http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=162&expand=
Y

Mechanisms underlying the cardioprotective effects of alcohol are
likely related to alcohol-induced changes in serum lipids, blood
clotting, inflammatory cytokines, and insulin resistance.[2] HDL
cholesterol may account for one half of the benefit; the remaining
benefit is contributed by alcohol-induced increased insulin
sensitivity, suppression of inflammatory markers, polymorphisms
among metabolizing enzymes resulting in reduced acetaldehyde
production, or perhaps constituents of beverages other than alcohol.

Lipid Profile
When the level of alcohol consumption in patients with prior MI was
investigated relative to plasma lipids and the risk of recurrent MI,
the relative risk for the highest intake category (3 or more
drink/d) as compared with the lowest (fewer than one drink/mo) was
0.45. Again noted was the inverse association of alcohol with the
risk of MI. Levels of total HDL and, most importantly, its HDL2 and
HDL3 subfractions were strongly associated with alcohol consumption
and appeared to mediate the protective effect.[16]

Biochemical Mechanisms
Protein kinase C (PKC) represents a family of isoenzymes, PKC-£`
appears to mediate the cardioprotective effect of ethanol by
mimicking ischemic preconditioning¡Xa process mediated by
mitochondrial ATP-sensitive potassium channel (KATP) opening, by
which a period of transient ischemia reduces damage produced during
subsequent prolonged ischemic episodes. Both PKC-£_ and PKC-£` are
activated by myocardial ischemia. Whereas PKC-£_ damages the
mitochondria and induces apoptosis, the expression of PKC-£` is
increased by moderate alcohol and appears to facilitate KATP opening
and hence activate a cardioprotective mechanism.[17-19] Pretreatment
with ethanol reduced MI size in experimental animals; inhibition of
PKC-£` resulted in a loss of the protective effect of ethanol.[19] In
experimental models of diabetes, alcohol consumption is associated
with an attenuation of the diabetic-induced alterations in PKC and
results in functional improvement.[20]

Hemostasis
Several studies have suggested that alcohol may affect blood
clotting, either by causing the blood to clot less avidly through
effects on coagulation factors and platelets or by enhancing the
ability of the blood to break up clots when they form.[21,22]
Fibrinogen, factor VII, and von Willebrand's factor all decline with
increasing alcohol intake.

Inflammation
Alcohol exerts not only immunosuppressant properties, but anti-
inflammatory properties as well. Alcohol intake is associated with
lower levels of inflammatory markers in older adults free of CV
disease.[23] Alcohol may produce a decrease in cytokines such as
tumor necrosis factor-£\ and interleukin-1-£], as well as the C
chemokines which have NF£eB, AP1, and ETR1 binding sites.[24-26]
Moderate alcohol consumption was associated with lower C-reactive
protein concentrations than no or occasional alcohol intake, an
effect that was independent of alcohol-related effects on lipids.[27]

Endothelial Function and Nitric Oxide (NO)
Studies utilizing endothelial cells from the aorta and cerebral
blood vessels have found that there is an increase in NO generation
with low concentrations of alcohol. Treatment with low
concentrations of alcohol activates the cell survival promoting
PI3K/Akt pathway in endothelial cells by an adenosine receptor-
dependent mechanism, and activation of the proapoptotic caspase
pathway by higher concentrations of alcohol via an adenosine-
independent mechanism can mask or counteract such effects.

CV Disease
After compensating for other known CHD risk factors, an overall
estimate from several prospective, large-scale cohort studies among
different populations is that there is a 30%-40% reduction in risk
of CHD morbidity and mortality for two drink/d among men and one
drink/d among women, with minimal additional benefit for higher
consumption levels.[2,7] Interestingly, follow-up of Framingham
participants consuming 2-2.5 drink/d over a 24-year period indicated
that increasing alcohol intake decreased the incidence rate of CHD
among nonsmokers, produced a U-shaped relationship among light
smokers and showed no association with CHD in heavy smokers.[8] In a
retrospective review of data from the Survival and Ventricular
Enlargement (SAVE) trial, in which 2231 patients with a left
ventricular ejection fraction <40% following MI were randomized to
an angiotensin-converting enzyme inhibitor or placebo, patients were
reevaluated based upon alcohol intake; light-to-moderate alcohol
intake (less than 10 drink/wk) either at baseline or following MI
did not alter the risk for the development of heart failure (HF)
requiring hospitalization or open-label addition of an ACE inhibitor.
[9] In participants in the Framingham Heart Study, alcohol
consumption was not associated with increased risk for congestive
HF, even among heavy drinkers (15 drink/wk or more in men and 8
drink/wk or more in women). To the contrary, when consumed in
moderation, alcohol appeared to protect against congestive HF.[10]
The risk reduction in CHD rate has also been observed in diabetic
subjects.

Stroke
There are over 1000 English language papers analyzing the
relationship between alcohol consumption and stroke. Light-to-
moderate alcohol consumption has been reported to reduce the rate of
both overall and ischemic stroke in the Physicians Health Study.[12]
Data from a meta-analysis of all the studies of alcohol consumption
and stroke reported from 1966 to 2002 demonstrate a decreased risk
of ischemic stroke with consumption of less than 12 g/d of alcohol
for both ischemic and hemorrhagic stroke.[13] During 14 years of
follow-up in 38,156 male health professionals, light-to-moderate
alcohol consumption could not be associated with an increased risk
for ischemic stroke; red wine appeared to be particularly
beneficial. Similar results have also been reported in Japanese men.

