Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry.

PURPOSE: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. RESULTS: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Carotid Artery Stenting Using Five-French Distal Radial Vascular Access.

Carotid artery stenting (CAS) is usually performed through a femoral vascular access using 6-9 Fr guiding catheters. We investigated whether a systematic distal radial approach using 5 Fr guiding sheaths was a safe and effective alternative to transfemoral approach for CAS. From July 2020 to October 2022, two operators at our center systematically performed CAS using a 5 Fr distal radial approach in consecutive patients. The main endpoints of the study were procedural success via distal radial and via proximal or distal radial access. The learning curve was evaluated by comparing the first half of patients versus the second half of patients enrolled. Procedural data and 30-day clinical outcomes were collected. Fifty-one patients were prospectively enrolled. CAS was effectively performed via distal radial access in 45 patients (88%). Overall radial artery success was 92%. Distal radial CAS was successfully performed in 20 out of the first 25 patients enrolled (80%), and in 25 of the last 26 patients enrolled (96%; p = 0.07). Significantly less contrast was administered in the last 26 patients compared to the first 25 enrolled (110 (70, 140) mL vs. 120 (107, 150) mL; p = 0.045). Radial artery occlusion was reported in 1 patient (2%). Only 1 minor stroke (2%) was reported in-hospital and at 30-day follow-up. In conclusion, distal radial CAS using 5 Fr catheters was a safe procedure with a high success rate. The procedure had a relatively short learning curve in operators familiar with transfemoral CAS.

Combined therapy with rotational atherectomy and drug coated balloon for superficial femoral artery in-stent restenosis: safety, efficacy, and two-year results of a single center experience.

BACKGROUND: The primary patency rate of superficial femoral artery (SFA) after percutaneous transluminal angioplasty (PTA) has improved with the use of self-expanding stents. However, occurrence of in-stent restenosis (ISR) still represents a frequent problem. Despite different studies have assessed the role of atherectomy and drug coated balloons (DCBs), no long-term data exist about combined use. The aim of this study was to evaluate safety and efficacy of combined treatment with Jetstream (Boston Scientific Corp., Marlborough, MA, USA) atherectomy and DCB for SFA intrastent restenosis (ISR) at 2-year follow-up. METHODS: 30 patients treated with PTA from November 2018 to September 2019 at Montevergine Clinic (Mercogliano, Avellino, Italy) were included in this analysis. All patients underwent PTA of SFA-ISR with Jetstream Atherectomy System followed by paclitaxel eluting balloon treatment. Patients were evaluated at 30 days, and every 3 months up to 24. RESULTS: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. No acute and sub-acute(in-hospital) procedure related complications occurred. During follow-up, 1 patient died due to stroke. Primary patency rate at 12 months was 93.4%. Primary patency rate at 24 months was 83.4%. Secondary patency rate at 24 months was 96.7%. One minor amputation, planned before treatment, was performed in the first 30 days. CONCLUSIONS: Our data suggest that combined therapy with Rotational Atherectomy and DCBs for SFA-ISR represents a safe and effective procedure with a high rate of primary patency at 2-year follow-up.

Stress Hyperglycemia Drives the Risk of Hospitalization for Chest Pain in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA).

OBJECTIVE: Ischemia with nonobstructive coronary arteries (INOCA) is a prevailing finding in patients with angina. However, the main factors underlying the risk of being rehospitalized for chest pain in patients with INOCA remain mostly unknown. RESEARCH DESIGN AND METHODS: We evaluated INOCA patients referred to the "Casa di Cura Montevergine" in Mercogliano (Avellino), Italy, from January 2016 to January 2021 for percutaneous coronary intervention (PCI). In these subjects, we assessed the impact of the stress hyperglycemia ratio (SHR), defined as the ratio of mmol/L blood glucose and % HbA1c, on the risk of rehospitalization for chest pain. RESULTS: A total of 2,874 patients with INOCA successfully completed the study. At the 1-year follow-up, the risk of rehospitalization for chest pain was significantly higher (P < 0.001) in INOCA patients with SHR >1 compared to patients with SHR ≤1. These findings were confirmed by multivariable analyses (adjusting for potential confounders, including age, BMI, blood pressure, heart rate, chronic kidney disease, and cholesterol), propensity score matching, and inverse probability of treatment weighting. CONCLUSIONS: Our data indicate, to our knowledge for the first time, that SHR on hospital admission significantly and independently increases the risk of rehospitalization for chest pain in INOCA patients.

Conduction delays after transcatheter aortic valve implantation with balloon-expandable prosthesis and high implantation technique.

