Category Archives: Coalition News

Morning Consult: Policy Reforms Needed to Address Most Traumatic Impacts of Diabetes

According to the American Diabetes Association, more than 30 million Americans today are living with diabetes. With a new diagnosis every 21 seconds, it’s a disease that’s forcing growing numbers of Americans to contend with a variety of significant health challenges. Uncontrolled, it can rob patients of their vision, kidneys and even their lives. In 2014, diabetes was the nation’s seventh leading cause of death.

Yet, even as millions of Americans learn to address – and hopefully avoid – some of diabetes’ most common complications, one of the most traumatic remains a dangerously silent threat, particularly for minority populations.

Diabetes is a major risk factor for Peripheral Artery Disease – a narrowing of the arteries feeding the body’s lower extremities, which causes pain, poor mobility, tissue death and life-threatening infections. Each year, tens of thousands of disproportionately African American patients undergo lower-limb amputations as a result of diabetes and PAD. According to recent research, regions across the country with larger populations of African Americans living with diabetes see amputation risks as much as three to four times higher than the national average.

Our initiative, Standing TALL, specifically aims to increase understanding about the startling racial disparities that exist among American amputees because far too many minority Americans experience limb removal when amputation could have been prevented.

It’s a trend that’s devastating both for vulnerable patients and our health care system. Nationally, the amputation rate among African American Medicare patients was nearly three times higher than the rate among other beneficiaries (5.6 per 1,000 vs. 2.0 per 1,000). The costs of these amputations to the U.S. health care system reach an estimated at $10.6 billion annually – with Medicare being the largest payer, covering an estimated 66 percent.

While health care providers, advocates and researchers have made enormous strides when it comes to diabetes education, treatment and even prevention, there is still a tremendous dearth of progress related to stopping the associated causes of PAD and amputations. It’s a shortfall largely attributable to lack of knowledge – both on the part of patients and their providers.

It’s estimated that as many as 18 million Americans unknowingly live with peripheral artery disease, unaware of the potentially significant implication of leg pain and the need for early screening and intervention. And even when patients do seek expert consultation and receive a PAD diagnosis, there is significant variation in whether a clinician chooses amputation versus limb-saving revascularization therapy.

Whenever options exist to help patients avoid amputation, it’s incumbent upon health care providers to use their knowledge and expertise to try to save the limb. Increased screening is, indeed, one of the best places to start. Today, although the U.S. Preventive Services Task Force cites insufficient evidence for PAD screening for the general population, guidelines issued by the American College of Cardiology and American Heart Association disagree: both groups recommend screening of at-risk patients (those over age 65, have a history of diabetes, smoking, and/or PAD; or have been diagnosed with other vascular disease).

Increased screening, along with the establishment of best practices for PAD patients facing amputation are long overdue. For example, there is still no intragovernmental federal health policy to ensure patients are assessed for non-amputation treatment options before they suffer limb loss. Instituting such a policy, which would require arterial testing – could push adoption of quality measures, guidelines and appropriate payment incentives to ensure patients receive appropriate arterial evaluation prior to costly amputations.

Working together, policymakers and the health care system have the power to reduce amputations, which are tragic, particularly when you consider that many are completely avoidable.  Increased awareness, screenings and multidisciplinary care – like centers of excellence across the country that have been effective in driving amputation rates down to near zero – will get us there.

We must, however, put muscle behind this effort, starting now.  As we round out National Diabetes Month, it’s important to advance initiatives that ensure PAD and limb loss don’t remain silent, avoidable and largely unknown consequences for patients with diabetes.

Jeffrey Carr is an interventional cardiologist and endovascular specialist, as well as the founding and immediate past president of the Outpatient Endovascular and Interventional Society, a multispecialty medical society, and the physician lead for the CardioVascular Coalition, a group dedicated to raising awareness for PAD and advocating for national health care policy and amputation prevention.

CardioVascular Coalition Urges Adoption of National Strategy to Address Unnecessary Amputations During Peripheral Artery Disease (PAD) Awareness Month

Vascular care leaders call for policies to prevent amputation without arterial testing, increase PAD awareness, support screening for at-risk populations and promote multidisciplinary care

WASHINGTON – The CardioVascular Coalition (CVC), a leading group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease, is urging healthcare leaders, policymakers, patient advocates and other stakeholders to join them in recognizing September as Peripheral Artery Disease (PAD) Awareness Month, a time designated to increasing awareness about the disease and calling attention to the need for a national initiative to reduce preventable PAD-related lower limb amputations.

PAD is a life-threatening circulatory condition, which affects as many as 18 million Americans, many of whom are at risk for non-traumatic amputation if their condition is left undiagnosed and untreated.  In fact, data suggest as many as 180,000 amputations are performed in the US each year, including 43,000 Medicare patients, which increases healthcare costs, harms patient quality of life and significantly increases patient mortality.

“As a public health crisis, PAD not only results in tens of thousands of preventable amputations, it also disproportionately impacts ethnic and racial minorities and costs taxpayers billions in additional spending,” said Jeffrey G. Carr, MD, FACC, FSCAI, an Interventional Cardiologist and Endovascular Specialist and the physician lead on the CardioVascular Coalition. “It is time for policy makers, healthcare professionals and the beneficiary communities to come together to adopt a national strategy that successfully increases understanding of this disease, improves patient access to clinically-appropriate interventional care and prevents amputation when a patient’s limb can be spared.”

Specifically, the CVC looks forward to working with both the Congress and the Administration to advance an initiative that will successfully lead to amputation reduction across the US, particularly among the Medicare population.  Four key tenets of such an initiative should include:

  • No amputation without arterial testing
  • Multi-disciplinary approach
  • PAD awareness programs
  • PAD screening for at-risk beneficiaries

Significant racial and geographic disparities in PAD-related amputation rates suggest that there is great opportunity for reducing amputation among these populations. African, Hispanic and Native Americans are two to four times more likely to undergo a lower-limb amputation due to PAD because of increased prevalence of diabetes, obesity and other risk factors as well as reduced access to screening and interventional procedures.

While not every patient experiences symptoms of PAD, the CVC urges patients to be aware of the symptoms, which include leg pain, numbness, tingling, or coldness in the lower legs or feet, and sores of infections of the feet or legs that heal slowly.

To access more information about PAD Awareness Month activities, visit cardiovascularcoalition.org/pad-awareness-month/.  Join the conversation on Twitter at #PADAwareness.

The Hill: We need a new strategy for tackling peripheral artery disease

It is simply unacceptable that in 2017, so many Americans undergo a non-traumatic limb amputation each year. Yet, as we recognize Peripheral Artery Disease (PAD) Awareness Month this September, estimates suggest between 160,000 and 180,000 Americans lose one of their limbs every year — about half of which are attributable to preventable vascular diseases. This figure includes 43,000 Medicare beneficiaries, according to Avalere.

This must change. As a public health crisis, PAD not only results in tens of thousands of preventable amputations, it also disproportionately impacts ethnic and racial minorities and costs taxpayers billions in additional spending.

PAD is caused when the arteries that carry blood from the heart to the limbs become blocked by plaque buildup. Typically, patients who smoke, are older than 65, or have a history of high blood pressure, diabetes, or high cholesterol are at an increased risk of developing PAD. Many of these risk factors are more common in African Americans, Native Americans and Hispanics, which makes them two to four times more likely as whites to develop PAD. Disparities also exist among Americans living in rural areas as well as those with lower incomes.

Compounding these issues is the fact that lifetime care for a person with limb loss can average as much as $500,000. Studies also show that patients who receive a first amputation are at an elevated risk of having to undergo another amputation and a significantly increased risk for mortality.

Fortunately, we already have the technology to identify and treat PAD before it progresses to a point where an amputation is required. We just need a comprehensive strategy to get the right treatment to the right people. If we are going to get serious about reducing limb loss from PAD, the US must adopt a new strategy that integrates increased public awareness and robust screening with non-amputation treatment measures and multidisciplinary care.

First, we must raise awareness about PAD. While as many as 18 million Americans are estimated to be living with the disease, many are completely unaware of the risks and thus may not seek care until it’s too late. Policymakers should consider what more we can do to ensure that there is a dedicated awareness effort to encourage doctors to make patient education a priority.

Second, more could be done to increase PAD screening for those already identified to be at risk. The American College of Cardiology and the American Heart Association recommend that all patients who smoke, are over 65, or have a history of diabetes or another vascular disease be screened for PAD. CMS should work to implement these screening guidelines so that no at risk patient is left unscreened. Earlier in the PAD disease progression, less invasive options such as medical therapy or even supervised exercise therapy can be helpful once the disease has been identified.

Third, policies should ensure that patients who are later in their disease progression are assessed for other treatment options before they undergo an amputation. We know techniques such as minimally-invasive revascularization can be used to clean clogged arteries in the legs and avoid amputation all together. However, studies show that as many as one third of late-stage PAD patients never receive arterial testing to evaluate whether they may be a candidate for this procedure.

Finally, there must be a strong effort to expand multidisciplinary care for at-risk patients. Hospitals and treatment centers that have adopted comprehensive amputation prevention programs have been successful in driving amputation rates to near zero. At the same time, however, the evidence shows that certain specialties are much more prone to amputate than revascularize. As a result, policymakers should consider ways to encourage multidisciplinary care to ensure the option to save a patient’s limb is considered.

The price of developing PAD should not be limb loss, especially when the technologies exist to identify these patients and save their limbs. This September, I hope that policymakers, providers and patients will take a moment to better understand PAD. Only then can we work together to save lives and limbs, and make non-traumatic amputations a thing of the past.

Jeffrey Carr, MD is an interventional cardiologist and endovascular specialist. He is the founding and immediate past president of the Outpatient Endovascular and Interventional Society, a multispecialty medical society. He is also the physician lead for the CardioVascular Coalition, a group dedicated to raising awareness for PAD and advocating for national health care policy and amputation prevention.

Click here to see the original article on The Hill’s website.

Nephrology News: How kidney disease, peripheral artery disease, and amputation intersect

As the ninth leading cause of death in the United States, and a condition that affects an estimated 26 million Americans, chronic kidney disease is a growing health epidemic that creeps in silently, but can quickly manifest in deafening ways. While kidney disease is widely recognized and understood by patients, it’s equally as important to focus on related disease conditions.

