Critical limb ischemia

NewsBot · Oct 12, 2012

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Press Release:
Loss of protective heart failure protein linked to critical limb ischemia
S100A1 could be a potential therapeutic target in critical limb ischemiato promote revascularization, say Thomas Jefferson University researchers from the Center for Translational Medicine

Restoring diminished levels of a protein shown to prevent and reverse heart failure damage could also have therapeutic applications for patients with critical limb ischemia (CLI), suggests a new preclinical study published online October 9 in Circulation Research from researchers at the Center for Translational Medicine at Thomas Jefferson University .

Low levels of the protein S100A1 have been linked to congestive heart failure and high blood pressure, and now appear to be associated with critical lower limb ischemia, a condition found in type 2 diabetic patients where blood flow to legs is cut off, often resulting in amputation.

Past studies have shown that returning the protein to normal levels or above prevented and/or reversed congestive heart failure in large animal models with gene therapy. Given these new findings, the researchers posit that S100A1 could also be a potential therapeutic target in CLI to promote revascularization.

The team was led by Patrick Most, M.D. , adjunct Assistant Professor of Medicine at Thomas Jefferson University, and lead author of the study who now heads the Center for Molecular and Translational Cardiology at the University of Heidelberg, Germany, and Karsten Peppel, Ph.D., an Associate Professor in the Center for Translational Medicine at Jefferson and senior author of the study.

"In patients with CLI, this protein appears to be reduced to extremely low levels, almost non-existent," said Dr. Peppel. "This dovetails with a finding we had when we were looking at patients with heart failure. We already know this protein has an important role in heart muscle cells. In patients who experience heart failure, there was reduced amount of the protein, down to about 40 percent of normal. Here, we showed in mice with CLI a similar defect in vascular cells and the inability to re-vascularize following arterial occlusion."

Without successful revascularization, up to 40 percent of patients with CLI require major limb amputations within a year of diagnosis. CLI has many of the same predisposing risk factors as arteriosclerosis, such as smoking, high blood pressure and Type 2 diabetes. According to the American Diabetes Association, there are over 65,000 lower limb amputations performed in the United States a year as a direct result of diabetes.

"Understanding the fundamentals of disease mechanisms is key to finding better therapies. This actually exceeds the capacity of one laboratory," said Dr. Most. "Our integrative model of sharing expertise and resources between our laboratories in the U.S. and Germany has proven to be quite successful over the last years."

Dr. Most's laboratory has been working on S100A1's role in heart disease for more than a decade, and together with a group from the Center for Translational Medicine at Jefferson, they have proven that loss of the protein causes diseased hearts to fail and that the protein is a potential target for gene therapy for heart failure.

S100A1, part of a larger family of proteins called S100, is primarily found at high levels in muscle, particularly the heart. Falling levels of S100A1 are critical in the loss of heart-pumping strength after a heart attack and play an important role in the progression to heart failure.

Dr. Most and his team have also found that loss of the protective heart failure protein causes high blood pressure.

"The mechanism is based more or less on the availability of nitric oxide," said Dr. Most. "S100A1 also regulates calcium cycling in the endothelial cell, and calcium is needed in the endothelial cell to stimulate nitric oxide production. The loss of S100A1 impairs the calcium mobilization of the endothelial cell – that's the link between less calcium, less nitric oxide, hypertension and endothelial dysfunction."

"Now, we have shown a down regulation of S100A1 in patients with CLI and identified the protein as critical for endothelial cell function in ischemic angiogenesis," he said. "This is a new therapeutic angle. Perhaps the most intriguing finding is that S100A1 stimulates directly the source enzyme of nitric oxide in endothelial cell. Without S100A1, this mechanism is simply blocked and the body's ability to generate new small vessels severely compromised."

The next step is to determine what causes that down regulation and look for therapeutic development, according to the researchers, adding that they will take advantage of the unique expertise and experience in developing molecular-targeted therapies at the Center.

"Our goal is to determine why these levels drop in patients with peripheral arterial occlusive disease, and how we can get them back up, and if restoration of this protein makes it better," said Dr. Peppel. "There is potential with therapeutics, mainly gene therapy, to restore levels and possibly improve revascularization, not only in patients with CLI but also in heart disease due to insufficient blood supply."
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NewsBot · Oct 12, 2012

Press Release:
Covidien Announces Final Results from Landmark DEFINITIVE LE Study in Patients with Peripheral Arterial Disease

LAS VEGAS--(BUSINESS WIRE)--Oct. 10, 2012-- Covidien (NYSE:COV), a leading global provider of healthcare products, today announced final 12-month results from its DEFINITIVE LE (Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) study.
DEFINITIVE LE study confirms that directional atherectomy with Covidien's TurboHawk(TM) device is an ...

DEFINITIVE LE study confirms that directional atherectomy with Covidien's TurboHawk(TM) device is an effective frontline therapy when treating PAD in diabetic and non-diabetic patients (Photo: Business Wire)

DEFINITIVE LE is the largest peripheral atherectomy study conducted to date with independent physician review of the outcomes. The study, which enrolled 800 patients at 47 centers in the U.S. and Europe, demonstrated the long-term effectiveness of directional atherectomy as a frontline therapy for the treatment of peripheral arterial disease (PAD). Directional atherectomy is a minimally invasive treatment that removes plaque from the body and restores blood flow in the native artery.

“For the first time, the DEFINITIVE LE study has provided robust evidence within a large and diverse PAD patient population,” said Lawrence A. Garcia, M.D., Chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth's Medical Center in Boston. “Directional atherectomy, with the SilverHawk and TurboHawk devices, delivers patency results at 12 months post-treatment that are comparable to those reported in stent studies—and with the important advantage of not leaving anything behind in the vessel.”

DEFINITIVE LE 12-Month Efficacy and Safety Results

Clinical outcomes were improved by 30 days and sustained through 12 months of follow-up. Directional atherectomy with the SilverHawk and TurboHawk devices delivered 12-month patency results that were comparable to those reported in stent studies.

Among patients with claudication, primary patency (i.e., the treated artery remained open) was 78% using a peak systolic velocity ratio (PSVR) < 2.4 at 12 months. Notably, this rate did not differ between patients with diabetes (77%) and those without diabetes (78%)—the first such results to be shown in a prospective, powered analysis. Among patients with critical limb ischemia (CLI - a severe form of PAD), 95% were able to avoid a major unplanned amputation of the target limb. The SilverHawk and TurboHawk devices were shown to have a strong safety profile in the study, with low complication rates.

According to the American Heart Association, approximately 10 million people in the U.S. are affected by PAD, which is one of the most common vascular diseases and can lead to heart attack, stroke, amputation and death. It occurs when arteries in the legs become narrowed or blocked by plaque; these blockages can result in severe pain for patients, limited physical mobility and non-healing leg ulcers.

"DEFINITIVE LE confirmed equivalent outcomes between diabetics and non-diabetics in terms of patency and persistent clinical improvement up to 12 months after treatment,” said Prof. Thomas Zeller, M.D., Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Kronzingen, Bad Krozingen, Germany. “Because diabetics have more advanced PAD, re-stenose faster and are more difficult to treat than non-diabetics, it is critical to preserve future treatment options in this patient population. The confirmation from DEFINITIVE LE of directional atherectomy as a treatment modality that provides strong clinical outcomes in diabetics is a welcome and practice-changing finding.”

Dr. Garcia and Prof. Zeller, together with Dr. James McKinsey, Chief of the Division of Vascular Surgery and Endovascular Interventions at New York-Presbyterian Hospital/Columbia University Medical Center, served as Co-Principal Investigators for the DEFINITIVE LE study.

DEFINITIVE LE Study Design

The prospective, multi-center study comprised two cohorts—those with claudication and those with CLI. A total of 1,022 lesions (up to 20 cm in length) were treated with the Covidien SilverHawk or TurboHawk Plaque Excision device. The study included a broad patient population, with 52% diabetic, 45% female and 75% claudicants, and a pre-specified sub-analysis comparing patency outcomes in diabetic and non-diabetic patients.

Several controls were included to ensure rigor in the study. These included Steering Committee oversight, adverse event adjudication by an independent physician Clinical Events Committee and endpoint analyses conducted by two different independent core laboratories—one that analyzed acute angiographic results and another that analyzed duplex ultrasound follow-up.

"We are pleased with the long-term results from our groundbreaking DEFINITIVE LE study, which is unique among atherectomy studies conducted to date because of the size of the study and the clinical rigor of execution,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We are continuing to invest in the DEFINITIVE clinical program around new innovative treatments as a reflection of our commitment to partnering with medical professionals to deliver the best treatment for patients suffering with PAD.”

Final results from the landmark study were presented today during the Late-Breaking Clinical Trials session at the Vascular InterVentional Advances (VIVA) Conference here.
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Admin2 · Oct 12, 2012

Related threads:
Other threads tagged with peripheral vascular disease

NewsBot · Oct 13, 2012

Outcomes of angiosome and non-angiosome targeted revascularization in critical lower limb ischemia.
Kabra A, Suresh KR, Vivekanand V, Vishnu M, Sumanth R, Nekkanti M.
J Vasc Surg. 2012 Oct 8.

