Giuseppe Galzerano

Subintimal Angioplasty with the Aid of a Re-entry Device for TASC C and D Lesions of the SFA

AIM The aim of this prospective study was to assess the clinical effectiveness and related midterm patency of subintimal angioplasty (SAP) in patients suffering from critical limb ischaemia (CLI) in a single tertiary care university centre. The secondary aim was to evaluate the safety and clinical effectiveness of using a re-entry device when re-canalisation by SAP was unsuccessful. METHODS From January 2005 to December 2007, consecutive patients suffering from CLI (Rutherford clinical categories: 4-6) were treated with SAP. All patients included in the study had occluded SFA (TASC C and D) and underwent clinical and ultrasound follow-up examinations at day 30 and at 3, 6, 9 and 12 months, and then yearly. A re-entry device (Outback, Cordis Corporation, Miami Lakes, Florida, USA in all cases) was only used when re-canalisation by simple SAP was unsuccessful, and stenting was used when residual stenosis was >30% or there was a flow-limiting dissection. Factors that could modify the outcome were analysed. RESULTS In this study, 145 patients were treated, with a technical success rate of 83.5% (121 of 145) for simple SAP. Stenting was performed in 43% (n=62) of successful SAP procedures. No death occurred in the perioperative period, while the 30-day mortality was 4.8% (7 of 145). The re-entry device (Outback) was used in 24 cases (16.5%). The technical success of the re-entry device was 79% (19 of 24), with a 90% success rate of stent placement at the site of re-entry. Complications occurred in 6.2% of all procedures (n=9) (three arterial perforations (2.1%), three distal embolisations (2.1%), two femoral artery pseudo-aneurysms (1.4%) and one arterio-venous fistula (0.7%)). Factors capable of independently affecting the patency were renal insufficiency (p=0.03), current smoking (p=0.01) and diabetes (p=0.04). The primary patency at 1 and 3 years was 70% and 34% and the secondary patency at 1 and 3 years was 77% and 43%, respectively. At the same time intervals, the limb-salvage rate was 88% and 49%. CONCLUSIONS SAP with the aid of a re-entry device for TASC C and D lesions of the SFA seems to be safe and clinically effective in patients suffering from CLI, according to the experience at our centre. Further follow-up and more data are necessary to confirm these findings.

Optical Coherence Tomography after Carotid Stenting: Rate of Stent Malapposition, Plaque Prolapse and Fibrous Cap Rupture According to Stent Design

OBJECTIVES This study aims to evaluate the rate of stent malapposition, plaque prolapse and fibrous cap rupture detected by optical coherence tomography (OCT) imaging according to carotid stent design. DESIGN It was a prospective single-centre study. MATERIALS AND METHODS Forty consecutive patients undergoing protected carotid artery stenting (CAS) and high-definition OCT image acquisition were enrolled in the study. OCT frames were analysed off-line, in a dedicated core laboratory by two independent physicians. Cross-sectional OCT images within the stented segment of the internal carotid artery were evaluated at 1-mm intervals for the presence of strut malapposition, plaque prolapse and fibrous cap rupture according to stent design. RESULTS Closed-cell design stents (CC) were used in 17 patients (42.5%), open-cell design stents (OC) in 13 (32.5%) and hybrid design stents (Hyb) in 10 (25%). No procedural or post-procedural neurological complications occurred (stroke/death 0% at 30 days). On OCT analysis the frequencies of malapposed struts were higher with CC compared to OC and Hyb (34.5% vs 15% and 16.3%, respectively; p < 0.01). Plaque prolapse was more frequent with OC vs CC (68.6% vs 23.3%; p < 0.01) and vs Hyb stents (30.8%; p < 0.01). Significant differences were also noted in the rates of fibrous cap rupture between CC and OC (24.2% vs 43.8%; p < 0.01), and between CC and Hyb (24.2% vs 39.6%; p < 0.01), but not between OC and Hyb stents (p = 0.4). CONCLUSION Intravascular OCT after CAS revealed that micro-defects after stent deployment are frequent and are related to the design of implanted stents. Stent malapposition is more frequent with CC stents, while plaque prolapse is more common with OC stents. It remains, however, unknown whether these figures now detected with OCT are of any clinical and prognostic significance.

AAA with a Challenging Neck: Early Outcomes Using the Endurant Stent-Graft System