Perhaps one of the most devastating impacts of CKD—and one we don’t hear about nearly enough—are complications associated with CKD and cardiovascular disease, particularly peripheral artery disease (PAD) and resulting limb amputation. Leading factors for both CKD and PAD are hypertension and diabetes, underscoring the multiple health risks patients face when diagnosed with these chronic conditions.

Research has further shown that Americans with CKD are at a higher risk than the general population of developing PAD, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs. Poor circulation not only causes excruciating pain, but can lead to tissue death and complex, untreatable ulcers.

Vascular disease—including PAD—is now responsible for 80% of all amputations. Undergoing an amputation due to advanced PAD is both physically and emotionally devastating. It can be a source of lifelong pain, impact a patient’s quality of life, and the ability to work and function independently. Amputations also bring enormous costs to the health care system—an estimated $10.6 billion annually.

But the news for CKD patients with PAD isn’t all bad. Current technologies are available that can help reverse some of the most devastating symptoms. Outpatient interventions like angiography, revascularization (which restores critical blood flow to affected limbs), and atherectomy (a minimally invasive endovascular technique that removes plaque from blood vessels), have helped decrease the incidence of major amputations by 75%.

The benefits of this type of care can be nothing short of life-changing. With access to a PAD specialist and appropriate intervention, patients can enjoy reduced pain, enhanced mobility, improved quality of life, and a better outlook overall. In fact, the mortality rate for those who avoid amputation drops to just 16–24% compared to 48-71% for those who undergo an amputation.

This data underscores the need for public policies that increase access to PAD diagnosis and intervention, particularly among older Americans dependent on Medicare to access care, and who are often living with multiple comorbidities common across this population, including diabetes and hypertension. Other important factors impacting both CKD and PAD patient groups are the racial disparities that exist, which show African and Hispanic Americans are at a measurably higher risk for both diseases conditions.

For CKD patients diagnosed with PAD, the critical importance of appropriate and timely clinical intervention cannot be overstated. Unfortunately, there are a host of challenges affecting this population, including delayed vascular specialist referral, and slow PAD treatment initiation. Furthermore, studies have shown that patients with CKD are less likely to be provided recommended “optimal” PAD care.

Combatting the silent devastation that comes with CKD means educating Americans about their risk factors and working to provide the very best care possible to help avoid CKD’s most serious complications. Better access to PAD treatment to ensure limb preservation is central to this effort.

Click here to see the original article on the Nephrology News website.

Morning Consult: Stand Together Against Limb Loss

Progress is not a myth. Over the past few decades — and even just the past few years — our nation’s health care system has evolved. More people than ever have access to health care and better treatments. However, one major problem continues to boil under the surface and hinder health outcomes: racial inequity.

There are many things to be said on this topic. But, instead, I will focus only on my area of medical expertise: limb loss due to pre-existing medical conditions. This is because large-scale change must start small. And when it comes to staving off life-altering amputation, there are some very practical ways that advocates and policymakers alike can make a difference.

The prevalence of limb loss is a significant burden on our nation’s health system with an estimated 500 Americans undergoing amputation each day. It’s also an inconceivable struggle, pushing patients to the brink both physically and psychologically.

However, not all Americans are affected equally; amputations are significantly more prominent among minority groups. African-Americans, for instance, are up to 400 percent more likely to have an amputation than their white counterparts. Similarly, Hispanic Americans are up to 75 percent more susceptible to limb loss than Caucasians. The scale of limb loss is particularly tragic because the condition is largely preventable. In fact, it’s now estimated that nearly 60 percent of amputations triggered by diabetes — one of the most prominent drivers of limb loss in minority populations — could have been evaded given proper attention.

Taken together, these numbers suggest something quite powerful. That is, despite innovative procedures and technologies designed specifically to prevent limb loss, minority populations are simply not reaping the benefits. And, as a result, they are needlessly losing limbs at an alarming rate.

It’s precisely for this reason that a new national awareness campaign to combat limb loss disparities has emerged here in the United States. Its name is Standing Tall Against Limb Loss (Standing TALL), and its mission is expanded access to clinically appropriate care, especially for minority groups. I’m proud support the Standing TALL initiative, as an advocate who is acutely aware that limb preservation fundamentally improves lives. But I’m also very conscious of the challenges ahead.

If I’ve learned anything during my five years of practicing medicine, it’s that limb loss is incredibly complex. Amputations not only derive from injury; they are commonly triggered by a range of pre-existing conditions. To reduce limb loss, we must strengthen understanding among the most at-risk populations while simultaneously improving access to interventional treatments across the care continuum.

One primary focus is peripheral artery disease — a life-threatening circulatory condition where arteries are narrowed, reducing blood flow to limbs. Crucially, PAD is exacerbated by diabetes, chronic hypertension, and renal disease, all of which are most prevalent in minority populations.

Despite being at greater risk of PAD, however, non-white Americans typically have inadequate access to interventional treatments, which can sure up blood flow and stave off limb loss from the start. The implication of this is clear: both patients and caretakers need to know more about vascular disease. And politicians must ensure that limb preservation procedures are available to all Americans, no matter where they live or how much money they make.

This will require the collaboration of many stakeholders. Thus, Standing TALL aims to coalesce patient advocacy, disease, minority, faith-based, veteran and professional organizations. I am confident that such unity — which expands outside the medical profession — can leverage broad-based knowledge into better health outcomes and slowly but surely alleviate racial disparities.

I am incredibly proud to be taking part in the National Minority Quality Forum’s Health Braintrust event this week with the Congressional Black Caucus, which aims to address African American and minority health disparities on Capitol Hill and create legislative and policy solutions to reduce health disparities and promote good health outcomes in multicultural communities. Coordinated efforts by health care professionals and lawmakers are necessary to ignite change for minority communities unfairly facing fewer health care options.

In the end, our Standing TALL campaign rests on a few basic principles. First, no one should experience limb loss unnecessarily. And second, Americans of all backgrounds should be treated equally for limb-threatening conditions and have access to limb preservation procedures. These are things we can all agree on. So now let’s turn understanding into action and ensure limb preservation is prioritized among clinicians and policy makers alike. 

Bryan T. Fisher is a recipient of the National Minority Quality Forum’s 40 Under 40 Leaders in Health and the co-director of Limb Preservation at Centennial Medical Center and is an endovascular surgeon at the Surgical Clinic in Nashville, Tenn.

Click here to see the original article on the Morning Consult website.

Standing TALL Seeks to Address Striking Limb Loss Disparities in the United States

Disproportionate amputation rates among minority groups is impetus for nationwide effort to improve policies to support limb loss preservation

WASHINGTON, D.C. — There is a new national awareness campaign to overcome limb loss disparities in the United States.  The effort, Standing Together Against Limb Loss (Standing TALL) will advocate for expanded access to interventional care to prevent limb loss, especially for minority groups that are disproportionately affected by life-altering, yet largely, avoidable amputations.

Estimates suggest nearly 500 Americans lose a limb each day, many resulting from Peripheral Artery Disease (PAD), is a limb-threatening circulatory condition where arteries are narrowed, reducing blood flow to limbs. However, amputations are significantly more prominent among minority groups. African Americans, for example, are up to 400 percent more likely to have an amputation than their white counterparts.  Similarly, Hispanic Americans are up to 75 percent more susceptible to limb loss than Caucasians.

In addition to dramatically reducing quality of life, amputation results in increased mortality rates.  Studies find that nearly 50 percent of amputees age 65 and older die within one year of amputation, underscoring the importance of limb salvaging procedures.

The scale of limb loss due to PAD and other medical conditions is particularly tragic because the condition is preventable. It is estimated that 60 percent of diabetes-related amputations, for instance, could be avoided. This suggests that despite innovative procedures and technologies designed specifically to improve blood flow that can prevent limb loss, minority populations are not receiving clinically appropriate care and, thus, are needlessly losing limbs at an alarming rate.

“Limb loss is a complex problem, as amputations derive from myriad pre-existing conditions. This means we need comprehensive solutions, which encourage prompt diagnosis and effective treatment long before amputation becomes an unfortunate reality,” said Bryan Fisher, MD a Standing TALL advocate and recipient of the National Minority Quality Forum’s Leaders in Health Award, honoring influential young minority leaders making a difference in health care. “Racial disparities in amputation are unfair and unacceptable, therefore we are bringing together concerned advocates to raise awareness and develop solutions so that no limb is needlessly removed on an individual who could otherwise live an active, high quality life.”

Peripheral artery disease (PAD) – one of the primary drivers of limb loss – is exacerbated by diabetes, chronic hypertension and renal disease, all of which are most prevalent in minority populations.  Despite this, limited access to interventional treatments has resulted in measurably higher rates of avoidable amputation.

Therefore, Standing TALL aims to end limb loss by advocating for policies to ensure that limb-salvaging procedures are completed before amputation occurs. It will do so by engaging patient advocacy, disease, minority, faith-based, veteran and professional organizations to increase understanding among policymakers, the media, and the general public.

“There is a long way to go before achieving equity in America, especially when it comes to healthcare,” emphasized Fisher.  “But progress is possible if lawmakers and advocates unite, and stand tall to end limb loss disparities.”

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In Recognition of Native American Heritage Month, Vascular Care Leaders Urge Native Americans to Understand Risks for PAD and Limb Amputations

Data show Native Americans twice as likely to receive amputation than Caucasian counterparts

WASHINGTON – The CardioVascular Coalition (CVC), a leading group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease, is calling attention to the racial disparities in amputation rates among Native Americans with Peripheral Artery Disease (PAD).  In recognition of Native American Heritage Month this November, vascular care leaders are urging at-risk populations to know their risks for PAD and treatment options to manage the disease and avoid related amputation.

PAD is a life-threatening circulatory condition, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs and affects as many as 18 million Americans, and disproportionately impacts Native American communities.  According to the First Nations Limb Preservation Foundation, data show that Native Americans experience both diabetes and PAD at a rate two times higher than other populations. Diabetes is a common risk factor for PAD.

A recent analysis, “Racial Disparities in Amputation Rates among Native Americans with Peripheral Artery Disease,” concludes that in specific regions of the country, Native Americans with PAD are substantially more likely to undergo a PAD-related amputation than are Caucasians.  The analysis concludes that variations in amputation rates appear to reflect differences in treatment patterns that are unrelated to illness severity, demographic factors or hospital characteristics, suggesting that disparities may reflect systematic differences in treatment patterns by race.

