest total number of patients (which is comparable to a ‘pilot’ trial), it is not clear whether this trial provides enough power to be definitive.”

Despite this, the findings are important and should lead to further investigation. However, “For now, clinicians should carefully evaluate the choice of agents in the treatment of HF when it complicates dialysis and make sure that drugs that antagonize both the [renin-angiotensin system] and adrenergic axes are considered,” Sipahi and Fang said.
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AMA adopts policy for physicians’ professional use of social media

The American Medical Association recently adopted a new social media policy that will help physicians better use social networking sites in developing relationships with patients.

The policy will guide physicians in maintaining a positive online presence and preserving the integrity of the patient-physician relationship when using these sites as a means of professional communication, according to an AMA press release.

“Using social media can help physicians create a professional presence online, express their personal views and foster relationships, but it can also create new challenges for the patient-physician relationship,” Mary Anne McCaffree, MD, an AMA board member, stated in the release. “The AMA’s new policy outlines a number of considerations physicians should weigh when building or maintaining a presence online.”

The policy encourages physicians to take the following steps:
use privacy settings to safeguard personal information and content to the fullest extent on social networking sites;
routinely monitor their Internet presence to ensure that the personal and professional information on their personal sites and content about them posted by others is accurate and appropriate;
maintain appropriate patient-physician relationship boundaries when interacting or consulting with patients online, while ensuring that patient privacy and confidentiality is maintained;
consider separating personal content from professional content online; and
recognize that actions online and posted content can negatively affect their reputations among patients and colleagues and may have consequences for their careers.

[Chevychelov]

Multiple MPI testing common, associated with high cumulative doses of radiation in patients
Einstein AJ. JAMA. 2010;304:2137-2144.

A retrospective cohort study of more than 1,000 patients has indicated that patients undergoing multiple myocardial perfusion imaging is common and is linked with high levels of cumulative estimated doses of radiation.

The New York-based researchers analyzed 1,097 consecutive patients who underwent index myocardial perfusion imaging (MPI) during the first 100 days of 2006 at Columbia University Medical Center. The main outcome measures were cumulative effective dose of radiation, indications for testing and number of procedures involving radiation.

Overall, the median number of procedures involving radiation in patients was 15 (interquartile range [IQR], 6-32), with a median of four (IQR, 2-8) being characterized as high-dose procedures of at least 3 mSv. Physicians performed multiple MPIs in 424 patients (38.6%), who had a cumulative estimated effective dose of 121 mSv (IQR, 81-189 mSv).

“We observed multiple testing with MPI to be common and in many patients to be associated with very high cumulative estimated doses of radiation,” the researchers wrote in their concluding statement. “Efforts are needed to decrease this high cumulative dose and its potential attendant risks.”
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Noninvasive 3.0-T MRI depicted coronary artery endothelial function
Hays A. J Am Coll Cardiol. 2010;56:1657-1665.

Researchers using 3.0-T MRI were able to noninvasively detect coronary artery area and blood flow in patients with and without coronary artery disease, according to recent findings.

“Abnormal endothelial function mediates the initiation and progression of atherosclerosis and predicts CV events. However, direct measures of coronary endothelial function have required invasive assessment,” the researchers wrote in their study.

This led them to test noninvasive 3.0-T MRI scanners in 20 healthy adults and 17 patients with CAD. The researchers measured cross-sectional coronary area and blood flow before and during isometric handgrip exercise.

MRI data from the healthy patients revealed a dilation of coronary arteries as a result of stress (P<.0001), whereas coronary artery area decreased with stress in patients with CAD (P≤.02), with both groups returning to baseline within 3 minutes of recovery. Similarly, among healthy patients, coronary blood flow increased notably with isometric handgrip (P<.0001), whereas blood flow decreased in patients with CAD (P=.01).

“The present study demonstrates that high-resolution MRI using commercial hardware and software, combined with isometric handgrip stress, provides a powerful new approach to the noninvasive assessment of endothelial-dependent coronary vasoreactivity,” the researchers said. “This approach will permit, for the first time, the direct evaluation of coronary endothelial function in low-risk populations, as well as repeated studies in patients over time.”

[Chevychelov]

Incidental findings prevalence varied by imaging modality and other factors
Orme N. Arch Intern Med. 2010;170:1525-1532.

New study data appearing in the Archives of Internal Medicine has indicated that the frequency of incidental findings varies significantly as a result of imaging modality, body region and age.

In this study, researchers analyzed medical records of patients undergoing a research imaging examination from January to March 2004 and whose results were interpreted by a radiologist. They estimated the frequency of incidental findings that generated further clinical action by modality, age, sex and body part, along with net medical benefit or burden.

