Transealing: a novel and simple technique for embolization of type 2 endoleaks through direct sac access from the distal stent-graft landing zone.

OBJECTIVE: Type 2 endoleak (T2EL) is the Achilles' heel of endovascular abdominal aortic aneurysm repair. Experience with transealing, an alternative technique for the treatment of T2ELs, is described. METHODS: The outcome of a group of patients treated with transealing has been reviewed. Femoral access was obtained with a 9-Fr sheath. A super-stiff guide wire and a stiff hydrophilic wire were placed inside the stent-graft and a Piton GC catheter inserted. The stiff hydrophilic wire was retrieved to allow the catheter to regain its curvature and the catheter tip was placed against the iliac wall, at the edge of the stent-graft. The hydrophilic wire was then forced between the stent-graft and arterial wall into the sac. A 5/6-Fr introducer was inserted inside the sac and angiography was performed to evaluate the leak. Coils, cyanoacrylate, or fibrin glue were deployed. After removal of the catheters, the iliac limb was ballooned. RESULTS: Seventeen patients were treated between February 2009 and April 2013. It was possible to access the aneurysm in 16/17 attempts. One patient treated with acrylic glue suffered from colon ischemia. One intraoperative secondary type 1b endoleak was treated with an iliac extension. Mean follow-up was 21.5 months. Three months of follow-up were completed in 14 patients with a 53% freedom from endoleak rate. At 1 year, the rate was 45%. During the study period, there was one surgical conversion, one aneurysm growth, and one re-embolization procedure. The remaining leaks remained stable. CONCLUSIONS: This study shows that transealing is feasible and represents a valid alternative in selected patients. The advantages of this technique are mainly its low invasiveness, reduced costs, and ease of use.

INCRAFT® Stent-Graft System: one-year outcome of the INNOVATION Trial.

AIM: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA. METHODS: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up. RESULTS: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA. CONCLUSION: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.

BRAVISSIMO: 12-month results from a large scale prospective trial.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

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.

Endovascular preservation of pelvic circulation with external iliac-to-internal iliac artery "cross-stenting" in patients with aorto-iliac aneurysms: a case report and literature review.

Endovascular success depends heavily upon anatomical suitability for secure graft placement. Common iliac artery (CIA) aneurysms frequently extend close to the iliac bifurcation, requiring distal fixation in the external iliac artery (EIA), in turn excluding the internal iliac artery (IIA). The preservation of circulation to at least one IIA artery is highly recommended. We report an endovascular technique for complete preservation of the hypogastric arteries of an aorto-iliac aneurysm extending into the iliac bifurcation and hypogastric artery. A left CIA aneurysm involving the iliac bifurcation was excluded with a covered Fluency stent-graft (Bard Inc., New Jersey, USA) deployed from the EIA into the IIA followed by the internal deployment of a Luminex uncovered stent (Bard Inc.) extended into one branch of the hypograstric artery. IVUS evaluation was essential in determining precise aneurysm and sealing zone measurements. Complete preservation of hypogastric circulation was achieved. The placement of the uncovered stent effectively extended the sealing zones without covering either of the hypogastric distal branches and concurrently corrected the Fluency stent kinking due to severe arterial tortuosity. In CIA aneurysms involving the IIA, an uncovered stent can extend the sealing zones, whilst maintaining complete preservation of pelvic circulation and offers support to the covered stent-graft. IVUS seems necessary for precise neck evaluation.

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.

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.

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.

[Differentiated carcinoma of the thyroid]. / Considerazioni sul carcinoma differenziato della tiroide.

Experience in differentiated thyroid carcinoma surgery is presented. It is considered that, although these neoplasias are not very aggressive, they should be treated radically with a combination of surgery and radioisotopes.

[Not the beta-thalassemia syndrome but hemoglobinopathy H. Studies of 3 clinical cases]. / Non sindrome beta-talassemica ma emoglobinopatia H. Osservazioni su tre casi clinici

Clinical and laboratory data for three patients are presented. Electrophoretic separation of the freshly obtained haemolysate showed a fast beta-chain fraction on each occasion. This is typical of Hb H disease. The test for erythrocyte inclusion bodies was also positive. The main clinical and haematological features of the disease are illustrated.