The analysis also compared the rates of PAD risk factors among Caucasians and Native Americans and found that in several leading risk factors – diabetes, chronic hypertension and chronic renal insufficiency (kidney disease) – the Native American sample had significantly higher rates of diagnoses.  Other risk factors – including smoking, high cholesterol and history of stroke – were common in the Caucasian sample.

If not properly managed, both diabetes and PAD can lead to non-traumatic lower limb amputations, which data show lead to lower quality of life, increased risk for death and higher healthcare costs.

“Our analysis underscores the critical need to address PAD and amputation rates among Native American communities.  Our data show that there is no clinical reason why amputation rates should be disproportionately higher among Native Americans.  This mirrors other data illustrating a need for increased understanding and access to appropriate interventional treatment for at-risk Native Americans,” said Harry Kotlarz, co-author of the analysis and Director of Healthcare Policy Cardiovascular Systems, Inc. “Native American Heritage Month reminds us that we must educate this vulnerable population to ensure limb preservation efforts are put in place and amputation rates decline.”

Morning Consult: Stopping Limb Loss Starts with Understanding Diabetes and PAD

Often referred to as the “silent killer,” diabetes is a disease that is notorious for surprising its victims. With very few noticeable symptoms at first, it can unknowingly build and build into a devastating crescendo of life-threatening problems that become anything but silent.

According to the American Diabetes Association, an estimated 30 million Americans are living with diabetes. These individuals, whose bodies have quietly endured elevated blood sugar levels due to age, obesity or other factors, ultimately find themselves contending with serious health issues like blindness, heart attack, stroke, kidney failure and vascular disease.

Perhaps one of the most life-changing sequela of diabetes, and one that we are starting to see far too often, is lower-limb amputation. According to the Amputee Coalition, nearly two million Americans are living with limb loss, and another 185,000 will undergo an amputation this year.

The physical and emotional costs of losing a limb are unquantifiable, but the economic impacts are well-documented and alarming: Amputation costs the U.S. health care system an estimated at $10.6 billion annually. Medicare, the largest payer of major amputations in America, covered 66 percent of all amputations in 2010.

As a cardiologist who specializes in peripheral artery disease, I have unfortunately had a front row seat in witnessing how so many patients with diabetes become amputees.

Diabetics face a higher risk of developing vascular disease, or PAD, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs. Poor circulation not only causes excruciating pain, it can also lead to complex, untreatable wounds or ulcers and tissue death. Today, 1 out of every 3 diabetics over the age of 50 is likely to have PAD.

The tragedy of losing a limb is compounded exponentially by the fact that amputations are, in many cases, avoidable. The Amputee Coalition estimates that nearly 60 percent of all amputations related to diabetes could be prevented by early and appropriate clinical intervention. Data also show diabetic patients are far more likely to undergo an amputation than the average American — at an astounding cost to their lives as well as the health care system.

Last, the impact these diseases have on the African American community is particularly troubling. PAD is more common in African Americans than any other racial or ethnic group because the greatest risk factors, including diabetes, are more common among African Americans. According to a Dartmouth Atlas Projectexamining 2007-11 data, African American Medicare patients with PAD are more than twice as likely as other patients to have a leg amputated. Data also suggest that as the population ages and comorbidities rise, PAD disparities may accelerate.

Thus, it’s critical that providers and policymakers work toward enhanced public awareness about the connection between diabetes and limb loss. Addressing amputation and racial disparities in limb loss begins with addressing diabetes and related health conditions including PAD.

November, which is American Diabetes Month, is an excellent time to start.

Our nation must better educate those with diabetes about the symptoms and risks of ulcers, vascular disease, and amputation, as well as proper disease management. We must also encourage the discovery and delivery of live saving and cost-saving interventional treatments, such as advanced revascularization for PAD. Doing so will help protect patients, end lower limb amputations and save billions of taxpayer dollars.

To that end, policymakers should establish policies that support clinically appropriate interventions to reduce health care spending, particularly Medicare expenditures. Increased accessibility of vascular care can help to dramatically reduce the number of amputations in patients with PAD. We know that there is room for improvement. In fact, one recent study found that 30 percent of patients who undergo non-traumatic amputation never receive arterial testing to evaluate whether they are candidates for revascularization or other interventions, which could potentially save their limb.

Although the onset of diabetes and related vascular diseases can be terrifyingly silent, we need to speak loudly related health risks and treatment options. It’s a matter of life — and limb — for patients when we don’t. 

Jeffrey Carr is an interventional cardiologist and endovascular specialist. He is the founding and immediate past president of the Outpatient Endovascular and Interventional Society, a multispecialty medical society. He is also the physician lead for the CardioVascular Coalition, a group dedicated to raising awareness for PAD and advocating for national health care policy and amputation prevention.

Click here to see the original article on the Morning consult website.

Understand the Connection Between Diabetes and Peripheral Artery Disease (PAD) During American Diabetes Month

Americans living with diabetes are at an increased risk for developing PAD, which disproportionately affects minority and underserved communities

WASHINGTON – The CardioVascular Coalition (CVC), a leading group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease, is highlighting the clinical link between peripheral artery disease (PAD) and diabetes this month during American Diabetes Month.

PAD is a life-threatening circulatory condition, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs and affects an estimated 18 million Americans.  Diabetics are among the patient groups most likely to receive a PAD diagnosis.  According to the American Diabetes Association, an estimated one out of every three people with diabetes over the age of 50 may also have PAD.

“Patients living with diabetes are one of the most at-risk patient populations for developing PAD, however many patients are unaware of this correlation. While diabetes is a chronic condition that most Americans understand and recognize, PAD is much different,” said Jeffrey G. Carr, MD, FACC, FSCAI, an Interventional Cardiologist and Endovascular Specialist and the physician lead on the CardioVascular Coalition. “Unfortunately, too many diabetic patients are simply not aware of PAD symptoms, which increases a patients’ risks for lower limb amputation. If diabetic patients are able to identify the signs of PAD, more timely interventions can help to reduce limb loss among this vulnerable population.”

If not properly managed, both diabetes and PAD can lead to non-traumatic lower limb amputations, which data show lead to lower quality of life and increased risk for death. According to the Amputee Coalition, nearly 60 percent of amputations due to diabetes are believed to be preventable.

The CVC also stresses that significant disparities exist among patient populations in both diabetes and PAD  related limb loss.  African Americans, for example, are more than twice as likely to be diagnosed with PAD and are at an increased risk of complications from diabetes, according to research analyzing the prevalence of and risk factors for PAD in the United States. New data further show that racial and ethnic disparities in amputation rates are substantial.  African Americans are approximately twice as likely undergo an amputation as Caucasians.  Similarly, Hispanic Americans are 50 to 75 percent more likely have an amputation than Caucasians.  Researchers warn that as the population ages and comorbidities rise, these disparities may accelerate.

While not every patient with diabetes experiences symptoms of PAD, the CVC urges patients to be aware of the risks. Other symptoms include leg pain, numbness, tingling, or coldness in the lower legs or feet, and sores or infections of the feet or legs that heal slowly.

“American Diabetes Month is an opportunity to underscore how both diabetes and PAD are resulting in unnecessary limb loss in America, which reduces patient quality of life, increases mortality rates and drives up the cost of care,” added Dr. Carr. “As patients, healthcare advocates and other stakeholders focus on diabetes education, awareness and prevention this month, we must also arm patients with the information they need to understand PAD and how to prevent limb loss related to these common chronic conditions.”

The Hill: It’s time for Americans to understand Peripheral Artery Disease

September is Peripheral Artery Disease (PAD) Awareness Month, a time designated to raise awareness of health problems caused by PAD. In a way, the term “Peripheral Artery Disease” is an unfortunate misnomer – this disease impacts so much more than the periphery of a patient’s life.

Peripheral artery disease causes narrowing or blockage of the arteries that carry blood from the heart to the legs (i.e., the “periphery”), typically due to plaque buildup in the vessel. Patients who smoke, are over age 60, or who have high blood pressure, diabetes, or high cholesterol are at increased risk for PAD. Because these risk factors are more common among African Americans and Hispanics, they are more than twice as likely as whites to have PAD.
Patients with PAD are at increased risk for heart attack, stroke, and even death. If left untreated, PAD may advance to a condition called critical limb ischemia (CLI), which is associated with lower limb amputation. While the rate of lower limb amputations among Medicare patients has declined over the years, health disparities still influence amputation rates; African-Americans are about twice as likely to be amputated as are Caucasians and Hispanics are 50-75% more likely to be amputated as Caucasians.

Patients who have undergone amputation have a higher mortality risk, are often unable to walk again, and are at higher risk for depression. Limb preservation treatments, on the other hand, reduce mortality, improve mobility, and patients are typically able to live independently in their own homes. Not only that, major amputation and associated care costs make it among the most expensive surgical procedures in the country, and Medicare pays for nearly two-thirds of them each year.

Raising awareness and advancing education about peripheral artery disease is part of my professional mission, which I work to advance as a board member for the CardioVascular Coalition and the Outpatient Endovascular and Interventional Society. Both organizations aim to advance quality, community-based care for patients with PAD. As a cardiologist practicing in East Texas, many of my patients come to me suffering from PAD.

Patients often live with debilitating pain in their lower legs for years. The pain, unfortunately is ascribed to various things, such as too much walking, or obscure medical conditions, for which patients may be prescribed ineffective medications and told to perform leg stretches.

For these reasons, many patients do not receive the appropriate diagnosis and necessary vascular intervention, which is due in part to a national lack of understanding of PAD.

Now, during PAD Awareness Month, is the time to change that.

All patients deserve the appropriate, limb-preserving treatment for their PAD, which is why we must work with lawmakers in Congress to advance policies to ensure all Medicare beneficiaries receive appropriate screening and intervention for PAD, so that no one loses a limb that could have been spared. No patient should face amputation without first ensuring that all limb-preserving treatment options are considered.

The first step to reducing avoidable amputations is knowledge. This month, I encourage everyone to understand the symptoms, signs and risks of PAD. Doing so can literally save limbs and save lives.

Dr. Jeff Carr, a board member at the CardioVascular Coalition and the founding and immediate past president of the Outpatient Endovascular and Interventional Society.

Click here to see the original article on The Hill Congress Blog’s website. 