During the 3-year follow-up, 567 of the 1,426 research imaging examinations (39.8%) had at least one incidental finding. Age significantly increased the risk of an incidental finding (per decade increase, OR=1.5; 95% CI, 1.4-1.7). Abdominopelvic CT (OR=18.9; 95% CI, 9.3-38.5) generated more incidental findings than thorax (OR=11.9; 95% CI, 6.1-23.3) and all other examinations (OR=5.8; 95% CI, 2.3-15.1) compared with ultrasonography. Additionally, MRIs of the head (OR=5.9; 95% CI, 2.9-11.7) and all other body parts (OR=3.0; 95% CI, 1.3-6.9) produced notably higher incidental findings than ultrasonography.

"This study demonstrates that research imaging incidental findings are common in certain types of imaging examinations, potentially offering an early opportunity to diagnose asymptomatic life-threatening disease, as well as a potential invitation to invasive, costly and, ultimately, unnecessary interventions for benign processes," the researchers commented in their study. "Timely, routine evaluation of research images by radiologists can result in identification of incidental findings in a substantial number of cases that can result in significant medical benefit to a small number of patients."

Bernard Lo, MD, with the program of medical ethics, University of California, San Francisco, wrote in an accompanying editorial that although incidental findings are common in research, researchers must develop a comprehensive plan for how they will respond to them, "including what findings they will offer to disclose to participants," he said. "The possibility of incidental findings, and their ramifications, should be part of the informed-consent process. The work by Orme et al helps us start to quantify their impact."

[Chevychelov]

Researchers find link between familial and new-onset AF
Lubitz S. JAMA. 2010;doi:10.1001/jama.2010.1690.

New-onset atrial fibrillation was found to be most common among those with familial atrial fibrillation when compared with those without familial atrial fibrillation, an association not attenuated by adjustment for atrial fibrillation risk factors, according to study data.

“We report an association between the occurrence of AF in a first-degree relative and risk of new-onset AF in 4,421 individuals of European descent,” the researchers commented in their study, adding that the findings support and extend previous reports of AF heritability.

The study included participants from the Framingham Heart Study who were at least 30 years of age, free of AF at baseline examination and had at least one parent or sibling enrolled in the study. Researchers followed up with the final study group (n=4,421; mean age, 54 years; 54% women) through 2007.

After 11,971 examinations, researchers reported familial AF in 1,185 participants (26.8%), with premature familial AF occurring in 351 cases (7.9%). Those with familial AF had a more common occurrence of AF than those without (5.8% vs. 3.1%), which was not attenuated, even after adjustment for AF risk factors (multivariable-adjusted HR=1.40; 95% CI, 1.13-1.74) or reported AF-related genetic variants.

Further data indicated that among the different features of familial AF examined, premature familial AF was associated with the greatest improved discrimination beyond traditional risk factors (P=.004).

As recommendations for additional research, the study investigators wrote, “Future efforts should attempt to discern the factors that mediate the association between familial AF and AF risk, further explore the relationships between premature familial AF and risk prediction, and determine whether incorporating genetic variants into an AF prediction model enhances its performance.”
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AEDs did not improve survival among hospitalized patients with cardiac arrest
Chan P. JAMA. 2010;304:2129-2136.

Patients hospitalized for cardiac arrest experienced no improvement in survival with the use of automated external defibrillators and, in some cases, had lower rates of survival when compared with those who were not treated with the device.

The study, published in the Journal of the American Medical Association, featured 11,695 patients, 9,616 (82.2%) with non-shockable rhythms such as asystole and pulseless electrical activity, and 2,079 (17.8%) with shockable rhythms, including ventricular fibrillation and pulseless ventricular tachycardia.

Of the study population, AEDs were used in 4,515 patients (38.6%), with 2,117 (18.1%) surviving to hospital discharge. Researchers reported AED use was significantly associated with a lower rate of survival after in-hospital cardiac arrest vs. no AED use (16.3% vs. 19.3%; adjusted rate ratio=0.85; 95% CI, 0.78-0.92).

Further, AED use among cardiac arrests due to non-shockable rhythms was associated with lower survival (10.4% vs. 15.4%; adjusted rate ratio=0.74; 95% CI, 0.65-0.83), whereas AED use for cardiac arrests due to shockable rhythms was not associated with survival (38.4% vs. 39.8%; adjusted rate ratio=1.00; 95% CI, 0.88-1.13).

“We found that use of AEDs among hospitalized patients with cardiac arrests was not associated with improved survival,” the researchers wrote. “While randomized controlled trials are needed to confirm these findings, current use of AEDs in hospitalized patients may warrant reconsideration.”

This is an interesting study that shows how a seemingly good idea can have unexpected negative consequences. In the in-hospital setting, delay to defibrillation is not, or should not be, nearly as great a problem as it is in the out-of-hospital setting. Out-of-hospital, highly trained rescuers must be called to the scene from a distance. The AED greatly increases the pool of potential rescuers and that's why they are effective in that setting. In-hospital, trained rescuers should be readily available. The time advantage gained by having an AED available is probably measured in seconds not minutes. Therefore, the gain that's accrued in ventricular tachycardia/ventricular fibrillation cases is small. In contrast, the potential for delays or interruptions in providing recommended therapy for pulseless electrical activity cases or other types of bradyasystolic arrests seems to have deleterious effects and negates any chance for overall benefit.

