How to simplify the approach to the supra-aortic trunks.

Carotid artery stenting (CAS) represents a valid alternative to carotid endarterectomy (CEA). Possible embolization during the approach and the cannulation of the supra-aortic arterial trunks remains an important obstacle to CAS. This risk is increased in elderly patients and complex anatomies. In order to achieve satisfactory technical and clinical outcomes, a thorough understanding of the patients' individual anatomy of the arch and the access vessels is essential. The cannulation of the common carotid artery represents the key maneuver for the entire CAS procedure. This review article will present the currents techniques and devices actually use in order to facilitate the approach to the supra-aortic vessels.

A new idea for a safer approach to the supra-aortic trunks: the Piton™ catheter.

Carotid artery disease is among the most common causes of stroke, and stroke is the third leading cause of death in industrialized countries. Thus the personal health and socioeconomic burden of carotid artery disease is significant. Carotid artery disease accounts for approximately 5-12% of new strokes in patients amenable to revascularization therapy. Atherosclerosis is the main reason for stroke and accounts for approximately one third of all cases. Carotid stenting is nowadays considered a valid standard alternative to surgical carotid endarterectomy, especially in patients having a high perioperative risk. The first carotid balloon angioplasty was carried out in 1979 and the first carotid balloon-expandable bare metal stents were implanted 10 years later, in 1989. However, carotid stenting at that time was associated with major complications, due to extrinsic compression and subsequent to the steel stents used. The Piton™ GC (carotid guide catheter) is intended to facilitate the introduction and placement of interventional devices (e.g., guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) into the human vasculature to treat vascular obstructive disease, including but not limited to the supra-aortic vessels.

Mechanical thrombectomy in in-stent restenosis: preliminary experience at the iliac and femoropopliteal arteries with the Rotarex System.

AIM: Iliac and femoropopliteal arterial stenting remains controversial due to frequent restenosis. This study aims to evaluate the efficacy of a mechanical rotational thrombectomy procedure with the Rotarex Mechanical Thrombectomy System (Straub Medical, Wangs, CH) and percutaneous transluminal angioplasty (PTA) in terms of technical success, patency rates and limb salvage. METHODS: From May 2006 to March 2010, 32 selected patients with sub-acute or chronic in-stent restenosis at the iliac or femoropopliteal arteries were treated with a Rotarex and then PTA procedure. RESULTS: Technical success was 100%. Intra-procedural complications included a superficial femoral artery (SFA) dissection (1), SFA (1) and external iliac (1) perforations and a groin hematoma (1). There was no incidence of embolization in this series. One patient required reintervention (3.1%); an attempted surgical bypass and amputation. Secondary reinterventions were required in 17 patients (53.1%). Limb salvage rate at 12 months was 90.6%. Primary patency at 30 days was 96.8%. Primary, primary assisted and secondary patency rates at 6 months were 75%, 75% and 89.6% and at 12 months were 58.1%, 58.1% and 75.5%, respectively. Late mortality was 18.75% at an average follow-up of 13.1 months (3-45) due to the severe disease state of these patients.. CONCLUSION: This treatment seems promising in terms of technical success and embolization risk. Reinterventions are frequently required but mid-term limb salvage rates are encouraging. Larger, randomised studies are needed to determine the cost/benefit advantage and long-term results.

Advancements in the Mo.Ma system procedure during carotid artery stenting.