Morning Consult: Curb Limb Loss in America

For the millions of Americans living with or caring for someone suffering from a chronic illness, the concept of loss is a familiar, yet unfortunate companion. Chronic illnesses such as heart disease and diabetes can strip away mobility, independence, productivity and quality of life. Even when properly diagnosed and well managed, these serious health conditions often demand significant changes in life and lifestyle.

Perhaps one of the most profound losses that can accompany chronic illness — and one that has become increasingly common — is the loss of a limb. More than 185,000 amputations occur each year in the United States — 54 percent of which are attributable to vascular disease.

It is vital to empower people affected by limb loss to reach their full potential, but it is also important to focus on preventing limb loss among populations at risk. Complicated by diabetes, heart disease, high cholesterol, smoking and even genetics, Peripheral Artery Disease narrows the blood vessels that supply the extremities, causing pain, reduced mobility, tissue death — and in the most severe cases, amputation. It is important to raise awareness about this issue.

Limb loss has indeed become a significant and growing health crisis across the United States, as the number of aging Americans and chronic illnesses continues to grow. Estimates suggest that anywhere from 12 to 20 percent of individuals over the age of 60 are living with PAD which could one day require amputation. It’s also important to note that African-Americans are at greater risk — up to four times more likely — to have an amputation than white Americans.

While individuals can go on to lead a full life with an amputation, the loss of a limb is associated with significant burden. Studies estimate the five-year mortality rate of persons with limb loss to be as high as 74 percent. Many living with limb loss experience barriers to participating in their communities and studies estimate the lifetime health care costs for a person with limb loss can be more than $500,000. Remarkably, this profound and complex loss can also be one of the most preventable.

During PAD Awareness Month this September, it’s overwhelmingly important for health care providers, patients, and policymakers to apply renewed focus towards preventing the amputation of a limb whenever possible. Indeed, it is estimated that upwards of 60 percent of amputations could be preventable through measures like patient education, regular visits with a doctor and/or podiatrist, and appropriate clinical intervention for vascular disease.

Health care providers and policymakers also have a responsibility to support appropriate clinical interventions that could help avoid amputation. Interventions like revascularization (which restores critical blood flow to affected limbs) has helped decrease the incidence of major amputations by 75 percent — yet these types of procedures may still not be widely available or routinely performed on some patient populations.

The benefits of these advanced treatment options, when appropriate, are noteworthy. Two-year mortality for revascularization patients falls between 16 to 24 percent, while amputees face mortality rates of up to 50 percent. And for payers, reduced amputations can mean huge health care savings: Annually, the immediate health care costs for the amputation of a limb — not including prosthetic costs or rehabilitation costs — total more than $8.3 billion.

The loss that comes with living with a chronic illness should not include losing a limb, when other treatment options are available to achieve the outcomes patients want. As we recognize PAD Awareness Month in September, I hope that providers and policymakers alike can move toward a greater understanding of this serious condition, and work together to empower patients in order to save limbs and save lives.

Jack Richmond is the interim president and CEO of the Amputee Coalition.

Click here to see the original article on the Morning Consult website.

Vascular News: CardioVascular Coalition urges increased awareness of peripheral artery disease in September

The CardioVascular Coalition (CVC)—a group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease—is urging healthcare leaders, policymakers, patient advocates and other stakeholders to join them in recognising September as “Peripheral Artery Disease (PAD) Awareness Month”, a time designated to increasing awareness about the disease and treatment options to save limbs and lives.

“Early diagnosis and clinically-appropriate intervention of PAD are critically important for our patients who, if undiagnosed and untreated, can face limb loss as a result of their disease,” says said Jeffrey G Carr, an interventional cardiologist and endovascular specialist and the physician lead for the CardioVascular Coalition. “Sadly, too many people experience limb loss as a result of PAD despite the fact that treatments and technologies are available that can prevent amputation. PAD Awareness Month is an important opportunity to increase awareness because, across the board, patients know far too little about PAD. By supporting PAD Awareness Month, we hope to change that.”

Underserved communities are at an even greater risk for both diabetes and PAD. For example, a CAV press release says that in the USA, African Americans are more than twice as likely to be diagnosed with PAD and are at an increased risk of complications from diabetes, according to research analyzing the prevalence of, and risk factors for, PAD in the USA.

While not every patient experiences symptoms of PAD, the CVC urges patients to be aware of the symptoms, which include leg pain, numbness, tingling, or coldness in the lower legs or feet, and sores of infections of the feet or legs that heal slowly.

CardioVascular Coalition Urges Increased Awareness of Peripheral Artery Disease (PAD) this September

Vascular Care leaders stress importance of PAD education and intervention to reduce limb loss in America during PAD Awareness Month 

WASHINGTON – The CardioVascular Coalition (CVC), a leading group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease, is urging healthcare leaders, policymakers, patient advocates and other stakeholders to join them in recognizing September as Peripheral Artery Disease (PAD) Awareness Month, a time designated to increasing awareness about the disease and treatment options to save limbs, and save lives.

PAD is a life-threatening circulatory condition, which affects an estimated 18 million Americans. Also known as claudication, poor circulation, vascular disease, or hardening of arteries, PAD is a chronic condition, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs.  The primary cause of PAD is the buildup of plaque in the arteries.

“Early diagnosis and clinically appropriate intervention of PAD are critically important for our patients who, if undiagnosed and untreated, can face limb loss as a result of their disease.  Sadly, too many Americans experience limb loss as a result of PAD despite the fact that treatments and technologies are available that can prevent amputation,” said Jeffrey G. Carr, MD, FACC, FSCAI, an Interventional Cardiologist and Endovascular Specialist and the physician lead on the CardioVascular Coalition. “PAD Awareness Month is an important opportunity to increase awareness because, across the board, Americans know far too little about PAD.  By supporting PAD Awareness Month, we hope to change that.”

If not properly managed, PAD can lead to non-traumatic lower limb amputations, which data show lead to lower quality of life and increased risk for death. According to the Amputee Coalition’s National Limb Loss Information Center, 54 percent of limb loss in the U.S. is the result are vascular disease, including PAD.

Underserved communities are at an even greater risk for both diabetes and PAD.  African Americans, for example, are more than twice as likely to be diagnosed with PAD and are at an increased risk of complications from diabetes, according to research analyzing the prevalence of and risk factors for PAD in the U.S.

While not every patient experiences symptoms of PAD, the CVC urges patients to be aware of the symptoms, which include leg pain, numbness, tingling, or coldness in the lower legs or feet, and sores of infections of the feet or legs that heal slowly.

To access more information about PAD Awareness Month activities, visit cardiovascularcoalition.org/pad-awareness-month/.  Join the conversation on Twitter at #PADAwareness.

 

New Report Concludes Endovascular Procedures Performed in Office-Based Facilities Result in Positive Patient Outcomes

Authors examine opportunities for optimizing patient safety and outcomes through office-based peripheral vascular intervention

WASHINGTON – The CardioVascular Coalition (CVC) – a leading group of community-based endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease – today said a new report published in Vascular underscores the value office-based endovascular care offers to patients, including individuals diagnosed with peripheral artery disease (PAD).

“Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice,” was published in the July edition of Vascular, the official journal of The International Society for Vascular Surgery.  In the report, the authors analyze treatment outcomes of office-based procedures and discuss lessons learned to achieve optimal patient outcomes and high quality care in the office-based clinical setting.

The study authors highlight many benefits associated with the delivery of care in the office-based setting, including improved patient satisfaction with expeditious outpatient experience, reduced financial burden in patient cost compared to hospital costs, and convenience in managing schedule in a physician’s own facility.

Procedures examined for this report include diagnostic arteriogram, therapeutic arterial intervention, and venous interventions, among others.  Key report findings include:

  • 3% of patients were discharged home from the recovery room following procedure without requiring inpatient care.
  • Only 1.4% of the procedures performed experienced a complication.
  • Common co-morbidities among the patient population included hypertension (58%), diabetes (33%) and coronary artery disease (23%).

“Our study, along with other reported experiences, have demonstrated that office-based vascular interventions can be performed safely with remarkable outcomes. Diligent efforts to not only reduce complications but also maintain quality of care are paramount in the continual success of this office-based practice,” the authors conclude.

For their analysis, the authors examined 5,134 endovascular procedures performed by vascular surgeons in office-based endovascular suites between April 2006 and December 2013.

Endovascular Care Leaders Stress Value of Outpatient Care Settings in Treating Growing Patient Population in the U.S.

Office-based care settings provide advantages for care delivery including improved efficiencies, increased patient satisfaction and health care savings   

WASHINGTON – In an article recently published in Endovascular Today, “Outpatient CLI Revascularization in the United States” a group of leading endovascular physicians and care providers outline the increasingly important role outpatient care settings have in delivering care to an estimated 18 million Americans living with peripheral artery disease, and more specifically, for at-risk critical limb ischemia (CLI) patients.

According to the article, approximately 160,000 to 180,000 individuals in the US with peripheral artery disease (PAD) will undergo a limb amputation as result of a PAD-related condition this year, despite improvements in technology that allow for the migration of revascularization services from hospitals to same-day interventions at a physician’s office.

The article outlines the benefits of care delivered in office interventional suites (OIS), or office-based labs, including their unique ability to treat very complex cases using the latest innovative technologies through a highly trained team in a timely and safe manner.  In this setting, endovascular physicians are using the latest procedures to help address the growing epidemic of PAD and CLI in the United States, and reduce amputations.

Stressing the value of OISs, the authors write, “There are many advantages to this health care delivery model, including more control of procedure scheduling, markedly improved physician efficiency, improved patient and physician satisfaction, a less stressful and confusing environment for the patient, physician ability to control quality, and the potential to save the health care system money.”

OISs are also increasing access to at-risk patients, which is helping to address racial, geographic and socioeconomic disparities that exist among the PAD and CLI patient populations.  PAD is more common among African Americans than any other racial or ethnic group, who data show receive fewer vascular screenings and treatments.  The availability of treatment in the OIS setting can help curb trends in care disparities, which endovascular care leaders hope result in more limb-saving procedures.

In closing, the authors stress the continued need for collaboration among the vascular care community, including care providers, physicians, patient advocates
and manufacturers to advance community-based solutions to bring safe, effective, and appropriate therapies to at-risk PAD and CLI patients, and improve access to high-quality care to underserved populations.

To read the full article in Endovascular Today, click here.