[Chevychelov]

Resistance exercise vs. aerobic exercise increased blood flow to limbs
Collier S. J Strength Cond Res. 2010;24:2846-2852.

Young, healthy normotensive men who had an acute bout of resistance exercise were shown to have increased blood flow to limbs despite increasing central arterial stiffness, whereas those after aerobic exercise had increased central arterial dispensability but no increase in blood flow, according to study results.

The study included 10 healthy, moderately active men aged 21 to 29 years, who were normotensive, nonobese and free from any known CV or metabolic disease. Researchers assessed forearm blood flow during reactive hyperemia before and 60 minutes after exercise, whereas aortic and femoral pulse wave velocity was measured as an index of arterial stiffness before, 40 and 60 minutes after an acute bout of aerobic and resistance exercise.

Central pulse wave velocity decreased 8% after aerobic exercise and remained at this level through 60 minutes, whereas resistance exercise increased central pulse wave velocity 9.8% from before exercise to 60 minutes after exercise. Area under the curve for forearm blood flow-reactive hyperemia significantly increased 38% after resistance exercise, but no significant change was reported after aerobic exercise. Additionally, forearm vasodilatory capacity increased after resistance exercise but not after aerobic exercise.

These findings, the researchers wrote, suggest “that [resistance exercise] may produce compensatory peripheral vascular effects, offsetting the increase in central arterial stiffness, while keeping BP fairly constant after an acute exercise bout. Future studies that measure endothelial function specifically may provide further evidence to suggest whether mechanisms responsible for enhanced blood flow are either a transient compensatory response to arterial stiffness or an increase in signaling of endothelium-dependent dilators after acute [resistance exercise].”
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Survival after CRT-D, ICD implantation comparable outside vs. inside clinical trial setting
Saxon L. Circulation. 2010;doi:10.1161/CIRCULATIONAHA.110.960633.

Patients treated with implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators in a naturalistic practice had a favorable survival rate compared with patients from clinical trials, according to new data published in Circulation.

Researchers compared the outcomes of patients in device clinic settings (total n=124,450; ICD and cardiac resynchronization therapy defibrillators [CRT-D], n=116,222; CRT-D only, n=8,228) with those who regularly transmitted remote data from the device an average of four times monthly (n=69,556). Mean patient age was 67 ± 13 years, and device implantation was followed for an average of 28 ± 17 months.

Overall, 1- and 5-year survival rates were 92% and 68% in the ICD implantation arm, and 88% and 54% in the CRT-D device arm, with a survival rate for patients with CRT-only of 82% at 1 year and 48% at 5 years.

For patients treated with ICD and CRT-D who received remote follow-up on the network, 1- and 5-year survival rates were higher vs. those treated with ICD and CRT-D who received device follow-up in device clinics only (ICD HR=0.56; CRT-D HR=0.45; P<.0001).

“This is the largest report to date on survival after device implantation and finds that survival benefits observed over shorter follow-up intervals in clinical trials are maintained,” the researchers wrote in their study. “This information is particularly important because there are upfront risks and costs associated with device implantation.”

[Chevychelov]

Response to Preventive Cardiac Resynchronization Therapy in Patients With Ischaemic and Nonischaemic Cardiomyopathy in MADIT-CRT
Barsheshet A, Goldenberg I, Moss AJ, et al.
Eur Heart J 2010 Nov 12:[Epub ahead of print].
Study Question: Do outcomes differ between patients with mildly symptomatic ischemic versus nonischemic cardiomyopathy following cardiac resynchronization with defibrillator therapy (CRT-D) versus implantable cardioverter-defibrillator (ICD) therapy alone?

Timing of Pre-Operative Beta-Blocker Treatment in Vascular Surgery Patients: Influence on Post-Operative Outcome
Flu WJ, Van Kuijk JP, Chonchol M, et al.
J Am Coll Cardiol 2010;56:1922-1929.
Study Question: What is the optimal time for initiation of preoperative beta-blocker therapy?

Clopidogrel Responsiveness Regardless of the Discontinuation Date Predicts Increased Blood Loss and Transfusion Requirement After Off-Pump Coronary Artery Bypass Graft Surgery
Kwak YL, Kim JC, Choi YS,Yoo KJ, Song Y, Shim JK.
J Am Coll Cardiol 2010;1994-2002.
Study Question: What is the association of platelet inhibition, as assessed by modified thromboelastography, with bleeding and transfusion requirement after off-pump coronary artery bypass graft (OPCABG) surgery?

