Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

AHA: Afib Stroke Risk Follows Heart Transplant

By Ed Susman, Contributing Writer,
November 15, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Note that in this single center retrospective study, atrial fibrillation was common after orthotopic heart transplant (9.4%) and was associated with adverse outcomes.


Further research is necessary to understand the etiology of atrial fibrillation after orthotopic heart transplantation and to determine if the association with adverse events is causal.
Review

ORLANDO -- Atrial fibrillation was present in a significant portion of perioperative heart transplant patients and correlated with a higher complication rate including stroke, according to a single-center study.

Perioperative atrial fibrillation was detected at a rate of 9.38% of consecutive heart transplant patients over a 12-year period, and the development of atrial fibrillation was associated with a trend toward a higher risk of long-term mortality (95% CI 0.98 to 2.33, P=0.06), reported Faisal Cheema, MD, from Columbia University College of Physicians and Surgeons, N.Y. at the annual American Heart Association meeting.

Cheema told MedPage Today that patients in his study who developed atrial fibrillation also appeared to have significant:
Need for ventricular assist devices: 2.85% of patients who had normal sinus rhythm required the device post-transplant surgery compared with 8.64% of patients who had atrial fibrillation
Need for pacemaker: 1.16% of patients with normal rhythm and in 4.94% of patients with atrial fibrillation
Respiratory failure: 6.9% of patients with normal rhythm compared with 13.6% of patients who had atrial fibrillation
Re-operations for bleeding: 11% of the patients with normal rhythms after surgery compared with 21.3% of those who were diagnosed with atrial fibrillation


Finally, stroke was reported in 1.3% of patients with normal rhythm and in 4.9% of those with atrial fibrillation.

All comparisons were significant at the P<0.05 level.

In the Columbia cohort, patients who developed atrial fibrillation were about 56 years-old compared with an average of 53 years-old for the patients who did not exhibit atrial fibrillation (P=0.009).

Less than 25% of both groups were women; the donor age was older in the patients with atrial fibrillation -- 40 versus 32 (P<0.0001).

About 55% of the patients who developed atrial fibrillation received a female heart compared with 40.8% of those who did not have atrial fibrillation (P=0.015).

Cheema explained that while atrial fibrillation is frequent after heart surgeries, it occurs less often in transplantation patients. "The lower incidence of postoperative atrial fibrillation or atrial flutter in orthotopic heart transplant patients has been attributed to pulmonary vein isolation as a result of the left atrial suture line," he said.

The development of atrial fibrillation and atrial flutter should be looked at as a marker for poor prognosis, he said, calling for more investigation into the etiology and prevention of atrial fibrillation. Additional studies also need to make a strong case for promptly initiating treatment in atrial fibrillation patients who have undergone heart transplantation procedures, he said.

Mariell Jessup, MD, at the University of Pennsylvania School of Medicine in Philadelphia, said that the pulmonary vein is not necessarily isolated during different types of transplant techniques involved.

"There are also medications used in transplantation that may increase the risk of arrhythmia, and inflammatory processes that occur in transplant procedures may also induce arrhythmias," Jessup said.

"The presence of atrial fibrillation could be a marker of a patient who is not doing well with his transplant," suggested Dan Roden, MD, from Vanderbilt University Medical Center in Nashville, Tenn., and an AHA spokesperson.

Jessup and Roden, who did not participate in this study, concurred that determination of the cause of the atrial fibrillation needs to be thoroughly investigated before aggressive treatment with drugs such as anticoagulants.

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AHA: Intracardiac Cell Therapy Hits and Misses

By Chris Kaiser, Cardiology Editor,
November 15, 2011

Action Points
Explain that a small feasibility study of intracardiac infusion of cardiac stem cells found improved left ventricular ejection fraction four months after the procedure; stem cells had been harvested during CABG.


Point out in contrast that intracardiac injection of autologous bone marrow mononuclear cells two to three weeks after an MI did not limit infarct size in a randomized, placebo-controlled trial.
Review

ORLANDO -- Whether intracardiac cell infusions can help repair the heart muscle after an MI could depend on the type of cells and when they are delivered, according to two studies presented here at the American Heart Association meeting.

In one ongoing study called SCIPIO, 14 patients with ischemic cardiomyopathy who underwent bypass surgery had improved left ventricular ejection fraction (LVEF) -- from 30.3% to 38.5% (P=0.001) -- four months after intracoronary infusion of autologous cardiac stem cells.

In contrast, the seven patients in the control group had no change in LVEF, reported Roberto Bolli, MD, from the University of Louisville in Kentucky, and colleagues.

In seven stem cell patients who could undergo cardiac MRI, researchers saw a significant 24% decrease in infarct size at four months and another one had a decrease of 30% at one year.

This is the first study of cardiac stem cells in humans, Bolli said, and the positive results mirror the preclinical work.

In the second study call LateTIME, Lemuel A. Moye, MD, PhD, from the University of Texas School of Public Health in Houston, and colleagues sought to test autologous bone marrow mononuclear cells (BMC) infused into patients two to three weeks after an MI.

Previous studies had shown positive results with intracoronary BMC infusion within the first week following MI. But since many patients cannot tolerate early cell delivery, researchers wanted to know if waiting a few weeks would make a difference. It did, and not for the better.

There were no significant differences between the 87 patients randomized in a 2:1 fashion to BMC or placebo in terms of LVEF, wall motion in the infarct zone or in the border zone, LV volumes, and infarct volumes at six months after infusion, Moye said.

The measurement of infarct size may be a more sensitive marker of cell therapy efficacy, Moye said, and in this trial, the decrease was similar in both groups.

Both studies were simultaneously published online to coincide with their presentation at the AHA meeting here, SCIPIO in The Lancet and LateTIME in the Journal of the American Medical Association.

"The results from SCIPIO raise new optimism because the study is based on rigorous quality standards and the reported benefits are of an unexpected magnitude. ... We will have to see whether further data will meet the promises of the present study: more patients will need to be followed-up over a longer period," wrote Gerd Heusch, MD, from the University School of Medicine in Essen, Germany, in an editorial in The Lancet.