Recent evidence suggests that it is the metabolic balance among the
primary alcohol metabolizing enzymes¡Xalcohol dehydrogenase,
aldehyde dehydrogenase, and cytochrome P450-2E1 (CYP2E1)¡Xthat
determines the kinetics of alcohol metabolism and thus could confer
either CV protection or render individuals susceptible to the
detrimental consequences of alcohol. Moderate drinkers who are
homozygous for the slow-oxidizing alcohol dehydrogenase-3 allele
have higher high-density lipoprotein (HDL) levels and a
substantially decreased risk of myocardial infarction (MI).[1] Slow
metabolizers of alcohol derive more CV benefits from moderate
alcohol consumption than do fast metabolizers, probably because
alcohol dehydrogenase metabolizes ethanol to acetaldehyde, a
molecule with potentially toxic effects. This oxidative reaction
increases reduced nicotinamide adenine dinucleotide (NADH) levels,
resulting in mitochondrial utilization of NADH from this source for
adenosine triphosphate (ATP) production rather than NADH derived
from fatty acid £] oxidation, ultimately leading to an increase in
fatty acids and fatty liver. Aldehyde dehydrogenase converts
acetaldehyde to acetate, a less toxic product. CYP2E1 is a
microsomal enzyme that can be upregulated by alcohol, which
typically induces a 10-fold increase in enzyme level. CYP2E1
promotes conversion of alcohol to acetaldehyde in a reaction coupled
to the generation of reactive oxygen species (ROS), that may then
lead to lipid peroxidation and ultimately to cardiac and liver
damage.

Approximately four fifths of men and two thirds of women consume
alcoholic beverages. Although excessive alcohol (ethanol, ethyl
alcohol) consumption has long been associated with such a wide range
of cardiovascular (CV) disorders, alcohol consumption is interwoven
into the cultural and social fabric of much of the American
population. However, there is now mounting and consistent evidence
that moderate alcohol consumption is cardioprotective, reducing the
rates of coronary heart disease (CHD), stroke, and peripheral
vascular disease. Over 100 observational studies (cross-cultural,
case-control, prospective-cohort) and over 80 short-term human
metabolic studies suggest CV benefits for 1-2 alcoholic beverages
per day.[1,2] For men and women, crude incidence rates show a
progressive decline in CV risk in going from nondrinkers to former
drinkers to moderate drinkers, possibly with a slight increase with
heavier consumption, producing the often-described J- or U-shaped
curve. Also, there is a steady decrease in the incidence of
intermittent claudication with increasing alcohol consumption.
Benefits are stronger for those who drink small amounts frequently,
as opposed to binge drinkers. Data from the Nurses' Health Study[3]
suggest that women reporting moderate alcohol consumption had better
mean cognitive scores than nondrinkers and may actually have a
decreased rate of cognitive decline.

The mechanisms by which alcohol can either protect or damage the CV
system are gradually being elucidated. In this update, we will
briefly present some information that may better prepare physicians
to address alcohol-related issues.

In the midst of concerns regarding implantable cardioverter
defibrillators (ICDs) and cardiac resynchronization defibrillators
(CRT-Ds), Guidant Corporation (Indianapolis, Indiana) also recently
issued another physician communication -- this time involving safety
concerns involving several of its pacemakers.

The company stated that it was issuing a voluntary recall because a
sealing component may experience a gradual degradation and
subsequent leak, resulting in increased moisture within the
pacemaker case. Such a failure, which is likely to occur late in the
device's service life, may cause "unanticipated device behaviors"
resulting in "serious health complications."

On July 22, the US Food and Drug Administration (FDA) classified
Guidant's action as a Class I recall, stating that "the problems may
occur without warning and can lead to loss of consciousness, and
possibly heart failure and death."

Increased Moisture From Sealing Leak can Inhibit Pacing Therapy or
can Cause a Sustained Rapid Heart Rate
The source of the problem stems from a gradual degradation in the
hermetic sealing component of the devices that results "in a higher
than normal moisture content within the pacemaker case late in the
device's service life." According to Guidant, the increased moisture
can cause:

"Premature battery depletion resulting in loss of telemetry and/or
loss of pacing output without warning


Inappropriate accelerometer function (if programmed ON), resulting
in:


Sustained pacing at the programmed maximum sensor rate (MSR)


Lack of appropriate accelerometer rate response during activity


Appearing of a reset warning message upon interrogation


Inappropriate early display of replacement indicators."

Glyburide may control gestational diabetes unresponsive to diet
therapy, according to a new report. "Glyburide is a reasonable
alternative to insulin therapy for women diagnosed with gestational
diabetes and who fulfill the criteria we used in our study," Dr.
Gavin F. Jacobson told Reuters Health.

Dr. Jacobson, from Kaiser Permanente Northern California, San
Francisco, and colleagues compared glyburide and insulin treatment
in nearly 600 women with singleton pregnancies who had gestational
diabetes diagnosed by oral glucose tolerance test between 12 and 34
weeks gestation, a fasting plasma glucose of 140 mg/dL or less, and
who failed diet therapy.

Women treated with glyburide had significantly lower mean fasting
and postprandial blood sugar levels, the authors report in the July
issue of the American Journal of Obstetrics and Gynecology. Maternal
hypoglycemia was rare with both treatments but more common in the
glyburide group (0.20%) than in the insulin group (0.08%).

Twenty-eight women (12%) in the glyburide group were switched to
insulin, the report indicates, including 14 for poor control and 8
for side effects attributed to hypoglycemia.

Most maternal and neonatal outcomes were similar between treatments,
the researchers note. Preeclampsia was more common in the glyburide
group, and neonates in the glyburide group were more likely to
receive phototherapy.

Neonates in the insulin group, however, were more likely to be
admitted to the neonatal intensive care unit, the results indicate.

There were no neonatal deaths, lethal anomalies, or exchange
transfusions in either treatment group, the investigators report.
Four infants in each group had congenital anomalies.

"Women should be switched to insulin if they are unable to achieve
adequate glycemic control on glyburide," Dr. Jacobson advised.

Also, he emphasized, "It is important women (treated with glyburide)
receive all the other standard prenatal, intrapartum, and postpartum
care that would have been provided if they were on insulin,
including frequency of visits, counseling, and antenatal
surveillance."

The study findings show that "glyburide can be used to achieve good
glycemic control in a large clinical setting in the majority of
women with gestational diabetes unresponsive to dietary management,"
write Dr. Celeste Durnwald and Dr. Mark B. Landon from The Ohio
State University Medical Center, Columbus, in a related
editorial. "Larger trials will also be of benefit in describing
clinical characteristics associated with glyburide failure."