OBJECTIVE:
Blood supply to the foot is from the posterior tibial, anterior tibial, and the peroneal arteries. Ischemic ulceration of the foot is the most common cause for major amputations in vascular surgical patients. It can be presumed that revascularization of the artery directly supplying the ischemic angiosome may be superior to indirect revascularization of the concerned ischemic angiosome.

METHODS:
This was a prospective study of 64 patients with continuous single crural vessel runoff to the foot presenting with critical limb ischemia from January 2007 to September 2008. Direct revascularization (DR) of the ischemic angiosome was performed in 61% (n = 39), indirect revascularization (IR) in 39% (n = 25). Open surgery was performed in 60.9% and endovascular interventions in 39.1%. All patients were evaluated for the status of the wound and limb salvage at 1, 3, and 6 months. The study endpoints were major amputation or death, limb salvage, and wound epithelialization at 6 months.

RESULTS:
In the study, 81.2% of patients had forefoot ischemia, 17.2% had ischemic heel, whereas 1.6% had midfoot nonhealing ischemic ulceration. The runoff involved the anterior tibial artery in 42.2% (27/64), posterior tibial artery in 34.4% (22/64), and the peroneal artery in 23.4% (15/64). All patients were followed at 1, 3, and 6 months postoperatively for ulcer healing, major amputation, or death. At the end of 6 months, nine patients expired, and six were lost to follow-up. Of 49 patients who completed 6 months, nine underwent major amputation, and 40 had limb salvage. Ulcer healing at 1, 3, and 6 months for DR vs IR were 7.9% vs 5%, 57.6% vs 12.5%, and 96.4% vs 83.3%, respectively. This difference in the rates of ulcer healing between the DR and IR groups was statistically significant (P = .021). The limb salvage in the DR group (84%) and IR group (75%) was not statistically significant (P = .06). The mortality was 10.2% for DR and 20% for IR at 6 months.

CONCLUSIONS:
To attain better ulcer healing rates combined with higher limb salvage, direct revascularization of the ischemic angiosome should be considered whenever possible. Revascularization should not be denied to patients with indirect perfusion of the ischemic angiosome as acceptable rates of limb salvage are obtained.
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Selwyn Firth · Oct 17, 2012

I have found 4 abstracts of articles proving that increasing circulation using a pneumatic compression device increase wound healing amongst diabetic patients.
The links are
http://1.usa.gov/19bas8
http://1.usa.gov/ndrMLV
http://1.usa.gov/QX4At9
http://1.usa.gov/WAerJi.

It seems that since circulation is a major factor in wound healing then any device which increases it should have a similar effect. There is but one battery powered portable device on the market and it has shown some remarkable success so far.

If anyone wishes to find out more they can find me on twitter.

Selwyn Firth

NewsBot · May 22, 2013

Endovascular Revascularization for Patients with Critical Limb Ischemia: Impact on Wound Healing and Long Term Clinical Results in 189 Limbs.
Bae JI, Won JH, Han SH, Lim SH, Hong YS, Kim JY, Kim JD, Kim JS.
Korean J Radiol. 2013 May;14(3):430-438.

OBJECTIVE:
To evaluate the impact on wound healing and long-term clinical outcomes of endovascular revascularization in patients with critical limb ischemia (CLI).

MATERIALS AND METHODS:
This is a retrospective study on 189 limbs with CLI treated with endovascular revascularization between 2008 and 2010 and followed for a mean 21 months. Angiographic outcome was graded to technical success (TS), partial failure (PF) and complete technical failure. The impact on wound healing of revascularization was assessed with univariate analysis and multivariate logistic regression models. Analysis of long-term event-free limb survival, and limb salvage rate (LSR) was performed by Kaplan-Meier method.

RESULTS:
TS was achieved in 89% of treated limbs, whereas PF and CF were achieved in 9% and 2% of the limbs, respectively. Major complications occurred in 6% of treated limbs. The 30-day mortality was 2%. Wound healing was successful in 85% and failed in 15%. Impact of angiographic outcome on wound healing was statistically significant. The event-free limb survival was 79.3% and 69.5% at 1- and 3-years, respectively. The LSR was 94.8% and 92.0% at 1- and 3-years, respectively.

CONCLUSION:
Endovascular revascularization improve wound healing rate and provide good long-term LSRs in CLI.
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Selwyn Firth · May 23, 2013

If the protein is so effective, it might be quicker and more effective to just make copies and give injections similar to insulin for the treatment of Type 1 diabetes. Cost of gene therapy may be too expensive and not cost effective based on expected extension of lifetimes.The researchers should try making and using the protein before moving into gene therapy.

NewsBot · Jun 1, 2013

Press Release:
Procedures saving limbs of more peripheral arterial disease patients, Mayo Clinic finds
Amputation study among several being presented at Society for Vascular Surgery conference

SAN FRANCISCO -- Peripheral arterial disease is a common circulation problem in which reduced blood flow can lead to complications that jeopardize the limbs, possibly even requiring amputation. Procedures known as revascularization have reduced the need for amputations 40 percent over two decades, Mayo Clinic research shows. The findings were among several studies presented at the Society for Vascular Surgery annual meeting in San Francisco.

In the amputation study, Mayo researchers analyzed patients in the Rochester Epidemiology Project, a National Institutes of Health-funded medical records pool that makes Olmsted County, Minn., the home of Mayo Clinic, one of the few places worldwide where scientists can study virtually an entire geographic population to identify health trends. They found that as use of revascularization to improve circulation rose, the amputation rate dropped. The study covered 1990-2009.

"This is an important study because frequently patients who have peripheral arterial disease -- and there are about 12 million Americans who have some leg pain that can be connected to it -- may progress to amputation. They may develop rest pain, gangrene, and if an intervention is not performed, they may lose the limb," says senior author Peter Gloviczki, M.D., a Mayo Clinic vascular surgeon and president of the Society for Vascular Surgery. "This study shows that the use of endovascular interventions -- stents, balloons or other catheter-based interventions — or open surgical bypass effectively reduced the amputation rate."

Patients with leg pain should report it to their physicians, and people with risk factors for peripheral arterial disease, such as smoking, high cholesterol, male gender, hypertension or diabetes, should take care of the medical conditions that may lead to or complicate peripheral arterial disease, he says.

"In addition, patients who have leg pain and peripheral arterial disease frequently have silent heart disease, so the patient and primary care doctor should evaluate, and if the condition is significant, if the pain is something that interferes with the quality of life, then they should consult with a vascular surgeon," says Dr. Gloviczki, the Joe M. and Ruth Roberts Professor of Surgery at Mayo Clinic.

Other Mayo studies presented at the conference found that:

There are very few deaths in the initial weeks after open-abdomen surgery or the minimally invasive endovascular stent repair of life-threatening abdominal aortic aneurysms. Patients who get stent grafts have shorter hospitalizations and fewer early complications, but the procedure was associated with a slightly higher rate of late death from all causes, the need for a repeat procedure at some point and a small but definite risk of eventual rupture, the researchers found.

"The trend is that we do more and more stent procedures because it is easier for the patient, it can be performed in very high-risk patients and there is less early complication. The drawback is that we have to follow these patients lifelong, every six months to a year, because secondary complications or secondary interventions may be needed. And rarely, even the stented aneurysm can rupture," says Dr. Gloviczki, a co-author, so it is not a complete solution for aneurysm repair yet. There are many patients who actually will do better with open repair, but stent repair is still an excellent new procedure that patients should ask about."

Stents are an effective way to treat bulging of the arteries behind the knee, a condition known as popliteal artery aneurysm, the second most common aneurysm after abdominal aortic aneurysm.

Popliteal artery aneurysms are dangerous because about 20 percent involve severe leg circulation problems, and this type of aneurysm can throw blood clots and might lead to amputations, says Dr. Gloviczki. The goal of aneurysm repair is to prevent amputation, improve circulation and help with problems walking, he says.

"The study found that use of a stent is a good and effective way to treat popliteal artery aneurysm," Dr. Gloviczki says. "It is not clearly better for all patients than open surgical bypass, but it is especially useful in patients who are high surgical risk for open surgery or anesthesia, such as patients who have had heart attacks or who have heart failure or any general overall condition that makes open surgery more complicated."
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NewsBot · Nov 29, 2013

Growing Impact of Restenosis on the Surgical Treatment of Peripheral Arterial Disease
Douglas W. Jones, MD; Andres Schanzer, MD; Yuanyuan Zhao, MA; Todd A. MacKenzie, PhD; Brian W. Nolan, MD; Michael S. Conte, MD; Philip P. Goodney, MD, MS, The Vascular Study Group of New England
J Am Heart Assoc. 2013; 2: e000345

Background Patients with peripheral arterial disease often experience treatment failure from restenosis at the site of a prior peripheral endovascular intervention (PVI) or lower extremity bypass (LEB). The impact of these treatment failures on the utilization and outcomes of secondary interventions is poorly understood.