OBJECTIVES The efficacy and safety of endovascular aneurysm repair is disputable in aneurysms with a short, angulated, wide, conical, or thrombus-lined neck making a reliable seal difficult to achieve. The influence of a challenging neck on early results using the Endurant stent-graft system in high risk patients was investigated. MATERIALS AND METHODS A retrospective study conducted on a prospectively compiled database of 72 elective patients with challenging neck treated with the Endurant system (Endurant Stent Graft, Medtronic AVE, Santa Rosa, CA, USA). These patients were compared to a control group (n = 65) without significant neck problems. Endpoints were early technical and clinical success, deployment accuracy and differences in operative details at one month follow-up. Data are reported as mean and standard deviation or as absolute frequency and percentage (%). Normality distribution and homogeneity of variances were tested by Shapiro-Wilks and Levene tests, respectively. Inter-group comparisons for each variable were made by t-test or χ2-test or Fisher exact test. A p < 0.05 was considered statistically significant. RESULTS Mean age was 76.12 years; 76.6% were males. Risk factors and pre-operative variables did not differ significantly between the two groups. Mean neck length was 10.56 mm in patients with challenging anatomies and 22.85 mm in controls. Patients with a challenging neck differed significantly (p < 0.001) from controls in terms of mean infrarenal (37.67° vs. 20.12°) and suprarenal angle (19.63° vs. 15.57°); 82% of patients with a challenging neck were ASA III/IV (vs. 86%). Technical success was 100%, with four unplanned proximal extension in challenging group. No type I endoleaks or aneurysm-related deaths occurred in either group; major complications were 1.54% vs. 1.39% (p = 0.942). Operative details were similar in both groups. CONCLUSION Treatment with the Endurant stent-graft is technically feasible and safe, yielding satisfactory results even in challenging anatomies. Medium- and long-term data are needed to verify durability, but early results are promising.

Safety and Feasibility of Intravascular Optical Coherence Tomography Using a Nonocclusive Technique to Evaluate Carotid Plaques Before and After Stent Deployment

Purpose To evaluate the safety and feasibility of optical coherence tomography (OCT) in patients with carotid stenosis undergoing carotid artery stenting (CAS). Methods In a prospective study, 25 consecutive patients (15 men; mean age 74±4 years) undergoing protected CAS were enrolled and underwent high-definition (homoaxial resolution 10 μm) OCT image acquisition before stent deployment, immediately after stent placement, and following postdilation of the stent (3 scans/patient). Pullbacks were started during a nonocclusive flush, mechanically injecting 24 mL of 50% diluted contrast at 6 mL/s to displace blood from the artery. Two independent physicians judged the quality of images on a predefined 1–10 scale. The proportions of specific agreement and kappa values (κ) were calculated. Results No procedural or in-hospital neurological complications occurred (any stroke/death 0%). The technical success of OCT pullbacks was 97.3% (73/75). The total amount of contrast was 86±18 mL/patient. No significant alteration in glomerular filtration rate or any other significant adverse event occurred. The images obtained were of high quality (mean value 8.1 out of 10), with good inter- and intraobserver agreement (κ = 0.81–0.87 and κ = 0.95, respectively). OCT images revealed innovative features such as rupture of the fibrous cap, plaque prolapse, and stent malapposition in a high percentage of the patients (range 24%–100%). Conclusion Intravascular OCT during a nonocclusive flush appears to be feasible and safe in carotid arteries. Since some original and unexpected information after CAS has been made available for the first time at such a high definition, future studies with OCT should focus on the interaction between carotid plaque and stent design, which might revolutionize our understanding of the mechanisms of carotid stenting, as well as influence our clinical policies.

How To Diagnose and Manage Infected Endografts after Endovascular Aneurysm Repair

The prevalence of endograft infections (EI) after endovascular abdominal aortic aneurysm repair is below 1%. With the growing number of patients with aortic endografts and the aging population, the number of patients with EI might also increase. The diagnosis is based on an association of clinical symptoms, imaging, and microbial cultures. Angio-computed tomography is currently the gold-standard technique for diagnosis. Low-grade infection sometimes requires nuclear medicine imaging to make a correct diagnosis. There is no good evidence to guide management so far. In the case of active gastrointestinal bleeding, pseudoaneurysm, or extensive perigraft purulence involving adjacent organs, an invasive treatment should always be attempted. In the other cases (the majority), when there is not an immediate danger to the patients life, a conservative management is started with a proper antimicrobial therapy. Any infectious cavity can be percutaneously drained. Management depends on the patients condition and a tailored approach should always be offered. In the case of a patient who is young, has a good life expectancy, or in whom there is absence of significant comorbidities, a surgical attempt can be proposed. Surgical techniques favor, in terms of mortality, patency, and reinfection rate, the in situ reconstruction. Choice of technique relies on the center and the operators experience. Long-term antibiotic therapy is always required in all cases, with close monitoring of the C-reactive protein.

Carotid Restenosis After Endarterectomy and Stenting: A Critical Issue?

BACKGROUND Carotid artery stenting (CAS) is currently considered a valid alternative to carotid endarterectomy (CEA) for the prevention of stroke in high-risk patients. One of the most important issues for both of these techniques is carotid restenosis. The aim of our study was to evaluate the incidence of post-CEA and post-CAS restenosis in a large cohort of patients in a single high-volume center. METHODS Between December 2000 and December 2010, 2453 CEA and 2628 CAS procedures were performed in the Vascular and Endovascular Surgery Unit at our institution. The mean age of patients was 73.8 years (range 55‒89 years), 78% of whom were men. Indications for carotid revascularization were: presence of symptomatic carotid artery stenosis of >70%, or asymptomatic stenosis of at least 80%, especially in patients with vulnerable plaques. RESULTS Mild and long-term results after CEA and CAS were similar. The overall perioperative neurologic complication rate (minor and major stroke) was similar in the 2 groups. At 1-year follow-up the restenosis rate after CEA was 1.58%. In-stent restenosis after CAS occurred in 1.67% of the procedures. All but 3 arteries had been treated for postsurgical restenosis. All lesions were approached secondarily with endovascular procedures. Statistical analysis demonstrated that post-CEA restenosis was the most important predictive factor for the development of in-stent restenosis after CAS. CONCLUSIONS This review of our 10-year experience confirms that patients who develop restenosis after CEA are also prone to developing in-stent restenosis after CAS.