The idea behind both trials is that the specialized cells will promote blood vessel growth, prevent cell death, and transform themselves into a number of tissues, including muscle.

Joshua M. Hare, MD, from the University of Miami, commenting in a JAMA editorial, said that the results of LateTIME argue compellingly against the value of BMC administration in this time frame, particularly given the trial's "rigorous design with placebo control, blinding, and sophisticated MR imaging."

Hare said there is a growing consensus that rather than using LVEF as the surrogate endpoint, direct determination of injured tissue and ventricular remodeling gives a more appropriate snapshot of the phenotype targeted by the therapy. And LateTIME is strengthened by its use of cardiac MRI to determine these metrics.

The LateTIME trial was a phase II, randomized, double-blind, placebo- controlled trial. Despite the high-risk nature of the patients, the number of events were low: three in the BMC group and six in the placebo group.

Moye noted the REPAIR-AMI trial, published in 2006, showed favorable effects in those receiving BMC five to seven days post-MI. He said that the timing of cell delivery may have a major influence on treatment effect and may have contributed to the negative findings. It is possible that the bone marrow is depleted of progenitor cells late after an MI, which also might have accounted for the negative findings in the study, the investigators wrote.

The same group of researchers are currently conducting another trial called TIME in which they are comparing the delivery of BMC at three and seven days post-MI, Moye said.

SCIPIO was a phase I, randomized, open-label, single-center trial of patients who had severe heart failure secondary to ischemic cardiomyopathy. Patients' stem cells were harvested from tissue taken during bypass surgery and delivered to the patients at a mean of four months post-CABG.

Eight patients in the intervention arm completed one-year follow-up and their LVEF continued to improve, reaching 42.5%. "Though not significant, it demonstrates that the cardiac stem cells continue to improve LV function beyond the first four months," Bolli said.

"Because there was no such improvement in the controls, the mechanism for improvement in the stem cell treated patients is unlikely to be wholly associated with CABG," he said.

The small number of patients in the SCIPIO study is a limitation, as is not having placebo-treated patients. However, the study was designed to assess safety and feasibility, not efficacy. The improved function was a surprise finding that needs to be replicated in subsequent studies, according to the investigators.

A limitation to the LateTIME study is that the cell product was not tested in vivo, so there could have been unknown changes to the product that contributed to the negative findings.

[Chevychelov]

AHA: Vital Elements Often Missing from Sports Physicals

By Todd Neale, Senior Staff Writer,
November 15, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Explain that a survey of physicians and athletic directors found that few providers or schools were compliant with AHA guidelines for screening young athletes by history and physical for risk of sudden cardiac death.


Note that the main reason given for lack of compliance was lack of awareness of the guidelines.
Review

ORLANDO -- Compliance with American Heart Association guidelines for pre-participation screening for cardiovascular abnormalities in young athletes is poor, a survey of physicians and athletic directors in Washington state showed.

Only about 6% of physicians were in complete compliance with the guidelines, and 13% performed two-thirds or fewer of the 12 items recommended to be part of the evaluation, according to Nicolas Madsen, MD, MPH, a pediatric cardiology fellow at Seattle Children's Hospital.

The low percentage of physicians who adhered to the guidelines was driven by a lack of knowledge of the guidance -- only 49% of pediatricians and 45% of family physicians knew about them, Madsen reported at the AHA meeting here.

The way forward would seem to be the development of a single, statewide pre-participation physical evaluation form that is well supported, he said.

In an interview, Christine Lawless, MD, co-chair of the American College of Cardiology's Sports and Exercise Cardiology Council, said that the problem of physicians not following guidelines is a national problem.

That's particularly true when the guidance is based largely on expert consensus, as is the case with the pre-participation screening guidelines, said Lawless, who practices with Sports Cardiology Consultants in Chicago.

A lack of awareness of the guidelines, or of the importance of specific recommendations within the documents, also may contribute to suboptimal adherence, she said.

She said the best way to overcome those issues is through a multipronged educational approach targeted to healthcare professionals who perform pre-participation physicals; coaches and athletic directors; parents; and the children and teens themselves.

The pre-participation physical evaluation is done to screen for risk of sudden cardiac death, which is the leading cause of mortality among young athletes, Marsden said. The estimated national cost of the screening is $250 million per year.

The AHA issued its guidelines for conducting the pre-participation physical in 1996 and reaffirmed them in 2007. The guidance includes a list of 12 items covering medical history, family history, and a physical examination that should be completed.

The researchers surveyed physicians and athletic directors in Washington to assess compliance with the guidelines. The participants included 559 members of the American Academy of Pediatrics, 554 members of the Washington Academy of Family Physicians, and 317 athletic directors.

Only about half of the physicians, and just 6% of the athletic directors, knew about the AHA guidelines.

Most of the physicians always asked the athletes they were screening about the five items of the medical history:
Chest pain
Syncope
Dyspnea/fatigue
Prior heart murmur
Elevated blood pressure


However, 6% to 18% of the respondents asked about them half of the time or less.

For family history, three-quarters of physicians always asked whether the athletes had a relative who had died before age 50, but only 43% asked about relatives with disabilities from heart disease before age 50, and 33% asked about a relative with known heart disease.

During the physical examination, the physicians performed well for always checking for heart murmur (95%) and brachial blood pressure (87%), but only half always checked for Marfan stigmata and only 29% checked femoral pulses.

Compliance with the guidelines improved among physicians who performed a greater number of physicals; made more cardiology referrals and had a higher comfort level about knowing when to refer; and who were satisfied with the physical evaluation (P<0.05 for all).

However, compliance did not differ based on provider type, years of experience, location, or exposure to sudden cardiac death.

The survey of athletic directors revealed that 0% of schools were in complete compliance with the AHA guidelines, and 60% used a form that included only eight of the 12 recommended elements of the pre-participation evaluation.

Most of the respondents favored adoption of a single statewide pre-participation physical evaluation form, with support strongest among the physicians.