Methods and Results In our regional vascular quality improvement collaborative, we compared 2350 patients undergoing primary infrainguinal LEB with 1154 patients undergoing secondary infrainguinal LEB (LEB performed after previous revascularization in the index limb) between 2003 and 2011. The proportion of patients undergoing secondary LEB increased by 72% during the study period (22% of all LEBs in 2003 to 38% in 2011, P<0.001). In‐hospital outcomes, such as myocardial infarction, death, and amputation, were similar between primary and secondary LEB groups. However, in both crude and propensity‐weighted analyses, secondary LEB was associated with significantly inferior 1‐year outcomes, including major adverse limb event‐free survival (composite of death, new bypass graft, surgical bypass graft revision, thrombectomy/thrombolysis, or above‐ankle amputation; Secondary LEB MALE‐free survival = 61.6% vs primary LEB MALE‐free survival = 67.5%, P=0.002) and reintervention or amputation‐free survival (composite of death, reintervention, or above‐ankle amputation; Secondary LEB RAO‐free survival = 58.9% vs Primary LEB RAO‐free survival 64.1%, P=0.003). Inferior outcomes for secondary LEB were observed regardless of the prior failed treatment type (PVI or LEB).

Conclusions In an era of increasing utilization of PVI, a growing proportion of patients undergo LEB in the setting of a prior failed PVI or surgical bypass. When caring for patients with peripheral arterial disease, physicians should recognize that first treatment failure (PVI or LEB) affects the success of subsequent revascularizations.
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NewsBot · Jan 5, 2014

Our treatment strategy for critical limb ischemia.
Yamada T, Onishi K, Utsunomiya M, Nakamura M.
Int J Vasc Med. 2013;2013:437471. doi: 10.1155/2013/437471.

For the treatment of critical limb ischemia, collaboration with wound specialists and cardiologists performing revascularization is important. The foot care unit affiliated with related departments opened at our hospital in July 2010 for limb salvage, mainly under the leadership of the departments of cardiovascular internal medicineand plastic surgery. We have treated 194 patients up until October 2012. The primary diseases included 81 cases (87 limbs) of foot ulcer and gangrene, with complications of peripheral arterial diseases (PADs) in all cases. Intravascular treatment was conducted for 69 limbs with PAD complications, and the initial success rate was 85.5%, of which surgical debridement or minor amputation was performed on 32 limbs. Regarding open wounds following operation and chronic ulcer, platelet-rich plasma therapy was conducted in 29 limbs and negative pressure wound therapy in 15 limbs. Among all of the patients treated, 58 limbs healed, 10 cases died, and the others are currently receiving ongoing treatment. Cardiovascular internal medicine specialists and plastic surgeons examine patients together at the outpatient clinic and prepare and implement a multidisciplinary treatment plan including vascular reconstructions and operation. We cooperate with physicians in each related department and efforts in team medicine have been made for the purpose of limb salvage.
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NewsBot · Jan 16, 2014

Peripheral Arterial Testing Before Lower Extremity Amputation Among Medicare Beneficiaries, 2000 to 2010.
Vemulapalli S, Greiner MA, Jones WS, Patel MR, Hernandez AF, Curtis LH.
Circ Cardiovasc Qual Outcomes. 2014 Jan 14

<0.001). The use of preamputation arterial testing varied significantly by location of amputation and was lowest for foot amputation (62.5%), followed by above-knee amputation (69.0%) and below-knee amputation (76.7%; P<0.001). After multivariable adjustment, older age, male sex, black race, renal disease, diabetes mellitus, known peripheral arterial disease, evaluation by a vascular specialist, and living in the East North Central region were associated with greater rates of preamputation arterial testing.Conclusions-Rates of evaluation for peripheral arterial disease before amputation were low, and testing varied by patient, provider, and regional characteristics.
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Admin2 · Jan 23, 2014

Multidisciplinary approach to treatment of patients with lower limb critical ischaemia.
Maksimov AV, Koreĭba KA, Nuretdinov RM, Usmanov MA, Glinkin VV.
Angiol Sosud Khir. 2013;19(4):122-126.

Analysed herein are the results of the joint work of the Pyoseptic Surgery Department of the Centre "Diabetic Foot" with the Vascular Surgery Department based in various clinics over 2 periods - 2010 and 2011. During the first period, a total of 126 patients with critical ischaemia were treated without using revascularizing methods, during the second period, a total of 205 patients with critical ischaemia were examined by vascular surgeons deciding upon the problem concerning possibility of revascularization. In 148 cases (72.2%) revascularization was regarded impossible due to pronounced trophic disorders and/or severity of the general somatic status. Fifty-seven patients were subjected to angiography. Of these, five patients were found to have contraindications to vascular reconstruction, with the remaining 52 patients being subjected thereto (65 operations, of which 22 roentgen-endovascular ones). One (1.9%) patient died. Clinical improvement was achieved in 47 (90.3%) cases, and with no dynamics in four (7.7%) subjects. Using a multidisciplinary approach resulted in a decrease in the incidence rate of high amputations in patients with lower limb chronic ischaemia at the department of Pyoseptic Surgery from 51.6% in 2010 to 35.4% in 2011 (p=0.0000). Of these, the number of the above-the-knee amputations decreased from 41.3% to 15.1%, respectively (p=0.0000). The proportion of crural amputations increased from 20.0% to 46.6% (p=0.04).
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NewsBot · Mar 15, 2014

From LER:
Exploring treatment options for intermittent claudication

NewsBot · Jun 3, 2014

Press Release:
THE SAGE GROUP LLC Announces Publication of an Article Titled “Cost-Benefit Analysis of Amputation in the Era of the Affordable Care Act. Is it Fiscally Responsible to Perform Primary Amputation as Treatment?” in the May Issue of Endovascular Today

ATLANTA--(BUSINESS WIRE)--The recently released May issue of Endovascular Today, which focuses on critical limb ischemia, includes an analysis of the economic costs and consequences of major amputations written by Mary L. Yost, President of THE SAGE GROUP.

“This is completely the opposite of current expert treatment recommendations—at most 10%-15% of CLI patients should have primary amputation and some limb salvage experts recommend none”

The article focuses on the continuing use of major amputation as a primary treatment for critical limb ischemia (CLI). Approximately 25%-33% of Medicare CLI patients undergo major amputation (above-the-knee and below-the-knee amputation).

Major amputation is frequently the only treatment that CLI patients undergo. Recent research has shown that 60%-71% of the major amputations are performed without any attempt at revascularization.

“This is completely the opposite of current expert treatment recommendations—at most 10%-15% of CLI patients should have primary amputation and some limb salvage experts recommend none,” stated Ms. Yost.

Although an angiogram has been shown to be highly protective against major amputation, reducing the odds by 90%, approximately 51%-73% of major amputations are performed without this basic diagnostic evaluation.

According to Ms. Yost, “The probability of major amputation depends on who you are and where you live, the ‘Amputation Lottery”. Amputation varies according to race, socioeconomic status, age, sex, type of hospital and geographic location.”

The discussion explores possible reasons for these practices as well as the high costs of amputation in terms of patient mortality and morbidity.

“Amputation is not only extremely undesirable from the patient’s viewpoint it is socially undesirable in terms of costs. CLI amputations cost almost $11 billion,” declared Yost. “Available evidence indicates that treating CLI patients with primary amputation is not cost-effective and represents a misallocation of scarce healthcare resources,” she concluded.

This article can be found on the Endovascular Today website at: http://evtoday.com/2014/05/cost-ben...chemia-in-the-era-of-the-affordable-care-act/
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NewsBot · Sep 13, 2014

Urgent endovascular revascularization in acute on chronic critical limb ischemia.
Troisi N, Ercolini L, Chisci E, Barbanti E, Peretti E, Setti M, Pitì A, Michelagnoli S.
J Cardiovasc Surg (Torino). 2014 Sep 12.

AIM:
To evaluate early and 1--year outcomes of urgent endovascular treatment in patients with acute on chronic critical limb ischemia (CLI).
METHODS:
Between January 2012 and December 2013 104 patients with acute on chronic CLI (Rutherford class 4--6) were referred to two tertiary hospitals. In all cases the urgent endovascular revascularization was considered the first therapeutic option. Twenty--seven patients (26%) were excluded from this approach (long occlusion >30cm of the femoro--popliteal tract and/or massive gangrene with abscess/osteomyelitis/necrotizing fasciitis).
RESULTS:
Seventy--seven out of the 104 patients received an urgent endovascular treatment. They were predominantly male (43, 55.8%) with a mean age of 76.5 years (range 47--94). In 67 cases (87%) the patients had leg/foot lesions (54, 70.1%, Rutherford class 5, and 13, 16.9%, Rutherford class 6). During the follow--up (mean duration 6.2 months, range 1--24) the healing of the lesions and the relief of rest pain were obtained in 46 cases (59.7%). Estimated 1--year primary patency, primary assisted patency, secondary patency, and limb salvage rates were 63.6%, 68.3, 69%, and 84.1%, respectively. At uni-- and multivariate analysis patients in Rutherford class 6 showed poor results in terms of primary patency, primary assisted patency, secondary patency, and limb salvage (p<.001).
CONCLUSIONS:
Urgent endovascular treatment in selected patients with acute on chronic CLI represents a safe and effective option with good results in terms of healing of the ischemic lesions, relief of rest pain, and limb salvage. Patients in Rutherford class 6 showed less benefits with this approach.
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NewsBot · Sep 28, 2014

Great Toe Necrosis Predicts an Unfavorable Limb Salvage Prognosis.
Sano, Hitomi MD, PhD; Ichioka, Shigeru MD, PhD
Plastic and Reconstructive Surgery; September 22, 2014

The initial location of necrosis may affect the limb salvage rate. This study of 130 patients with chronic toe ulcers or gangrene was performed to assess whether the location of initial necrosis in the toes affected limb salvage prognosis. The patients were divided into 2 groups according to whether the initial necrosis was in the great toe or in other toes. Limb salvage prognosis was determined retrospectively. In the great toe group, the rates of total toe loss and major amputation were 50.0% and 24.4%, respectively. When the initial necrosis was in other toes, these rates were 27.3% and 9.3%, respectively. Great toe necrosis is associated with significantly higher rates of total toe loss (odds ratio = 3.10; P = 0.003; 95% confidence interval, 1.43-6.68) and major amputation (odds ratio = 3.66; P = 0.007; 95% confidence interval, 1.37-9.79). The great toe is supplied by 3 source arteries, whereas the lesser toes are fed by 1 or 2 arteries. Therefore, necrosis initiating from the great toe may reflect the presence of severe vascular disorders. The great toe is also anatomically connected to much of the foot via the tendons. Infection is more likely to spread along these tendons, which may reduce limb prognosis. Thus, the initial location of necrosis may be predictive of limb prognosis.
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NewsBot · Oct 3, 2014

A systematic review of intermittent pneumatic compression for critical limb ischaemia.
Moran PS, Teljeur C, Harrington P, Ryan M.
Vasc Med. 2014 Sep 30.

