'Paradigm shift' in how physicians treat peripheral artery disease

NewsBot · Oct 5, 2010

Members do not see these Ads. Sign Up.
Press Release:
'Paradigm shift' in how physicians treat peripheral artery disease

A balloon angioplasty device that sucks up dangerous plaque debris could trigger a "paradigm shift" in how physicians treat peripheral artery disease, researchers write in the current issue of Endovascular Today.

"We will see a shift in how we treat lesions," write Dr. Robert Dieter of Loyola University Health System and Dr. Aravinda Nanjundappa of West Virginia University.

In two clinical trials totaling 123 patients, the device had a success rate of 97 percent to 99 percent and consistently outperformed filter devices typically used to capture debris particles, Dieter and Nanjundappa write.

The Food and Drug Administration has approved the device, Proteus®, made by Angioslide, for angioplasties that treat peripheral artery disease (PAD) in the legs. PAD is caused by clogged arteries that restrict blood flow to the legs. Symptoms include painful cramping in the hips, thighs or calves when walking, climbing stairs or exercising. Advanced PAD can cause gangrene or even lead to limb loss.

A balloon angioplasty is among the standard treatments for PAD. A physician inserts a catheter in an artery and guides it to the blockage, then opens the artery by inflating a balloon at the tip of the catheter. The physician typically deploys a stent to keep the artery open.

Inflating the balloon can knock loose particles of plaque, which travel down the leg. A large particle can block blood flow, a condition called distal embolization. In the most severe cases, distal embolizations can require leg amputation or even be fatal.

Until now, some physicians have used a filter device to prevent debris from escaping. However, the filter can damage the artery, and can be difficult to deploy. Moreover the FDA has not approved filter devices for use in leg arteries. Using filters for PAD procedures, although routine, must be done "off label."

The new device that Dieter used opens the artery just like a standard angioplasty balloon. After the artery is opened, the physician deflates the balloon. The negative pressure sucks up the debris, which is trapped inside as the balloon retracts.

"This is a much more simple and elegant approach than filter devices," said Dieter, an interventional cardiologist and vascular specialist.

Dieter is an assistant professor in the Department of Medicine, Division of Cardiology at Loyola University Chicago Stritch School of Medicine and Director of Vascular Medicine and Peripheral Vascular Interventions at Edward Hines VA Hospital. Dieter has used the device on patients at Loyola and Hines.

His first Loyola patient was Patricia Durkin of Oak Forest, Il. Before the procedure, the top of the iliac artery that supplies blood to her left leg was 90 percent blocked. "If I walked in the mall, I had to stop every few minutes," she said. "It made my leg feel heavy. It got to the point where I didn't want to walk any distance."

The procedure restored normal blood flow. "I don't have that heavy feeling anymore," Durkin said.

Other interventional cardiologists at Loyola also plan to use the device, said Dr. John Lopez, director of Interventional Cardiology Research and professor in the Department of Medicine, Division of Cardiology.

"At Loyola, interventional cardiology is very progressive, and at the forefront of technology for the treatment of PAD," Lopez said.
Click to expand...

NewsBot · Oct 5, 2010

Embolic Capture Angioplasty.
Robert S. Dieter, Aravinda Nanjndappa.
Endovascular Today, September 2010

Numerous studies have shown that embolic debris are liberated in lower extremity endovascular interventions. The clinical significance of distal embolization can and should be further investigated. Until now, filterbased platforms have been the primary type of embolic protection systems to prevent distal embolization.

With the introduction of the Proteus device, there will be a paradigm shift in how we treat lesions. The Proteus angioplasty balloon is simple to use and has been shown both clinically as well as in bench top models to be effective in both angioplasty as well as embolic capture.
Click to expand...

Full article

Admin2 · Oct 5, 2010

Related threads:
Other threads tagged with peripheral vascular disease

NewsBot · Oct 5, 2011

Primary infragenicular angioplasty for diabetic neuroischemic foot ulcers following the angiosome distribution: a new paradigm for the vascular interventionist?
Alexandrescu V, Hubermont G.
Diabetes Metab Syndr Obes. 2011;4:327-36.