Dr. Jacobson added: "We are currently looking at the use of
glyburide to treat a subgroup of women diagnosed with gestational
diabetes in a nontraditional manner, specifically women diagnosed by
a very high 1 hour GLT (>200mg/dl) and an elevated fasting (>105
mg/dl),"

Am J Obstet Gynecol 2005;193:118-124,1-2

Atrial fibrillation, the most common sustained arrhythmia in
patients with chronic heart failure, is associated with poor
outcome, researchers report in the July issue of the European Heart
Journal.

Lead investigator Dr. Karl Swedberg told Reuters Health that
even "in patients with chronic heart failure on optimal
pharmacological treatment including beta-blockers, the presence of
atrial fibrillation is a significant risk factor for mortality or
hospitalization for heart failure."

Moreover, "new onset of atrial fibrillation among these patients is
associated with significant mortality and morbidity."

Dr. Swedberg of Sahlgrenska University Hospital in Gothenburg,
Sweden, and colleagues examined data on 3029 patients with chronic
heart failure who were randomized to carvedilol or metoprolol
tartrate and followed for a mean of 58 months.

In all, 600 (19.8%) had atrial fibrillation at baseline. These
patients were more likely to be men than women (88% versus 78%),
were older (65 years versus 61 years) and had more severe symptoms
and a longer disease duration than other patients.

Atrial fibrillation was associated with significantly increased
mortality, higher all-cause death or hospitalization and
cardiovascular death or hospitalization.

New onset atrial fibrillation, which was seen in 580 patients, was
associated in a time-dependent manner with a significant increase in
subsequent all-cause mortality (relative risk, 1.90).

The researchers note that after adjusting for age and gender, atrial
fibrillation was no longer an independent predictor of mortality.
However, treatment with carvedilol, they conclude "remained of
independent beneficial importance for all-cause mortality" (relative
risk, 0.84).

Eur Heart J 2005;26:1303-1308

Although there is evidence that stroke patients with high or even
normal blood pressure can benefit from antihypertensive therapy at
hospital discharge, a large number of patients do not receive these
drugs, new research suggests.

The findings also reveal great variability between hospitals in
antihypertensive prescription rates for stroke patients, according
to the report in the August issue of Stroke.

"There should be a concerted effort, involving patients and their
doctors, to make sure that patients do not leave the hospital
without being on at least one blood pressure agent to reduce their
risk for secondary stroke," lead author Dr. Bruce Ovbiagele, from
the University of California at Los Angeles, said in a statement.

The study involved an analysis of data from 764 consecutive patients
who were logged in the California Acute Stroke Prototype Registry
(CASPR) between 2002 and 2004. The subjects had been treated for a
stroke or TIA at 11 hospitals in California.

About 30% of subjects were discharged without receiving a
prescription for at least one antihypertensive drug. The
antihypertensive prescription rates ranged from 55% to 100% among
the hospitals studied.

Hypertension, diabetes, and older age all increased the odds that an
antihypertensive agent would be prescribed at discharge, the authors
note.

Stroke 2005

One of the safety recommendations made to physicians by Guidant
Corp. on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK
RENEWAL AVT implantable cardioverter defibrillators (ICDs) may
significantly increase the risk to patients, according to a letter
to physicians sent last Friday.

The original recommendation was based on two reports of
functional "latching" that suspended detection and treatment of
atrial and ventricular arrhythmias. Following receipt of a third
report of latching on July 11, the company determined that the event
occurred despite reprogramming of the Atrial Tachy Episode Data
Storage to 0% as recommended.

As in the first two events, no patient injury occurred beyond device
replacement. Additional events, including a possible injury, are
being evaluated. Approximately 20,950 devices have been implanted to
date.

Further analysis revealed that programming the data storage to 0%
results in a significantly higher probability of latching (estimated
at 0.086% per month) in atrial therapy (AVT) devices that have
previously stored episode data.

Physicians are advised to schedule follow-up visits as soon as
possible for patients with devices reprogrammed as per original
instructions and for all patients with Atrial Episode Data Storage
programmed to less than 20%. During the visit, normal device
function should be verified according to normal procedures, and the
data storage programmed to 20%.

In addition, the risk reduction benefit of programming
antitachycardia pacing therapy to "OFF" should be evaluated as per
rate occurrence estimates available online at:
http://www.guidant.com/physician_communications/AVT_2.pdf.

The company is currently developing a noninvasive software solution
for VITALITY AVT and all RENEWAL AVT devices. The software update
may be available in the fourth quarter, pending approval by the U.S.
Food and Drug Administration (FDA).

Further information may be obtained by contacting Guidant Technical
Services at 1-800-CARDIAC (1-800-227-3422).

Adverse events related to the use of the ICD devices should be
reported to the FDA's MedWatch program by telephone at 1-800-FDA-
1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane,
Rockville, MD 20852-9787

Have you guys heard about how scientists are trying to find a way to
treat heart attacks with stem cells and have already accomplished
doing so with pigs??  I find this really interesting.  It would be
pretty remarkable if they really found a way to treat heart attacks
with stem cells.
-Michael

http://health.dailynewscentral .com/content/view/0001354/31// treating_...
Stem-Cell Study May Point to Cure for Heart Attacks
         PDF     Print   E-mail
Contributed by Jai A. Dennison|  26 July, 2005  14:34 GMT
a d v e r t i s e m e n t
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Stem cells heart attack cure
Stem cell therapy can be used effectively to treat heart attacks in
pigs, according to a study published in the Proceedings of the National
Academy of Sciences. Stem cells harvested from a healthy pig's bone
marrow and injected into another pig's damaged heart restored its
function and repaired damaged heart muscle by 50 to 75 percent within
just two months.

The Johns Hopkins researchers who conducted the study initially
presented their findings last fall at the 2004 Scientific Sessions of
the American Heart Association.

Repair and Reverse Damage

Two participants already have been enrolled in a Phase I clinical
trial, which is designed to test the safety of injecting adult stem
cells at varying doses in patients who recently have suffered a heart
attack. In total, 48 patients will participate in this study, which is
taking place at several sites across the country. Results are expected
by mid-2006.

"Ultimately, the goal is to develop a widely applicable treatment to
repair and reverse the damage done to heart muscle that has been
infarcted, or destroyed, after losing its blood supply," says
cardiologist Joshua Hare, MD, professor of medicine at The Johns
Hopkins University School of Medicine and its Heart Institute, and
senior author of the study and lead trial investigator.

