[SICI-GISE position paper on the requirements for diagnostic and interventional procedures in patients with peripheral arterial disease]. / Documento di posizione SICI-GISE sui requisiti di processo diagnostico ed interventistico riferiti a pazienti affetti da patologia vascolare periferica.

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. To achieve this goal, interventional cardiologists require particular facilities and clinical skills. The objectives of this position paper from the Italian Society of Interventional Cardiology (SICI-GISE) are (i) to define the theoretical background and practical training required to ensure that interventional cardiologists maintain high-quality standards also in the field of treatment of peripheral arterial disease, by establishing shared rules and drafting papers; (ii) to standardize the procedures of interventional cardiology operational units that treat patients with peripheral arterial disease in Italy on the basis of scientific evidence, and (iii) to establish common requirements in terms of facilities and regulations.

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. METHODS: From January 2006 to December 2009, 220 patients undergoing CAS using PEO have been randomly assigned to one of the study arms (control arm: 100 UI/kg UFH or bivalirudin arm: 0.75 mg/kg intravenous bolus and intraprocedural infusion at 1.75 mg/kg/h). RESULTS: Procedural success was achieved in all the patients. No episodes of intraprocedural thrombosis occurred. One major stroke occurred in the bivalirudin arm, and two minor strokes occurred, one in each group. A significant difference in the incidence of postprocedural bleedings was observed between the study groups; bivalirudin use was associated with reduced number of bleedings according to Thrombolysis In Myocardial Infarction criteria. CONCLUSIONS: The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings.

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 (17.8%) of 343 limbs with complex total occlusions of the popliteal and/or infrapopliteal vascular territory. Of these antegrade failures, 51 (82.2%) limbs in 51 patients (32 men; mean age 72+/-8 years) were suitable for a retrograde attempt. From this subgroup, 45 (88.2%) were treated via a percutaneous transpedal access site and 6 (11.8%) via a transcollateral intra-arterial technique. RESULTS: The overall success rate was 86.3% (44/51); adjunctive stenting was needed in 21 (41.1%) to optimize results. Only 1 (1.9%) major complication (a pedal access site occlusion) and 4 (7.8%) minor sequelae (arterial perforation in 3 and a pedal hematoma without consequence) were documented. CONCLUSION: In complex popliteal to infrapopliteal occlusions, an antegrade recanalization attempt can fail in up to 20% of the cases. The additional use of a retrograde approach seems feasible and safe and can favorably modify this failure rate. This technique could be valuable for patients with critical limb ischemia due to popliteal and infrapopliteal occlusions once larger studies with follow-up confirm safety, efficacy, and clinical benefit.

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%. Endovascular treatment included guidewire traversal and excimer laser angioplasty followed by balloon angioplasty with optional stenting. RESULTS: Occlusions were present in 92% of limbs. A mean of 2.7+/-1.4 lesions were treated per limb; the total median treatment length was 11 cm (mean 16.2, range 0.2-123). Stents were implanted in 45% of limbs. Procedural success, defined as <50% residual stenosis in all treated lesions, was seen in 86% of limbs. At 6-month follow-up, limb salvage was achieved in 110 (92%) of 119 surviving patients or 118 (93%) 127 limbs. CONCLUSION: Excimer laser-assisted angioplasty for CLI offers high technical success and limb salvage rates in patients unfit for traditional surgical revascularization.

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. All patients were treated with balloon-expandable coronary stents with a stent length of 33 mm and a nominal diameter of 3.5 mm. Enrolment was limited to patients treatable with a single stent. 30 patients (56.7% male, mean age 71.4 years, 83.3% diabetics) received a sirolimus-eluting balloon-expandable stent. 30 patients (63.3% male, mean age 73.0 years, 76.6% diabetics) were treated with uncoated bare-metal stents. At follow-up, the cumulative rates of Major Adverse Events were 10.0% vs. 46.6%. The rates of major amputation, bypass surgery or Target Lesion Revascularisation (TLR) were all zero for the sirolimus group compared with 10.0%, 0% and 23.3% in the bare metal stent group. There were 7 deaths (sirolimus =3, bare metal =7). Angiographic follow-up comparing sirolimus vs. bare metal revealed stent occlusion 0% vs. 17.4%, restenosis >50% of 0% vs. 39.1% (p 0.0007) and mean degree of in-stent restenosis of 1.8+/-4.8% vs. 53+/-40.9% (p <0.0001) respectively. CONCLUSION: In this registry sirolimus-eluting stents were shown to be safe and effective in the treatment of focal infrapopliteal obstructions.

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. MATERIALS AND METHODS: One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. RESULTS: A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. CONCLUSIONS: Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty.

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. METHODS AND RESULTS: Seven patients with critical PAOD were treated with an intra-arterial infusion of autologous CPCs (39+/-24 x 10(6)) isolated from peripheral blood. Pre-interventional stimulation with G-CSF and CPC application was well tolerated. Twelve weeks after CPC administration, the pain-free walking distance increased from 6+/-13 to 195+/-196 m. A significant increase in the ankle-brachial index, transcutaneous O(2), flow-dependent vasodilation, flow reserve in response to adenosine, and endothelium-dependent vasodilation was observed. CONCLUSION: These preliminary data in a small series of patients with CLI without surgical or interventional options indicate that CPC application is safe, feasible, and may improve both functional and clinical indices.