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Tuesday, December 14, 2010


Bloomberg News (11/24, von Schaper) reports, "The French habit of drinking wine almost daily is less taxing to the heart than the Irish custom of downing an equivalent amount of beer on one or two nights a week," according to a study published Nov. 23 in the British Medical Journal. "Middle-aged men in Belfast had almost double the risk of developing heart disease, compared with French drinkers who spread their consumption over a week." Bloomberg News notes that the study "bolsters the findings of previous studies suggesting a link between ischemic heart disease...and drinking patterns."

WebMD (11/23, Hendrick) reported that after examining the "alcohol drinking patterns of 9,758 men in France and Belfast over a 10-year period," researchers found that "men who binge drink have nearly twice the risk of heart attack or death from heart disease than regular drinkers over a 10-year period." For study purposes, "binge drinking was defined as excessive alcohol consumption, or the equivalent of four or five drinks in a short period of time such as a weekend day."

HeartWire (11/23, Nainggolan) reported that an accompanying editorial noted, "Middle-aged men should be made aware that if they are irregular heavy drinkers, the possible cardioprotective properties of alcohol consumption may not apply to them, and in contrast they may be putting themselves at increased risk of having a heart attack." BBC News (11/24) also covers the story.

Friday, December 10, 2010


The Los Angeles Times (11/19, Zajac) reported, "The maker of Darvon [propoxyphene] and Darvocet [acetaminophen and propoxyphene] announced Friday that it will stop marketing the widely used painkillers in the US because of a new study linking the active ingredient in the drugs to serious and sometimes fatal heart rhythm abnormalities." Xanodyne Pharmaceuticals Inc. "agreed to the ban at the request of the Food and Drug Administration, which also asked makers of generic versions of the drugs' core compound, known as propoxyphene, to stop selling it in the US."

Bloomberg News (11/19, Peterson) reported Xanodyne "will withdraw Darvon and Darvocet, a product that combines Darvon's active ingredient with acetaminophen." The FDA "requested the move after evaluating study data, and asked makers of generic versions to take them off the market as well." Xanodyne's "new clinical research, combined with new epidemiological data, led the FDA to conclude that propoxyphene's benefits no longer outweigh its risks, said John Jenkins, director of the agency's Office of New Drugs."

The AP (11/19) reported, "Britain and the European Union decided to ban Darvon in 2005 and 2009, respectively, due to a long trend of suicides and accidental overdoses." The FDA said it "decided to take action based on a recent study showing Darvon interferes with the electrical activity of the heart, causing irregular heart rhythms that can be fatal. Xanodyne conducted the study last year at the government's request."

The Washington Post (11/19, Stein) reported, "The FDA has received two requests to remove the drug from the market since 1978 but had previously determined the benefits outweighed the risks." Consumer advocates "welcomed the announcement but sharply criticized the agency for failing to act sooner." The New York Times (11/19) "Prescriptions" blog, the Wall Street Journal (11/20, Dooren, subscription required), HeartWire (11/22), and the CNN (11/19) "The Chart" blog also reported the story.

Tuesday, December 7, 2010


The New York Times (11/21, A25, Singer) reported, "Patients with chronic kidney disease (CKD) who took Vytorin [ezetimibe and simvastatin], a cholesterol-lowering pill, had one-sixth fewer heart attacks, strokes or operations to unblock their arteries than patients taking a placebo, according to" research presented during the American Society of Nephrology's 43rd Annual Meeting and Scientific Exposition. "The main benefit was not in reducing the risk of heart attacks and related deaths, but in reducing the artery operations and certain kinds of strokes," the Times added. The study's authors pointed out that "the difference in operations to unblock arteries -- 284 in the treated group compared with 352 in the placebo group -- was statistically significant."

"The trial was the largest ever on Vytorin," Bloomberg News (11/20, Cortez) reported. "Patients on the drug were 16 percent less likely to suffer a heart attack or stroke, need a procedure to clear arteries or die from heart disease than those given a placebo over five years." Based on these findings, Merck "said it will seek US approval to use the drug in" CKD patients.

The AP (11/21) reported, "The Oxford University study looked at more than 9,000 patients who had advanced or end-stage" CKD. According to Merck, "the result is significant because kidney patients have a high risk of vascular disease."

However, the "lipid-lowering therapy did not significantly affect progression of kidney disease, investigators reported," according to MedPage Today (11/20, Bankhead). "Renal outcomes in the trial included progression to end-stage renal disease (ESRD), ESRD or death, and ESRD or a twofold increase in serum creatinine level. The simvastatin/ezetimibe and placebo groups did not differ significantly in the rates of any renal endpoints," MedPage Today noted. The Wall Street Journal (11/22, Loftus, subscription required) and HeartWire (11/20, Wood) also covered the story.

Friday, December 3, 2010


At 18 hospitals in the U.S. and U.K., researchers have suspended pictures, face up, from the ceilings in emergency-care areas. The reason: to test whether patients brought back to life after cardiac arrest can recall seeing the images during an out-of-body experience.

People who have these near-death experiences often describe leaving their bodies and watching themselves being resuscitated from above, but verifying such accounts is difficult. The images would be visible only to people who had done that.

"We've added these images as objective markers," says Sam Parnia, a critical-care physician and lead investigator of the study, which hopes to include 1,500 resuscitated patients. Dr. Parnia declined to say whether any have accurately described the images so far, but says he hopes to report preliminary results next year.

The study, coordinated by Southampton University's School of Medicine in England, is one of the latest and largest scientific efforts to understand the mystery of near-death experiences.

At least 15 million American adults say they have had a near-death experience, according to a 1997 survey—and the number is thought to be rising with increasingly sophisticated resuscitation techniques.


People often describe moving down a dark tunnel toward a bright light after a near death experience.

Dead or Alive?

An analysis of 613 near-death experiences gathered by the Near Death Research Foundation found:

  • About 75% included an out-of-body experience
  • 76% reported intense positive emotions
  • 34% described passing through a tunnel
  • 65% described encountering a bright light
  • 22% had a life review
  • 57% encountered deceased relatives or other beings

Note: Patients could report more than one sensation.

In addition to floating above their bodies, people often describe moving down a dark tunnel toward a bright light, feeling intense peace and joy, reviewing life events and seeing long-deceased relatives—only to be told that it's not time yet and land abruptly back in an ailing body.

The once-taboo topic is getting a lot of talk these days. In the new movie "Hereafter," directed by Clint Eastwood, a French journalist is haunted by what she experienced while nearly drowning in a tsunami. A spate of new books details other cases and variations on the theme.

Yet the fundamental debate rages on: Are these glimpses of an afterlife, are they hallucinations or are they the random firings of an oxygen-starved brain?

"There are always skeptics, but there are millions of 'experiencers' who know what happened to them, and they don't care what anybody else says," says Diane Corcoran, president of the International Association for Near-Death Studies, a nonprofit group in Durham, N.C. The organization publishes the Journal of Near-Death Studies and maintains support groups in 47 states.

Dr. Corcoran, a retired Army colonel who heard wounded soldiers talk of such experiences as a nurse in Vietnam, says many military veterans have had near-death experiences but are particularly hesitant to talk them for fear of being branded psychologically disturbed.

Some investigators say the most remarkable thing about near-death reports is that the core elements are the same, among people of all cultures, races, religions and age groups, including children as young as 3 years old.

In his new book, "Evidence of the Afterlife," Jeffrey Long, a radiation oncologist in Louisiana, analyzes 613 cases reported on the website of his Near Death Research Foundation and concludes there is only one plausible explanation: "that people have survived death and traveled to another dimension."

Skeptics say there is no way to verify such anecdotal reports—and that many of the experiences can be explained by neurobiological changes in the brain as people die.

In the 1980s, British neuroscientist Susan Blackmore theorized that oxygen deprivation was to blame and noted that fighter pilots also encountered tunnel vision and hallucinations at high altitudes and speeds.

This year, a study of 52 cardiac-arrest patients in Slovenia, published in the Journal of Critical Care, found that the 21% who had near-death experiences also had high blood levels of carbon dioxide, which has been associated with visions, bright lights and out-of-body experiences.

A study of seven dying patients at George Washington University Medical Center, published in the Journal of Palliative Medicine, noted that their brainwaves showed a spurt of electrical activity just before they were pronounced dead. Lead investigator Lakhmir Chawla, an intensive-care physician, notes that the activity started in one part of the brain and spread in a cascade and theorized that it could give patients vivid mental sensations.