Intermittent pneumatic compression (IPC) is designed to aid wound healing and limb salvage for patients with critical limb ischaemia who are not candidates for revascularisation. We conducted a systematic review of the literature to identify and critically appraise the evidence supporting its use in this population. A search was conducted in Embase, MEDLINE and clinical trial registries up to the end of March 2013. No date or language restrictions were applied. Quality assessment was performed by two people independently. Quality was assessed using the Cochrane risk of bias tool and the NICE case-series assessment tool. Two controlled before-and-after (CBA) studies and six case series were identified. One retrospective CBA study involving compression of the calf reported improved limb salvage and wound healing (OR 7.00, 95% CI 1.82 to 26.89, p<0.01). One prospective CBA study involving sequential compression of the foot and calf reported statistically significant improvements in claudication distances and SF-36 quality of life scores. No difference in all-cause mortality was found. Complications included pain associated with compression, as well as skin abrasion and contact rash as a result of the cuff rubbing against the skin. All studies had a high risk of bias. In conclusion, the limited available results suggest that IPC may be associated with improved limb salvage, wound healing and pain management. However, in the absence of additional well-designed analytical studies examining the effect of IPC in critical limb ischaemia, this treatment remains unproven.
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NewsBot · Oct 6, 2014

An early validation of the Society for Vascular Surgery Lower Extremity Threatened Limb Classification System.
Cull DL, Manos G, Hartley MC, Taylor SM, Langan EM, Eidt JF, Johnson BL.
J Vasc Surg. 2014 Oct 1

OBJECTIVE:
The Society for Vascular Surgery (SVS) recently established the Lower Extremity Threatened Limb Classification System, a staging system using Wound characteristic, Ischemia, and foot Infection (WIfI) to stratify the risk for limb amputation at 1 year. Although intuitive in nature, this new system has not been validated. The purpose of the following study was to determine whether the WIfI system is predictive of limb amputation and wound healing.
METHODS:
Between 2007 and 2010, we prospectively obtained data related to wound characteristics, extent of infection, and degree of postrevascularization ischemia in 139 patients with foot wounds who presented for lower extremity revascularization (158 revascularization procedures). After adapting those data to the WIfI classifications, we analyzed the influence of wound characteristics, extent of infection, and degree of ischemia on time to wound healing; empirical Kaplan-Meier survival curves were compared with theoretical outcomes predicted by WIfI expert consensus opinion.
RESULTS:
Of the 158 foot wounds, 125 (79%) healed. The median time to wound healing was 2.7 months (range, 1-18 months). Factors associated with wound healing included presence of diabetes mellitus (P = .013), wound location (P = .049), wound size (P = .007), wound depth (P = .004), and degree of ischemia (P < .001). The WIfI clinical stage was predictive of 1-year limb amputation (stage 1, 3%; stage 2, 10%; stage 3, 23%; stage 4, 40%) and wound nonhealing (stage 1, 8%; stage 2, 10%; stage 3, 23%; stage 4, 40%) and correlated with the theoretical outcome estimated by the SVS expert panel.
CONCLUSIONS:
The theoretical framework for risk stratification among patients with critical limb ischemia provided by the SVS expert panel appears valid. Further validation of the WIfI classification system with multicenter data is justified.
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NewsBot · Mar 7, 2015

Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease: Consensus Definitions From Peripheral Academic Research Consortium (PARC).
Patel MR et al
J Am Coll Cardiol. 2015 Mar 10;65(9):931-941. doi: 10.1016/j.jacc.2014.12.036.

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.
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NewsBot · Mar 11, 2015

Predictors of Delayed Wound Healing after Endovascular Therapy of Isolated Infrapopliteal Lesions Underlying Critical Limb Ischemia in Patients with High Prevalence of Diabetes Mellitus and Hemodialysis.
Shiraki T et al
Eur J Vasc Endovasc Surg. 2015 Mar 3

OBJECTIVES:
Acceptable limb salvage rates underlie the widespread use of endovascular therapy (EVT) for patients with critical limb ischemia (CLI) secondary to isolated infrapopliteal lesions; however, post-EVT delayed wound healing remains a challenge. Predictors of delayed wound healing and their use in risk stratification of EVT in patients with CLI due to isolated infrapopliteal lesions are explored.
METHODS:
This was a retrospective multicenter study. 871 consecutive critically ischemic limbs were studied. There was tissue loss in 734 patients (age: 71 ± 10 years old; 71% male) who had undergone EVT between April 2004 and December 2012. The wound healing rate after EVT was estimated by the Kaplan-Meier method. The association between baseline characteristics and delayed wound healing was assessed by the Cox proportional hazard model.
RESULTS:
Diabetes mellitus and regular dialysis were present in 75% (553/734) and 64% (476/734) of patients, respectively; 67% of limbs (585/871) had Rutherford class 5 CLI; 8% (67/871) of wounds were located in the heel only; 25% (219/871) of limbs had Rutherford 6 (involving not only the heel); and 42% (354/871) of wounds were complicated by infection. The rate of freedom from major amputation at 1 year reached 88%, whereas the wound healing rate was 67%. Median time to wound healing was 146 days. By multivariate analysis, non-ambulatory status (hazard ratio [HR], 1.58; 95% confidence interval [CI] 1.31-1.91) serum albumin <3 g/dL (HR 1.42; 95% CI 1.08-1.86), Rutherford 6 (not only heel) (HR 1.68; 95% CI 1.33-2.14), wound infection (HR 1.24; 95% CI 1.03-1.50), EVT not based on angiosome concept (HR 1.28; 95% CI 1.06-1.55), and below the ankle (BTA) 0 vessel runoff after EVT (HR 1.45; 95% CI 1.14-1.86) were independent predictors of delayed wound healing.
CONCLUSIONS:
Non-ambulatory status, low albumin level, Rutherford 6 (not only heel), wound infection, indirect intervention, and poor BTA runoff were independent predictors for delayed wound healing after EVT in patients with CLI secondary to infrapopliteal lesions, and their use in risk stratification allows estimation of the wound healing rate.
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NewsBot · Apr 6, 2015

Press Release:
Lower extremity revascularization not effective in majority of nursing home residents
UCSF researchers find most patients still alive gain little, if any, function

nly a few U.S. nursing home residents who undergo lower extremity revascularization procedures are alive and ambulatory a year after surgery, according to UCSF researchers, and most patients still alive gained little, if any, function.

The study appears in the April 6 issue of JAMA Internal Medicine.

"Our findings can inform conversations among physicians, patients and families about the risks and expected outcomes of surgery and whether the surgery is likely to allow patients to achieve their treatment goals," said senior author Emily Finlayson, MD, MS, associate professor of surgery and geriatrics in the Philip R. Lee Institute for Health Policy Studies at UCSF. "Our findings also highlight the importance of carefully considering a prognosis independent of vascular disease and assessing the goals of care."

Lower extremity peripheral arterial disease is common among nursing home residents, a substantial number of whom also are at risk for critical limb ischemia. Lower extremity revascularization through stents and other devices is frequently performed to preserve functional independence through limb preservation. However, these procedures have an operative risk, and their benefit in maintaining walking ability is debatable.

In this study, researchers led by Finlayson analyzed Medicare claims data for 2005-2008 for nursing home residents nationwide who underwent lower extremity revascularization, with follow up through 2009. Changes were examined in the residents' ambulatory and functional status after surgery. Also identified were patient and surgery characteristics associated with a composite measure of clinical and functional failure, defined as death or nonambulatory status a year after surgery.