The angiosome principle was first described by Jan Taylor in 1987 in the plastic reconstructive surgery field, providing useful information on the vascular anatomy of the human body. Specifically concerning foot and ankle pathology, it may help the clinician to select better vascular access and specific strategies for revascularization. This knowledge may be particularly beneficial when treating diabetic neuroischemic foot wounds associated with particularly aggressive atherosclerotic disease and a poor collateral circulation. The implementation of angiosome-based strategies in diabetic infragenicular vascular reconstruction may afford encouraging wound healing and limb preservation rates using both bypass and endovascular techniques. The minimal invasiveness of these novel strategies enables us to perform more specific and more distal tibial and/or foot arterial reconstructions, in one or multiple targeted vessels. This paper reviews the available literature on this revascularization strategy and focuses on the potential benefit of angiosome-guided primary angioplasty for diabetic ischemic foot ulcers.
Click to expand...

NewsBot · Jan 13, 2012

Factors Influencing Wound Healing of Critical Ischaemic Foot after Bypass Surgery: Is the Angiosome Important in Selecting Bypass Target Artery?
Azuma N, Uchida H, Kokubo T, Koya A, Akasaka N, Sasajima T.
Eur J Vasc Endovasc Surg. 2012 Jan 9

OBJECTIVES:
The aim of the study is to determine factors affecting ischaemic wound healing and role of the angiosome concept in bypass surgery.

DESIGN:
Single-centre, retrospective clinical study.

MATERIALS AND METHODS:
A total of 249 consecutive critical ischaemic limbs with tissue loss in 228 patients who underwent distal bypasses from 2003 to 2009 were reviewed. A total of 81% of patients were diabetic, and 49% of patients had dialysis-dependent renal disease (end-stage renal disease, ESRD). Distal targets of bypasses were the crural artery (57%) and the pedal artery (43%).

RESULTS:
The complete healing of ischaemic wounds was achieved in 211 limbs (84.7%). ESRD (odds ratio (OR) 0.127, p < 0.001), diabetes (OR 0.216, p = 0.030), Rutherford category 6 (R6) with heel ulcer/gangrene (OR 0.134, p < 0.001), R6 except heel (OR 0.336, p = 0.025) and low albuminaemia (OR 0.387, p = 0.049) were negative predictors of wound healing. Regarding the angiosome, the healing rate in the indirect revascularisation (IR) group was slower than in the direct revascularisation (DR) group, especially in patients with ESRD (p < 0.001). However, the healing rates of the DR and IR groups were similar after minimising background differences with propensity score methods (p = 0.185).

CONCLUSIONS:
In the field of bypass surgery, the angiosome concept seems unimportant, at least in non-ESRD cases. The location and extent of ischaemic wounds as well as co-morbidities may be more relevant than the angiosome in terms of wound healing.
Click to expand...

NewsBot · Apr 24, 2012

Bypass to the ankle and foot in the era of endovascular therapy of tibial disease.Results and factors influencing the outcome.
Gargiulo M, Giovanetti F, Bianchini Massoni C, Freyrie A, Faggioli G, Muccini N, Stella A.
J Cardiovasc Surg (Torino). 2012 Apr 20.

AIM:
Endovascular therapy (ET) is the treatment of choice for critical limb ischemia (CLI) and tibial arteries disease (TAD) in focal lesions with restorable run-off; ankle and foot bypass (BPG) is indicated in patients unfit for ET with foot or ankle arteries suitable for surgery. The aim of this study was to evaluate limb salvage (LS), primary patency (PP) and survival (S) of patients underwent BPG in the era of ET for TAD and to define the correlated prognostic factors.

METHODS:
Between February 2000 and November 2008, patients with CLI and TAD were collected prospectively in a data-base (demographics, Fontaine's stage, Texas University Wound Classification [TUC]of ulcers, risk-factors, TAD, techniques of foot revascularization and surgical factors). BPG was performed in tibial arteries occlusion longer than 4 cm or focal occlusion without line-flow to pedal arteries. Clinical and Duplex-ultrasound follow-up was performed at discharge, 1, 3, 6 months and every 6 months. LS, PP, and S rates were assessed with Kaplan-Meier method; factors influencing outcomes were sought by multivariate Cox proportional hazards model analysis.