Lawless said a standardized form within each state would help improve compliance with the guidelines.

[Chevychelov]

AHA: Same-Time Afib Ablation Okay for Seniors

By Ed Susman, Contributing Writer,
November 15, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Note that in this study of surgical atrial fibrillation ablation performed during other cardiac surgery procedures, mortality, and maintenance of sinus rhythm were similar in subjects older than 74 and in younger patients.


This small, retrospective study has several important limitations and does not address whether surgical atrial fibrillation ablation has long-term benefits, such as reduction of stroke risk.
Review

ORLANDO -- Older patients who were treated with surgical atrial fibrillation ablation during other cardiac procedures appeared to handle the additional surgery as well as younger patients, researchers said here.

Among patients 74 years or older, 98.3% survived to discharge compared with 99% of the patients less than 75 years (P=1.0), reported Lori Soni, MD, from Columbia University College of Physicians and Surgeons in New York. About 95% of the older patients survived at least 90 days compared with 98% of the younger patients (P=0.36).

Rhythm success was achieved in 75.6% of the younger patients and in 65.1% of the older patients (P=0.22), she reported at the American Heart Association Scientific Sessions.

"Many surgeons do not offer surgical atrial fibrillation ablation as an option to elderly patients undergoing other procedures," Soni told MedPage Today. "What we found in our study is that when surgeons consider surgical atrial fibrillation ablation to a concomitant procedure, patient age should not be a deterrent."

Soni and her research team retrospectively reviewed outcomes among 160 consecutive patients who were treated at one institution from January 2008 through June 2010. In the study, 100 patients were less than 75 while 60 were 75 or older. Those in the older group were more likely to be white and female. They also were more likely to have been diagnosed with hypertension, diabetes, and chronic obstructive pulmonary disease than their younger counterparts.

"We know that older people are going to have more comorbidities and more complications from surgery than younger individuals," commented Dan Roden, MD, from Vanderbilt University Medical Center in Nashville, Tenn., and an AHA spokesman.

"However, age alone should not be a reason for not performing ablation in these patients," he told MedPage Today. Roden was not a participant in the study.

Soni said that the older group of patients did have a longer length of stay in the hospital -- nine days compared with 7.1 days for the young group (P=0.02). They also were less likely to be discharged to home rather than to a long-term-care facility. About 92% of the younger group went home, compared with 63% of the older patients (P<0.01). Time to extubation was 14.1 hours in the younger patients and 16.7 hours in the older patients (P=0.17).

Serious complications were not statistically significant in either group although there was a trend toward more pleural effusion that required intervention in the older group. The complication was experienced by 6% of the younger patients and 15% of the older population (P=0.06).

"In comparison to a younger patient cohort," Soni said, "surgical atrial fibrillation ablation in the elderly population has a comparable success rate, morbidity, and short-term mortality."

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AHA: Elective PCI Still Not for Just Any Hospital

By Crystal Phend, Senior Staff Writer,
Reviewed by
November 15, 2011

Review
ORLANDO -- Centers considering elective stenting and angiography without on-site cardiac surgery after the positive results reported with it here at the American Heart Association meeting need to proceed thoughtfully, according to this exclusive InFocus report.

The safety of that approach found support in the CPORT-E trial, explains Timothy Gardner, MD, a cardiovascular surgeon and director of the heart program at the Christiana Care Health System in Wilmington, Del.

The study found no mortality or adverse event disadvantage to non-primary percutaneous coronary intervention (PCI) at hospitals without on-site cardiac surgery capabilities compared with ones that did.


But those results were from a study done among selected patients and at experienced centers with formal programs in place.

To follow in their footsteps, community hospitals need a good relationship with a referral hospital to take any cases that end up needing emergency surgery, says Gardner, a past president of the AHA.

High volume may be less critical than previously thought, but credentials and high standards for the PCI team should be nonnegotiable, he told MedPage Today Senior Staff Writer Crystal Phend.

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ELEVATE-TIMI 52: High-dose clopidogrel reduced platelet reactivity in CYP2C19*2 carriers
By

AHA Scientific Sessions 2011

ORLANDO — Higher doses of clopidogrel, up to 300 mg daily, were more effective than standard doses in patients with the CYP2C19 gene variant, according to late-breaking research from the ELEVATE-TIMI 56 trial.

These findings suggest that it may be possible to adjust clopidogrel (Plavix, Sanofi-Aventis) dosage in these patients to improve its effect, according to Jessica L. Mega, MD, MPH, and colleagues.

It is estimated that one-third of patients do not respond optimally to the currently recommended dose of clopidogrel (Plavix; Bristol-Myers Squibb, Sanofi Aventis).

ELEVATE-TIMI 56 is the first study to examine maintenance doses of clopidogrel up to four times the usual dose in patients with particular CYP2C19 gene variations, researchers said. The multicenter, randomized, double blind trial included 335 patients with coronary artery disease (mean age, 60 years; 88% white; 75% men). Three-quarters of the study cohort were non-carriers of the CYP2C19*2 allele, 24% were heterozygotes and 2% were homozygotes.

Non-carriers of the CYP2C19*2 allele received 75-mg or 150-mg doses in 2-week sequences. Carriers received doses of 75 mg, 150 mg, 225 mg and 300 mg daily in random sequence. Each dose was administered every 2 weeks, followed by platelet assessment, for 8 weeks.

Mega, of the department of cardiovascular medicine at Brigham and Women’s Hospital, and the ELEVATE-TIMI 56 researchers found no significant increase in adverse events as dosage increased during the study duration.

According to results, platelet reactivity was higher in both heterozygotes (P<.001) and homozygotes (P<.001) at the 75-mg dose. However, boosting clopidogrel doses resulted in a graded reduction in platelet reactivity among heterozygous patients (P<.001). As doses increased, the number of non-responders decreased (52% at 75 mg, 26% at 150 mg and 10% at both 225 mg and 300 mg).

When doses were tripled (225 mg) or quadrupled (300 mg), responses among heterozygous carriers were comparable to non-carriers who were given the standard dose.

