Обзор американских кардиологических журналов за неделю (ссылки)

[Chevychelov]

HFSA: Depressed Spouse Affects HF Patient, Too

By Todd Neale, Senior Staff Writer, September 22, 2011

Today 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 for patients with heart failure, their quality of life suffers most when both they and their caregivers are depressed.


Note that the next lowest physical and mental quality of life scores occurred when only the patient was depressed.
Review

BOSTON -- Heart failure patients' quality of life suffers most when both they and their caregivers are depressed, researchers found.

In a study of 91 patient-caregiver pairs, a patient's physical and mental quality of life scores were lowest when both the patient and his or her caregiver were depressed (P<0.05), according to Misook Chung, PhD, RN, of the University of Kentucky in Lexington.

The next lowest scores occurred when only the patient was depressed, she reported at the Heart Failure Society of America meeting here.

In this study, nearly three-quarters of the caregivers were spouses, and 76% of them were women.

From the caregiver's perspective, quality of life scores were similarly low when both the patient and the caregiver were depressed and when the caregiver was the only one who was depressed.

The findings indicate that healthcare professionals in a heart failure program should be focusing on both the patient's and the caregiver's well-being, which is not generally done, Chung said.

"Because caregivers are hidden patients, too, and a lot of caregivers of heart failure patients have stress, especially emotional stress. And they also have a lot of comorbidity because they are burdened," she said. "So I think the dyadic approach must be done."

Previous studies have shown that up to three-quarters of patients with heart failure report at least some depressive symptoms; up to 35% of those report high levels.

But depression is common among the caregivers as well, with studies indicating that 23% to 47% of spouses of patients of heart failure have mild-to-moderate depressive symptoms.

To explore the impact of depression in both the patient and the caregiver, Chung and her colleagues assessed depression, quality of life, and family function among 91 patient-caregiver dyads in Kentucky.

The caregivers were an average of 5.4 years younger than the patients with heart failure (56.7 versus 62.1, P<0.001). About half of all caregivers and patients had less than a high school education and most were white.

Nearly one-third of caregivers had at least one comorbidity, but information documenting comorbidities was missing for 23% of caregivers, so the rate could have been higher. Also, 30.8% of caregivers worked full or part-time outside the home.

All of the participants underwent screening with the Beck Depression Inventory, the McMaster Family Assessment Device, and the Short Form-36 to measure levels of depressive symptoms, family function, and quality of life, respectively.

Overall, 30% of patients and 25% of caregivers had at least mild depressive symptoms. On average, the level of depressive symptoms was higher in the patients (P=0.011).

The caregivers and patients gave similar scores on all three subscales of family function -- problem solving ability, communication, and general family function.

Physical quality of life scores were lower in the patients, although scores on mental quality of life were similar in the two groups.

On a scale of 0 (poor) to 100 (best), when neither party was depressed, patients reported a score of 34.6 compared with 26.0 when both were depressed (P<0.001). Scores for caregivers were 45.5 and 39.8, respectively (P<0.001).

In general, family function and quality of life were harmed most when both the patient and caregiver were depressed and least when neither was depressed.

For example, on a scale of 1 (healthy function) to 4 (unhealthy function), the general family function when neither party was depressed was 1.8 from both the patient and caregiver's perspective. When both parties were depressed, the scores rose to 2.3 and 2.4 for patient and caregiver, respectively (P=0.001 and P=0.05).

Chung said that she and her colleagues are conducting a pilot study among 38 dyads to see whether an intervention targeting both patients with heart failure and their caregivers can improve outcomes for both compared with usual care. The intervention involves cognitive behavioral therapy and the teaching of self-management skills.

[Chevychelov]

HFSA: Novel IV Drug No Help in Acute HF

By Todd Neale, Senior Staff Writer, September 22, 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 the use of intravenous cinaciguat, an activator of soluble guanylate cyclase, in patients with acutely decompensated heart failure, was not associated with improved clinical outcome and was associated with significant hypotension as an adverse event.
Review
BOSTON -- An investigational IV agent for acute decompensated heart failure does not appear to reduce dyspnea, although some questions remain about whether development should continue, researchers found.

In a series of three phase IIb trials, cinaciguat -- an activator of soluble guanylate cyclase -- failed to show substantial benefits over placebo, and resulted in a higher rate of severe hypotension, according to Mihai Gheorghiade, MD, of Northwestern University School of Medicine in Chicago.

That risk resulted in the premature termination of two of the three trials -- COMPOSE 1 and COMPOSE EARLY -- after only 74 patients were enrolled, he reported at the Heart Failure Society of America meeting here.


The third trial -- COMPOSE 2 -- was stopped early after only four patients enrolled because of indications that the trial could not be completed in a reasonable amount of time.

"Short-term treatment with intravenous cinaciguat in heart failure should no longer be investigated given its hypotensive effects at relatively low doses without a substantial benefit in terms of dyspnea, wedge pressure, or cardiac output," Gheorghiade concluded.

But in comments following Gheorghiade's presentation, John Burnett Jr., MD, of the Mayo Clinic in Rochester, Minn., said that the potential benefits of lower doses of cinaciguat could not be determined because that trial -- COMPOSE 2 -- only enrolled four patients before stopping.

He called for further research, perhaps in a chronic heart failure population instead of an acute population.

"I think we're premature in calling an end at this point with this small number of patients in a trial that's been terminated early," Burnett said.

But Gheorghiade stuck with his conclusion that it would be futile to continue looking at the short-term use of cinaciguat, and that there have to be options to stop investigating agents early in the process of development when they fail to show any signs of benefit.

"In the future, given the fact that we have so many molecules now in heart failure, we need to develop methods where we can stop early," he said.

"We cannot afford another ASCEND trial," he added, referring to the ASCEND-HF trial that showed nesiritide (Natrecor) -- widely used for acute decompensated heart failure at one time -- was no help or harm in that population.

The COMPOSE program included three randomized, placebo-controlled, phase IIb trials of cinaciguat in patients with chronic heart failure who were hospitalized with dyspnea and congestion.

The program was started based on preclinical studies that showed cardiorenal protective effects from the agent, independent of its powerful vasodilatory effects.

COMPOSE 1 (12 patients) and COMPOSE 2 (four patients) evaluated the hemodynamic effects of five IV doses of cinaciguat administered over 24 to 48 hours -- 10 and 25 µg/h (COMPOSE 1) and 50, 100, and 150 µg/h (COMPOSE 2). All of the patients in these two trials required invasive hemodynamic monitoring, and the primary outcome was an effect on pulmonary capillary wedge pressure at eight hours.

COMPOSE EARLY (62 patients) evaluated the three higher doses in patients hospitalized with worsening heart failure who were randomized within 12 hours of presentation. The primary outcome was an effect on dyspnea at eight hours.

Because of the low patient numbers, Gheorghiade presented descriptive analyses for COMPOSE 1 and COMPOSE EARLY only.