The key findings are:

A total of 10,784 long-term nursing home residents received lower extremity revascularization. The average age was 82 years, and 60 percent had cognitive impairment, 57 percent had congestive heart failure, and 29 percent had renal failure.
Prior to surgery, of the 10,784 residents, 75 percent were not walking, and 40 percent had decline in overall physical functioning.
A year after surgery, 51 percent of these patients had died, and among survivors, 28 percent were nonambulatory and 32 percent had decline in overall physical functioning.
Of the 1,672 residents who were ambulatory before surgery, 63 percent died or now were nonambulatory at one year.
And among 7,188 patients who were nonambulatory prior to surgery, 89 percent died or remained nonambulatory.
As a result, the researchers learned that in patients undergoing lower extremity revascularization, the outcomes in nursing home residents were substantially worse than has been reported in the general population of the same age. These findings are consistent with previous studies that found individuals who are ambulatory prior to this procedure have better outcomes than those who are nonambulatory, and revascularization rarely allows a patient who is nonambulatory to become ambulatory after surgery.

"Among the treatment options, nonoperative symptom management, local wound care, primary amputation and lower extremity revascularization are associated with different risks, benefits and expected outcomes," Finlayson said. "Our findings should be interpreted cautiously; successful relief of pain, healing of wounds and avoidance of major amputation may benefit some of the patients who underwent lower extremity revascularization in the short term."
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NewsBot · Jun 18, 2015

Prognosis of critical limb ischemia: Minor vs major amputation comparison.
Matsuzaki K et al
Wound Repair Regen. 2015 Jun 17

Healthcare providers treating wounds have difficulties assessing the prognoses of patients with critical limb ischemia who had been discharged after complete healing of major amputation wounds. The word "major" in "major amputation" gives the impression of "being more severe" than "minor amputation". Therefore, even if wounds are healed after major amputation, they imagine that prognosis after major amputation would be poorer than that after minor amputation. We investigated the prognosis of diabetic nephropathy patients 2 years after amputations. Those patients underwent dialysis as well as amputation following percutaneous transluminal angioplasty for their foot wounds. They were ambulatory prior to these surgeries. Among 56 cases of minor amputation, 45 were males and 11 were females, and mortality was 41.1%. The mortality of cases with and without a coronary intervention history was 53.1% and 25.0%, respectively (p=0.034). Among 10 cases of major amputation, 9 were males and 1 was female, and mortality was 60%. The mortality of cases with and without a coronary intervention history was 75.0% and 0%, respectively. Although we predicted poor prognosis in cases with major amputation, there was no significant difference in mortality 2 years after amputations (p=0.267). Thus far poor prognosis has been reported for major amputation. It might be due to inclusion of the following patients: patients with wounds distal to ankle joints, patients with extensive gangrene spreading to the lower legs, patients with septicemia from wound infection and who died around the time of operation, and patients with malnutrition. The results of our present study showed that the outcomes at 2 years postoperatively were similar between patients with major amputations and those with minor amputations, if surgical wounds were able to heal. We should not estimate the prognosis by the level of amputation, rather we should consider the effect of coronary intervention history on prognosis. This article is protected by copyright. All rights reserved.
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NewsBot · Oct 23, 2015

Outcomes of One straight-line flow with and without pedal arch in patients with critical limb ischemia.
Higashimori A et al
Catheter Cardiovasc Interv. 2015 Oct 22

OBJECTIVES:
This study aimed to compare the outcomes of revascularization strategies for patients with critical limb ischemia (CLI) whereby single vessel run off to the foot was established with or without flow into a patent pedal arch.
METHODS:
We retrospectively analyzed data from 312 consecutive patients with CLI who underwent endovascular therapy (EVT) between December 2009 and February 2011. Below-the-knee angiography identified one vessel run off in 137 patients (44%), and we aimed to compare the outcomes between those patients where revascularization resulted in one-straight-line flow into a patent pedal arch (76 limbs, Group A) versus those who attained one straight-line flow to the distal end of a tibial vessel without flow into a patent pedal arch (61 limbs, Group B). The study endpoints were amputation free survival rate, limb salvage rate and wound healing rate at 12 months after EVT.
RESULTS:
Amputation free survival rate differed significantly between groups (88.2% in group A vs. 65.6% in group B, P = 0.01). Limb salvage rate also differed between groups (98.4% vs.89.3%, P = 0.03). Wound healing rate showed a trend towards difference between the two groups (89.4% vs. 80.6% P = 0.11).
CONCLUSIONS:
Among patients with CLI where only one vessel runoff can be established to the foot, direct flow into a patent pedal arch is essential to improve their clinical outcomes
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NewsBot · Dec 3, 2015

Functional Imaging of the Foot with Perfusion Angiography in Critical Limb Ischemia.
Reekers JA et al
Cardiovasc Intervent Radiol. 2015 Dec 1

PURPOSE:
To report on the first clinical experience with perfusion angiography (PA) of the foot in patients with chronic critical limb ischemia.
MATERIALS AND METHODS:
PA is a post-processing software algorithm and no extra digital subtraction angiography (DSA) has to be performed for this analysis. The data used to test the feasibility of PA were obtained from a consecutive group of 89 patients with CLI who were treated with standard below the knee angioplasty and 12 separate patients who were not suitable for endovascular revascularization.
RESULTS:
Motion artifacts in the dataset of the DSA made post-procedural analysis impossible in 10 % intervention. In the majority of patients (59/68) PA showed an increase in volume flow in the foot after successful angioplasty of the crural vessels. However, in 9/68 patients no increase was seen after successful angioplasty. With the use of a local administered competitive α-adrenergic receptor antagonist, it is also possible to test and quantify the capillary resistance index which is a parameter for the remaining functionality of the microcirculation in CLI patients.
CONCLUSION:
PA might be used as a new endpoint for lower limb revascularization and can also be used to test the functionality the microcirculation to identify sub-types of patients with CLI. Clinical evaluation and standardization of PA is mandatory before introduction in daily practice.
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NewsBot · Jul 16, 2016

Below-the-Knee Angioplasty for Critical Limb Ischemia: Results of a series of 157 procedures and impact of the Angiosome Concept
Marie Pave et al
Annals of Vascular Surgery; 15 July 2016

Purpose
To evaluate the long-term clinical results of Below-the-Knee Percutaneous Transluminal Angioplasty (BTK-PTA) with or without stenting, in patients with Critical Limb Ischemia (CLI), and to determine factors affecting clinical results including the role of the angiosome concept.

Methods
All patients undergoing primary BTK-PTA from January 2007 to December 2011 were included. Primary patency, assisted patency, limb salvage, survival and wound healing were assessed using the Kaplan-Meier method. Predictors of patency, limb salvage, survival, and wound healing, including the role of the angiosome theory, were determined using multivariate models.

Results
157 procedures were performed in 139 patients with CLI (Rutherford IV 10.8%; Rutherford V-VI 89.2%). Mean age was 74.2 years and 68.3% were men; 60% had diabetes and 31% renal insufficiency. PTA was confined to the infra-popliteal segment alone in 53.5% of cases. Technical success was 87.9%. Stents were placed in 42.6% of cases. The mean follow-up was 14.7 months (range 1-67 months). Four-year primary and secondary patency were 51% and 61%, respectively. Limb salvage at 4 years was 68.8%. Complete wound healing was 52% at 4 years. Positive predictors of survival were the absence of renal insufficiency (p<0.0001) and technical success (p=0.029). Target vessel occlusion of >50% was a negative predictor of limb salvage (p=0.0072). Positive predictors of wound healing were technical success (p=0.0067), the absence of renal insufficiency (p<0.0001) and continuity between a leg artery and a foot artery (p=0.02).

Conclusion
BTK-PTA can be performed with favorable long term results in patients with limited longevity. Secondary interventions may be necessary to maintain target vessel patency. In our experience, the angiosome concept had no impact on clinical success.
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NewsBot · Jul 18, 2016

Determining End Points for Critical Limb Ischemia Interventions.
Cooper KJ, Pe?a C, Benenati J
Tech Vasc Interv Radiol. 2016 Jun;19(2):104-112. doi: 10.1053/j.tvir.2016.04.003. Epub 2016 Apr 22.

Critical limb ischemia is a condition that has increased in prevalence and carries a high degree of morbidity. Although endovascular therapy for treatment of patients with critical limb ischemia has undergone significant advances with improved outcomes over the past decade, these patients often have multilevel disease, and it may take weeks or months for ulceration healing. For this reason, the acceptable therapeutic end points during and immediately following revascularization remain somewhat obscure. There are multiple tools available to guide the treating vascular specialist in this regard. Establishment of in-line flow to the foot and the angiosome containing the ulceration, appearance of a "wound blush," restoration of pulses, and bleeding at the ulcer site are basic tenets intraprocedurally. Postprocedural noninvasive testing including the ankle-brachial and toe-brachial indices, segmental pressure measurements, pulse volume recordings, transcutaneous oxygen tension, skin perfusion pressures (SPPs), and toe pressures all play a role in determining the likelihood of clinical improvement. Newer technologies such as two-dimensional (2D) perfusion angiography, fluorescence angiography, and tissue oxygen saturation mapping may allow better real-time assessment of flow restoration. In combination with close clinical follow-up and wound care, these tools provide treating physicians with a better grasp of the necessary end points to optimize patients for clinical improvement.
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NewsBot · Dec 14, 2016

Lumbar sympathectomy techniques for critical lower limb ischaemia due to non-reconstructable peripheral arterial disease.
Karanth VK, Karanth TK, Karanth L.
Cochrane Database Syst Rev. 2016 Dec 13;12:CD01151

