rome and Constriction--Pathologic

To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study.. Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months.. In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003).. In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Lasers; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Retreatment; Risk Factors; Rome; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB).. Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis.. Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04).. The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Lower Extremity; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Rome; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices

Popliteal artery entrapment syndrome is increasingly described in the world literature as a cause of lower limb arterial impairment. It is caused by the anomalous interrelationship between the popliteal artery and its surrounding muscular and/or tendineous structures. The first case surgically treated was reported in 1959 and since then more than 300 cases have been reported including our personal experience (31 cases in 23 patients). We have treated surgically 19 males and four females with symptoms which were moderate (cramping after intensive physical training, paraesthesia, etc.) in 14 limbs, intermittent claudication in 16 and necrosis (first toe) in one. Preoperative arteriography showed arterial occlusion in eight limbs, stenosis in eight and aneurysms in two. In 11 limbs stenosis or occlusion was only shown after active plantar hyperextension and in two arteriography was not done because surgical indications were established on the basis of a venogram positive for popliteal vein entrapment syndrome. Ten different anatomical variants were seen and the medial head of gastrocnemius muscle was involved in 74.2%. Surgical treatment consisted of division of the aberrant musculotendinous tissue in 18 cases (in two of these balloon angioplasty was also used). In 12 cases a vascular reconstruction was also required, while one case was explored without a specific procedure being warranted. Optimal results were obtained when the syndrome was treated at an early stage by simple division of musculotendinous tissue (94.4% long-term patency rate, mean follow-up 46.0 months, min 2, max 120 months). When arterial grafting was required the long-term patency rate was only 58.3% (mean follow-up 43.5 months, min 1, max 100 months).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Constriction, Pathologic; Female; Humans; Intermittent Claudication; Leg; Male; Muscles; Popliteal Artery; Rome; Vascular Diseases