Healthboards.com

Those few people who have been following my CABG posts on a small health-oriented site called Healthboard.com, may have noticed my posts disappeared. I also have been banned from the site. I am not certain whether my banishment is temporary or is of the lifetime variety. Anyone interested in the latest information about noninvasive treatments for Coronary Artery Disease or Unstable Angina can still read and reply to comments here, where there never will be any censorship

You also can contact my cardiologist at the address, phone number and URLs listed below:

Dr. Howard Wayne

The Noninvasive Heart Center
2550 Fifth Avenue, Suite 706
San Diego, California 92103
(619) 544-0200
www.heartprotect.com

Lifestyle Changes Endorsed by Medicare

Medicare will reimburse heart patients for two wellness programs that focus on wholesale changes. Supporters see the move as a shift toward proactive care.

By Hilary E. MacGregor
Times Staff Writer

June 12, 2006

LIFESTYLE changes can boost the health and well-being of heart patients, proponents of such programs have long said. Now Medicare has acknowledged that as well.

The federal insurance program will now pay for the intensive cardiac rehabilitation plans created by preventive health guru Dr. Dean Ornish and mind-body medicine pioneer Dr. Herbert Benson — the first time the federal government has agreed to reimburse consumers for specific lifestyle intervention programs.

"This exciting breakthrough could change the face of medical care," said Ornish in a statement.

He and Benson have been working for years to obtain Medicare reimbursement for their cardiac wellness programs because it's seen as a critical first step to making their programs more widely available — and getting other insurance providers to pay for them as well.

Both have conducted clinical research demonstrating that comprehensive lifestyle changes — including support groups; good nutrition and low-fat diets; exercise; and stress management, such as yoga, meditation or deep breathing — may begin to reverse even severe coronary heart disease without drugs or surgery.

Ornish's Program for Reversing Heart Disease is offered at eight sites in Pennsylvania and at five medical centers in West Virginia. At least one private insurer in each state already has agreed to cover the programs in those states.

Cardiac wellness programs by Benson, who more than 25 years ago wrote the groundbreaking "Relaxation Response," are offered in Indiana, Rhode Island, Tennessee, Washington and Virginia.

Considered by many to be the father of meditation in this country, Benson has shown that 10 minutes of meditative technique a day can increase concentration and counteract the harmful effects of stress, such as high blood pressure and strokes.

His Cardiac Wellness Program combines these stress reduction techniques with nutrition, cognitive restructuring and exercise to lower cholesterol and blood pressure. Patients report fewer symptoms of chest pain.

Medicare, however, will not cover enrollment in the programs for as long as both centers frequently recommend. Instead, it will guarantee coverage for 36 sessions within an 18-week period, with a possible extension to 72 sessions for 36 weeks. The final details of how much will be covered are still under negotiation, Ornish said.

Although Medicare already pays for some cardiac rehabilitation programs, officials hailed the inclusion of both programs as an important shift toward preventive rather than rehabilitative medicine.

As of March, the definition of who can take advantage of the cardiac rehab benefit under Medicare has been expanded from conditions such as acute myocardial infarction (heart attack) and coronary artery bypass graft to include patients with less severe heart conditions, such as valve replacement.

"The programs of Dr. Ornish and Dr. Benson focus on a prevention model," said a spokesperson with the Centers for Medicare and Medicaid Services. "Now we are going to take even individuals with mild cardiovascular disease and show them how to ameliorate it or reverse it to avoid more serious disease."

Although the details of coverage have not been finalized, doctors who run similar lifestyle intervention programs to treat and prevent heart disease supported the move.

"It is just phenomenal that Medicare has decided to cover these programs since Medicare sets the precedent for all of the other insurance companies," said Dr. Mimi Guarneri, a cardiologist who co-founded and runs the Scripps Center for Integrative Medicine in La Jolla.

"What's really important is this is truly shifting the paradigm of healthcare from focusing on chronic disease to focusing on prevention."

L.A. Times

Yet Another Physician Decries Unnecessary CABG

Coronary Angioplasty Indications
by Ron Kennedy, M.D., Santa Rosa, California

When to have invasive procedures and when not — what your doctor may not tell you.

