Tag Archives: cardiovascular disease

TAVI Trek Begins

It took just two days after the Nov. 2 FDA approval of the Edwards SAPIEN transcatheter aortic valve for New York-Presbyterian Hospital/Columbia University Medical Center to claim bragging rights as the first center in the United States to implant the device as an FDA-approved standard of care.

The center will be one of four sites to train U.S. doctors in the procedure, and is promising to lead a live demonstration tomorrow (Nov. 9) at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco for those eager to get a front row view of transcatheter aortic valve implantation (TAVI).

Courtesy Edwards Lifesciences

The FDA approval also put the U.S. in the rare position of following the footsteps of some 40 countries that have already approved the SAPIEN valve including Latvia, Iran, and Russia. This fact elicited a good laugh at the recent Heart Valve Summit 2011 in Chicago, but also prompted much dialogue about some of the thorny ethical and economical consequences that still lay ahead.

“Is anyone at the government talking about rationing of care?” asked Dr. Stephen Strelec, an anesthesiologist at University of Pennsylvania Medical Center, at the summit. It’s not just the 92-year-old who says “I want to live,” but the younger patient facing a valve procedure who decides they don’t want to be on anticoagulants and undergo surgery because they can afford this expensive new transcatheter valve in 2 years. “There’s an economic consequence to that decision as well,” he said.

Dr. Robert Bonow, director of the center for cardiovascular innovation at Northwestern, said the issue is being looked at by federal agencies and insurers, but added that it is “one of the biggest hot-button items about this whole technology because it’s not going to be cheap.”

Dr. David Adams, chair of cardiothoracic surgery at Mount Sinai Medical Center, said they’ve already had their share of 90-year-olds wheeled in from the nursing home by family members who read about TAVI in the newspaper and want mom to stay alive.

The suggestion was made that surgeons and interventional cardiologists will have to hone their skills in making the very specific diagnosis of medical futility, and that a board-certified palliative care physician will be one of the most valuable members of the multidisciplinary teams treating these patients.

“Every PARTNER site looking back over their patients can name patients that they wish they didn’t enroll in the trial and done the valve on,” said Dr. Howard Herrmann, director of interventional cardiology and cardiac catheterization at the Hospital of the University of Pennsylvania. “The question is how to recognize them up front.”

Edwards Lifesciences and the FDA are setting up an intensive training program with simulations, an expert review of cases and a proctoring system. Still, the challenge for Edwards and other companies that will follow will be enormous in terms of launching this technology outside the clinical trial setting, said Dr. Adams, co-principal investigator of Medtronic’s CoreValve trial.

“You can not overestimate the amount of company support you’re going to need to do these things safely,” he said. “This is not a new widget you can pick up in one or two tries like a new ring or new stent…It’s a whole new process.”

The European experience, albeit the initial experience, suggests there’s a distinct learning curve to TAVI. A meta-analysis of 12 TAVI trials presented at this summer’s European Society of Cardiology Congress, reported a flattening of mortality curves 8 years after the first human case in 2002, with procedural mortality decreasing from 16.7% in 2004 to 0.0-0.6% in 2010 and 30-day mortality plummeting from 67% to 11% over the same time period. The authors, led by Dr. Pablo Salinas, University Hospital La Paz, Madrid, credit technical improvements in the devices, better patient selection and on-site case proctoring as helping to shorten the learning curve.

—by Patrice Wendling

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Conflicts of Interest at the UN Noncommunicable Disease Summit? Bingo.

Just in advance of the United Nations High Level Meeting on the Prevention and Control of Non-communicable Disease, a coalition comprising more than 140 nongovernmental and public health organizations has called on the UN to restructure the way in which the food and beverage industry has been involved in the policy negotiations.   

Photo by Christian Cable / Wikimedia Commons

The Conflicts of Interest Coalition (COIC) describes itself as a group of “civil society organizations united by the common objective of safeguarding public health policy-making against commercial conflicts of interest through the development of a Code of Conduct and Ethical Framework for interactions with the private sector.” 