Among homozygotes, however, despite a graded response with higher doses, a small number of patients did not reach a range comparable to non-carriers, even with the 300-mg dose. Compliance was good, with 97% to 98% across all doses, according to Mega. Though only administered in a 14-day series, during the time patients took clopidogrel there were no notable differences in adverse events among the groups, she said.

“Among patients with stable CV disease, looking at CYP2C19*2 heterozygotes, tripling the maintenance dose of clopidogrel to 225 mg daily achieved levels of platelet reactivity similar to the standard 75-mg dose in non-carriers. However, among homozygotes, even 300 mg of clopidogrel daily is unlikely to result in optimal degrees of platelet inhibition.” – by Stacey L. Fisher and Katie Kalvaitis

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CLEVER: Supervised exercise bests stenting, home care in claudication, aortoilic disease
By

AHA Scientific Sessions 2011

ORLANDO — Walking ability in patients with symptom-limiting claudication improved when supervised treadmill exercise was added to standard therapy, as compared with stenting alone, according to new data from the CLEVER study.

“In the past, guideline-driven interventions that have included exercise have also included placement of stents in pharmacotherapy, but invasive stent procedures, the most commonly used current therapy, have not been shown to offer better outcomes for patients with claudication and exercise performed in a supervised setting alone,” Alan Hirsh, MD, director of vascular medicine, University of Minnesota, said during his presentation of the Claudication: Exercise vs. Endoluminal Revascularization (CLEVER) study.

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Researchers randomly assigned 111 patients (mean age, 64 years; 61% men) with aortoiliac peripheral artery disease into three treatment groups:
Cilostazol (Pletal, Otsuka Pharmaceuticals) with home exercise (optimal medical care group);
Optimal medical care plus supervised exercise for 6 months (supervised exercise group); or
Optimal medical care plus primary stent revascularization (stent revascularization group).

Change in peak walking times vs. baseline times were assessed as the primary endpoint, while secondary endpoints included free-living step activity, quality of life and biomarkers of CVD risk.

At 5-month follow-up, the supervised exercise group experienced the greatest change in peak walking time with an improvement of 5.8 minutes from baseline. The stent revascularization group had intermediate change (3.7 minutes), and the optimal medical care group had the least change (1.2 minutes). Quality of life scores, assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire, also showed greater improvement in the supervised exercise and stent revascularization groups vs. optimal medical care (P=.03 and P<.001).

Alan
Hirsch


Ankle-brachial index measurements were not significant when compared with baseline in the optimal medical care and supervised exercise groups, but resting ankle-brachial index improved by 0.29 in the stent revascularization group (P<.001). Both the supervised exercise and stent revascularization groups showed improvement in claudication onset time vs. optimal medical care at 6 months (P=.003 and P=.006).

Compared with supervised exercise or optimal medical care alone, researchers found that change in free-living step activity was greatest in the stent revascularization group vs. optimal medical care and supervised exercise (114.3 vs. -5.6 and 72.6).

“Very simply, among patients with moderate to severe claudication and significant aortoiliac disease, supervised exercise offers better treadmill walking performance than stent revascularization alone, and both are superior to home care,” Hirsh said. “We do note that these are both quality of life interventions and stenting was associated with major improvements in quality of life.”

These results represent 6-month follow-up. An 18-month follow-up is still underway. – by Casey Murphy

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AHA: ALPHEE Results Derail Celivarone Development

By Crystal Phend, Senior Staff Writer,
November 16, 2011

Action Points
Note that celivarone, a modified version of dronedarone, is a benzofuran derivative that blocks calcium, sodium, and several potassium channels. It has been under development for use in atrial and ventricular arrhythmias.


Point out that in this double-blind, placebo-controlled study, celivarone was not effective in preventing occurrence of ventricular tachycardia/ventricular fibrillation–triggered ICD interventions or sudden death.
Review

ORLANDO -- The novel antiarrhythmic celivarone doesn't reduce defibrillator shocks or sudden death, researchers found.

Implantable cardioverter-defibrillator (ICD) patients taking the drug were just as likely to get appropriate shocks or die suddenly as those on placebo, at 54.9% to 67.0% across celivarone dose groups versus 61.5% in the ALPHEE study.

"I don't think we're going to see any further clinical development," Peter R. Kowey, MD, of Lankenau Hospital in Wynnewood, Penn., concluded in reporting the results here at the American Heart Association meeting.

The findings were simultaneously released in Circulation: Journal of the American Heart Association.

The drug, a modified version of dronedarone (Multaq), had failed in a prior study for acute atrial fibrillation termination and in a second for atrial fibrillation prevention.

But a third study, the phase II ICARIOS trial, had offered some hope of benefit in ICD patients.

Now with the negative phase IIB results in ALPHEE, "it's three strikes and you're out," Kowey told MedPage Today at a press conference. "I would be surprised if there was a path forward for the drug."

Study discussant Cynthia M. Tracy, MD, of George Washington University in Washington, D.C., suggested that perhaps celivarone's failure was because it is "the daughter of dronedarone."

Other studies have suggested a heart failure and mortality risk to dronedarone in high-risk patients, she noted in the press conference.

The PALLAS dronedrone study, reported alongside ALPHEE in the same late-breaking clinical trials session, showed a more than doubling in stroke, MI, systemic embolism, or death from cardiovascular causes together and 95% excess unplanned cardiovascular admissions and deaths.

ALPHEE included 486 patients randomized to receive double-blind treatment with one of three celivarone doses (50, 100, or 300 mg per day) or placebo or amiodarone as a calibrator (Cordarone, Pacerone, 200 mg daily after 600 mg loading dose for 10 days).

Inclusion criteria were a left ventricular ejection fraction less than 40% and at least one ICD shock for ventricular tachycardia or fibrillation in the prior month or having gotten an ICD in the prior month for documented ventricular tachycardia or fibrillation.