The past 20 years has seen a proliferation of bypass surgery and angioplasty, in spite of strong scientific evidence that neither may be helpful in the long run for the overwhelming majority of patients. In general, the only reason for the one million such procedures each year is the high number of working cardiologists and cardiovascular surgeons in the medical community and the extremely high profitability of these procedures, around $70,000 for a bypass and $30,000 for an angioplasty.

The landmark CASS Study (stands for Coronary Artery Surgery Study) in 1984 demonstrated the irrelevance of bypass surgery and angioplasty to survival after the diagnosis of coronary artery disease is made. Analysis of outcome in 780 patients demonstrated no statistical difference in survivability between patients who both went to surgery and were treated medically and patients who were treated medically without surgery. Neverhteless, this extremely well documented study is generally ignored by doctors who do these procedures and never mentioned to patients who they consider candidates for bypass or angioplasty.

"Blockages," as reported from angiography are not an accurate reflection of blood flow according to a 1984 study published in the New England Journal of Medicine. No correlation between blockage and blood flow means the angiogram is worthless for gauging degree of blockage. (2)

If "blockages" are visible on angiogram, this does not mean bypass surgery or angioplasty should be done, since blood flow does not correlate with these images. What this study can tell you is if you have some plaque formation. However, the important item is blood flow. What does correlate with blood flow is the "ejection fraction," that percentage of the blood the left ventricle can eject from its volume at full expansion. For example, if the heart can empty ½ the volume it contains before contraction, the ejection fraction is said to be 50%.

If a cardiologist recommends angiogram (catheterization), the chances are it is not needed by the standards of the AMA. Ask your doctor to determine the ejection fraction and if it is 40% or better, decline the angiogram because your pump is healthy enough that whatever the results of angiogram, no surgery is advisable according to AMA guidelines. Why place yourself at the risk of death (1-2% for angiogram and 5% for bypass) if your pump is working?

According to the AMA the indications for bypass surgery are:

1. when the left main coronary artery is blocked,
   
2. when the patient has severe anginal pain which is unresponsive to all other therapies,
   
3. when there is evidence of blockages in three coronary arteries and the ejection fraction is below 40%.

In these cases surgically treated patients do better than non-surgically treated. (3)

In summary, the salient points to consider when confronted with a heart doctor who wants to operate are:

1. Angiograms are inaccurate and irrelevant to blood flow. This is proven by the Graboy study.
   
2. The important measurement is the ejection fraction which reflects the health of the heart as a pump. A heart with an ejection fraction of 40% or greater should not be operated on.
   
3. Coronary bypass surgery and angioplasty are irrelevant to your chances of survival. The CASS study of thousands of patients showed a 1.6% per year mortality in those randomly assigned to surgery and also 1.6% per year in those randomly assigned to medical management.
   
4. The cardiopulmonary pump used during bypass surgery can cause brain damage in any patient. This damage can lead to memory loss, paralysis and personality change after the operation. It is estimated that 50% of patients have measurable brain damage from the effect of the use of the pump.
   
5. Bypass surgery and angioplasty are not curative; they do not address the cause of vascular disease. Vascular disease in other parts of the body will progress unimpeded.
   
6. Due to changes in blood flow the artery or arteries operated on progress toward reblockage at a rate ten times faster than before. This is why these procedures typically fail after a few months or years.
   
7. Up to 90% of bypass operations are done with an ejection fraction of greater than 50% (i.e. on normal hearts from the pumping point of view). This means that 90% of angiograms and 90% of bypass procedures are unnecessary, at least unnecessary for the patient's health and well-being.
   