BACKGROUND:
Critical lower limb ischaemia (CLI) is a manifestation of peripheral arterial disease (PAD) that is seen in patients with typical chronic ischaemic rest pain or patients with ischaemic skin lesions - ulcers or gangrene - for longer than 2 weeks. Critical lower limb ischaemia is the most severe form of PAD, and interventions to improve arterial perfusion become necessary. Although surgical bypass has been the gold standard for revascularisation, the extent or the site of disease may be such that the artery cannot be reconstructed or bypassed. These patients require other modalities of treatment, for example, vasodilatation by drugs or lumbar sympathectomy to relieve pain at rest and to avoid amputations. A systematic review of randomised controlled trials is required to evaluate the effects of lumbar sympathectomy in treating patients with CLI due to non-reconstructable PAD.
OBJECTIVES:
The objective of this review is to assess the effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD.
SEARCH METHODS:
The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (January 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12). In addition, the CIS searched clinical trials databases for details of ongoing and unpublished studies.
SELECTION CRITERIA:
Randomised controlled trials (RCTs) comparing any of the treatment modalities of lumbar sympathectomy, such as open, laparoscopic and chemical percutaneous methods, with no treatment or with any other method of lumbar sympathectomy for CLI due to non-reconstructable PAD were eligible. To decrease the bias of including participants that may be incorrectly diagnosed with CLI, review authors defined CLI as persistently recurring ischaemic rest pain requiring regular analgesia for more than two weeks, or ulceration or gangrene of the foot or toes, attributable to objectively proven arterial occlusive disease by measurement of ankle pressure of < 50 mmHg or toe pressure < 30 mmHg. We defined non-reconstructable PAD as a resting ankle brachial index (ABI) < 0.9 when no reasonable open surgical or endovascular revascularisation treatment option is available, as determined by individual trial vascular specialists.
DATA COLLECTION AND ANALYSIS:
Two review authors independently assessed studies identified for potential inclusion in the review. We planned to conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Review of Interventions.
MAIN RESULTS:
We identified no studies that met the predefined inclusion criteria. To decrease the bias of including participants who may be incorrectly diagnosed with CLI, we based our inclusion criteria on objective tests, as described above. The randomised trials identified by the literature search were performed before such objective criteria for selection were applied and therefore were not eligible for inclusion in the review.
AUTHORS' CONCLUSIONS:
We identified no RCTs assessing effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD. High-quality studies are needed.
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NewsBot · Jan 28, 2018

Risk Factors for Mortality Among Individuals With Peripheral Arterial Disease
S.M. Amrock, C.Z. Abraham, E. Jung, P.B. Morris, M.D. Shapiro
Am J Cardiol 2017;120:862-7.

Conclusions
Tobacco use increased the risk of all-cause and cardiovascular death, whereas physical activity was associated with a decreased mortality risk. A low ankle to brachial index (ABI) and diabetes were also predictive of cardiovascular death.
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Summary
Morbidity and mortality from peripheral arterial disease (PAD) continues to increase. Traditional cardiovascular risk factors are implicated in the development of PAD, yet the extent to which those risk factors correlate with mortality in such patients remains insufficiently assessed. Using data from the 1999 to 2004 National Health and Nutrition Examination Survey, Cox proportional hazards models were used to examine the association of cardiovascular risk factors and all-cause and cardiovascular mortality. A total of 647 individuals ≥40 years old (less than 400 pounds in weight) with PAD (ie, ankle-brachial index [ABI] ≤0.9) were followed for a median of 7.8 years (interquartile range 4.8-9.7 years; mean, 7.2 years). There were 336 deaths, of which 98 were attributable to cardiovascular disease. Mortality was determined by a probabilistic record match of the National Death Index. Compared with never smokers, current (hazard ratio [HR], 2.45; 95% confidence interval [CI], 1.62-3.71) and former (HR, 1.62; 95% CI, 1.14-2.29) smokers with PAD had higher rates of death (all-cause mortality). Moderate or vigorous physical activity of ≥10 minutes monthly was associated with lower death rates (HR, 0.63; 95% CI, 0.44-0.91). Assessment of diabetes, hypertension, hypercholesterolemia, and inflammation was not prognostic of all-cause mortality among individuals with PAD. Associated with increased rates of cardiovascular death were an ABI of <0.5 (HR, 2.56; 95% CI, 1.28-5.15, compared with those with an ABI of 0.7-0.9) and diabetes mellitus (HR, 2.50; 95% CI, 1.33-4.73). Hypertension had a trend but not statistically significant increased risk of cardiovascular mortality with neither C-reactive protein nor body mass index associated with cardiovascular mortality.
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NewsBot · Jun 14, 2018

Recurrence of Critical Limb Ischemia After Endovascular Intervention in Patients with Diabetic Foot Ulcers.
Meloni M et al
Adv Wound Care (New Rochelle). 2018 Jun 1;7(6):171-176. doi: 10.1089/wound.2017.0778.

Objective: To establish the rate of clinical recurrence of critical limb ischemia (CLI) in diabetic patients with ischemic foot ulcers (DFUs) treated by percutaneous transluminal angioplasty (PTA). Approach: The study group was composed of 304 patients with ischemic DFUs treated by PTA. We evaluated the rate of clinical recurrence of CLI requiring a second PTA (repeated PTA [rePTA]), the factors related to CLI relapse, and the outcomes of rePTA patients. The follow-up was 12.5 ± 6.6 months. Results: Seventy-four of 304 patients (24.3%) needed rePTA. The mean time to rePTA was 3.5 ± 0.64 months. rePTA group in comparison with no rePTA group had lower rate of healing (28.5% vs. 71.9% p = 0.0001), higher rate of ulcer recurrence (20% vs. 10.3% p = 0.03), major amputation (24.3% vs. 4.3% p = 0.0005), and death (33.3% vs. 7.9% p = 0.002). Glycated hemoglobin, type A1C (HbA1c; 2.2 [1.9-2.7] p = 0.02) and dialysis (1.5 [1.4-3.6] p = 0.006) were independently associated to clinical recurrence of CLI after PTA. Innovation: To identify the outcomes of patients with clinical recurrence of CLI and the clinical factors involved to reduce the rate of restenosis after endovascular treatment and improve the rate of limb salvage. Conclusions: Clinical recurrence of CLI is associated with a high rate of nonhealing ulcer recurrence, major amputation, and death. Dialysis and impaired glycemic control were independent predictors of CLI relapse after endovascular treatment.
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NewsBot · Aug 3, 2018

The impact of foot infection on infrainguinal bypass outcomes in patients with chronic limb-threatening ischemia.
Mayor JM et al
Vasc Surg. 2018 Jul 28. pii: S0741-5214(18)31068-1

BACKGROUND:
Despite advances in endovascular therapy, infrainguinal bypass continues to play a major role in achieving limb salvage. In this study, we sought to compare outcomes of infrainguinal bypass in patients with limb-threatening ischemia who presented with or without foot infection.

METHODS:
We conducted a retrospective cohort study of patients who underwent infrainguinal bypass for chronic limb-threatening ischemia at a single institution. End points of interest included long-term mortality, 45-day readmission, postoperative length of stay (LOS), major amputation, and time to wound healing. Multivariable Cox, logistic, and robust regressions were used to model time to event outcomes, readmission rates, and LOS.

RESULTS:
There were 454 infrainguinal bypass procedures analyzed. Demographics and baseline characteristics were similar, except congestive heart failure and diabetes were more common in the infection group. Presence of foot infection had no impact on mortality (hazard ratio [HR], 0.78; P = .243). Significant predictors of long-term mortality included increasing age, hypoalbuminemia, and congestive heart failure; preoperative use of clopidogrel was protective. Presence of foot infection was an independent predictor of major amputation. In the multiple regression model, the presence of foot infection was independently associated with amputation rate (HR, 2.14; 95% confidence interval, 1.42-3.22; P < .001); use of venous conduit and increasing age and body mass index were protective. Foot infection was an independent predictor of prolonged LOS (mean LOS was 1.54 days longer in patients with vs those without infection; P = .001). Other independent predictors of prolonged LOS included intraoperative blood loss and reoperation; history of continuous preoperative aspirin use and normal baseline renal function and albumin levels were associated with decreased LOS. Readmission was influenced by reoperation (odds ratio [OR], 2.51; P < .001) but not by presence of foot infection (OR, 1.21; P = .349). There was a strong trend for prolonged wound healing time in patients with diabetes (HR, 1.58; P = .05) but not in those with foot infection (OR, 0.74; P = .36).