RESULTS:
A total of 410 revascularizations were performed in patients with CLI and TAD; BPG in 153 patients (mean age:69.3±10.6, male/female=117/36, diabetes mellitus=75.2% hyperlypidemia=54.9%, hypertension=87.6%, renal disease=32.7%, coronary arteries disease=51.6%, Fontaine stage IV=96.1%, TUC grade-III=65.4%, TUC stage-D=51%). All autologous grafts in 96.7% (non-reversed saphenous vein=74.5%, reversed=7.2%, composite vein graft=12.4%, arm's veins=2.6%). LS and S after 1 month were 88.2% and 97.1%, respectively. Mean follow-up was 23 months. At 12 and 36 months: LS 76.7% and 70.9%, PP 62.3% and 52.9%, S 91.5% and 74.6%. LS was negatively associated with age (HR=1.041 [95%CI=1.005-1.079]), infected ulcers (HR=3.377 [95%CI=1.571-7.258]), run-off arteries diameter <1.8 mm (HR=5.854[95%CI=2.274-15.070]). PP was negatively associated with hyperlipidemia (HR=2.555 [95%CI=1.418-4.603]), female gender (HR=2.125[95%CI=1.182-3.823]), run-off arteries diameter <1.8 mm (HR=6.165 [95%CI=2.774-13.699]), reversed saphenous graft (HR=3.105 [95%CI=1.166-8.272]), composite vein graft (HR=2.930 [95%CI=1.406-6.107]) and homograft (HR=2.762 [95%CI=1.040-7.333]); instead it is positively related with hypertension (HR=4.229 [95%CI=2.089-8.563]). S was negatively correlated with renal disease (HR=3.035 [95%CI=1.363-6.756]).

CONCLUSION:
BPG may be a reasonable first treatment for CLI patients with TAD unfit for ET; female gender, hyperlipidemia, use of reversed saphenous, composite vein or alternative grafts, foot infection and renal disease are associated with worse outcome.
Click to expand...

NewsBot · Dec 20, 2012

Press Release:
Lifestyle changes linked to better outcomes after peripheral intervention
Findings from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry show dramatic underuse of basic medical therapy

Patients who quit smoking and took an aspirin and statin before undergoing treatment for blocked leg arteries were less likely to suffer a complication six months later, according to new research led by the University of Michigan Cardiovascular Center.

But few patients made the lifestyle changes and were on recommended medical therapy that can relieve leg pain and cramping associated with peripheral arterial disease, or PAD.

The registry findings were published online ahead of print in Circulation: Cardiovascular Interventions and reveal a dramatic underuse of basic medical treatment for PAD.

PAD is on the rise as people age and conditions such as diabetes, high blood pressure and obesity affect circulation. Peripheral vascular interventions, such as angioplasty, improves blood flow, specifically to the legs.

But before PVI, more than half of patients studied failed to receive minimal medical therapy, meaning that the patient quit smoking and took an aspirin and a statin -- drugs that can reduce blood clots and improve blood flow.

Even the doctors treating the patients for their blockages didn't always ensure that their patients went home from the hospital with a prescription.

At admission, 46.7 of patients were on aspirin, a statin and did not smoke; at discharge 71 percent were on both drugs and either did not smoke or still smoked but had smoking cessation counseling.

"The modest improvement in statin prescription before patients were discharged signifies a missed opportunity to provide a life-saving intervention for PAD patients," says lead study author P. Michael Grossman, M.D., an interventional cardiologist at the University of Michigan Cardiovascular Center.

Users of both aspirin and statins had a lower incidence of peripheral events such as repeat PVI, limb salvage surgery and amputation – 7 percent compared to 15.8 percent.

The study included 1,357 patients identified in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Peripheral Vascular Intervention database. The BMC2 PVI registry includes patients from Michigan hospitals who underwent an intervention for treatment of PAD. Patients are often referred for PVI to manage leg pain and cramping – a symptom that doctors call claudication.

More study is needed to determine reasons for the lack of medical therapy. Meanwhile the underuse of medical treatment known to reduce symptoms of claudication and adverse events is a "pressing quality gap," authors say.

"Although a considerable effort has been focused on the impact of guideline adherence in patients with heart attack and heart failure, there are currently no such national programs focused on patients with PAD," Grossman says.

"In Michigan, BMC2 PVI is actively working to improve the medical therapy and outcomes of patients with PAD who undergo revascularization procedures. Data such as this have allowed us to recognize the issues and give us the tools necessary to impact change," he says.
Click to expand...

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Admin2 Administrator Staff Member

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Share This Page