Category Archives: Coalition News

Vascular care leaders stress importance of PAD education and intervention to reduce limb loss in America by asking lawmakers to join Congressional PAD Caucus

WASHINGTON – Today marks the start of Peripheral Artery Disease (PAD) Awareness Month and this September the CardioVascular Coalition (CVC), a leading group of providers, physicians, and manufacturers, commends lawmakers Donald M. Payne, Jr. (D-NJ-10) and Gus Bilirakis (R-FL-12) for launching the new Congressional PAD Caucus to educate Congress and communities about PAD while supporting legislative activities to improve PAD research, education, and treatment. The ultimate goal of the caucus is to advance policies to prevent non-traumatic amputation due to PAD and other related diseases.

With the launch of the PAD caucus this September, CVC also urges healthcare leaders, patient advocates and other stakeholders to take part in increasing PAD awareness by asking lawmakers to join the caucus to expand Congressional knowledge about this disease.

PAD is a life-threatening circulatory condition, which affects nearly 20 million Americans and an estimated 200,000 of them are disproportionately from minority communities. It 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. Estimates suggest that anywhere from 12 to 20 percent of individuals over the age of 60 are living with PAD.

If not properly diagnosed and managed, PAD can lead to non-traumatic lower limb amputations, which data show lead to lower quality of life and increased risk for death. Estimates suggest 54 percent of limb loss in the U.S. is the result of vascular disease, including PAD.

“As we recognize PAD Awareness Month, I am encouraged to see lawmakers dedicating attention to PAD and coalescing around solutions to address research, education, and treatment through the  PAD Caucus.  It is a needed first step in acknowledging PAD as a mounting health concern nationwide, and particularly among minority communities. We look forward to working with Congressmen Payne and Bilirakis and their colleagues to advance policy solutions to increase understanding of PAD to ultimately reduce preventable amputations,” said Jeffrey G. Carr, MD, FACC.

Underserved communities are at greatest risk for developing PAD.  African Americans, for example, are twice as likely to be diagnosed with PAD and up to 3 times more likely to have an amputation than white Americans. Hispanic Americans are 50 to 75 percent more likely to undergo an amputation and Native Americans are twice as likely to undergo an amputation than Caucasians.

“By launching the PAD Caucus, Congressmen Payne and Bilirakis are showing true leadership in the vascular community, emphasizing the need for increased awareness so that more at risk populations are prepared to recognize the symptoms to enable early diagnosis, which is the key to preventing limb loss,” Dr. Carr continued.

The CVC urges patients to be aware of symptoms, which 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.  By being properly aware of this disease and the treatments available, patients can avoid limb loss.

To access more information about PAD Awareness Month, CLICK HERE.

To ask your lawmakers to join the PAD Caucus, CLICK HERE.

Join the conversation on Twitter at #PADAwareness.

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Thank you for drawing much-needed attention to disparities in unnecessary limb amputations for communities of color (“Diabetic Amputations A ‘Shameful Metric’ Of Inadequate Care,” May 1). While I applaud your article’s focus on diabetes, understanding related diseases like peripheral artery disease (PAD) is just as important.

As a limb salvage specialist in the Mississippi Delta, I know firsthand that African American patients with diabetes are over three times more likely to have their limbs surgically removed — with even higher rates in Mississippi. Sadly, a majority of the estimated 200,000 annual non-traumatic amputations —many stemming from PAD, a complication of diabetes –– can be avoided with the proper care.

Tragically, even though PAD is as serious as cancer, more than 90% of the amputees I have met have never had a diagnostic test for PAD or an appropriate vascular evaluation to salvage their limbs. Most have never even heard of PAD until it is too late.

To stop these troubling trends in my community, I created a team to aggressively screen, diagnose and treat each one of our 10,000 patients early and often. With no institutional or outside financial support, our practice was able to decrease PAD-related amputation rates in the region by 87.5%.

More must be done on the federal level to address America’s “amputation lottery.” The United States Preventive Services Task Force (USPSTF), for example, should change its recommendation for screening at-risk patients including racial and ethnic minorities and low socioeconomic populations who have a disproportionately higher prevalence of PAD and amputation rates. The current recommendation makes the USPSTF complicit in perpetuating current PAD-related amputation disparities in treatment and outcomes.