Endovascular Today: Outpatient CLI Revascularization in the United States

This year in the United States, approximately 160,000 to 180,000 of the estimated 18 million Americans with peripheral artery disease (PAD) will undergo amputation of a limb as a result of PAD-related complications. An unacceptable amputation rate of > 30% without any vascular evaluation persists, despite the education and attention given to critical limb ischemia (CLI).1 Epidemiologic studies have shown that there are differences in outcomes based on access to care and revascularization.

Fortunately, the treatment of CLI with revascularization is becoming more widespread, and the interest in comprehensive team-based limb preservation programs is growing. This parallels the marked growth of office interventional suites (OISs) throughout the country. These OISs (also known as office-based labs) can often provide treatment for CLI in a more time- and cost-efficient manner while maintaining safety outcomes on par with patients treated in the hospital setting.2 Endovascular revascularization in OISs can help bring safe, effective, and appropriate therapies to a complex and at-risk CLI patient while improving access to care.

PAD AND CLI: THE EPIDEMIC AND THE IMPERATIVE

Improvements in technology have allowed for the migration of revascularization services from the hospital setting to same-day interventions in the office setting. Care in community-based, freestanding office facilities focuses on providing endovascular revascularization with minimally invasive techniques and offers a cost-efficient, patient-preferred alternative site of care for patients. In many cases, these freestanding office-based vascular care centers are located in geographically convenient areas and offer reduced wait times for treatment, making quality vascular care more accessible for patients in need.

Although challenges related to PAD and CLI treatment exist, current technologies are available that not only help diagnose PAD, but also help to treat it. Outpatient interventions, such as angiography and endovascular revascularization, that employ the various technologies available have helped decrease the incidence of major amputations by 75%.3 Data suggest that increased accessibility to peripheral vascular intervention in the community setting may have contributed to the reduction in lower extremity amputations for patients with severe lower extremity PAD in the United States. According to one study, the rate of lower limb amputations among Medicare patients in the United States decreased by 45% from 1996 to 2011; during this time, endovascular treatment options and beneficiary access measurably improved.4

The accessibility of care in the community setting is also vital to addressing racial, geographic, and socioeconomic disparities that exist among the PAD patient population. For example, PAD is more common in African Americans than any other racial or ethnic group because conditions that increase the risk for developing PAD (eg, diabetes, high blood pressure) are more common among African Americans.5 Data also show patients from a minority group are much less likely to receive preventive and therapeutic vascular screening and procedures.6 Among PAD patients specifically, minorities are less likely to have limb-sparing procedures, such as angioplasty and lower extremity bypass, and more likely to undergo amputation.7 In addition to these disparities in care, there is still an unacceptably high rate of amputations among all patients with CLI.

Leaders from the vascular care community, including care providers, physicians, patient advocates, and manufacturers, have come together to form the CardioVascular Coalition (CVC) to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease with a primary focus on PAD and amputation prevention. In conjunction with the CVC, the Outpatient Endovascular and Interventional Society (OEIS) is developing policies designed to reduce lower-limb amputations by ensuring patients receive arterial testing and therapy, if indicated, in advance of nontraumatic, nonemergent amputations. Together, we must all do more by working to strengthen limb preservation efforts in the United States.

OFFICE INTERVENTIONAL SUITE VERSUS HOSPITAL FOR CLI TREATMENT: ACCESS
TO CARE

The complex nature of CLI dictates that patients with CLI are typically the most demanding, time-consuming, and resource-intensive cases. Many of these patients are not only very sick, but also require treatment in an expeditious fashion. Many are elderly and have diabetes and advanced or end-stage renal disease, which means coordination of care is essential. Care coordination can often be more expeditiously achieved in the outpatient setting than in a large, complex, often fractionated hospital environment. Some of the basic differences between the two approaches based on our experience are presented.

In an OIS that focuses on the treatment of patients with CLI, resources will be devoted toward the streamlined treatment of patients. If the physician in an OIS setting decides that a patient requires urgent treatment, she/he will simply make that determination, and the patient receives prompt and timely therapy. In many hospitals, the patient is often at the mercy of a scheduler who has many impediments and often little to no incentive to facilitate this coordination. Additionally, the hospital staff has the challenge of accommodating the needs of multiple physicians, groups, and specialties.

There has been a perception that operators in an OIS “cherry-pick” straightforward cases from the hospital when, in fact, the situation in most OISs is exactly the opposite. To perform very complex cases, new and innovative technology is often needed. Our experience is that it is often much easier to obtain new devices and offer an array of needed technologies in an OIS than in a hospital, particularly when the hospital is part of a larger system. Many experienced operators in the OIS setting are more comfortable treating a complex patient in the office because of the availability of experienced and dedicated staff.

To highlight safe, effective, and patient-focused decision making in the OIS in a real-world CLI patient, consider this example:

A diabetic patient with CLI undergoing dialysis 3 days per week is seen on Monday afternoon. He has a significant ulceration with some necrotic tissue on his foot that needs debridement by his podiatrist as soon as possible with upfront revascularization. The patient wants his case to be done on Tuesday or Thursday to avoid his dialysis days and wants a morning-only time slot because of his diabetes. The patient receives the same endovascular therapy with the same devices performed by the same operator as he would have had in the hospital, but in a more timely fashion.

In the end, the focus of care in the OIS is that the patient receives the right care, at the right time, in the right place, by the right provider—a true demonstration of the role of the OIS in CLI.

ESSENTIALS FOR TREATING CLI IN THE OIS

The transition from hospital- to office-based endovascular care requires coordination and planning. From diagnosis to discharge and follow-up, the organization must function in a patient-centered manner to achieve the best outcomes for the patients. The OIS must be appropriately equipped and the operators and staff adequately trained and prepared for all possible situations and outcomes. This means an “all-in” commitment from the highest level toward building a successful OIS. Imaging equipment needs to meet certain standards and must have digital subtraction ability to be able to perform high-quality CLI interventions. Patient safety and achieving successful outcomes must be the primary drivers for selection of equipment.

An investment into the development of vascular sonographic capability is highly recommended, if not essential. More advanced labs in the OIS report 100% usage of ultrasound-guided access for femoral or alternative access locations (ie, pedal, transtibial, etc).

To borrow from a well-known quote, “It takes a village” to build a successful office-based CLI program, and this begins with education and training. First and foremost, the physician operators should have experience, training, and credentialing to perform these complex CLI procedures as well as skill sets for bailout of potential complications. Support from the entire organization is essential to providing the timely and comprehensive care required by the patients.

Cardiovascular technologists must become adept in using the multitude of devices and techniques employed to treat CLI, and these competencies are often easier to attain and maintain in the OIS. All staff must be certified in advanced cardiovascular life support and trained to watch for and manage signs of access site- or procedure-related complications and to initiate emergency protocols. Practice-wide education (ie, midlevel practitioners, schedulers, etc) must be conducted to ensure that staff fully appreciates the importance of expedited access for the CLI patients. The importance of educating other community physicians, podiatrists, and other health care providers to deliver coordinated CLI care is also essential.

The care continuum does not stop when the patient gets out of bed following the procedure. Detailed discharge instructions must be provided to the patient and his/her support person. Follow-up calls are essential, and a quick and easy path to postcare evaluation must be available for any issue that may need attention. Consideration should also be given to enrolling CLI patients into a chronic care management program or other coordinated care program to ensure appropriate and timely extended care.

Finally, to ensure that appropriate and quality care is given, a quality review program (such as recommended by the OEIS) must be initiated, watching for trends or concerns and promptly responding to any red flags.

MAINTAINING THE GAIN THROUGH OEIS

OEIS was formed in August 2013 by a multidisciplinary group of physicians who shared an interest in performing procedures in an OIS. These physicians were equally represented by vascular surgery, interventional cardiology, and interventional radiology specialties. It is a unique medical society in that these frequently competitive specialties work together to promote education and improvement of care in the OIS. There are many advantages to this health care delivery model, including more control of procedure scheduling, markedly improved physician efficiency, improved patient and physician satisfaction, a less stressful and confusing environment for the patient, physician ability to control quality, and the potential to save the health care system money.

The OEIS is very interested in promoting high-quality, ethical, and cost-effective care. The society’s six quality initiatives include promotion of safety, credentialing of optimally trained operators, measuring outcomes, ensuring compliance with state and federal regulations and coding, procedure and patient selection appropriateness, and peer review (Table 1). Future goals for the OEIS include an organized national registry to collect data and participation in an existing or new accreditation pathway for all office interventional procedures to help further the quality and standards in the OIS.

CONCLUSION

Enhanced by the continued work of professional organizations and refinement of measurement tools, endovascular physicians are using the OIS as a unique site of service to help address the growing epidemic of CLI. OISs help bring safe, effective, and appropriate therapies to the complex and at-risk CLI patient and provide an option to improve a high-quality access to care to this underserved population.

For more information about the OEIS, please visit www.oeisociety.org, and for more information about the CVC, please visit www.cardiovascularcoalition.com.

Click here to see the original article on the Endovascular Today website.

Morning Consult: National Minority Health Month: End Racial Disparities in Limb Loss

It’s often said that serious illnesses don’t discriminate. Health crises are the great equalizer – striking men, women, the elderly and even children with terrifying unpredictability.

Yet, some of the most life-threatening and life changing health conditions are anything but random. Far from it – they disproportionately affect certain communities and populations often times despite (or in spite of) our best efforts.  History has shown that collective knowledge and awareness as well as considerable energy aimed at prevention are our best weapons at combating these often devastating diseases.

For African Americans in the United States, limb amputation has become a distressingly common, although often preventable, health crisis. Largely attributable to increased rates of high blood pressure and diabetes, which are key risk factors for the development of Peripheral Artery Disease (PAD), African Americans are four times more likely to undergo an amputation than white Americans.

The statistics are grim: an estimated one in four African Americans between the ages of 65 and 74 has diabetes. Likewise, high blood pressure affects more than 40 percent of African Americans, develops earlier in life, and is usually more severe than with white Americans.

Twelve million African Americans – twice as often as their white counterparts – have developed PAD, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs.  Poor circulation not only causes excruciating pain, but can lead to tissue death and complex, untreatable ulcers. Today, one out of every three diabetics over the age of 50 has PAD, and vascular disease is now responsible for 80 percent of all amputations.

And while it’s an unfortunate but well-known fact that societal, social and genetic factors contribute to higher rates of PAD among African Americans, what’s more egregious is our lack of progress in slowing their rate of life-changing amputations.