Gender Differences in the Implementation of Cardiovascular Prevention Measures After an Acute Coronary Event
Dallongevillle J, De Bacquer D, Heidrich J, et al., on behalf of the EUROASPIRE Study Group.
Heart 2010;96:1744-1749.
Study Question: Do women receive similar risk factor management after a coronary event as men?
Eplerenone in Patients With Systolic Heart Failure and Mild Symptoms
Zannad F, McMurry JJ, Krum H, et al., on behalf of the EMPHASIS-HF Study Group.
N Engl J Med 2010;Nov 15:[Epub ahead of print].
Study Question: Does eplerenone impact outcomes in patients with systolic heart failure (HF) and mild symptoms?

Safety and Efficacy of Long-Term Statin Treatment for Cardiovascular Events in Patients With Coronary Heart Disease and Abnormal Liver Tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: A Post-Hoc Analysis
Athyros VG, Tziomalos K, Gossios TD, et al., on behalf of the GREACE Study Collaborative Group.
Lancet 2010;Nov 24:[Epub ahead of print].
Study Question: Is statin therapy safe and effective in coronary heart disease (CHD) patients who have abnormal liver function tests?

In-Center Hemodialysis Six Times per Week Versus Three Times per Week
The FHN Trial Group.
N Engl J Med 2010;Nov 20:[Epub ahead of print].
Study Question: What is the impact of increasing the frequency of hemodialysis in patients undergoing maintenance hemodialysis?

Effect of Celiprolol on Prevention of Cardiovascular Events in Vascular Ehlers-Danlos Syndrome: A Prospective Randomised, Open, Blinded-Endpoints Trial
Ong KT, Perdu J, De Backer J, et al.
Lancet 2010;376:1476-1484.
Study Question: What is the impact of celiprolol, (a β-1 receptor antagonist and a β2 receptor agonist) on the incidence of arterial dissections and ruptures in vascular Ehlers-Danlos syndrome?

Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade
Nicholson W, Nicholson WJ, Tolerico P, et al.
Arch Intern Med 2010;170:1827-1831.
Study Question: What is the prevalence of fracture and embolization of the Bard Recovery and Bard G2 inferior vena cava (IVC) filters?

National Estimates of Emergency Department Visits for Hemorrhage-Related Adverse Events From Clopidogrel Plus Aspirin and From Warfarin
Shehab N, Sperling LS, Kegler SR, Budnitz DS.
Arch Intern Med 2010;170:1926-1933
Study Question: What is the frequency and nature of emergency department (ED) visits arising from hemorrhages related to use of dual antiplatelet therapy (DAT)?

Trends in Door-to-Balloon Time and Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Flynn A, Moscucci M, Share D, et al.
Arch Intern Med 2010;170:1842-1849.
Study Question: What is the effect of a decline in door-to-balloon (DTB) time in patients with ST-elevation myocardial infarction (STEMI) on clinical outcomes?

ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate Use Criteria for Echocardiography: A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Society of Echocardiography, American Heart Association, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance
Douglas PS, Garcia MJ, Haines DE, et al.
J Am Coll Cardiol 2010;Nov 19:[Epub ahead of print].
Perspective: This Appropriate Use Criteria statement addresses appropriate indications for the use of transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and stress echocardiography.

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SPIRIT IV: Everolimus-eluting stent outperforms paclitaxel-eluting stent in patients without diabetes
Kereiakes D. J Am Coll Cardiol. 2010;56:2084-2089.

The latest results from the SPIRIT-IV trial have shown everolimus-eluting stents to produce superior clinical outcomes in patients without diabetes, despite both stents performing similarly in patients with diabetes.

“The SPIRIT IV trial confirms and extends the observation made in the SPIRIT III trial of a significant interaction between randomized stent type everolimus-eluting stent (Xience V, Abbott Vascular) vs. paclitaxel-eluting stent (Taxus Express, Boston Scientific) and the presence of diabetes on the primary composite safety-plus-efficacy clinical endpoint,” the researchers wrote.

The randomized, prospective, single blind study included 3,687 patients with up to three de novo native coronary artery lesions who received either an everolimus-eluting stent (n=2,458) or a paclitaxel-eluting stent (n=1,229). Clinical outcomes were analyzed in randomly assigned patients with (n=1,185) and without (n=2,498) diabetes.

One-year results indicated that among patients without diabetes, everolimus-eluting stent vs. paclitaxel-eluting stent reduced the primary endpoint of target lesion failure by 54% (3.1% vs. 6.7%; P<.0001) and major adverse CV events by 52% (3.2% vs. 6.7%; P<.0001). Use of everolimus-eluting stent also resulted in lower rates of the major secondary endpoints of ischemia-driven target vessel revascularization, as well as the composite occurrence of cardiac death or target vessel MI (P=.05).

However, among patients with diabetes, there were no statistically significant differences in outcomes at 1 year between randomly assigned stent types for both target lesion failure and major adverse CV events.