There also needs to be broad adoption of non-amputation treatment measures such as revascularization in all algorithms for wounds to heal properly before amputation is ever needed. Finally, policymakers should advance a comprehensive strategy that combines increased public awareness, robust screening and better access to multidisciplinary care for at-risk populations. Together, these steps could go far in reducing limb loss, especially among minority communities.

— Dr. Foluso Fakorede, co-chair of the PAD Initiative for the Association of Black Cardiologists and CEO of Cardiovascular Solutions of Central Mississippi, Cleveland, Miss.

Click here to see the article on the Kaiser Health News website. 

With the holiday season fast approaching, most Americans are looking forward to feasting with family and friends and taking a much-needed break from work.

However, for over 30 million Americans living with diabetes and 84.1 million living with prediabetes, the consumption of unhealthy food and long periods of inactivity during the holiday season can make symptoms worse.  Diabetes is a public health crisis, costing $327 billion dollars per year, according to the most recent analysis from the American Diabetes Association. As many as 1 in 3 U.S. adults could have diabetes by 2050 if current trends continue, according to a new analysis from the CDC.  Racial and ethnic minorities have a higher prevalence and greater burden compared with whites. Disparities in health and health care lead to higher rates of complications in minority populations.

November is National Diabetes Month and is the perfect time to promote awareness of diabetes and diabetes-related complications so that, through awareness, we can prevent the suffering diabetes causes to ourselves, our families and our friends.   It is important for everyone to be aware of this disease and its complications.

Click here to see the full article on the AJMC website.

CVC supports bipartisan group of lawmakers for signing letter to CMS opposing the proposed 30% cut in the CY 2019 Physician Fee Schedule Proposed Rule 

WASHINGTON– The Cardiovascular Coalition (CVC), a consortium of physicians, care providers, advocates, and manufacturers working to improve awareness and prevention of peripheral artery disease (PAD), today praised a bipartisan group of lawmakers for cautioning against proposed cuts to revascularization services used to prevent amputation in PAD patients.

In a letter submitted yesterday to Centers for Medicare & Medicaid (CMS) Administrator Seema Verma, 23 bipartisan lawmakers expressed concern that the CY 2019 Physician Fee Schedule (PFS) Proposed Rule would inappropriately cut reimbursement rates for performing revascularization procedures, which are vital for clearing patients’ arteries of dangerous clogs and significantly preventing thousands of unnecessary amputations. The Proposed Rule would slash payments for revascularization services performed in an office-setting by as much as 30 percent.

Yesterday’s letter, led by Congressman Erik Paulsen (R-MN) and Donald Payne (D-NJ), follows previous letters to CMS that emphasized the critical need to prevent unnecessary non-traumatic amputations from occurring. Revascularization services are critical for achieving this goal. Data show as many as 200,000 non-traumatic amputations take place each year in the U.S.

“In order to protect a critical tool in the arsenal against amputation, we urge you to work with stakeholders to properly value revascularization services in the 2019 PFS Final Rule as we expect that stakeholders will be submitting data on these missing inputs and other misvalued services,” the lawmakers wrote to Verma.

In addition to Congressmen Paulsen and Payne, Representatives Joyce Beatty (D-OH), Bonnie Watson Coleman (D-NJ), Carlos Curbelo (R-FL), Vicente Gonzalez (D-TX), Lynn Jenkins (R-KS), Mike Kelly (R-PA), Leonard Lance (R-NJ), Sheila Jackson Lee (D-TX), Kenny Marchant (R-TX), Luke Messer (R-IN), Gregory Meeks (D-NY), Tom Reed (R-NY), Tom Rice (R-SC), David Phil Roe, MD (R-TN), Peter Roskam (R-IL), Dennis Ross (R-FL), Bobby Rush (D-IL), Pete Sessions (R-TX), Glenn “G.T.” Thompson (R-PA), Fred Upton (R-MI) and Frederica Wilson (D-FL) also signed the letter.

