Francesco Squizzato

Outcomes of endovascular aneurysm repair with contemporary volume-dependent sac embolization in patients at risk for type II endoleak

OBJECTIVE The aim of this study was to evaluate outcomes of intraoperative aneurysm sac embolization during endovascular aneurysm repair (EVAR) in patients considered at risk for type II endoleak (EII), using a sac volume-dependent dose of fibrin glue and coils. METHODS Between January 2012 and December 2014, 126 patients underwent EVAR. Based on preoperative computed tomography evaluation of anatomic criteria, 107 patients (85%) were defined as at risk for EII and assigned to randomization for standard EVAR (group A; n = 55, 44%) or EVAR with intraoperative sac embolization (group B; n = 52, 42%); the remaining 19 patients (15%) were defined as at low risk for EII and excluded from the randomization (group C). Computed tomography scans were evaluated with OsiriX Pro 4.0 software to obtain aneurysm sac volume. Freedom from EII, freedom from EII-related reintervention, and aneurysm sac volume shrinkage at 6, 12, and 24 months were compared by Kaplan-Meier estimates. Patients in group C underwent the same follow-up protocol as groups A and B. RESULTS Patient characteristics, Society for Vascular Surgery comorbidity scores (0.99 ± 0.50 vs 0.95 ± 0.55; P = .70), and operative time (149 ± 50 minutes vs 157 ± 39 minutes; P = .63) were similar for groups A and B. Freedom from EII was significantly lower for group A compared with group B at 3 months (58% vs 80%; P = .002), 6 months (68% vs 85%; P = .04), and 12 months (70% vs 87%; P = .04) but not statistically significant at 24 months (85% vs 87%; P = .57). Freedom from EII-related reintervention at 24 months was significantly lower for group A compared with group B (82% vs 96%; P = .04). Patients in group B showed a significantly overall mean difference in aneurysm sac volume shrinkage compared with group A at 6 months (-11 ± 17 cm(3) vs -2 ± 14 cm(3); P < .01), 12 months (-18 ± 26 cm(3) vs -3 ± 32 cm(3); P = .02), and 24 months (-27 ± 25 cm(3) vs -5 ± 26 cm(3); P < .01). Patients in group C had the lowest EII rate compared with groups A and B (6 months, 5%; 12 months, 6%; 24 months, 0%) and no EII-related reintervention. CONCLUSIONS This randomized study confirms that sac embolization during EVAR, using a sac volume-dependent dose of fibrin glue and coils, is a valid method to significantly reduce EII and its complications during early and midterm follow-up in patients considered at risk. Although further confirmatory studies are needed, the faster aneurysm sac volume shrinkage over time in patients who underwent embolization compared with standard EVAR may be a positive aspect influencing the lower EII rate also during long-term follow-up.

Quantitative analysis and predictors of embolic filter debris load during carotid artery stenting in asymptomatic patients