CONCLUSIONS:
Among patients requiring infrainguinal bypass for limb-threatening ischemia, infection was more common in patients with diabetes and was a significant predictor of major amputation and prolonged LOS. Infection was not predictive of mortality, wound healing time, or readmission. These findings lend support to the inclusion of infection in risk stratification schemes for patients with chronic limb-threatening ischemia, as recommended in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system, because of its adverse impacts on limb salvage
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NewsBot · Dec 11, 2018

Clinical characteristics of Japanese diabetic patients with critical limb ischemia presenting Fontaine stage IV
Mitsuyoshi TakaharaOsamu IidaYukihiro FujitaMasakazu Haneda
Diabetology International: 08 December 2018

The aim of the current study was to reveal the clinical characteristics of Japanese diabetic patients with critical limb ischemia (CLI) presenting ischemic unhealed ulcer/gangrene (Fontaine stage IV) in the real-world settings. The current retrospective cross-sectional study included consecutive 282 Japanese diabetic patients who underwent endovascular therapy for CLI presenting Fontaine stage IV. The prevalence of diabetes-related complications was estimated adopting multiple imputation (50 times). The patients were aged 70 ± 10 years. Median duration of diabetes was 21 (interquartile range 12–31) years. The prevalence of proliferative diabetic retinopathy, end-stage renal disease on regular dialysis, stroke, coronary artery disease, and chronic heart failure was estimated at 48% (95% confidence interval 39–56%), 52% (46–58%), 34% (28–39%), 48% (42–54%), and 35% (29–41%), respectively. The prevalence of stroke, coronary artery disease, and chronic heart failure was not significantly associated with the duration of diabetes (all p > 0.05). On the other hand, the prevalence of proliferative diabetic retinopathy and end-stage renal disease on regular dialysis was significantly positively associated with the duration of diabetes (both p < 0.05). However, these prevalences reached as high as ~ 30% even in patients with duration of diabetes < 10 years. In conclusion, the advanced stage of diabetes-related complications was prevalent in patients with CLI presenting Fontaine stage IV.
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NewsBot · Oct 11, 2020

A Review and Proposed Classification System for the No-Option Patient With Chronic Limb-Threatening Ischemia
Tanner I. Kim, MD, Shant S. Vartanian, MD, Peter A. Schneider, MD
Journal of Endovascular Therapy October 9, 2020

A growing, but poorly defined subset of patients with chronic limb-threatening ischemia (CLTI) have “no option” for revascularization. One notable subgroup includes patients with severe ischemia and advanced pedal artery occlusive disease, termed “desert foot,” who are at high risk for major amputation due to a lack of conventional revascularization options. Although new therapies are being developed for no-option patients with desert foot anatomy, this subgroup and the broader group of no-option patients are not well defined, limiting the ability to evaluate outcomes. Based on a systematic review, a classification of the no-option CLTI patient was constructed for use in clinical practice and studies. Several no-option conditions were identified, including type I—severe and pedal occlusive disease (desert foot anatomy) for which there is no accepted method of repair; type II—lack of suitable venous conduit for bypass in the setting of an acceptable target for bypass; type III—extensive tissue loss with exposure of vital structures that renders salvage impossible; type IV—advanced medical comorbidities for which available revascularization options would pose a prohibitive risk; and type V—presence of a nonfunctional limb. While type I and type II patients may have no option for revascularization, type III and type V patients have wounds, infection, comorbidities, or functional status that may leave them with few options for revascularization. As treatment strategies continue to evolve and novel methods of revascularization are developed, the ability to identify no-option patients in a standardized fashion will aid in treatment selection and assessment of outcomes.
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NewsBot · Jun 24, 2021

Research priorities for lower limb amputation in patients with vascular disease
DC Bosanquet et al
Source

Introduction Lower limb amputation is a life-changing event for patients and can be associated with high mortality and morbidity rates. Research into this critical part of vascular surgery is limited. The Vascular Society of Great Britain and Ireland (VSGBI) in partnership with the James Lind Alliance (JLA) process, aimed to identify and develop key research priorities for amputation.

Methods A modified JLA Priority Setting Partnership was undertaken, encompassing all vascular practice. Two separate Delphi processes to identify research topics were undertaken with healthcare professionals, patients and carers, led by the VSGBI. The priorities were then ranked by the same participants and amalgamated to produce a list for final prioritisation. The final consensus meeting was attended by patients, carers and healthcare professionals from a variety of backgrounds involved in the care of people with amputation. Using a nominal group technique, the top ten research priorities were identified.

Results A total of 481 clinicians submitted 1231 research questions relating to vascular surgery in general. 63 amputation-specific research questions were combined into 5 final clinical questions. 373 patients or carers submitted 582 research questions related to vascular surgery in general. Nine amputation-specific research questions were identified after combining similar questions. Amalgamating both the clinician and patient questions, 12 questions were discussed at the final prioritisation meeting and the top 10 identified. These related to amputation prevention, supporting rehabilitation, improving clinical outcomes following amputation (preventing/treating pain including phantom limb pain and improving wound healing) and research into information provision for patients undergoing amputation.

Conclusion The top 10 research priority areas in vascular amputation provide guidance for researchers, clinicians, and funders on the direction of future research questions that are important to both healthcare professionals and patients.
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NewsBot · Feb 8, 2022

Continuous peripheral nerve block for in-patients with lower limb ischemic pain
Hermann Dos Santos Fernandes et al
Clinics (Sao Paulo). 2021;76:e2805

Objectives: Demonstrate that continuous peripheral nerve block (CPNB) may be an alternative with adequate analgesia and a lower incidence of side effects for ischemic pain due peripheral obstructive arterial disease (POAD).

Methods: Retrospective cohort study with 21 patients with POAD, Fontaine IV graded, with foot pain. Patients were submitted to continuous sciatic nerve block (CSNB), through a perineural catheter. Primary outcomes were pain intensity (by numerical rating scale) and opioid consumption (in oral morphine equivalents).

Results: During CSNB, pain scores markedly decreased in comparison to the pre-block period.

Conclusions: CPNB may be a good option for ischemic pain treatment in in-patients, as it provides effective pain control with fewer adverse effects.
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NewsBot · May 1, 2022

Hospital Payer Mix and Amputation Rates Among Patients with Peripheral Artery Disease Complications
Deeksha Bidare, Neal R Barshes
Ann Vasc Surg. 2022 Apr 25

Background: /Objective: Studies have shown that Medicaid coverage is associated with higher rates of primary amputation among patients with peripheral artery disease (PAD). We sought to identify whether hospital payer makeup also influences outcomes among these patients.

Methods: Patients who underwent treatment for foot complications in Texas were identified and aggregated by hospital. Hospitals were grouped by payer mix: low-income payer predominant vs high-income payer predominant. Variance analyses were used to find differences between the groups. Individual and hospital-level regression analyses were used to find associations with amputation rates.

Results: Out of 21,592 patients, 9,098 (42%) underwent amputation. They presented to 337 hospitals out of which 49 (15%) had a low-income predominant payer mix and 109 (32%) had a high-income predominant payer mix. Patients at low-income payer predominant hospitals were more likely to present with gangrene (0.74 vs 0.65, p<0.01), undergo emergency admissions (0.67 vs 0.50, p<0.01), undergo amputation (0.53 vs 0.42, p<0.05), and incur higher per-day charges ($8145 vs $6790, p<0.05). At the individual level, despite risk-adjusting for disease-specific factors, amputation rate was associated with hospital payer mixes with greater proportions of Medicaid and lower proportions of commercially insured patients. At the hospital level, amputation rate was associated with higher proportion of Medicaid patients in hospital payer mix, lower hospital volumes, lower per-day charges, and higher gangrene and osteomyelitis rates (R2=0.30, p<0.01).

Conclusion: Higher proportion of Medicaid patients in a hospital payer mix is associated with an increased risk of primary amputation for PAD patients regardless of insurance coverage.
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NewsBot · Jun 8, 2022

Management of the no-option foot: Deep vein arterialization
Sadia Ilyas, Richard J Powell
Semin Vasc Surg. 2022 Jun;35(2):210-218

The incidence of peripheral artery disease continues to rise worldwide, with a concomitant rise in the subset of patients who manifest with chronic limb-threatening ischemia (CLTI). A mainstay of CLTI treatment is revascularization through open surgical bypass, endovascular therapy, or hybrid approaches combining the two modalities. However, a significant proportion of these patients are considered to have nonreconstructable, or no-option, CLTI. This is related to either significant pedal arterial occlusive disease or lack of a bypass conduit. Deep vein arterialization has been used as a potential treatment option for this cohort of patients. We explore the various described methodologies of deep vein arterialization, including open, hybrid, and totally percutaneous. These studies suggest that deep vein arterialization is a promising treatment paradigm for patients with no-option CLTI, with encouraging results in terms of technical feasibility, wound healing, and ultimately limb salvage. However, further study of appropriate patient selection, standardization of techniques, and long-term follow-up are needed.
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NewsBot · May 19, 2023

Press release:
Insights from largest chronic limb-threatening ischemia study to inform quality of care improvements
Data from a cohort of one million patients with chronic limb-threatening ischemia (CLTI) were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions. Using data from Medicare, the cohort, Chronic Limb threatening Ischemia Process PERformance (CLIPPER), found one out of six patients with CLTI died within their first year of diagnosis and 50% survived at five years.

CLTI is a serious condition in which blood flow to the feet or legs is severely limited by atherosclerotic plaque. Patients with CLTI are at high risk of lower extremity amputation and death without prompt diagnosis and treatment. Though CLTI is common and highly morbid, there are no established process measures to guide high-quality care. Using data from Medicare, the CLIPPER cohort was created to develop and test process measures for CLTI, which could ultimately be used to measure and improve quality of care.

Using inpatient and outpatient claims data from patients with fee-for-service Medicare from 2010 to 2019, a coding algorithm was used to identify patients with CLTI. To qualify for a CLTI diagnosis, patients had either 1) one diagnostic code for peripheral artery disease and one diagnostic code for ulceration, infection, or gangrene on the same inpatient or outpatient claim, or 2) one CLTI-specific diagnostic code, as well as a procedure code indicating arterial vascular testing within six months before or after the qualifying CLTI diagnostic code(s).