“These findings suggest the need for further studies to elucidate the mechanistic pathways underlying the poor prognosis of patients with diabetes mellitus, with a focus toward development of novel drugs and stents to improve outcomes in this high-risk patient cohort,” the researchers wrote.
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Lap-Band safe and effective in less obese, FDA advisors vote

An FDA Gastroenterology and Urology Devices Advisory Panel backed the use of the Lap-Band Adjustable Gastric Banding system in obese people with a BMI as low as 30.

The 10-person panel voted 8-2 that the Lap-Band is safe for reducing weight in obese patients with a BMI of at least 35 or at least 30 with one or more comorbid conditions. In a similar vote of 8-1 with one abstention, the panel concluded that the device is effective in this patient population.

The panel convened to discuss device marker Allergan's proposed modified indication for patients who are less obese than for those the device is currently indicated. The FDA first approved the Lap-Band in 2001, and is currently indicated for patients with severe obesity, defined as a BMI of at least 40 or at least 30 plus severe cormobidities, or for those who are 100 lb heavier than their estimated ideal weight. Approved persons have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and modification programs.

In a third vote, eight panelists determined that the benefits of the Lap-Band for the stated indication outweigh the risks for purposes of approval.

"This is not a new device; it has been around, [but] in a slightly different population," Jon C. Gould, MD, associate professor, department of surgery, University of Wisconsin School of Medicine and Public Health, said of his vote yes. "Although the current study is small, there is reasonable assurance that this is an acceptable change."

Allergan presented and the FDA reviewed results of a study showing that 81% of 149 obese people with a BMI of at least 35 or at least 30 plus comorbid conditions lost at least 30% of their excess weight, the study's primary endpoint. In addition, there were no unexpected adverse complications, and serious adverse events were rare.

Dissenting voters expressed concern about the length of the study.

"I don't think that a 1-year, 150-patient study should be anywhere near satisfactory for changing the standard of care in this field," Thomas H. Inge, MD, PhD, director of the Center for Bariatric Research and Innovation, Cincinnati Children's Hospital Medical Center, said during the meeting.

The high number of white women included in the study was another issue raised by the panel; nonwhite men appear to be underrepresented in the data. The panel asked for additional data on men and other ethnic groups in addition to Caucasian.

"I do think that the sponsor should develop a registry where every patient who has a [Lap-Band] device is entered … I'd like to know what happens across the national [with this device], as we do with other operations," Walter J. Pories, MD, professor of surgery at East Carolina University, said. Pories voted in favor of the device for the proposed population.

While Steven D. Schwaitsberg, MD, chief of surgery at Cambridge Health Alliance, Boston, does not expect the experience in a less obese population will be "radically different" than what has already been implanted in the obese population, he said even 10 years' follow-up is not long enough for a "lifelong implantable device.

"We should start now, and these patients should all be followed for life," he said.

Jason T. Connor, PhD, a biostatistician at Berry Consulting, LLC, Orlando, FL, had a unique suggestion for follow-up: "We should ask patients at 5 years, 'Would you do this again?' That seems like great information for a surgeon to tell his or her patient."

If the proposed indication is approved by the FDA, guidelines for obesity surgery may need to be modified. Current guidelines from leading organizations generally recommend surgical intervention for obese people with a BMI greater than 35. In addition, all but two panelists felt that while BMI is a poor measure of who requires surgery for obesity, the data presented are sufficient to suggest that current guidelines need to change. This device could move forward lowering the threshold for BMI as an indication for the Lap-Band, chairperson Karen L. Woods, MD, clinical associate professor of medicine, Baylor College of Medicine, summarized.

Allergan estimates that more than 300,000 people worldwide have been given the Lap-Band. The surgery can cost $12,000 to $20,000.

While the FDA is not required to follow the recommendations of the advisory committee, it usually does.

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Fruit, vegetable consumption in childhood associated with adult pulse wave velocity
Aatola H. Circulation. 2010;122:2521-2528.

Low consumption of fruits and vegetable during one’s lifetime is related to arterial stiffness during young adulthood, according to researchers in Finland.

The association between childhood vegetable consumption and adulthood pulse wave velocity remained significant after adjustment for traditional risk factors, including HDL cholesterol, LDL cholesterol, triglycerides, systolic BP, BMI and smoking.

“Lifetime lifestyle risk factors, most specifically vegetable consumption, are associated with arterial stiffness measured by pulse wave velocity,” the researchers wrote. “The decrease in pulse wave velocity appears to be more pronounced if dietary habits remain favorable from childhood to adulthood. These findings highlight the importance of emphasizing dietary habits as early as in childhood in the primary prevention of cardiovascular disease.”

The researchers studied 1,622 adults who were aged 3 to 18 years when they enrolled in the Cardiovascular Risk in Young Finns Study in 1980. The participants were followed for 27 years, and they had lifestyle risk factor data available since their enrollment. In 2007, arterial pulse wave velocity was measured.