Despite the wide availability of technologies that help patients avoid amputations, African American patients are less likely to have access to them. Outpatient interventions like angiography, revascularization (which restores critical blood flow to affected limbs), and atherectomy (a minimally invasive endovascular technique that removes plaque from blood vessels), have helped decrease the incidence of major amputations by 75 percent. Still, studies show that African American patients hospitalized for complications of peripheral arterial disease (PAD) have significantly lower rates of potentially limb-saving lower extremity angioplasty.

Lack of access to these technologies is a nationwide problem. Data indicate that of the more than 18 million Americans currently suffering from PAD, only two million will receive a diagnosis that will help to save their limb. It’s a problem that robs patients of their mobility, quality of life, and leads to lifelong physical and emotional burdens – not to mention expense.

It’s estimated that amputations cost the U.S. healthcare system an estimated at $10.6 billion annually. The largest payer of major amputations in America, Medicare, covered 66 percent of all amputations in 2010.

Avoiding amputations through revascularization procedures will not only help avoid the expense of amputation, it also allows patients to thrive: research shows that 80 percent of revascularization patients are walking again after two years, whereas 60 to 80 percent of amputation patients will never walk again. Fewer than 20 percent of patients require discharge to a skilled nursing facility after revascularization, compared to 70 percent of amputation patients who require either SNF or rehab care. Most notably, 2-year mortality for revascularization patients falls between 16 to 24 percent, while amputees face mortality rates of up to 50 percent.

The racial and ethnic disparities in amputation rates, especially with the existence of technology that could prevent them, deserve increased attention and action by our lawmakers – particularly as we observe National Minority Health Month in April.  Ongoing initiatives to reduce amputation rates, like those supported by the CardioVascular Coalition, seek to make limb preservation practices and the standard of care.  By doing so, we know that healthcare costs will decrease, but more importantly lives will be saved.

Bryan T. Fisher Sr., MD is the co-director of Limb Preservation at Centennial Medical Center and is an endovascular surgeon at the The Surgical Clinic in Nashville, Tennessee.

Click here to see the original article on the Morning Consult website.

CardioVascular Coalition Convenes Educational Briefing on Peripheral Artery Disease and Highlights Impact on Minority Populations

Leading experts call for increased access to advanced interventional care to prevent amputations and reduce healthcare costs 

Washington, DC – The CardioVascular Coalition (CVC) today hosted a Capitol Hill briefing bringing together leading physicians and policy experts to discuss Peripheral Artery Disease (PAD) in America and the need for policy solutions that support access to clinically appropriate care to reduce avoidable amputations. As revascularization technologies have rapidly advanced, access to interventional care has become paramount to saving both life and limb for patients diagnosed with PAD.

Currently, PAD affects more than 18 million Americans, but estimates suggest only two million receive a diagnosis.  As a result, approximately 160,000 to 180,000 of these patients will undergo amputation of a limb as a result of PAD-related complications each year. In fact, 25 percent of patients diagnosed with the worst stage of PAD will have an amputation. It has also been documented that minority populations, including African-American and Hispanics, are twice as likely to face the threat of an amputation resulting from PAD.

Panelists noted however, that major technological advances have been made in recent years that when used at the appropriate time can greatly reduce the number of amputations among vulnerable populations. For instance, a study at one freestanding vascular care center saw that with the increased use of angiography, – a medical imaging technique used to visualize the inside of blood vessels – the incidence of major amputations fell 75 percent.

“We’ve made great strides in diagnosing, treating and preventing complications of PAD in the last 30 years,” stated Jeff Carr MD, Founding and Immediate Past President of the Outpatient Endovascular and Interventional Society. “But there is still vast room for improvement. As an immediate next step, we should enact policies that require vascular evaluation by a trained specialist before non-traumatic amputations are performed. We have the necessary tools and technology – now we must ensure that all patients reap the benefits.”

When patients receive access to a PAD specialist and appropriate intervention, their quality of life can improve significantly. Indeed, the mortality rate for those whose limbs are saved drops to just 16 to 24 percent compared to 48 to 71 percent for those who undergo an amputation. Eighty percent of those whose care prevents an amputation are able to walk again, while 60 to 80 percent who have an amputation are never able to walk again.

In addition to improved health outcomes, early intervention for patients with PAD reduces spending to the overall healthcare system. A recent Avalere analysis found that reducing the number of Medicare patients with major amputations by half through the encouragement of revascularization could reduce Medicare spending by $2 billion over 10 years.

“As the medical and health policy communities continue to work together to strengthen our healthcare delivery system, we look forward to partnering with policy makers to prioritize solutions that improve access to quality healthcare for all patients with PAD,” added Carr.

CardioVascular Coalition Urges Increased Awareness of Peripheral Artery Disease (PAD) Among Diabetes Patients During American Diabetes Month

Americans living with diabetes are at an increased risk for developing PAD, which disproportionately affects minority and underserved communities

WASHINGTON – The CardioVascular Coalition (CVC), a leading group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease, is highlighting the strong clinical link between peripheral artery disease (PAD) and diabetes this month during American Diabetes Month.

PAD is a life-threatening circulatory condition, which affects more than 18 million Americans. Also known as claudication, poor circulation, vascular disease, or hardening of arteries, PAD is a chronic condition, which causes narrowing or blockage of the vessels that carry blood from the heart to the legs. The primary cause of PAD is the buildup of plaque in the arteries.

“Diabetics are at an increased risk for developing PAD due to high risk factors such as high blood pressure and obesity, however many patients do not recognize the warning signs and delay seeking the care they need until it’s too late,” said Jeffrey G. Carr, MD, FACC, FSCAI, an Interventional Cardiologist and Endovascular Specialist and the physician lead on the CardioVascular Coalition. “Early diagnosis and clinically appropriate intervention of PAD are critically important for our patients who, if undiagnosed and untreated, can face limb loss as a result of their disease. Sadly, too many diabetic patients are simply not aware of PAD symptoms and risks.”

If not properly managed, both diabetes and PAD can lead to non-traumatic lower limb amputations, which data show lead to lower quality of life and increased risk for death. According to the National Limb Loss Information Center, nearly 80 percent of amputations due to diabetes are believed to be preventable.

Underserved communities are at an even greater risk for both diabetes and PAD. African Americans, for example, are more than twice as likely to be diagnosed with PAD and are at an increased risk of complications from diabetes, according to research analyzing the prevalence of and risk factors for PAD in the United States.

While not every patient with diabetes experiences symptoms of PAD, the CVC urges patients to be aware of the risks. Other symptoms include leg pain, numbness, tingling, or coldness in the lower legs or feet, and sores of infections of the feet or legs that heal slowly.

“American Diabetes Month is an opportunity for increased awareness of all risks associated with diabetes and related conditions for all Americans,” added Dr. Carr. “PAD, in particular, is a disease that too few Americans understand and recognize, and we are hoping to change that.”

 

Dr. Jeffrey Carr: Era of Change in Sites of Service for Peripheral Vascular Intervention Requires New Ways to Look at Costs

I read with interest the article by Jones et al. (1) in the March 10, 2015, issue of the Journal. I am concerned that, based on the methodology and data presented, the conclusions may be misleading and suggest that interventionalists are making treatment decisions for peripheral vascular interventions (PVIs) and the choice of atherectomy, particularly, based on financial remuneration rather than on scientific evidence, depth of clinical experience, and interest in improving outcomes for patients.

The article presented data for Medicare fee-for- service beneficiaries between 2006 and 2011, showing no statistical increase in overall rate of PVIs, but with significant shifts in site of services from inpatient hospitalization to outpatient and office settings. Additionally, increases in atherectomy procedures during that time period were presented as two-fold in the hospital outpatient setting and 50-fold in the office setting. The authors concluded that changes in reimbursement intended to result in cost savings to Medicare inadvertently drove the shift in PVI site of service and the increase in atherectomy procedures in outpatient and office settings, thereby neutralizing cost savings. However, several points of clarification are necessary for accurate interpretation of the presented data.

First, the article presents an increase in atherectomy procedures up to 50-fold in the office setting during the study period. However, unlike percutaneous trans- luminal angioplasty (PTA) and stenting, atherectomy was essentially nonexistent in the office setting until 2011, when it first became eligible for reimbursement for similar Medicare beneficiaries as the study population. Ignoring this development and reporting a trend over the entire time period of 2006 to 2011 is misleading.

Moreover, Table 1 shows that from 2006 to 2011, the majority of atherectomies (95.7%) were per- formed in the hospital setting versus the office (4.2%). By comparing absolute numbers of atherectomy procedures in the office setting in 2010 (n 1⁄4 w0 pro- cedures) versus 2011 (n 1⁄4 292 procedures) (see Table 3 in Jones et al. [1]), this relatively small absolute in- crease becomes overmagnified when quantified as a percentage. Atherectomies performed in the office in 2011 represented only 16% of the total number of atherectomies performed for that year in all 3 settings. Second, mean costs of atherectomy procedures are presented as exceeding those of stenting and PTA procedures during the study period. However, in the hospital outpatient setting, atherectomy was reimbursed at the same level as PTA until 2008, and less than or equal to stent procedures since 2008 (Table 1). In addition, the utilization and costs of atherectomy are likely overestimated relative to those of stenting as the PVIs in the article were categorized as angio- plasty, stenting, or atherectomy, without regard to procedures involving more than one treatment modality, and the costs of procedures using both atherectomy and stenting were only attributed to
atherectomy in the analysis.

Third, the analysis excluded patients undergoing expensive surgical or hybrid revascularization procedures (n 1⁄4 8,901 [20.6%]) from the entire pool of 39,339 patients who underwent revascularization. Therefore, the conclusion about the erosion of savings due to shift in site of service and outpatient reimbursements is based on incomplete information that ignores the substantial reduction in the rate of surgical bypass procedures (33%; p < 0.001) during the study period. Considering that lower extremity bypass surgery is an expensive, inpatient-only procedure typically requiring a 3.8- to 10-day length of stay (LOS) and with Medicare costs ranging from $17,215 to $28,983 per bypass procedure (FY 2011 rates), the significant reduction in surgical procedures which likely resulted in significant cost savings to Medicare is not represented fairly in this analysis. (Medical provider analysis and review data for fiscal years [FY] 2009–2012, and FYs 2011–2014 Final Rules also are available at the Centers for Medi- care and Medicaid Services website.)