Over a median of nine months on treatment, the rate of sudden death or ICD shocks or pacing triggered by ventricular tachycardia or fibrillation was:
61.5% with placebo
67.0% with 50-mg celivarone
58.8% with 100-mg celivarone
54.9% with 300-mg celivarone
45.3% with amiodarone


While none of celivarone comparisons against placebo came out statistically significant, Kowey noted that the efficacy of amiodarone versus placebo was as expected, supporting that the lack of benefit of celivarone was real.

He cautioned that the trial was not intended to make direct comparisons between celivarone and amiodarone.

One surprising finding, though, was the 3.327-fold elevated mortality rate seen with amiodarone compared with placebo (P=0.0158).

"We've been accumulating information over the last several years that amiodarone, although it is commonly used in patients like this, patients with pretty advanced cardiovascular disease, may not be as safe or as effective a drug as we would have hoped in this population," Kowey told reporters.

But another explanation, in part, for the unexpectedly high mortality rate with amiodarone (17.0% versus 5.5% with placebo) might have been that nearly 20% of patients didn't get a beta-blocker with it, Tracy pointed out.

"The benefit of amiodarone has been primarily demonstrated in the presence of a beta-blocker," she noted.

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ASN: Calcium Score Predicts CVD Risk in Kidney Disease

By Charles Bankhead, Staff Writer,
November 16, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Explain that in patients with chronic kidney disease (CKD), coronary artery calcification predicted the risk of cardiovascular disease (CVD) events, especially in those with no history of CVD.


Point out that a coronary artery calcification (CAC) score of >0 to <100 or a score >100, as compared with 0, was associated with a significantly increased risk for CVD in patients with an eGFR ≥45 mL/min.
Review

PHILADELPHIA -- In patients with chronic kidney disease (CKD), coronary artery calcification predicted the risk of cardiovascular disease (CVD) events, especially in those with no history of it, investigators reported here.

In a multivariable analysis, a coronary artery calcification (CAC) score >100 tripled the risk of myocardial infarction (MI), and any accumulation of coronary calcification tripled the risk of CVD.

An analysis that compared patients with and without CVD showed that increasing amounts of CAC predicted an increased risk of CVD events in patients with CKD, but no history of cardiovascular events (P<0.0001).

In contrast, rising CAC scores did not predict CVD events in CKD patients with established CVD, as reported at the American Society of Nephrology meeting. A similar pattern of association was observed in patients with, and without, diabetes in those with more severe CKD.

"Our study indicates that CAC predicts the increased risk of development of MI and CVD events beyond traditional risk factors among patients with CKD," said Jing Chen, MD, of Tulane University in New Orleans.

"CAC can be used in clinical settings for risk classification and prediction among patients with CKD, especially among those without a history of CVD."

CAC is common in patients with CKD, but the clinical significance and predictive value of CAC across the spectrum of values have not been studied extensively. To inform on the issues, Chen and colleagues analyzed data from a subgroup of participants in the Chronic Renal Insufficiency Cohort (CRIC) study.

As part of the CRIC study design, 1,902 participants had baseline assessments of CAC by electron-beam CT (EBCT). Follow up in the subgroup continued for a median of 2.1 years.

Investigators examined the association between CAC and various clinical events and overall mortality, grouping patients by Agatston score:
0=none
>0 to ≤100=moderate calcification
>100=increased calcification


Multivariate analysis revealed two significant associations: an Agatston score >100 was associated with an MI hazard ratio of 3.14 (P=0.018), as compared with less amounts of calcification. A score >100 was associated with a hazard ratio of 3.02 for CVD events, and a score of >0 to <100 was associated with a hazard ratio of 2.79 (P=0.014).

CAC did not predict the risk of CVD events in patients with CVD at baseline, as patients with an Agatston score of 0 had an event rate of 5.73% per year compared with 7.67% and 7.60% for study participants with higher scores.

Among patients with no history of CVD, the event rate increased from 0.7% per year in association with an Agatston score of 0 to 2.46% for a score >0 to <100 and 3.84% for a score >100 (P<0.0001 for trend).

CAC predicted the risk of CVD event in patients with and without diabetes.

In CRIC participants with diabetes at baseline, an Agatston score of 0 was associated with an annual event rate of 2.82%, increasing to 5.19% for an Agatston score of >0 to <100, and 6.58% for a score >100 (P=0.03).

Among patients without diabetes, a CAC score of 0 was associated with an annual event rate of 0.49%, increasing to 2.28% and 3.37% for patients with higher Agatston scores (P=0.0007).

Examination of CAC score and estimated glomerular filtration rate (eGFR) showed that CAC predicted the risk of CVD events across the spectrum of eGFR values.

In patients with an eGFR <45 mL/min, the annual event rate increased from 1.96% to 6.52% as the CAC score increased (P=0.0003).

In the subgroup with an eGFR ≥45 mL/min, the annual CVD event rate increased with CAC score from 0.29% to 2.94% (P=0.009).

A multivariate analysis of the risk of CVD events by CAC score showed that a score of >0 to <100 or a score >100, as compared with 0, was associated with a significantly increased hazard ratio in patients with:
No history of CVD: HR 3.56 (1.33 to 9.56), HR 3.39 (1.22 to 9.38)
No history of diabetes: HR 5.63 (1.36 to 23.3), HR 5.95 (1.3 to 27.31)
An eGFR ≥45 mL/min: HR 5.73 (1.04 to 31.6), HR 11.2 (1.71 to 73.9)

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ASN: Diabetes Drugs Differ in Effects on Weight in ESRD

By Charles Bankhead, Staff Writer,
November 15, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Explain that both sitagliptin and glipizide lowered HbA1c in type 2 diabetes patients with end-stage renal disease to a comparable degree, but sitagliptin was associated with fewer hypoglycemic episodes.


Note that sitagliptin treatment was associated with a slight weight loss while those taking glipizide had a tendency to gain weight; the difference between the two arms was about 3 lb.
Review

PHILADELPHIA -- Two oral hypoglycemic drugs achieved similar diabetes control in patients with type 2 diabetes and end-stage renal disease, but sitagliptin (Januvia) did so without weight gain, investigators reported here.