The COIC sent a Statement of Concern to the President of the United Nations General Assembly and the UN summit’s facilitators, decrying the lack of clarity regarding the role of the private sector in public policy-making in relation to the prevention and control of non-communicable diseases (NCDs).  

“Since the major causes of preventable death are driven by diseases related to tobacco, unhealthy diet, physical inactivity and alcohol drinking, we are concerned that many of the proposals to address NCDs call for ‘partnerships’ in these areas with no clarification of what this actually means. Public-private partnerships in these areas can counteract efforts to regulate harmful marketing practices,” the COIC wrote.

Calling industries “both part of the NCD problem and the solution,” the COIC believes industry should be involved in the implementation of policy but not its development. To that end, the group’s Statement offered two proposals:

First, a change in the nomenclature of nongovernmental organizations (NGOs) to distinguish between those that are industry-supported and those that are strictly civil society: “Business-interest-not-for profit organizations (BINGOs) and public interest nongovernmental organizations (PINGOs).

Second, a “code of conduct” that sets out a clear framework for interaction with the food and beverage industry and managing conflicts of interest, differentiating between policy development and implementation. 

“We ask for the UN to consider our comments and take them into account for the UN High Level Meeting in September,” the COIC wrote in the Statement, a version of which was published Sept. 16 online in The Lancet.  

Indeed, food industry lobbying is believed to have played a role in the removal of specific targets and indicators for reductions in salts, sugars, and saturated fats from earlier versions of the Political Declaration that will be voted on at the UN High-Level meeting, but it is probably too late to change that document since the vote is expected to take place Monday morning, according to Ann Keeling, chair of the Noncommunicable Disease Alliance (NCDA), the leading NGO that pushed for the Summit.

Ann Keeling photo courtesy of the International Diabetes Federation

However, she told me in an email, there will be time to address the conflict of interest issue in 2012, when the UN will be making decisions on both the establishment of partnerships as well as targets and indicators.

“The view of the NCDA is that the private sector, subject to ethical frameworks on conflict of interest, must be part of the solution, especially in implementation. We believe there should be a ‘triple partnership’ going forward – public/private/people with NGOs being the people and with far greater involvement from global to community level of people with NCDs.”

–Miriam E. Tucker (@MiriamETucker on Twitter)

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Noncommunicable Disease Alliance Fights to Retain Goals

The international noncommunicable disease movement has hit a snag. Negotiations have been delayed in drafting the official Political Declaration for the United Nations High-Level Meeting on the Prevention and Control of NCDs, scheduled for Sept. 19-20. The main issue, according to the NCD Alliance, a lobbying coalition of global NCD-related organizations, is that the United States, Canada, and the European Union are blocking proposals for the inclusion of the specific goal of cutting by 25% all preventable deaths from cancer, cardiovascular disease, diabetes, and chronic respiratory disease by 2025.

Arnaldo Pomodoro's "Sphere within Sphere" sculpture at UN Headquarters in New York/ Photo by Miriam E. Tucker

In a statement, the alliance said “The situation is urgent. Yet, it is reported that sound proposals for the draft Declaration to include time-bound commitments and targets are being systematically deleted, diluted and downgraded.” The alliance has sent a letter to UN Secretary-General Ban Ki-moon to express “grave concern at the current state of preparations” for the high-meeting, which is to be only the second-ever such UN meeting focusing on a global health issue. The first one, on HIV/AIDS in 2001, is credited with spurring global political, social, and financial action to address that problem.

According to the alliance, language about “action-oriented outcomes” is being replaced with “vague intentions” to “consider” and “work towards” NCD reduction goals, moves they deem “simply unacceptable.” Along with the 2025 goal, the letter reiterates previous demands that UN member states must develop a set of specific, evidence-based targets and global indicators, a clear time line for tackling the epidemic of the four major NCDs, and “a high-level collaborative initiative of government and UN agencies with civil society to stimulate and assess progress.”

In an interview with Reuters, NCD chair Ann Keeling said that money was the main sticking point, with wealthier nations reluctant to commit to paying for chronic disease care in poor countries at a time when even “rich” economies are in a downturn. Indeed, the sum is considerable, as NCDs now account for 63% of all deaths worldwide and half of all global disability, posing a serious threat to development in many lower-income nations. “The reason we called for a UN summit in the first place was to move toward a global action plan…The world is essentially sleepwalking into a sick future,” said Ms. Keeling, who is also chief executive officer of the International Diabetes Federation.