8. After bypass surgery your risk of a heart attack is greater than if you are treated medically, without surgery.
   

Sources:

1. Alderman EL, et al. Ten year follow-up of survival and myocardial infarction in the randomized coronary artery surgery study (CASS). Circ. 82:1629-46, 1990 CASS Principle Investigators and Their Associates: Myocardial infarction and morbidity in the coronary artery surgery study (CASS) randomized trial. New England Journal of Medicine310:750-8, 1984
   
2. Graboys TD, et al. Result of second opinion program for coronary artery bypass surgery. Journal of the American Medical Association 268:2537-40, 1992
   
3. Graboys TD, et al. Result of second opinion program for coronary artery bypass surgery. Journal of the American Medical Association258:1611-4, 1987
   
4. Winslow CM, et al. The appropriateness of performing coronary artery bypass surgery. Journal of

Women Bypass Patients More Likely to Die

women who have heart bypass surgery are far more likely than their male counterparts to die within days or weeks of their operation. This gender gap means many "extra" female deaths among the 270,000 Americans who have bypass surgery each year.

Now, a new University of Michigan study suggests that the answer to the mystery may lie with infections, regardless of their location in the body.

Want to read more?

New Noninvasive Imaging Technique

A study focusing on a new non-invasive imaging technology--one that may enable more precise diagnosis of coronary artery disease and treatment tailoring in individual patients--was released by Israeli researchers at SNM's 53rd Annual Meeting June 3-7 in San Diego.

"This work presents a new non-invasive cardiac imaging technology for the assessment of ischemic heart disease--also known as coronary artery or coronary heart disease--caused by the narrowing of heart arteries, which prevents blood and oxygen from reaching the heart muscle," said Zohar Keidar, deputy director of the nuclear medicine department at Rambam HealthCare Campus in Haifa, Israel. "This new modality (or technique) enables--in a single imaging session--accurate evaluation of cardiac blood vessel narrowing and blood supply to the heart muscles," said the co-author of "Assessment of Hemodynamically Significant Coronary Artery Lesions--Initial Experience With an Integrated SPECT/CT Device." He added, "These initial results suggest that this novel non-invasive imaging technology will enable more precise diagnosis of coronary artery disease, thus leading to treatment tailoring in the individual patient who may be directed to either invasive or conservative medical procedures."

Get the whole story.

Another Clean Bill of Health

Two years ago, a cardiologist in Indianapolis, attempted to scare me into having a quintuple coronary artery bypass graft (CABG). I was referred to him because I was having some rather troublesome angina pains in my chest whenever I walked as little as a few blocks. I had failed my stress test and the cardiologist said I needed a cardiac catheterization to evaluate my problem further. He warned me I might need to have a stent or two put in when he did the cath. Upon returning from the cath lab, I awoke from the twilight sleep given me to find a cardio-thoracic surgeon standing over me, along with my cardiologist.

I was told the cath showed two coronary arteries that were 100% blocked and three that were over 85% blocked. He said, that although my heart was in great shape, my arteries were terrible. I then asked a simple question the cardiologist would not or could not answer, "How can my heart be in such good shape if the arteries whose job it is to supply them with oxygen are almost totally blocked?" He simply said I needed an immediate CABG to save my life.

I sought a second opinion from a noninvasive cardiologist in San Diego named Howard Wayne. He confirmed that my arteries indeed were very bad, but told me the reason my heart was still very healthy was because other vessels, collaterals, had taken over their job and my body was also making new vessels, a process called "angiogenesis." Dr. Wayne began treating me in June 2004. I returned for followup exam a year later. I had not experienced one episode of angina since staring his medication regimen. Today, I returned from my second followup visit to Dr. Wayne. I am still angina-pain-free and his tests of my heart all came out perfectly normal.

Please, if you are told you need Bypass surgery -- Get a second opinion from a noninvasive cardiologist. You will be so glad you did. You can learn more about Dr. Wayne here.

DO YOU REALLY NEED BYPASS SURGERY? A SECOND OPINION

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Dr. Wayne's newest book Do You Really Need Bypass Surgery will be available by the end of the summer or early Fall. The price of the book has not yet been determined. Some of the subject material is listed below.

You will learn from Do You Really Need Bypass Surgery:

• That you are a victim of medical terrorism when a doctor threatens that you could have a massive heart attack or die unless you undergo immediate bypass surgery or angioplasty, and that there are no other options for treatment. Are such threats true? Almost never!
• This book will show that the heart attack and death rate after bypass surgery is 5-10 times that of medical treatment with drugs. Bypass surgery, angioplasty and stent insertion do not prevent heart attacks or death but actually cause them.