Vegetable consumption in childhood was inversely related to pulse wave velocity, although the association was lower in females. Fruit consumption, butter use, smoking and physical activity index were not associated with pulse wave velocity in childhood. Adulthood vegetable and fruit consumption were significantly related to pulse wave velocity. There was no significant association between alcohol consumption, smoking or physical activity with pulse wave velocity.

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RESTOR-MV: Patients with functional mitral regurgitation benefited with ventricular shaping
Grossi EA. J Am Coll Cardiol. 2010;56:1984-1993.

Ventricular shaping compared with standard surgery in patients with functional mitral regurgitation requiring revascularization improved survival and rates of major adverse outcomes, according to new data from RESTOR-MV.

The Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV) study was a randomized, prospective, multicenter study featuring 165 patients with functional mitral regurgitation and coronary disease. Patients treated with CABG and mitral repair were randomly assigned to receive either CABG plus mitral ring annuloplasty (control; n=75) or CABG plus Coapsys (Myocor Inc.; n=74), whereas patients receiving CABG alone were randomly assigned to either CABG plus Coapsys (n=8) or CABG alone (control; n=8). The study was terminated when the sponsor (Myocor) did not secure ongoing funding.

According to study data, patients treated with Coapsys had a greater decrease in left ventricular end-diastolic dimension (P=.021), as well as improved survival rating (87% vs. 77%; HR=0.421; 95% CI, 0.200-0.886), when compared with the control at 2 years. Mitral regurgitation grades were decreased at least two grades or was grade 1 or less in 92% of the control arm vs. 66.7% in the treatment arm (P=.02).

Additionally, rates of complication-free survival — which included death, MI, stroke and valve reoperation — at 2 years were higher in the Coapsys group (85% vs. 71%; HR=0.372; 95% CI, 0.185-0.749).

“On the basis of intention-to-treat analyses, the RESTOR-MV trial found that patients with [functional mitral regurgitation] who required revascularization and were treated with ventricular reshaping rather than the standard surgical approach had HRs of less than one-half for both mortality and major adverse outcomes,” Eugene A. Grossi, MD, and fellow researchers wrote of their study’s findings. “This unique approach to reshaping the left ventricle and treating the valve has effected a meaningful impact on the clinical outcomes of patients with [functional mitral regurgitation].”

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Researchers shed light on role of human cardiac stem cells in organ aging
Kajstura J. Circ Res. 2010;107:1374-1386.
Porrello E. Circ Res. 2010;107:1292-1294.

Myocardial aging in men and women may be associated with time-dependent increase of human cardiac stem cells and cardiomyocytes, new study data suggest.

In the study, researchers measured the interaction of myocyte replacement, cellular senescence, growth inhibition and apoptosis in human hearts of normal women (n=32) and men (n=42) who died from causes other than CVD between the ages of 19 and 104 years.

The researchers found that a progressive loss of telomeric DNA in human cardiac stem cells occurs with aging. “Although the pool of functionally competent [human cardiac stem cells] expands with time and generates a larger myocyte progeny, the newly formed cardiomyocytes inherit short telomeres and rapidly reach the senescent cell phenotype,” they wrote.

Also revealed in their findings was the larger pool of functionally competent human cardiac stem cells and younger myocytes present in the female heart when compared with the male myocardium, with the replicative potential being higher and telomeres longer in female human cardiac stem cells. Specifically, myocyte turnover was found to occur at an annual rate of 10% at 20 years of age, 14% at 60 years and 40% at 100 years in the female heart, whereas those same ages corresponded with a myocyte turnover of 7%, 12% and 32%, respectively, in men.

For the researchers, this documented that cardiomyogenesis involves a large and progressively increasing number of parenchymal cells with aging, and from 20 to 100 years of age, the myocyte compartment is replaced 15 times in women and 11 times in men.

Enzo R. Porrello, PhD, and Eric N. Olson, PhD, with the department of molecular biology, University of Texas Southwestern Medical Center, Dallas, wrote in an article accompanying the study that the findings will provoke interest and prompt reconsideration of the biological processes that contribute to cardiac senescence.

“Although the present study by Kajstura et al is unlikely to completely resolve ongoing debates regarding the degree of myocyte repopulation in the human heart, this study provides some fascinating clues that point toward a previously unrecognized role for cardiac stem cells in the aging process,” they said

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Title: Association of Prior Coronary Artery Bypass Graft Surgery With Quality of Care of Patients With Non–ST-Segment Elevation Myocardial Infarction: A Report From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines
Date Posted: December 2, 2010
Authors: Kim MS, Wang TY, Ou FS, et al.
Citation: Am Heart J 2010;160:951-957.