Negotiations on the Political Declaration are set to resume Sept. 1. In the meantime, the IDF has recently launched a postcard campaign urging President Obama to attend the high-level meeting, which is expected to draw heads of state from many UN member nations. The IDF has also organized a rally - with the support of several U.S.-based diabetes organizations and bloggers and other international NCD-related groups - to be held in New York City’s Central Park on Sunday, Sept. 18 to raise public awareness about the worldwide impact of NCDs.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Seeing Red: Heart Disease and Women

The Red Dress Campaign has caught women’s attention regarding the very real dangers of cardiovascular disease, but a new study shows they may not be taking the message to heart.

Photo courtesy of The Heart Truth®, NHLBI, NIH

The study, presented at the recent American College of Cardiology meeting, found that the overall incidence of acute MI decreased among 315,246 patients admitted to New Jersey hospitals 1986-2007. The decrease was significant among both men and women, but was more prominent among men.

The incidence of acute MI fell from 598 to 311 per 100,000 men and from 321 to 197 per 100,000 women, according to cardiologist Dr. Liliana Cohen and her colleagues at the Robert Wood Johnson Medical School in New Brunswick, N.J. They also identified a growing gap in the rates of left heart catheterization and percutaneous coronary intervention between men and women.

The rates of catheterization increased fivefold in women and threefold in men over the 22-year study period, but the likelihood of catheterization remained lower for women. Moreover, the difference among male and female cath patients going on to receive PCI increased from 2.2% in 1986 to 9.4% in 2007.

Finally, both in-hospital and 1-year mortality remained higher among women, and failed to show a significant decrease after 2002 – the year the National Heart Lung and Blood Institute launched the Red Dress campaign.

“Although awareness of cardiovascular disease in women has increased in the general population, there has been much less translation of this into clinical practice,” Dr. Cohen told me.

This may be due to women presenting later because they doubt an MI can happen to them or that physicians still are not treating women as aggressively as they treat men, she said. It also may relate to the fact that women have more difficult cardiac anatomy, so that once they receive cardiac cath, PCI remains difficult.

Photo courtesy of The Heart Truth®, NHLBI, NIH

Dr. Cohen suggests that in its next phase, the campaign needs to continue to focus on public health awareness, but also on research into how to translate public awareness into clinical practice by focusing on physicians and into newer techniques of PCI for the smaller blood vessels in women.

Quibble if you will about the generalizability of data from a single state or the potential impact of a single PR campaign, but it’s hard to ignore these disappointing outcomes.

I once heard a bold and blistering guest lecture at a cancer meeting by Nancy Goodman Brinker, founder and CEO of Susan G. Komen for the Cure, who told several thousand — mostly male — oncologists that a survival rate topping 90% for early stage breast cancer simply wasn’t good enough.  Truer words were never spoken.

— Patrice Wendling

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In the Developing World, Diseases Defy Definition

Before last week, I thought I knew the definition of “noncommunicable disease.” Then I attended “The Long Tail of Global Health Equity: Tackling the Endemic Non-Communicable Diseases of the Bottom Billion.”

 Held on the campus of Harvard Medical School in Boston March 2nd and 3rd, the 2-day conference was sponsored by Partners In Health, an international nonprofit organization that conducts research, does advocacy, and provides direct health care services for people living in poverty around the world. The “Bottom Billion” of the meeting’s title refers to the world’s poorest people living on less than $1 per day.

 In a 2008-2013 action plan, the World Health Organization refers to “the four noncommunicable diseases – cardiovascular diseases, diabetes, cancers and chronic respiratory diseases and the four shared risk factors – tobacco use, physical inactivity, unhealthy diets and the harmful use of alcohol.” Together, these conditions account for approximately 60% of all global deaths, of which 80% occur in low- and middle-income countries. 