The cohort comprised 1,130,065 patients diagnosed with CLTI between 2010 and 2019. Mean age of the cohort was 75 ± 5.8 years; 48.4% were women and 14.6% were Black. Within 30 days of CLTI diagnosis, 20.4% of patients underwent percutaneous or surgical revascularization. Within 6 months, 3.3% of patients underwent major amputation; 16.7% of patients died at 1-year follow-up and 50.3% at 5-year follow-up.

“CLTI is an incredibly deadly disease if not treated quickly after diagnosis, but we know very little about how hospitals perform with respect to treatment,” said Alexander Fanaroff, MD, MHS and Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania and lead author. “Comprehensive process measures are needed for patients in order to advance care and improve the chance of survival. Our hope is that this study is a first step toward developing better process measures.”

NewsBot · Aug 2, 2023

Lower extremity Allen test in critical limb ischemia
Khurram H Khan et al
Source

According to the Centers for Disease Control and Prevention, 6.5 million people over the age of 40 have peripheral artery disease. The major risk factors for developing peripheral artery disease are smoking and diabetic mellitus. A history and physical is the first line of defense in assessing this disease process. The lower-extremity Allen test can serve as one of the physical exam modalities to assess the relative vascular contribution to the distal perfusion of the lower extremity. We present a case report utilizing this technique in a 56-year-old African American woman who manifested with increasing pain, swelling, and numbness in her bilateral hallux toes for 2 weeks duration. We employed a modified lower-extremity Allen test to demonstrate an irregularity in vascular perfusion in the foot after a difference in pitch between the dorsalis pedis artery and the posterior tibial artery was heard using a hand-held Doppler. Non-invasive vascular studies were unremarkable and did not suggest peripheral artery disease. Further angiographic testing revealed occlusions at multiple levels of the lower extremity. The simplified lower-extremity Allen test allowed for efficient bedside assessment of the relative vascular contribution to the foot and can be an important tool in the clinical diagnosis of peripheral artery disease.
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NewsBot · Sep 20, 2023

Hospital clinicians’ perceptions and experiences of care pathways for chronic limb-threatening ischaemia: a qualitative study
Eleanor Atkins, Ian Kellar, Panagiota Birmpili, Jonathan R. Boyle, Arun D. Pherwani, Ian Chetter & David A. Cromwell
Journal of Foot and Ankle Research volume 16, Article number: 62 (2023)

Background
Chronic limb-threatening ischaemia (CLTI) is a condition associated with significant risks of lower limb loss and mortality, which increase with delays in management. Guidance recommends urgent referral and assessment, but delays are evident at every stage of the CLTI patient pathway. This study uses qualitative methods to explore hospital clinicians’ experiences and perceptions of the existing CLTI pathway.

Methods
A qualitative interview study was conducted. Semi-structured interviews were undertaken with 13 clinicians involved in the assessment of patients referred to hospital with suspected CLTI, identified via purposive sampling from English vascular surgery units. Clinicians included podiatrists, vascular specialist nurses and doctors. Reflexive thematic analysis was performed on the data from a critical realist position.

Results
The need for speed was the single overarching theme identified. Four linked underlying themes were also identified;

1. Vascular surgery as the poor relation (compared to cancer and other specialties), with a sub-theme of CLTI being a challenging diagnosis.

2. Some patients are more equal than others, with sub-themes of diabetes vs. non-diabetes, hub vs. spoke and frailty vs. non-frail.

3. Life in the National Health Service (NHS) is tough, with sub-themes of lack of resource and we’re all under pressure.

4. Non-surgeons can help.

Conclusions
The underlying themes generated from the rich interview data describe barriers to timely referral, assessment and management of CLTI, as well as the utility of non-surgical roles such as podiatrists and vascular specialist nurses as a potential solution for delays. The overarching theme of the need for speed highlights the meaning given to adverse consequences of delays in management of CLTI by clinicians involved in its assessment. Future improvement projects aimed at the CLTI pathway should take these findings into account.
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NewsBot · Apr 11, 2024

News Release 10-Apr-2024
Revascularization enhances quality of life for patients with chronic limb threatening ischemia

Study reveals diminished quality of life among patients with chronic limb-threatening ischemia, a severe form of peripheral artery disease, and emphasizes the benefits of revascularization on wellbeing

Over 200 million people around the world experience peripheral artery disease (PAD) – a condition caused by the narrowing of the blood vessels from the heart to the lower limbs that leads to pain when walking – and for roughly 1-in-10 this advances to chronic limb-threatening ischemia (CLTI), an advanced form of PAD. Those with CLTI often suffer severe pain even at rest, caused by fatty plaque buildup obstructing blood flow, typically to the leg or foot. Those with CLTI face elevated risks of amputation, cardiovascular disease and premature death, yet research on the condition’s impact on quality of life remains limited.

Investigators from both of Mass General Brigham’s founding members, Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), as well as Boston Medical Center (BMC), sought to address this problem. Following their previous study highlighting the clinical results of the BEST-CLI trial – Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia – published in the New England Journal of Medicine (NEJM), the team assessed patient health-related quality of life before and after revascularization treatment. Results are published in Circulation.

“Our study indicates that patients with CLTI have a notably poor quality of life – substantially lower than with many other chronic conditions,” said Matthew Menard, MD, co-director of the Endovascular Surgery Program at BWH and co-principal investigator of BEST-CLI. “Our findings show that revascularization, which restores sufficient blood flow back into the legs, significantly improves quality of life. This confirms the critical role that revascularization plays not just in extending the length of patients’ lives but also its importance in optimizing their wellbeing.”

Among patients with CLTI, those eligible for surgical treatment often have two options: surgical bypass (Bypass), where surgeons restore blood and oxygen to the lower limb by reconstructing the blocked vessel, or endovascular therapy (Endo), which involves placing a stent or catheter inside an artery and opening it up to bring blood flow through a blockage.

Funded by the National Heart, Lung, and Blood Institute, with ongoing post-enrollment support from the Novo Nordisk Foundation, the BEST-CLI trial enrolled over 1,800 patients with CLTI from 150 research sites in the U.S., Canada, Finland, Italy, and New Zealand between August of 2014 and October of 2019. Investigators assessed how clinical outcomes (previously reported in NEJM) and quality of life metrics varied between revascularization techniques.

“Medicine is generally moving towards a more patient-centric model of care. That means looking at what’s best for each patient, taking into account an evidence-based approach. Quality of life is one important element in this determination,” said co-principal investigator Kenneth Rosenfield, MD, head of the Section of Vascular Medicine and Intervention in the Division of Cardiology at MGH.

Investigators sorted 1,528 participants into two cohorts. The first cohort was made up of 1,193 patients, all of whom had an available, good-quality, single-segment great saphenous vein (SSGSV), which previous studies have shown is optimal for Bypass. The second cohort was made up of 335 patients who did not have an available SSGSV. Patients in both cohorts were randomized to undergo Bypass or Endo procedures. Researchers assessed quality of life by administering voluntary surveys asking participants about pain levels, activities of daily living, disease symptoms and severity, physical activity, and mental health (anxiety and depression). Surveys were collected at baseline, 30 days post-procedure, at three months, 12 months, then once yearly until the end of the study.

“Patient-reported outcome measures are essential to our understanding of the patient experience,” said co-principal investigator Alik Farber, MD, MBA, interim chair of the Department of Surgery, chief of the Division of Vascular and Endovascular Surgery at BMC and professor of Surgery and Radiology at Boston University Chobanian & Avedisian School of Medicine. “Yet these metrics are not often used and sometimes ignored. Here we found an opportunity to hear our patients’ voices and use them to improve CLTI outcomes.”

While the trial’s previously published clinical outcomes revealed that patients treated with Bypass had fewer major amputations and less need for repeat procedures than those treated with Endo, quality of life did not significantly differ between treatments. Survey results instead revealed that participants generally experienced significant improvements in quality of life after treatment, regardless of their cohort or whether they underwent Bypass or Endo. They further highlighted that patients with CLTI overwhelmingly conveyed that their quality of life was low upon entering the trial, before receiving treatment.

This study is limited in that patients filled out quality-of-life questionnaires at distinct periods throughout the trial, but these time points did not necessarily line up with significant health events such as additional revascularization procedures or amputations. Further, there remains a dearth of quality-of-life research for patients with PAD, and there are no specific metrics to assess the quality of life for patients with PAD or CLTI.

Going forward, the team aims to assess differences in the cost-effectiveness of these procedures, and how cost, among other factors, affects patient quality of life and overall health outcomes.

“The next step is to integrate quality-of-life measures into a more sophisticated care plan to account for the clinical status of the patient and the cost-effectiveness of treatment options, both for the patient and the viability of the healthcare system,” said Farber.

Authorship: Additional authors include Richard J. Powell, Michael S. Conte, Taye H. Hamza, John A. Kaufman, Mark J. Cziraky, Mark A. Creager, Michael D. Dake, Michael R. Jaff, Diane Reid, George Sopko, Christopher J. White, Michael B. Strong, Max van Over, Emiliano Chisci, Philip P. Goodney, Bruce Gray, Ahmed Kayssi, Jeffrey J. Siracuse (BWH), Niteesh K. Choudhry (BWH).

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