Special Kind of Stem Cell

"There is reason for optimism about these findings, possibly leading to
a first-ever cure for heart attack in humans," says Dr. Hare.

"If a treatment can be found for the damage done by a heart attack to
heart muscle, then there is the potential to forestall the serious
complications that traditionally result from a heart attack, including
disturbances of heart rhythm that can lead to sudden cardiac death, and
decreased muscle pumping function that can lead to congestive heart
failure," he notes.

The researchers are using a special kind of stem cell in an early stage
of development, called adult mesenchymal stem cells, to avoid potential
problems due to the tendency of the human immune system to attack stem
cells from sources other than the self.

Bone marrow adult stem cells do not have the same potential to develop
into different organ tissues, as do embryonic stem cells, whose use is
more controversial.

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In patients with systemic lupus erythematosus (SLE), valvular heart
disease appears to be a source of emboli that cause ischemic brain
injury, results of a study show.

Cerebrovascular disease and valvular heart disease are both common
in patients with SLE, Dr. Carlos A. Roldan and his associates note
in their report, published in the June 15th American Journal of
Cardiology. In order to evaluate any association between the two
disorders, they performed clinical and laboratory evaluations, MRI
of the brain, and transesophageal echocardiography in 37 patients
with SLE.

Nineteen (51%) had cerebrovascular disease (stroke, transient
ischemic attack or cerebral infarcts associated with nonfocal
neurologic deficits). Twenty-five (68%) had valve vegetations,
moderate or severe valve thickening, or moderate to severe
regurgitation.

Valvular heart disease was present in 16 (84%) of those with
cerebrovascular disease and 9 (50%) of those without cerebrovascular
disease (p = 0.04).

Multivariate analysis showed that mitral regurgitation and lupus
anticoagulant antibody were the only independent predictors of
cerebral infarcts, while mitral valve thickening was the only
predictor of stroke or TIA.

"We know that valve vegetations and valve thickening are substrates
for formation of microthrombi, even in patients with no underlying
hypercoagulable state," Dr. Roldan said in an interview with Reuters
Health. So regardless of whether they have hypercoagulability, he
added, "lupus patients with valve disease should be considered for
antiplatelet therapy, such as aspirin, to decrease the rate of
microemboli to the brain."

Dr. Roldan pointed out that lupus patients have such a large
constellation of symptoms and a high incidence of physiological
heart murmurs that valvular heart disease may be overlooked.

"Clinicians may need to be more careful about their patient
interviews as well as cardiovascular physical exams in order to find
a clinical reason to order echocardiography," he added, but without
a cost-effectiveness analysis, he is not yet ready to propose
echocardiography as a routine screening tool in patients with SLE.

Am J Cardiol 2005;95:1441-1447

Metformin is markedly more effective than clomiphene citrate for
improving fertility in nonobese anovulatory women with polycystic
ovary syndrome (PCOS), according to an Italian prospective double-
blind study.

In the study - the first head-to-head comparison of these two
agents - both drugs were similarly well tolerated and "highly
effective" for inducing regular ovulatory cycles. The higher
pregnancy rate with metformin, however, suggests that this drug is
more effective in treating the anovulatory infertility in nonobese
women with PCOS, investigators conclude in The Journal of Clinical
Endocrinology and Metabolism for July.

Dr. Stefano Palomba from University "Magna Graecia" of Catanzaro in
Naples and colleagues randomly assigned 100 nonobese infertile
anovulatory women with PCOS to receive metformin (850 mg twice
daily) plus placebo or placebo plus clomiphene citrate (150 mg for 5
days from the third day of a progesterone withdrawal bleeding) for 6
months.

They report that the ovulation rate was not statistically different
between the two groups - 62.9% for metformin and 67.0% for
clomiphene citrate. However, the pregnancy rate was significantly
higher in the metformin arm - 15.1% compared with 7.2% in the
clomiphene arm. The cumulative pregnancy rate was also significantly
higher with metformin (68.9% versus 34.0%).

Moreover, with metformin, the abortion rate was significantly lower
(9.7% versus 37.5% with clomiphene).

Because metformin was administered until a pregnancy was
confirmed, "we can hypothesize that the known beneficial effects of
metformin on pregnancy were exerted in our sample population by an
action on oocytes and/or embryos and/or endometrium," Dr. Palomba
and colleagues suggest.

As for the high rate of abortion in the clomiphene arm, they point
out that women with PCOS are known to be at increased risk for
abortion, and clomiphene citrate "probably increases this risk."

J Clin Endocrinol Metab 2005;90:4068-4074

Half of patients who survive myocardial infarction (MI) have insulin
resistance, which is linked to worse outcomes and greater mortality,
Italian researchers report in the July 19, 2005 issue of the Journal
of the American College of Cardiology.

The researchers also found that patients who lost weight during the
first six months after MI reduced their risk of developing diabetes,
while weight gain increased the risk.

Dr. Roberto Marchioli of the Consorzio Mario Negri Sud in Santa
Maria Imbaro and colleagues analyzed database of the GISSI-
Prevenzione Trial, including 11,323 patients who had MI within the
past three months, to determine the effect of metabolic syndrome on
risk in post-MI patients. Patients were followed for up to 42 months
after MI.

One in five of the patients had diabetes, while 29.3% had metabolic
syndrome, the researchers found. During follow-up patients with
metabolic syndrome had a 29% increased risk of death and a 23%
greater risk of cardiovascular events. Diabetes conferred a 68%
increased mortality risk and a 47% higher risk of cardiovascular
events. Patients with metabolic syndrome had nearly double the risk
of developing diabetes during follow-up, and this risk increased
with the number of metabolic syndrome components they had.

Diabetic patients had an increased risk of hospitalization for heart
failure during follow-up, while those with metabolic syndrome did
not.

Greater risk of death, cardiovascular events and diabetes were seen
among women with metabolic syndrome compared to men, although these
increases were not statistically significant.

People with metabolic syndrome who reduced their weight moderately,
by 6% to 10%, reduced their diabetes risk by 18%, while those who
lost more than 10% of their body weight reduced this risk by 40%.
Weight gain was linked to increased risk of diabetes among these
patients.