AIM: The aim of this paper was to reduce the incidence of clamping intolerance, asystolia, immediate mortality and neurological complications associated with carotid artery stenting (CAS) using the Mo.Ma system (Invatec, Roncadelle Brescia, Italy) embolic protection device (EPD). METHODS: CAS was perfomed using the Mo.Ma system in 312 patients between January 2002-October 2009. From October 2008 variations to the standard technique were introduced. A total of 214 patients were treated with the standard technique, and 88 with the new technique. Improvements include the engagement of the guidewire's floppy tip through the lesion whilst the cerebral blood flow is maintained, a slow release post-dilation (1 atm/2 s), a quicker manual aspiration procedure following post-dilation, a redirection of blood flow into the external carotid artery (ECA) with the post-dilation balloon inflated in the internal carotid artery (ICA), and a further manual aspiration and the subsequent release of the Mo.Ma system. RESULTS: This study reports reduced incidence of clamping intolerance (7.9% vs. 4.5%), asystolia (0 vs. 1.9%), immediate mortality (0 vs. 0.9%) and neurological complications (1.1% vs. 3.7%). The only neurological complication associated with the new technique was a transient ischemic attack (TIA). CONCLUSIONS: The new variations of the standard Mo.Ma technique seem rational in the improvement of the safety and efficacy of CAS using an EPD, in reducing the incidence of clamping intolerance and asystolia, immediate mortality and neurological complications. This series indicates a positive trend for this revised technique, but a multicentre registry is required to validate these promising results.

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results.

AIM: The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent. METHODS: This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions > or = 4.0 mm and < or = 7.0 mm in diameter, and > or = 40 mm and < or = 200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents. RESULTS: Mean target lesion length was 108 +/- 44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6 +/- 0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9 +/- 15.5 % (range 41.3 to 100) to 19.0 +/- 8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a > or = 30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63 +/- 0.20 to 0.94 +/- 0.17 and from 0.44 +/- 0.23 to 0.85 +/- 0.21, respectively (P<0.001 each). CONCLUSION: The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions:

Effectiveness and safety of carotid endarterectomy under remifentanil.

AIM: The aim of this study was to evaluate the effectiveness and safety of carotid endarterectomy (CEA) with conscious sedation under remifentanil (Remifentanil anesthesia - RA) vs conventional loco-regional anesthesia (Conventional-LRA) in the current practice of a vascular surgery unit. METHODS: We introduced the ''Remifentanil-RA'' in our practice according to a two-step protocol. In the first step we performed a pilot prospective study to assess the procedure's safety and reproducibility in our setting on 60 consecutive patients with symptomatic and/or high-grade (>70%) internal carotid artery stenosis and alternately assigning them either to ''Remifentanil-RA'' or ''Conventional-LRA'' CEA. In the second step we analysed our routine operative records as to effectiveness and safety on 533 patients who consecutively underwent ''Remifentanil-RA'' CEA. We compared them with 533 age- and sex-matched historical controls who underwent ''Conventional-LRA'' CEA. RESULTS: The patients' mean age was 71.2+/-6.8 vs 71.8+/-6.1 (''Remifentanil-RA'' vs ''Conventional-LRA''). About 73% of them were male and 56% had a symptomatic carotid stenosis. Neither the pilot study nor second step comparison showed differences in outcome measures. We found only higher peri-operative nausea/ vomit (3.6% vs 0.4% ''Remifentanil-RA'' vs ''Conventional-LRA'', P<0.0002) and fewer re-operations for post-operative hematomas (3% vs 5.4% respectively, P=0.048). CONCLUSIONS: We found that ''Remifentanil-RA'' CEA was safe, effective and satisfactory. Nevertheless, with the potential problems of intubation and those already found with side effects, a randomized control trial (RCT) is needed in order to prove that this method is superior to ''Conventional-LRA'' CEA.

PRIAMUS--proximal flow blockage cerebral protectIon during carotid stenting: results from a multicenter Italian registry.