Study Question:
What is the association between a history of coronary artery bypass grafting (CABG), current treatment patterns, and in-hospital outcomes using data from the National Cardiovascular Data Registry (NCDR), an initiative from the American College of Cardiology Foundation?
Methods:
The investigators analyzed 47,557 patients with non–ST-segment elevation myocardial infarction (NSTEMI) in the 2007-2008 NCDR Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines. Treatment patterns were compared between patients with and without prior CABG. Multivariable regression with generalized estimating equations was used to evaluate the association between prior CABG and in-hospital outcomes.
Results:
In this study, 8,790 NSTEMI patients (18.5%) had a history of CABG. Prior CABG was associated with a significantly lower adjusted likelihood of early cardiac catheterization (adjusted odds ratio [OR], 0.88; 95% confidence interval [CI], 0.83-0.92), higher rates of short-term clopidogrel use (adjusted OR, 1.08; 95% CI, 1.02-1.14), and comparable use of anticoagulant therapy (adjusted OR, 0.96; 95% CI, 0.88-1.04). Adjusted risks of bleeding and in-hospital mortality did not differ significantly between the two groups (adjusted ORs, 1.00; 95% CI, 0.92-1.11 and 0.99, 95% CI 0.87-1.11, respectively).
Conclusions:
The authors concluded that patients with prior CABG are less likely to undergo guideline-recommended early cardiac catheterization, but equally or more likely to receive guideline-recommended antiplatelet and anticoagulant therapy.
Perspective:
This large national cohort study suggests that patients with prior CABG are less likely to undergo an early invasive treatment strategy, but more likely to receive early clopidogrel and short-term anticoagulant therapy when compared to patients without prior CABG. However, despite lower rates of guideline-recommended early cardiac catheterization, patients with a history of CABG presenting with NSTEMI did not appear to have worse short-term clinical outcomes compared to their non–prior CABG counterparts. Additional studies are indicated to assess the long-term effect of these practice differences as well as the impact of these findings on quality metrics.

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Title: Comparison of Outcomes in Patients Aged <75, 75 to 84, and ≥85 Years With ST-Elevation Myocardial Infarction (From the ACTION Registry-GWTG)
Date Posted: December 6, 2010
Authors: Forman DE, Chen AY, Wiviott SD, Wang TY, Magid DJ, Alexander KP.
Citation: Am J Cardiol 2010;106:1382-1388.

Study Question:
What is the contemporary outcome of ST-segment elevation myocardial infarction (STEMI) in the elderly?
Methods:
The authors used the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Network Registry–Get With The Guidelines (ACTION-GWTG) database to assess the impact of age on outcome of patients presenting with STEMI.
Results:
The overall cohort was comprised of 30,188 patients who were treated at 285 hospitals between January 2007 and June 2008. An overwhelming majority (79.7%) of patients were <75 years old, 14.2% were 75-84 years old, and 6.1% were ≥85 years old. The oldest old ranged in age from 86-91 years, with a median age of 88 years. More than 42% of the oldest old were cited as having contraindications to reperfusion, but patient preference was the most common reason indicated (45%) for failure to administer reperfusion. Among reperfusion-eligible patients, reperfusion therapy was provided in 84% of the patients who were older than 85 years of age. After adjusting for baseline differences, reperfusion therapy was associated with a significantly better outcome in patients younger than 75 years of age (odds ratio, 0.58; 95% confidence interval, 0.40-0.84), but not in the elderly.
Conclusions:
The authors concluded that reperfusion therapy is less often used in elderly patients and this is partly related to a greater prevalence of contraindications.
Perspective:
Elderly patients with STEMI face high mortality and morbidity, and there are limited data to guide therapy in the very elderly. The lack of adequate randomized data results in uncertainty about benefits and risks, particularly with invasive treatments and use of medications with a narrow therapeutic window in the setting of frailty and complex comorbidities. The oldest old are the most rapidly growing demographic of the population, and there is an urgent need for pragmatic clinical trials that can help establish an evidence base to guide patients and physicians to tackle these complex issues.
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Meta-Analysis: Age and Effectiveness of Prophylactic Implantable Cardioverter-Defibrillators
Santangeli P, Di Biase L, Russo AD, et al.
Ann Intern Med 2010;153:592-599.
Study Question: Do implantable cardioverter-defibrillators (ICDs) improve survival in elderly patients when used for primary prevention of sudden death?

Microsimulation and Clinical Outcomes Analysis Support a Lower Age Threshold for Use of Biological Valves
Stoica S, Goldsmith K, Demiris N, et al.
Heart 2010;96:1730-1736.
Study Question: Does prosthesis type (mechanical vs. bioprosthesis) affect outcomes, and at what age at implant are outcomes different?