Inguinal field block for femoral artery exposure during endovascular aneurysm repair.

Purpose To analyze the feasibility and outcomes of an inguinal field block (IFB) for femoral artery exposure in patients undergoing elective endovascular aneurysm repair (EVAR). Methods Between January 2004 and June 2012, 784 patients (597 men; mean age 76 years) underwent elective EVAR via surgical cutdown to the common femoral arteries. The data from these procedures were retrospectively analyzed to determine the technical feasibility of IFB, need for conversion to general anesthesia, mortality, and complication rate. Results IFB was successfully performed in 768 (97.9%) patients. Conversion from IFB to general anesthesia was necessary in 11 (1.4%) patients owing to patient discomfort (n=3, 0.4%), anxiety (n=5, 0.6%), and persistent patient movement (n=3, 0.4%). The remaining 5 (0.7%) patients underwent EVAR under general anesthesia because they refused IFB. Technical success of EVAR was 99.7%; the mean operation time was 84 minutes and the radiation time was 13 minutes. The mean hospital stay was 3.7 days; no patient required intensive care. At 6 months, there were no reports of local/systemic complications related to IFB, such as infection, seroma, hematoma, nerve injury, or allergic/toxic reactions. Conclusion Our study demonstrated that performing EVAR with femoral cutdown under IFB is a feasible, safe, and effective surgical and anesthetic combination, with very little need for conversion to general anesthesia.

Diabetic foot: surgical approach in emergency.

Introduction. Critical limb lschemia (CLI) and particularly diabetic foot (DF) are still considered “Cinderella” in our departments. Anyway, the presence of arterial obstructive disease increases the risk of amputation by itself; when it is associated with foot infection, the risk of amputation is greatly increased. Methods. From January 2007 to December 2011, 375 patients with DF infection and CLI have been admitted to our Unit; from 2007 to 2009, 192 patients (Group A) underwent surgical debridement of the lesion followed by a delayed revascularization; from 2010 to 2011, 183 patients (Group B) were treated following a new 4-step protocol: (1) early diagnosis with a 24 h on call DF team; (2) urgent treatment of severe foot infection with an aggressive surgical debridement; (3) early revascularization within 24 hours; (4) definitive treatment: wound healing, reconstructive surgery, and orthesis. We reported rates of mortality, major amputation, and foot healing at 6 months of followup. Results. The majority of patients in both groups were male; no statistical differences in medical history and clinical condition were reported at the baseline. The main difference between the two groups was the mean time from debridement to revascularization (3 days in Group A and 24 hours in Group B). After 6 months of follow-up, mortality was 11% in Group A versus 4.4% in Group B. Major amputation rate was 39.6% and 24.6% in Groups A and B, respectively. Wound healing was achieved in 17.8% in Group A and 20.8% in Group B. Conclusions. This protocol requires a lot of professional skills that should to reach the goal to avoid major amputations in patients with DF. Only an interdisciplinary integrated DF team and an early intervention may significantly impact the outcome of our patients: “Time is Tissue”!

Economic impact of endarterectomy vs carotid artery stenting : a one year, single centre study

AIMS Carotid artery stenting (CAS) has been suggested by some clinicians as an alternative to endarterectomy (CEA), especially in some specific subgroups of the population. The aim of this study is to evaluate the costs of these two procedures. METHODS AND RESULTS A review of costs was performed on all patients who underwent elective treatment of carotid artery stenosis between January and December 2006 (184 CAS vs 97 CEA). Clinical data had been prospectively gathered from both the CAS and the CEA groups, while financial data was obtained retrospectively to match hospital admissions with the generated charge from the hospital business office. In this series there was one major event in CEA and one transient ischaemic attacks (TIA) in CAS. One death procedure-related event occurred in CEA. The mean total cost associated with a single CEA was slashed integral 3,897.86, whereas the cost associated with CAS was slashed integral 3,806.66. It was apparent that the increasing costs involved in purchasing material for CAS, were balanced by the lower spending for hospital stay. CONCLUSIONS Costs for CAS and CEA are comparable. In our experience, the choice between CAS and CEA is based on the comorbidity of the patient, the type of the lesion and the preferences of the patient, without economic criteria being important.

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

Objective: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30‐day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure‐related mortality, complications, and reinterventions. Methods: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. Results: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46‐65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1‐year follow‐up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA‐related deaths occurred. Freedom from aneurysm‐related reintervention was 98.3% at 1‐month and 94.7% at 12‐month follow‐up. Conclusions: The preliminary results of this real‐world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure‐related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long‐term follow‐up data.