In COMPOSE 1, the hemodynamic study, each of the three doses of cinaciguat was associated with a greater reduction in systolic and diastolic blood pressure at eight, 24, and 48 hours, compared with placebo. There were no major changes in heart rate, cardiac index, right atrial pressure, or pulmonary capillary wedge pressure, Gheorghiade said.

In COMPOSE EARLY, there was also a substantial drop in blood pressure with each dose of cinaciguat, with no major changes in heart rate, renal function, creatinine, B-type natriuretic peptide (BNP), or N-terminal pro-BNP.

Dyspnea was not affected, although Gheorghiade noted that even though the average time to randomization was well within the 12-hour limit (5 hours 36 minutes), most patients did not have severe dyspnea when the infusions started.

Most of the treatment-emergent adverse events were related to severe hypotension, which was more frequent with cinaciguat than with placebo both in COMPOSE 1 (22% versus 0%) and COMPOSE EARLY (28% versus 5%).

Although Gheorghiade said cinaciguat should no longer be investigated, he said chronic cyclic guanosine monophosphate modulation with available oral soluble guanylate cyclase activators and stimulators should continue because of the cardiorenal protective effects seen in preclinical studies that were separate from their vasodilatory effects.

[Chevychelov]

Platelet Testing Not Ready for Prime Time

By Chris Kaiser, Cardiology Editor, September 22, 2011

Action Points
Note that this study found that high residual platelet reactivity during clopidogrel treatment is a poor prognostic sign, but treatment adjustment based upon this finding did not improve clinical outcome.


Note that the editorialist concluded that the currently available evidence does not support routine use of testing platelet function with subsequent adjustment of antiplatelet dosing in clinical practice.
Review
Patients undergoing percutaneous coronary interventions who have high residual platelet reactivity following clopidogrel (Plavix) loading are at an increased risk for adverse outcomes, but that study finding is not necessarily an argument for routine platelet testing, according to an outside commentator.

The primary endpoint rate -- a composite of cardiac death, myocardial infarction, any urgent coronary revascularization, and stroke at two years -- was greater in patients with high residual platelet reactivity (HRPR) compared with those with low residual platelet reactivity (LRPR) (14.6% versus 8.7%, P=0.003), reported David Antoniucci, MD, from Careggi Hospital in Florence, Italy, and colleagues.

Stent thrombosis, part of the secondary endpoint, also was higher in the HRPR group compared with the low reactivity group (6.1% versus 2.9%, P=0.01), according to the study, which was published in the Sept. 21 issue of the Journal of the American Medical Association.


While high platelet reactivity is prognostic for adverse events in this patient population, there are varying platelet function tests and cutoff values that make broad pronouncements about routine testing difficult to make, said Dominick J. Angiolillo, MD, PhD, of the University of Florida College of Medicine-Jacksonville, in an accompanying editorial.

For example, Antoniucci and colleagues in this study, called RECLOSE 2–ACS, used the gold standard platelet function test of light transmittance aggregometry, but this test is not user-friendly and "is limited only to experienced research laboratories," Angiolillo said.

It would have been of greater practical value to use a point-of-care assay, especially considering the large number of patients (1,789) with acute coronary syndrome (ACS) that were evaluated, he said.

In addition, the cutoff value of platelet aggregation of 70% or greater that investigators used was one they had previously defined, but they had derived it from a patient population with a different risk profile, Angiolillo said. He also had concerns about using one platelet measurement shortly after PCI rather than serial measurements.

More importantly, however, the platelet testing and subsequent titrating of clopidogrel or ticlopidine did not result in improved outcomes, similar to the result seen in the GRAVITAS trial.

While Angiolillo praised this and similar studies, he said that platelet function testing should be reserved for research, at least until "appropriately powered randomized controlled trials demonstrate efficacy and safety (in particular, low bleeding risk)."

In the Responsiveness to Clopidogrel and Stent Thrombosis 2–ACS (RECLOSE 2–ACS) study, researchers followed 1,789 patients from a single center for a median of 2.8 years. The incidence of HRPR was 14% and these patients tended to be older, have a higher incidence of diabetes and hypercholesterolemia, and were more likely to have a history of previous MI, compared with those with LRPR.

Even after antiplatelet treatment adjustment for those with HRPR, nearly 40% still had platelet aggregation values greater than 70%.

Researchers said the dual antiplatelet compliance rate at six months was above 97% in groups with and without HRPR, but the rate dropped to 63% and 68% in the low and high groups, respectively, at the median follow-up.

The absolute 5.9% difference in primary endpoint rates was mostly a factor of cardiac mortality, which was nearly 10% in the HRPR group compared with 4.3% in the LRPR group (P<0.001).

Kaplan-Meier curves showed that those with HRPR had twice the rate of primary endpoint and cardiac death at six months (P<0.001 for both), which remained significant out to two years (P=0.001 and P=0.002, respectively).

The stent thrombosis rate was also twice as high in the HRPR group compared with the low reactivity group, although the study was not powered for this adverse event, Antoniucci and colleagues said.

After multivariable analysis, researchers found HRPR to be independently associated with the primary endpoint (HR 1.49, 95% CI 1.08 to 2.05, P=0.02) and with cardiac mortality (HR 1.81, 95% CI 1.18 to 2.76, P=0.006).

The study is limited by its nonrandomized design. Also, the researchers cannot rule out the possibility of other medications having an effect on platelet responsiveness. They also noted that these results should be considered "hypothesis generating for further studies of tailored therapy using new antithrombotic agents" such as prasugrel (Effient) or ticagrelor (Brilinta).

[Chevychelov]

Cardiac Rehab Lowers Risk After Mild Stroke, Too

By Crystal Phend, Senior Staff Writer, September 22, 2011

Action Points
Note that coronary heart disease and stroke share many modifiable risk factors, and cardiovascular disease is often a comorbidity in patients presenting with TIA or stroke.


Point out that in this study, investigators were able to show that comprehensive cardiac rehabilitation successfully reduced multiple risk factors in patients presenting with TIA or mild stroke.
Review
Comprehensive cardiac rehabilitation may help patients who've had a transient ischemic attack (TIA) or a mild stroke avoid a second event, a feasibility study suggested.

The program of exercise, counseling, and medical management reduced key risk factors, including cholesterol and weight, significantly compared with baseline, according to Neville Suskin, MBChB, MSc, of the London Health Sciences Center Cardiac Rehabilitation & Secondary Prevention Program in London, Ontario, and colleagues.

The six-month intervention also shifted 25.6% of individuals into the lowest mortality risk category on the Duke Treadmill Score (P<0.001), the group reported in the November issue of Stroke: Journal of the American Heart Association.


Those benefits "could potentially play out into a reduction in strokes and TIAs and coronary events as well, although we have to follow up and validate that," co-author Peter L. Prior, PhD, told MedPage Today in an interview.

