Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.

PURPOSE: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries. MATERIALS AND METHODS: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed. RESULTS: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up. CONCLUSIONS: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results. CLINICAL IMPACT: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system.

Recanalization of Chronic Femoropopliteal Total Occlusions after Failed Anterograde Attempt: Use of an Intravascular Ultrasound-Guided Re-entry Catheter versus the Bidirectional Approach.

PURPOSE: To analyze the feasibility and effectiveness of the use of an intravascular ultrasound (IVUS)-guided re-entry catheter (IGRC) for femoropopliteal chronic total occlusions (FP-CTOs) after a failed anterograde approach compared with the bidirectional approach without the IGRC. MATERIALS AND METHODS: Between June 2019 and December 2022, an IGRC (Pioneer Plus; Philips Volcano, San Diego, California) was used in 52 patients after failure of conventional recanalization techniques (Group A). In the same period, 48 patients who were also eligible for IGRC use were treated without IGRC using the bidirectional approach (Group B). In Groups A and B, 12 (23.1%) and 3 (6.2%) patients experienced claudication, and 40 (76.9%) and 45 (93.7%) patients experienced critical limb-threatening ischemia, respectively. Clinical and procedural records, angiographic imaging findings, and follow-up data were collected, analyzed, and reviewed. RESULTS: Technical success was achieved in 49 (94.2%) patients in Group A and 44 (91.7%) patients in Group B (P = .616). Use of the IGRC was associated with a reduction of procedural time (120 vs 133 minutes; P < .001), radiation exposure (47 vs 59 Gy cm2; P < .001), iodinated contrast medium use (98 vs 138 mL; P = .028), and intraprocedural discomfort (numerical rating scale score, 4 vs 6; P < .001). CONCLUSIONS: Use of the IGRC was equivalently successful for FP-CTO recanalization compared with the use of the bidirectional approach, but it reduced radiation exposure, iodinated contrast medium used, patient discomfort, and procedural time. These advantages suggest that IGRC could be favored as the next-choice option for FP-CTOs after failure of anterograde recanalization.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia.

OBJECTIVE: The aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). METHODS: Between January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. RESULTS: At 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). CONCLUSIONS: Both bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

Chimney endovascular aneurysm repair (ChEVAR) for hostile neck complex aneurysm.

OBJECTIVE: Recent guidelines recognize the role of chimney endovascular aneurysm repair (ChEVAR) in the treatment of complex aortic disorders. The optimal configuration and number of visceral vessels that can be incorporated is still controversial. We aim to review outcomes from a multi-institutional decade-long experience with ChEVAR. METHODS: Patients undergoing ChEVAR with multiple (≥2) chimney branches were selected from a prospectively maintained database at the two academic university hospitals. All patients were poorly suited for fenestrated or branched endograft repair (F/BEVAR) and deemed poor-risk for open surgery. RESULTS: Forty-nine multiple ChEVAR were performed in 44 men and 5 women, with complete outcome data at a mean follow-up of 18 months. Overall, 2 patients died during follow-up (4%) with no aneurysm-related mortality and two ruptures after ChEVAR (4.1%) due to a type Ib endoleak from iliac limb pullout and persistent gutter-flow, both repaired with endovascular means. No stroke or spinal cord ischemia was noted during the follow-up period. Reintervention was undertaken in eight patients (16.3%) with five reinterventions for persistent gutter-flow and four chimney graft-associated. Three-vessel ChEVAR was performed in 16 patients, with two-vessel ChEVAR in 33 patients for a total of 114 chimney branches (mean 2.3 chimneys per patient). There were 21 superior mesenteric artery (SMA), 45 right renal, 46 left renal artery (LRA), and two accessory LRA chimneys placed. Antegrade configuration of chimney branches was chosen in 43 patients (88%). There were no significant differences between three-vessel and two-vessel ChEVAR upon univariate analysis in aneurysm size (65.6 vs 60.5 mm; p = 0.059), iliac diameter (7.3 vs 7.1 mm; p = 0.85), or endograft oversizing (30 vs 32.5%; p = 0.43). Three-vessel ChEVAR was associated with a larger aneurysm neck diameter (28.4 vs 25.0 mm; p = 0.021), shorter native infrarenal neck (0.5 vs 3.37 mm; p = 0.002) as well as longer seal zone (36.33 vs 22.67 mm; p = 0.005) compared with two-vessel ChEVAR. At follow-up, there were no significant differences in gutter area between three-vessel and two-vessel ChEVAR (18.9 vs 15.7 mm3; p = 0.73) nor the rate of persistent gutter-flow (12.5 vs 9.1%; p = 0.71). CONCLUSION: Reintervention to multiple chimney grafts and for persistent gutter-flow is higher compared to single chimneys and demands close surveillance. However, based upon this combined transantlantic experience, we believe multiple ChEVAR provides a reasonable and safe option for complex aortic aneurysm repair when open or custom endografts are not available or indicated based on their Instructions For use, even when triple chimney grafts are required. The optimal configuration for multiple ChEVAR still warrants further study, although theoretical preliminary advantages may exist for a combination of antegrade and retrograde chimneys.