Fourth, the patients treated with atherectomy in the study represented a sicker population than those who received stents. Atherectomy patients were more likely to be older black males (p < 0.002) with diabetes, hypertension, renal failure, ischemic heart disease, heart failure, and stroke, compared to patients who underwent stenting (p < 0.001). These comorbidities are associated with critical limb ischemia (CLI) and amputation as well as longer, complex, and more heavily calcified lesions in the infrapopliteal arteries, which may result in less effective treatment with balloons and stents alone (2). The differences in patient populations could also indicate an improved access to care (i.e., patients were treated who would otherwise have been treated surgically or who would not have undergone revascularization at all). These clinical considerations in treatment
choices were not addressed in the authors’ conclusions, nor did the authors assess the patient outcomes.

Fifth, the authors cited lack of efficacy and comparative evidence to justify the increased use of atherectomy. However, during the study period, paucity of data was true for the entire field of peripheral artery disease (PAD) treatment. Often, practice patterns change in advance of published data, based on clinical experience to support therapeutic decision making. In the last several years, numerous clinical device trials in PAD patients have reached completion, and evidence has been published.

In the Zilver PTX trial, data clearly demonstrate that PTA alone in the femoropopliteal artery segment is not a satisfactory procedure due to high restenosis rates, resulting in a poor 12-month primary patency rate as low as 32.8%. Similar poor results were seen in the clinically driven target lesion revascularization (TLR) rate at 12 months post-PTA of 17.5% (3). Although some bare-metal and drug-eluting stents have improved patency and TLR rates significantly (3), concerns remain regarding the high cost of treating in-stent restenosis (ISR).

Atherectomy (plaque removal) is a therapeutic mo- dality that preserves the native vessel for future treatment options without leaving a permanent implant (metal stent) behind. In addition, atherectomy reduces the need for costly revision of in-stent reste- nosis, avoids or reduces the amount of barotrauma to the vessel, and has a lower dissection rate than PTA, while reducing the rates of target lesion revascularization. One of the largest, prospective, multicenter studies, the DEFINITIVE LE study (Determination of EFfectiveness of the SilverHawk PerIpheral Plaque ExcisioN System [SIlverHawk Device] for the Treat- ment of Infrainguinal VEssels/Lower Extremities), included 800 patients and confirmed the fact that directional atherectomy is safe and effective (78% overall primary patency, 95% prevention of major amputation in CLI patients) in a variety of lesions, in patients with and without diabetes, and in claudicants and CLI patients (4). Additionally, the EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial demonstrated a significant reduction in TLR that favored laser atherectomy over PTA for femoropopliteal ISR in a randomized, controlled trial with long lesions (5). The ongoing large LIBERTY 360 trial is attempting to demonstrate real-world comparative outcomes for multiple atherectomy, PTA, and stent modalities in diverse lesion subsets involving the popliteal and infrapopliteal arteries.

Devices and techniques for revascularization have evolved rapidly since 2006. Several different atherectomy devices, including directional, orbital, rotational, excisional, and laser atherectomy devices, have been approved in the United States since 1998. However, some devices only gained significant adoption in recent years due to technological evolution, clinical evidence, and improved understanding of endovascular techniques. Of note, the article sug- gests that improved outpatient reimbursement led to growth in use of atherectomy in the outpatient setting (1); in fact, inpatient atherectomy procedures increased 30.3% from 2010 to 2011 (see Table 3 in Jones et al. [1]), whereas outpatient atherectomy increased by 20.4%, potentially indicating that other (nonfinancial) factors may have influenced the in- crease in atherectomy use. Although significant challenges exist in designing and funding random- ized comparative effectiveness trials for all patient and lesion subsets, we continue to gain new information regarding performance and durability of procedures.

Although there are economic drivers that dictate care in all locations of service, outliers exist in every specialty and site of service. It is believed that most physicians strive to do what is in the best interest of their patients. There is concern with singling out a specific therapy from a retrospective dataset without consideration of all the inherent episodic costs, especially when excluding data representing probable significant savings to Medicare by reduction in more costly inpatient surgical services. In the interests of the patients who present with this challenging dis- ease state, the interventionalists who are thought- fully trying to care for them, and the payers, such as Centers for Medicare and Medicaid Services, who are interested in reducing overall costs, additional financial analyses and assessments of true costs are critical for accurate and informed decision making. Only then can conclusions be made about value for specific therapies to treat PAD in each site of service, with the overall aim of improving patient access to quality care.

*Jeffrey G. Carr, MD
*Tyler Cardiac and Endovascular Center

Morning Consult: Medicare Advisory Committee Examines Benefits of Vascular Disease Intervention

Vascular disease is becoming increasingly common in America – particularly among Medicare aged individuals – however, it’s a health condition less commonly understood by patients and policymakers alike.

An estimated 18 million Americans are living with Peripheral Arterial Disease, a condition where blood flow to the extremities is restricted, resulting in pain, infection and deterioration of a limb.[i] When blood can’t reach a patient’s extremity because of poor circulation, the tissues will eventually die – with potentially lethal, systemic results. Left untreated, PAD in its worst form can lead to lower extremity amputation and even death.

Modern interventions and greater access to vascular interventions however, are helping to preserve both life and limb. Yet, while data exists to illustrate both the physical and economic benefits of increased vascular care and intervention, the nation’s largest insurer – Medicare – is still grappling with evidence and outcomes associated with the treatment of PAD and other associated vascular diseases.

Scientific evidence and outcomes were the topics of a Medicare Evidence Development & Coverage Advisory Committee meeting last month – during which experts were called upon to address what is known, and unknown, about successfully treating PAD. The meeting was a positive step toward federal regulators more fully understanding vascular disease, its patient populations, effective treatments, costs and the ramifications – both clinical and fiscal – of inaction.

Part of that discussion was how Medicare should approach important coverage decisions for millions of its beneficiaries living with PAD.

For any American who has benefitted from life and limb saving interventions, and their providers, the evidence is clear.

Data show increased access to PAD interventions, including revascularization through stenting, angioplasty and atherectomy, has resulted in a measureable decline in the total number of lower-limb amputations in the United States, despite increases in the number of patients living with PAD – up nearly 25 percent globally in ten years.[ii]By offering patients appropriate, clinically-effective peripheral vascular intervention in convenient community-based vascular centers, we have witnessed a reduction in amputations, which spare patients the emotional, physical, and even financial pain that often accompanies amputation.

Data show limb preservation benefits patients, payers and our healthcare delivery system as a whole:

  1. Saving a patient’s limb overwhelmingly preserves quality of life. Research shows that 80 percent of revascularization patients are walking again after two years, whereas up to 80 percent of amputees will never walk again. Immediately following a revascularization procedure, fewer than 20 percent of patients require discharge to a nursing home, compared to 70 percent of amputation patients who require either nursing home or inpatient rehab care.
  1. Intervention improves patient mortality rates. Overall, 2-year mortality for revascularization patients falls between 16 to 24 percent, while amputees face mortality rates of up to 50 percent. [iii]
  1. Limb preservation is good for Medicare and other insurers. Between 1996 and 2011, peripheral vascular interventions helped reduce the number of Medicare patients requiring lower extremity amputations by 45 percent.[iv] That’s a remarkable drop when you consider that major amputation is the sixth most costly surgical procedure in the United States – costing taxpayers $10.6 billion annually. Medicare alone is the highest payer of major amputations in the United States – covering 66 percent of all amputations in 2010.[v]
  1. Vascular intervention in the physician-office setting ensures patient choice, increases access and reduces delays in treatment. Vascular care in the community-based setting offers patients readily available access to treatments to alleviate their pain and halt the progression of PAD.

Despite what MEDCAC ultimately recommends to CMS, or the economic savings to the healthcare system and the American taxpayer, most of my patients would say that avoiding an amputation is immeasurably valuable. Revascularization not only helps preserve a limb, but usually restores function and relieves years of unrelenting pain.  It can help patients return to work, spend quality active time with their families, and improve their outlook on life.

And you can’t put a price on that.

[i] SAGE Group, 2010]

[ii] Fowkes, Gerald, The Lancet, “Comparison global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis.” August 2013.

[iii] Yost, Mary. Cost-Benefit Analysis of Critical Limb Ischemia in the Era of the ACA, May 2014.

[iv] JAMA Surgery, Fifteen-Year Trends in Lower Limb Amputation, Revascularization, and Preventative Measures Among Medicare Patients, January 2015.

[v] Yost ML. The economic cost of dysvascular amputation. Atlanta (GA): The Sage Group. In press.

Dr. Jeffrey G. Carr is an Interventional Cardiologist and Endovascular Specialist. He is the Founding and Immediate Past President of the Outpatient Endovascular and Interventional Society, a multispecialty medical society. He is also the physician lead on the CardioVascular Coalition, a group dedicated to raising awareness for PAD and advocating for national healthcare policy and amputation prevention. Trained at UCLA Medical Center, he practices full time in a single specialty group in Tyler, Texas.

 

Click here to see the original article on the Morning Consult website.

CQ: CMS Mulls Next Steps on Leg-Artery Treatments

Officials at the Centers for Medicare and Medicaid Services are planning a deep look into treatments available to improve poor blood flow in the legs, a condition that can lead to gangrene and amputations in severe cases and raises risk for strokes and heart attacks.

The agency may take as long as eight months to consider what steps it may take next regarding the condition, known as peripheral artery disease, said Tamara Syrek Jensen, director of CMS Coverage and Analysis Group, at the conclusion of a Wednesday meeting of an evidence and coverage committee to assess evidence supporting treatments for the disease.

About 8 million to 12 million people in the United States have clogging of the arteries in legs, which can make walking painful. Given the rising incidence of diabetes and the aging of the nation’s population, more Americans likely will suffer ill affects from this clogging of arteries in their legs. Medicare covers many of the services and products used for peripheral artery disease through the most common agency approach, one that rests some flexibility about administering policies with contractors.

CMS could look to establish more of a blanket policy regarding treatments of peripheral artery disease through a national coverage decision, or NCD. CMS uses relatively rarely uses this approach. An agency database shows information about 338 national coverage decisions.

“That’s why were looking at this today, to determine whether we want to open up an NCD,” Jensen said at the meeting.