A randomized clinical trial is now under way to compare safety and efficacy with a control group, which the feasibility study did not include.

It shouldn't be difficult to expand such rehabilitation programs from their traditional cardiac population to include stroke patients as well, the researchers suggested.

"We're looking at a commonality of risk factors and physiology between cerebrovascular and cardiovascular populations," said Prior, a psychologist at the London Health Sciences Center Cardiac Rehabilitation & Secondary Prevention Program.

Basic secondary prevention at stroke prevention clinics typically includes only medical management and fairly low intensity counseling on risk factors, referring out for exercise, diet, and other interventions, he noted.

But putting all the aspects together in a single comprehensive program likely would improve participation and adherence rates, Prior speculated.

The study included 110 consecutive patients with at least one vascular risk factor who agreed to join such a program after a TIA or mild, nondisabling stroke in the prior 12 months.

These patients joined heart patients in a six-month outpatient cardiac rehab program that included an education component, depression screening and referral, encouragement to join an on-site smoking cessation program, and nutritional counseling with a registered dietitian emphasizing the Mediterranean diet.

Also part of the program was exercise four times a week -- supervised on-site, followed up at home, or both -- and medical management following clinical guidelines.


Patients also got standard secondary prevention clinic care.

At six months, significant changes from baseline included:
A 31.4% boost in aerobic capacity by 2.05 METs, considered clinically relevant (P<0.001)
A 0.30 mmol/L drop in total cholesterol (P=0.008)
An 11.6% reduction in total cholesterol to HDL ratio (P<0.001)
A 0.27 mmol/L decrease in triglycerides (P=0.003)
Loss of an average 2.44 cm in waist circumference (P<0.001)
A drop in body mass index by 0.53 kg/m2 (P=0.003)
Weight loss of 1.43 kg (3.15 pounds, P=0.001)
Fewer participants continued to smoke (P=0.008)


LDL fell by 10.3% (P=0.015) and HDL rose by 4.4% (P=0.069), while systolic and diastolic blood pressure also improved by 3.21 and 2.34 mm Hg, respectively, although none of those changes met the P=0.01 level required for statistical significance in the study.

Use of secondary prevention medications didn't improve, which may point to a need for better management, the researchers noted.

The average Duke Treadmill Score -- validated for prediction of mortality risk in outpatients suspected of having cardiovascular disease although not for stroke -- improved from 4.49 at baseline to 7.88 at the end of the six months (P<0.001).

Overall, the annualized rate of stroke recurrence was 4.6%, which fit in the low end of published risk estimates for this population and supported the safety of cardiac rehab for them, Suskin's group wrote.

They cautioned that without a control group the study couldn't rule out the possibility that usual care interventions accounted for the benefits seen over the course of cardiac rehab.

But Prior noted that the patient experience in Ontario was likely representative of that in the U.S. and elsewhere.

[Chevychelov]

Europe Eyes Afib Drug Restriction

By Chris Kaiser, Cardiology Editor, September 22, 2011

Review

The European Medicines Agency (EMA) today recommended restricting the use of the antiarrhythmic drug dronedarone (Multaq) because of its adverse event profile.

The drug has been associated with an increased risk of liver, lung, and cardiovascular adverse events.

The EMA's Committee for Medicinal Products for Human Use (CHMP) said dronedarone should be prescribed only for maintaining sinus rhythm after successful cardioversion in patients with paroxysmal or persistent atrial fibrillation or after alternative treatment options have been considered and rejected.

In January, the FDA said it would require a warning about the potential for liver injury added to the drug's label.

Then in July, drugmaker sanofi-aventis pulled the plug on the PALLAS trial because of an increase in cardiovascular events. PALLAS was testing dronedarone in patients with permanent atrial fibrillation, for which it is not approved.

The EMA committee initiated its review of the drug following reports of severe liver injury and the discontinuation of the PALLAS trial.

The committee acknowledged, however, that dronedarone remains a useful treatment option for some patients.

It also cautioned that the drug must not be used in patients with permanent atrial fibrillation, heart failure, or left ventricular systolic dysfunction and that doctors should consider discontinuation of treatment if atrial fibrillation reoccurs.

Patients on amiodarone should have regular monitoring of lung and liver function and heart rhythm. It's especially important to monitor liver function closely during the first few weeks of treatment, according to the committee.

The European Commission will consider the committee's recommendation.

[Chevychelov]

Cardiac Echo: There Is an App for That

By Todd Neale, Senior Staff Writer, September 23, 2011

Action Points
Explain that a field study of portable echocardiography in Honduras found that remote expert interpretation could be performed at both a workstation and smartphone with more than 90% agreement.

Note that diagnoses made by a cardiology fellow in the field performing the echocardiograms were overridden by the experts in more than one-third of cases.
Review

Remote interpretation of echocardiograms on a smartphone may help expand the use of such tests to previously inaccessible settings, researchers found.

There was relatively little loss of accuracy when electrocardiographic data transmitted from a remote Honduran village by a nonexpert was interpreted in the U.S. using a specially equipped smartphone instead of a full workstation, according to Brian Choi, MD, MBA, of George Washington University in Washington, D.C., and colleagues.

Among two expert echocardiographers, the intertechnology agreement between interpretations done on the smartphone and the workstation was 90% (P<0.01), the researchers reported online in the Journal of the American Society of Echocardiography.

"Our study does show that although pocket-size cardiac ultrasound may be inferior to complete echocardiographic evaluation, given the concordance of interpretation by expert readers using different methods to review the transmitted images, pocket-size cardiac ultrasound as an adjunct to traditional physical examination and with remote expert overread may provide additional diagnostic capability in remote or hostile environments," they concluded.

To test the accuracy of using a smartphone running medical imaging software compliant with the Health Insurance Portability and Accountability Act to interpret echocardiographic data from a remote location, the researchers conducted a study using 89 patients in a remote Honduran village and two expert echocardiographers in the U.S.

All of the Honduran patients (mean age 54; 58% female) underwent echocardiography by a nonexpert cardiology fellow who was on a humanitarian mission using a pocket-size ultrasound device.

The most common indications for echocardiography were arrhythmia (33%), cardiomyopathy (28%), and syncope or presyncope (15%).

The fellow, who had completed a three-month rotation in an academic echocardiography lab, provided a point-of-care diagnosis before transmitting the images to the U.S. by dial-up modem. The electronic files were sent by broadband from an urban center when field connectivity was unavailable.

The two expert echocardiographers in the U.S. first interpreted the findings on a workstation. After a minimum of four weeks, the studies were randomized and stripped of identifying information and sent to the readers via their smartphones, which had pinch zoom capabilities for both still images and cine loops.

Using the workstation, point-of-care diagnoses from the cardiology fellow were changed in 38% of patients; 41% of the changes were left ventricular function correction and 38% were valvulopathy correction. Another 18% of the changes involved poor image quality that prevented confirmation of the diagnosis.