Performing transcatheter aortic valve implantation with high implantation technique, i.e. with an aorto-ventricular ratio > 60/40, reduces the need of permanent pacemaker implantation. Valve calcification and prosthesis oversizing are predictors of permanent pacemaker implantation, but there are no available data on their role when transcatheter aortic valve implantation is performed with an aorto-ventricular ratio > 60/40. The aim of this study was to evaluate the effect of leaflets/annulus calcification and prosthesis oversizing on the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation with a high implantation technique. Transcatheter aortic valve implantation was performed in 48 patients implanting a balloon-expandable transcatheter heart valve with an aorto-ventricular ratio > 60/40. Calcium burden was assessed by preprocedural multidetector computed tomography. An invasive electrophysiological study was performed before and after transcatheter aortic valve implantation. Five patients (10.4%) needed permanent pacemaker implantation. At univariate analysis, baseline right bundle branch block and postprocedural PR, QRS and His-ventricular interval elongation significantly predicted permanent pacemaker implantation (p < 0.05). Receiver-operating characteristic curve analysis showed a correlation between transcatheter heart valve oversizing and permanent pacemaker implantation need, with the best cut-off being 17% (AUC = 0.72, p = 0.033). Linear regression analysis demonstrated that QRS complex elongation was related to total, left and non-coronary leaflet calcification (p < 0.05). This study demonstrates that, when transcatheter aortic valve implantation is performed using a balloon-expandable transcatheter heart valve deployed with an aorto-ventricular ratio > 60/40, the presence of leaflets/annulus calcification or the need to oversize the prosthesis correlate with the occurrence of pathological cardiac conduction delays.

Three-year outcome of directional atherectomy and drug coated balloon for the treatment of common femoral artery steno-occlusive lesions.

BACKGROUND: Endarterectomy is considered the gold standard therapy for common femoral artery (CFA) steno-occlusive lesions, but a significant risk of perioperative mortality and complications has been reported. OBJECTIVE: Aim of this study is to evaluate the efficacy at a long-term follow-up of patients with CFA steno-occlusive lesions treated with directional atherectomy and drug coated balloon (DCB). MATERIAL AND METHODS: In this single-center registry, 78 patients (male: 80.7%; age: 71 ± 15 years; occlusions: 25%) with 80 CFA lesions were included, with 39.7% of them undergoing directional atherectomy and drug coated balloon due to critical limb ischemia and 60.3% due to lower-limb intermittent claudication. The long-term follow-up was completed by 75 patients (3 years). The 31 patients with critical ischemia (39.7%) were further subdivided into 20 (25.6%) patients with pain at rest and 11 (14.1%) with trophic changes, ulcers and/or tissue loss. We considered the primary and the secondary outcome, referring, respectively to peak systolic velocity ratio (PSVR) ≥ 2.4 on duplex or > 50% stenosis on digital subtraction angiography at 36 months and to clinically driven target lesion revascularization at 36 months. RESULTS: The primary and secondary outcome was obtained in 84% and 86.7% of patients, at 36 months of follow up. Bailout stenting was necessary in 6/80 cases (7.5%) for suboptimal result. Freedom from MALE was obtained in 98.6% of patients. CONCLUSIONS: These results confirm that directional atherectomy and drug coated balloon strategy for the treatment of CFA lesions is effective at a long-term follow-up and could be considered as a good alternative to surgery.

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Incidence and predictors of acute kidney injury in patients undergoing proximal protected carotid artery stenting.

AIMS: Many studies have analysed the occurrence of acute kidney injury (AKI) after percutaneous coronary intervention (PCI) but there are limited data relating to AKI risk in patients undergoing carotid artery stenting (CAS). The aim of this study was to determine the incidence and predictors of AKI in patients undergoing proximal protected CAS. METHODS AND RESULTS: We analysed 456 patients undergoing proximal protected CAS. A binomial multivariate logistic model was developed including patients' clinical and angiographic/procedural characteristics. AKI (defined as an sCr increase ≥0.3 mg/dl or ≥1.5-fold sCr increase from baseline or more than 50% increase from baseline, within 48 hours post procedure) occurred in 155 patients (34%). AKI patients were more frequently affected by hypertension, diabetes, dyslipidaemia and anaemia, and presented lower renal function at baseline. Higher contrast volume to creatinine clearance ratio (2.40±1.44 vs. 2.08±1.15; p=0.01), lower post-procedural mean arterial pressure (MAP) (94.3±17.7 vs. 99.6±18.5 mmHg; p=0.003) and a more frequent post-procedural systolic pressure drop (∆SBP >50 mmHg) (23.9% vs. 14.3%, p=0.01) were observed in the AKI group of patients. At multivariate analysis, independent predictors of AKI were ∆SBP >50 mmHg, diabetes mellitus and dyslipidaemia. CONCLUSIONS: AKI can occur quite frequently after proximal protected CAS and is related to clinical and procedural features. These data should be confirmed in larger registries or randomised trials.

Prosthesis depth and conduction disturbances after last generation balloon-expandable transcatheter aortic valve implantation.