"Our findings underline the need to identify precociously and treat
more aggressively patients with (metabolic syndrome) with coronary
heart disease who have an absolute cardiovascular risk that is
definitely higher than that of primary prevention," the researchers
conclude.

J Am Coll Cardiol 2005;46:277-283

Treadmill exercise testing of patients with asymptomatic aortic
stenosis can predict the development of spontaneous symptoms,
according to a report in the European Heart Journal for July. "In
this study," the investigators say, "symptoms during exercise
testing were superior to clinical history and echocardiography in
predicting the imminent onset of spontaneous symptoms."

Surgical referral for aortic valve replacement should ideally occur
just before the onset of symptoms, explain Dr. Paul Das and
colleagues from Guy's and St. Thomas' Hospitals, London, UK, but
there is uncertainty about the best way to predict clinical outcomes
with aortic stenosis.

The team investigated whether treadmill exercise testing parameters
could predict the onset of spontaneous symptoms within 12 months in
125 patients with apparently asymptomatic aortic stenosis.

Thirty-six patients (29%) developed spontaneous symptoms within 12
months of testing, the authors report. Patients who developed
symptoms were more likely to have positive exercise tests than those
who remained symptom-free.

More than half the patients (51%) with limiting symptoms on exercise
testing developed spontaneous symptoms within 12 months of testing,
the results indicate, compared with only 11% of those who did not
have limiting symptoms on exercise testing.

The accuracy of limiting symptoms in predicting symptom onset within
12 months was 57% for the whole population and 79% for patients
under 70 years old, the researchers note.

"In physically active patients under 70 years, clear symptoms on
exercise testing indicate a very high likelihood of symptom
development within 12 months and valve replacement should be
recommended," writes Dr. Helmut Baumgartner from Medical University
of Vienna, Wien, Austria in a related editorial.

Exercise testing is less helpful in patients with low physical
activity and those over 70 years, Dr. Baumgartner points out. "The
test should, therefore, primarily be recommended for physically
active patients under 70 years."

Eur Heart J 2005;26:1309-1313,1252-1253

In patients with acute MI undergoing primary or rescue percutaneous
coronary intervention (PCI), supplementing the procedure with manual
thrombus aspiration results in better myocardial reperfusion, a new
study from Italy shows.

Dr. Francesco Burzotta of the Catholic University in Rome and
colleagues, along with other investigators, had previously produced
data suggesting manual aspiration could help reduce the thrombus
burden within a culprit coronary lesion, easing myocardial
reperfusion.

They conducted the current randomized study, reported in the July 19
issue of the Journal of the American College of Cardiology, to
determine the effect of the technique in an unselected group of
patients undergoing PCI.

One hundred consecutive patients with ST-segment elevation acute MI
were randomized to PCI with or without manual thrombus aspiration,
and 99 completed the study. In patients who had manual thrombus
aspiration, the aspirating catheter was advanced while aspirating
two to five times after guidewire placement, and then the procedure
was continued.

Thrombus burden was significantly reduced and TIMI flow score was
improved in patients who underwent thrombus aspiration, the
researchers found.

Rates of myocardial blush grade of two or above, one of the study's
primary endpoints, were 68% in the thrombus aspiration group
compared to 58% in those who did not receive aspiration.

ST-segment resolution of 70% or above, the study's other primary
endpoint, occurred in 44.9% of patients who underwent thrombus
aspiration compared to 36.7% of those who did not.

Finally, optimal reperfusion as measured both angiographically and
electrocardiographically was achieved by 46.0% of patients who
underwent thrombus aspiration and 24.5% of those who did not,
yielding an odds ratio of 2.6.

While the results were positive, Dr. Burzotta and colleagues note,
more than half of patients who underwent thrombus aspiration did not
achieve both primary endpoints, while about one in five experienced
distal embolization, slow-flow or no-reflow. "These figures leave
room for further improvement by means, for instance, of adjunct
pharmacology or non-occlusive distal protection devices," they
conclude.

J Am Coll Cardiol 2005;46:371-376

In patients with acute MI complicated by cardiogenic shock, the use
of percutaneous coronary interventions (PCI) decreases mortality,
according to a new report. "We recommend more aggressive use of
early mechanical revascularization, including early CABG surgery" in
this setting, say the authors.

Since 1999, national guidelines have supported the use of early
mechanical revascularization in patients younger than 75 years with
acute MI and cardiogenic shock, Dr. Judith S. Hochman and colleagues
note in their report in the July 27th issue of the Journal of the
American Medical Association.

They assessed trends in early revascularization and mortality using
data from the National Registry of Myocardial Infarction for the
period 1995 to 2004. The Registry included approximately 25,000
patients with ST-elevation MI and cardiogenic shock.

The rate of primary PCI among these patients increased from 27.4% to
54.4%, while overall in-hospital mortality for these patients
decreased from 60.3% in 1995 to 47.9% in 2004. The mortality decline
was observed for individuals < 75 years old and those 75 years old
and older.

Multivariate analysis adjusting for potential confounders showed
that primary PCI was a strongly independent predictor of lower
mortality (adjusted odds ratio 0.46).

The improved mortality parallels the overall increase in PCI rates,
the authors note, but seemed to be unaffected by publication of the
guidelines. The use of coronary bypass grafting (CABG) during the
same period actually decreased from 11.5% to 8.8%.

Dr. Hochman's group concludes: "The findings of our study support
the need for efforts aimed at guideline adherence to improve
survival of patients with cardiogenic shock."

JAMA 2005;294:448-454

Results of a Dutch study support the use of statins in patients with
microalbuminuria and the metabolic syndrome to prevent the
occurrence of major adverse cardiac events.

Microalbuminuria frequently clusters with the metabolic syndrome and
may reflect the atherosclerotic burden present in patients with the
metabolic syndrome, Dr. Christiane A. Geluk from University Medical
Center Groningen, the Netherlands, noted in comments to Reuters
Health. Dr. Geluk and colleagues report the results of the PREVEND
Intervention Trial in the July 2005 issue of the European Heart
Journal.