The two U.S. experts agreed on the interpretation of the point-of-care diagnosis in 82% of cases (P<0.0001), which was excellent, according to the researchers.

"Smartphone interpretations by expert echocardiographers agreed with the point-of-care diagnoses in 61% of cases," they said. Further analysis comparing interpretations on workstations and the smartphone found excellent agreement of 90%.

Choi and colleagues noted that, because of the ubiquity of Internet access in the healthcare environment, the costs of starting a system involving remote interpretation of echocardiographic data on smartphones are limited to the point-of-care device, the smartphone, and the special software.

"Furthermore, as we find ourselves domestically to be in an era of more aggressive cost containment and care shifting more to mid-level practitioners, mobile consultation could provide improved access to specialists with advanced training, which may help limit cost growth without compromise of care," they wrote.

The researchers acknowledged some limitations of the study, including the fact that the indications for echocardiography were heavily weighted toward three conditions; the possibility that the point-of-care diagnostic accuracy would have been improved by having an expert echocardiographer there; significant transmission delays from the field; and the fact that the device used did not have spectral Doppler, electrocardiographic, or M-mode capabilities.

"Although larger, more robust echocardiographic equipment may have been more capable of acquiring superior data, such machines may not be practical in inaccessible locations, whether it be an austerely equipped humanitarian mission environment or in a crowded room at the bedside of a critically ill patient," the authors noted.

[Chevychelov]

Heart Failure Society of America
Boston • September 18 - 21, 2011
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Novel IV Drug No Help in Acute HF
BOSTON -- An investigational IV agent for acute decompensated heart failure does not appear to reduce dyspnea, although some questions remain about whether development should continue, researchers found.
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Depressed Spouse Affects HF Patient, Too
BOSTON -- Heart failure patients’ quality of life suffers most when both they and their caregivers are depressed, researchers found.
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Longer Look Confirms Nesiritide’s Flop
BOSTON -- Six-month follow-up in the ASCEND-HF trial confirmed a lack of significant clinical benefit -- or harm -- from nesiritide (Natrecor) in patients with acute decompensated heart failure, researchers found.
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Statins Tied to Lower Mortality in Afib
BOSTON -- Among patients with atrial fibrillation, those who are taking a statin may be less likely to die during follow-up than those who are not taking a statin, a retrospective study showed.
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CABG Has Benefit in Ischemic Heart Failure
BOSTON -- Adding CABG to guideline-based medical therapy improved quality of life in patients with ischemic heart failure, although the clinical significance of the findings remains unclear, an analysis of the STICH trial showed.
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Remote HF Monitoring Cuts Readmissions
BOSTON -- Monitoring heart failure patients remotely -- either through simple telephone calls or more complex telemonitoring -- can improve outcomes, with particular benefits in driving down hospital readmissions, a subanalysis of a Cochrane review showed.
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HF Outcome Better With Biomarker Panel
BOSTON -- A panel of seven biomarkers was highly predictive of adverse outcomes in patients with chronic heart failure, researchers found.
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Heart Failure Risk Rises as the Blood Boils
BOSTON -- Individuals who are prone to getting angry may have a higher risk for heart failure, researchers found.
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Tracking Fluid Build-Up Fails to Help HF Patients
BOSTON -- Measuring intrathoracic impedance in patients with heart failure -- and alerting the patients at a certain threshold -- did not improve outcomes, researchers found.
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Controversy Highlighted at Upcoming Meeting
BOSTON -- Much progress has been made in managing heart failure, but there are still some areas of controversy that will be highlighted at the upcoming meeting of the Heart Failure Society of America here.
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[Chevychelov]

European Association for the Study of Diabetes
Lisbon • September 12 - 16, 2011
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Gliptin Tx Works Long-Term for Glycemic Control
LISBON -- Long-term treatment of type 2 diabetes with dipeptidyl peptidase-4 (DPP-4) inhibitors for two years appeared to maintain improvement in glycosylated hemoglobin A1c levels, researchers reported here.
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Debate Brings Incretin Risks to Forefront
LISBON -- Whispered concerns about a higher risk of certain cancers linked with incretin therapies for diabetes have become more audible after a debate here between top researchers.
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Meta-Analysis Confirms Value of CGM in Type 1 Diabetes
LISBON -- Despite its limitations, continuous glucose monitoring (CGM) appears to improve glycemic control compared with self-monitoring in type 1 diabetes patients, researchers reported here.
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Closed-loop System on Par With Open-loop for Glucose Control
LISBON -- A bihormonal closed-loop system in patients with diabetes that delivers rescue glucagon as well as insulin may be comparable with open-loop administration of the two hormones, researchers said here.
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Breast Cancer in Diabetes May Be Artifactual
LISBON -- An apparent risk of breast cancer in postmenopausal women recently diagnosed with type 2 diabetes may in fact be related to detection bias, researchers reported here.
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’Gliptin’ Diabetes Drugs May Be Heart Savers
LISBON -- While searching for potential cardiovascular risks among studies involving dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetics, researchers made a surprising discovery -- treatment with the so-called gliptin class appears to protect the heart.
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Contest Offers $100K for "New Insulin"
LISBON -- One diabetes advocacy group is betting that the next big thing in treatment, especially for type 1 disease, will come not from within the field, but from putting together many heads from various disciplines.
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Novel Drug BRIGHTENs Diabetes Research
LISBON -- The investigational drug ipragliflozin improved glycemic control and decreased body weight and blood pressure, according to the phase III BRIGHTEN study.
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Once-Weekly Exenatide Flops Against Liraglutide
LISBON -- A trial failed to prove that once-weekly injections of exenatide (Bydureon) were equal to daily injections of liraglutide (Victoza) in reducing glycosylated hemoglobin A1c in type 2 diabetes patients, researchers reported here.
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No Microvascular Benefit With Intense BP, Glucose Control
LISBON -- Aggressively lowering blood pressure and blood glucose together won’t provide any microvascular benefits to type 2 diabetes patients, researchers said here.
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Biomarkers May Predict CAD, Death in Diabetics
LISBON -- Two biomarkers may be associated with cardiovascular events and death in type 2 diabetes patients, researchers reported here.
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Liraglutide Plus Insulin Does Not Add Weight
LISBON -- The addition of insulin to the treatment regimen of type 2 diabetes patients on liraglutide (Victoza) doesn’t wipe out previously seen weight loss -- and insulin appears to help these patients achieve glycemic control, researchers said here.
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Gestational Diabetes Guidelines Controversial
LISBON -- International guidelines on screening for gestational diabetes that will likely raise the prevalence of the condition have sparked questions over appropriate diagnostic tools and cost efficacy, researchers said here.
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Intensive Glucose Control Cuts Renal Risks
LISBON -- Intensive glucose-lowering may protect against end-stage renal disease (ESRD) in diabetic patients, according to an analysis of data from the ADVANCE trial.
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Diabetes, MI, Feeling Bad Add Up to Shorter Life
LISBON -- Men with type 2 diabetes and an acute myocardial infarction who score lower on quality-of-life measures have a greater mortality risk than other men with these conditions whose scores indicate they feel better about their health, researchers reported here.
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Diabetes Estimate Now 366 Million
LISBON -- About 366 million people worldwide have diabetes, according to the latest figures from the International Diabetes Federation, released in advance of a United Nations summit on non-communicable diseases in New York next week.
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Hot Controversies, but No Hot-Line Sizzlers
LISBON -- Though there’s "no major endpoint trial" being presented at this year’s European Association for the Study of Diabetes meeting here, executive director Viktor Joergens, MD, said there will be plenty of debate over several recent controversies.
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[Chevychelov]