The risk of carotid plaque instability in patients with metabolic syndrome is higher in women with hypertriglyceridemia.

BACKGROUND: Metabolic syndrome certainly favors growth of carotid plaque; however, it is uncertain if it determines plaque destabilization. Furthermore, it is likely that only some components of metabolic syndrome are associated with increased risk of plaque destabilization. Therefore, we evaluated the effect of different elements of metabolic syndrome, individually and in association, on carotid plaques destabilization. METHODS: A total of 186 carotid endarterectomies from symptomatic and asymptomatic patients were histologically analysed and correlated with major cardiovascular risk factors. RESULTS: Metabolic syndrome, regardless of the cluster of its components, is not associated with a significant increase in risk of plaque destabilization, rather with the presence of stable plaques. The incidence of unstable plaques in patients with metabolic syndrome is quite low (43.9 %), when compared with that seen in the presence of some risk factors, but significantly increases in the subgroup of female patients with hypertriglyceridemia, showing an odds ratio of 3.01 (95% CI, 0.25-36.30). CONCLUSIONS: Our data may help to identify patients with real increased risk of acute cerebrovascular diseases thus supporting the hypothesis that the control of hypertriglyceridemia should be a key point on prevention of carotid atherosclerotic plaque destabilization, especially in post-menopausal female patients.

Successful conversion strategy in patient submitted to EVAR demanding open surgery: comparative analysis 1997-2011 vs 2012-2020.

Late open conversion in our center has been reviewed in the past 8 years, comparing 1997-2011 (first period group A) with 2012-2020 (second period group B). A retrospective analysis of patients treated at our centre by standard EVAR for infrarenal aortic aneurysm requiring late open conversion between January 1997 and February 2020 was performed. All stent grafts were implanted according to their current IFU all patients. The data concerning intra and postoperative complications were collected. Post-operative evaluated data include: ICU (Intensive Care Unit) stay, major peri-operative (<30 days) complications, in hospital mortality, length of hospital stay, 30-days mortality, and mid-term outcomes. Between January 2012 and February 2020 (group B), in our institution 8 patients previously treated by stent graft with endoleak underwent open surgery. The incidence of conversions and the 30-day mortality rate were compared with that of previous years, from January 1997 to December 2011 (group A). 481 patients submitted to EVAR in a second part of the analysis have been considered, 8 patients underwent late open conversion (1.7%) (Group B) due to endoleak. Among January 1997 and December 2011 overall 268 EVAR were performed; during this first study period, surgical conversion had been performed in 14 patients (5.2%) (Group A). The average time from EVAR to open conversion was four years (range 12-88 months) in Group B, and it was 30 months (range 1-82 months) in Group A. In most cases, in both group A and group B the proximal aortic cross-clamping were infrarenal. After the emergent procedure in Group B (12.5%), we have observed a death, whereas three patients died in Group A in urgent situations (21.4%). The more frequent indication for open surgery is the Endoleak type 1 and migration in the two considered periods. Adherence with current IFU and the technical progress in endoprosthesis design maintain lower rate incidence. In most cases, open surgery for prostheses that require explantation can be performed with infrarenal clamping. Partial removal of the endoprosthesis in selected cases makes open conversion easier and appears durable. The results are unfair by numerous comorbidities; in both periods, urgent graft removal seems to elevate both mortality and morbidity, compared to elective surgery.

Polyester Stent Graft Devices and Higher Risk of Post-Implantation Syndrome after EVAR: Single-Center Analysis of 367 Patients.