Objective: The objective of this study was to perform a quantitative analysis and to identify predictors of embolic filter debris (EFD) load during carotid artery stenting (CAS) in asymptomatic patients. Methods: All patients with asymptomatic carotid stenosis >70% undergoing CAS between 2008 and 2016 were included in a prospective database. A distal filter protection device was used in all patients. At the end of the procedure, the filter was fixed in formalin and then analyzed with a stereomicroscope. Morphometric analysis was performed with Image‐Pro Plus software (Media Cybernetics, Rockville, Md). The total area of the filter membrane and the area covered by particulate material were quantified. The quantity of membrane occupied by debris was expressed as percentage of covered surface area. Anatomic and clinical variables were evaluated for their association with EFD load using multiple logistic regression. Results: Among the 278 patients undergoing CAS, an open‐cell stent was implanted in 211 patients (76%); 67 patients (24%) received a closed‐cell stent. Overall technical success and clinical success were both 99%; no perioperative death was reported. Stroke rate was 1.8% (major, n = 1 [0.4%]; minor, n = 4 [1.4%]); transient ischemic attacks occurred in 5% of cases (n = 14). The quantitative analysis of the filter revealed that EFD was present in 74% of cases (n = 207). The mean EFD load was 10% of the filter surface (median, 1; range, 0‐80); it was <10% in 203 patients (73%), between 11% and 20% in 39 patients (14%), between 21% and 30% in 14 patients (5%), and >31% in 22 (8%). Patients with any type of ischemic neurologic event after CAS (stroke and transient ischemic attack) had a significantly higher mean EFD load compared with uneventful cases (26.7% ± 19.0% vs 8.5% ± 13.5%; P < .001). The observational frequency distribution analysis identified the presence of >12.5% EFD load as the optimal cutoff for the association with clinically relevant perioperative ischemic events (sensitivity, 78%; specificity, 77%; area under the curve, 0.81). The multivariate analysis demonstrated that age >75 years (odds ratio [OR], 2.56; P = .003), pre‐existing ipsilateral ischemic cerebral lesions (OR, 2.09; P = .047), hypoechogenic plaque on the preoperative duplex ultrasound examination (OR, 6.05; P < .001), and plaque length >15 mm (OR, 1.79; P = .049) were independent predictors of EFD load >12.5%. Conclusions: The majority of asymptomatic carotid stenoses treated with CAS have detectable embolic debris in the protecting filter. Age >75 years, pre‐existing ipsilateral cerebral ischemic lesions, hypoechogenic plaque, and plaque length >15 mm should be taken into consideration as independent predictors of clinically relevant embolic debris during the procedure. Graphical Abstract: Figure. No Caption available.

Definition of Type II Endoleak Risk Based on Preoperative Anatomical Characteristics

Purpose: To define the risk for type II endoleak (EII) after endovascular aneurysm repair (EVAR) based on preoperative anatomical characteristics. Methods: Between January 2008 and December 2015, 189 patients (mean age 78.4±7.6 years; 165 men) underwent standard EVAR. Mean aneurysm diameter was 5.7±0.7 cm and mean volume 125.2±45.8 cm3. Patients were assigned to the “at-risk” group (n=123, 65%) when at least one of the following criteria was present: patency of a >3-mm inferior mesenteric artery (IMA), patency of at least 3 pairs of lumbar arteries, or patency of 2 pairs of lumbar arteries and a sacral artery or accessory renal artery or any diameter patent IMA; otherwise, patients were entered in the “low-risk” group (n=66, 35%). EII rates and freedom from EII reintervention were compared using Kaplan-Meier curves. Preoperative clinical and anatomical characteristics were evaluated for their association with EII and EII reinterventions using multiple logistic regression analysis; results are presented as the odds ratio (OR) and 95% confidence interval (CI). Results: Freedom from endoleak was lower in the at-risk group compared with the low-risk group at 36 months after EVAR (p=0.04). Freedom from EII-related reinterventions was significantly lower in the at-risk group (80% vs 100%, p=0.001) at 48 months. Based on the multiple regression analysis, the at-risk group had a higher likelihood of both EII (OR 9.91, 95% CI 2.92 to 33.72, p<0.001) and EII-related reinterventions (OR 9.11, 95% CI 1.06 to 78.44, p=0.04). These criteria had 89.4% (95% CI 83.9% to 93.2%) sensitivity and 48.0% (95% CI 40.7% to 55.3%) specificity for EII; sensitivity and specificity for EII reintervention were 100% (95% CI 93.8% to 100%) and 38.8% (95% CI 31.9% to 46.2%). Within the at-risk group, a sac thrombus volume <35% was an additional predictor for both EII (OR 5.21, 95% CI 1.75 to 15.47, p=0.003) and EII-related reinterventions (OR 8.33, 95% CI 2.20 to 31.51, p<0.002). Conclusion: The selection criteria effectively discriminated between low-risk patients and patients at risk for EII and associated reinterventions. A thrombus volume <35% was an additional predictor for EII and EII-related reintervention among patients at risk. These criteria may be useful for preemptively selecting patients who may benefit from EII prevention procedures or a more aggressive surveillance protocol.