Dabigatran: A New Option for Anticoagulation in Atrial Fibrillation and Venous Thromboembolism
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"Smart" Coaching to Promote Physical Activity, Diet Change, and Cardiovascular Health
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What should be the blood pressure target for diabetic patients?
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Focus on: Antiplatelet therapies

The evolution of antiplatelet therapy in cardiovascular disease
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The pharmacogenetics of antiplatelet agents: towards personalized therapy?
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Cost-effectiveness of oral antiplatelet agents—current and future perspectives
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Managing adverse effects and drug–drug interactions of antiplatelet agents
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The role of aspirin for stroke prevention in atrial fibrillation
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Appropriate ICD interventions found in half of ARVD/C patients

Bhonsale A. J Am Coll Cardiol. 2011;58:1485-1496.

About one-half of patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy after placement of an implantable cardioverter defibrillator for primary prevention experience appropriate interventions, new data suggest.

The study included patients from the Johns Hopkins registry with definite or probable arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C), defined by the presence of major and minor diagnostic criteria according to the 2010 revised Task Force Criteria, who underwent ICD implantation for primary prevention. Researchers obtained detailed phenotypic, genotype and ICD event information and assigned appropriate ICD therapies based on patients’ intracardiac electrograms.

There were 84 ARVD/C patients who received an ICD for primary prevention of sudden cardiac death, and 48% of patients received appropriate ICD therapy during a mean of 4.7 ± 3.4 years. According to researchers, proband status (HR=6.4; 95% CI, 2.3-18.2), the presence of nonsustained ventricular tachycardia (HR=3.8; 95% CI, 1.9-7.6), inducibility at electrophysiologic study (HR=3.1; 95% CI, 1.4-6.9) and Holter premature ventricular complex count of more than 1,000/24 hours (HR=3.1; 95% CI, 1.1-8.3) were predictors of appropriate ICD therapy; and nonsustained ventricular tachycardia (HR=10.54; 95% CI, 2.40-46.18) and inducibility at electrophysiologic study (HR=4.5; 95% CI, 1.37-14.96) were predictors of appropriate ICD interventions on multivariable analysis.
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Coronary CTA bested MPI in patients with acute chest pain

Goldstein J. J Am Coll Cardiol. 2011;58:1414-1422.

The use of coronary CTA resulted in a more rapid, cost-efficient diagnosis than rest-stress myocardial perfusion imaging in ED acute, in low-risk patients with chest pains, according to study results.

From June 2007 to November 2008, patients with acute chest pain admitted to the ED were randomly assigned to a coronary CTA group or a myocardial perfusion imaging (MPI) group. According to researchers, patients included in the study had chest pain suspicious for angina; were aged 25 years or older; had a time from onset of chest pain to presentation of 12 hours or less; had a time from ED presentation to randomization of 12 hours or less; had normal or nondiagnostic rest electrocardiogram evidence of ischemia; and had a thrombolysis in MI risk score of 4 or less for unstable angina or non-STEMI. Researchers defined the primary outcome as diagnostic efficiency starting when patients were randomly assigned into coronary CTA or MPI groups and ending when test results were called to ED physicians; secondary outcomes were defined as ED cost of care and safety.

Researchers reported a 54% reduction in time to diagnosis when using the coronary CTA diagnostic strategy demonstrating a more rapid diagnosis vs. MPI (P<.0001). In secondary outcomes, there was a 38.2% reduction in total ED costs of care in the coronary CTA diagnostic strategy vs. MPI (P<.0001), and the safety endpoint showed that both strategies had similar low number of cases with adjudicated major adverse cardiac events (P=.29) and that there were no deaths in either group.

Overall, 361 patients were enrolled in the coronary CTA group. More than minimal CAD was ruled out in 82.2% of coronary CTA patients, more than 70% stenosis was detected in 3.6% of patients, intermediate stenosis was found in 10.2% of patients, and 3.9% of cases had scans that were not fully interpretable, according to researchers. Of the 37 coronary CTA patients who had rest-stress MPI performed, 23 had either intermediate lesions or nondiagnostic scans, 10 had normal CCTA, and four showed more than 50% narrowing. Index testing among 338 MPI patients was normal or probably normal in 89.9%, and 89.1% were discharged within 6 hours. Invasive coronary angiography was performed in 24 coronary CTA cases vs. 21 MPI cases.

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American Society of Nuclear Cardiology
Denver • September 8 - 11, 2011

Criteria to Guide Stress SPECT Need Work
DENVER -- Wide variations in the predictive power of appropriateness criteria for SPECT myocardial perfusion imaging warrants further research before lab accreditation becomes mandatory next year, researchers said here.
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Guidelines for Stress SPECT Improve Outcomes
DENVER -- Adherence to the appropriateness criteria for stress SPECT myocardial perfusion imaging (MPI) can lead to better utilization and outcomes, but inappropriately ordered tests offer a less useful diagnostic yield, a single-center study found.
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Stress Tests Clarified With CT Angiography
DENVER -- In patients with prior inconclusive stress tests and recurring chest pain, the use of coronary CT angiography (CCTA) can reduce downstream tests, a single-center retrospective study found.
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Stress Imaging Drug Works As-Needed
DENVER -- The use of regadenoson (Lexiscan) is safe and can lead to cost and time efficiencies in patients undergoing exercise SPECT myocardial perfusion imaging.
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Imaging Agent May Target LV Ablation Hot Spots
DENVER -- An imaging radiotracer used for cardiac innervation may identify left ventricular (LV) areas linked to tachyarrhythmic events, subsequently aiding ablation procedures, a small study found.
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IV Drug KOs GI Discomfort of Stress Imaging
DENVER -- Aminophylline is safe and feasible with the newer generation vasodilator regadenoson (Lexiscan) in patients undergoing myocardial perfusion imaging (MPI), a new study demonstrated.
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More Patients May Be Candidates for Exercise Stress
DENVER -- Primary care physicians appear more likely to select patients for pharmacological stress testing, even though these patients may be capable of an exercise stress test, a single-center study found.
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Gender, Language May Sway Selection for Exercise MPI
DENVER -- English-speaking men are more likely to be referred for an exercise stress with SPECT myocardial perfusion imaging (MPI) versus a pharmacological stress test, a large database study found.
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Age Alone May Put Symptom-Free People at Risk for Silent Ischemia
DENVER -- Traditional risk factors were predictive of silent ischemia in younger individuals, while age seemed to be the main predictor in those ages 74 and up, researchers found.
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Workforce Challenges, Novel Tracers Top Meeting
DENVER -- It’s an interesting time to be a nuclear cardiologist, with both challenges and exciting new developments on the horizon, said the Mayo Clinic’s Todd Miller, MD, program chair of American Society of Nuclear Cardiology meeting.
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A review of the 2011 ESC guidelines on cardiovascular disease in pregnancy
An article from the e-journal of the ESC Council for Cardiology Practice.