Familial Defective Apolipoprotein B-100 and Increased Low-Density Lipoprotein Cholesterol and Coronary Artery Calcification in the Old Order Amish
Shen H, Damcott CM, Rampersaud E, et al.
Arch Intern Med 2010;170:1850-1855.
Study Question: Are there specific single nucleotide polymorphisms associated with low-density lipoprotein cholesterol (LDL-C) and subclinical coronary atherosclerosis?
Oral Rivaroxaban for Symptomatic Venous Thromboembolism
The EINSTEIN Investigators.
N Engl J Med 2010;Dec 4:[Epub ahead of print].
Study Question: What is the efficacy and safety of rivaroxaban compared with standard therapy consisting of enoxaparin and a vitamin K antagonist in patients with acute, symptomatic deep-vein thrombosis (DVT)?

Delay From Symptom Onset to Hospital Presentation for Patients With Non–ST-Segment Elevation Myocardial Infarction
Ting HH, Chen AY, Roe MT, et al.
Arch Intern Med 2010;170:1834-1841.
Study Question: What are the secular trends and factors associated with delay in presentation after symptom onset in patients with non–ST-segment elevation myocardial infarction (NSTEMI)?

Importance of Biomarkers for Long-Term Mortality Prediction in Acutely Dyspneic Patients
Januzzi JL Jr, Rehman S, Mueller T, van Kimmenade RR, Lloyd-Jones DM.
Clin Chem 2010;56:1814-1821.
Study Question: What is the added prognostic value of biomarkers for predicting long-term mortality in patients presenting to the emergency department with acute dyspnea?

Management of Chronic Heart Failure Guided by Individual N-Terminal Pro–B-Type Natriuretic Peptide Targets: Results of the PRIMA (Can PRo-brain-natriuretic peptide guided therapy of chronic heart failure IMprove heart fAilure morbidity and mortality?) Study
Eurlings LW, van Pol PE, Kok WE, et al.
J Am Coll Cardiol 2010;25:2090-2100.
Study Question: Does N-terminal pro–B-type natriuretic peptide (NT-proBNP)-guided heart failure (HF) management improve outcomes compared with standard care?

Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices
Resnic FS, Gross TP, Marinac-Dabic D, et al.
JAMA 2010;304:2019-2027.
Study Question: Can automated safety surveillance using computerized tools applied to clinical registries provide early warnings regarding the safety of new cardiovascular devices?

Lifetime Fruit and Vegetable Consumption and Arterial Pulse Wave Velocity in Adulthood: The Cardiovascular Risk in Young Finns Study
Aatola H, Koivistoinen T, Hutri-Kähönen N, et al.
Circulation 2010;122:2521-2528.
Study Question: Are childhood and young adulthood lifestyle risk factors determinants of pulse-wave velocity (PWV) in adults?

Effect of an Intensive Exercise Intervention Strategy on Modifiable Cardiovascular Risk Factors in Subjects With Type 2 Diabetes Mellitus: A Randomized Controlled Trial: The Italian Diabetes and Exercise Study (IDES)
Balducci S, Zanuso S, Nicolucci A, et al.
Arch Intern Med 2010;170:1794-1803.
Study Question: What is the efficacy of an intensive exercise intervention strategy in promoting physical activity and improving glycated hemoglobin (HbA1c) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM)?

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PRIMA: NT-proBNP measurement increased HF medication use but not survival rate outside hospital setting
Eurlings L. J Am Coll Cardiol. 2010;56:2090-2100.
Troughton R. J Am Coll Cardiol. 2010;56:2101-2104.

Measuring N-terminal pro-B-type natriuretic peptide in patients with HF advanced detection of HF-related events and influenced therapy, but it did not produce a significant improvement on the number of days of survival outside the hospital, study results indicated.

The PRIMA trial was conducted in 12 Dutch university and general hospitals. All patients (n=345) were hospitalized for decompensated, symptomatic HF, including elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at admission. After discharge, patients were randomly assigned to either clinically guided outpatient management (n=171) or management guided by an individually set NT-proBNP (n=174).

Researchers reported that management guided by an individualized NT-proBNP target did not significantly improve the primary endpoint of number of days alive outside the hospital (685 days vs. 664; P=.49), despite increasing the use of HF medication (P=.006) and detecting 64% of the imminent HF-related events. Patients in the NT-proBNP-guided group experienced nonstatistically significant lower rates of mortality compared with the clinically guided group (26.5% vs. 33.3%), whereas there were no differences between the total number of CV and HF-related admissions between groups.

These findings, the researchers concluded, show that unstable NT-proBNP levels indicate imminent events, although intensification of currently used medication in patients on optimal HF therapy does not prevent further deterioration.

In an editorial accompanying the study, Richard W. Troughton, MB ChB, PhD, Chris M. Frampton, PhD, and M. Gary Nicholls, MD, said the findings of PRIMA are important additions to the series of biomarker-guided HF studies.

“Use of a single target level of BNP or NT-proBNP, perhaps adjusted for clinical covariates such as age, appears to offer the best opportunity for the biomarker-guided strategy to alter management. As is the case for their use as diagnostic markers, changes in serial BNP and NT-proBNP levels should be interpreted within the entire clinical context, including reference to other tests, such as those for renal function,” they wrote.