The researchers evaluated the impact of pravastatin (40 mg daily) on
the incidence of myocardial infarction, revascularization procedures
or death in 864 patients with microalbuminuria defined according to
the NCEP Adult Treatment Panel (ATP)-III criteria. Fewer than 5% had
a history of cardiovascular disease before study entry. Thirty-three
percent had the metabolic syndrome.

During 4 years of follow up, patients with the metabolic syndrome
experienced more cardiac events (9.1%) than those without the
metabolic syndrome (3.6%).

"In patients with microalbuminuria and the metabolic syndrome who
were treated with pravastatin, a 60% reduction in cardiac events was
shown during 4 years of follow up," Dr. Geluk told Reuters Health.

In 578 patients with microalbuminuria but without the metabolic
syndrome, no reduction in events was evident with pravastatin. "This
difference in treatment effect between subjects with and without the
metabolic syndrome could not be attributed to differences in
cholesterol lowering, since these were equal in both groups," Dr.
Geluk noted.

"Our findings suggest that patients with both the metabolic syndrome
and microalbuminuria are among the most vulnerable for development
of major adverse cardiac events," Dr. Geluk said. In line with
earlier large statin trials, "we have shown that statin treatment in
these subjects at high cardiovascular risk reduces their risk of
cardiac events."

UK-based co-authors of an editorial caution that "while the concept
of the metabolic syndrome has proven useful in demonstrating
pathophysiological parallels between conditions such as diabetes and
CVD, it is far too premature to incorporate specific metabolic
syndrome criteria, such as the ATP III criteria, shortly to be
revised, into clinical practice for CVD risk prediction."

"The clinical utility of metabolic syndrome criteria for this
purpose can thus presently be regarded as 'work in progress,'" Drs.
Naveed Sattar from Glasgow Royal Infirmary and Nita G. Forouhi from
MRC Epidemiology Unit in Cambridge conclude.

Euro Heart J 2005;26:1249-1251,1314-1320

Adding whey to meals with rapidly digested and absorbed
carbohydrates stimulates insulin release and reduces postprandial
blood glucose excursions in patients with type 2 diabetes, according
to findings published in the July issue of the American Journal of
Clinical Nutrition.

"Whey proteins have insulinotropic effects and reduce the
postprandial glycemia in healthy subjects," Dr. Mikael Nilsson, of
Lund University, Sweden, and colleagues write. "The mechanism is not
known, but insulinogenic amino acids and the incretin hormones seem
to be involved."

The researchers examined whether supplementing meals with a high
glycemic index (GI) with whey proteins increases insulin secretion
and improves blood glucose control in patients with type 2 diabetes.
They also measured the responses of serum insulin, glucose-dependent
insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-
1).

A total of 14 patients were served a high-GI breakfast (white bread)
and subsequent high-GI lunch (mashed potatoes with meatballs). Whey
supplementation was provided with both meals on one day, and whey
was exchanged for lean ham and lactose on another day. The
investigators obtained venous blood samples before and during 4 h
after breakfast and 3 h after lunch in order to measure blood
glucose, serum insulin, GIP, and GLP-1.

The insulin responses were higher after both breakfast (31%) and
lunch (57%) when the meals were supplemented with whey compared to
when whey was not included. The blood glucose response was
significantly reduced (-21%; 180 min area under the curve) after the
lunch meal was supplemented with whey.

The team observed higher postprandial GIP responses after whey
ingestion. No differences were observed in GLP-1 between the
reference and test meals.

"The lesser insulinotropic effect of whey after breakfast, in
combination with the fact that the insulin resistance may be higher
in the morning after the overnight fast, may explain the inability
of whey to reduce the blood glucose increment after breakfast," Dr.
Nilsson's team explains.

Am J Clin Nutr 2005;82:69-75

Rates of blood pressure control at the community level are low,
particularly among older women with hypertension, findings from a
new study indicate.

"Despite numerous trials demonstrating the benefits of blood
pressure lowering among older individuals with hypertension,
available data suggest that rates of treatment and control are
suboptimal," Dr. Donald M. Lloyd-Jones, from Northwestern University
in Chicago, and colleagues note.

Using data from the Framingham Heart Study, the investigators
assessed the prevalence and control of hypertension in three age
groups: younger than 60 years, 60 to 79 years, and 80 years or
older. A total of 5296 subjects with more than 14,000 person-
examinations of observation were included in the analysis.

The researchers' findings appear in the Journal of the American
Medical Association for July 27.

As anticipated, the prevalence of hypertension increased with age.
Drug treatment for high blood pressure also rose with age, and yet
control rates were lowest among women in the oldest age group.

The percentage of hypertensive men with controlled blood pressure,
defined as < 140/90 mm Hg, did not change much with age, hovering
around 37%. By contrast, among women, the percentage ranged from 38%
in the youngest group to just 23% in the oldest group.

Absolute risks for hypertension-related cardiovascular disease
increased markedly with age, the researchers point out. In the
oldest age group, subjects with the worst hypertension were 2.4-
times more likely to experience a major cardiovascular event than
their peers with normal blood pressure.

"Short-term risks for cardiovascular disease are substantial,
indicating the need for greater efforts at safe, effective risk
reduction among the oldest patients with hypertension," the
investigators conclude.

JAMA 2005;294:466-472

In patients of more than 65 years of age, aortic valve replacements
with stentless biological valves achieve similar outcomes to those
using mechanical valves, German researchers report in the August
issue of Heart.

"The majority of elderly patients benefits from aortic valve
replacement with stentless bioprostheses due to the total avoidance
of an anticoagulation therapy, resulting in an equal quality of life
compared to the age-matched general population," lead investigator
Dr. Ines Florath told Reuters Health.

Dr. Florath and colleagues at Herzzentrum Lahr/Baden conducted a
retrospective follow-up study of 392 patients with a mean age of 74
years. All had undergone aortic valve replacement with a stentless
Freestyle bioprosthesis (Medtronic) or a mechanical prosthesis (St.
Jude Medical).

Overall, there was no significant outcome difference between groups.
However, patients older than 75 years with mechanical valves had an
increased risk of major bleeding.

Moreover, questionnaire responses showed a twofold increase in
impaired emotional reaction in those who require coumarin
anticoagulant therapy.