About 30% of patients achieved a hemoglobin A1c (HbA1c) <6.5% after a year of treatment with sitagliptin or glipizide. Additionally, 44% of sitagliptin-treated patients and 56% of those treated with glipizide reached the less stringent HbA1c target of <7%, Juan Camilo Arjona Ferreira, MD, of Merck in Rahway, N.J., and colleagues reported.

An evaluation of HbA1c levels over time showed that the two drugs maintained similar control during 54 weeks of follow-up.

However, patients in the glipizide arm had a tendency to gain weight, whereas those treated with sitagliptin had a small decrease in weight.

"In patients with type 2 diabetes and ESRD on dialysis, treatment with sitagliptin 25 mg once daily for 54 weeks provides clinically meaningful reductions from baseline in A1c and fasting plasma glucose, similar to those observed with glipizide," the investigators concluded.

"Sitagliptin is generally well tolerated, with a numerically lower incidence of symptomatic hypoglycemia and a lower incidence of severe episodes of hypoglycemia than glipizide. Sitagliptin results in a trend toward weight loss compared with weight gain with glipizide."

Diabetes has become the leading cause of ESRD, and studies have shown that good glycemic control improves outcomes in patients with type 2 diabetes and ESRD.

However, dialysis patients with type 2 diabetes have fewer therapeutic options for diabetes control because some agents are contraindicated in patients with impaired kidney function, according to the background of the presentation.

To compare the safety and efficacy of two different hypoglycemic drugs for patients with type 2 diabetes and ESRD, investigators randomized 129 patients to sitagliptin or glipizide.

Patients allocated to glipizide started treatment at a dose of 2.5 mg once a day and titrated up or down at clinician discretion to a maximum dose of 10 mg twice a day.

Because sitagliptin is eliminated largely unchanged via renal excretion, patients randomized to the agent received 25 mg once a day, or 25% of the usual dose.

The primary endpoints were the change from baseline to week 54 in HbA1c, safety, and tolerability. Secondary endpoints included the frequency of hypoglycemic events and change in fasting plasma glucose.

The patients had a mean age of about 60, mean body mass index of 26 to 27, mean diabetes duration of 16 to 19 years, and a baseline HbA1c of 7.8% to 7.9%.

About 65% to 70% of the patients were treated by hemodialysis and the rest by peritoneal dialysis. Almost a third of the patients had a history of cardiovascular disease, and about 10% had congestive heart failure.

Analysis of the primary endpoint showed that patients randomized to sitagliptin had a mean reduction in baseline HbA1c of 0.72%, versus 0.87% with glipizide. Both values differed significantly from baseline (P<0.001) but not from each other.

Hypoglycemia occurred in 10.8% of patients treated with glipizide versus 6.3% of those in the sitagliptin arm, a nonsignificant difference. Additionally, 7.7% of patients in the glipizide arm had severe hypoglycemic episodes versus none in the sitagliptin arm.

The rate of adverse events was similar in the two treatment groups. Drug-related adverse events occurred more often in the glipizide arm (20.0% versus 15.6%) but was not significantly different between the groups. Serious adverse events occurred in 35.9% of patients treated with sitagliptin and 32.3% of those in the glipizide arm. The rates of adverse events leading to discontinuation were 10.9% with sitagliptin and 12.3% with glipizide.

Serious cardiovascular and heart failure events also occurred in a similar proportion of patients in each group.

The trend toward weight loss in the sitagliptin arm and toward weight gain in the glipizide arm resulted in a between-group difference of about 3 lb.

[Chevychelov]

AHA: Ablation Stops Paroxysmal Afib

By Ed Susman, Contributing Writer,
November 18, 2011

Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.


Explain that first line treatment of paroxysmal atrial fibrillation with catheter-based radiofrequency ablation gives patients more long-term relief from the cardiac rhythm disturbances than drug therapy.


Point out that crossover to ablation occurred in just over one-third of drug therapy patients.
Review

ORLANDO -- First-line treatment of paroxysmal atrial fibrillation with catheter-based radiofrequency ablation gives patients more long-term relief from the cardiac rhythm disturbances than drug therapy, researchers suggested here.

"At 24 months, atrial fibrillation burden and occurrence of any and symptomatic atrial fibrillation were significantly lower in the radiofrequency ablation group than in the anti-arrhythmic drug group of patients (P=0.007)," said Jens C. Nielsen, MD, professor of medicine at Aarhus University Hospital, Skejby, Denmark.

In all, 22 of the 146 patients who underwent ablation experienced any atrial fibrillation, compared with 43 of the 148 patients being treated with drugs (P=0.004), during the two-year period of the Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial, the researchers reported at the American Heart Association meeting.

"We think these data support radiofrequency ablation as a first-line treatment in patients with paroxysmal atrial fibrillation," Nielsen said. He added, however, that because this study population represents a selected patient population that might be of younger age than than those seen in general practice, the results of his work should be taken with caution.

The patients in the study were about 55 years of age, and about 70% were men; less than 20% had been diagnosed with heart disease.

"We do not think that these results should be an argument for offering all patients with paroxysmal atrial fibrillation radiofrequency ablation," Nielsen said.

"At baseline there was no difference in atrial fibrillation burden between the groups, and this was also true at 3 months and at six months," he said in his presentation. "There is a trend toward a significant difference in favor of catheter-based therapy at 12 months and at 18 months; and by 24 months, this becomes highly statistically significant."

In the study, Nielsen and colleagues recruited 294 patients, of whom 146 were randomized to receive radiofrequency ablation through isolation of the pulmonary vein, while 148 patients were assigned to treatment with anti-arrhythmic drugs.

Symptomatic atrial fibrillation was experienced by 10 of 146 ablation patients at two years, compared with 24 of 148 patients on medical treatment (P=0.012).

Occurrence of atrial flutter did not differ significantly between the groups. He stated that 30 patients had atrial flutter in the radiofrequency ablation cohort compared with 40 patients on drug therapy (P=0.25).

Serious adverse events were recorded in 19 patients in the radiofrequency ablation group and in 15 patients in the anti-arrhythmic drug group.