Warner Bros. Pictures

Matt Damon, left, plays a psychic in the movie 'Hereafter,' which explores themes of the afterlife.

Some scientists have speculated that the life review some patients experience could be due to random activation of the dying brain's memory circuits. The sensation of moving down a tunnel could be due to long-buried birth memories suddenly retrieved. The feeling of peace could be endorphins released during extreme stress.

Other researchers say they have produced similar experiences by stimulating neurons in parts of the brain—or by giving patients ketamine, a tranquilizer and sometime party drug.

Yet researchers who have studied near-death experiences note that such experiments tend to produce only fragmentary visions and hallucinations, not the consistent, lucid and detailed accounts of events that many resuscitated patients report. One study found that people who had near-death experiences had higher blood oxygen levels than those who didn't.

Several follow-up studies have found that people undergo profound personality changes after near-death experiences—becoming more altruistic, less materialistic, more intuitive and no longer fearing death. But some do suffer alienation from spouses or friends who don't understand their transformation.

Other relatives understand all too well.

Raymond Moody, who first coined the term near-death experience in his 1975 book "Life After Life," explores the even stranger phenomenon of "shared death experiences" in a new book, "Glimpses of Eternity." He recounts stories of friends, family and even medical personnel who say they also saw the light, the tunnel and accompanied the dying person partway on his or her journey. "It's fairly common among physicians who are called to resuscitate someone they don't know—they say they've seen a spirit or apparition leave the body," says Dr. Moody.

Meanwhile, in his book, "Visions, Trips and Crowds," David Kessler, a veteran writer on grief and dying, reports that hospice patients frequently describe being visited by a deceased relative or having an out-of-body experience weeks before they actually die, a phenomenon called "near-death awareness." While some skeptics dismiss such reports as hallucinations or wishful thinking, hospice workers generally report that the patients are otherwise perfectly lucid—and invariably less afraid of death afterward.

Mr. Kessler says his own father was hopeless and very sad as he was dying. "One day, he had an amazing shift and said, 'Your mother was here—she told me I'd be dying soon and it will be fine—everyone will be there."

Dr. Parnia, currently an assistant professor of critical care at State University of New York, Stony Brook, says verifying out-of-body experiences with pictures on the ceiling is only a small part of his study. He is also hoping to better understand whether consciousness exists apart from the brain and what happens to it when the brain shuts down. In near-death experiences, people report vivid memories, feelings and thought processes even when there is no measurable brain activity.

"The self, the soul, the psyche—throughout history, we've never managed to figure out what it is and how it relates to the body," he says. "This is a very important for science and fascinating for humankind."

More Information

* International Association of Near-Death Studies
* Near-Death Research Foundation
* "The Big Book of Near-Death Experiences" by P.M.H. Atwater
* "Consciousness Beyond Life: The Science of the Near-Death Experience" by Pim Van Lommel
* "Evidence of the Afterlife" by Jeffrey Long and Paul Peery
* "Glimpses of Eternity" by Raymond Moody and Paul Perry
* "Visions, Trips and Crowded Rooms: Who and What You See Before You Die" by David Kessler
* "Heaven: Our Enduring Fascination With the Afterlife" by Lisa Miller

October 25, 2010; Wallstreet Journal, Health Journal


Monday, November 29, 2010


Of all the problems with the U.S. health-care system, one of the most vexing for patients is simply sitting in the doctor's waiting room. Being ushered into the exam room, only to be left shivering in a paper gown, to wait some more, adds to the aggravation. It's the health-care equivalent of being stuck on the tarmac in a crowded plane.

The average time patients spend waiting to see a health-care provider is 22 minutes, and some waits stretch for hours, according to a 2009 report by Press Ganey Associates, a health-care consulting firm, which surveyed 2.4 million patients at more than 10,000 locations. Orthopedists have the longest waits, at 29 minutes; dermatologists the shortest, at 20. The report also noted that patient satisfaction dropped significantly with each five minutes of waiting time.

Physicians rightly bristle that they aren't serving french fries. Patients are different, and their needs are unpredictable. What's more, doctors say that fee-for-service medicine with low reimbursement rates forces them to keep packing more patients into each day, compounding the opportunity for delays.

"I live my life in seven-minute intervals," says Laurie Green, a obstetrician-gynecologist in San Francisco who delivers 400 to 500 babies a year and says she needs to bring in $70 every 15 minutes just to meet her office overhead.

Some practices, like Dr. Green's, pride themselves on running efficiently, and others are finding ways to streamline office-traffic flow and cut waiting time. "Patients' time is valuable. I think practitioners understand that more and more," says Andre W. Renna, executive director of a group of 14 gastroenterologists in Lancaster, Pa. He says even the term "waiting room" has a bad connotation. Many offices prefer "reception area" instead.

Some steps to reduce patient wait times are as simple as leaving a few "catch-up" slots empty each day or stocking the same supplies in the same place in every exam room. "That way, doctors don't have to stick their heads out the door and ask where things are. It saves a lot of time," says L. Gordon Moore, a family physician and faculty member of the Institute for Healthcare Improvement, a Cambridge, Mass.-based non-profit group that advises medical practices.

Cutting waiting times is also part of the movement toward turning primary-care practices into what reformers call "patient-centered medical homes."

For now, patients themselves can minimize waits by asking for the first appointment of the day or right after lunch, when doctors are least likely to be backed up.

Measures the health-care industry is trying or reviewing include:

"Open-access" scheduling: Doctors used to think that having their appointments booked weeks in advance was a mark of prestige. It can also make for delays. Patients scheduled far in advance often cancel or fail to show. So offices, like airlines, tend to overbook, then struggle to fit everyone in.

"Those things have ripple effects, and the barometer is the waiting room," says Terry McGeeney, president and CEO, of TransforMED, a subsidiary of the American Academy of Family Physicians (AAFP) working to improve medical-practice design.

Instead, the AAFP and other primary-care groups now urge practices to leave as much as 70% of their schedules open for same-day appointments. Patients with immediate concerns are more likely to show up, on time, and stick to the point. "When patients think they may not be back in for a few months, they have a tendency to say, 'Can we also talk about this other thing?' so what should have been a 15-minute appointment ends up to being 30," Dr. McGeeney says.

Efficient offices also monitor their ebbs and flows in patient traffic and leave more slots open, say, on Mondays and Fridays and during flu season.

Switching to open-access scheduling can take months of transition time, and some doctors worry that appointment slots will go unfilled. "But the reality is you have the same number of patients and the same number of problems," says Dr. McGeeney. "And over time, patients flow through the office much more quickly."

Minimize office visits: Many follow-up doctor visits could easily be handled via phone, email or video chat. But in the past, doctors had to have patients return to the office in order to get reimbursed for their time and expertise. Now some insurers are beginning to cover nontraditional visits, including phone consultations in some circumstances. "I think we'll even get to the point where we'll have some of these visits by smartphone," says Douglas Wood, chairman of health-care policy and research at the Mayo Clinic in Rochester, Minn.

Advance prep: Having patients complete registration forms, medication lists and other paperwork in advance, via computer or mail, can also speed office visits considerably. So does having a receptionist or nurse make sure that all necessary test results and records have been received before the patient arrives.
Self Scheduling

Some pilot programs even let patients schedule their own visits via computer, minimizing overbooking and making patients more aware of a doctor's time constraints. "Some patients say, 'Hey, it's getting close to 11:30. I better wrap it up,'" Dr. Moore says.

Huddling up: Some of the unpredictability practices face actually is predictable if practices know their patients well.

"Here's Mr. So and So. He's in a 15-minute slot, but we know he's a 45-minute guy," says Dr. Moore. "Or Mrs. Jones is bringing in a kid with a sore throat. But we know she always brings in the other three."

By reviewing the upcoming patient list several times a day, doctors and other staffers can anticipate and plan around some delays.

Teamwork: Many primary-care physicians spend much of the day doing tasks that other staffers could do, experts say. If the practice is big enough, nurse practitioners, medical assistants and other "physician extenders" could handle many aspects of patient care and cut waiting time, while the doctor is busy elsewhere. "In my office, everyone has a flu shot before I even get in the room," says Melissa Gerdes, a family physician in Whitehouse, Texas, who was part of a TransforMED pilot project.