PC054. Clinical Impact of Routine Cardiology Consultation before Elective Carotid Endarterectomy in Neurologically Asymptomatic Patients

before surgery. Other outcomes analyzed were 30-day major adverse event rate (composite of stroke, death, and myocardial infarct), death, stroke, disabling stroke, myocardial infarct, neck hematoma, cranial nerve palsy, reoperation, and readmissions in hospital at 30-days rate and timing to CEA. Results: There were 81 CEAs included in the study, 32 in group A (40%) and in group B 49 (60%). Recruitment patient rate per month doubled (1.1 vs 2.8 patients per month) after stroke unit establishment. Comorbidities were similar between the two groups. Minor stroke and transient ischemic attack distribution was significantly different: 31% (n 1⁄4 10) and 69% (n 1⁄4 22), vs 59% (n 1⁄4 29) and 41% (n 1⁄4 20) in groups A and B, respectively (P 1⁄4 .014). Timing to CEA was similar and all CEAs of group B were performed within 7 days from symptoms onset. The Table sum ups the 30-day results. Any death or disabling stroke occurred in both groups. Thirty-day improvement in neurologic status was higher in group B (30.6% v s12.5%; P 1⁄4 .06) and predictors for improvement in neurologic status were centralization in a stroke unit (odds ratio [OR], 10.99; 95% confidence interval [CI], 5.3-22.9; P 1⁄4 .004), minor stroke as symptom onset (OR, 0.22; 95% CI, 0.15-0.34; P < .001), and timing to CEA between 2 and 7 days (OR, 1.89; 95% CI, 1.5-2.3; P < .001). Timing to CEA 2 increased the risk of impairment in neurologic status on univariate (P 1⁄4 .037), but not on multivariate analysis. Conclusions: According to this preliminary experience, the introduction of a stroke unit for selected (NIHSS < 5) symptomatic carotid stenosis increases significantly the rate of patients referred to CEA per month. Centralization in a stroke unit, and timing to CEA between 2 and 7 days are safe and associated with 30-day improved neurologic status.

FT15. Endovascular vs Open Treatment of Severe Aortoiliac Occlusive Disease: Outcomes of Kissing Self-Expanding Covered Stent for Reconstruction of the Aortic Bifurcation

Results: Thirty-one CLI pairs were matched and analyzed (71.0% vs 64.5% in dialysis, 80.6% vs 83.9% in diabetes, and 54.8% vs 48.4% in ischemic heart disease, for UGNB vs GA, respectively). IPABG with UGNB included five below-knee popliteal bypasses, on the other hand, IPABGs with GA were totally distal bypasses (P 1⁄4 .02). Intraoperatively, operation time was longer in UGNB (401 6 107 vs 341 6 107 minutes; P 1⁄4 .04), whereas the amount of dopamine, infusion, and blood transfusion was less in UGNB (0.676 0.75 vs 1.53 6 1.99 mg/kg, P 1⁄4 .03; 1700 6 800 vs 2812 6 1195 mL, P < .01; and 237 6 342 vs 462 6 321 mL, P 1⁄4 .02, respectively) despite of equal blood loss (280 vs 296mL; P1⁄4 .81). Postoperatively, starting timing of drinking and diet after surgery were 0.61 days and 0.97 days in UGNB and 1.45 days and 2.48 days in GA, respectively (P < .01 for each). The amount of postoperative blood transfusion was less in UGNB (1242 6 1036 vs 2264 6 1298 mL, P < .01; and 147 6 172 vs 352 6 409, P 1⁄4 .01, respectively). Postoperative delirium occurred significantly less in UGNB (19.4% vs 48.4%; P 1⁄4 .02). No early mortality was seen in UGNB compared with one patient in GA (3.2%; P 1⁄4 .3). Early thrombosed graft was seen in two limbs (6.5%) in UGNB and in one limb in GA (3.2%), but was not significant. Conclusions: This is the first study of the usefulness of UGNB for IPABG. IPABG was technically accomplished for CLI patients with high-risk factors under UGNB. UGNB has advantages in intraoperative and postoperative managements in IPABG and could be a useful method to prevent operative complications for high-risk patients with CLI.