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PAD community emphasizes importance of protecting access to revascularization services to reduce amputations in Medicare patients

Washington, DC– Citing the pressing need to prevent unnecessary limb amputation in Medicare patients, the CardioVascular Coalition (CVC), a leading group of providers, physicians, and manufacturers, urged Congress to act to protect access to vital revascularization services during Peripheral Artery Disease (PAD) Awareness Month this September.

Noting that the 2019 Physician Fee Schedule (PFS) Proposed Rule cuts reimbursement for revascularization services by up to 30 percent or more, the CVC emphasized the key role Members of Congress play in calling on the Centers for Medicare & Medicaid Services (CMS) to not include these cuts in the final rule.

“As we recognize PAD Awareness Month, it is especially timely for our elected lawmakers to protect the estimated 18 million individuals who suffer from PAD across the country by doing all they can to protect revascularization services by blocking these proposed cuts,” stated Jeffrey Carr, MD, FACC. “These cuts stem from CMS’ proposal to update equipment and supply pricing data in the Medicare Physician Fee Schedule database. We have concerns with the accuracy of this data for revascularization codes as some of these inputs have no pricing data at all in the CMS database. It is time for Congress and CMS to come together to ensure that unnecessary limb amputation becomes a thing of the past.”

Nearly 20 percent of Americans over the age of 70 suffer from PAD – the hardening of arteries that causes narrowing or blockage of vessels that carry blood from the heart to the legs – which can lead to significant buildup of plaque in the arteries known as atherosclerosis. Minimally invasive revascularization can effectively prevent the need for limb amputation and, thereby, improve patients outcomes and reduce Medicare spending. It is incumbent on Congress to protect funding for this vital PAD treatment.

Access to revascularization therapies is especially vital to the African American, Hispanic and Native American populations who are two to four times more likely to undergo a limp amputation due to PAD due to an increased prevalence of diabetes, obesity and other risk factors.

CVC noted that the lack of any listed price for supply inputs used in revascularization services means providers are not being reimbursed for the resource cost of those inputs. The time has come for all Members of Congress to urge CMS to properly value critical revascularization services.

To learn more about PAD and PAD Awareness Month, CLICK HERE. 

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PAD Task Force urges lawmakers to support establishment of intragovernmental workgroup on amputation reduction and oppose proposed Medicare cuts to PAD treatments

WASHINGTON– Members of the newly formed PAD Task Force – including the Association of Black Cardiologists, CardioVascular Coalition, Preventative Cardiovascular Nurse Association and Society for Cardiovascular Angiography and Interventions– today commended Congressman Erik Paulsen (MN-3) and Congressman Donald Payne (NJ-10) for sponsoring a Capitol Hill briefing yesterday to raise awareness about the risks of peripheral artery disease (PAD) and the need for policies to reduce preventable amputations.

PAD is a limb-threatening circulatory condition, that when left undiagnosed and untreated can result in lower-limb amputation. It is exacerbated by conditions like diabetes, chronic hypertension and renal disease, which are most prevalent in minority populations. According to estimates, PAD results in 180,000 amputations annually in the United States. These non-traumatic amputations often occur without any diagnostic testing, meaning PAD patients are losing limbs before they receive the testing to determine if limb-saving treatments are an option.

“I applaud Congressmen Payne and Paulsen for sponsoring today’s briefing and offering us a platform to call attention to the devastating impact of PAD on communities across the country, particularly minority populations that disproportionately experience preventable amputations,” said Bryan Fisher, moderator of today’s briefing and a member of the CardioVascular Coalition. “As we recognize PAD Awareness Month this September, we are urging policymakers to work with us to advance a comprehensive strategy to combat PAD in the United States that includes increased screening for at-risk patients as well as access to multidisciplinary care and vascular evaluations.”

Earlier this year, 32 members of the U.S. House of Representatives sent a letter – lead by Congressmen Paulsen and Payne – urging the Department of Health and Human Services and the Veterans Health Administration to adopt a national strategy to reduce non-traumatic amputations through increased awareness of peripheral artery disease (PAD), increased screenings for at risk populations, and improved access to multidisciplinary care.