BACKGROUND: The post-implantation syndrome may occur shortly after endovascular aneurysm repair in patients treated for abdominal aortic aneurysm. Different types of biomaterials may provoke varying inflammatory responses in patients receiving different endografts. The purpose of this article is to evaluate the PIS after EVAR and the influence of different types of device fabric. METHODS: All patients submitted to elective AAA endovascular repair at our institution from January 2014 to December 2019 were enrolled. The PIS was defined by a body temperature of >38°C and WBC >12'000/µl without any evidence of an infection during (48h) the observation period. RESULTS: Three hundred and sixty-seven patients (89% males) were enrolled in this study and post-implantation syndrome occurred in 41 cases (11.2%). The incidence of PIS was significantly higher (P< 0.001) in patients treated with polyester stent grafts (39/201, 19,4%) compared to patients with PTFE stent grafts (2/166, 1,2%). CRP was related to the presence of PIS with a cut-off values of 109.31 mg/dL (P = 0.0052). The median in-hospital stay considering the polyester group was 6,2 days, while in the PTFE group it was 5,6 days (P = 0.04). CONCLUSIONS: The postoperative inflammatory response after EVAR seems significantly higher by using polyester stent graft compared to PTFE devices. CRP could be a useful biomarker in defining PIS. Multi-center studies are necessary to confirm these data.

The Paradox Effect of Calcification in Carotid Atherosclerosis: Microcalcification is Correlated with Plaque Instability.

BACKGROUND: this study aims to investigate the possible association among the histopathologic features of carotid plaque instability, the presence of micro- or macrocalcifications, the expression of in situ inflammatory biomarkers, and the occurrence of the major risk factors in this process in a large series of carotid plaques. METHODS: a total of 687 carotid plaques from symptomatic and asymptomatic patients were collected. Histological evaluation was performed to classify the calcium deposits in micro or macrocalcifications according to their morphological features (location and size). Immunohistochemistry was performed to study the expression of the main inflammatory biomarkers. RESULTS: results here reported demonstrated that calcifications are very frequent in carotid plaques, with a significant difference between the presence of micro- and macrocalcifications. Specifically, microcalcifications were significantly associated to high inflamed unstable plaques. Paradoxically, macrocalcifications seem to stabilize the plaque and are associated to a M2 macrophage polarization instead. DISCUSSION: the characterization of mechanisms involved in the formation of carotid calcifications can lay the foundation for developing new strategies for the management of patients affected by carotid atherosclerosis. Data of this study could provide key elements for an exhaustive evaluation of carotid plaque calcifications allowing to establish the risk of associated clinical events.

Outcomes of endovascular repair of abdominal aortic aneurysms in narrow aortic bifurcations using the ultra-low profile "INCRAFT" device: A retrospective multicenter study.

OBJECTIVE: Although the long-term results of endovascular aortic repair (EVAR) with low-profile devices in patients with hostile iliac anatomies have been published, there are no reported results specifically for narrow aortic bifurcations (NAB). This study investigated the outcomes of EVAR with the INCRAFT device in NAB (<16 mm). METHODS: This multicenter retrospective study involved five vascular surgery centers. From November 2014 until June 2018, 127 patients were treated with the INCRAFT device. The patient population was divided into two groups based on aortic bifurcation diameter. They were designated as the (1) standard aortic bifurcation (SAB) group (>16 mm) and the (2) the NAB group (<16 mm). Primary end points were the differences between the two groups in terms of technical success, survival at 30 days, iliac limb patency, and reinterventions. RESULTS: The SAB group included 96 patients and the NAB group included 31 patients. The mean aortic bifurcation diameter was 25.5 mm in the SAB group and 13.2 mm in the NAB group. It is noteworthy that, in the NAB group, 21.8% of patients had aortic bifurcations with focal calcific lesions (less than one-third of the circumferential length of the bifurcation) and 48.3% showed extensive calcifications (two-thirds of the circumferential length of the bifurcation), for 29.9% of the patients in the NAB group the aortic bifurcation had a circumferential highly calcific lesion (complete occlusion of the circumferential length of the bifurcation). Technical success was 98.9% in the SAB group and 96.7% in the NAB group (P = .1). The need for iliac component stenting was not significantly different between the groups (SAB 2.0% vs NAB 3.2%; P = .07). The 1-year survival was 97.9% and 96.7% in the SAB and NAB groups, respectively, with no aneurysm-related mortality. The mean follow-up was 18.4 months and 15.3 months in the SAB and NAB groups, respectively. The iliac primary patency was 98.9 % in the SAB group and 96.8% in the NAB group (P = .088), and the primary assisted patency was 100% in both groups. CONCLUSIONS: EVAR with INCRAFT in NABs showed acceptable results. In this multicenter study, the results were comparable in terms of technical success and iliac patency rate between patients with SABs and NABs.