The impact of treatment with radiofrequency ablation may have been muted, Nielsen suggested, because 54 patients who were first assigned to medical therapy underwent radiofrequency ablation during the course of the trial; 13 patients in the original radiofrequency ablation group switched over to take drugs during the course of the trial.

In commenting on the study, invited discussant William G. Stevenson, MD, director of the clinical electrocardiography program at Brigham & Women's Hospital/Harvard Medical School, Boston, said that performing clinical trials in the atrial fibrillation population is difficult. But because one in four Americans are destined to developed the rhythm disorder, the need for these studies is important, he said.

"Paroxysmal atrial fibrillation is often a very symptomatic phase of the illness," Stevenson said. He said that paroxysmal atrial fibrillation comes on suddenly and goes away suddenly.

"Many patients complain of palpitations, lightheadedness, and dizziness, and quality of life is really the major consideration," he said. Drug therapy has been disappointing, with about 70% of patients who take medicine to control atrial fibrillation experiencing continuing rhythm disturbances.

"In MANTRA, the drug group's efficacy was a bit better, but I would point out that the crossover rate in the trial was relatively substantial -- 36% of the patients who were randomized to drug therapy subsequently had a catheter ablation," Stevenson noted. "That actually underestimates a bit the efficacy of catheter-ablation and overestimates the efficacy of drug success."

He also pointed out that about half the catheter patients required more than one procedure, which mirrors what occurs in practice.

He expressed concern that one procedural death occurred while performing ablation to correct an essentially benign condition where the main reason for seeking therapy was quality-of-life issues.

"A careful balance of risk and benefit is going to be required," Stevenson said. He noted that the trial supports recommendations from the European Society of Cardiology that catheter ablation can be offered as an initial treatment in selected patients.

[Chevychelov]

American Association for the Study of Liver Diseases
San Francisco • November 4 - 8, 2011

Virus Shuts Down Liver Cancer in Early Trials
SAN FRANCISCO -- Patients with advanced hepatocellular carcinoma appeared to gain a survival benefit when treated with the higher of two doses of an investigational oncolytic virus, results of a small phase II trial showed.
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Platelet Booster Aids HCV Therapy
SAN FRANCISCO -- Patients with chronic hepatitis C virus infection and thrombocytopenia had significant improvement in virologic response when pegylated interferon alpha 2a was given with eltrombopag, results of a randomized trial showed.
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Milk Thistle No Help in Chronic HCV
SAN FRANCISCO -- A botanical agent used in the treatment of liver disorders had no detectable effect on hepatitis C virus disease activity in comparison with placebo in patients with previously treated chronic disease, results of a randomized trial showed.
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New PI Effective, Safe in HCV Trial
SAN FRANCISCO -- An investigational hepatitis C drug was safe and effective in a small randomized trial, a researcher said here.
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HCV Drug Effective in Patients Co-Infected With HIV
SAN FRANCISCO -- In patients with both HIV and hepatitis C virus, response rates to a direct-acting agent that targets the liver virus were high, a researcher said here.
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MicroRNA Drug Safe in Ongoing HCV Study
SAN FRANCISCO -- A novel hepatitis C virus drug targeting genetic material in the liver was safe and well tolerated in a small, dose-finding clinical trial, a researcher said here.
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Fatty Liver May Benefit from Mediterranean Diet
SAN FRANCISCO -- The so-called Mediterranean diet may be a way to treat non-alcoholic hepatic steatosis or fatty liver disease, a researcher said here.
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Oral HCV Combo Yields Rapid Response
SAN FRANCISCO -- A combination of two investigational antiviral drugs with different mechanisms of action against hepatitis C virus yielded quick and persistent responses in previous nonresponders without the use of pegylated interferon, a researcher said here.
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Antiviral Likely Too Costly for Initial HCV Tx
SAN FRANCISCO -- First-line treatment with the direct-acting antiviral agent telaprevir (Incivek) appeared unlikely to be cost-effective for hepatitis C virus infection in patients with the favorable CC IL28B polymorphism, according to a decision modeling analysis.
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Hepatitis E Rare After Heart Transplant
SAN FRANCISCO -- Hepatitis E virus infection occurred as an infrequent complication after heart transplantation, but when it did, it ran an unpredictable clinical course with a wide range of severity, results of a Dutch study showed.
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Drug for Autoimmune Liver Disease Promising
SAN FRANCISCO -- An investigational drug aimed at primary biliary cirrhosis, an autoimmune liver disease, showed "clear biochemical improvement" in a short trial, a researcher said here.
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New HCV Drugs Draw Attention
SAN FRANCISCO -- Two new agents that act directly on the hepatitis C virus are already approved and details on many more now in the pipeline are being reported here at the annual meeting of the American Association for the Study of Liver Diseases.
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Cirrhosis Patients Benefit from Anticoagulant
SAN FRANCISCO -- In people with advanced cirrhosis, a low molecular weight heparin can prevent portal vein thrombosis, a researcher said here.
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Hepatitis C Now Bigger Killer than HIV
SAN FRANCISCO -- Mortality associated with hepatitis C has surpassed that of HIV, a researcher said here.
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Many Liver Recipients Fare Well 20 Years Out
SAN FRANCISCO -- Quality of life and mental health for 20-year survivors of liver transplantation was comparable to that of the general population, and pediatric recipients had similar physical status, investigators reported here.
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Livers from Older Donors Okay for Transplant
SAN FRANCISCO -- Donor age did not affect recipient survival after liver transplantation over the past five years, data from a single-center experience showed.
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New HCV Drug Promising, Cuts Out Interferon
SAN FRANCISCO -- Treatment with an investigational hepatitis C drug allowed investigators to dispense with an old stand-by -- pegylated interferon-alpha.
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Alcohol Not Main Killer of Older Drinkers
SAN FRANCISCO -- Older people who drink heavily don’t necessarily have to fear dying of liver disease, a researcher said here.
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HCV Phone Program Equals Office Visits
SAN FRANCISCO -- Patients treated by telemedicine for hepatitis C do as well as those that can come to a specialist’s office, a researcher said here.
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High-Risk HPV Seen in Low-Risk Liver Tx Patients
SAN FRANCISCO -- A substantial proportion of women evaluated for liver transplant had coexisting infection with the hepatitis C virus and high-risk human papillomavirus, investigators reported here.
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African-Americans Face Hep C ’Triple Whammy’
SAN FRANCISCO -- African Americans don’t spontaneously clear the hepatitis C virus as often as other racial and ethnic groups, a researcher reported.
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HCV Testing by Birth Cohort Cost-Effective
SAN FRANCISCO -- Birth-cohort screening for hepatitis C virus infection proved highly cost-effective, even when universal treatment with direct-acting antiviral therapy was factored in, according to a study reported here.
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[Chevychelov]