A cancer patient in Rwanda receives chemotherapy as her husband and physician discuss her treatment / Photo courtesy of Partners In Health

But as I learned at the conference, among the Bottom Billion, rheumatic heart disease is often the result of an untreated streptococcal infection early in life, diabetes is frequently associated with malnutrition rather than over-nourishment, and cervical cancer due to human papillomavirus is far more common than in the developed world, where women routinely receive PAP screenings and a vaccine can now also prevent the infection.   

And most startling to me: Among the world’s poorest, smoking is not the most common cause of chronic obstructive pulmonary disease. Cooking with biomass fuels is.   

Individually, these and other so-called “endemic NCDs” including Burkitt’s lymphoma, sickle cell disease, and tropical diseases are far less common than those within the WHO’s “four-by-four” definition. But together, that “long tail” of chronic conditions contributes to a great deal of suffering. 

In May 2010, the United Nations announced that it would hold a high-level meeting on NCDs in 2011, now set for September 19-20. It will be only the 29th such meeting that the UN has ever held (formerly called “special sessions“), and just the second pertaining specifically to a health issue. The first one, the 2001 Summit on HIV/AIDS, is credited with focusing global attention and obtaining public and private funding for that cause. 

Speakers at the Partners In Health meeting stressed that the NCD movement should not be undertaken as an “us against them” competition with infectious disease for scarce resources. In a statement that will be presented to the heads of government at the UN summit, the group called instead for “strengthening and adjusting health systems to address the prevention, treatment, and care of NCDs, particularly at the primary health care level.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Video of the Week: CRP Screening Doesn’t Improve Heart Risk Assessment

Researchers presented data at the the annual scientific sessions of the American Heart Association showing that screening high-sensitivity C-reactive protein was not useful in refining cardiovascular risk assessment beyond that provided by the classic risk factors.

The data — from a new secondary analysis of the ASCOT (the Anglo-Scandinavian Cardiac Outcomes Trial) trial — throw into question the biomarker’s appropriate role in clinical practice. Our reporter Bruce Jancin was in Chicago and talked with Dr. Donald Lloyd-Jones, who was tasked with discussing the study’s findings at the meeting. Dr. Lloyd-Jones is a professor of preventive medicine at Northwestern University in Chicago.

We have to remember that this is actually a secondary analysis — a post-hoc analysis — of a previously published trial. So we should take it with a grain of salt.

You can read Bruce’s story online at Internal Medicine News, where you can read more coverage of the AHA meeting.

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Recycling From the Heart

The concept of green living  takes on an entirely new meaning in light of new data showing that implantable cardioverter defibrillators (ICDs) can be removed and safely reused in other patients.

Dr. Behzad Pavri, an electrophysiologist at  Thomas Jefferson University in Philadelphia, and colleagues from across the United States, sent ICDs with at least 70% battery life to India where the devices were cleaned, sterilized, and re-implanted in 40 patients who were at risk of life-threatening arrhythmias, but could not afford the $25,000 price tag for a new device.

During 2 years of follow-up, 35% of patients received appropriate shocks from their ICDs, and no infections were observed, Dr. Pavri reported at the scientific sessions of the American Heart Association.

Five patients received a second recycled device, including one in as little as a year. While some may consider this an unacceptable life span for a device, Dr. Pavri pointed out that during the life of the first device the patient received as many as 50 life-saving shocks for a condition known as VF storm.

“I have stacks of letters from patients and from family members of these patients expressing their gratitude for having sent them what is basically our trash,” he said in an interview.

Dr. Pavri said the idea to recycle ICDs was hatched over a decade ago by physicians who wanted to provide the life-saving devices, earmarked for the trash or return to the manufacturer, to patients in need in their native countries. While the donated devices are removed for upgrade or infection, Dr. Pavri said he can foresee eventually reaching out to funeral homes for post-mortem device retrieval.

“I would like to see this effort grow, but I emphasis that it has to remain a charitable effort,” he said. “The moment it becomes commercially slanted, the purpose will have been defeated.”

Patients and physicians interested in donating a defibrillator can contact Dr. Pavri at behzad.pavri@jefferson.edu.

—Patrice Wendling (on Twitter @pwendl)

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