You will learn:

• That other complications of bypass surgery, such as brain damage and loss of memory and reasoning, occur in over one-third of patients
• That patients undergoing bypass surgery have an accelerated progression of their coronary artery disease.
• That symptom relief after bypass surgery is due to a dozen other reasons that have nothing to do with the bypass procedure.
• That successful treatment of coronary artery disease with medication not only saves lives and prevents future heart attacks, but can be accomplished at a fraction of the cost of surgery and without its side effects.

Learn:

• Why coronary artery disease is no longer the lethal disease it once was but with modern treatment with FDA approved medications has become as benign as mild arthritis.
• Why blockage of a coronary artery may really be an adaptive mechanism on the part of the heart to protect the arterial wall downstream. Removal of that blockage may actually be the wrong thing to do!
• Why a cardiologist trained at the Cleveland Clinic (birthplace of bypass surgery and angiograms) gave up bypass surgery in favor of medical treatment with drugs.
• Why cardiologists continue to recommend bypass surgery even though it is obsolete.
• Why the angiogram is not only the most inaccurate test in cardiology but the most dangerous.
• Why the angiogram should never be used alone to diagnose and treat coronary artery disease.
• Why the number of blocked arteries on an angiogram is irrelevant because the heart creates its own bypasses through angiogenesis and the formation of new blood vessels.
• Why noninvasive imaging tests, at a fraction of the cost of an angiogram, and without its dangers, provide all the information necessary to diagnose and treat coronary artery disease successfully.

This book can not only save your life but the lives of your family, friends and loved ones.

Generx shows promise

There is a new product that shows much promise in the quest to prove CABG is not the best treatment for CAD.

Of the major interventions performed for treating severe coronary heart disease in the United States, namely percutaneous coronary intervention (PCI or angioplasty) and coronary artery bypass graft (CABG) surgeries, more than one million procedures are performed annually and more than two-thirds of these are performed on men. While angioplasty and stenting or CABG surgeries can be used to mechanically open or surgically bypass blockages of the large epicardial blood vessels that surround the myocardium, neither angioplasty nor CABG are believed to be capable of also addressing blockages or flow limitations affecting the mid-sized to smaller blood vessels which are located deeper within the heart muscle. These deeper blood vessels, which form the underlying coronary "microcirculation," are directly responsible for conveying oxygenated blood into close proximity with the adjacent heart tissue. In addition, microcirculatory impedance or resistance to flow at the downstream level can contribute substantially to reducing overall blood flow through the myocardium - which may be a contributory cause of ischemia in patients with heart disease. In that regard, many patients continue to experience angina even after surgical and other interventions have been performed to mechanically open or bypass accessible portions of the large upstream blood vessels that initially conduct blood flow into the heart.

Cardiovascular disease is also becoming the number one health problem globally. According to the World Health Organization, by 2020 heart disease and stroke will be the leading causes of death and disability worldwide, with the number of fatalities projected to increase to more than 20 million per year. Additional information regarding heart disease in both men and women can be found in the publications of the American Heart Association, including Heart Disease and Stroke Statistics, and in the reports of the World Health Organization and its affiliates.

About Generx

Generx (alferminogene tadenovec) is the lead development product in a new class of cardiovascular biologics that is being developed to leverage the body's natural healing processes in response to repeated ischemic stress (insufficient blood flow and myocardial oxygen supply due to severe coronary artery disease). The natural biologic response to repeated transient ischemia is angiogenesis, the growth of new collateral blood vessels, which is orchestrated by a complex and incompletely understood cascade involving many myocardial-derived growth factors. These newly-formed vessels can effectively augment blood flow and oxygen delivery to parts of the patient's heart downstream from a blockage in a coronary artery. In many patients however, including those with recurrent angina, coronary collateral vessel formation is insufficient to meet the heart's needs during stress. Currently available anti-anginal drugs, which may provide temporary symptomatic relief, are generally designed to alter the oxygen demand of the heart muscle or dilate vessels to relieve angina without changing the underlying medical condition.