Ferreira R.
Topics: Pregnancy and Heart Disease
Authors: Ferreira, R.
Increasing prevalence of hypertension, obesity and diabetes, coupled with a rise in the age of expectant mothers, have contributed to increasing the burden of cardiac disease during pregnancy. The new ESC 2011 guidelines for the management of cardiovascular disease during pregnancy (1) provide physicians with new recommendations that come to update the 2003 ESC consensus document on this subject (2) and this paper aims to review its main recommendations.

A review of Recommendations
I - General

a- Childbearing age
cardiac disease
Risk assessment

b- Pre-pregnancy
In known or suspected congenital or acquired cardiovascular and aortic disease
Risk assessment and counseling

c- Pre-pregnancy and during pregnancy
cardiac disease
Risk assessment; with high risk patients to be treated in specialised centres by a multidisciplinary team
In congenital heart disease or congenital arrhythmia, cardiomyopathies, aortic disease or genetic malformations associated with CVD
Genetic counseling

d- During pregnancy
in unexplained or new cardiovascular signs or symptoms
Echocardiography; if echocardiography is insufficient for diagnosis gadolinium-free MRI to be considered

e- Delivery
in dilatation of the ascending aorta >45mm, severe aortic stenosis, Eisenmenger syndrome or severe heart failure
C-Section (Cesarean section) to be considered
in Marfan patients with an aortic diameter 40-45mm
C-section may be considered; but avoiding prophylactic antibiotic therapy during delivery.
II - Pulmonary Arterial Hypertension (PAH)

PAH as described (5) includes 1) all idiopathic and heritable forms of the disease
and 2) pulmonary hypertension associated with congenital heart disease with or without previous corrective surgery.

a- Child-bearing age
in pulmonary hypertension or in those with oxygen saturation below 85% at rest
to be advised against becoming pregnant
in suspicion of pulmonary embolism as causing or suspected to partly having caused pulmonary hypertension
associated anticoagulant treatment to be considered

b- During Pregnancy
In pulmonary arterial hypertension before becoming pregnant
continuation to be considered after delivering information regarding associated teratogenic effects
III - Aortic Disease

Heritable disease such as Marfan syndrome, bicuspid aortic valve, Ehlers Danlos syndrome, Turner syndrome and other forms of congenital heart disease predispose to both aneurysm formation and aortic dissection.

a- Child-bearing age
to be counseled on the risk of aortic dissection and the recurrence risk for the offspring

b- Pre-pregnancy
Marfan syndrome or other known aortic disease
imaging of the entire aorta (CT/MRI)
if ascending aorta >45mm
surgical treatment required
aortic disease associated with a bicuspid aortic valve when the aortic diameter is >50mm
surgical treatment to be considered

c- Pregnancy
with ascending aorta dilatation
echocardiographic imaging every 4-8 weeks
with dilatation of distal ascending aorta, aortic arch or descending aorta
gadolinium-free MRI

d- Delivery
for patients with ascending aorta >45mm
C-section to be considered
IV - Acquired and congenital valvular heart disease

a- Child-bearing age
atrial fibrillation, left atrial thrombosis or prior embolism
therapeutic anticoagulation
in 1) severe MS or 2) asymptomatic severe AS with symptoms development during exercise test or 3) severe aortic or mitral regurgitation and symptoms or impaired ventricular function or dilatation

b- Pregnancy
severe symptoms or systolic pulmonary artery pressure >50mmHg despite medical therapy
percutaneous mitral commissurotomy to be considered
severe aortic stenosis -symptomatic or LVEF<50%-
intervention
in patients with mechanical valves - until the 36th week
OAC recommended from second trimester
in patients with mechanical valves - after the 36th week and having stopped OAC
dose- adjusted UFH or LMWH
LMWH to be replaced by iv UFH at least 36 hours before planned delivery.

c- Delivery
If delivery starts while in OAC
C-section
V - Coronary Artery Disease

a- Pre-Pregnancy
in known CAD
pregnancy may be considered in the absence of residual ischemia and LV dysfunction

b- During pregnancy (9):
ACS is rare and strongly related to the major CAD risk factors
chest pain,
ECG and troponin levels to be taken
STEMI,
coronary angioplasty is preferred reperfusion therapy
non ST-elevation ACS without risk criteria,
conservative management is to be considered
VI - Acquired and inherited cardiomyopathies and heart failure

a- Child-bearing age
information to be delivered on the risk of deterioration of the condition during gestation and peripartum

b- During pregnancy
intracardiac thrombus, detected by imaging, or with evidence of systemic embolism
Anticoagulation
hypertrophic cardiomyopathy (HCM)
with atrial fibrillation
therapeutic AC with LMWH or oral vitamin K antagonists, according to the stage of pregnancy
with persistent AF
cardioversion to be considered

c- During pregnancy and after delivery
Peripartum cardiomyopathy (PPCM) is a form of dilated CM presented as heart failure with LV systolic dysfunction towards the end of pregnancy or in the months following delivery. It is a diagnosis of exclusion (10).
heart failure treatment according to general guidelines for the treatment of acute and chronic heart failure, - while avoiding ACE inhibitors, angiotensin II receptor blockers and rennin inhibitors

d- Delivery
In hypertrophic cardiomyopathy.
Delivery under Beta-blocker protection

VII - Arrhythmias

a- Before or during pregnancy
Ventricular tachycardia (VT)(11):
implantation of an ICD, if clinically indicated

b- During pregnancy
Episodes of tachyarrhythmia
DC conversion to restore sinus rhythm - all antiarrhythmic drugs to be considered toxic for the fetus
Atrial flutter and fibrillation in relation with structural heart disease leading to haemodynamic instability
electrical cardioversion
haemodynamicaly stable patients
pharmacological treatment to be considered

supraventricular tachycardia (12):
acute conversion of paroxysmal SVT
vagal maneuvre followed by i.v. adenosine
acute treatment of any tachycardia with haemodynamic instability
Immediate electrical cardioversion
pharmacological conversion of paroxysmal SVT i.v.
metoprolol or propranolol to be considered
pharmacological conversion of paroxysmal SVT i.v.
verapamil to be considered

sustained, unstable and stable VT
immediate electrical cardioversion with implantation of permanent pacemaker or ICD with echocardiographical guidance to be considered, especially if the foetus is beyond 8 weeks gestation
drug-refractory and poorly tolerated tachycardias
catheter ablation to be considered
VIII - Hypertensive Disorders