Speakers at yesterday’s briefing included representatives from the PAD Task Force, which was formed to collectively advance a comprehensive strategy that combines increased public awareness and robust screening with non-amputation treatment measures and multidisciplinary care. Specifically, the PAD Task Force is asking the Administration to convene an intragovernmental workgroup to develop a standardized model for amputation reduction and raise awareness on the issue.

“As a member of the PAD Task Force, The Society for Cardiovascular Angiography and Interventions looks forward to with working with others in the vascular care community to advocate for the creation of an intragovernmental workgroup on amputation reduction. It is past time for a meaningful solution to this complex problem, which can only be achieved through enhanced screening, vascular evaluations before amputation and an emphasis on multidisciplinary care,”  said Ehrin J. Armstrong, MD, MSc, MAS, FSCAI. 

The Administration has the capacity to take significant steps towards the total elimination of PAD-related non-traumatic amputations by convening an intragovernmental workgroup to develop a standardized model for amputation reduction, which can be modeled after existing programs including the Department of Veterans Affairs’ Preventing Amputations in Veterans Everywhere (PAVE) program.

Further, members of the PAD Task Force are asking lawmakers to urge the Centers for Medicare & Medicaid Services (CMS) to prevent cuts of 30 percent or more to revascularization procedures used to treat PAD included in the 2019 Physician Fee Schedule (PFS) Proposed Rule. Stakeholders are concerned the cuts stem from CMS’ proposal to update equipment and supply pricing data in the Medicare Physician Fee Schedule database based on inaccurate and incomplete data.

“We hope lawmakers in Congress will support the delivery of quality PAD care, oppose deep Medicare cuts to PAD treatments and advance the establishment of a standardized model for amputation reduction,” added Foluso Fakorede, MD, Association of Black Cardiologists’ PAD Initiative Co-chair and CEO, Cardiovascular Solutions of Central Mississippi. “Yesterday’s briefing is a positive step toward the development of a standard model for PAD care and amputation reduction that I hope will save limbs and save lives for individuals diagnosed with PAD.”

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Bipartisan group of lawmakers call for a national strategy to reduce non-traumatic amputations to zero

Washington – The CardioVascular Coalition (CVC) today applauded 32 members of the U.S. House of Representatives for urging the Department of Health and Human Services and the Veterans Health Administration to adopt a national strategy to reduce non-traumatic amputations through increased awareness of peripheral artery disease (PAD), increased screenings for at risk populations, and improved access to multidisciplinary care.

In the letter, which was sponsored by Representatives Erik Paulsen (R-MN) and Donald Payne, Jr. (D-NJ), the lawmakers ask the administration to provide Congress with information about any current or planned efforts by the federal government to reduce unnecessary non-traumatic amputations. The letter also calls on all relevant agencies to provide information about their regulatory authority to implement any such policy and asks whether any new statutory authority is needed.

“On behalf of the vascular care community, I would like to sincerely thank Representatives Paulsen, Payne, and their colleagues for working to make non-traumatic amputations a thing of the past,” said Jeffrey Carr, MD, a member of the CVC Board of Directors and Founding President of the Outpatient Endovascular and Interventional Society. “Thanks to their leadership, we are closer to advancing initiatives to address the alarming rate of limb loss in America, particularly in minority communities.”

Each year, nearly 185,000 Americans undergo an amputation, about half of which can be attributed to preventable vascular diseases such as PAD. Studies show that minority populations are significantly more impacted by the effects of PAD with amputation rates between two to four times higher than Caucasian Americans. Even more alarming is the fact that up to one-third of patients with late-state PAD never receive arterial testing to determine if they might be a candidate for limb-saving, revascularization surgery.

“This is a significant public health concern that deserves a response from the federal government,” Carr continued. “We already have the capabilities to identify and treat PAD before it progresses to the point of amputation. We just need a national strategy to get the right treatment to the right people at the right time. With lawmakers, we’re calling on the Administration to make PAD awareness and prevention a national priority.”

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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.

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.

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.

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.

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.”

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. 

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.

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.

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.

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.

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.

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