Cutting "cycle time": In medical jargon, "cycle time" refers to the period from when a patient first arrives at the office until departure. Many practices are making a point to measure and reduce it. In Dr. Gerdes's demonstration project, patients themselves were given clipboards to record each phase of the visit, from when they arrived at the office, time in the waiting and exam rooms, time with the physician and time checking out. By identifying bottlenecks, she and her colleagues were able to cut about 12 minutes from the typical 40 minutes per hour.

"It did two things. It taught us how we were doing, but it also communicated to the patients that we were serious about improving," Dr. Gerdes says.

Keep patients informed: Simply keeping waiting patients informed about delays—and giving them the option to reschedule—can also go a long way. "It's just like sitting on an airplane—you want the pilot to tell you what's going on and what to expect," says Roland Goertz, president of the AAFP.
Tracking Apps

To that end, some practices now use automated programs to notify patients when they're behind schedule, even before patients get to the office. One Web-based tool, called MedWaitTime, lets patients check how late the doctor is running, much like airline passengers can get a flight-update. But it does require office staffers to manually update the information.

How we doing? Experts urge practices to periodically survey their patients to find out what they think about the office's efficiency. A simple note card asking them to rate aspects of the visit can yield some surprising insights.

A program called, designed by Dartmouth Medical School professor John H. Wasson, provides a detailed online questionnaire for patients to evaluate doctors' practices and give more detailed information about their own that can be integrated into the offices' electronic-medical records. The system, which is free for patients and a nominal $350 for practices, also allows doctors to compare their office scores with national averages and share ideas with other practices.

"It's really a combination of common sense, mathematics and eliminating stupid practices," Dr. Wasson says.
OCTOBER 19, 2010 Wallstreet Journal; Health Journal

Tuesday, November 23, 2010


Date Posted: October 12, 2010
Authors: Goodpaster BH, DeLany JP, Otto AD, et al.
Citation: JAMA 2010;Oct 9:[Epub ahead of print].

What are the effects of weight loss and physical activity intervention on the adverse health risks of severe obesity?


A single-blind randomized trial was conducted from February 2007 through April 2010 at the University of Pittsburgh. Participants were 130 (37% African American) severely obese (class II or III) adult participants without diabetes recruited from the community. Patients were provided a 1-year intensive lifestyle intervention consisting of diet and physical activity. One group (initial physical activity) was randomized to diet and physical activity for the entire 12 months; the other group (delayed physical activity) had the identical dietary intervention, but with physical activity delayed for 6 months. Primary outcome was change in weight. Secondary outcomes were additional components comprising cardiometabolic risk, including waist circumference, abdominal adipose tissue, and hepatic fat content.


There was no difference between groups for: mean age 46 years, 10% men, mean body mass index 43.5 kg/m2, and 75% had class III obesity. Of 130 participants randomized, 101 (78%) completed the 12-month follow-up assessments. Although both intervention groups lost a significant amount of weight at 6 months, the initial-activity group lost significantly more weight in the first 6 months compared with the delayed-activity group (10.9 kg, 95% confidence interval [CI], 9.1-12.7 vs. 8.2 kg, 95% CI, 6.4-9.9; p = 0.02 for group × time interaction). Weight loss at 12 months, however, was similar in the two groups (12.1 kg, 95% CI, 10.0-14.2 vs. 9.9 kg, 95% CI, 8.0-11.7; p = 0.25 for group × time interaction). Waist circumference, visceral abdominal fat, hepatic fat content, blood pressure, and insulin resistance were all reduced in both groups. The addition of physical activity promoted greater reductions in waist circumference and hepatic fat content.


Among patients with severe obesity, a lifestyle intervention involving diet combined with initial or delayed initiation of physical activity resulted in clinically significant weight loss and favorable changes in cardiometabolic risk factors.


The findings are intuitive. Experience in our center is that patients who commit to both exercise and diet do better with weight loss and metabolic parameters, at least in part because of improved diet compliance in those who exercise

Friday, November 19, 2010


The CBS Evening News (11/14, story 11, 0:20, Mitchell) reported, "Findings of the longest major study on stress in women are in this evening. The 10-year study found women with demanding jobs were 40% more likely to have a heart attack or stroke as women with less stressful jobs."

The AP (11/14) reported that the study presented at the American Heart Association conference on Nov. 14 followed "17,415 participants in the Women's Health Study" for 10 years. The investigators then discovered that "women with demanding jobs and little control over how to do them were nearly twice as likely to have suffered a heart attack as women with less demanding jobs and more control."

"Women with high-stress jobs face about 88 percent more risk of a heart attack than if they had low workplace strain," Bloomberg News (11/14, Lopatto) reported. The study authors "defined the stressful positions as those with demanding tasks and little authority or creativity," Bloomberg News noted. HealthDay (11/14, Gardner), the Los Angeles Times (11/14, Roan) "Booster Shots" blog, BBC News (11/15), CNN / (11/14, Harding), and the UK's Daily Mail (11/15, Borland) also covered the story.

Tuesday, November 16, 2010


A Pilot Double-Blind, Randomized, Placebo-Controlled Study
JACC 10-10

The primary objective of this study was to assess the effect of a 6-month testosterone supplementation therapy on functional capacity and insulin resistance in female patients with chronic heart failure (CHF).
Background: Patients with CHF show decreased exercise capacity and insulin sensitivity. Testosterone supplementation improves these variables in men with CHF. No study has evaluated the effects of testosterone supplementation on female patients with CHF.

Thirty-six elderly female patients with stable CHF, (ejection fraction 32.9 ± 6) were randomly assigned (2:1 ratio) to receive testosterone transdermal patch (T group, n = 24) or placebo (P group, n = 12), both on top of optimal medical therapy. At baseline and after 6 months, patients underwent 6-min walking test (6MWT), cardiopulmonary exercise test, echocardiogram, quadriceps maximal isometric voluntary contraction, dynamic quadriceps isokinetic strength (peak torque), and insulin resistance assessment by homeostasis model.

Distance walked at 6MWT as well as peak oxygen consumption significantly improved in the T group, whereas they were unchanged in the P group (p < 0.05 for all comparisons). The homeostasis model was significantly reduced in the T group in comparison with the P group (-16.5% vs. +5%, respectively; p < 0.05). Maximal voluntary contraction and peak torque increased significantly in the T group but did not change in the P group. Increase in distance walked at 6MWT was related to the increase in free testosterone levels (r = 0.593, p = 0.01). No significant changes in echocardiographic parameters were observed in either group. No side effects requiring discontinuation of T were detected.


Testosterone supplementation improves functional capacity, insulin resistance, and muscle strength in women with advanced CHF. Testosterone seems to be an effective and safe therapy for elderly women with CHF.

Monday, October 25, 2010


Title: Proton-Pump Inhibitors Are Associated With Increased Cardiovascular Risk Independent of Clopidogrel Use: A Nationwide Cohort Study
Date Posted: October 8, 2010
Authors: Charlot M, Ahlehoff O, Norgaard ML et al.
Citation: Ann Intern Med 2010;153:378-386.

Clinical Trial:
Clopidogrel and the Optimization of Gastrointestinal Events Trial

Study Question:
What is the risk for adverse cardiovascular outcomes related to concomitant use of proton pump inhibitors (PPIs) and clopidogrel compared with that of PPIs alone in adults hospitalized for myocardial infarction (MI)?

This was a nationwide cohort study based on linked administrative registry data. The primary outcome was a composite of rehospitalization for MI or stroke or cardiovascular death. Patients were examined at several assembly time points, including 7, 14, 21, and 30 days after MI. Follow-up was 1 year.

Of 56,406 included patients, 9,137 (16.2%) were rehospitalized for MI or stroke or experienced cardiovascular death. Of the 24,702 patients (43.8%) who received clopidogrel, 6,753 (27.3%) received concomitant PPIs. The hazard ratio for cardiovascular death or rehospitalization for MI or stroke for concomitant use of a PPI and clopidogrel among the cohort assembled at day 30 after discharge was 1.29 (95% confidence interval, 1.17-1.42). The corresponding ratio for use of a PPI in patients who did not receive clopidogrel was 1.29 (CI, 1.21-1.37). No statistically significant interaction occurred between a PPI and clopidogrel (p = 0.72).

The authors concluded that PPIs seem to be associated with increased risk for adverse cardiovascular outcomes after discharge, regardless of clopidogrel use for MI.