IP135. Early Outcomes of Routine Shunting With Delayed Insertion During Carotid Endarterectomy in Asymptomatic Patients

Objectives: The use of shunting techniques during carotid endarterectomy (CEA) is controversial. Objective of this study was to evaluate early outcomes of CEA with routine “delayed” (just after plaque removal) shunt insertion for asymptomatic patients. Methods: A retrospective review of all asymptomatic patients who underwent CEA during a 26-year single-center experience (January 1990 to December 2016) was performed. Under general anesthesia carotid endarterectomy was routinely performed with delayed shunt insertion; the further time-consuming maneuvers as accurate peeling and CEA closure with synthetic patch or internal carotid artery (ICA) reimplantation were performed under shunting; before suture completion, the shunt was removed and the suture secured. We analyzed demographic characteristics, relevant clinical and intraoperative variables, and 30-day outcomes between the three decades. Results: A total of 3843 elective CEAs were performed in asymptomatic patients with

Carotid Artery Stenting in a Patient With a Continuous-Flow Left Ventricular Assist Device.

70% stenosis between 1990 and 2016. Overall, 334 patients (8.7%) presented with contemporary contralateral stenosis

Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions

70%, and 73 patients (1.9%) had contralateral ICA chronic occlusion. The mean first clamping time was 5.9 6 2.4 minutes, while the mean shunt time was 25.2 6 9.6 minutes. Perioperative relevant neurologic complication rate (RNCR) was 0.76% (major stroke: n 1⁄4 8 [0.21%]; minor stroke: n 1⁄4 21 [0.55%]); transient ischemic attacks (TIAs) were 0.94% (n 1⁄4 36); early mortality was 0.1% (n 1⁄4 5). Major cardiac complications were 1.8% (IMA: n 1⁄4 37 [0.97%]; cardiac arrest: n 1⁄4 10 [0.26%]; arrhythmias, n 1⁄4 22 [0.57%]). The cumulative surgical complication rates were 4.5% (cervical hematoma, n 1⁄4 88 [2.3%]; ICA dissection, n 1⁄4 8 [0.2%]; cranial nerve injury, n 1⁄4 73 [1.9%]; subarachnoid hemorrhages, n 1⁄4 4, [0.1%]; ICA rupture, n 1⁄4 2 [0.05%]). RNCR distribution was maintained equal comparing different operators (P1⁄4 .983) and the time period divided into decades (1990-2000, 2001-2010 and 2011-2016; P 1⁄4 .376). Multivariate analysis demonstrated that none of the major clinical and anatomical factors analyzed had an impact on neurologic complication rate, such as ICA kinking (odds ratio [OR], 1.64; P1⁄4 .559), contralateral carotid significative stenosis (OR, 2.01; P 1⁄4.396), or occlusion (OR, 2.88; P 1⁄4 .250). Conclusions: Routine shunting with delayed insertion after plaque removal seems to be a safe and effective technique, that contributed to maintain RNCR <1% during carotid endarterectomy in asymptomatic patients independently from operators, time period, and other major clinical factors.

The PETTICOAT Technique for Complicated Acute Stanford Type B Aortic Dissection Using a Tapered Self-Expanding Nitinol Device as Distal Uncovered Stent

Purpose: To demonstrate the safety and feasibility of carotid artery stenting (CAS) in a patient with a continuous-flow left ventricular assist device (LVAD). Case Report: A 54-year-old woman with a LVAD was referred for a 90% stenosis of the right internal carotid artery (ICA). The patient was offered CAS, and oral anticoagulant was not discontinued in the periprocedural period. Because of absent arterial pulses, percutaneous transfemoral access was obtained under ultrasound guidance. Particular attention was paid to cannulation of the innominate artery; a 7-F guiding catheter was advanced from the descending aorta into the innominate artery under road-mapping, avoiding maneuvers in the ascending aorta where the outflow Dacron graft of the LVAD was anastomosed. To avoid cerebral flow modifications, the Angioguard RX was used as the cerebral protection device rather than other devices such as the flow reversal or flow-clamping systems. At this point, CAS was performed in a standard fashion using the 7×30-mm Precise ProRX stent. The computed tomography angiogram at 6 months showed patency of the stented right ICA. Conclusion: With adequate planning, CAS appears feasible in patients with a LVAD.