Nevertheless, there was a survival advantage with mechanical valves
in patients with severe combined aortic valve disease. There was
also a decreased risk of prolonged ventilation.

Furthermore, patients with severely reduced cardiac function who
received a stentless bioprosthesis were at increased risk of stroke
and of a prolonged stay in intensive care.

Candidates for stentless bioprostheses should be chosen with care,
the researchers conclude, but Dr. Florath pointed out that "despite
the demanding operation technique, their operative risk and
complication rates were not increased compared to mechanical valves."

Heart 2005;91:1023-1029

In patients with systemic lupus erythematosus (SLE), valvular heart
disease appears to be a source of emboli that cause ischemic brain
injury, results of a study show.

Cerebrovascular disease and valvular heart disease are both common
in patients with SLE, Dr. Carlos A. Roldan and his associates note
in their report, published in the June 15th American Journal of
Cardiology. In order to evaluate any association between the two
disorders, they performed clinical and laboratory evaluations, MRI
of the brain, and transesophageal echocardiography in 37 patients
with SLE.

Nineteen (51%) had cerebrovascular disease (stroke, transient
ischemic attack or cerebral infarcts associated with nonfocal
neurologic deficits). Twenty-five (68%) had valve vegetations,
moderate or severe valve thickening, or moderate to severe
regurgitation.

Valvular heart disease was present in 16 (84%) of those with
cerebrovascular disease and 9 (50%) of those without cerebrovascular
disease (p = 0.04).

Multivariate analysis showed that mitral regurgitation and lupus
anticoagulant antibody were the only independent predictors of
cerebral infarcts, while mitral valve thickening was the only
predictor of stroke or TIA.

"We know that valve vegetations and valve thickening are substrates
for formation of microthrombi, even in patients with no underlying
hypercoagulable state," Dr. Roldan said in an interview with Reuters
Health. So regardless of whether they have hypercoagulability, he
added, "lupus patients with valve disease should be considered for
antiplatelet therapy, such as aspirin, to decrease the rate of
microemboli to the brain."

Dr. Roldan pointed out that lupus patients have such a large
constellation of symptoms and a high incidence of physiological
heart murmurs that valvular heart disease may be overlooked.

"Clinicians may need to be more careful about their patient
interviews as well as cardiovascular physical exams in order to find
a clinical reason to order echocardiography," he added, but without
a cost-effectiveness analysis, he is not yet ready to propose
echocardiography as a routine screening tool in patients with SLE.

Am J Cardiol 2005;95:1441-1447

Half of patients who survive myocardial infarction (MI) have insulin
resistance, which is linked to worse outcomes and greater mortality,
Italian researchers report in the July 19, 2005 issue of the Journal
of the American College of Cardiology.

The researchers also found that patients who lost weight during the
first six months after MI reduced their risk of developing diabetes,
while weight gain increased the risk.

Dr. Roberto Marchioli of the Consorzio Mario Negri Sud in Santa
Maria Imbaro and colleagues analyzed database of the GISSI-
Prevenzione Trial, including 11,323 patients who had MI within the
past three months, to determine the effect of metabolic syndrome on
risk in post-MI patients. Patients were followed for up to 42 months
after MI.

One in five of the patients had diabetes, while 29.3% had metabolic
syndrome, the researchers found. During follow-up patients with
metabolic syndrome had a 29% increased risk of death and a 23%
greater risk of cardiovascular events. Diabetes conferred a 68%
increased mortality risk and a 47% higher risk of cardiovascular
events. Patients with metabolic syndrome had nearly double the risk
of developing diabetes during follow-up, and this risk increased
with the number of metabolic syndrome components they had.

Diabetic patients had an increased risk of hospitalization for heart
failure during follow-up, while those with metabolic syndrome did
not.

Greater risk of death, cardiovascular events and diabetes were seen
among women with metabolic syndrome compared to men, although these
increases were not statistically significant.

People with metabolic syndrome who reduced their weight moderately,
by 6% to 10%, reduced their diabetes risk by 18%, while those who
lost more than 10% of their body weight reduced this risk by 40%.
Weight gain was linked to increased risk of diabetes among these
patients.

"Our findings underline the need to identify precociously and treat
more aggressively patients with (metabolic syndrome) with coronary
heart disease who have an absolute cardiovascular risk that is
definitely higher than that of primary prevention," the researchers
conclude.

J Am Coll Cardiol 2005;46:277-283

Cardiac synchronization therapy (CRT) appears effective in end-stage
heart failure patients regardless of the presence of diabetes, Dutch
researchers report in the July 1st issue of the American Journal of
Cardiology.

Investigator Dr. Jeroen J. Bax told Reuters Health that CRT is a
promising technique in patients with heart failure and many patients
with diabetes eventually develop heart failure. Nevertheless, he
pointed out, "Since the pathophysiology of heart failure in diabetes
is different, the effect of CRT may also differ in these patients."

However, the current findings "clearly demonstrate a similar effect
of CRT in heart failure patients with and without diabetes. The
effect of CRT was comparable in terms of clinical benefit and
improvement in systolic left ventricular function."

Dr. Bax of Leiden University Medical Center and colleagues evaluated
32 heart failure patients with diabetes and 62 without diabetes both
before and after device implantation.

In total, 72 (74%) patients were deemed to be responders on the
basis of an improvement of at least 1 in New York Heart Association
Class at 6 months. There was no significant difference in the
proportion of diabetic (63%) and non-diabetic patients (80%) in this
group.

There also were no differences in a variety of other parameters, and
during a mean follow-up of about 16 months, 7 diabetic patients
(22%) died compared with 6 non-diabetic patients (9%).

Dr. Bax concluded, "long-term survival was slightly better in non-
diabetics, but the difference did not reach statistical
significance."

Am J Cardiol 2005;96:108-111

Despite "extreme" differences in exercise levels in pairs of
identical twins, lipoprotein and weight responses to dietary changes
are remarkably concordant, researchers report in the July issue of
the American Journal of Clinical Nutrition.

As lead investigator Dr. Paul T. Williams told Reuters
Health, "people respond differently to diet, and one recommendation
does not necessary fit everyone. Our twin study shows that genes
largely determine whether a person can lower LDL-cholesterol ... by
lowering their dietary fat."