For more information, check out http://www.pharmalive.com/News/index.cfm?articleid=346686&categoryid=40

Bypass Goof Sparks Lawsuit

Another lawsuit has been filed by the family of a patient who died after heart surgery at Mary Washington Hospital.

The suit alleges that Ralph P. Holt died because he received contaminated medicine during bypass surgery last year.

The suit was filed last week in Spotsylvania County Circuit Court and brings to eight the number of suits brought by heart patients and their survivors who believe that bacteria-laden solution caused their injuries and deaths.

The Holt case is similar to a case filed in March by the family of another man who died after heart surgery. It also resembles six other cases filed Monday in Spotsylvania court.

All involve former bypass patients at Mary Washington Hospital. The cases name as defendants Central Admixture Pharmacy Services, or CAPS, the maker of the suspect medicine; B. Braun Medical, its parent company; and MediCorp Health System, parent company of the hospital.

Holt's death was one of three cases that brought about a temporary halt to heart-bypass cases at Mary Washington. Hospital officials suspended heart surgeries in September, blaming a cardioplegia solution purchased from CAPS for a cluster of poor outcomes.

Efforts to reach CAPS representatives for comment yesterday were unsuccessful. In one court document, they blame Mary Washington for the patients' problems, saying the solution was "further prepared" at the hospital.

Hospital officials deny this, saying bacteria were discovered by independent labs in unopened bags of the cardioplegia.

After Mary Washington complained about the solution, the U.S. Food and Drug Administration did inspections and ordered the temporary closure of CAPS' Lanham, Md., plant because of bacterial contamination.

The Holts' court filing also offers a glimpse at the personal side of these cases, how a relatively healthy person can enter the hospital for surgery, only to have it take an unexpected turn.

"Obviously, he was in the hospital for surgery, but he was expecting to have a long and happy life," said Charles A. Gavin, the Richmond attorney representing the Holt family.

Holt was a 75-year-old resident of Fredericksburg, the father of one son and one daughter. He and his wife, the former Dona Grise, were within weeks of celebrating their 54th wedding anniversary.

The Holts met while attending the University of Central Arkansas in Little Rock. After graduation, he entered the Marines and served tours of duty in Okinawa, Korea and Vietnam.

After his retirement in 1981, the couple settled in the Fredericksburg area and purchased The Flower Shop in Fredericksburg. They ran the business together, with Ralph Holt doing much of the book work and deliveries, and Dona Holt specializing in floral arrangements. They sold the business in 2001.

Afterward, the couple enjoyed traveling, something they had done frequently while he was a Marine.

"Ten days prior to his surgery, they were in Colorado," Gavin said.

They also enjoyed golf, playing together three or four times a week. A dream for both was to attend the Masters golf tournament in Augusta, Ga. Each year they tried unsuccessfully to purchase tickets. They were able to get tickets for the 2006 tournament.

Friends describe Holt as a vigorous man who exercised regularly and appeared younger than his years. His widow's lawsuit describes him as "in general good health, fully independent, active and loved by his family."

But he experienced a "spell" at church one day and went for a cardiac catheterization at Mary Washington on Aug. 16. The test revealed a blockage, and his physician recommended coronary artery bypass graft surgery.

Dr. John M. Armitage performed the surgery on Aug. 31.

During the surgery Armitage used a cardioplegia solution manufactured by CAPS in Lanham where the suspect material was made.

Cardioplegia is a mixture of chemical compounds routinely used during open-heart surgery to still the beating heart. It comes in a three-bag set and is administered intravenously throughout the surgery.

Holt never recovered from the bypass surgery. His blood pressure plummeted, and he bled internally. Eventually his kidneys failed. The constellation of symptoms is called systemic inflammatory response syndrome.

Armitage decided to reopen Holt's chest two days later, but his condition worsened throughout the day.

"They couldn't figure out what was going on," Gavin said.

Holt died that evening, Sept. 2.

Friends joined the family for the funeral at Fredericksburg United Methodist Church. Holt was buried at Quantico National Cemetery.