This study found no evidence that concomitant PPI therapy increases risk for adverse cardiovascular events in patients who receive clopidogrel and is consistent with the results of the COGENT trial. PPIs appear to be associated with an increased risk for adverse cardiovascular outcomes regardless of clopidogrel use, and this increased cardiovascular risk is likely explained by unmeasured confounders. These results seem to refute concerns about increased risk for ischemic events during concomitant PPI and clopidogrel therapy, and provide further reassurance about safety of PPIs in patients on dual antiplatelet therapy when such therapy is indicated.

Thursday, October 21, 2010


Title: Long-Term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals With Type 2 Diabetes Mellitus: Four-Year Results of the Look AHEAD Trial
Date Posted: September 30, 2010
Authors: The Look AHEAD Research Group.
Citation: Arch Intern Med 2010;170:1566-1575.

Study Question:
Does a lifestyle modification intervention result in long-term changes in weight and cardiovascular disease risk factors among patients with type 2 diabetes?

The Look Ahead Study is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention versus diabetes support and education. Patients all had type 2 diabetes and were between the ages of 45 and 76 years. Additional inclusion criteria included a body mass index (BMI) of 25 or greater. The intensive intervention included diet modification for a goal weight loss of 7% over the first year, with weight loss maintenance over the following years. Participants met with study members weekly in the first 6 months, then three times per month for the next 6 months, followed by once per month for the following study follow-up period. The control group had three group sessions each year.

A total of 5,145 overweight or obese patients with diabetes (mean age 58.7 years, 59.5% female) were included in the study. Over the 4-year follow-up, patients in the intensive lifestyle modification group had greater weight loss compared to the control group (-6.15% vs. -0.88%, p < 0.001) and greater improvement in treadmill fitness (12.74% vs. 1.96%, p < 0.001). The intensive intervention also resulted in lower glycated hemoglobin levels, and lower systolic and diastolic blood pressure compared to the control group. Lipid profiles among those in the intensive group also improved with great increases in high-density lipoprotein (HDL) cholesterol (3.67 vs. 1.97, p < 0.001) and reductions in triglyceride levels (-25.56 vs. 19.75 mg/dl, p < 0.001). Reductions in low-density lipoprotein cholesterol were greater in the control group, as compared to the intensive lifestyle group (-11.27 vs. 12.84 mg/dl, p = 0.009); however, lipid-lowering medication use was higher in the control group, which may explain this finding. At 4 years, those patients in the intensive intervention group had greater improvements in weight, fitness, glycated hemoglobin, systolic blood pressure, and HDL cholesterol compared to those in the control group.

The investigators concluded that an intensive lifestyle modification program can result in reductions in weight and improvements in cardiovascular disease risk factors and fitness over several years.

Lifestyle modification can result in significant improvements of risk factors, including blood pressure and lipids. These findings are encouraging in that the intervention resulted in long-term improvements, which have the potential to result in reductions in cardiovascular disease events. However, the ability to implement such intensive programs in the community remains unclear.

Monday, October 18, 2010


The hottest topic this week in Washington at the annual TCT is percutaneous valves. Beaumont will be one of the sites participating and Steven Almany will be one of the investigators. The therapy offers great promise to many with aortic stenosis where the risk of surgery might be prohibitive. It is of course early and there are risks which are described in the summary below about the trial presented.

As many as one-third of patients with severe aortic stenosis (AS) are high-risk surgical candidates and are conservatively managed. However, nonsurgical management of symptomatic AS is associated with a median survival of about 2 years. The PARTNER trial sought to compare outcomes between standard therapy and transcatheter aortic valve implantation (TAVI) in patients with inoperable AS. TAVI is a new procedure in which a bioprosthetic aortic valve is inserted through a catheter and implanted within the diseased native aortic valve.

TAVI would be superior to standard therapy in patients who are at high risk for mortality with aortic valve surgery.

Drugs/Procedures Used:
TAVI was performed under general anesthesia, and under transesophageal echocardiographic guidance. A standard balloon aortic valvuloplasty (BAV) was initially performed, followed by transfemoral insertion of either a 22- or 24-French sheath (for a 23 or 26 mm valve, respectively). The valve itself was part of the Edwards SAPIEN heart-valve system, which consists of a trileaflet bovine pericardial valve mounted on a balloon-expandable, stainless steel support frame. This system was advanced across the native aortic valve. The valve and support frame were then balloon expanded across the native valve during rapid ventricular pacing. Standard therapy consisted of medical management and BAV alone if deemed necessary.

Concomitant Medications:
All patients undergoing TAVI received heparin during the procedure, and dual antiplatelet therapy consisting of aspirin and clopidogrel for 6 months after the procedure.

Principal Findings:
Of the more than 3,000 patients with severe AS who were screened, a total of 358 patients (12%) were randomized across 21 sites, 179 to TAVI, and 179 to standard therapy. Baseline characteristics were fairly similar between the two arms. The mean Society of Thoracic Surgeons (STS) score was 11.6%, with a corresponding mean logistic EuroSCORE of 28.4. Other conditions contributing to a high-risk designation included heavily calcified (“porcelain”) aorta in 15.1%, chest wall deformity or irradiation (13.1%), oxygen-dependent respiratory insufficiency (23.5%), and frailty based on prespecified criteria (23.1%).

About 93% of the patients had New York Heart Association (NYHA) class III or IV symptoms, with a mean aortic valve area of 0.6 cm2, and a mean aortic valve gradient of 44 mm Hg. The mean left ventricular ejection fraction (LVEF) was 52%, with moderate to severe mitral regurgitation present in about 23% of the patients. Pulmonary hypertension was present in about 43% of the patients. Coexisting coronary artery disease was noted in about 71% of the patients, with 41% having undergone prior coronary artery bypass grafting, and 27% prior percutaneous coronary intervention. About 20% of patients had undergone BAV at some point prior to randomization.

There was no difference in 30-day mortality between the TAVI and standard therapy arms (5.0% vs. 2.8%, p = 0.41). However, at 1 year, the primary endpoint of all-cause mortality was significantly lower in the TAVI arm (30.7% vs. 50.7%, hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.40-0.74, p < 0.001).

Other outcomes such as cardiovascular death at 1 year (20.5% vs. 44.6%, HR 0.39, 95% CI 0.27-0.56, p < 0.001) and death or rehospitalization at 1 year (42.5% vs. 71.6%, HR 0.46, 95% CI 0.35-0.59, p < 0.001) were also lower in the TAVI arm. Major strokes at 30 days (5.0% vs. 1.1%, p = 0.06) and at 1 year (7.8% vs. 3.9%, p = 0.18) were numerically higher in the TAVI arm. Major vascular complications were significantly higher in the TAVI arm, both at 30 days (16.2% vs. 1.1, p < 0.001) and at 1 year (16.8% vs. 2.2%, p < 0.001). Similarly, major bleeding was higher in the TAVI arm at 30 days (16.8% vs. 3.9%, p < 0.001) and at 1 year (22.3% vs. 11.2%, p = 0.007).

Other complications such as acute kidney injury, endocarditis, and new pacemaker requirement were similar between the two arms. BAV was necessary in 36.9% of the patients in the standard therapy arm over 1 year of follow-up, whereas repeat TAVI was necessary in three (1.7%) patients in that time frame.

Echocardiographic parameters such aortic valve area (0.6-1.5 cm2) and mean aortic valve gradient (44.5-11.1 mm Hg) showed significant improvement in the TAVI arm at 30 days (p < 0.001 for both). Moderate or severe paravalvular and valvular aortic regurgitation were noted in 11.8% and 1.3% of the patients at 30 days, respectively, in the TAVI arm. NYHA class demonstrated significant improvements in the TAVI arm at 30 days and at 1 year, as compared with the standard therapy arm (p < 0.001).

PARTNER is a landmark trial in the field of structural heart disease and in the management of patients with severe AS. Patients in this trial were very high risk to begin with, as evidenced by >50% mortality at 1 year in the standard therapy arm. The results of the inoperable group of patients (cohort B) are reported here. TAVI resulted in 45% reduction in all-cause mortality and 61% reduction in cardiovascular mortality at 1 year in these high-risk AS patients compared with standard therapy. Echocardiographic criteria such as aortic valve area and mean aortic valve gradients, and symptom criteria such as NYHA class, also demonstrated a significant improvement.