The agency asked its advisory panel to widely review the data available to support use of treatments such as surgical interventions and drugs. At the end of the meeting, the panel gave mixed reviews to the body of research in a series of six votes. CMS had asked the panelists to use a scale of 1-5, with a 1 indicating little or no confidence that the current body of evidence showed a treatment had near- or long-term benefit for patients.

The panel’s ratings ranged from a low of 1.4 on a question about whether sufficient evidence exists that treatments produce a near-term benefit for people who are not yet suffering any obvious symptoms from peripheral artery disease. The highest score given by the panel, a 3.6, was given for the evidence on near-term benefit for people with more advanced disease.

In preparing for the meeting, CMS and the panel looked to a 2013 report from the Agency for Healthcare Resources and Quality that concluded that advances in care in both medical therapy and invasive therapy have not been rigorously tested.

At the meeting, representatives of makers of medical devices and groups representing doctors who treat peripheral artery disease sought to counter that conclusion. Roughly two dozen speakers gave short presentations, many of which were intended to highlight newer data and studies showing progress in the development of medical devices. Among the speakers was Jeff Carr of the CardioVascular Coalition, which represents about 150 stand-alone medical center focused on cardiac and peripheral artery conditions.

He summed up his arguments after the meeting in an e-mail to CQ HealthBeat. “Research indicates preventing amputations through treatment of clogged leg arteries can reduce health costs, particularly those for Medicare,” he wrote.

“Studies indicate that the rate of lower limb amputations among Medicare patients in the U.S. decreased by 45 percent over nearly 15 years, correlating with a significant increase in access to endovascular interventions,” Carr said. “In addition to reducing healthcare costs, interventions can ultimately result in limb preservation that offer the best possible clinical outcome and improved quality of life for our patients.”

A notable drop in leg and foot amputations was reported in 2012 by the Centers for Disease Control and Prevention. Looking at cases reported for diabetics 40 and older, a group more at risk for losing limbs than the general population, CDC reported a decline of 65 percent in leg and foot amputations between 1996 and 2008.

In calculating these figures, researchers focused on amputations due to disease, and not trauma and injuries such as car accidents. The rate of lower limb amputations linked to poor blood flow was 3.9 amputations per 1,000 people with diagnosed diabetes in 2008 compared to 11.2 per 1,000 people in 1996.

Members of the Medicare advisory panel, though, cautioned against linking the decline directly to the increased use of treatments such as surgery and implanted medical devices for peripheral artery disease. Reductions in smoking and other public health gains likely played a role, they said.

The agency has a difficult task in trying to make decisions now about treatments, given the current gaps in knowledge about the outcomes achieved, said Julie Swain, a member of the panel and a former Food and Drug Administration adviser who is now a researcher at Mount Sinai Heart Institute at New York.

CMS has a problem right now with using evidence-based medicine because there is very little good evidence on the leg-artery treatments, Swain said.

Click here to see the original article on the CQ website.

Letter to the Editor Re: “Medicare Bills Rise For Stents Put Into Limbs”

 

The following letter was submitted to the New York Times in response to an article titled Medicare Bills Rise For Stents Put Into Limbs:

As President and a Founding Member of the Outpatient Endovascular and Interventional Society (OEIS), I am writing in response to an article published in the January 30, 2015 issue of the New York Times titled “Medicare Bills Rise For Stents Put Into Limbs”.

The OEIS is a national multispecialty society comprised of interventional radiologists, interventional cardiologists, and vascular surgeons. The organization was formed to establish standards of safety, appropriateness, and quality of procedures performed in office interventional suites. Our society promotes the highest ethical standards and stands against abuses, placing the patient first in decision making.

The article fails to capture the extraordinary value that minimally invasive peripheral vascular procedures — delivered in the outpatient setting — provide to both the patient and taxpayer.

The article’s conclusion, which attributes to a 66% increase in opening blood vessels among Medicare patients to unnecessary and over-utilized procedures, is grossly inaccurate.  Actually, the number of arterial cases has remained relatively flat since 2005, while peripheral cases have risen due to an increase in vein closure cases involving varicose veins, which do not include the use of a stent as suggested in your headline.

The real story is that physician specialists treating patients with peripheral artery disease (PAD) in this clinically advanced, patient-preferred setting are on the forefront of preventative and interventional medicine, providing patients with less surgical trauma, shorter recovery times, and fewer complications without reducing clinical efficacy or quality. Further, the shift to same day office interventions is an effort to deliver care in a cost-effective outpatient setting.

For patients, data has shown this approach results in fewer complications and higher patient satisfaction.

As a multispecialty society formed specifically to promote the responsible delivery of quality care by outpatient and office based vascular physicians and centers, we are proud to be part of this transformation in healthcare and are committed to establishing standards of care and best practices to ensure that all patients receive effective, safe and appropriate care.

Our organization appreciates the opportunity to provide the above comments relative to this critical issue.

By: Dr. Jeffrey G. Carr

Endovascular Today: The Outpatient Endovascular and Interventional Society

Although outpatient or office-based interventional suites have been operational for many years, there has been a marked proliferation of these sites in multiple states in the past 3 years. It is estimated that nearly 350 to 400 office-based labs exist in the United States to date, and that number is growing rapidly. Office-based labs, also referred to as outpatient interventional suites, access centers, or office-based endovascular suites, offer many distinct advantages and provide an alternative care delivery model to patients, payers, and physicians that is believed to be more efficient and cost effective than many hospital-based interventions. Patient satisfaction is very high in these centers, which are dedicated to the patient experience and optimal outcomes.

The Outpatient Endovascular and Interventional Society (OEIS) was conceived to address the unique needs and promote the attributes of these outpatient interventional suites.

STARTING A NEW MEDICAL SOCIETY
With the growth of office-based suites around the country, many physicians and affiliated organizations have felt alone and sometimes isolated in the process of establishing and building their practices. Until now, there has been no representation or collective experience to draw upon. The existing national societies, although supportive of the cause, have other interests that are often a singular-specialty focus. Additionally, there has been no formal representation to payers and regulatory agencies. A need arose to bring together physicians and independent facilities that have common experiences and goals and to ensure that cost-efficient, quality care is provided.

The society was born out of a vision from a few individual physicians and then culminated at an Endovascular Thought Leader Meeting in Napa, California in April 2013. The discussions at the meeting sparked the idea to unite three specialties—interventional cardiology, interventional radiology, and vascular surgery—and foster key leaders. It was clear that there are similar concerns common to all centers, regardless of specialty or types of interventions performed, and there was great enthusiasm to develop a new society.

A sentinel meeting took place in Dallas, Texas, on August 24, 2013. Fifteen founding physicians, five from each of the three specialties and representing different geographic areas of the country, came together to develop the society’s goals, bylaws, and objectives. In that meeting, the unity of purpose and approach to forging the society was remarkable. On October 24, 2013, the OEIS became an official nonprofit entity.

A NEW VOICE FOR OUTPATIENT ENDOVASCULAR CENTERS
Among the many goals of OEIS are to enhance the safety, quality, and efficacy of outpatient and office-based interventional procedures. To achieve that goal, the society plans to develop and promote standards of care, appropriateness criteria, safety, and outcomes measures unique to the office-based setting. The society plans to promote research and education regarding medical, economic, and longitudinal management issues relating to these procedures. It will also provide a forum to collaborate and share best-practice experiences among other practitioners. In these ways, the OEIS plans to enhance the endovascular and interventional fields by leading with innovations, product development, and modes of care delivery.

With the nationally changing health care landscape, the society will help bring together experiences and thought leaders that are innovating ways to deliver cost-effective, quality care. Cost containment remains a core focus in outpatient interventional suites. The model of more directly aligning providers with patients’ best interests and high-quality care continues to drive expansion of these centers. Payers continue to support development of these centers because it is cost effective. To date, there remains a significant geographic treatment gap in the United States in regards to offering endovascular therapies to peripheral arterial disease patients with critical limb ischemia.1 Executed properly, office-based suites are positioned to positively impact patients’ access to affordable, quality care at a local level.

With a collective voice on behalf of patients and physicians, the OEIS will be a strong advocate with payers, legislative bodies, and industry. A poignant example of this need occurred this past summer, as Centers for Medicare & Medicaid Services (CMS) announced the 2014 Proposed Rule for the Medicare Physician’s Fee Schedule, which included steep pay reductions for peripheral arterial disease and other procedures. This proposed reduction in payment and new payment system would have a significant impact on the ability to provide services in the office-based setting and implications for patient access and choice. A coalition effort from many individuals and organizations was successful in educating CMS to not finalize the Rule.
In the future, further organized efforts will be needed to partner with other societies, service organizations, and industry to continue to educate CMS and other payers about the high value of office- and outpatient-based interventional services for patients and health care systems. OEIS will take a central and leading role in these efforts on state and national levels.

A MULTIDISCIPLINARY, INCLUSIVE APPROACH
In contrast to other, predominately single-specialty societies, our aim is to include practitioners from different specialties. The society aims to bring together like-minded physicians who are dedicated to patient-centered, quality interventions and concerned about appropriateness, safety, and long-term outcomes. Rather than be competitive, the leadership of the OEIS hopes to foster close partnerships and collaborative relationships with many established medical societies and specialists to work toward common educational, strategic, and advocacy goals. The OEIS also desires to seek unity, collegiality, and partnerships among a variety of specialists and industry organizations that traditionally have been quite competitive. It is increasingly important to band together around our common goals, not only to defend against the whirlwind of health care changes but also to lead toward improving processes and incentives. Together, we will aim to build the platform for value-based purchasing related to endovascular procedures and various interventions.

OEIS INAUGURAL MEETING 
The OEIS will be hosting its Inaugural Scientific and Business Meeting on May 16 to 18, 2014. This promises to be an interactive, informative, and innovative meeting with practical information and content that will benefit physicians already performing percutaneous procedures in an office setting, industry and organizations involved with providing services, and those just interested in understanding more about this cutting-edge endovascular service model.

For those interested in learning more about our society’s efforts and how to join, please contact us at OEISociety.org. We are excited about the future of office-based procedures and strive to set standards of care and excellence to further endovascular care.

Jeffrey Carr, MD, FACC, is the Founding President of the Outpatient Endovascular and Interventional Society. He is the National Medical Director of National Cardiovascular Partners. He is also the Medical Director of the Tyler Cardiac and Endovascular Center in Tyler, Texas. He has disclosed that he has no financial interests related to this article. Dr. Carr may be reached at jeffcarr@me.com.

Published by Endovascular Today. See the original article here.