Includes (13) 1) Pre- pregnancy hypertension: BP>140/90 mmHg or developing before 20 weeks of gestation 2) Gestational hypertension - Develops after 20 weeks’ gestation and resolves in most cases within 42 days postpartum 3) pre-eclampsia - when associated with significant proteinuria 4) Pre-existing hypertension with further worsening of BP and protein excretion >3g/day in 24 hour urine collection after 20 weeks’ gestation 5) Antenatal unclassifiable hypertension. When BP is first recorded after 20 weeks of gestation and hypertension is diagnosed.

a- During pregnancy (14):
SBP of 140-150 mmHg or DBP of 90-99mmHg
non-pharmacological management
SBP>170mmHg
emergency hospitalisation
In pre-eclampsia associated with pulmonary edema,
infusion i.v. nitroglycerine
In severe HT
drug treatment with i.v. labetalol or oral methyldopa or nifedipine
With continued pre-pregnancy HT
pre-pregnancy medication to be continued- provided ACE inhibitors, angiotensin II antagonists and direct renin inhibitors be kept under close BP control

b- For delivery
in gestational HT with proteinuria with adverse conditions
Induction
IX - Venous thromboembolism including pulmonary embolism

a- Pre-pregnancy and early pregnancy
risk factors for VTE to be assessed - mainly previous history of unprovoked DVT or PE and thrombophilias forming high, intermediate and low risk groups
- high risk
to receive antenatal profilaxis with LMWH as well as 6 weeks postpartum
- intermediate risk
postpartum prophylaxis with LMWH to be given for at least 7 days or longer, if >3 risk factors persist

b- During pregnancy
in suspected VTE
D-Dimer measurement and compression ultrasonography
in acute VTE
pregnancy UFH is in high risk and LMWH in non-high risk patients

c- During pregnancy and puerperium
increased incidence of venous thromboembolism (VTE) and its clinical manifestations (PE).
Conclusion
Suspected cardiac disease in childbearing age should prompt physician to offer counseling and special care
Cardiac disease during pregnancy to be managed by interdisciplinary teams
High risk patients to be sent for treatment in specialised centers
Diagnostic procedures and interventions to be performed by specialists with great expertise in the individual techniques
Registries and prospective studies to be implemented to improve current state of knowledge.

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Bayer Claims ACS Benefit for Xarelto

By Peggy Peck, Executive Editor, Reviewed by
September 29, 2011

Review

Rivaroxaban (Xarelto) plus standard therapy reduced death, myocardial infarction, and stroke in a study of acute coronary syndrome, according to Bayer, which announced the topline results.

But, the company said the drug, an oral direct factor Xa inhibitor, was associated with an increased risk of bleeding.

Earlier this week Astellas announced it was halting development of darexaban maleate, its entry in the oral anticoagulant field, after an acute coronary syndrome study revealed a higher bleeding risk associated with the drug -- and almost a year ago a trial of apixaban (Eliquis) in ACS was halted when excess bleeding was observed.

Bayer said it "intended to present these data as soon as possible at a forthcoming scientific congress as well as to file for market authorization by the end of this year."

Rivaroxaban, which is marketed in the U.S. under a collaboration with Johnson & Johnson, is FDA approved for prevention of deep vein thrombosis in patients undergoing joint surgery. The FDA is currently considering the company's application to market the drug for the prevention of stroke in patients with nonvalvular atrial fibrillation.
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CMS to Decide on Paying for New Valve Procedure

By Emily P. Walker, Washington Correspondent, Reviewed by
September 29, 2011

Review

WASHINGTON -- Responding to requests from two major cardiology groups, the Centers for Medicare and Medicaid Services (CMS) has started the process of determining whether it should have an official payment policy for transcatheter aortic valve replacement (TAVR) to treat aortic stenosis.

The American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) formally petitioned CMS to open a "National Coverage Analysis" on the new procedure -- more familiarly known as TAVI -- during which an artificial valve is inserted percutaneously into the patient's own aortic valve.

The procedure is intended as an alternative for patients with severe aortic stenosis who are too frail for open-heart surgery.

Opening a National Coverage Decision is a highly unusual move on CMS' part because there is not yet an FDA-approved valve to use in the procedure. The agency hardly ever starts investigating whether Medicare should cover a device or drug before it's been approved.

There are a number of TAVI devices in development, but Edwards Lifesciences' Sapien transcatheter heart valve is expected to hit the market first. In July, the FDA's Circulatory System Devices panel voted 9-0, with one abstention, to recommend approval for Sapien.

Although the FDA has yet to make its decision, the company is expecting approval in October. The agency doesn't have to follow the advice of its advisory committees, although it often does.

While members of the advisory panel were concerned with the stroke risk observed in the Edwards Lifescience's two-part PARTNER trial, they ultimately felt the benefits of the device -- 20% more patients were alive one year after receiving the Sapien device than with standard therapy -- outweighed the risks.

Those risks are reduced when the procedure is performed in a specialized heart center by a multidisciplinary team in which each member has appropriate training and credentialing; in a modified cardiac lab or hybrid operating room with the necessary specialized equipment; and when the team uses a pre-planned approach on how to manage the decision-making during the procedure, the presidents of the ACA and TCT wrote in a Sept. 22 letter to Louis Jacques, MD, director of the coverage and analysis group for CMS.

The groups urged CMS to make coverage contingent on the procedure being performed in an optimal setting.

In addition, the groups said it's "critical" that long-term follow-up be performed (most data in Partner only went up to two years) and that all patients undergoing TAVI be enrolled in a registry to track long-term outcomes. They said CMS should not cover the procedure unless it's reported in a mandatory registry.

It its announcement, CMS said it is particularly interested in a definition of when TAVI is "reasonable and necessary" -- the standard the agency adheres to when deciding whether Medicare will cover a procedure. The agency also said the question has been raised of how generalizable the study data are to a "real world" setting.

The Partner trial tested the transcatheter technology in patients too frail to undergo surgery as well as in patients who were candidates for surgical repair. The primary endpoint was a comparison of survival through the full duration of the study. Patients with the Sapien device had better survival rates at one year than those in the control group -- 69% compared with 50% (P<0.0001).

However, there was a higher incidence of stroke observed in the trial: After 30 days, 13 patients in the TAVI group had a stroke, compared with just three in the standard treatment arm. After one year, 25 patients in the TAVI group had had a stroke, compared with eight in the control group.