The procedure is complex and fraught with numerous complications, however, as evidenced by a significantly higher risk of major vascular complications and major bleeding, and a trend towards a higher risk of major stroke in the TAVI arm. Thus, while the overall results are very encouraging, the high complication rate should temper any tendencies toward the overaggressive use of TAVI (if FDA approved for the treatment of AS) in lower-risk patients, and surgical AVR should still be considered the gold standard for treatment of AS in these patients. The availability and performance of smaller profile TAVI delivery systems, a comparison of transfemoral to transapical TAVI (cohort A patients), and long-term follow-up are eagerly awaited.

On another note, the design and execution of the PARTNER trial highlight the importance of close collaboration between interventional cardiologists and cardiac surgeons in the management of this complex group of patients.

Friday, October 15, 2010



In a small study, allopurinol improved exercise tolerance in patients with CAD.

Experimental evidence suggests that allopurinol lowers myocardial oxygen consumption. To assess whether this effect might benefit patients with cardiac ischemia, U.K. investigators randomized 60 patients with chronic stable exertion- induced angina, angiographically proven coronary artery disease, and positive exercise stress tests to add daily allopurinol (600 mg) or placebo to their baseline angina medications for 6 weeks; patients then crossed over to the opposite treatment for 6 weeks.

Exercise stress testing was performed after randomization and at the end of each treatment period. Compared with placebo recipients, allopurinol recipients exhibited significantly longer mean total exercise time (393 vs. 307 seconds), mean time to ST depression (298 vs 249 seconds), and mean time to symptoms (304 vs. 272 seconds). No adverse treatment effects were noted.

The anti-ischemic effect of allopurinol that was demonstrated in this study is comparable to that of other drugs such as amlodipine and nitrates, but its mechanism remains obscure. The authors speculate that allopurinol might reduce oxidative stress, thereby making more molecular oxygen available to ischemic myocardium and improving endothelial function. Although allopurinol generally is tolerated well, serious adverse effects occur occasionally. Thus, in future trials, researchers should compare allopurinol to other anti-anginal agents and include more patients and clinical outcomes.

Noman A et all. Effect of high-dose allopurinol on exercise in patients with chronic stable angina: A randomized, placebo controlled crossover trial.
Lancet 2010 Jun 19; 375:2161

Wednesday, September 22, 2010


Experts Say Laser Could Make Heart Procedure More Accurate
Sarah Mayberry, M.P.H.

It sounds like a super hero power -- being able to see through blood. But doctors say it's possible, and it's already helping patients suffering from a common heart problem.

Patricia Stroker of Clinton Township, Mich., has suffered from an abnormal heart rhythm for three and a half years.

"It terrified me. I used to come in and tell her, 'I'm afraid to go to sleep at night,'" said Stroker. "It would wake me up from sleep. It would get me when I was eating dinner. Basically any time of the day or night, and it wasn't anything that you could foresee."

The grandmother of two was diagnosed with atrial fibrillation. Experts said it's the most common heart rhythm problem, affecting more than two million Americans.

"Atrial fibrillation is an irregular heart rhythm that starts in the top part of the heart. The top part of the heart goes about 350 to 500 beats a minute. It's a very irregular rhythm," said Dr. Ilana Kutinsky, an electrophysiologist at Beaumont Hospital.

According to the American Heart Association, about 15 percent of strokes occur in people with atrial fibrillation.

"Because the top part of the heart goes so rapidly, it doesn't squeeze effectively, and when it doesn't squeeze effectively, blood can clot and then clots can fleck off and cause a stroke," said Kutinsky.

"I would get lightheaded and dizzy along with it, so I think that scared me more than the rapid heartbeat," said Stroker.

When medicine could no longer control Stroker's symptoms, Kutinsky suggested a procedure to destroy the heart tissue that was causing her problems. Generally, doctors perform this procedure without being able to actually see the heart.

"We use indirect measures of where the heart is. So we'll do a CT scan, or we'll use X-rays, or we use 3-dimensional mapping, but we can't actually see the tissue of the heart," said Kutinsky.

Beaumont offered a different option. The hospital is part of a national clinical trial testing a device called the Cardiofocus Cardiac Laser Ablation system. It's made up of a thin tube with a camera, a balloon, and a rotating laser. It gives doctors a "super power" of sorts.

"It is actually an infrared light that allows us to see through blood," said Kutinsky.

Doctors carefully thread the laser through a vein up to the heart and zap the tissue causing the irregular rhythm.

"It's an incredible advance as far as I'm concerned. I think that is has helped immensely," said Kutinsky. "To actually visualize what I'm doing has made a huge difference. To be able to see through blood is pretty remarkable."

Stroker was the first person in Michigan to be treated with the device. She said she's happy she had access to the latest high-tech advance.

"It makes you feel wonderful that they can see what they're doing, rather than taking a stab in the dark," said Stroker.

A week after the procedure --

"I feel great. I've had a couple little flip flops, which apparently are very normal, but I haven't had any a-fib episodes, and I feel good," said Stroker.

Kutinsky said the traditional procedure has a success rate of about 50 percent on the first attempt, which means many patients need to have a second procedure. She said this laser device could improve that initial success rate. Beaumont plans to enroll more patients in the clinical trial in the months to come.


We are frequently consulted in the hospital about a patient with an elevated troponin. Although a valuable biomarker I thought it would be helpful for our referring physicians to discuss its significance.

Measurement of cardiac troponin (cTn) has revolutionized the evaluation and management of patients with suspected acute coronary syndrome (ACS). Recent consensus statements endorse the use of cTnI or cTnT as the biomarker of choice for such application.1 In order to maximize sensitivity for diagnosis of ACS, as well as for superior prognostication, these same consensus statements endorse the use of the lowest cTn cut-off point, down to the “99th percentile” of a normal population as long as the assay used delivers imprecision < 10% at this cut-off point.1 While the most widely-used conventional cTn methods cannot deliver this combination of sensitivity and precision, novel very high sensitivity cTn (hsTn) assays have now been developed; these assays have a greatly improved detection limit (10- to 100-times lower than that of currently available commercial assays) with improved precision.2 hsTn assays are soon to be more widely used.

Despite the value of cTn for ACS diagnosis, risk stratification and management, it has become quite evident that non-ACS elevation of the marker is not uncommon. In a recent study examining 69,299 patients admitted through the emergency department(ED), 48% had their cTn measured. Of these, 2,344 patients (3.3% overall, or 7.0% of those that had a cTn measured) had an elevated cTn concentration. Of those with a positive cTn, 42.7% of the patients did not have ACS.3

Given this fact, and the emerging use of hsTn assays, clinicians should understand that cTn is not solely a biomarker of ischemic myocardial infarction (MI), and such clinicians must be well-versed in the differential diagnosis of an elevated cTn value outside of ACS, in order to avoid unnecessary and potentially harmful misdiagnosis and treatment for presumed ACS, while also avoiding delay in the correct treatment for the underlying cause of the elevated value. Indeed, independent of mechanism, non-ACS cTn elevations are most often prognostically meaningful (Figure 1).

Troponin Elevation: Biological and Analytical Considerations
The cTn complex is found both in the sarcomere (accounting for ~95% of cTn in the heart) as well as to a lesser extent in the cytosol of cardiomyocytes. In the setting of irreversible myocardial cell injury, the contents of the cTn complex are released into circulation. With older conventional assays, cTnI or T is typically measurable as early as 3-4 hours following myocardial injury. However, when using hsTn assays, a rising (or falling) pattern may be seen as early as one hour after myocardial injury.4 Importantly, the phenomenon of cTn release is independent of mechanism—thus, cardiomyocyte necrosis of any kind—ischemic, infectious, toxic, or otherwise—is not infrequently detectable.