Dona Holt didn't attend the Masters tournament in April, Gavin said, and she has not played golf since her husband's death.

Study says do not underestimate the pain factor

The results of a study published in the Journal of Thoracic and Cardiac Surgery shows postoperative pain in patients who have had CABG surgery is significant.

Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: A cross-sectional study

• Nonanginal chronic postoperative pain affected 23% of patients.
  

• Eighty percent of them had pain 1 or more days per week.
  

• The worst and usual pain intensities during the week preceding the survey reached moderate to severe levels (4/10) in more than half of the patients.
  

• Thirty-one percent of the patients with chronic postoperative pain had taken analgesic pain medication during that week.
  

• During the same period, pain interfered significantly (4/10) with various aspects of patients' daily life (eg, general activity level: 39.1%, sleep: 36.7%).
  

• When patients with and without chronic postoperative pain were compared, the former group had significantly higher levels of anxiety and depression, and they perceived their health-related quality of life as more compromised.
  

• Multivariate logistic regression analysis revealed that greater analgesic needs in the first few days postoperatively were associated with an increased risk of chronic postoperative pain.
  

• The only other significant factor was the time elapsed from surgical intervention to survey: the longer it was, the less likely the patients were to report chronic postoperative pain.

CONCLUSION: The prevalence, severity, and effect of chronic postoperative pain after cardiac surgery should not be underestimated. Longitudinal prospective studies are needed to further evaluate risk factors, including inadequate postoperative pain relief in the acute period.

• 
  

CABG Makes Many Lose Their Minds, at least for a while

As many as 90 percent of patients who undergoCoronary Artery Bypass Graft Surgery, experience Mild Cognitive Impairment afterwards. This condition, which also is the pre sequellar to Alzheimer's Diseases, persists in as many as 24 percent of them. Allon Therapeutics, Inc. thinks they may be onto a treatment for this side effect of CABG surgery.

Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection Company^TM, today announced that patient enrolment has begun for a Phase II human clinical trial evaluating the Company's product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.

Gordon McCauley, President and CEO of Allon, said the Phase II trial will evaluate the safety and effectiveness of AL-208 at preventing or reducing MCI in CABG surgery patients aged 65 to 79. Preventing or reducing MCI post-CABG has a potential market estimated at US$500-million for which there is no available treatment today.

"This clinical trial is particularly significant for Allon because it is the first trial that will evaluate the effectiveness of one of our drugs in patients," McCauley said. "We believe this will be the first of several human clinical trials starting in the next year to evaluate the effectiveness of our drugs in different neurodegenerative diseases and conditions."

The initial portion of the study in which all patients receive AL-208 will be open-label to confirm safety, followed by a randomized placebo-controlled portion. In total, approximately 200 patients will be treated with AL-208 (or placebo) during surgery. The patients will be assessed using standard cognitive tests, administered several weeks after surgery, to determine the impact on cognitive function of patients treated with AL-208 versus patients in the control group. The trial will be conducted in approximately 20 hospitals in the US and Canada.

The Company expects results of the Phase II trial will be released during the second half of 2007.

Allon's compounds have been shown to be effective in preventing and repairing brain cells from disease or injury in 14 different pre-clinical animal models of eight central nervous system conditions. In some acute animal models, a single administration of AL-208 has provided 30 days of neuroprotection and maintenance of cognitive function after a single administration.

About MCI-post CABG

Mild cognitive impairment is a common result after coronary artery bypass graft surgery (CABG - commonly known as "bypass surgery").

Some studies estimate that cognitive impairment occurs in 90% of cases in the first week post-surgery, that more than 50% of patients show impairment when discharged from the hospital, and that 24% continue to show impairment after six months.

Approximately 500,000 patients in the United States and 800,000 patients worldwide undergo coronary artery bypass graft surgery every year. Currently there is no therapy available that ameliorates or treats the cognitive damage associated with artery bypass surgery.

About Allon

Allon Therapeutics Inc. is a Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as Alzheimer's disease, mild cognitive impairment, stroke, traumatic brain injury, multiple sclerosis and neuropathy. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection Company) and based in Vancouver.