Aims: Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate. Methods and results: Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (ß = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024). Conclusions: A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation.

Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes.

AIMS: Surgical endarterectomy is the therapy of choice for atherosclerotic common femoral artery (CFA) obstruction. Recently, some large single-centre series have shown encouraging results for the percutaneous treatment of CFA obstructions. The purpose of this study was to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of CFA obstructions with combined use of directional atherectomy (DA) and a paclitaxel-coated balloon (DCB). METHODS AND RESULTS: Between January 2012 and July 2014, 30 consecutive patients with severely calcified obstructions of the common femoral artery were treated in our centre using DA followed by DCB dilatation. Provisional stenting was allowed in the case of a suboptimal result. Twenty cases (66%) were isolated CFA interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively. Chronic total CFA occlusions (CTO) were recanalised in six cases (20%). Procedural success was achieved in all cases; stenting was needed in three cases (10%). At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively. The secondary patency rate was 96.7%. CONCLUSIONS: This single-centre prospective study suggests that the combined use of DA and DCB is a safe and effective alternative to surgery, a treatment option for common femoral artery lesions and provides encouraging results in this setting.

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). METHODS: From March 2010 to March 2012, 605 consecutive patients underwent proximal protected CAS at our institution. To identify independent predictors of OI, a multivariate logistic regression model was developed that included all patients' clinical/angiographic and procedural characteristics. RESULTS: OI developed in a total of 184 patients (30.4%). Compared with patients in whom OI did not develop, those who experienced OI had lower occlusion pressure (OP) (42.3 ± 12.7 mm Hg vs. 61.9 ± 15.4 mm Hg, p < 0.001). Receiver-operating characteristic curve analysis demonstrated that OP was the most consistent predictor of OI with a C-statistic of 0.85 (95% confidence interval [CI]: 0.82 to 0.88) with best cutoff being ≤40 mm Hg (sensitivity, 68.5%; specificity, 93.3%). By logistic regression analysis, the most powerful independent predictor of OI developing was an OP ≤40 mm Hg (odds ratio: 33.2, 95% CI: 19.1 to 57.7) and the most powerful clinical predictor of such OP was the presence of contralateral internal carotid artery occlusion (odds ratio: 3.1, 95% CI: 1.5 to 6.2). CONCLUSIONS: OI may occur in as many as one-third of the patients undergoing proximal protected CAS. This event is more common in those patients with an OP ≤40 mm Hg. Patients presenting with concomitant occlusion of the contralateral internal carotid artery more frequently have an OP ≤40 mm Hg.

SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation.

BACKGROUND: Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy. METHODS AND RESULTS: From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group (p<0.05). No differences in the clinical status were detected between the groups up to 6 months. CONCLUSIONS: This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI.

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. METHODS: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. RESULTS: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). CONCLUSIONS: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.

Percutaneous sympathectomy of the renal arteries: the OneShot Renal Denervation System is not associated with significant vessel wall injury.

AIMS: Renal artery denervation (RADN) is an emerging technique for the treatment of resistant hypertension (RH). However, the use of the available systems has been associated with vascular injury, resulting in vasospasm and vessel wall thrombosis. The OneShot System (Covidien, San Jose, CA, USA) is an irrigated radiofrequency balloon designed to reduce vessel heating and injury during RADN. METHODS AND RESULTS: The aim of the present study was to evaluate the target vessel morphological features before and after renal ablation using the OneShot RADN system. In this prospective observational study, 12 renal arteries of patients underwent RADN using the OneShot™ RADN System. Pre-procedural and post-procedural optical coherence tomography (OCT) pullbacks were performed and evaluated. No evidence for vasospasm, oedema or intraluminal thrombus formation was detected. Limited arterial dissections, after RADN, occurred in three renal arteries and did not require additional treatments. A sustained reduction of office blood pressure levels was observed over six months of follow-up in all the patients. CONCLUSIONS: This study demonstrates that, in a small patient population, RADN using the OneShot Renal Denervation System is not associated with arterial spasm or thrombus formation on the vessel wall.

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. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents. METHODS: From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months. RESULTS: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year. CONCLUSIONS: The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.

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. METHODS: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had life limiting claudication (LLC) (n=18) and 12 a critical limb ischemia (CLI) with baseline Rutherford class 4.2±1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis>50%) by visual estimation. After the intervention patients were followed up to 12 months. RESULTS: Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2±1.2, ABI was 0.8±0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n=30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR=10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. CONCLUSION: The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.

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.

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. Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure. RESULTS: Procedural success was achieved in 99.7% of patients. In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction. At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%). The 30-day stroke and death incidence was 1.38% (n = 19). Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs. 0.82%; p < 0.05). No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n = 12) and average surgical risk (1.07; n = 7) (p = NS). Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events. CONCLUSIONS: The use of PEO for CAS is safe and effective in an unselected patient population. Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events.