In general, the prevalence of cTn elevation in the general population is low when currently available assays are used. A community-based sample of 3557 participants showed that the frequency of elevated cTnT using was 0.7%,5 and typically associated with risk factors for heart disease or heart failure (HF). Importantly, even minimally elevated cTn levels in asymptomatic, apparently healthy older adults have been shown to be associated with adverse outcomes; having elevated cTn increased the risk of all-cause and cardiovascular mortality two-fold.6

Chest Pain, non-ACS Cardiac Diagnoses and Elevated cTn
Cardiac Tn is most commonly measured for the evaluation of chest discomfort and in this context, a rising and/or falling pattern of cTn should be interpreted as being reflective of ACS. However, many non-ACS diagnoses should be kept in mind as potential cause for cTn elevation. Both acutely decompensated and chronic HF are associated with elevated cTn values, which may frequently be substantial. Elevation of cTn in the context of HF often occurs in the absence of coronary ischemia, and frequently occurs even in the absence of coronary artery disease. Various mechanisms for HF-related cTn elevation have been proposed, including subendocardial ischemia from wall tension, apoptosis, spontaneous necrosis, as well as inflammation. Linked to ventricular remodeling, elevated cTn in HF should not be discarded as ‘false positive’ as the prognosis associated with elevated cTn in this setting is poor.7
An important non-ACS diagnosis to consider in a patient presenting with chest pain and elevated cTn is acute aortic dissection (AAD). Cardiac Tn is elevated in up to 18% of patients with AAD,8 indicative of the high acuity of illness than specific to aortic dissection itself, although coronary artery occlusion in this setting is well-described.9 Misdiagnosis of AAD may potentially result in incorrect administration of anticoagulation therapy, or lead to a risky delay in the correct diagnosis.10

Another common non-ACS cause of chest pain and cTn elevation is pulmonary embolism (PE).11 The frequency of elevated cTn is 10-50% in such patients,12-13 and may be related to a combination of acute right ventricular strain and injury, hypoxia and tachycardia. Elevated cTn is strongly associated with mortality in acute PE; in a meta-analysis of 20 acute PE studies, patients with an elevated cTn had more than 5-fold increase in mortality (19.7% vs. 3.7%).14

Other relevant cardiac diagnoses that may present with both chest pain and elevated cTn include post-revascularization myocardial injury states, myocarditis (where cTn elevations are common and prognostically meaningful),15-16 acute pericarditis,17 and blunt force trauma to the heart.18

Acute Illness
In the context of life-threatening illness, the prevalence of elevated cTn is considerable (table 1). In 1130 patients presenting to an emergency department (ED) without chest pain, the frequency of elevated cTn was 3.6% and was associated with an increased mortality.19 This prevalence increases further in population presenting with chest pain to 4.5%,20 while in critically ill patients without ACS, the frequency ranges from 27% to 55%.21

An elevation of cTn in such situations may in fact have an ischemic origin: a recent study demonstrated that an elevated hsTnT in patients without ACS was strongly associated with the presence and severity of coronary artery disease and heart muscle disease, implying that non-ACS cTn elevation may result from coronary ischemia in the absence of plaque rupture or coronary thrombosis; this situation of supply-demand mismatch is known as a Type II MI.22

Common causes of non-ACS cTn elevation in the acutely ill patients include severe hypertension or hypotension,23 severe upper gastrointestinal bleeding,24 as well as systemic inflammatory response syndrome (with or without acute respiratory distress syndrome); in each case, elevated cTn is often associated with myocardial dysfunction and worse prognosis.25 Severe central nervous system injury due to an acute stroke or head trauma may cause elevated cTn values.26 Lastly, cardiotoxic chemotherapy is well recognized to increase cTn, and when this occurs, it can help to identify a patient at risk for cardiomyopathy.27-28

Chronic Diseases
A number of chronic diseases are associated with increased frequency of elevated cTn including infiltrative cardiac diseases (e.g. amyloidosis), systemic hypertension, left ventricular hypertrophy, HF, pulmonary hypertension and chronic kidney disease (CKD).28

Troponin elevation in CKD is worth discussion, as the interpretation of elevation of cTn in non-ACS patients may be difficult. Elevated cTn in asymptomatic CKD is common, the frequency which is dependent on the assay (cTnT > cTnI) and cut-off value used. Due to this fact, the specificity of cTn for ACS in this patient population is lower compared with patients without renal disease. This is of course problematic, as the incidence and prevalence of coronary artery disease and ACS is high in this population.

While cTn elevation in CKD necessarily leads to a higher risk for false positive ACS diagnosis, cTn values in this setting are to be taken seriously; a true positive cTn related to ACS in patients with CKD is associated with a heightened risk for mortality29 compared to non CKD patients, while an asymptomatic elevation in cTn in severe CKD is associated with an increased incidence of ACS30 and a 2- to 5-fold increase in mortality.31 Serial measurement, observing for a rise and/or fall of an elevated cTn value in a patient with CKD is recommended to differentiate ACS from non-ACS causes of cTn elevations.

Other Causes
Cardiac Tn elevations have been reported in patients with snake or scorpion bites, and thought to be in part due to myocardial injury by biologic toxins, vasospasm and coagulation abnormalities.28 Elevated cTn levels have been reported to be frequently elevated in asymptomatic athletes who complete endurance exercise. The exact mechanism by which cTn release occurs in this setting remains unknown but may be due to right ventricular injury.32

Elevated cTn values outside of ACS are not uncommon and reflect cardiomyocyte necrosis from a wide array of cardiac, pulmonary and systemic diseases. The growing use of hsTn assays will no doubt lead to more frequent detection of elevated cTn values, thus the topic is timely. The clinician is advised to be familiar with the broad differential diagnosis of an elevated cTn, to avoid false attribution of “acute MI” to a patient without an ACS. Importantly, an elevated cTn in the absence of ACS is most often associated with a worse prognosis and should not be disregarded as a ‘false positive’ result.

acc cardiosource 9-2010


In the Washington Post (09/14/10) "The Checkup" blog, Rob Stein wrote that research reported in the journal Circulation: Cardiovascular Quality and Outcomes suggests people with type D personalities may be "prone to heart problems." These people tend "to experience a lot of negative emotions, such as pessimism, anxiety, irritation, depressed mood," don't often share their emotions, and fear disapproval.

According to US News & World Report (09/14/10, Haupt), type D personalities "are at three times the risk for future heart problems, including peripheral artery disease, heart failure, and death, compared to more optimistic sorts." Researchers "analyzed 49 previous studies involving more than 6,000 people" to arrive at their conclusions. Barry Jacobs, a clinical psychologist and American Heart Association spokesman, said, "It really adds weight to the argument that this core, hostile personality is a concern -- or ought to be a concern -- for people who have it."

According to MedPage Today (09/14/10, Walsh), the researchers wrote that "there are plausible biological and behavioral pathways linking type D to cardiac risk," as "this personality type is associated with elevations in blood pressure, heart rate, and cardiac output, as well as with increases in the activity of proinflammatory cytokines," increased cortisol, and increased oxidative stress. "In addition, patients with the distressed personality type D, also are less likely to seek timely medical care or to adhere to medication, according to the researchers."

Steven Almany, MD

Tuesday, September 21, 2010

INTRESTING ARTICLE- posted by Joel Kahn, MD

A study, published in the October/November, 2009 issue of the Journal of Clinical Endocrinology and Metabolism, has found that reducing the amounts of processed and fried foods in the diet can promote weight loss, reduce inflammation and restore the body's natural defenses against disease for both young and old, regardless of the status of their health. Cutting back on the processed and fried foods can reduce your family's risk of kidney disease, heart disease, hypertension, diabetes and obesity, and may even increase longevity.

Processed and fried foods are high in glycotoxins called Advanced Glycation End products (AGEs). AGEs proliferate when food is heated, pasteurized, fried, smoked or grilled. Once they are inside the body, they bind themselves to tissues and oxidize them. This oxidation process causes inflammation, which in turn can cause disease. These toxins, or oxidants, may be more responsible than genetics for causing certain diseases and conditions.

Findings show that people can benefit from a diet low in AGEs without reducing calories or nutrient intake. That means it is possible to lose weight and improve your health without reducing calories. Of course, if you are overeating, reducing the amount you put in your mouth is a good idea, but this study could give your weight loss efforts an added boost.

Eliminating processed foods from your family's diet may seem impossible. They have become the mainstay of the Western diet. Manufacturers make it even easier to consume these foods at a "savings" with coupons and special offers. The truth is that the processed foods you eat are not saving you any money in the long run. They may actually be costing you money in the form of future medical bills, time lost at work due to illness, and even unemployment or disability due to serious illness. Eating an AGEless diet may mean a little more work in the kitchen, but the long term health benefits far outweigh any inconvenience.

Read more: How to Restore Your Body's Defenses: The AGEless Diet |

Wednesday, September 8, 2010

CURBSIDE- September 2010

Title: Waist Circumference and All-Cause Mortality in a Large US Cohort
Date Posted: August 9, 2010
Authors: Jacobs EJ, Newton CC, Wang Y, et al.
Citation: Arch Intern Med 2010;170:1293-1301.