AIM: The aim of this Italian prospective registry was to evaluate the applicability and efficacy of the Mo.Ma Device (Invatec, Roncadelle, Italy) for the prevention of cerebral embolization during carotid artery stenting (CAS) in a real world population. METHODS: In 4 Italian centers, 416 patients (300 men; mean age 71.6+/-9 years) between October 2001 and March 2005 were enrolled in a prospective registry. Two-hundred and sixty-four symptomatic (63.46%) with >50% diameter stenosis and 152 (36.54%) asymptomatic patients with >70% diameter stenosis were included. The Mo.Ma Proximal Flow Blockage Embolic Protection System was used to perform protected CAS, achieving cerebral protection by endovascular clamping of the common carotid artery (CCA) and of the external carotid artery (ECA). RESULTS: Technical success, defined as the ability to establish protection with the Mo.Ma device and to deploy the stent, was achieved in 412 cases (99.03%). The mean duration of flow blockage was 4.91+/-1.1 min. Transient intolerances to flow blockage were observed in 24 patients (5.76%), but in all cases the procedure was successfully completed. No peri-procedural strokes and deaths were observed. Complications during hospitalization included 16 minor strokes (3.84%), 3 transient ischemic attacks (0.72%), 2 deaths (0.48%) and 1 major stroke (0.24%). This resulted in a cumulative rate at discharge of 4.56% all strokes and deaths, and of 0.72% major strokes and deaths. All the patients underwent thirty-day follow-up. At thirty-day follow-up, there were no deaths and no minor and major strokes, confirming the overall cumulative 4.56% incidence of all strokes and deaths rate, and of 0.72% rate of major strokes and deaths at follow up. In 245 cases (58.89%) there was macroscopic evidence of debris after filtration of the aspirated blood. CONCLUSIONS: This Italian multicenter registry confirms and further supports the efficacy and applicability of the endovascular clamping concept with proximal flow blockage in a broad patient series. Results match favorably with current available studies on carotid stenting with cerebral protection.

First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting.

OBJECTIVES: This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting. METHODS: Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis > or =75% (mean 87%) or a symptomatic stenosis > or =60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up. RESULTS: Stenting was performed in all but one patient. The mean flow occlusion time was 10.6+/-6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up. CONCLUSIONS: This first clinical experience with the Mo.Ma device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.

Experience with the Stentor endograft at four Italian centers.

PURPOSE: To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device. METHODS: Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms. RESULTS: Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques. CONCLUSIONS: The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.

The Italian trial of endovascular AAA exclusion using the Parodi endograft.

PURPOSE: To report the outcome of the prospective 11-center Italian Parodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). METHODS: From April 1994 to July 1995, 27 patients were evaluated and selected for endovascular AAA exclusion. The Parodi devices were delivered through femoral arteriotomies using 18 to 22F introducers and deployed by balloon expansion of the terminal stents. RESULTS: Of 27 cases attempted, 24 endografts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 access failures [11.1%] were converted). Three endoleaks (12.5%) were treated intraoperatively with covered stents, two successfully, and the third sealed within 30 days. Three (12.5%) of the 24 treated patients died in-hospital of device-(n = 2) and procedure-related (n = 1) causes; the remaining 21 patients were discharged within 8 days. Of the 8 aortomonoiliac grafts in follow-up, only 1 (12.5%) failed in the mean 23-month (range 18 to 30) follow-up: however, 4 (31%) of 13 tube graft patients were converted to surgery within 18 months. Of the 16 (66.7%) surviving endografts at 2 years, 6 (38%) showed no change in the AAA diameter, while 10 (62%) had shrunk. CONCLUSIONS: The tube graft was applicable in only about 5% of cases, and accurate endograft sizing and distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the advent of newer endograft models, the Italian Parodi Trial has been terminated.

[Carotid endarterectomy using the classical technique and by eversion]. / Endoarteriectomia carotidea con tecnica classica e per eversione.

After a brief introduction on the history of the surgical treatment of carotid stenosis the authors illustrate both the classical endarterectomy and the eversion endarterectomy. The constant search for a technique which could be of easy execution and also reduce the risk of complication (especially late ones, such as restenosis), brought the authors to adopt the eversion endarterectomy with reimplantation of internal carotid artery. From 1990 through 1995, 1034 carotid endarterectomies were performed, of which 611 with eversion technique and 423 with others techniques. The average follow-up was 38 months. The eversion endarterectomy group had lower neurological morbidity and mortality rates, both early and late. Even more important, they had a lower incidence rate of hemodynamically relevant restenosis (0.37% in the eversion endarterectomy group vs 1.97% in the other group).