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Aims: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS)., Methods and Results: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into <7.5 mm2 or >7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 <7.5 mm2 open-cell, and 197 >7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a <7.5 mm2 open-cell (1.26%), and six in those treated with a >7.5 mm2 open-cell stent (3.05%) (p=0.045)., Conclusions: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk.

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.

Aims: We aimed to appraise the predictive accuracy of a novel and user-friendly risk score, the ACEF (age, creatinine, ejection fraction), in patients undergoing PCI for coronary bifurcations., Methods and Results: A multicentre, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 in 22 Italian centres. Patients with complete data to enable computation of the ACEF score were divided into three groups according to tertiles of ACEF score. The primary endpoint was 30-day mortality. The discrimination of the ACEF score as a continuous variable was also appraised with area under the curve (AUC) of the receiver-operating characteristic. A total of 3,535 patients were included: 1,119 in the lowest tertile of ACEF score, 1,190 in the mid tertile, and 1,153 in the highest tertile. Increased ACEF score was associated with significantly different rates of 30-day mortality (0.1% in the lowest tertile vs. 0.5% in the mid tertile and 3.0% in the highest tertile, p<0.001), with similar differences in myocardial infarction (0.3% vs. 0.7% and 1.8%, p<0.001) and major adverse cardiac events (MACE, 0.5% vs. 1.2% and 4.3%, p<0.001). After an average follow-up of 24.4±15.1 months, increased ACEF score was still associated with a higher rate of all-cause death (1.3% vs. 2.4% and 11.0%, p<0.001), cardiac death (0.9% vs. 1.4% and 7.2%, p<0.001), myocardial infarction (3.4% vs. 2.7% and 5.7%, p<0.001), MACE (13.6% vs. 15.9% and 22.3%, p<0.001), and stent thrombosis (2.3% vs. 1.8% and 5.0%, p<0.001). Discrimination of ACEF score was satisfactory for 30-day mortality (AUC=0.82 [0.77-0.87], p<0.001), 30-day MACE (AUC=0.73 [0.67-0.78], p<0.001), long-term mortality (AUC=0.77 [0.74-0.81], p<0.001), and moderate for long-term MACE (AUC=0.60 [0.57-0.62], p<0.001)., Conclusions: The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality.

Aims: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxel-coated stents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions., Methods and Results: The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture in the mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintaining SB access during procedure. From December 2008 to February 2010, 101 patients were prospectively enrolled in a non-randomised, multicentre study. Lesion criteria were: vessel size 2.5-3.5 mm in the parent vessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean age was 63 years, 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement of both branches. The study stent was successfully attempted and implanted in 98%. SB received additional stent in 26% final kissing-balloon inflation was performed in 93% and lesion (angiographic) success was achieved in 98%. There was only one non-Q myocardial infarction during hospitalisation, and no additional events up to 30 days., Conclusions: Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstrated encouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcation lesions, including high device and procedural success. Overall, there was only one major adverse cardiac event during hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted.

Aims: Optical coherence tomography (OCT) is an increasingly used intravascular imaging modality to assess coronary stent implantation and vessel healing. A recently developed catheter (C7 Dragonfly; LightLab Imaging Inc.,Westford, MA, USA) allows visualisation of peripheral arteries up to 10 mm of diameter with high speed pullback. Safety, feasibility and the technique of OCT following carotid artery stenting (CAS) were evaluated in the present study., Methods and Results: OCT was performed in seven consecutive patients following successful CAS using proximal cerebral protection devices, occluding the common and external carotid artery and gentle manual injection of a total of 8-14 ml of 50% diluted contrast media with normal saline in order to displace the blood from the artery. Once the blood was displaced, pullback was started through the stented segment continuing the gentle contrast injection. After completion of the pullback all injected contrast was aspirated and discarded. In the first three patients, OCT was also performed without internal carotid artery flow blockage. Due to the high blood flow in the ICA it was not possible to replace all residual blood and obtain adequate OCT images. No procedural, in-hospital, or 30-day follow-up complications occurred. One patient experienced transient intolerance to vessel occlusion without any neurological sequels. OCT images were of good quality providing important information regarding stent geometry, presence and lack of strut apposition, plaque fracture, and plaque prolapse., Conclusions: Intravascular OCT under occlusive proximal protection appears feasible and safe to assess stent implantation in carotid arteries.

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. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up., Conclusions: The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Aims: Transcatheter aortic valve implantation (TAVI) is becoming a safe and effective technique for treating symptomatic aortic valvular stenosis (AVS) as an alternative to surgery in very high-risk patients. A possible consequence of valve implantation is the obstruction of coronary ostia., Methods and Results: Here we report five cases of angiographically confirmed left main (LM) obstruction, occurred immediately after balloon expandable aortic valve implantations at our institution. In four of these cases, LM obstruction was resolved with an emergency percutaneous coronary intervention (PCI). In the remaining case, obstruction transiently occurred only at the time of balloon valvuloplasty and did not required treatment. During this type of intervention, performing an aortography at the time of balloon valvuloplasty could help to identify patients at risk for coronary obstructions., Conclusions: These cases illustrate that obstruction of the coronary ostia following TAVI is a possible complication. As the use of TAVI becomes widespread, the operators should be aware of this dangerous complication in their case preparation should it arise.

Aims: Recent studies of drug-eluting stents for unprotected left main coronary artery (LMCA) disease have been encouraging. We examined the performance of sirolimus-eluting stents (SES) for this indication., Methods and Results: This retrospective study included 228 consecutive patients (mean age = 68 +/- 11 years, 80.6% men, 26.3% diabetics) who underwent implantation of SES for de novo LMCA stenoses. The mean additive and logistic EuroSCOREs were 5.2 +/- 3.9 and 8.2 +/- 13.2, respectively. The main objective of this study was to measure the rate of major adverse cardiac events (MACE), including death, myocardial infarction and target lesion revascularisation (TLR) at 12 months. Other objectives were to measure the rates of in-hospital MACE and 12-month TLR. Outcomes in 143 patients with (BIF+ group), versus 84 patients without (BIF-group) involvement of the bifurcation were compared. The pre-procedural percent diameter stenosis (%DS) was 60.1 +/- 11.2 in the BIF+ versus 54.7 +/- 12.2% in the BIF- group (p=0.008), and decreased to 18.0 +/- 9.7 and 13.9 +/- 11.3%, respectively (ns), after SES implant. The overall in-hospital MACE rate was 3.5%, and similar in both subgroups. The 1-year MACE rate was 14.5% overall, 16.8% in the BIF+ and 10.7% in the BIF- subgroup (ns)., Conclusions: SES implants in high-risk patients with LMCA stenoses were associated with a low 1-year MACE rate. Stenting of the bifurcation was associated with significant increases in neither mortality nor 1-year MACE rate.

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., Methods and Results: From September 2004 to December 2006, CAS was performed in 500 unselected cases using PEC. In sixty cases (12%) a severe ipsilateral ECA stenosis (>/=80%) was identified by angiography. In all these cases procedural success, defined as the ability to establish cerebral protection as well as stent deployment with a residual stenosis <30%, was achieved. Time of flow blockage was 188+/-37 sec. Clamping intolerance, a transient neurological deficit lasting < 20 min, occurred in five of 60 patients. In-hospital MACCE included only one minor stroke, but no major strokes, AMI or death., Conclusions: This experience indicates that the use of PEC, also in the presence of a critical ECA stenosis, is safe and effective. Therefore critical ECA stenosis should no longer be considered a contraindication to PEC.