CMS will accept public comments on transcatheter aortic valve replacement through Oct. 28 and is slated to issue a final decision by March 28, 2012.

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Afib Patients Often Uninformed About Stroke Risk

By Chris Kaiser, Cardiology Editor, Reviewed by September 29, 2011

Review

People with atrial fibrillation were more concerned about heart attacks than stroke, and only half of more than 500 Afib patients said they considered themselves at risk for having a stroke, according to a survey by the American Heart Association.

Out of 502 respondents (236 men), 42% said heart disease and myocardial infarction are their main health concerns, while stroke was cited as the greatest concern by only 8%. Beating out stroke were cancer (13%), obesity (11%), and diabetes (10%).

Twenty-five percent of those who answered the emailed survey said they were not at risk of stroke, while another 25% were not sure about the risk. More women than men were "not sure" (29% versus 20%), but there were no significant differences between men and women who said either they were or were not at risk.

Interestingly, only two-thirds of respondents said they discussed stroke risk with a healthcare professional, with men reporting that they were more likely to have discussed stroke risk with their doctors -- 74% versus 60% -- despite the fact that there were more high-risk women in the sample than high-risk men.

"The systems of healthcare are such that practitioners are under pressure to see patients quickly," Mark Estes III, MD, a professor of medicine at Tufts University School of Medicine in Boston and a spokesperson for the AHA, told MedPage Today. "In that context, both patients and physicians have to be proactive. Physicians can give patients written material and direct them to various websites."

When respondents were asked which health concern they "feared" the most, the top answer was stroke, even though heart disease and myocardial infarction were ranked as the leading health concerns.

Twenty-six percent of those surveyed said they feared stroke versus 15% who said they feared heart attack.

The fear of stroke increased with age so that only 16% of people younger than 55 said they worried about stroke versus 31% of those who were older than 65.

This is not surprising as the risk of stroke increases with age, Estes said. "Generally, the age cutoff where the risk of stroke increases substantially is 65, and over 75 is where we feel the risk is significant."

Other health concerns that were feared included heart failure (14%), disability (12%), and death (12%).

Another indication of a knowledge gap for those with atrial fibrillation was when respondents were asked whether they agreed with this statement: "Everyone with atrial fibrillation is at risk for a stroke." Only two-thirds agreed with it, but perhaps more troubling was the answer given by 17% of those surveyed -- they called the statement false.

Estes said that it is not just patients who are confused or misinformed about atrial fibrillation, noting that many healthcare providers overestimate the risk associated with warfarin therapy. That, coupled with the inconvenience of warfarin maintenance, leads many physicians to assume that patients won't want to initiate therapy.

But open communication between physicians and patients often solves these problems.

"Physicians can have a discussion with patients, give them information, outline the options, and let them know that a decision has to be made and work with them to select the best option for their particular situation," Estes said. "Ongoing discussions can help answer concerns and address compliance issues."
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Left Atrium Key to Stroke Risk After Afib Ablation

By Crystal Phend, Senior Staff Writer,
September 29, 2011

Action Points
This single center cohort study examined the risk of stroke after radiofrequency and cryoablation Maze procedure in 150 patients who were in sustained sinus rhythm post-procedure.


Lack of left atrial mechanical contractility was associated with a five-fold increased risk of stroke, and increased left atrial size was associated with a threefold increased risk of stroke.


Echocardiographic evaluation of the left atrium may be useful for risk stratification after Maze procedure; however, further study is needed to validate these findings.
Review

Stroke risk may remain high for atrial fibrillation patients despite a successful Maze procedure if the left atrium doesn't regain mechanical function, researchers found.

Lack of left atrial contractility predicted a persistent five-fold elevation in stroke risk (P=0.02) in a single center study by David Luria, MD, of the Sheba Medical Center in Tel Hashomer, Israel, and colleagues.

A large left atrium was another substantial post-Maze stroke risk factor, the group reported in the Oct. 4 issue of the Journal of the American College of Cardiology.

"Anticoagulant treatment should be strongly considered" for patients with the two risk factors, the group suggested in the paper.

This simple noninvasive echocardiographic approach would be reasonable as a first step to identifying anticoagulant candidates, Shunichi Homma, MD, and Marco Di Tullio, MD, both of Columbia University Medical Center in New York City, agreed in an accompanying editorial.

It could point to patients who need further assessment for more direct stroke risk indicators, such as spontaneous echo contrast or thrombus in the surgical stump of the appendage, they noted.

However, further validation in prospective studies is needed before initiating anticoagulation solely on the basis of large atrial volume or lack of left atrial mechanical contraction, they argued.

The study included 150 patients in sustained sinus rhythm after a modified Maze procedure using a combination of radiofrequency and cryoablation without the use of atrial incisions done from 2004 through 2009.

At three-month echocardiographic follow-up, 31% had no evidence of left atrial mechanical contraction. None of these 47 patients later regained contractile function.

During a mean follow-up of 24.5 months, ischemic stroke occurred in 15 patients (10%), most of whom had no left atrial contractility (10 patients, 21% of the 47).

Cumulative probability of surviving to year two without a stroke was thus only 43% for patients who had no left atrial mechanical contraction versus 95% for those who had atrial contractility (P=0.003).

In an analysis separating out patients on anticoagulants and with prosthetic mechanical valves that could influence stroke risk independently of left atrial mechanics, the researchers again showed an effect of absent contractility on stroke risk with 45% versus 95% cumulative stroke-free survival probability (P=0.01).

For patients with left atrial volume index of 33 mL/m2 or greater, the cumulative probability of going without a stroke was 55% compared with 94% in those with smaller left atria (P=0.01).

The multivariate-adjusted stroke risk associated with large atrial volume was 3.23-fold (P=0.03).

Notably, the CHADS2-VASc score wasn't predictive in patients without left atrial mechanical contraction, which Luria's group pointed to as evidence that "left atrial mechanical standstill is an independent and powerful risk factor for thromboembolic stroke."

The researchers noted that they did not consider risk in patients with decreased, rather than absent, left atrial contraction.

Other limitations included the nonrandomized, retrospective design and small number of thromboembolic strokes that occurred, leaving it underpowered to detect interactions, they added.

The editorialists warned about generalizability given the "unusually high" stroke incidence compared with other studies (10% versus 1.6% in one comparable study), "possibly indicating the selection of a population at especially high baseline risk and likely reflecting the absence of anticoagulation."

Also, only five of the 15 stroke patients had transesophageal echo confirmation that the left atrial appendage was effectively obliterated, "leaving the possibility that thrombus in the surgical stump may have contributed to the clinical event in the others," they noted.

But since all five cases checked affirmed successful obliteration, the single surgeon who did nearly all the obliterations likely had similar success on those that weren't checked, the researchers argued.