Study Question:
Is waist circumference associated with risk of death within body mass index (BMI) categories?

Data from the Cancer Prevention Study II (CPS-II) Nutrition Cohort (established in 1992) were used for the current study. The CPS-II Nutrition Cohort is a subset of the CPS-II cohort established by the American Cancer Society in 1982. Subjects enrolled between 1992 and 1993 and were mailed questionnaires in 1997, in which they were asked to measure their waist circumference. Validity of self-report was not completed. Body mass index (BMI) was calculated from reported weight on the 1997 survey, and height was reported in the 1982 survey. Subjects who had lost ≥10 lbs or gained more than 25 lbs between 1992 and 1997 were excluded. Subjects with missing data on waist circumference or BMI were also excluded. Mortality was assessed through the National Death Index through December 31, 2006.

A total of 48,500 men and 56,343 women, 50 years or older, were included in this analysis. Median age at baseline was 69 years for men and 67 years for women. The cohort was predominately white. Subjects in the highest category of waist circumference were more likely to be less educated, have a high BMI, be sedentary, and were former smokers compared to subjects with lower waist circumference. This group was also more likely to have a history of cardiovascular disease, cancer, or respiratory disease. Between 1997 and 2006, 9,315 men and 5,332 women had died. After adjustment for BMI and other risk factors, increased waist circumference (≥120 cm compared to <90 cm) was associated with a twofold higher risk of mortality among men (relative risk [RR], 2.20; 95% confidence interval [CI], 1.71-2.39). For women, a waist circumference ≥110 cm compared to <75 cm was also associated with increased risk of death (RR, 2.36; 95% CI, 1.98-2.82). Waist circumference was positively associated with mortality in all categories of BMI. In men, a 10 cm increase in waist circumference was associated with RRs of 1.16 (95% CI, 1.09-1.23) for normal (18.5 to <25) BMI, 1.18 (95% CI, 1.12-1.24) for overweight (25 to <30) BMI, and 1.21 (95% CI, 1.13-1.30) for obese (≥30) BMI. In women, corresponding RRs were 1.25 (95% CI, 1.18-1.32), 1.15 (95% CI, 1.08-1.22), and 1.13 (95% CI, 1.06-1.20).

The investigators concluded that waist circumference is important as a risk factor for mortality among older adults, regardless of BMI.

These data highlight the clinical significance of waist circumference. Clinicians may want to consider making waist circumference part of the vital signs for each patient, and to make clear to patients the potential benefits of preventing abdominal obesity.

Title: Effect of Low Doses of N-3 Fatty Acids on Cardiovascular Diseases in Post-MI Patients
Trial Sponsor: Netherlands Heart Foundation, The Hague, The Netherlands, National Institutes of Health, Unilever
Year Presented: 2010
Summary Posted: 09/08/2010

Reviewer Disclosure: RESEARCH/RESEARCH GRANTS: Astra Zeneca, Heartscape, Eisai, Sanofi Aventis, The Medicines Company, Ethicon, Bristol Myers Squibb Cogentus, PLx Pharma, Takeda

The goal of the trial was to evaluate treatment with supplemental omega-3 fatty acids (N-3) among patients with prior myocardial infarction (MI). Fatty acids in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), whereas fatty acids in plants are alpha-linolenic acid (ALA).

Omega-3 fatty acids will be more effective at reducing major adverse cardiovascular events.

Drugs/Procedures Used:

Patients who had suffered an MI within the last 4 years were randomized to one of four margarines for dietary consumption: 1) EPA-DHA 400 mg daily + ALA placebo (n = 1,192), 2) EPA-DHA placebo + ALA 2 g daily (n = 1,197), 3) EPA-DHA 400 mg daily + ALA 2 g daily (n = 1,212), or 4) EPA-DHA placebo + ALA placebo (n = 1,236).

Concomitant Medications:
At baseline in the EPA-DHA + ALA group, the use of lipid-lowering drugs was 87%.

Principal Findings:
Overall 4,837 patients were randomized. In the EPA-DHA + ALA group, the mean age was 69 years, 22% were women, 20% were diabetic, systolic blood pressure was 141 mm Hg, and body mass index was 28 kg/m2. Compliance with study medication was verified by measurement of serum fatty acids.

The primary outcome, major adverse cardiovascular events (MACE), was similar between the EPA-DHA group and placebo group (hazard ratio [HR] 1.01, p = 0.93) and between the ALA group and placebo group (HR 0.91, p = 0.20). Among women in the ALA group, there was a nonsignificant reduction in the primary outcome (HR 0.73, p = 0.07) and among diabetics in the ALA group, there was a significant reduction in ventricular arrhythmia-related adverse events (HR 0.39, p = 0.002).

Among patients with prior MI, dietary supplementation of omega-3 fatty acids was not beneficial since this therapy did not reduce MACE. Subgroup analysis revealed a nonsignificant reduction in MACE among women treated with ALA, and a significant reduction in ventricular arrhythmia-related adverse events among diabetics treated with ALA. Both of these subgroups should be interpreted with caution until further analysis can be performed. We continue to use FISH Oil capsules in patients that have very high triglycerides >500). The patients need follow up lipid evaluations as the LDL CAN UP AS MUCH AS 20% in patients taking fish oil. Most side effects are tolerable. Patients who get GERD with fish oil capsules might benefit from freezing the capsules.

Steven Almany, MD

Tuesday, August 10, 2010

CURBSIDE- August 2010

Two New Studies Lend More Support To Compression-Only CPR.

NBC Nightly News (07/28/10, story 9, 1:45, Williams) reported, "The rules of CPR may be about to change," as two newly published studies "question the way millions of us learn to administer" it. Indeed, "most experts all agree the most important thing to do is call 9-1-1 immediately. It's the next part that's in dispute."

Now, new research "confirms" that "for bystanders with no training, chest compressions on adults are enough to restore life," ABC World News (07/28/10, story 7, 2:30, Sawyer) reported. "And there is no benefit to performing mouth-to-mouth resuscitation." This is noteworthy, because it's estimated that "only one third of those who go into cardiac arrest get CPR from a bystander. The hope is that by making it easier to do, more people will be willing to do it." The American Heart Association agrees with that line of thought, the CBS Evening News (07/28/10, story 7, 0:20, Couric) reported. It "says the simpler method will save more lives because it's easier to do."

In fact, the "American Heart Association, which trained 13 million people in CPR last year, is developing new guidelines for resuscitation that will be released in October," the Washington Post (07/29/10, Brown) reports. The "current guidelines encourage bystanders to at least do chest compressions, also known as hands-only CPR." The "prevailing theory is that not interrupting chest compressions with rescue breaths might ultimately deliver more oxygen than standard CPR in the crucial seven or eight minutes before paramedics arrive." Notably, "both studies, published Thursday in the New England Journal of Medicine, found a trend in that direction."

During the first and larger study, a team comprised of researchers from the University of Seattle and London "considered 1,941 people in cardiac arrest who needed bystanders to perform CPR until an ambulance arrived," Bloomberg News (07/29/10, Fridson) reports. "The scientists reported finding no significant difference between the 981 patients who received chest compression alone and the 960 who received both that procedure and mouth-to-mouth breathing." In fact, the "first group survived to hospital discharge at a rate of 12.5 percent and the second had an 11 percent survival rate, the scientists wrote."

The "second study was done in Sweden...included nearly 1,300 people," and reached similar conclusions, the AP (07/29/10, Stobbe) reports. "The studies also spotlighted the importance of having forceful dispatchers coaching bystanders," explained one expert who was not involved. "When dispatchers told callers to start CPR, about 80 percent attempted it when given hands-only instructions, more than the 70 percent who tried the standard version." The increase is being attributed to "dispatchers who immediately told callers what to do, instead of first asking them if they'd had CPR training or if they'd be willing to try it until medical help arrives."

There are, however, "exceptions to the" hands-only rule, according to the author of an editorial accompanying the studies. Dr. Myron Weisfeldt, of Johns Hopkins University, told CNN (07/29/10, Hellerman), "It is very important to understand that the patients in this study were adults and that for most children who suffer cardiac arrest, such as drowning victims, we must do rescue breathing." And, "patients with chronic lung disease or acute asthma, should also receive mouth-to-mouth."

The Los Angeles Times (07/29/10, Maugh) reports that "communities that are already using the new approach are seeing dramatic increases in survival of people who experience heart attacks, said Dr. Paul E. Pepe, head of the emergency medicine department of the University of Texas Southwestern Medical School in Dallas."

