Predictors of carotid occlusion intolerance during proximal protected carotid artery stenting.

Objectives: The aim of this study was to identify predictors of occlusion intolerance (OI) developing during proximal protected carotid artery stenting (CAS).

Background: The use of proximal embolic protection devices, such as endovascular occlusion, during CAS has been demonstrated to be particularly safe and effective. However, endovascular occlusion can expose the ipsilateral hemisphere to hypoperfusion and produce transient neurological symptoms (OI).

Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up.

Objectives: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).

Background: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up.

Evaluation of the biodegradable peripheral Igaki-Tamai stent in the treatment of de novo lesions in the superficial femoral artery: the GAIA study.

Objectives: This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.

Background: Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery.

Methods: A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents.

[SICI-GISE position paper on the requirements for diagnostic and interventional procedures in patients with peripheral arterial disease].

Interventional procedures on peripheral vessels are the field of a novel specialty dedicated to the diagnosis and minimally invasive endovascular treatment of diseases involving the cerebral, thoracic and abdominal arteries (including renal and visceral arteries), as well as the peripheral arteries (femoro-popliteal arteries and the arteries below the knee). At present, physicians with three different types of medical training, each involving particular strengths and characteristics, specialize in endovascular treatment of patients with peripheral arterial disease: vascular surgeons, interventional radiologists and interventional cardiologists. Treatment of high-risk patients in terms of anatomical and clinical (serious comorbidities) complexity raised the need for the interventional cardiologist to face issues related to technical aspects of the procedure, multilevel pathology management and adequate indication.

2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.

Objectives: This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons.

Background: Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results.

Methods: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry.

Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis.

Objectives: The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).

Background: The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem.

Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results.

Background: The use of directional atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract.

Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry.

Objectives: This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.

Background: Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis.

A new paclitaxel-eluting balloon for angioplasty of femoropopliteal obstructions: acute and midterm results.

Aims: To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.

Methods And Results: In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB.

Heparin versus bivalirudin for carotid artery stenting using proximal endovascular clamping for neuroprotection: results from a prospective randomized study.

Background: General recommendations indicate that, during a carotid artery stenting (CAS), sufficient unfractionated heparin (UFH) has to be given to maintain the activated clotting time between 250 to 300 seconds. Bivalirudin use is able to reduce postprocedural bleedings in percutaneous interventions when compared with UFH. The study purpose was to evaluate, in a randomized study, the safety and efficacy of bivalirudin versus heparin during CAS, using proximal endovascular occlusion (PEO) as a distal protection device.

Renal artery stenting in patients with chronic ischemic heart disease.

Objectives: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis.

Methods: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events.

Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: a multicenter registry.

Background: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians.

Purpose: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators.

Classification for carotid artery stenting complications: manifestation, management, and prevention.

Carotid artery stenting is a rapidly evolving method for treating carotid artery disease. Various intraprocedural and postprocedural complications have been reported in the literature. However, the absence of a unified classification scheme for these complications makes it difficult, if not impossible, to study their precise incidence, predictors, and management.

Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.

Objectives: This single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population.

Background: In published multicenter registries, the use of PEO for carotid artery stenting (CAS) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions.

Methods: From July 2004 to May 2009, 1,300 patients underwent CAS using PEO.

Retrograde approach for complex popliteal and tibioperoneal occlusions.

Purpose: To describe the technical aspects of the retrograde approach for endovascular treatment of complex popliteal and/or tibioperoneal occlusions and determine its efficacy in minimizing failure rates.

Methods: An observational registry of retrograde revascularizations was maintained at our institution over 14 months (September 2006 to December 2007). During this time frame, antegrade revascularization failed in 62 (17.

Multicenter experience with a new "hybrid" carotid stent.

Purpose: To report the results from a prospective multicenter registry evaluating the safety and performance of a new hybrid stent specifically engineered for carotid indications.

Methods: Between October 18, 2006, and March 28, 2007, 124 patients (88 men; mean age 71.8+/-7.

Use of endovascular clamping as neuroprotection during carotid stenting in the presence of a critical ipsilateral stenosis of the external carotid artery.

Aims: Proximal endovascular clamping (PEC) appears to be a safe and effective cerebral protection technique for carotid artery stenting (CAS). So far the presence of severe stenosis of the ipsilateral external carotid artery (ECA) was considered a contraindication to PEC. This study presents the results of PEC for CAS in patients simultaneously presenting an ipsilateral ECA stenosis.

A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries.

Endovascular therapy is a rapidly evolving field for the treatment of patients with peripheral arterial disease, and a magnitude of studies reporting on various modern revascularization concepts have been recently published. Thus, studies assessing the efficacy of endovascular therapy of peripheral arteries do not operate with uniformly defined endpoints, rendering a direct comparison of studies difficult. The purpose of this consensus statement is to highlight differences in the terminology used in the current literature and to propose some standardized criteria that must be considered when reporting results of endovascular revascularization for chronic ischaemia of lower limb arteries.

Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions.

Background: Drug-eluting stents have been shown to be very effective in the treatment of coronary artery disease. In this independent, single-centre registry we assess the safety and efficacy of the sirolimus-eluting stent versus bare-metal balloon expandable stent for symptomatic infrapopliteal obstructions.

Methods And Results: A total of 60 consecutive patients with infrapopliteal arterial obstructions were treated by stent implantation into the tibial and peroneal arteries and the data was entered into a prospective registry.

Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results.

Purpose: To report the findings from a multicenter study of patients treated with cryoplasty who were then followed for an average of > 2 years post-treatment.

Methods: Extended clinical follow-up was obtained for 70 patients (45 men; mean age 70.5 +/- 8.

Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial.

Purpose: To evaluate the effectiveness of laser-assisted angioplasty for patients with critical limb ischemia (CLI) who were poor candidates for surgical revascularization.

Methods: A prospective registry at 14 sites in the US and Germany enrolled 145 patients with 155 critically ischemic limbs; the patients were poor candidates for bypass surgery owing to inadequate target vessel or saphenous vein, prohibitive cardiac disease, or significant comorbidities (ASA class 4). Additional comorbid risk factors included diabetes in 66%, hypertension in 83%, previous stroke in 21%, and myocardial infarction in 23%.

Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry.

Purpose: Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease.

Therapeutical potential of blood-derived progenitor cells in patients with peripheral arterial occlusive disease and critical limb ischaemia.

Aims: Despite considerable advances in the therapy of patients with peripheral arterial occlusive disease (PAOD) and critical limb ischaemia (CLI), a substantial number remain, in whom amputation has to be considered the only and final option. Recent evidence from animal models of hind limb ischaemia suggests that neovascularization induced by circulating blood-derived progenitor cells (CPCs) may permit limb salvage. It remains unclear, however, whether an intra-arterial application of autologous CPCs in patients with infrapopliteal PAOD and CLI is safe, feasible, and of potentially beneficial effects.