American Society of Nephrology
Philadelphia • November 8 - 13, 2011

Declining GFR Linked to Mortality Risk After MI
PHILADELPHIA -- Patients with chronic kidney disease had a significantly increased risk of death after myocardial infarction, and the risk increased as glomerular filtration rate declined, a review of 103,000 myocardial infarction patients showed.
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Calcium Score Predicts CVD Risk in Kidney Disease
PHILADELPHIA -- In patients with chronic kidney disease, coronary artery calcification predicted the risk of cardiovascular disease events, especially in those with no history of it, investigators reported here.
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Renal Benefits of Diabetes Control Emerge Late
PHILADELPHIA -- The risk of progressive kidney disease decreased by 50% in patients with type 1 diabetes managed by tight glycemic control, a new analysis of two landmark trials showed.
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Diabetes Drugs Differ in Effects on Weight in ESRD
PHILADELPHIA -- Two oral hypoglycemic drugs achieved similar diabetes control in patients with type 2 diabetes and end-stage renal disease, but sitagliptin did so without weight gain, investigators reported here.
[Ссылки доступны только зарегистрированным пользователям ]

Google of Some Benefit as Renal Training Tool
PHILADELPHIA -- Google might help internal medicine residents identify rare kidney problems but offered no help in the diagnosis of common renal conditions, investigators reported here.
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Less CV Risk in Dialysis With Pomegranate
PHILADELPHIA -- Patients on hemodialysis had significant improvement in their cardiovascular risk profile after consuming pomegranate juice weekly for a year, Israeli investigators reported here.
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Tacrolimus KOs Nephrotic Syndrome in Kids
PHILADELPHIA -- Tacrolimus (Prograf) was better than cyclophosphamide at inducing and sustaining remission of proteinuria in pediatric patients with steroid-resistant nephrotic syndrome, an Indian study showed.
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Vitamin D No Help for Enlarged Heart
PHILADELPHIA -- Daily use of a synthetic form of vitamin D failed to reduce left ventricular mass in chronic kidney disease patients with mild to moderate left ventricular hypertrophy, a trial showed.
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Mixed Results for Fish Oil in Preventing Blocked Dialysis Grafts
PHILADELPHIA -- Although a trial of fish oil capsules to prevent stenosis of hemodialysis grafts failed to meet its primary endpoint, the supplement may still have a role to play, a randomized, placebo-controlled trial showed.
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Kidney Patients Using Harmful Dietary Supplements
PHILADELPHIA -- From 10% to 15% of patients with chronic kidney disease reported using potentially nephrotoxic dietary supplements, an analysis of a large government database showed.
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High Systolic BP Tied to Declining Renal Function
PHILADELPHIA -- A rise in systolic blood pressure is associated with greater odds of a rapid decline in kidney function in the general older population, researchers found.
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HCV Infection Virtually Untreated in Dialysis Patients
PHILADELPHIA -- Hepatitis C virus (HCV) infection is associated with an increase in mortality in patients on hemodialysis, but treatment is rare in that population, researchers found.
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Hypertension in Pregnancy Has Lingering Effects
PHILADELPHIA -- Development of a hypertensive pregnancy disorder was associated with greater risks of adverse cardiovascular and renal outcomes for the mother later in life, researchers affirmed.
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Diabetes Plus Dialysis Equals Glycemic Control Dilemma
PHILADELPHIA -- There is a sweet spot for glycemic control among patients with end-stage renal disease, such that treatment that is either too intensive or too lax is associated with higher mortality, two studies showed.
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Sweetened Drinks Tied to Hypertension Risk
PHILADELPHIA -- Consuming beverages flavored with either sugar or artificial sweeteners was associated with a higher risk of developing hypertension, researchers found.
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Kidney Risk Higher in Diabetic Women than Men
PHILADELPHIA -- Among patients with type 2 diabetes, women were more likely to have risk factors for chronic kidney disease than men, which may also put them at risk for poorer outcomes, researchers found.
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Nephrologists Focus Globally
PHILADELPHIA -- This year’s meeting of the American Society of Nephrology -- now called Kidney Week instead of Renal Week -- will have a worldwide focus, program chair Mark Okusa, MD, told MedPage Today.
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[Chevychelov]

Medical News from
AHA: American Heart Association Meeting
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[Chevychelov]

Beta-blockers may prevent complications from breast cancer therapy
By

AHA Scientific Sessions 2011

ORLANDO, Fla. — Beta-blockers appear to help prevent CV-related complications associated with trastuzumab, according to results presented at the American Heart Association Scientific Sessions 2011.

Researchers studied data on 197 patients with breast cancer and no history of prior HF who were taking trastuzumab (Herceptin, Genentech). Thirty patients were assigned beta-blockers for high BP and other heart conditions before starting trastuzumab.

During 12 months, 14 patients developed a new diagnosis of HF and 72 developed a new diagnosis of left ventricular dysfunction. Fewer patients in the beta-blocker group had evidence of LV dysfunction than in the group that did not take beta-blockers, the researchers said. No patients in the beta-blocker group had HF during the study.

Although the researchers found a positive effect of beta-blockers, the same was not observed with ACE inhibitors, anthracycline or other types of chemotherapy before treatment with trastuzumab. However, current smokers were at significantly greater risk for LV dysfunction.