The Wall Street Journal (07/29/10, Wang, subscription required), the Boston Globe (07/28/10, Cooney) "White Coat Notes" blog, HeartWire (07/28/10, Wood), and HealthDay (07/28/10, Gordon) also covered the studies.

Friday, June 25, 2010

CURBSIDE- June 2010

Dear Colleagues:


MHG has created a blog! We will continue to publish the Curbside on a bi-monthly basis along with other current medical information relating to Cardiology! However, we will be doing so via the Michigan Heart Group Blog. We are hoping that this information can help serve as a link between our practice and yours. If you would like to receive email updates with an attached link when the blog is updated, please email or call Stacie Batur at 248-267-5050 (x6509) and she will add you to the distribution list. THIS LIST IS NOT SHARED WITH ANYONE! As always, if you have any questions, please feel free to contact any of us at anytime. Thank you and we look forward to working with you in the future!

Title: Practice Patterns Among United States Cardiologists for Managing Adults With Atrial Fibrillation (From the AFFECTS Registry)
Topic: Arrhythmias
Date Posted: 3/4/2010
Author(s): Reiffel JA, Kowey PR, Myerburg R, et al.
Citation: Am J Cardiol 2010;Feb 22:[Epub ahead of print].
Clinical Trial: No

Journal Scan: Warfarin and Aspirin Use in Atrial Fibrillation Among Practicing Cardiologists (From the AFFECTS Registry)

Study Question: How do community-based cardiologists treat atrial fibrillation (AF)?

Methods: This was an analysis of 1,461 patients (mean age 66 years) who had AF (paroxysmal in 80%, symptomatic in 77%) without structural heart disease and who were enrolled in a multicenter, prospective registry. Participating cardiologists were trained in the practice guidelines of the American College of Cardiology/American Heart Association/European Society of Cardiology (ACC/AHA/ESC). Follow-up data were gathered for 1 year after enrollment. The choice of therapy was at the treating physician’s discretion.

Results: At baseline, a rhythm-control strategy was chosen for 64% of patients and a rate-control strategy for 36%. Rhythm control was attempted significantly more often for paroxysmal AF (67%) than for persistent AF (55%). A rhythm-control strategy also was selected more often for symptomatic than asymptomatic persistent AF (60% vs. 40%, respectively), but in a similar proportion of patients with symptomatic and asymptomatic paroxysmal AF (68% and 63%, respectively). The most common first-line rhythm-control drugs were sustained-release propafenone (43%) and sotalol (17%), and the most common second-line drugs were sustained-release propafenone (36%) and amiodarone (22%).

Conclusions: Community-based treatment of AF in patients without structural heart disease is fairly compliant with ACC/AHA/ESC practice guidelines.

Perspective: The ACC/AHA/ESC guidelines recommend that a rate-control strategy be used for patients with minimally symptomatic or asymptomatic AF. It is noteworthy that a large proportion of patients with asymptomatic AF nevertheless are treated with rhythm-control drugs in community practice. It appears that, despite current guidelines, many cardiologists have not abandoned the deep-rooted (and logical) belief that sinus rhythm is better than AF for many patients.

Title: Glycated Hemoglobin, Diabetes, and Cardiovascular Risk in Nondiabetic Adults
Topic: Prevention/Vascular
Date Posted: 3/3/2010 5:00:00 PM
Author(s): Selvin E, Steffes MW, Zhu H, et al.
Citation: N Engl J Med 2010;362:800-811.
Clinical Trial: No

Study Question: Is the glycated hemoglobin in persons without diabetes predictive of cardiovascular outcomes?

Methods: The prognostic value of glycated hemoglobin and fasting glucose were assessed for their ability to identify adults at risk for diabetes or cardiovascular disease. Glycated hemoglobin (glycohemoglobin or HgA1c) was measured in whole-blood samples from 11,092 black or white adults who did not have a history of diabetes or cardiovascular disease and who attended the second visit (occurring in the 1990–1992 period) of the Atherosclerosis Risk in Communities (ARIC) study.

Results: Fifty-eight percent were women, 77% were white, 32% had hypertension, and 22.7% had a family history of diabetes. Mean values for risk factors were as follows: age 57 years, fasting blood sugar (FBS) 105 mg/dl, glycated hemoglobin 5.5%, low-density lipoprotein cholesterol 133 mg/dl, high-density lipoprotein cholesterol 51 mg/dl, and body mass index 27.7 kg/m2. The glycated hemoglobin value at baseline was associated with newly diagnosed diabetes and cardiovascular outcomes. For glycated hemoglobin values of less than 5.0%, 5.0 to less than 5.5%, 5.5 to less than 6.0%, 6.0 to less than 6.5%, and 6.5% or greater, the multivariable-adjusted hazard ratios for diagnosed diabetes were 0.52, 1.00 (reference), 1.86, 4.48, and 16.47, respectively. For coronary heart disease, the hazard ratios were 0.96, 1.00 (reference), 1.23, 1.78, and 1.95, respectively. The hazard ratios for stroke were similar. In contrast, glycated hemoglobin and death from any cause were found to have a J-shaped association curve. All these associations remained significant after adjustment for the baseline fasting glucose level. The association between the fasting glucose levels and the risk of cardiovascular disease or death from any cause was not significant in models with adjustment for all covariates as well as glycated hemoglobin. For coronary heart disease, measures of risk discrimination showed significant improvement when glycated hemoglobin was added to models including fasting glucose.

Conclusions: In this community-based population of nondiabetic adults, glycated hemoglobin was similarly associated with a risk of diabetes and more strongly associated with risks of cardiovascular disease and death from any cause, as compared with fasting glucose. These data add to the evidence supporting the use of glycated hemoglobin as a diagnostic test for diabetes.

Perspective: Persons with a glycated hemoglobin ≥6.5% or FBS >126 mg/dl are characterized as diabetics. The former represent the average blood sugar over 2 to 3 months. A level greater than 5.5% is associated with an increase in risk for diabetes and coronary disease independent of other variables, and the relative risk for 0.5% increments is considerable. The authors concluded that a glycated hemoglobin exceeding 6% may be a useful marker to identify persons at risk for development of diabetes, and cardiovascular disease and death. Consideration should be given to replacing the FBS with glycated hemoglobin for risk stratification of adults with and without vascular disease.

Title: Warfarin and Aspirin Use in Atrial Fibrillation Among Practicing Cardiologists (From the AFFECTS Registry)
Topic: Arrhythmias
Date Posted: 3/4/2010
Author(s): Kowey PR, Reiffel JA, Myerburg R, et al.
Citation: Am J Cardiol 2010;Feb 22:[Epub ahead of print].
Clinical Trial: No

Related Resources

Journal Scan: Practice Patterns Among United States Cardiologists for Managing Adults With Atrial Fibrillation (From the AFFECTS Registry)

Study Question: What is the pattern of anticoagulation use in patients with atrial fibrillation (AF) in contemporary practice?

Methods: This was an analysis of 1,461 patients (mean age 66 years) who had AF (paroxysmal in 80%) without structural heart disease and who were enrolled in a multicenter registry. Participating cardiologists were trained in the practice guidelines of the American College of Cardiology/American Heart Association/European Society of Cardiology. Follow-up data were gathered for 1 year after enrollment. The choice of therapy was at the treating physician’s discretion. The Congestive heart failure, Hypertension, Age, Diabetes, Stroke (CHADS2) score was determined by post-hoc record review. A CHADS2 score ≥2 was considered indicative of a high risk of stroke.

Results: A rhythm-control strategy was used in 64% of patients and a rate-control strategy in 36%. Overall, 83% of patients received either warfarin (64%) or aspirin (32%), with no significant difference between the rhythm-control and rate-control groups. Among the high-risk patients, warfarin was used in 66% of rhythm-control patients and 73% of rate-control patients. Among the low-risk patients (CHADS2 <2),>

Conclusions: Anticoagulation use in patients with AF often is inconsistent with practice guidelines.

Perspective: Several studies have indicated that warfarin is underused in patients with AF. The registry data in this study demonstrate that this continues to be the case, with approximately 25-35% of high-risk patients not receiving warfarin despite the guidelines training provided to the treating physicians. The results emphasize the need for more effective dissemination and implementation of practice guidelines.

Steven C. Almany, M.D., F.A.C.C.