Dr. Williams of Lawrence Berkeley National Laboratory, California
and colleagues enrolled 28 pairs of male monozygotic twins. In each
pair, one twin ran an average of 50 km per week more than did the
other.

In a crossover study, the twins went from a 6-week 40% fat diet to
another 6 weeks of a 20% fat diet. Fat was reduced primarily by
reducing both saturated and polyunsaturated fat from 14% to 4%.
Carbohydrate intake was increased from 45% to 65%.

Despite the twins' difference in physical activity, there were
significantly correlated changes in total cholesterol, LDL
cholesterol, apolipoprotein A-1 and body weight.

Increased dietary fat did not significantly change body weight, say
the researchers. Although there was considerable variability in body
responses, these alterations were significantly correlated within
twin pairs.

"We were able to show the importance of genetics," Dr. Williams
commented, "without having to first identify the specific genes
involved." These data, he concluded, "justify more detailed studies
that look for specific genes using DNA."

Am J Clin Nutr 2005;82:181-187

In patients with MI-related cardiogenic shock, a percutaneous left
ventricular assist device (VAD) improves hemodynamic and metabolic
parameters more effectively than does standard treatment with an
intra-aortic balloon pump (IABP), according to German investigators.
However, they say, the benefits may not always outweigh the
complications.

"Although a VAD is more efficient in hemodynamics, it does not
necessarily result in a favorable outcome," Dr. Holger Thiele from
University of Leipzig-Heart Centre, Germany told Reuters
Health. "Therefore, before the use of VADs, they should be tested in
sufficiently large randomized trials."

Dr. Thiele and colleagues compared the hemodynamic and metabolic
effects of an IABP or VAD (using the Tandem Heart, Cardiac Assist,
Pittsburgh, Pennsylvania) in a randomized trial involving 41
patients with cardiogenic shock after revascularized acute MI.

Cardiac power index -- a function of the cardiac index and mean
arterial pressure -- showed greater improvement with VAD than IABP
support, the team reports in the July European Heart Journal, and
the greater improvement persisted at 8, 64, and 72 hours.

VAD treatment was also associated with greater improvements in
cardiac output, pulmonary capillary wedge pressure, pulmonary artery
pressure, serum lactate levels, and renal function, the report
indicates.

Nonetheless, VAD patients spent more time on mechanical ventilation
than did IABP patients, the researchers note, and more developed
limb ischemia and required transfusions of packed red blood cells.

Also, more patients in the VAD group than in the IABG group
developed disseminated intravascular coagulation, the investigators
report, but early mortality was the same in both groups (4
patients). Five additional patients in each group died within the
first 30 days.

"In patients with severe depression of left ventricular performance,
circulatory support derived from a VAD is significantly more
effective when compared with IABP," the authors conclude. "The
complications associated with the highly invasive nature of the
procedure and the extracorporeal support need to be weighed against
the benefits."

Eur Heart J 2005;26:1276-1283

The variability in response to the antiplatelet drug clopidogrel is
linked to variants in the drug's target receptor gene, Austrian
researchers report. They identified a polymorphism in the P2Y12 gene
associated with a four-fold higher risk of neurological adverse
events among peripheral artery disease (PAD) patients taking
clopidogrel.

As reported in the July issue of Stroke, Dr. Sophie Ziegler of the
Medical University of Vienna and colleagues investigated whether two
single nucleotide polymorphisms located in the coding region of the
gene, 34C>T and 52G>T are associated with risk of ischemic stroke or
carotid revascularization among PAD patients. The study included137
patients taking clopidogrel and 336 patients taking aspirin who were
followed for a median 21 months.

Half of the patients had at least one 34C>T mutation, while 30% had
52G>T mutations.

Eight percent of the patients experienced neurological events during
follow-up.

Neither variant of the gene was linked to risk among patients taking
aspirin, but those on clopidogrel who had at least one 34T allele
were four times more likely to have a neurological event than those
with two 34C alleles. The variant also was linked to neurological
outcome in the 32 patients who had a stroke or transient ischemic
attack, but only among those on clopidogrel.

The researchers suggest that the mutation may produce greater mRNA
stability and a resulting greater density of receptors on the
platelet surface, resulting in a lack of effect with standard doses
of the drug.

"Whether determination of the P2Y12 polymorphism (34C>T) could serve
as a risk stratification marker to predict possible failure of
therapy or to identify patients who are candidates for alternate
agents or higher doses of clopidogrel should be the subject of
future testing," Dr. Ziegler and colleagues conclude.

Stroke 2005;36:1394-1399

Rates of blood pressure control at the community level are low,
particularly among older women with hypertension, findings from a
new study indicate.

"Despite numerous trials demonstrating the benefits of blood
pressure lowering among older individuals with hypertension,
available data suggest that rates of treatment and control are
suboptimal," Dr. Donald M. Lloyd-Jones, from Northwestern University
in Chicago, and colleagues note.

Using data from the Framingham Heart Study, the investigators
assessed the prevalence and control of hypertension in three age
groups: younger than 60 years, 60 to 79 years, and 80 years or
older. A total of 5296 subjects with more than 14,000 person-
examinations of observation were included in the analysis.

The researchers' findings appear in the Journal of the American
Medical Association for July 27.

As anticipated, the prevalence of hypertension increased with age.
Drug treatment for high blood pressure also rose with age, and yet
control rates were lowest among women in the oldest age group.

The percentage of hypertensive men with controlled blood pressure,
defined as < 140/90 mm Hg, did not change much with age, hovering
around 37%. By contrast, among women, the percentage ranged from 38%
in the youngest group to just 23% in the oldest group.

Absolute risks for hypertension-related cardiovascular disease
increased markedly with age, the researchers point out. In the
oldest age group, subjects with the worst hypertension were 2.4-
times more likely to experience a major cardiovascular event than
their peers with normal blood pressure.

"Short-term risks for cardiovascular disease are substantial,
indicating the need for greater efforts at safe, effective risk
reduction among the oldest patients with hypertension," the
investigators conclude.

JAMA 2005;294:466-472

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